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Hemostemix Plans to Revolutionize Stem Cell Therapy with Scalable Production and New Sales Goals

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.




Thomas Smeenk provides an update on Hemostemix’s ACP-01 stem cell treatment for heart disease

Peter Clausi interviews Hemostemix Inc.’s (TSXV: HEM | OTCQB: HMTXF) Co-Founder, President and CEO Thomas Smeenk about an update on their stem cell therapeutics to treat heart diseases and critical limb ischemia. Providing an update on the production timeline for ACP-01, Thomas discusses how Hemostemix has strengthened its scientific advisory board.

Thomas talks about the appointment of Dr. Nadia Giannetti and Dr. Renzo Cecere, two of the world’s top cardiovascular physicians and stem cell scientists, as Co-Lead Medical Consultants, Cardiovascular Medicine and Clinical Trials. He explains how the recent addition to its scientific advisory board is a significant validation of ACP-01 to be “a first-to-patient approved therapeutic to treat heart disease and critical limb ischemia amongst other diseases of ischemia.”

To access the full InvestorIntel interview, click here

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About Hemostemix Inc.

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. Seven studies including 260 ACP-01 recipients define its safety and efficacy profile as a treatment for heart diseases such as Dilated and Ischemic Cardiomyopathy, Angina, and diseases of Ischemia such as Critical Limb Ischemia. The Company owns 91 patents across five patent families. For more information, please visit www.hemostemix.com.

To learn more about Hemostemix Inc., click here.

Disclaimer: Hemostemix Inc. is an advertorial member of InvestorIntel Corp.

This interview, which was produced by InvestorIntel Corp., (IIC), does not contain, nor does it purport to contain, a summary of all the material information concerning the “Company” being interviewed. IIC offers no representations or warranties that any of the information contained in this interview is accurate or complete.

This presentation may contain “forward-looking statements” within the meaning of applicable Canadian securities legislation. Forward-looking statements are based on the opinions and assumptions of the management of the Company as of the date made. They are inherently susceptible to uncertainty and other factors that could cause actual events/results to differ materially from these forward-looking statements. Additional risks and uncertainties, including those that the Company does not know about now or that it currently deems immaterial, may also adversely affect the Company’s business or any investment therein.

Any projections given are principally intended for use as objectives and are not intended, and should not be taken, as assurances that the projected results will be obtained by the Company. The assumptions used may not prove to be accurate and a potential decline in the Company’s financial condition or results of operations may negatively impact the value of its securities. Prospective investors are urged to review the Company’s profile on Sedar.com and to carry out independent investigations in order to determine their interest in investing in the Company.

If you have any questions surrounding the content of this interview, please contact us at +1 416 792 8228 and/or email us direct at [email protected].




Hemostemix posts promising clinical trial results from heart failure and limb ischemia treatment

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.




Thomas Smeenk of Hemostemix talks about market reaction to successful litigation settlement

In this InvestorIntel interview with host Stephen Lautens, Hemostemix Inc.’s (TSXV: HEM | OTCQB: HMTXF) Co-Founder, President and CEO Thomas Smeenk talks about Hemostemix achieving a major milestone this week by announcing it had successfully settled all litigation regarding its ownership of its intellectual property and the market’s immediate positive reaction.

In the interview, which can also be viewed in full on the InvestorIntel YouTube channel (click here), Thomas Smeenk talks about Hemostemix’s portfolio of autologous stem cell therapies that uses patient’s own blood to save limbs from amputation, treat heart diseases and other conditions of ischemia. With 91 patents issued worldwide, Thomas says that with the successful return of all of its intellectual property and clinical trial data, Hemostemix is now cleared to continue to move forward with its promising therapies.

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About Hemostemix Inc.

Hemostemix is a publicly traded autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company developed and has published seven peer reviewed articles about the safety and efficacy of its lead product ACP-01 as a treatment of CLI, PAD, Angina, Ischemic Cardiomyopathy, Dilated Cardiomyopathy and other conditions of ischemia. ACP-01 has been used to treat over 300 patients, and it is the subject of a randomized, placebo-controlled, double blind trial of its safety and efficacy in patients with advanced critical limb ischemia who have exhausted all other options to save their limb from amputation.

