Hemostemix Inc. (TSXV: HEM | OTCQB: HMTXF | FSE: 2VF0) has developed an effective “stem cell therapy” for the treatment of ischemic (lack of blood flow) disease and several other diseases including cardiomyopathy (heart tissue disease) and neuropathy (nerve cell disease). Hemostemix’s initial goal is to treat heart attack (ischemic heart disease) and various ischemic conditions such as ischemic limb disease.

Hemostemix’s Product Platform (targets to repair) – ACP-01 (blood vessel cells), NCP-01 (nerve cells), CCP-01 (heart cells)

Source: Hemostemix company presentation

Hemostemix’s leading product is called ACP-01. It refers to Hemostemix’s first stem cell treatment called angiogenic cell precursor (“ACP”) one (“01”). The ACP technology uses a patient’s own stem cells to treat that patient’s disease by extracting the stem cells, growing the number of cells within 7 days, then using them to treat the patient with their own harvested stem cells. According to Hemostemix: “ACP-01 has been used as a treatment of 500 subjects, studied in including clinical trials, and are demonstrated to be completely safe and effective as a treatment of Angina, Dilated and Ischemic Cardiomyopathy, Peripheral Arterial Disease and Critical Limb Ischemia.”

Hemostemix plans to increase production of their ACP stem cell therapy for ischaemic disease

In some recent news announced in January this year, Hemostemix has ramped up their team in order to increase the production of ACP-01. Hemostemix President and CEO, Thomas Smeenk, stated: “Adding four employees to our team enables Hemostemix to produce up to 20 ACP treatments per month for clinical trials and compassionate treatments approved by regulators……We expect up to 174 revenue production slots for the first full year of production. To fill them and balance our production schedule, we are working on a forward sales plan.“

A “sales plan” suggests that the commercialization of ACP is potentially in the near term.

In a recent InvestorIntel CEO video, Thomas Smeenk revealed more about Hemostemix’s master plan. He said Hemostemix’s goal is to scale up production of ACP to “4,000 or more batches per month” and “the numbers are very significant, at $25,000 per treatment…$30,000 per treatment…..the numbers get very large very fast”.

Hemostemix’s scalable production plans over a 60-month period

Hemostemix’s sales target is to reach $360 million of risk-adjusted sales in 2027 (see below or page 14). Quite impressive given Hemostemix’s current market cap is C$16 million.

Hemostemix’s sales target is to reach $360 million of risk-adjusted sales in 2027

Source: Hemostemix company presentation

Is Hemostemix’s stem cell therapy effective?

Hemostemix’s ACP treatments have been successful to date. For example, in a 2019 Phase II CLI Trial with 12 randomized double-blind subjects, the results included: “Healing of ulcers and resolution of ischemic rest pain occurred in 10 of the 12 patients (83%). There were no clinically significant safety issues. Outcomes were maintained for up to 4.5 years……“

You can see more results including pictures in a past InvestorIntel article here.

Closing remarks

Some risks apply and there is still work ahead for Hemostemix to implement its plan of action. At this stage, the Company has received US FDA Clinical Trial approval and further regulatory approvals may be necessary, as well as further funding to achieve the Company’s goals.

The best companies develop effective products that both help society and fill a strong need. Tesla (NASDAQ: TSLA) is doing this with electric vehicles (EVs) and sustainable energy. Hemostemix is working towards becoming a leading biotech health company using stem cells to significantly help some of society’s most common and severe diseases. They have already won the World Economic Forum Technology Pioneer Award, have proven their treatment efficacy in clinical trials, and have a highly qualified management team and reputable advisors.

2023 could potentially be a breakout year for Hemostemix Inc.

Since we last covered Hemostemix where they released the promising results of their retrospective study of heart disease and the phase II clinical trial results of ACP-01 as a treatment for critical limb ischemia, their team has been making serious moves.

You may recall that Hemostemix Inc. (TSXV: HEM | OTCQB: HMTXF) is developing new treatments to treat ischemic (restricted blood flow) diseases by collecting a patient’s own cells from their blood and manufacturing a personalized regenerative therapy that can be administered to a patient within 7 days. The efficient, scalable, and cost-effective platform has the potential to generate therapies for a broad range of ischemic diseases.

In a quartet of recent press releases, Hemostemix announced the addition of four new distinguished members to its Scientific Advisory Board – Dr. Terry Hébert, Ph.D., Dr. Nadia Giannetti, MD, Dr. Johannes Grillari, and Dr. Renzo Cecere, MD, FRCSC. They are all internationally recognized experts in their respective fields with a wealth of experience in cardiovascular care, clinical research, and drug development.

Through his research, Dr. Hébert strives to improve our understanding of G protein-coupled receptor (GPCR) and G protein signaling architectures to enhance drug discovery for heart disease and other serious diseases. Dr. Hébert’s expertise will be a valuable asset to the Hemostemix team as they continue to work to develop innovative treatments for patients with cardiovascular disease.

Dr. Giannetti is a highly respected researcher and physician who has worked with more than 1000 patients with heart failure. She is a clinical researcher interested in improving care and outcomes for patients with heart failure and dilated cardiomyopathy. She is also the co-principal investigator of a large initiative looking at the role of stem cells in personalized therapy for cardiomyopathy, making her an excellent addition to Hemostemix’s Scientific Advisory Board.

