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Media Releases

Sangui Bio Tech:
- Revenues of USD 67,000 in fiscal year 2017
- Granulox license income increased by 37%

Witten, Germany, July 18, 2017

According to preliminary unaudited figures, Sangui BioTech International Inc. achieved revenues in the amount of approximately USD 67,000 from license fees in the course of its financial year 2017 (as of June 30, 2017). Due to increased revenues of the wound spray Granulox the resulting licensing income could be increased by 37% compared to the previous year. Both revenues in the first and second half of the year were significantly higher than in the corresponding prior-year periods. After a decline in sales in the third quarter as a result of the good year-end business in the second quarter, sales of Granulox rose by 58% in the fourth quarter.

While the 2016 financial year was characterized by declining sales due to a lack of comprehensive reimbursement in Germany, this trend was more than compensated for by the increase in sales in other sales areas in the financial year just ended. As a result of the reimbursement achieved in 2016 in the Netherlands and Great Britain, Granulox sales in these countries were already 20% higher than in 2016 for the period from January to June 2017. The market in Mexico continues to be very pleasing. Here, the inclusion of Granulox in the list of hospitals available products (Cuaro basico) led to increasing demand. Increasing sales are also reported from Poland: a recent study published in Poland in patients with venous ulcers supported the efforts of the Polish sales partner.

The sales partnership concluded with Zuellig AG for South-East Asia in the autumn of 2016 is developing according to plan. Thus, Granulox was presented in Thailand as part of a national wound congress. The lectures and presentation of the therapy results obtained from Thai patients were very well received and led to the first shipments to Thailand.

"We are extremely satisfied with this development, as it is within the scope of our planning and shows that our sales concept for Granulox continues to take effect. By the end of the year 2017, we will start the launch of Granulox in Malaysia, the Philippines and Singapore together with our sales partners. We are expecting approval for Granulox for Russia in December 2017 at the latest. Our Russian cooperation partners are already working very hard on the market launch today, " explains Michael Sander, Managing Director of SastoMed GmbH, to which Sangui BioTech GmbH has licensed the worldwide distribution rights for the wound spray Granulox.

Sangui Bio Tech:
- Sales of USD 35,508 in the first half year
- Costs and loss is further reduced

Witten, Germany, February 24, 2017

In the first six months of fiscal year 2017 (to 31/12/2016) Sangui BioTech International Inc. achieved revenues from royalty income and product sales of USD 35,508. In the same period of the previous year the comparable revenue amounted to USD 26,856. Due to increased revenues of the wound spray Granulox, the resulting royalty income in the first half year increased by 32% compared to the same period of the previous year. After a cautious first quarter, especially a strong end-of-year business was responsible for this development. The cost – cutting – and liability – protection program adopted during the last year also had an effect in the reporting period: In the first half of the year, operating business expenses were reduced by a further USD 22,752 or 8% to USD 253,465. As a result of this, the operating loss of the first half year decreased compared to the prior year by USD 30,975 to USD 218,615. Accordingly, the cash position of the Company during the reporting period improved.

The sales of Granulox are subject to seasonal fluctuations. As in previous years, a strong year-end business was pleasing. As planned, sales of Granulox and royalty income in the following quarter will not reach the level of the previous quarter. For the full year 2017, however, the company is still expecting the increase in sales of Granulox and corresponding royalty revenues.

Sangui Bio Tech:
- Revenues of USD 36,000 in the first half-year
- Granulox license income increased by 33%

Witten, Germany, January 12, 2017

According to preliminary unaudited figures, Sangui BioTech International Inc. achieved revenues in the amount of approximately USD 36,000 from license fees in the first half year of fiscal 2017 (as of December 31, 2016). Due to increased revenues of the wound spray Granulox, the resulting licensing income in the first half year increased by 33% compared to the same period of the previous year. After a cautious first quarter, especially a strong end-of-year business was responsible for this development. Particularly pleasing was the fact that the increase in revenues was caused by expanding business with existing partners, e.g. Silanes in Mexico, and not by one-time effects with new contract partners.
"As in previous years, we were able to look back on a strong year-end business. The development in Mexico is more than pleasing. The fact that Granulox's foreign revenues have more than doubled over the past 12 months shows that the business is developing on an increasingly broader basis. This effect will be intensified by the planned activities of our partners in Southeast Asia, Russia and the UK, among others. Our business is also subject to seasonal fluctuations. As a result, revenues of the following quarter are not expected to reach that of the quarter under report. For the full year 2017, however, we are counting on the further growth in total revenues for Granulox, "explains Michael Sander, Managing Director of SastoMed GmbH, to which Sangui BioTech GmbH has licensed the worldwide distribution rights for the wound spray Granulox.

Sangui Bio Tech:
- SastoMed enters into sales agreement for Turkey
- Firm purchase commitments agreed
- Granulox receives product approval in Kuwait

Witten, Germany, December 21, 2016

Following the successful integration of the sales regions Southeast Asia and Russia in October this year, SastoMed GmbH, to which Sangui BioTech GmbH has licensed the worldwide distribution rights for the wound spray Granulox, has also entered into a sales partnership in Turkey. With SAF Pharma Health Services S.A. (SAF), a powerful partner for the introduction of Granulox in this important territory was won. As was already the case with Zuellig Pharma for Southeast Asia and the MDP Group for Russia, it was also possible to agree with SAF guaranteed minimum purchase commitments for Turkey. In the course of the next five years, SAF will, in line with the anticipated course of the approval and reimbursement procedure, obtain annually increasing minimum volumes with a total volume in the high five-digit range. "With Turkey a further, promising sales region with 78 million inhabitants could be awarded to an ambitious partner. The fact that minimum quantities could be agreed again underscores the confidence of our partners in the successful market launch of Granulox, "says Michael Sander, Managing Director of SastoMed GmbH.

In December, the product approval procedure for Granulox in Kuweit was successfully completed. The product approval is essential for a successful distribution of Granulox. Granulox was therefore approved for the first time in an Islamic state. "This approval demonstrates that the marketing of Granulox is also possible in countries which, due to religious practices, are actually concerned about products containing porcine ingredients. Outstanding performance from clinical and health economical perspective has convinced local authorities and helped overcome limitations. This is an important precedent that supports our efforts in other Muslim countries such as Indonesia, "says Michel Sander.

Sangui Bio Tech:
- Sales of USD 9,711 in the first three months
- Costs and loss halved

Witten, Germany, November 22, 2016

In the first three months of fiscal year 2017 (to 30/09/2016) Sangui BioTech International Inc. achieved revenues from royalty income and product sales of USD 9,711. In the same period of the previous year the comparable revenue amounted to USD 11.471.
The cost – cutting – and liability – protection program adopted during the last year shows first success. Thus, the cost of business operations for the quarter could be reduced by USD 93,490 or 54% to USD 79,322. As a result of this, the operating loss of the quarter decreased compared to the prior year quarter by USD 91,533 to USD 69,893. Accordingly, the cash position of the Company during the reporting period improved.
After declining royalty income due to lower turnover of the wound treatment product Granulox in previous quarters, the company expects for the further development of the fiscal year 2017 rising sales of Granulox and accordingly increasing royalty income.
This forecast is based on the successful integration of new sales partners (UK and Southeast Asia) as well as positive developments in already developed sales areas.

Sangui Bio Tech:
- SastoMed enters into sales agreements for Southeast Asia, Poland and Russia
- Firm purchase commitments agreed

Witten, Germany, November 01, 2016

SastoMed GmbH, to which Sangui BioTech GmbH has licensed the worldwide distribution rights for the wound spray Granulox, concluded a comprehensive licensing and sales agreement for eight Southeast Asian States with Zuellig Pharma, Singapure (www.zuelligpharma.com) one of the world's leading service providers of the pharmaceuticals. Zuellig Pharma is responsible for market launch and distribution of Granulox in the territories of HongKong, Singapore, Thailand, Malaysia, Taiwan, Vietnam, Indonesia and the Philippines. In addition to the complete processing and financing of admission in the individual territories, Zuellig Pharma has committed itself to the purchase of significant quantities of Granulox within the next five years. Furthermore, two high – performance distribution partners could be bound: Hexanova Sp.z.o.o. for Poland (www.hexanova.pl) and MDP Group for Russia (www.mdp-group.net). In both cases, minimum purchase commitments were also been agreed upon.
"With these agreements, we have succeeded in pushing forward into new dimensions. Inside the newly acquired sales areas, more than half a billion people live. We have now reached an important milestone on our path to global expansion. In addition to the quantitative dimension, the qualitative contract value of the agreements was also increased. In the past five years, Granulox has proven in field that it keeps what it promises on paper. When granting new territories, we now benefit from the appreciation Granulox has now gained. For instance, Zuellig Pharma for Southeast Asia and the MDP Group for Russia, two veritable global players with a corresponding sales force and financial strength, could be obtained for Granulox. Both partners have committed themselves to realize the necessary regulatory approvals and subsequent market launch of Granulox in the respective territories. Guaranteed purchase commitments were agreed with both partners. The annual minimum purchase quantities fixed within the next five-year period up to 2021 are based on the time-staggered progress of the product launches expected by Zuellig Pharma and MDP Group. Starting with the approval of Granulox, followed by the starts of the marketing campaigns and Granulox's positive sales development, specific verifiable milestones were established together with our partners for the individual territories. The cumulative purchase commitments for quantities over the next five years are well in the middle six-digit range. On the one hand, this minimum order gives us further planning certainty and ensures that we achieve our ambitious goals. On the other hand, this fact underscores the strong confidence our partners have in the future success of the cooperation with SastoMed ", explains Michael Sander, CEO of Sastomed GmbH.
"We congratulate SastoMed on these breakthroughs. After the inclusion of Granulox in the Drug Tariff of the British NHS at the beginning of October 2016, SastoMed herewith has reached further trend-setting successes. Sangui as licensors for Granulox will definitively benefit from these success. In this regard, the year 2016 can be described as very successful ", says Thomas Striepe, President and CEO of Sangui BioTech International Inc.

According to preliminary, unaudited figures, Sangui Biotech International, Inc. generated revenues from royalty income of approximately tUSD 10 during the first quarter of fiscal year 2017 (as of September 30, 2016). Revenues in the first quarter of fiscal 2016 (as of September 30, 2015) amounted to t USD 11.

Sangui Bio Tech:
- Sales of USD 48,000 in fiscal year 2016
- Cost reduction program: Cost reduction by 50%
- Annual loss significantly reduced
- Sales of USD 10,000 in the first quarter of fiscal year 2017

Witten, Germany, October 13, 2016

As can be seen from the audited consolidated financial statements, Sangui BioTech International Inc. was able to generate revenues from royalty income and product sales of tUSD 48 in its fiscal year 2016 (as of June 30, 2016). In the same period of the previous year, the comparable revenues amounted to tUSDt127. This decline was attributable to a decrease in license revenues due to lower turnover of the wound treatment product Granulox. On the other hand, the cost - cutting and liability protection program implemented in the fiscal year had a positive impact. The operating expenses for the reporting year were reduced by tUSD 470 or 53% to tUSD 409. This was mainly due to cost reductions of tUSD 162 in the area of research and development as well as savings at professional fees of tUSD 273. As a result, the operating loss of the year under review decreased by tUSD 391 to tUSD 361 compared to the previous year. Lower cash drains from operating activities of tUSD 208 and a decrease of cash flow from investing and financing activities of only tUSD 55 improved the company's liquidity situation accordingly during the reporting period.

According to preliminary, unaudited figures, Sangui Biotech International, Inc. generated revenues from royalty income of approximately tUSD 10 during the first quarter of fiscal year 2017 (as of September 30, 2016). Revenues in the first quarter of fiscal 2016 (as of September 30, 2015) amounted to t USD 11.

