March 29, 2023 (Source) – Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) (“Hemostemix” or the “Company“) is pleased to announce it has engaged Montreal’s RobboDesign to revise and search engine optimize its website, to engage with critical limb ischemia “CLI” and peripheral arterial disease “PAD” patients, globally. The purpose of the revisions are to engage with CLI and PAD patients, to provide them with ACP-01 as limb saving treatment, and to provide them with strategies that may improve their quality of life. For example, when an individual seeks a solution to PAD or CLI, the Hemostemix site will be the first website that they obtain. Within the CLI landing page, it will contain the following information:
- ACP-01 treatment options and the regulatory pathway to obtain a compassionate treatment exemption.
- The healthcare protocols that were followed by patients in the ACP-01 CLI clinical trial that led to the dramatic reductions of amputations, as compared to “normal care” for this patient population.
- Patient testimonials of the outcomes of an ACP-01 exempt compassionate treatment.
- A portal for peer to peer engagement, including peer to peer coaching led by a Hemostemix coach who is familiar with the no-option patient population.
“Hemostemix’ ACP-01 CLI wound healing and amputation data describes saving 93.5% of treated limbs from amputation, and a dramatic reduction of the size and and magnitude of ulcers in the treated population,” stated Thomas Smeenk, CEO. “Many of the Principle Investigators of the CLI clinical trial have commented to me that the clinical trial protocol, as compared to normal care of the no-option patient population, led to dramatic differences, and that it should be implemented as a way to help improve patients’ lives. So, that is what we are going to offer while we also offer ACP-01 as an exempt compassionate treatment,” Smeenk said.
ACP-01 is a safe and effective cell therapy for the treatment of CLI, a loss of circulation (atherosclerosis) in the limbs that leads to severe pain, ulcerating wounds, gangrene and amputation. ACP-01 has completed a Phase II clinical trial for CLI. In the 17 center Phase II clinical trial of 68 subjects randomized 2:1 to receive ACP, 93.5% of ACP-01 treated limbs were saved from amputation. In the ACP-01 randomized Phase I trial of 20 subjects followed for two years, there were no deaths and 70% (7/10) of treated limbs were saved from amputation. In the control group (non-treated), there were two deaths and 75% (6/8) of limbs were lost to amputation.
The annual incidence of CLI is estimated to be 220-3,500 per 1,000,000 and its prevalence is estimated to be 1% of the adult population (CLI epidemiology and clinical presentation). It is estimated there are 236 Million who suffer from peripheral arterial disease (PAD), and up to 10% of PAD patients progress to CLI (23,600,000). The company will generate revenue by the sale of ACP-01 to no-option CLI patients who face amputation, who can obtain a compassionate treatment exemption, and it is working on a program to sell 500 exempt compassionate treatments on a first come first serve basis at $35,000 each as Tranche 1 ($17.5 Million). Thereafter, sell tranche 2 to generate revenue, and scale production to meet demand. Hemostemix is scaling production to 4,000 batches per month by 2027 to optimize its costs and margins while completing its clinical trials.
ACP-01 as a treatment of heart disease (ischemic cardiomyopathy), demonstrated statistically significant improvements in 245 patients who participated in one of three phase 1 studies (171 subjects), or who were consecutively treated compassionately for ischemic cardiomyopathy (74 subjects) and studied retrospectively. In the retrospective study, left ventricle ejection fraction, a key measure of heart health, improved 27% on average at 12 months after treatment (p=0.003). The potential market for these two indications alone is >$9 Billion.
Hemostemix is an autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, and is scaling a patient’s blood-based stem cell therapeutics platform that includes angiogenic cell precursors, neuronal cell precursor and cardiomyocyte cell precursors. For more information, please visit www.hemostemix.com.
For further information, please contact:
Thomas Smeenk, President, CEO & Co-Founder
Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Information: This news release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information in relation to: the financing of the Company and its lead product ACP-01 and the commercialization of ACP-01 via the sale of compassionate treatments subject to exemption from regulatory approval. There can be no assurance that such forward-looking information will prove to be accurate. Actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix’s current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the underlying value of Hemostemix and its Common Shares; the successful resolution of the litigation that Hemostemix is pursuing or defending (the “Litigation“); the results of ACP-01 research, trials, studies and analyses, including the analysis being equivalent to or better than previous research, trials or studies; the receipt of all required regulatory approvals for research, trials or studies; the level of activity, market acceptance and market trends in the healthcare sector; the economy generally; consumer interest in Hemostemix’s services and products; competition and Hemostemix’s competitive advantages; and Hemostemix obtaining satisfactory financing to fund Hemostemix’s operations including any research, trials or studies, and any Litigation. Forward-looking information is Subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: the ability of Hemostemix to complete clinical trials, complete a satisfactory analyses and file the results of such analyses to gain regulatory approval of a phase II or phase III clinical trial of ACP-01; potential litigation Hemostemix may face; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in Hemostemix’s markets and the markets in which it expects to compete; lack of qualified, skilled labour or loss of key individuals; and risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, disruptions to economic activity and financings, disruptions to supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession or depression; the potential impact that the COVID-19 pandemic may have on Hemostemix which may include a decreased demand for the services that Hemostemix offers; and a deterioration of financial markets that could limit Hemostemix’s ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in Hemostemix’s disclosure documents on the SEDAR website at www.sedar.com. Although Hemostemix has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of Hemostemix as of the date of this news release and, accordingly, it is Subject to change after such date. However, Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.