Dr. Grillari is a renowned expert on cellular aging and tissue regeneration, with over 20 years of research experience in the field. His appointment will bring a wealth of knowledge and expertise to the Hemostemix team and will help to further their understanding of the molecular and physiological changes that occur during cell aging. His contributions will be invaluable in helping their team to achieve their goal of improving heart disease patient outcomes.

Dr. Cecere is an expert in the field of stem cell research and has been investigating novel methods to strengthen the stem-cell-induced regeneration of infarcted heart tissue for over a decade. In fact, Dr. Cecere’s recent publication–systematic review and meta-analysis–demonstrates that stem cells, along with bioactive scaffolds, provide enhanced tissue regeneration in animal models of myocardial infarction (MI) compared to stem cells injected alone.  His study gives more backing to the theory that ACP-01 bioactive scaffolds improve stem cell-induced repair after a patient suffers a MI.

The new Scientific Advisory Board members’ experience should greatly assist in advancing to their phase II clinical trial, a step towards the goal of bringing ACP-01 to market and potentially improving the lives of heart failure patients around the world.

Hemostemix is also poised to gain more value from its NCP-01, which are autologous neuronal cell precursors. These precursors have the potential to treat the central and peripheral nervous systems. Hemostemix has announced Mr. Thomas Abraham has been appointed as President of PreCerv Inc., a wholly owned subsidiary of Hemostemix. PreCerv has obtained a global field of use license to NCP-01 and its autologous stem cell technologies from Hemostemix. This license will allow PreCerv to fund its studies to unlock NCP’s value for the shareholders of Hemostemix. Mr. Abraham is a highly accomplished business professional with more than 25 years of experience in financing, business development, governance, and risk management. He will be responsible for financing and leading the team that studies, develops, and commercializes NCP-01 and ACP-01 in the neuronal field, and bringing them to market for the benefit of patients suffering from neurological diseases.

Success for a public company often owes a lot to the team and talent it assembles, especially in the field of biotech and therapeutics. With these additions, Hemostemix has taken a big step toward advancing its suite of products in development.

Heart failure (HF) is a growing epidemic in the United States, with an estimated 6 million people affected. HF is a debilitating condition that can significantly reduce patient quality of life and, in severe cases, prove fatal. Within five years of hospitalization, the death rate for HF patients ranges from 45% to 60%. Given the high mortality rate and the significant impact on quality of life, there is a great need for effective treatments for HF.

Stem cell therapy has been touted as a revolutionary medical treatment for a variety of conditions for some time. Stem cells have a number of properties, including paracrine and anti-inflammatory effects, that are potentially useful for conditions where conventional medical treatments do not lead to enough optimal patient outcomes.

Acute cardiac progenitor cells (ACP-01) have emerged as a promising therapeutic option for HF. These cells have the ability to replace damaged cells, stimulate new blood vessel growth, and reduce inflammation. One company, in particular, has been working for years to develop and commercialize these cells in new treatments.

Hemostemix Inc. (TSXV: HEM | OTCQB: HMTXF) is developing new treatments to treat ischemic (restricted blood flow) diseases. Hemostemix’s technology uses a patient’s own cells, collected through a simple blood draw, to treat that patient’s disease. Its proprietary technology collects synergetic cell population and manufactures a personalized regenerative therapy that can be administered to a patient within 7 days of the initial cell collection. The efficient, scalable, and cost-effective platform has the potential to generate therapies for a broad range of ischemic diseases.

On August 30th, 2022, Hemostemix announced the results of their retrospective study of heart disease and the phase II clinical trial results of  ACP-01 as a treatment for critical limb ischemia.

In the heart disease study, patients received a direct injection into the heart, or a balloon angioplasty-like release of ACP-01 into the heart’s vasculature to address either hardening of the arteries (ischemic cardiomyopathy), or thickening of the heart wall (dilated cardiomyopathy).

The study showed that ACP-01 positively affects cardiac function in patients with both types of severe heart failure. The researchers measured cardiac function in terms of the volume of blood the heart pumps with each beat, the ejection fraction of the left ventricle (LVEF%) before and after ACP treatment at an average of 4 and 12 months. It was found that the LVEF% was increased by 16.08% in all patients at first follow-up and by 26.88% on final follow-up. These results suggest that ACP-01 may be a viable treatment option for patients with severe heart failure.

The results of ACP-01 treatment for critical limb ischemia showed that ACP-01 was safe, trended to improve the healing of ulcers at 3, 6, and 12 months, and trended to a reduction in pain at 12 months. In a previous randomized trial of 20 subjects, after 2 years there were no deaths and 7 of 10 limbs were saved from amputation, compared to the control group where 2 patients died and 6 of 8 limbs were lost to amputation. Hemostemix’s press release noted that its previous management team truncated the trial to 65 subjects, which effected the power of the study. The overall encouraging results of these studies showcase the need for further clinical trials of ACP-01.

Thomas Smeenk, CEO of Hemostemix, commented in the press release that the results show ACP-01 is safe and statistically effective as a treatment of heart disease, safe as a treatment of critical limb ischemia, and worthy of additional clinical trials. “Proving the efficacy of ACP-01 in prospective, blinded, randomized clinical trial, to gain regulatory approval is next,” he said.

Hemostemix has said that its next move is to go “forward with a phase II clinical trial of heart disease financed, ideally, through a partnership.” Clinical trials can be expensive, and it is not uncommon for smaller biotechnology companies to partner with larger companies or pharmaceutical giants to fund their way through different levels of trials to regulatory approval, provided early results are promising. Hemostemix’s results could well attract the right kind of attention.