Sangui Bio Tech:
- British National Health Service NHS granted wound spray Granulox reimbursement
- British National Health Service NHS confirmed effectiveness and efficiency of Granulox
- Cost savings of several thousand British pounds per patient

Witten, Germany, September 30, 2016

The SastoMed GmbH has announced that the British National Health Service (NHS) has taken the wound spray Granulox licensed by Sangui to SastoMed GmbH on the list of reimbursable products under a discrete category (NHS Drug Tariff Part IX) effective October 01, 2016. The NHS provides to each resident of the UK medical care in the primary (general practitioner GP) and secondary level (hospitals) free of charge. Furthermore, in a declaration recently published the Scottish Health Technologies Group (SHTG - a division of NHSScottland) has clearly recommended the application of Granulox to all doctors working for NHSScottland because of Granulox’ efficacy and marked cost savings of several thousand British pounds proved by several studies.
Michael Sander, Managing Director of SastoMed GmbH commented: "InFirst Healthcare as our partner in the UK, has done an excellent job. Because of the convincing data submitted a worldwide respected and efficient health care system such as the NHS has not only appreciated the significant improvement in the quality of life for millions of patients suffering from chronic wounds, but also confirmed the significant cost reduction potential by using Granulox. We see this as a breakthrough success, which will integrated Granulox in modern wound treatment system not only in Great Britain. In parallel InFirst is working hard on the approval for the US market - even for that the extensive data from England constitute an important basis ".

Sangui Bio Tech:
- Sales of USD 37,005 in the first nine months;
- Cost cutting program is effective: cost reduction by 60%;
- Reimbursment Commitments of Granulox in the Netherlands and the Czech Republic.

Witten, Germany, June 6, 2016

In the first nine months of fiscal year 2016 (to 31/03/2016) Sangui BioTech International Inc. achieved revenues from royalty income and product sales of USD 37,005. In the same period of the previous year the comparable revenue amounted to USD 116,500.

The cost – cutting – and liability – protection program adopted during the last quarter shows first success. Thus, the cost of business operations for the quarter could be reduced by USD 124,376 or 60% to USD 81,626. For the first three quarters of the fiscal year the cost reduction totaled USD 334 414 or 48%. As a result of this, the operating loss of the quarter decreased compared to the prior year quarter by USD 88,735 to USD 106,795 respectively for the first nine months from USD 579,088 to USD 365,387. Accordingly, the cash position of the Company during the reporting period improved.

After declining royalty income due to lower turnover of the wound treatment product Granulox in previous quarters, the company expects for the further development of the fiscal year 2016 and the fiscal year 2017 rising sales of Granulox and accordingly increasing royalty income.

This prediction is supported by successful efforts of the licensee, the Sastomed GmbH to grant reimbursement commitments for the costs caused by using Granulox from the relevant health insurance companies.

During the current quarter, the reimbursement of 100 % respectively 75 % of the costs caused by using Granulox could be reached in the Netherlands respectively in the Czech Republic. Discussions with the not yet reimbursing health insurance companies in Germany will continue.

Accessorily SastoMed GmbH was able to acquire a strong and experienced partner during the quarter for Poland. Negotiations with potential partners about distribution rights for territories in the South-East Asian region are in an advanced stage. In addition, the continuously increasing sales efforts of SastoMed - partners in the already developed territories will lead to increasing sales figures of Granulox. Here the partners in Mexico and Peru are mentioned in particular.

Sangui Bio Tech International publishes preliminary figures for first half year
- Revenues of $ 27,000 in the first half year;
- Increase in Granulox royalty income by 28%
- Cost cutting program is effective
- Sale of minority stake

Witten, Germany, February 1, 2016

According to preliminary unaudited figures, Sangui BioTech International Inc. achieved revenues from royalty income and product sales in the amount of approximately $ 27,000 in the first half of its fiscal year 2016 (Dec. 31,.2015). The development of royalty income can be described as positive. Due to increased sales of the wound treatment product Granulox the resulting royalties increased in the second quarter by 28% as compared to the first quarter. This development reflects the successful efforts of the licensee, SastoMed GmbH, to obtain reimbursement commitments from relevant health insurance companies for costs caused by the prescription of Granulox, particularly in Europe.

The adopted cost-cutting - and liquidity-protection program has been implemented successfully in the second quarter of the fiscal year. After complete implementation costs in a significant amount will be saved per annum. Accordingly, the breakeven point will be reached considerably earlier.

Shareholders' equity of SastoMed GmbH was strengthened at the end of December 2015 by a capital increase by the majority shareholders. Due to the fact that Sangui BioTech GmbH has not exerted its subscription rights, the participation rate of Sangui BioTech GmbH of originally 25% was significantly reduced by the capital increase. Sangui BioTech GmbH sold its stake in SastoMed GmbH to the co-shareholder at the end of 2015. The persisting licensing agreement between Sangui BioTech GmbH and SastoMed GmbH is not affected by this sale.

This above-mentioned first capital increase contributes to further expand the sales and marketing activities of SastoMed GmbH for its wound treatment product Granulox at home - and abroad. This measure will have positive effects on the Sangui BioTech GmbH prospective accruing royalties.

Sluggish revenue development continues / Comprehensive cost containment program under preparation / Joachim Fleing stepped down

Witten, Germany, October 28, 2015

According to preliminary, unaudited figures Sangui Biotech International, Inc. yielded revenues from royalties and product sales of around USD12,000 in the course of the first three months of its 2016 financial year, ended September 30, 2015. In the first quarter of the 2015 financial year (ended September 30, 2014) revenues amounted to USD73,740 due to one large order.

According to information provided by global licensee SastoMed GmbH a significant increase in revenues is not to be expected until the years 2017/2018. The Board of Directors currently works on a comprehensive cost containment concept in order to adapt the ongoing expenses to the overall income. Research and development, also in view of the SBT102 and SBT1001 projects, will be under review and stalled if necessary until separate project financing will become available.

Dr. Joachim Fleing stepped down from his positions as a Director and Officer of the Company on October 27, 2015, with immediate effect. For an interim period he has offered to assist the Company with the ongoing accounting, compliance and stock related activities. The management regrets this decision. It extended its gratitude for a good and successful cooperation and its best wishes for his future.

 

Shareholder Information (Update):

Witten, Germany, October 6, 2015

An 8-K announcement was erroneously filed in the EDGAR system of the SEC by a company unknown to Sangui on September 18, 2015. As per our requested this announcement was removed in the meantime by the SEC.

On Monday, September 28, 2015, an information meeting of Sangui Biotech International, Inc. took place in Hamburg, Germany. In the course of the meeting Michael Sander, the Managing director of SastoMed GmbH, reported on the status of the market entry activities of the Granulox product in Germany and internationally. Among other facts he mentioned that additional, large scale wound healing studies have been applied for or are under preparation in the USA and Europe. Moreover, he explained the typical milestones of a market entry which can extend the time frame until significant revenues can be generated to up to 74 months in each individual country. While this intensive market preparation phase is currently being pushed forward in more than 20 countries, a significant increase in revenues is being expected for the years to come. As far as Sangui is concerned, the focus will remain on securing the necessary financing of its ongoing activities until reaching break-even on the basis of the revenues from license fees on Granulox sales. Additional cost reductions are to render a material contribution to attaining this goal.

 

Revenues of USD 127,000 in financial year 2015; net loss, cash burn reduced;
revenues from Granulox license fees in EUR up 34.4%

Witten, Germany, September 29, 2015

For its financial year 2015 (ended June 30, 2015) Sangui BioTech International, Inc. reports revenues from product sales and royalties in the amount of USD127,469, a decrease of 4.5% as compared to the revenues in the financial year 2014, which came in at USD133,470. Revenues in the fourth quarter were recorded at USD10,909 (Q4/2014: USD43,729). The decrease for the financial year and the quarter is due primarily to a sharp decline in product sales. Royalties from the licensing agreement regarding the wound treatment product Granulox engrossed by SanguiBioTech GmbH in the operating currency EUR, however, increased by 34.4% in the 2015 financial year. Granulox is the first dressing to significantly improve oxygen supply to wounds with poor blood supply and thereby decisively accelerates wound healing.

Research and development expenses decreased to USD204,987 (FY 2014: USD543,071). The previous year position included the purchase of a comprehensive set of clinical data. This decrease along with cost saving efforts contributed to a significantly reduced net loss attributable to shareholders in the amount of USD0.7 million (FY 2014: USD1.4 million). Cash outflows from operations were also reduced and amounted to USD0.6 million (FY 2014: USD0.8 million). They were not fully offset by cash inflows from financing and investing activities which amounted to USD0.5 million (FY 2014: USD0.7 million).

 

Positive Outlook after Weak Fourth Quarter / Cost Cutting Initiated

Witten, Germany, August 27, 2015

According to preliminary, unaudited figures Sangui Biotech International, Inc. yielded revenues from royalties and product sales of less than USD130,000 in the course of its financial year 2015, ended June 30, 2015. In the financial year 2014 revenues amounted to USD133,470. Revenues in the fourth quarter came in at around USD11,000 (Q4/2014: USD43,729).

Royalties from the licensing agreement regarding the wound treatment product Granulox engrossed by SanguiBioTech GmbH in the operating currency EUR, however, increased by 34.4% in the 2015 financial year.

SanguiBioTech GmbH has reacted to the sluggish top line development by starting a new round of cost cutting involving personnel expenses and office space as well as reducing patent expenses by giving up marginal patents, in particular those protecting the cosmetics business.

According to preliminary information provided by global licensee SastoMed GmbH Granulox sales are expected to increase again slightly in the current quarter (ending September 30) and more significantly in the December quarter.

 

Sangui BioTech International files S-1 Registration Statement with the SEC
Prerequisite for drawing upon financial framework agreement with US investor of $5 million

Witten, Germany, June 26, 2015

Sangui Biotech International, Inc. has filed a preliminary S-1 Registration Statement with the Securities and Exchange Commission. It is being expected that the SEC will declare the Prospectus effective within the next couple of weeks. The exact timeline depends on SEC approval procedures which cannot be anticipated by the company. The S-1 becoming effective is prerequisite for Sangui to start drawing upon the financial framework agreement with US investor Southridge as announced on May 12, 2015.

Under the terms of this agreement Sangui Biotech International, Inc. acquired the right to sell shares to a fund of Southridge LLC, an institutional investor, located in Connecticut and New York in the amount of up to $5 million over a period of three years.

This financial instrument is one element of Sangui's plan to carry out the preclinical phase of its SBT102 product which underwent successful preclinical testing. SBT102 developed by SanguiBioTech improves the oxygen supply of vital organs. It's intraperitoneal application is an innovative and effective therapy to avoid tissue hypoxemia in cases of septic shock. It can be expected that the restoration of intestinal oxygenation will have an impact on tissue integrity and eventually on patient survival.

 

Practitioners present wound healing case studies under Granulox treatment
European Wound Management Congress shows increasing interest in Granulox as a successful approach to support wound therapies

Witten, Germany, June 2, 2015

This year's annual congress of the European Wound Management Association (EWMA, May 13 - 15, 2015) in London staged medical researchers and practitioners from different European countries who reported about successful treatment of chronic wounds using the Sangui developed Granulox medical device, distributed by global licensee SastoMed GmbH. Presented were results of studies and series of therapies carried out in Birmingham and Brentwood (United Kingdom), Ljubljana (Slovenia), Zurich (Switzerland) as well as Frankfurt (Germany).

Well attended was a symposium chaired by professor Joachim Dissemond of Essen University, on invitation of SastoMed GmbH. Speakers included Assistant Professor Severin Läuchli, Head of the Department of Dermatology of the University Hospital in Zurich/Switzerland, who presented numerous case studies and came to the conclusion that the additional use of Granulox is able to induce granulation in a large share of previously non healing wounds and that this therapeutic option means a significant improvement for patients.

Dr. Paul Chadwick and Joy Tickle are members of an expert panel convened in the United Kingdom and assessing healing technologies designed to improve wound care standards. They presented the first national consensus recommendation on use of topical hemoglobin spray for the treatment of chronic wounds. The recommendation is based on a diligent assessment of all available scientific data as well an own set of individual trials to assess viability and effectiveness of a Granulox treatment. (cf. www.wounds-uk.com, EWMA 2015 Special Edition).

In one of the plenary sessions, moreover, Assistant Professor Joachim Klode presented initial results of a study regarding the use of photo-acoustic tomography, an innovative imaging process which was deployed to reliably image and quantify the concentration of oxygenated and des-oxygenated hemoglobin in wounds. This enables practitioners to verify and document the systematic connection between improved oxygenation as induced by the use of Granulox on the one hand and the observed improvements of healing and patient quality of life on the other. Another presentation held in this session was based on a 72 patient study. The statistical assessment and simulated extrapolation of healing processes indicated a significant improvement of wound healing under a treatment with Granulox.

