Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) (“Hemostemix” or the “Company”) is pleased to announce it is completing a second round of interviews with candidates who may join the company as Executive Vice President, Business Development.
Calgary, Alberta--(Newsfile Corp. - April 3, 2023) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) (“Hemostemix” or the “Company”) is pleased to announce it is completing a second round of interviews with candidates who may join the company as Executive Vice President, Business Development. The EVP Business Development will be responsible for building and leading a team focused on the following:
- The sale of Tranch 1 - 500 ACP treatment convertible debentures at USD $35,000 each, to raise USD $17.5M, a mostly non-dilutive financing. Thereafter, the sale of tranche 2, etc., to finance production.
- Commence the roll-up of USA-based Podiatry clinics.
- Demonstrate to Podiatrists the impact to the clinic’s revenue and margins of the addition of exempt ACP-01 treatments. For example, model the sale of up to 16 ACP, 30 minute, aseptic CLI injection procedures per day in keeping with the phase II injection protocol.
- Sell and close podiatry clinicians on how they can monetize the value of their sweat equity, exchanging it for shares of Hemostemix.
- Provide direction and analyses of potential Podiatry clinic acquisitions globally, analyzing market access in the EU, Mexico, Central and South America, the Middle East, India, Japan, and S. Korea.
- Hire and manage articulate, multi-lingual, biotech-seasoned business development sales executives to increase the velocity of podiatry clinic acquisitions and ACP compassionate sales.
The five year survival rate of CLI amputees is < 30%. ACP-01 is a safe cell therapy for the treatment of CLI, a loss of circulation (atherosclerosis) in the limbs that leads to severe chronic pain at rest, ulcerating wounds that will not heal, 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. An interim data point of the phase II trial published by UBC and U of T noted healing of ulcers and resolution of ischemic rest pain occurred in 10 of 12 patients, and that outcomes were maintained for up to 4.5 years.
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). Hemostemix is scaling its patented automated cell therapy system (“ACTS Production) to 4,000 batches per month by the end of 2027 to optimize its costs and margins while completing its clinical trials. Thereafter, ACTS production pods may be located in centralized production plants that scale to meet demand.
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.
ABOUT HEMOSTEMIX
Hemostemix is a patient’s blood-sourced stem cell therapy platform that includes angiogenic cell precursors, neuronal cell precursor and cardiomyocyte cell precursors. Founded in 2003, a winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, and is scaling by the end of 2027 the manufacture of 4,000 patient treatments per month in its automated cell therapy system (“ACTS”) manufacturing cell. ACP-01 is created from the patient’s blood. Six published studies of ACP-01, and a retrospective study of 53 consecutively treated ischemic cardiomyopathy patients, 345 study subjects in total, demonstrate ACP-01 is safe and preliminarily efficacious in the treatment of critical limb ischemia, angina, ischemic and dilated cardiomyopathy. The Company is selling ACP-01 forward on an exempt compassionate basis (see press release of March 7th) while it completes its clinical trials to obtain exclusive market access for certain medical indications. For more information, please visit www.hemostemix.com.
For further information, please contact:
Thomas Smeenk, President, CEO & Co-Founder
EM: tsmeenk@hemostemix.com
PH: 905-580-4170
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 mayface; 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.
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