April 03, 2023 (Resource) – Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) (“Hemostemix” or the “Business“) is pleased to announce it is completing a second round of interviews with candidates who may possibly be a part of the business as Government Vice President, Company Progress. The EVP Company Improvement will be dependable for building and major a staff concentrated on the following:
- The sale of Tranch 1 – 500 ACP treatment method convertible debentures at USD $35,000 every single, to elevate USD $17.5M, a typically non-dilutive financing. Thereafter, the sale of tranche 2, etcetera., to finance manufacturing.
- Start the roll-up of United states-centered Podiatry clinics.
- Display to Podiatrists the impact to the clinic’s income and margins of the addition of exempt ACP-01 treatments. For illustration, model the sale of up to 16 ACP, 30 minute, aseptic CLI injection procedures for every day in maintaining with the stage II injection protocol.
- Promote and near podiatry clinicians on how they can monetize the benefit of their sweat equity, exchanging it for shares of Hemostemix.
- Give route and analyses of potential Podiatry clinic acquisitions globally, examining sector accessibility in the EU, Mexico, Central and South The united states, the Center East, India, Japan, and S. Korea.
- Use and manage articulate, multi-lingual, biotech-seasoned business progress revenue executives to boost the velocity of podiatry clinic acquisitions and ACP compassionate sales.
The five 12 months survival level 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 mobile treatment platform that involves angiogenic cell precursors, neuronal mobile precursor and cardiomyocyte cell precursors. Launched in 2003, a winner of the World Economic Forum Technologies Pioneer Award, the Corporation has created, patented, and is scaling by the close of 2027 the manufacture of 4,000 affected person treatment plans for every month in its automatic cell treatment technique (“ACTS”) producing cell. ACP-01 is established from the patient’s blood. 6 posted reports of ACP-01, and a retrospective analyze of 53 consecutively handled ischemic cardiomyopathy patients, 345 review subjects in total, show ACP-01 is harmless and preliminarily efficacious in the cure of crucial limb ischemia, angina, ischemic and dilated cardiomyopathy. The Firm is promoting ACP-01 forward on an exempt compassionate basis (see push launch of March 7th) when it completes its scientific trials to receive special market place access for selected healthcare indications. For more information, make sure you visit www.hemostemix.com.
For even further details, be sure to contact:
Thomas Smeenk, President, CEO & Co-Founder
EM: [email protected]
PH: 905-580-4170
Neither the TSX Undertaking Exchange nor its Regulation Support Company (as that phrase is described underneath the insurance policies of the TSX Enterprise Trade) accepts responsibility for the adequacy or accuracy of this release.
Forward-Searching Data: This news launch incorporates “forward-wanting information” in just the which means of applicable Canadian securities laws. All statements, other than statements of historic actuality, incorporated herein are ahead-wanting information and facts. In certain, this information release is made up of ahead-looking data in relation to: the funding of the Firm and its direct item ACP-01 and the commercialization of ACP-01 via the sale of compassionate therapies matter to exemption from regulatory approval. There can be no assurance that these types of ahead-wanting facts will establish to be correct. Genuine outcomes and foreseeable future events could differ materially from these expected in these ahead-seeking data. This forward-on the lookout information reflects Hemostemix’s present-day beliefs and is based mostly on information presently out there to Hemostemix and on assumptions Hemostemix believes are realistic. These assumptions include, but are not confined to: the fundamental worth of Hemostemix and its Prevalent Shares the profitable resolution of the litigation that Hemostemix is pursuing or defending (the “Litigation“) the outcomes of ACP-01 exploration, trials, experiments and analyses, including the assessment being equal to or far better than former research, trials or research the receipt of all essential regulatory approvals for exploration, trials or scientific studies the amount of exercise, market acceptance and current market developments in the healthcare sector the economy normally shopper interest in Hemostemix’s solutions and goods levels of competition and Hemostemix’s competitive pros and Hemostemix acquiring satisfactory financing to fund Hemostemix’s functions which include any research, trials or research, and any Litigation. Forward-hunting information is Subject to known and unfamiliar hazards, uncertainties and other variables that may cause the actual success, degree of action, performance or achievements of Hemostemix to be materially distinct from individuals expressed or implied by these forward-wanting data. This sort of pitfalls and other components may perhaps include, but are not constrained to: the skill of Hemostemix to entire clinical trials, complete a satisfactory analyses and file the effects of this sort of analyses to get regulatory approval of a section II or stage III medical trial of ACP-01 probable litigation Hemostemix mayface normal company, economic, competitive, political and social uncertainties general money industry disorders and market price ranges for securities hold off or failure to get board or regulatory approvals the actual benefits of future functions together with the real benefits of potential investigation, trials or reports competitors variations in legislation affecting Hemostemix the timing and availability of exterior financing on acceptable conditions long-term funds demands and long run developments in Hemostemix’s marketplaces and the markets in which it expects to compete absence of capable, qualified labour or loss of important individuals and risks related to the COVID-19 pandemic including a variety of recommendations, orders and steps of governmental authorities to try to limit the pandemic, together with journey restrictions, border closures, non-vital enterprise closures assistance disruptions, quarantines, self-isolations, shelters-in-location and social distancing, disruptions to markets, disruptions to economic exercise and financings, disruptions to offer chains and profits channels, and a deterioration of typical financial circumstances like a possible countrywide or international recession or depressionthe opportunity impact that the COVID-19 pandemic may well have on Hemostemix which could involve a reduced demand for the expert services that Hemostemix provides and a deterioration of fiscal marketplaces that could limit Hemostemix’s means to get external funding. A description of further danger variables that may possibly result in true final results to differ materially from forward-seeking facts can be identified in Hemostemix’s disclosure files on the SEDAR site at www.sedar.com. Even though Hemostemix has tried to identify critical elements that could bring about actual outcomes to differ materially from people contained in forward-on the lookout details, there could be other factors that lead to outcomes not to be as anticipated, approximated or intended. Readers are cautioned that the foregoing checklist of variables is not exhaustive. Visitors are even more cautioned not to position undue reliance on forward-looking information and facts as there can be no assurance that the strategies, intentions or anticipations on which they are placed will arise. Ahead-seeking data contained in this information launch is expressly qualified by this cautionary statement. The ahead-hunting information contained in this news release represents the expectations of Hemostemix as of the date of this news launch and, appropriately, it is Subject to improve immediately after these kinds of date. Even so, Hemostemix expressly disclaims any intention or obligation to update or revise any forward-searching information, regardless of whether as a final result of new details, future situations or normally, except as expressly essential by relevant securities legislation.