The proceedings of the Congress demonstrate an increasing international regard to the innovative hemoglobin spray aimed to support the healing of chronic wounds. It also exemplifies what an intensive and persistent discussion within the expert community it takes to promote the market entry of a completely innovative treatment.

 

Lower revenues in the third quarter

Witten, Germany, Mai 15, 2015

For the nine months (as of March 31, 2015) of its 2015 financial year Sangui BioTech International, Inc. reports revenues from product sales and royalties in the amount of USD116,560, an increase of 29.9% over the revenues in the first nine months of the financial year 2014 when revenues amounted to USD89,741 (previous period numbers not adjusted for exchange rate changes). In the third quarter (January through March 2015) revenues amounted to USD11,654 a decrease of 62.6% as compared with the most recent quarter(October through December 2014). According to information provided by global licensee SastoMed GmbH revenues from license fees are expected to increase significantly over the remaining quarters of the calendar year after the slump of the March quarter.

Research and development expenses amounted to USD171,427 (9M/2014: USD139,978). The increase is due to the preclinical trials which demonstrated the functionality of Sangui's technology with respect to the septic shock indication. The net loss attributable to shareholders of the parent company came to USD537,282 (9M/2014: USD1,257,727). In the respective period of the previous year, this position included the loss incurred from the write down of a loan extended to an unrelated party. The cash outflow from operations during the nine months amounted to USD445,557 (9M/2014: USD452,192).

As of December 31, 2014, the equity ratio was minus 113.6% (June 30, 2014: 2.8%).

In the course of the third quarter, the series of preclinical trials at Giessen University inview of the indication septic shock was concluded successfully. Sangui is currently preparing the next steps in the preclinical development of its SBT102 product. An essential sub-project will be the establishment of the final manufacturing process for the test substance and eventually for an industry scale production.

 

Sangui BioTech International secures financial framework of $5 million over three years

Witten, Germany, May 12, 2015

Sangui Biotech International, Inc. has signed an agreement securing a financial framework of USD 5 million. Under the terms of this agreement Sangui Biotech International, Inc. acquires the right to sell shares to a fund of Southridge LLC, an institutional investor, located in Connecticut and New York in the amount of up to $5 million over a period of three years. The dilution of existing shareholders is limited to a maximum of 25 million shares of common stock. The agreement is subject to Sangui filing a S-1 registration statement with the SEC.

Southridge is a diversified financial holding company specializing in direct investment and advisory services to small and middle market companies. Since 1996 the structured finance team has made direct investment of over $1.7 billion into growth companies globally. Southridge is dedicated to helping clients achieve their intended goals. Its expertise lies in its ability to customize a financing plan for the prospective client and then execute on that plan without fail.

Thomas Striepe, President and CEO of Sangui Biotech International, Inc., stated: "This financing enables us to proceed with our next large project: to obtain a CE certification for SBT 102, a hemoglobin formulation designed to save lives in cases of septic shock. After the great progress made in the course of the current year we are now able to finalize our detailed planning for the preclinical phase and start implementing it."

 

Series of preclinical trials concluded successfully

Witten, Germany, March 18, 2015

The research cooperation team embracing SanguiBioTech GmbH, the Excellence Cluster Cardio Pulmonary System (ECCPS) and TransMIT Gesellschaft für Technologietransfer mbH has now successfully concluded a series of preclinical trials at Giessen University dedicated to the indication of septic shock. The interim results which were communicated in November 2014 were now confirmed on a statistically significant basis. The hemoglobin based product SBT102 developed by SanguiBioTech does improve the oxygen supply of vital organs. Professor Ralph T. Schermuly, head of the research team alongside with Professor Ardeschir Ghofrani comes to the conclusion: "The intraperitoneal application of SBT102 is an innovative and effective therapy to avoid tissue hypoxemia. It can be expected that the restoration of intestinal oxygenation will have an impact on tissue integrity and eventually on patient survival." A comprehensive scientific report is currently being elaborated.

Severe sepsis and septic shock are among the most common causes of death in intensive care. Studies in Germany showed that sepsis had a prevalence of 11% in German intensive care units and a 90-day mortality of 54%. Direct cost associated with treating these patients amount to around EUR1.77 bn., representing 30% of the intensive care budget. Indirect cost are being estimated to reach around EUR4.5 bn. It is to be assumed, therefore, that the total cost relating to severe sepsis and septic shock for the German health system amount to approx. EUR6.3 bn. per year.

ECCPS is an organization set up jointly by the universities of Frankfurt and Giessen together with the Max Planck Institute for Heart and Lung Research in Bad Nauheim. It ranks among the world's leading organizations of this type. This unique centre for translational medicine combines innovative medical research in the field of heart and lung diseases with their practical advancements based on preclinical and clinical studies. Its aim is to work together with industry on developing innovative drugs and substances.

TransMIT Gesellschaft für Technologietransfer mbH (www.transmit.de) being the unit in charge of technology transfer at Justus-Liebig University in Giessen is involved in carrying out this project.

 

Revenues slightly improved in the first half of the 2015 financial year
Research and development focuses on preclinical trials

Witten, Germany, February 12, 2015

For the first half (as of December 31, 2014) of its 2015 financial year Sangui BioTech International, Inc. reports revenues from product sales and royalties in the amount of USD104,906 an increase of 74.0% over the revenues in the first half of the financial year 2014. In the second quarter (October through December 2014) revenues amounted to USD31,166 a decrease of 57.7% as compared with the most recent quarter(July through September 2014).
Research and development expenses amounted to USD134,977 (H1/2014: USD 107,234). The increase is due to the ongoing preclinical trials aimed at demonstrating the functionality of Sangui's technology with respect to various indications. The net loss attributable to shareholders of the parent company came to USD355,928 (H1/2014: USD570,032), the cash outflow from operations during the six months amounted to USD318,740 (H1/2014: USD337,419).
As of December 31, 2014, the equity ratio was minus 33.3% (June 30, 2014: 2.8%).

In the course of the second quarter, preclinical trials at Giessen University demonstrated that a hemoglobin based product developed by SanguiBioTech is apt to improve the oxygen supply of vital organs. It is now being supposed that Sangui's hemoglobin-based artificial oxygen carriers may interrupt the self-perpetuating mechanism of septic shock, that has so far been highly resistant to treatment, and may thus ultimately reduce the high mortality rates.

SastoMed closes contracts with distribution partners in six additional markets in Eastern Europe

Witten, Germany, February 3, 2015

SastoMed GmbH has informed Sangui of having closed contracts for initiating distribution and sales of the Sangui developed dressing material Granulox in six Eastern European countries. In 2015 the three Baltic countries will join the family of Granulox territories along with the Czech Republic, Slovakia and Hungary.
Like in three Scandinavian markets it will be an enterprise belonging to the Mediq group which will start initiating the distribution in Estonia, Latvia and Lithuania. Mediq Eesti OÜ (www.mediq.ee) is a wholesale company which has been successfully trading medical and health care products throughout the Baltic countries for many years. Its core business is in medical products and laboratory equipment. A care a.s. (http://www.acare.cz/cs) was entrusted with the Granulox business in the Czech Republic and in Slovakia. The company specializes in medical products, in particular in the fields of wound management, interventional cardiology and radiology as well as neuroradiology. Halley Pharma Ltd. (http://halleypharma.com) will look after the Hungarian market in which they already distribute a wide array of other wound management products.
In total there are distribution partnerships in place now for 40 countries worldwide, in 24 of which Granulox is already available for doctors and patients. In the remaining 16 countries market entry is scheduled for the next few months after the training of the sales force will have been completed, or after the local registration procedures will have been accomplished, respectively, which is the case in some Central and South American countries.

Shareholder Letter

Witten, Germany, January 28, 2015

Dear Shareholders:

Today, at the beginning of 2015, Sangui is in a far better position than twelve months ago, though this is not reflected in the share price. SastoMed GmbH, our sales joint venture, reported on the stage achieved in the distribution reach of Granulox and the sales growth during its financial year 2014. We would like to summarize their report. In addition, the successful conclusion of the first series of preclinical trials has delivered impressive confirmation of our theoretical approach, and we are planning the necessary steps for obtaining certification/licensing of our hemoglobin hyperpolymers as medical or pharmaceutical products, respectively.
SastoMed GmbH raised its Granulox sales by 80 % compared with 2013 and anticipates sustained, strong growth in 2015. In the words of Michael Sander, SastoMed's Managing Director: "The reason for the growth is the growing acceptance of the product by the expert community: In transnational wound congresses, such as the European Wound Management Association held in Madrid, as well as in the context of many national events the effectiveness of Granulox was impressively illustrated using case studies, from Croatia and Serbia, across Italy and right through to the UK and Sweden. These events were flanked by similarly broad-based reporting in the media: a double-digit number of specialized publications and case studies (known as posters) also raised the awareness of patients and therapists in 2014.
The process of internationalization is advancing, and Granulox has already become available as part of the health care system in 24 countries. The product launch in Mexico was a special highlight: Our new Mexican partner devoted a whole day to training more than 200 employees in selling Granulox. Overall, for the first time, more sales were generated through exports than through domestic business in 2014. In Germany, 'Plusminus' and 'Visite' ran TV documentaries which boosted demand from patients. However, the general problem of a number of health insurance companies not reimbursing the costs of the product has not yet been definitively resolved."


Since sales territories in Europe have already largely been covered, SastoMed has informed us that it will now also be concentrating on expanding outside Europe. Acting on this, promising discussions were held in Korea at the start of January, with further appointments scheduled in the coming months for promoting expansion into India, China and Russia. Growth will therefore be driven from two sources in 2015: Depending on the degree of market penetration in countries already covered and on the sales uptrend in these countries, new sales territories will commence with selling. In this context, we make renewed reference to market preparation which takes an average of three years before notable revenues can be generated in the relevant territories.
Let us now turn to the preclinical trials with our hemoglobin hyperpolymers: the co-operation between our team and the Excellence Cluster Cardio-Pulmonary System at Giessen University (ECCPS) is progressing well towards agreed goals in a very constructive atmosphere. Professors Ralph Schermuly and Ardeshir Ghofrani, scientific directors at ECCPS, are especially committed as, for many years, they have both accorded huge importance to septic shock, which is our key initial indication, and anticipate great benefit from our approach.
In the first phase which lasted until November 2014 various approaches to hemoglobin formulations produced in our Witten laboratory were tested in a process of comparison. The formulation labeled SBT 102 achieved outstanding results as it succeeded in delivering a significant improvement in absolute and relative terms in the oxygenation of the internal organs examined of all the animals treated. This makes our SBT 102 the first product in the wake of a long series of earlier studies by ECCPS to actually yield a positive effect. Summarized in the words of the researchers: "The restoration of intestinal oxygenation will have an impact on tissue integrity and ultimately on patient survival."
Based on this ground-breaking intermediate result, we are currently planning and initiating the next tasks together with our partners: Among other activities, this stage involves:

  • defining and creating a GMP compatible production process,
  • application to other indications which have been jointly envisaged, and
  • the detailed planning of the regulatory parameters for certification and/or licensing.

The year 2015 will be important for determining the future direction. In any event, this milestone raises the issue of financing the further development. Naturally, it is clear to all of us, you and ourselves as shareholders, that the next steps will entail financing instruments which take the form of an unavoidable placement of further shares from Authorized Capital.
You may remember that the capital was authorized by the shareholders in 2008 for this specific purpose, and, ultimately, the market perception will determine the value of the company while the actual number of shares outstanding will then be irrelevant. Having a higher share price would therefore be helpful and is more than desirable. We are convinced that the current share price in no way appropriately reflects the progress made by the company and its prospects: Based on the success to be achieved in the current financing rounds, we are determined to step up our capital markets communication and to improve the position of our share: reverse split, preparing a prospectus and new stock markets are some of the options.


The outlook for the company is better than ever: We have a product in the market which is already gaining momentum in the market entry phase, and we have launched a project with leading scientists that may prove to be life saving for many thousands of people in intensive care. It is our firm belief that this is worth fighting for.

