Vancouver, British Columbia–(Newsfile Corp. – December 1, 2020) – Hemostemix Inc. (TSXV: HEM) (OTCBB: HMTXF), a clinical stage biotechnology company with a patented stem cell technology platform, has successfully, following lengthy litigation, obtained its entire clinical trial database from Medrio Inc., which was hosting the database for Aspire Heath Science LLC. For more details on the litigation, please refer to today’s news release.
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The company’s principal business is to develop, manufacture and commercialize blood-derived stem cell therapies to treat various diseases not adequately addressed by current therapeutics. The company’s process for harvesting stem cells is less invasive, as the stem cells are taken from a patient’s blood, which is a simplified process as compared to taking stem cells from fatty tissue or bone marrow.
Critical limb ischemia or CLI, a severe blockage in the arteries of the lower extremities, which markedly reduces blood-flow, is deadliest form of peripheral arterial disease or PAD, with limited treatment options and no current approved drug treatments. The company’s lead product, ACP-01 is the subject of a Phase II clinical trial of its safety and efficacy in patients with advanced CLI, who have exhausted all other options to save their limb from amputation.
Hemostemix owns 91 patents related to its products and manufacturing processes and has entered into a contract with a new clinical research organization which is completing the midpoint statistical analyses of the efficacy of ACP-01. A winner of the World Economic Forum Technology Pioneer Award, Hemostemix developed and is commercializing its lead product ACP-01.
Hemostemix announced the abstract and interim results presented to the 41st annual Canadian Society for Vascular Surgery meeting, which noted healing of ulcers and resolution of ischemic rest pain occurred in 83 per cent of patients studied by lead investigators at the University of British Columbia and the University of Toronto with outcomes maintained for up to 4.5 years.
Thomas Smeenk, CEO, stated: “As every biotech investor knows, it is all about the data! Blinded, we will know in short order if our HS 12-01 midpoint results equal the interim clinical trial results that 83 per cent of patients followed for up to 4.5 years experienced. Fortunately, we have a lot of data of the efficacy of ACP. For example, we have the clinical trial results of the 41 patients treated for cardiomyopathy. And, we have the results of the 106 ischemic heart disease patients on maximal medical therapy who had no option for revascularization, who experienced significant improvement.”
Hemostemix is addressing a huge potential market. According to The Sage Group LLC, in the United States alone, approximately 20 million people are affected by PAD, and it is estimated that approximately 7 to 8 million people in the United States and Europe suffer from CLI. The Sage Group estimates that in the United States, medical costs attributable to CLI amount to US$25 billion annually.
The company has also announced a non-brokered private placement. The company is looking to raise gross proceeds of up to $2.5 million from the placement of up to 250 million units priced at $0.01 per unit. The units consist of 1 share and 1 warrant, with each warrant exercisable at $0.05 for 12 months, subject to an acceleration clause. The shares are currently trading at $0.01. However, the company has obtained shareholder approval for a 20 for one share consolidation.
In addition to accredited investors, this placement is available under certain security exemptions to existing shareholders, friends and family, and those investors having received advice under the investment dealer exemption.
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