Yours sincerely
Thomas Striepe, Hubertus Schmelz, Joachim Fleing

 

SanguiBioTech yields revenues of over USD31,000 in Q2 2015 according to preliminary figures

Witten, Germany, January 28, 2015
According to preliminary, unaudited figures Sangui Biotech International, Inc. yielded revenues from royalties and product sales of more than USD31,000 in the course of the second quarter of its financial year 2015, ended December 31, 2014. In the first quarter of the 2015 financial year (ended September 30, 2014) revenues had amounted to USD73,740; in the second quarter of its financial year 2014 (ended December 31, 2013) the company reported revenues of USD33,776. According to those preliminary figures, revenues in the first six months of the 2015 financial year amounted to approximately USD105,000 after USD60,303 in the respective period of the previous year.

Sangui Biotech International, Inc.,
Revenue Development for the 2013 through 2015
Financial Years (per quarter)


Fin. Quarter

USD

2013 Q1

20,549

2013 Q2

27,494

2013 Q3

33,388

2013 Q4

24,056

2014 Q1

26,527

2014 Q2

33,776

2014 Q3

29,438

2014 Q4

43,729

2015 Q1

73,740

2015 Q2 (p)

>31,000

 

Revenues improved in the first quarter of the 2015 financial year
Research and development for preparing and carrying out preclinical trials

Witten, Germany, November 13, 2014
For the first quarter (as of September 30, 2014) of its 2015 financial year Sangui BioTech International, Inc. reports revenues from product sales and royalties in the amount of USD73,470 (Q1/2013: USD26,527). This is an improvement of 73% as compared with the fourth quarter of the previous financial year (as of June 30, 2014).
Research and development expenses amounted to USD93,103 (Q1/2014: USD36,308). The increase is due to preparing and carrying out preclinical trials aimed at demonstrating the functionality of Sangui's technology with respect to various indications. The net loss attributable to shareholders of the parent company came to USD194,168 (Q1/2013: USD172.202), the cash outflow from operations during the quarter amounted to USD207,675 (Q1/2013: USD189,860).
Primarily due to the net loss for the quarter, our stockholders’ equity decreased by USD75,501 from USD7,276 at June 30, 2014 to a stockholders’ deficit of USD68,225 at September 30, 2014.

The complete quarterly report on Form 10-QSB is available at www.sec.gov and www.sanguibiotech.com.

 

Preclinical trials demonstrate: Sangui hemoglobin preparation improves oxygen supply of vital organs

Witten, Germany, November 11, 2014
A possible success in treating septic shock has now been attained by the research team embracing SanguiBioTech GmbH, the Excellence Cluster Cardio Pulmonary System (ECCPS) and TransMIT Gesellschaft für Technologietransfer mbH. Preclinical trials at Giessen University underpin that a hemoglobin based product developed by SanguiBioTech is apt to improve the oxygen supply of vital organs. It is now being supposed that Sangui's hemoglobin-based artificial oxygen carriers may interrupt the self-perpetuating mechanism of septic shock, that has so far been highly resistant to treatment, and may thus ultimately reduce the high mortality rates.
A septic shock is the life threatening final phase of a sepsis. The blood circulation, else exactly tuned to meet the needs of the body, begins to severely malfunction which results in deficient oxygen supply of the body tissue. This hypoxia induces a progressional intoxication of the body with bacteria and bacteria debris. Modern medical science has not yet identified suitable therapies to effectively fight this self-perpetuating mechanism of septicemia, which, therefore, results in mortality rates of 50 to 60 percent.

Preclinical trials in Giessen now demonstrate that an oxygen-carrying hemoglobin liquid in the abdomen did significantly improve the oxygen supply to the intestines. This is likely to be a decisive new therapeutic approach to disrupting this lethal loop. The preclinical trials are being continued as planned, extending the scope to additional indications such as ARDS (acute respiratory distress syndrome) and further hemoglobin preparations as developed by SanguiBioTech.

Sangui BioTech International officially approved as trading on OTCQB

Witten, Germany, November 6, 2014
OTC Markets Group has officially informed Sangui Biotech International, Inc., that the application of the company for continued trading on the OTCQB venture market place for early stage and developing companies was approved of today. Subsequent to the reorganization of the OTC markets, resulting in higher transparency levels and significantly improved services for issuers and investors in particular on OTCQB, Sangui has submitted all the mandatory documents and successfully met all of the initial requirements.

Sangui BioTech henceforth trades on the OTCQB venture stage marketplace for early stage and developing U.S. and international companies (OTCQB:SGBI). Companies are current in their reporting and undergo an annual verification and management certification process. Investors can find real-time quotes and market information for the company on www.otcmarkets.com.

 

Laboratorios Silanes start marketing Granulox in Mexico
Applications for licensing in all Central American countries under way

Witten, Germany, November 3, 2014
Laboratorios Silanes (www.silanes.com.mx) commenced with the marketing of the dressing material Granulox in Mexico on November 1, 2014, based on an exclusive agreement with SastoMed GmbH. At the same time, Silanes has taken over the distribution for the remaining countries of Central America and is currently applying for the necessary certifications in the respective individual markets. To be ready for the start of distribution, Silanes ordered, received and paid for merchandise in the previous quarter, which was reflected in a considerable five-digit license income by Sangui as of 30 September 2014.

Laboratorios Silanes was founded in 1943 and, with a workforce of around 700 employees, today ranks among the leading mid-sized pharmaceutical companies of Central America and in terms of revenues occupies third place in the league of the highest-volume suppliers of products suitable for diabetics.

Prior to the start of the distribution, 250 sales representatives took part in a training event which also included an in-depth presentation by Michael Sander, Chief Executive Officer of SastoMed GmbH, the global licensee for the sale of Granulox. The sales force was introduced to the mode of action and the application in a series of detailed scientific and practical presentations, and given the marketing goals and materials.

"The start to marketing by Silanes concludes intensive preliminary work which took two years and the restructuring of our Mexico business", explained Michael Sander. "Thanks to the support of BioMac CEO John McArdle, we now have gained a highly professional partner in Silanes which has the market position to leverage the public profile of Granulox locally and to translate it into tangible success."

Antonio Lopez de Silanes, jr., the owner of Laboratorios Silanes, explained at a national sales congress organized by his company that Granulox had the potential for developing into a core component of the product portfolio. He anticipates that the investments in pre-marketing and marketing will soon pay off.

sangui
Michael Sander, General manager of SastoMed GmbH, the global licensee for the sale of Granulox, lectures about experiences with applying Granulox to different kinds of wounds in the course of the annual sales meeting of Laboratorios Silanes.

 

sangui
John McArdle, CEO of BioMac Pharma, and at the same time SastoMed GmbH contact person for the Granulox marketing in Mexico addresses the attendees to the Granulox day at the national sales meeting of Laboratorios Silanes.

 

sangui
250 sales representatives of Laboratorios Silanes were introduced to the mode of action and the application in a series of detailed scientific and practical presentations, and given the marketing goals and materials.

(Source: SastoMed GmbH; for photos in print quality please contact. fleing@sangui.de)

 

SanguiBioTech yields revenues of over USD70,000 in Q1 2015 according to preliminary figures

Witten, Germany, October 07, 2014
According to preliminary, unaudited figures Sangui Biotech International, Inc. yielded revenues from royalties and product sales of more than USD70,000 in the course of the first quarter of its financial year 2015, ended September 30, 2014. In the fourth quarter of the 2014 financial year (ended June 30, 2014) revenues had amounted to USD43,729; in the first quarter of its financial year 2014 (ended September 30, 2014) the company reported revenues of USD26,527.

Sangui Biotech International, Inc.,
Revenue Development for the 2013 thru 2015
Financial Years (per quarter)


Fin. Quarter

USD

2013 Q1

20.549

2013 Q2

27.494

2013 Q3

33.388

2013 Q4

24.056

2014 Q1

26.527

2014 Q2

33.776

2014 Q3

29.438

2014 Q4

43.729

2015 Q1 (p)

>70.000

 

Revenues attain USD 133,000 in financial year 2014

Witten, Germany, September 25, 2014
For its financial year 2014 (ended June 30, 2014) Sangui BioTech International, Inc. reports revenues from product sales and royalties in the amount of USD133,470 USD after USD105,487 in the previous financial year. This increase is primarily attributable to royalties on sales of the Granulox wound dressing, marketing and sales of which are out-licensed to SastoMed GmbH, a joint venture company in which Sangui holds a stake of 25%. Revenues in the fourth quarter of the 2014 financial year came in at USD43,729 USD (Q4/2013: USD24,056). Granulox is the first dressing to significantly improve oxygen supply to wounds with poor blood supply and thereby decisively accelerates wound healing.

Research and development expenses increased to USD543,071 (FY 2013: USD65,010). The position includes the purchase of a comprehensive set of clinical data. This also led to the increase of total operating expenses to USD1.4 million (FY 2013: USD1.3 million). The net result attributable to shareholders amounts to minus USD1.4 million up from minus USD2.1 million in the previous financial year when an impairment of receivables in the amount of USD1.0 million had occurred which had been brought in as capital into SastoMed GmbH. Cash outflow from operations in the amount of USD0.8 million (FY 2013: USD0.8 million) and from investing activities in the amount of USD0.2million (FY 2013: USD0,9 million) were offset by an cash inflow from financing of USD0.9 million (FY 2013: USD1.4 million).

 

Start of preclinical trials
Target: certification of an oxygen carrier as a Class III medical product

UPDATE: August 8, 2014
In order to avoid any misunderstandings we would like to point out that the ethics commission as part of the Regional Council of Giessen did approve of the application for the trials.

Witten, Germany, August 6, 2014
Together with Excellence Cluster Cardio-Pulmonary System (ECCPS) and TransMIT Gesellschaft für Technologietransfer mbH (TransMIT), Sangui is investigating new therapeutic approaches to treating septic shock and acute respiratory distress syndrome (ARDS).

Owing to their incidence rate, complexity and poor prognosis, the two diseases constitute a huge challenge in both in terms of their socio-economic impact and the associated intensive medical care, and incur unacceptably high mortality rates, despite progress made in intensive medicine. In Germany alone, 150,000 people a year are afflicted by sepsis, and the mortality rate is 30–50% even with maximum therapy. Targeted antibiotic therapy, artificial respiration, preserving the functions of organs, and supporting circulation through liquid infusions and hypertension-inducing drugs form part of an optimised therapy. The infusions of vasoconstrictive substances, such as adrenaline or noradrenaline, are intended to normalise dangerously low blood pressure. Raising the global blood pressure (macrocirculation) is, however, detrimental to the closing of small vessels (microcirculation) whose main task is peripheral oxygen delivery. This lack of oxygen poses a huge problem for many organs, such as the kidneys or intestines.

The approach adopted here by Sangui, ECCPS and TransMIT presupposes that self-perpetuating septic shock, that has so far been highly resistant to treatment, can be interrupted by Sangui's artificial haemoglobin-based oxygen carrier, which would ultimately lower mortality rates. The preclinical trials at ECCPS which are now approved aim to investigate the effect of various haemoglobin preparations on the oxygen supply of a number of organs in septic shock and ARDS models. The research alliance has devised a plan which uses a preparation similar to Granulox provided by Sangui and will work towards certification as a Class III medical device if the approach proves its worth and is successful.

 

Granulox technology patent now legally binding

Witten, Germany, July 31, 2014

The period for objection against European Patent EP 2550973, „Wound Spray“) elapsed without any objection being raised. The patent, therefore, has now become effective and legally binding. Sangui was notified in this respect by SastoMed GmbH.

The patent expands the existing protection of the wound therapeutic Granulox and additionally safeguards its technology in terms of production as well as in terms of application. In particular, the patent protection now applies to all member countries of the European Union and was extended for another 18 years until the year 2031. SastoMed expects to get the first patents granted resulting from the numerous patent applications filed outside Europe in the course of the coming months.

SastoMed GmbH is a joint venture of SanguiBioTech GmbH (25%) and SanderStrothmann GmbH (75%). It has been granted the global distribution rights as licensee. SanguiBioTech GmbH receives royalties on all product sales and is entitled to a share in all net profits corresponding to its share in the company.

 

SanguiBioTech yields revenues of around USD42,000 in Q4 2014 according to preliminary figures

Witten, Germany, July 29, 2014

According to preliminary, unaudited figures Sangui Biotech International, Inc. yielded revenues from royalties and product sales of USD42,000 in the course of the fourth quarter of its financial year 2014, ended June 30, 2014. In the third quarter (ended March 31, 2014) revenues had amounted to USD29,438; in the fourth quarter of its financial year 2013 (ended June 30, 2013) the company reported revenues of USD24,056. Based on this preliminary state of accounting Sangui will presumably present revenues of more than USD130,000 for its 2014 financial year (FY 2013: USD105,487).

 

Oxygen Supply for Chronic Wounds Meets Enhanced Public Awareness
Number of Reports about Successful Treatments with Sangui Developed Hemoglobin Based Wound Spray Keeps Increasing

Witten, Germany, May 26, 2014

Since 2002 Sangui has been pursuing the approach to fight lack of oxygen (hypoxia) as the ultimate cause of the delay in healing of chronic wounds by applying hemoglobin as oxygen carrier. Subsequent to the development of a hemoglobin based wound spray which has undergone numerous successful practical trials there is now an easy to use cost saving therapeutic at hand. Global distribution rights are out licensed to SastoMed GmbH who market the spray under the Granulox brand name (www.granulox.de). Market entry efforts include sensitizing health system, especially wound care practitioners as well as the general public for chronic wound issues, their causes and the additional healing opportunities offered by this new technology.

For the first time now, the topic of care for chronic wounds meets a higher awareness among the German public. Recent media reports in German radio (www.deutschlandfunk.de/schwerpunktthema-chronische-wunden.709.de.html?dram:article_id=285794) and television (www.daserste.de/information/wirtschaft-boerse/plusminus/sendung/ndr/2014/amputationen-100.html and www.ndr.de/fernsehen/sendungen/visite/visite9782.html) show that many patients have not been receiving the sort of systematic treatment which does aim at ultimately relieving them of their painful wounds. On the contrary, the increasing number of amputations indicates that ill-focused incentives in the health system lead to inappropriate therapies encumbering the patients rather than providing remedy.

On the other hand doctors and institutions who were able to gather experience in applying the wound therapeutic continue to administer it to their patients because of the improved healing successes. At the German Wound Congress held in Bremen, May 7-8, 2014, a wound expert from Nordwest Hospital, Frankfurt, Germany, emphasized that they had already successfully treated more than 400 patients with the hemoglobin based therapeutic.

Experiences like this contribute to the increasing awareness of the topics of hypoxia and oxygen supply among practitioners and scientists. For the first time, they were dedicated a key session at the annual congress of the European Wound Management Association (EWMA, held in Madrid, Mai 14-16, 2014), a topic which was also highlighted by the Organizing Committee in its introductory remarks.

The hemoglobin wound spray technology was among the topics dealt with during the key session. In the course of the congress as many as eight scientists from different regions presented case studies of successful wound treatments with the hemoglobin based spray.

The international reach of the wound spray distribution has also increased. Over the past few weeks SastoMed has been able to sign distribution contracts with sales partners in Austria, Denmark, Norway, Sweden, Romania and Peru. In total, closed for 26 countries on three continents have now been included in the distribution network, actual sales were initiated in 15 countries so far.

Market entry in each country requires registration by the local authorities, obtaining the Notified Body's approval of the country specific variation as well as the creation of local packaging and documentation. Except for the comprehensive trainings of the respective local sales force held by SastoMed staff members all expenses incurred in the market entry, marketing and sales processes are borne by the local partners. As soon as the required permissions have been granted the product is being presented to relevant opinion leaders in ambulant and stationary wound care practice as well as to the benefactors such as health insurances. This preparatory market entry phase lasts for around one year. It is only then that actual sales can be initiated. This entails that it may take up to three years from signing the distribution contract until a significant revenue stream can be expected in the respective country. The fact that as of now only one year after the signing of the first international contracts SastoMed has not only been receiving the usual initial orders but also the first repeat orders may serve as another indicator of the increasing market acceptance of the wound therapeutic and the expectations it raises.

SastoMed is confronted with considerable distributor interest in the few European territories currently not yet covered by distribution agreements. Sangui regards the progress achieved so far as a sound basis for extending the reach of its wound spray technology even further and for its future success also on the financial side.

 

Sangui BioTech announces results of the first nine months of its 2014 financial year

Witten, Germany, May 15, 2014

For the nine months (as of March 31, 2014) of its 2014 financial year Sangui BioTech International, Inc. reports revenues from product sales and royalties in the amount of USD89,741 (9M/2013: USD81,431). In the third quarter (January through March 2014) revenues amounted to USD29,438 (Q3/2013: USD33.388).

Because of the ongoing preparatory work aimed at the in-vitro and animal experiments for internal applications of Sangui's hemoglobin formulations research and development expenses in the nine months of FY2014 amounted to USD139,978 (9M/2013: USD29,736). General and Administrative expenses in the amount of USD1,075,392 (9M/2013: USD885,936) include a non cash effective impairment of a loan as of March 31, 2014. By contrast, the cash outflow from operations was reduced to USD452,192 (9M/2013: USD505,698).

The net loss attributable to shareholders of the parent company came to USD1,257,727 (9M/2013: USD781,253).

The wound therapeutic Granulox the technology of which was developed by Sangui and the global distribution rights of which are licensed to SastoMed GmbH is among the topics of this year's Annual Conference of the European Wound Management Association (May 14 - 16, 2014). Subsequently and in accordance with SastoMed GmbH Sangui will comment on the current development, probably around the end of this month.

 

Sangui, ECCPS and TransMIT start biological in vitro experiments aimed at the characterization of hemoglobin polymers

Witten, Germany, April 25, 2014

Staff members of the Excellence Cluster Cardio-Pulmonary System (ECCPS) have started to carry out in vitro experiments aimed at the biological characterization of Sangui's artificial oxygen carrier (hemoglobin hyperpolymers) in laboratories of Giessen University. Target of the tests are the effects of hemoglobin polymers on the blood pressure in freshly isolated ex vivo perfused and ventilated lungs of mice. Native hemoglobin (positive control) and an aqueous colloid/electrolyte solution without hemoglobin (negative control) will serve as comparison perfusion media. All test batches containing hemoglobin are being produced in the Sangui laboratories in Witten, Germany. SanguiBioTech GmbH scientists are accompanying the test series.
Native hemoglobin in the blood plasm generates hypertension, as it effects a constriction of the arteries and arterioles of the blood vessel system. This happens because it permeates the endothelium of the vessels, thereunder it binds (and thus removes) a messenger substance that serves to relax the blood vessels. Sangui assumes that the hemoglobin hyperpolymers developed by the company are too big to permeate the vascular endothelium. Therefore, they will not induce hypertension or only to a negligible degree. This property is an important precondition for the successful application of a blood additive.
In the meantime TransMIT Gesellschaft für Technologietransfer mbH, which is involved in carrying out the project as co-contractor, has informed SanguiBioTech GmbH that due to changes in the formalities required for the appointment of animal protection officers recently imposed by the district president which had to be adopted beforehand by TransMIT, regrettable delays had occurred in the approval process of the animal tests applied for by Sangui. The district president boards in charge of approvals are expected to consult about the application in the course of the month of May 2014.

 

Revenues slightly improved in the first half of the 2014 financial year
Research and development for new patent application, preparation of animal test continued

Witten, Germany, February 14, 2014

For the first half (as of December 31, 2013) of its 2014 financial year Sangui BioTech International, Inc. reports revenues from product sales and royalties in the amount of USD60,303 an increase of 25.5% over the revenues in the first half of the financial year 2013. In the second quarter (October through December 2013) revenues amounted to USD33,776 an improvement of 27.3% as compared with the most recent quarter(July through September 2013).
Research and development expenses amounted to USD107,234 (H1/2013: USD 23,950). The increase is due to the preparations made for filing a new patent application as well as of animal testing aimed at demonstrating the functionality of Sangui's technology with respect to various indications. The net loss attributable to shareholders of the parent company came to USD570,032 (H1/2013: USD665,579), the cash outflow from operations during the six months amounted to USD337,416 (H1/2013: USD266,507).
As of December 31, 2013, the equity ratio was 59.2% (June 30, 2013: 56.7%).
In the course of the second quarter the shareholders of SastoMed GmbH resolved to swap the shareholder loans outstanding for equity preserving their respective share in the stock of the company. The resulting obligation to invest another EUR200,000 was fulfilled during the quarter. SanguiBioTech GmbH holds 25% in SastoMed GmbH, Sangui has granted SastoMed the global distribution rights for the wound therapeutic Granulox.

 

Shareholder Letter

Witten, Germany, January 14, 2014

Dear Shareholders,

Our purpose with this letter is to summarise last year's highlights and to inform you about some of our most important goals in 2014.

SastoMed GmbH's management was unswervingly committed to persuading the dominant operators in the German healthcare market, namely the GKV, Germany's statutory health insurance funds, to comply with the regulations. Regrettably, not all health insurance organisations fulfil their duties in this respect, which has encumbered the economic performance of Granulox in Germany. The due and proper reimbursement of healthcare benefits by the GKV in accordance with Germany's Code of Social Law (SGB V) is the most important pillar which supports the way business is conducted in the healthcare sector. SastoMed GmbH submitted three legal opinions in total which clearly substantiate the GKV's reimbursement obligation under the Code of Social Law. This consists, on the one hand, of the expert assessment of Granulox by the mandated parties and, on the other, the legal classification derived therefrom. The GKV in its entirety has been called upon to fulfil its statutory obligations. Together with SastoMed GmbH, we anticipate that this will happen. At the same time, the option of taking legal steps as the ultima ratio is also being investigated and will be pursued if necessary.

Apart from this, the sale of Granulox, particularly in terms of international circulation, has made progress. The pace of expansion into other countries was faster than anticipated: Along with Germany, Granulox will be available in 18 other countries in 2014, promoted by contracts signed with ten distributors.

  • Strategic licence agreements were signed with Infirst Healthcare to cover England and Ireland, with the optional contracts for USA, Canada, Australia and New Zealand. Infirst has meanwhile commenced preparations for licensing in the USA. Similar to all the other distribution partners, Infirst bears all the costs incurred by market entry, which includes the licensing itself.
  • A distribution agreement was signed in South America with a company in Colombia. Other cooperations are at the preparation stage.

In the meantime, we can report licensing agreements for 25 countries in total.

Another gratifying development: As an organisation of the European commission, the GMDN database has listed Granulox as a dressing and allocated it a uniform, pan-European code.

In addition, the product portfolio of the SastoMed GmbH joint venture has been supplemented by two other products, "Dermacyn" for debridement and and the "Aldanex" decubitus prophylaxis and therapy which, alongside presenting a more rounded offering for wound care, also contribute through earnings to the overall performance.

Lastly, the broad-based recognition of Granulox in the scientific community and in practice also deserves a mention:

  • publication of a prospective placebo-controlled, randomised and double-blind study in the peer-reviewed journal "Der Hautarzt" 3/2013,
  • international publication of the same study in the EWMA Journal 10/2013,
  • scientific analysis of the pharmacoeconomic benefit of using Granulox in "Healthcare Management" 11/2013.

Michael Sander, SastoMed GmbH's Managing Director, outlines the goals for the coming year:

  • Securing the eligibility of Granulox for reimbursement in Germany on a broad basis.
  • Successful market launch in European and non-European territories which have been won for distribution.
  • Pursuit of the expansion strategy through winning additional distributors and licensed partners: Negotiations for more territories have already reached an advanced stage.
  • Development of a Granulox Line Extension (launch envisaged for Q1/2015), with storage and stability tests already initiated. This concerns a new form of administering Granulox, making it even more flexible and economic for application.

Developments with patents also deserve a mention: The European Patents Office granted SastoMed GmbH a European patent (EP 2550973, "Wound Spray") which significantly extends the current protection of Granulox as a wound management product in terms of time and place. Furthermore, SanguiBioTech GmbH has applied for patents which will considerably enlarge the area of indications for our artificial oxygen carriers.

The associated resumption of one of the major central projects of our company is progressing well. With the application to the Ethics Commission submitted last December, the topic of blood additive and proof-of-concept studies is proceeding as planned. We anticipate a positive response to our application over the course of the first quarter of the calendar year 2014. Animal experiments in the ECCPS laboratories in Giessen will commence directly afterwards. The study designs have been coordinated with the partners and completed. We will be investigating shocks arising from sudden ischemic conditions as indications. The series of experiments on the two indications selected will be carried out one after the other. As things stand, results useful to the proof of concept should be available within a period of around two to three months.

Your active support has made this progress possible. Many investors have individually reaffirmed their trust in us in the calendar year 2013 and provided us with funds of over € 1 million. We are more than grateful to you for this. In 2014, our task, as before, will be to create the prerequisites for ensuring that your commitment pays off.

Kind regards,

Thomas Striepe, Hubertus Schmelz, Dr. Joachim Fleing

 

Partner Companies in Italy, Finland and Portugal Prepare to Sell Granulox

Witten, Germany, December 5, 2013
Contracts with distribution partners for the wound therapeutic Granulox in three additional European countries were signed over the past few days, SastoMed GmbH notified its shareholders. SanguiBioTech GmbH holds a stake of 25% in SastoMed which is the licensee of the global distribution rights for Granulox.

According to the notification, SIAD Healthcare S.p.a. (www.siadhealthcare.com) assumed responsibility for the Italian market, ICF Woundcare OY (www.icf.fi) start to prepare the market entry of Granulox in Finland, while Portuguese SPCare Especialidades Farmaceuticas Lda. are adding the wound therapeutic to their product portfolio. All three companies are well established in their respective markets, have proven expertise in wound management or are even fully specializing in this segment. Like all other distribution partners they will bear all cost related to market entry as well as ongoing marketing and sales. As SIAD explained in a press release, they expect to strengthen their presence in the wound care business segment with this new partnership.

Currently distribution agreements are in force with partners covering seventeen European and four American countries (including the USA and Canada) as well as for Australia and New Zealand. Negotiations targeting additional markets are being pursued. Thanks to the great interest of distributors and with great personal commitment SastoMed has been able to accelerate the expansion of the international distribution network over the past months.

 

Granulox distribution rights for the UK, Ireland, USA, Canada, Australia and New Zealand granted to infirst HEALTHCARE
UK sales to start early in 2014

Witten, Germany, November 15, 2013
infirst HEALTHCARE has been awarded the rights to exclusively market Granulox in the UK. Ireland, USA, Canada, Australia and New Zealand by global licensee SastoMed GmbH. Granulox is a patented novel treatment which is proven to significantly shorten healing time of chronic wounds, and which holds a Europe-wide medical device license (CE mark). In the UK and Ireland infirst will start preparing distribution and sales of the wound therapeutic immediately. A distribution strategy regarding the English speaking markets overseas will be implemented in due course. This will include infirst undertaking to obtain the legally required authorizations to address those markets.

Manfred Scheske, infirst HEALTHCARE’s CEO who led Glaxo Smithkline’s North American and European Consumer Healthcare businesses for a combined 12 years, commented: “Granulox is a perfect fit with our strategic agenda and we are convinced that this product will contribute to reduce suffering of patients, improve public health and significantly reduce the associated healthcare costs.”

infirst HEALTHCARE’s commitment is another indication of the market potential assigned to Granulox by medical and market experts. The company has the financial strength and management capacities needed to successfully tackle territories of this size and diversity.

infirst HEALTHCARE is a UK-based healthcare company which spun out of the SEEK drug discovery group in early 2013. Its developments aim to build on the trust and safety of well-known drugs and to develop formulations which result in a genuinely perceived difference in performance. The ultimate goal is improved and highly effective health management at an early intervention stage, involving patients, the family practitioners and pediatricians as well as pharmacists. Among infirst HEALTHCARE’s shareholders is Invesco Perpetual, one of the UK’s largest independent investment funds.

 

Sangui BioTech: Revenues slightly improved in the first quarter of the 2014 financial year
Research and development for new patent application, preparation of animal test

Witten, Germany, November 6, 2013
For the first quarter (as of September 30, 2013) of its 2014 financial year Sangui BioTech International, Inc. reports revenues from product sales and royalties in the amount of USD26.527 (Q1/2013: USD1.794). This is an improvement of 10% as compared with the fourth quarter of the previous financial year (as of June 30, 2013).

Research and development expenses amounted to USD36.308 (Q1/2013: USD 8.444). The increase is due to the preparations made for filing a new patent application as well as of animal testing aimed at demonstrating the functionality of Sangui's technology with respect to various indications. The net loss attributable to shareholders of the parent company came to USD172.202 (Q1/2013: USD180.205), the cash outflow from operations during the quarter amounted to USD189.860 (Q1/2013: USD204.473).

As of September 30, 2013, the equity ratio was 70.5% (September 30, 2012: 56.7%).

After the end of the quarter the shareholders of SastoMed GmbH resolved to swap the shareholder loans outstanding for equity preserving their respective share in the stock of the company. SanguiBioTech GmbH holds 25% in SastoMed GmbH, Sangui has granted SastoMed the global distribution rights for the wound therapeutic Granulox.

 

Sangui joint venture SastoMed expands its product portfolio by an innovative wound debridement

Witten, Germany, October 14, 2013
SastoMed GmbH, in which Sangui holds a 25% share, has expanded its product portfolio. Dermacyn is an innovative wound debridement solution, produced by the Petaluma, California, based company Oculus Innovative Sciences. We are excited about this enhancement of SastoMed's business, in the success of which we shall also participate.

Prof. Axel Kramer, a leading German hygienist, analyzed its physiological effectiveness and called it "a revolution and an outstanding alternative to other substances". The fact that the distribution of an internationally successful product like this was entrusted to SastoMed, is a strong indication of how remarkable a reputation SastoMed already enjoys in the market.

For more information (regrettably only German language as of now) please refer to the following links: www.sangui.de and www.presseportal.de.

 

Sangui BioTech GmbH and ECCPS commence with studies on curing life-threatening ischemic conditions in the body
Cooperation agreement signed with TransMIT Gesellschaft für Technologietransfer mbH for the "Excellence Cluster Cardio-Pulmonary System"

Witten, Germany, October 15, 2013
Sangui BioTech GmbH and Excellence Cluster Cardio-Pulmonary System (ECCPS, www.eccps.de) will be cooperating in developing applications using artificial oxygen carriers, which also includes both eventual drug approval and medical device certification. In the first stage, the ECCPS laboratories based in Giessen will conduct animal testing to demonstrate functionality of Sangui's technology with respect to various indications. A respective application to the Ethics Commission is currently being drafted, the animal test protocols as the guiding scheme of the studies have been finalized already.

During the run-up to the agreement, ECCPS had already submitted a detailed concept for the further development. ECCPS is an organisation set up jointly by the universities of Frankfurt and Giessen together with the Max Planck Institute for Heart and Lung Research in Bad Nauheim. It ranks among the world's leading organisations of this type. This unique centre for translational medicine combines innovative medical research in the field of heart and lung diseases with their practical advancements based on preclinical and clinical studies. Its aim is to work together with industry on developing innovative drugs and substances. TransMIT Gesellschaft für Technologietransfer mbH (www.transmit.de) being the unit in charge of technology transfer at Justus-Liebig University in Giessen is involved in carrying out this project.

Curing oxygen deficiencies in the human body is the primary purpose of Sangui BioTech GmbH's business. Sangui owns numerous patents and patent applications for the production and application of oxygen carriers based on natural haemoglobin. The technologies and applications covered by these patents may be able to secure the supply of oxygen to vital organs despite vasoconstrictions or other insufficiencies, at least temporarily.

"We believe that the deliberations and research results on haemoglobin-based artificial oxygen carriers put forward by Sangui are very promising", said Prof. Dr. Ralph T. Schermuly, head of the ECCPS project team. "If this concept proves its worth the way will be paved for completely new therapeutic approaches to a whole range of application areas, especially for life-threatening conditions, such as shock lung and similarly critical indications. We are very interested in accompanying the process of clinical and regulatory developments through to market maturity."

Hubertus Schmelz, Managing Director of SanguiBioTech GmbH, emphasised that "in ECCPS, we have gained a partner which has extensive experience and competence in the interface between research and application. Especially given the extremely constructive preliminary work, we anticipate an efficient cooperation in the first steps taken towards preclinical and clinical development."

 

Sangui joint venture SastoMed expands its product portfolio by an innovative wound debridement

Witten, Germany, October 14, 2013
SastoMed GmbH, in which Sangui holds a 25% share, has expanded its product portfolio. Dermacyn is an innovative wound debridement solution, produced by the Petaluma, California, based company Oculus Innovative Sciences. We are excited about this enhancement of SastoMed's business, in the success of which we shall also participate.

Prof. Axel Kramer, a leading German hygienist, analyzed its physiological effectiveness and called it "a revolution and an outstanding alternative to other substances". The fact that the distribution of an internationally successful product like this was entrusted to SastoMed, is a strong indication of how remarkable a reputation SastoMed already enjoys in the market.

For more information (regrettably only German language as of now) please refer to the following links: www.sangui.de and www.presseportal.de.

 

Wound management specialist dealer will distribute Granulox in Switzerland
SastoMed GmbH and Agentur Scherrer GmbH sign agreement

Witten, Germany, October 8, 2013
In Switzerland the wound therapeutic Granulox is going to be distributed by Agentur Scherrer GmbH (http://www.stomocur.ch) located in Weite, canton St. Gallen. The specialist wholesale dealer focused on wound and stoma care products signed an agreement to this effect with SastoMed GmbH, the global licensee for this product.

Agentur Scherrer distributes a wide range of innovative and effective products in the wound, stoma and fistula care segments including products under the Polymem, CUREA and XTRATA brands. Its customer base includes pharmacies, drug stores and users in all Swiss cantons.

Doris Scherrer, General Manager of Agentur Scherrer, explains: „For our business Granulox is more than just another complementation of our wound management product portfolio. Thanks to its proven effectiveness we expect significant attention and demand by patients and medical and care professionals throughout the country.“

„Agentur Scherrer is a well established and successful specialist wholesale dealer the sales network of which embraces all of Switzerland,“ says Michael Sander, the Managing Director of SastoMed. „The agreement with Scherrer gives us access to another interesting market in central Europe. By now Granulox is represented in eleven European and two Latin American countries with a total of around 300 million inhabitants. More agreements covering additional markets are expected to follow suit in due course.“

 

Revenues exceed USD100.000 in the 2013 financial year
Losses reduced in spite of impairment of notes receivable, indications for increase in sales of wound therapeutic

Witten, Germany, September 27, 2013
In its financial year 2013 (ended June 30, 2013) Sangui BioTech International, Inc. recorded revenues from product sales and licensing fees in the amount of USD105.487 after USD14.949 in the previous year. The highest annual revenues since 2007 results mainly from royalties on sales of the wound therapeutic Granulox, the distributions rights of which are licensed to the joint venture company SastoMed.
SastoMed GmbH, in which Sangui holds a stake of 25%, now informed Sangui management, that there are firm indications that the ground breaking efforts of the recent months start to bear fruit. Granulox sales have begun to pick up by the end of the current quarter due to the growing number of international distribution partners on the one hand but also due to an increase in repeat orders in the German home market on the other. So far, distribution agreements have been signed covering eleven European and two South American countries.
Nevertheless, as mandated by US GAAP and in the interest of an utmost conservative bookkeeping, the outstanding notes receivable from SastoMed were fully impaired in the financial statements of the Group. Sangui, however, believes that the foreseeable increase in market penetration of the wound spray product will result in the recovery of its investment. This assumption is supported by the ongoing payments of license fees by the joint venture company.
The impairment contributes in the amount of USD 1.0 million to the net loss after minorities for the period of USD2.1 million (2012 net loss USD3.5 million). The cash outflow from operations of USD0.8 million (2012: USD0.7 million) and from investing activities of USD0.9 million (2012: USD0.7 million) contrasts with a cash inflow ofUSD1.4 million (2012: USD1.6 million).
In order to guard the distribution in Mexico from political influence SastoMed GmbH in cooperation with local partners has restructured the sales network to arrive at more efficient processes aimed at a nationwide professional market development. This was also resolved before the backdrop of the fact that a large order announced in December 2012 will not be carried out due to a change of government. Currently, an additional pharmaco-economical expert study is nearing completion which will secure availability in every public hospital throughout all Mexican states. At the same time the product is being presented to all social and health security institutions as well as on the occasion of trade shows and congresses. SastoMed expects this new systematic approach to result in a far reaching and sustainable market penetration.

At the same time, SastoMed GmbH continues to negotiate with potential distribution partners for a number of additional international markets. SastoMed reckons with a significant expansion of the global distribution area in the course of the coming months.
As could be seen from the recent filing of a new patent application SanguiBioTech GmbH in the meantime is working towards further developing in-vivo-applications of its artificial oxygen carriers.

 

Granulox to enter Columbian market – SastoMed signs contract with distributor Colpharma

Witten, Germany, September 23, 2013
Colpharma Laboratorios S.A., Bogotá, Columbia, (www.colpharma.com.co) will introduce the wound therapeutic Granulox to the Columbian market. An agreement to this effect was signed with global Granulox licensee SastoMed GmbH. In order to accomplish a fast market entry the necessary authorizations are being obtained with the national authorities already. Presentations of Granulox to the Columbian health system on the occasion of Conferences and Congresses will start as early as November 2013. Actual sales will start immediately after the authorization will have been passed.
Established in 1986, Colpharma sells and distributes all of its pharmaceutical and medical products with a strong sales force on a national level. The portfolio embraces 73 licensed and own brand products. The company focuses on strategic cooperation with international pharmaceutical groups, in order to upgrade the portfolio with outstanding innovative products.
Elkin José Cano, General Manager of Colpharma, emphasizes: “Granulox with its unique efficacy and fast healing time is definitely the most exciting new product to be launched in Colombia. To be selected as its distributor represents a major step forward in achieving our business growth objectives. Colpharma will carry out all the necessary pre-marketing activities in order to achieve a rapid and significant market penetration.”
„Columbia is one of the most exciting health markets in South America with its 48 million inhabitants,, its solid economic growth for a row of consecutive years now and steady ongoing improvements throughout the medical sector“, says Michael Sander, the Managing Director of SastoMed: „We are glad to having contracted Colpharma: a strong and valuable partner who is deeply rooted in the Colombian health system and pursues a convincing growth strategy focusing on innovative products.”

 

Granulox wound spray is most innovative aerosol product of the year
European industry federation FEA honors SastoMed during annual congress in Madrid

Witten, Germany, September 17, 2013
The European Aerosol Federation (FEA, www.aerosol.org) has honors the hemoglobin wound spray Granulox as the most innovative aerosol product of 2013. The prize will be awarded to SastoMed GmbH during a dinner reception on the occasion of the 28th International Aerosol Congress in Madrid on September 25, 2013 (http://www.aerosolmadrid2013.com). Other awards are being offered in the categories of packaging design, environment and sustainability as well as marketing strategies for aerosol products.

 

Sangui BioTech: Start of Granulox-Sales in Greece scheduled for October 31, 2013

Witten, Germany, September 10, 2013
Ramma Dental SA, Athens, has assumed responsibility for distributing the wound therapeutic Granulox in Greece with immediate effect. A contract to this effect was signed between Ramma Dental and SastoMed GmbH, which holds the global distribution rights as licensee. Actual sales are scheduled to begin on the occasion of the Greek Wound Management Congress on October 31, 2013.
Established in 1992 by CEO Ioannis Katsiropoulos, Ramma Dental initially specialized in import and distribution of medical products in the fields of surgery and in particular dental surgery („ramma” being the Greek word for suture). Since then the scope of its product portfolio has expanded considerably. Ramma Dental serves as distribution partner for global medical groups such as Johnson & Johnson or Integra Life Sciences. Since 2005 Ramma Dental has also been selling wound care products on behalf of 3M.
„In our country, the demand for special products for chronic wounds has increased noticeably”, emphasizes Ioannis Katsiropoulos. „Granulox as an innovative and effective wound therapeutic is an important complement of our respective product portfolio. Not only is it unmatched in effectiveness. This effectiveness also helps to reduce treatment costs. We are convinced that it will be highly appreciated by patients suffering from chronic wounds as well as by healthcare professionals.”
Michael Sander, SastoMed Managing Director, underlines: „Ramma Dental is a well established, yet fast growing distributor. Thanks to its extended customer base ranging from wholesalers to hospitals and to the individual patient our new partner will tap promising sales potential in the Greek market with its almost 11 million inhabitants. We are looking forward to cooperating for the benefit of the patients and of both our enterprises.”

 

Sangui BioTech files comprehensive new patent application significantly expanding the protection of its hemoglobin formulations

Witten, Germany, September 4, 2013
Sangui BioTech GmbH has filed another patent application with the German Patent Office (DPMA) in Munich; international applications are planned to follow. The patent application is to significantly expand the protection of the hemoglobin formulations developed by Sangui. It will encompass a greater array of ischemic conditions of the human body, for instance in the case of severe dysfunctions of the lung. If the treatment described in the patent application will successfully pass clinical development it can help save human lives in intensive care units bridging the existing gap between high pressure respiration and the costly and high-risk extra-corporeal blood oxygenation (in the „lung“-section of a life support machine).
The patent application also protects the option to seek new opportunities for a fast track authorization of hemoglobin formulations aiming at such indications with a high mortality.

 

SanguiBioTech: Wound therapeutic Granulox obtains another 18 years of patent protection for the entire European Union

Witten, Germany, August 13, 2013
The European Patent Office has granted SastoMed GmbH a European patent (EP 2550973, „Wound Spray“). The patent expands the existing protection of the wound therapeutic Granulox and additionally safeguards its technology in terms of production as well as in terms of application. In particular, the patent protection now applies to all member countries of the European Union and was extended for another 18 years until the year 2031. SastoMed expects a positive decision with regard to the corresponding application for an international patent.

„With the complementary European and international patents we expand the reach of our protection well beyond the current core markets and we double the period of validity as compared with the first patent“, explains SastoMed Managing Director Michael Sander. „This move was carried out in mutual understanding among all partners and within the framework of our agreements. We are experiencing a strong interest in Granulox from numerous different European countries. The territorial and temporal extension of the patent protection is an excellent basis for a sustainable flow of revenues. SastoMed GmbH and its shareholders SanderStrothmann GmbH and SanguiBioTech GmbH will profit significantly from the enhanced revenue and earnings potential. SanguiBioTech as licensor will also be able to capitalize on an increase in royalty volume.“

SastoMed GmbH is a joint venture of SanguiBioTech GmbH (25%) and SanderStrothmann GmbH (75%). It has been granted the global distribution rights as licensee. SanguiBioTech GmbH receives royalties on all product sales and is entitled to a share in all net profits corresponding to its share in the company.

 

Sangui BioTech: SastoMed gains top-class
Granulox distribution partner in Southeast Europe

Witten, Germany, July 16, 2013
MEDiLAB c.o.o., Zagreb, Croatia, undertakes the distribution of the wound therapeutic Granulox in Slovenia, Croatia, Serbia, Bosnia and Herzegovina as well as Macedonia with a combined population of over 20 million inhabitants. A contract to this effect was now signed with global licensee SastoMed GmbH. MEDiLAB was established in 1991 and employs more than 120 employees in its three operating units. The company which has repeatedly obtained excellence awards represents companies such as B. BRAUN, BAYER Diabetes Care, Siemens MSD, Diesse and Buhlmann. It is renowned for its close cooperation with professionals, medical doctors of various specialties, nurses and pharmacists. As a first key step in Granulox promotion MEDiLAB intends to create opportunities for specialist doctors to obtain positive experiences through direct use of the product. Promotion is beginning these days while actual sale to consumers will begin at the end of this year.
„We believe that Granulox is a real gem in a line of our key products“, emphasized MEDiLAB founder and General Manager Marko Džepina. „Its unique performance demands and deserves intensive work with leading experts in chronic wounds management, as well as a position in therapy algorithms of chronic wounds treatment. We believe that its compatibility with our existing products brings added value to our company business activities, both in the eyes of medical professionals and in the financial plan. In cooperation with business partners from the region we plan to change the image of chronic wounds management market in the region.“
Michael Sander, Managing Director of SastoMed GmbH, confirms: „We esteem MEDiLAB a very dynamic enterprise, which excels in proactivity, creativity, diligence and reliability. It ranks among the most successful mid-size companies in its home markets. In addition it has a wide experience in diabetes treatment and hence in chronic wounds. We are looking forward to closely cooperating in the interest of the patients and of both partners.“
„It is all but an easy task to identify and contract top-class partners such as MEDiLAB“, adds Hubertus Schmelz, Director of Sangui BioTech International, Inc. “We do appreciate that SastoMed applies high standards in its search for international distribution partners. Internationalization from our point of view is one decisive lever to widely establish Granulox in the wound management markets and to harvest the expected business success.“

 

Sangui reports increase in revenue, looking at longer Granulox market entry phase

Witten, Germany, Mai 21, 2013
In the third quarter of its 2013 financial year Sangui BioTech International, Inc., realized revenues from product sales and royalties of above USD 33,000 (Q3 2012: USD 571). In the first nine months of the financial year revenues amounted to more than USD 81,000 (9M 2012: USD 2,795). This can be derived from the quarterly 10-QSB report published today. Over the nine months the company used cash in operations of approximately USD 500,000 (9M 2012: approx. USD 461,000). It invested almost USD 900,000 of loans in promoting the market entry of its wound therapeutic Granulox (9M 2012: almost USD 667,000). Cash inflow from financing activities amounted to USD 1.27 million (9M 2012: 1.05 million).
Sangui Director Hubertus Schmelz explained: “A year ago, when Granulox was successfully presented in the market we had hoped for a faster market penetration. We underestimated the inertia of the health system. Today it seems realistic to be prepared for a more extended market entry phase.” As before successful treatments are well received by medical experts and among patients. According to the global licensee the repurchase rate is high. In the next step its focus will be on expanding the number of doctors actually using the wound therapeutic, further stimulating the demand from patients and entering new international markets.
A German language independent market research study will be made available on www.sanguibiotech.com today. It covers the wound care market and discusses market entry scenarios.

 

Sangui BioTech: First Step towards a European Granulox Distribution Network
BiologiQ and SastoMed Agree upon Exclusive Sales Partnership for the Benelux Countries

Witten, Germany, April 22, 2013
The sales area for Granulox the Sangui developed wound therapeutic is being expanded. SastoMed GmbH global licensee for the distribution of Granulox has come to a sales agreement with BiologiQ thus securing the first partner for the planned European network. The Apeldoorn, Netherlands, based wound management specialists have been operating successfully in the Benelux markets since 2005 and have already implemented some initial marketing activities. Actual sales are to be started in summer.
BiologiQ and SastoMed are heading for a joint presentation of Granulox on the European Wound Management Association (EWMA) Congress in Copenhagen in May. That was agreed upon between Hans Willemsen, BiologiQ General Manager and SastoMed Managing Director Michael Sander.
Hans Willemsen emphasized: “Granulox perfectly matches our strategy to offer the health system effective and safe products for improved wound healing. Clinical results and practical experience have convinced us that we are up to expanding our portfolio by a most promising therapeutic.“

BiologiQ is an independent Dutch medical company (est. 2005), headquartered in Apeldoorn (NL), specialized in marketing, sales and distribution of safe and effective Bio-active and Biotech products and therapies for Wound Care.

 

Approval of blood additive appears possible, expedient and promising
Feasibility study available

Witten, Germany, April 9, 2013
An approval of Sangui's haemoglobin hyperpolymers as a blood additive appears possible, expedient and promising. This was attested to by a feasibility study prepared by an expert panel of medics, biologists, application engineers, regulatory experts and patent lawyers on behalf of SanguiBioTech GmbH. If approved, the product could save the lives of hundreds of thousands of people. It functions as a carrier supplying oxygen to parts of the body which have an oxygen deficiency due to a narrowing or blocking of the arteries (arteriosclerotic obstruction): the main cause of stroke, heart attack etc.
Different options for financing the undertaking, initially until completion of the preclinical studies, are being reviewed, including the procuring of public funding. The authors of the study conclude that Sangui's haemoglobin hyperpolymers are superior to the approaches pursued by the pharmaceuticals sector so far. The study is based on a wide-ranging critical literature review, in-deep database research and opinions by renowned experts. After extensive scrutiny, which includes competitor approaches, the study affirms the correctness and resilience of the concepts presented by Sangui. Accordingly, Sangui's haemoglobin hyperpolymers fulfil all the requirements discussed to date in respect of an oxygen carrying blood additive. The study includes a discussion of two possible indications for initial approval: acute myocardial infarction (heart attack), on the one hand, and ALI/ARDS, lung damages, on the other, both of which often lead to death. Both acute emergency indications can be alleviated by introducing the blood additive, giving patients valuable survival time until basic medical aid can be administered. Also, the severe multiple damages to the body after suffering such oxygen deficiency can be minimised.
After due consideration, the experts initially recommend that approval for ALI/ARDS be sought. These indications have a mortality rate of 40 percent, causing around 290,000 deaths in total in the USA and in the EU every year. The authors anticipate that classification as an orphan disease, i.e. as a disease neglected by research, may also be possible. This would fast track the process.
In the event of success, Sangui and its potential partners would tap a market worth billions. Even a slight one-percent market penetration would yield a high return potential.


Continuous trading in Sangui shares restored in German markets
Additional listing on Berlin stock exchange

Witten, Germany, March 22, 2013
As of today, the shares of Sangui BioTech International, Inc. can be traded continuously again on an additional German stock exchange. Stock broker mwb Fairtrade AG had applied for a listing on the Berlin stock exchange in addition to the one auction only trading on the stock Hamburg exchange and the continuous trading on the OTCQB marketplace. The German share identification number continues to be 906757.


BioTech company Sangui strikes a positive half year balance
Revenues grow, additional investments in marketing and sales

Witten, Germany, February 15, 2013 - While daily revenues of the wound therapeutic Granulox grew continuously, Sangui Biotech saw its revenues from product sales and royalties increasing quarter by quarter since the distribution of Granulox started in April 2012. In the first six months of its current financial year they reached almost USD50,000.
Increasingly, the wound therapeutic Granulox is the main growth driver. Distribution rights for this product were awarded to SastoMed GmbH by Sangui. Already, Granulox can build upon high satisfaction with patients, excellent awareness among professionals as well as a steady increase of order intake. In a recently published clinical study carried out at the Charles University in Prague (Czech Republic) a significant reduction of wound size was obtained at 97 percent of patients treated with Granulox. Documentations of scientific radiance like this one enable SastoMed to present the benefits of Granulox to patients and medical practitioners in an even more convincing way.
„We note that all tokens lead to the right direction“, Sangui Director Hubertus Schmelz emphasizes. „Granulox business has gained considerable momentum now which can be derived from the steady increase of incoming orders and revenues. As for the quarters to come we are looking forward to additional growth in Germany and abroad, a development which will meet our unchanged support as shareholders of SastoMed.”


Biotech company Sangui presents Granulox wound treatment study
Efficiency of hemoglobin spray exceeds expectations

Witten, Germany, February 5, 2013 - Sangui BioTech International, Inc. (symbol: „SGBI“) underpins the efficiency of its wound therapeutic Granulox with the results of a clinical study carried out at the Charles University in Prague (Czech Republic). A significant reduction of wound size was obtained at 97 percent of patients treated with Granulox.
Positive effects of the hemoglobin spray Granulox are being made highly evident on a scientific level by the clinical study of wound healing of patients with venous leg ulcers. The team led by Prof. Dr. Petr Arenberger of Charles University in Prague (Czech Republic) observed over 13 weeks how the wound size changed under the influence of Granulox spray as compared with a treatment with a placebo solution. In 33 of 34 patients treated with hemoglobin spray (97%) a significant reduction of wound size was observed as compared with the control group. In the group treated with Granulox pain also decreased significantly while the control group continued to complain about pain in the wound area. „Based on the good experiences practitioners persistently make using Granulox we expected to see a convincing outcome. But the results now presented exceed all expectations,“ Sangui director Hubertus Schmelz said.
The major areas of indication for Granulox are chronic wounds resulting in most cases from insufficient oxygen supply (hypoxia) to the respective part of the body due to restricted blood circulation. One very frequent origin of this phenomenon is diabetes. Diabetes damages the vessels leading to circulatory disorder in legs and feet. On a global scale approximately 37 million cases of treatments of chronic wounds occur every year.

The study appears in Der Hautarzt 2013/3 (Springer Publishing House, Berlin Heidelberg). Online versions are available for download at the journal itself and at the PubMed database.



Biotech enterprise Sangui starts expanding internationally recording large order from Mexico

Witten, Germany, December 21, 2012
Effective now, Sangui BioTech International, Inc. (Symbol: SGBI ) has its wound therapeutic Granulox being sold in Mexico. Sangui BioTech GmbH has licensed the respective rights to its affiliate SastoMed GmbH. SastoMed is already distributing Granulox in Germany. At the outset of the international expansion a large order could be recorded yielding an expected sales volume of over EUR500,000.
The largest customer purchasing from the first delivery of Granulox to Mexico is the State of Tamaulipas. Here, governmental health institutions will be equipped with the wound therapeutic. Granulox is being applied as a spray. Main indications are chronic wounds, originating in most cases in lack of oxygen supply (hypoxia) or insufficient blood flow to the respective part of the body. In many cases diabetes is the primary disease. Diabetes affects the blood vessels thus causing circulation disturbances in legs and feet. Around 37 million treatments per annum occur on a global scale. More than one fourth of those are being registered in Latin America. Expansion to Mexico is seen as the first step to addressing this market.
The expansion shall be promoted based on a contractually agreed cooperation with the Mexico based distribution partner Bio-Mac Pharma the management of which has a track record of successfully supporting the sales of other renowned pharmaceutical companies like Pfizer, Novartis and Schering Plough.


Most extensive clinical study so far at Karls University in Prague shows:
Granulox has positive influence on healing of leg ulcers
Results to be published in issue 3/2013 of renowned medical journal

Witten, Germany, December 12, 2012
A report on the course and results of a comparative clinical study carried out under the direction of professor Petr Arenberger, MD, at the clinic of dermatology at the Karls University in Prague was now accepted for publication. The study aimed to investigate into the influence of a hemoglobin based spray on the healing progress of leg ulcer. Leg ulcer is one the most prolific origins of chronic wounds with a prevalence of about 1.5 million cases p. a. in Germany alone. This was the most extensive clinical study regarding this technology to support wound healing as developed by Sangui. The prospective, randomized and placebo controlled study gave highly significant evidence that there is a clearly positive influence of the hemoglobin spray on wound healing. The eminent efficacy of Granulox (e. g. in patients suffering from leg ulcer) is now documented one more time on the highest scientific level. The entire study including all findings, in particular regarding the improvement of healing times and the reduction of pain experienced by the patients will be published in the 3/2013 issue of „Der Hautarzt“ (Springer Verlag (Heidelberg)).
„Der Hautarzt“ enjoys international acceptance and is amply quoted. The journal informs clinical and practising dermatologists on a regular basis of all important developments in all areas of dermatology. Articles are not published unless they have passed a peer review.


Sangui patent for Production of Artificial Oxygen Carriers granted

Witten, Germany, October 17, 2012
As expected and previously indicated, the European Patent Office has granted a patent based on Sangui’s application (EP 01 945 245): “Mammalian hemoglobin compatible with blood plasma, cross-linked and conjugated with polyalkylene oxides as artificial medical oxygen carriers, production and use thereof”.
The grant is effective today, October 17, 2012, subsequent to its official publication by the Patent Office.


Sangui and SastoMed Complement Licensing Agreement in View of Increasing Sales Success

Witten, Germany, August 27, 2012
Sangui BioTech GmbH and SastoMed GmbH cordially adjusted the existing sales strategy as the introduction of Granulox to professional circles proves to be increasingly successful. In consideration of corresponding contributions the existing licensing contract was partially complemented resulting in the following conditions:
As licensor SanguiBioTech GmbH is awarded a fixed licensing fee as a percentage of each and every external revenues incurred by SastoMed from sales of the Granulox product (based on SastoMed selling prices). The percentage ranges in the uppermost zone of what is usually granted in the pharmaceutical and medical products industries and thus well above the average licensing rate of 7.5% of sales revenues as calculated by market analysts. In addition and complementing this basic agreement the percentage will be permanently increased by one fourth of the current rate as soon as cumulated sales revenues at SastoMed will have exceeded the total of €50,000,000.
As shareholder SanguiBioTech GmbH will benefit additionally from all future dividends to be paid by the subsidiary according to the percentage of its stake in SastoMed that is at a rate of 25%. Should eventually all the shares of SastoMed GmbH be sold in total to a third party, the existing licensing contract with SanguiBioTech GmbH will persist unchanged.
„This amendment of our licensing contract“, emphasized Hubertus Schmelz, Managing Director of SanguiBioTech GmbH, „is another token of the close and cordial cooperation based on mutual trust and aiming at our joint success. Our business model proves its worth not least because of the professional and effective work of our partners which meets our support in every respect.”


Over 500 Customers: Granulox Sales Ahead of Planning
Initial investments will have amortized by 2014 according to SastoMed /
Licensing agreement will yield income for Sangui with the beginning of 2013, exponential growth expected

Witten, Germany, August 13, 2012

SastoMed GmbH, global licensee of the Sangui patented wound spray, has submitted the announced report covering the first 100 days of Granulox product sales. Its results meet and in some parts considerably exceed the expectations which were directed at the joint venture company by SanguiBioTech GmbH as the licenser. SastoMed assumes that the initial investments will have amortized by 2014. Before that already, Sangui will participate in each Euro of revenue in Germany and abroad and will profit by the considerable growth dynamic.
The sales strategy is based on an exemplary assessment of the complex health market the accuracy of which is underpinned by the presented sales progress. Until July 31, the sales force had arranged for almost 4,800 meetings and handed over more than 1,000 samples. After no more than 100 days about 500 customers have been registered as actively purchasing the product. With this customer base SastoMed are ahead of planning. In addition, the sales team is present at most conferences, trade shows or workshops dedicated to wound management. The communication with opinion leaders and the expert public will now be complemented by an extensive advertising campaign in the consumer media and the internet. Still, personal contact and practical experience are decisive to convince the users.
As had been expected according to the findings of Sangui research and development, impressive documentation of successful wound treatments underline the excellent efficacy of Granulox in everyday health care practice. For some time it had been known among medical researchers that there is a correlation between hypoxia and impeded wound healing. Thanks to its research focus on oxygen Sangui was the first and only company to draw the right conclusions and to develop a hemoglobin based technology which actually and effectively enhances the oxygen supply and thus supports wound therapies.
The growing dynamics in penetrating the market will even increase further next year according to SastoMed: Overall another 5,000 doctors and 500 hospitals are planned to be gained to regularly administer Granulox in Germany alone. At the same time internationalizing the business will move up on the agenda.

The current positive experiences made in Germany will among others also lead to entrusting the leadership in operating sales in Mexico to SastoMed - for the sake of a consistent market appearance and in accordance with the Mexican partners. In parallel, market entry in Austria, the United Kingdom and Turkey are under preparation. Additional European markets are planned to be addressed in 2014. The international business will be directed by a top marketing and sales manager with international track record. More details will be disclosed after the signing of the final articles of employment.
Hubertus Schmelz, Managing Director of SanguiBioTech GmbH, was impressed by these preliminary statements: "We at Sangui are particularly proud of the fact that our yearlong focus on this technology was the right move. We are especially glad to obtain such a positive response from competent experts, who confirm our great expectations. And we are delighted to see how many patients now experience the benefits of Granulox treatment. Our strategic decision to transfer marketing and sales of the Sangui developed technology to highly professional partners has proven to be the best possible choice. We support this intense growth course also on the financial side and intend to push-start the international activities. We can foresee that beginning end of this year but increasingly so over the years to come the positive cash flow from the joint venture company will more than justify our decisions."

 

Sangui BioTech International, Inc. ("SGBI") is a holding company the shares of which are being traded on the OTCQB marketplace (www.otcmarkets.com: SGBI) and the OTC market of Hamburg-Hannover stock exchanges. Its purpose is to provide financing and access to the capital markets for the enterprises of the Sangui group. SanguiBioTech GmbH is a ninety percent subsidiary of Sangui BioTech International, Inc.

For more information please contact:
Joachim Fleing
Phone: +49 (179) 7963472
Fax: +49 (2302) 915191
e-mail: fleing@sangui.de

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