On October 21, 2019, the Company announced the results from its Phase II CLI trial abstract presentation entitled “Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Follow-up” which noted healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years.

The Company owns 91 patents across five patent families titled: Regulating Stem Cells, In Vitro Techniques for use with Stem Cells, Production from Blood of Cells of Neural Lineage, and Automated Cell Therapy.

To learn more about Hemostemix Inc., click here.

Disclaimer: Hemostemix Inc. is an advertorial member of InvestorIntel Corp.

This interview, which was produced by InvestorIntel Corp., (IIC), does not contain, nor does it purport to contain, a summary of all the material information concerning the “Company” being interviewed. IIC offers no representations or warranties that any of the information contained in this interview is accurate or complete.

This presentation may contain “forward-looking statements” within the meaning of applicable Canadian securities legislation. Forward-looking statements are based on the opinions and assumptions of the management of the Company as of the date made. They are inherently susceptible to uncertainty and other factors that could cause actual events/results to differ materially from these forward-looking statements. Additional risks and uncertainties, including those that the Company does not know about now or that it currently deems immaterial, may also adversely affect the Company’s business or any investment therein.

Any projections given are principally intended for use as objectives and are not intended, and should not be taken, as assurances that the projected results will be obtained by the Company. The assumptions used may not prove to be accurate and a potential decline in the Company’s financial condition or results of operations may negatively impact the value of its securities. Prospective investors are urged to review the Company’s profile on Sedar.com and to carry out independent investigations in order to determine their interest in investing in the Company.

If you have any questions surrounding the content of this interview, please contact us at +1 416 792 8228 and/or email us direct at [email protected].




Hemostemix’s stem cell therapy pursues ‘Your Fountain of Youth’

What’s a company worth to investors that could improve numerous medical conditions related to ischemia (lack of blood flow) and tissue damage, and potentially improve the quality of life? It would be hard to put a price on such a company if they could successfully commercialize or license their product or technology.

Today’s company, Hemostemix Inc. (TSXV: HEM | OTCQB: HMTXF | FSE: 2VFO), is having remarkable success, yet due to its early stage has a market cap of only C$19 million. That company is developing methods that use our own bodies’ stem cells to heal certain diseases. The key diseases of focus for now are those revolving around ischemia, such as heart disease, stroke, and diabetic vascular disease and its complications such as limb loss. Over the next year, there will also be a lot of work done on nerve cell regeneration.

Hemostemix Inc. is developing ‘stem cell therapy’ for the treatment of ischemic disease and several other diseases. Hemostemix owns 91 patents across five patent families titled: Regulating Stem Cells, In Vitro Techniques for use with Stem Cells, Production from Blood of Cells of Neural Lineage, and Automated Cell Therapy.

Results to date have been outstanding, as shown in the image below.

Hemostemix summary of the business and ACP-01

ACP-01 is Hemostemix’s pioneering first stem cell treatment called angiogenic cell precursor (“ACP”).  Hemostemix states: “ACP-01 has been used to treat over 300 patients, and it is the subject of a randomized, placebo-controlled, double-blind trial of its safety and efficacy in patients with advanced critical limb ischemia who have exhausted all other options to save their limb from amputation. On October 21, 2019, the Company announced the results from its Phase II CLI trial abstract presentation entitled “Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Follow-up” which noted healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years.”

Note: Bold emphasis by the author.

With such stunning success, it is little wonder that Hemostemix is very keen to protect their intellectual property.

On February 14, 2022 Hemostemix announced that they had “been granted International Trademark Registration No. 1624069 for Your Fountain of Youth, a registration that is valid for a period of 10 years.”  Hemostemix further announced on March 23, 2022 that it had resolved outstanding  litigation with a settlement agreement that requires the other parties to return all data and intellectual property in relation to ACP-01 in their possession to Hemostemix.

This is a great outcome for Hemostemix and good news to investors, as the Company believes their ACP-01 intellectual property is incredibly valuable.

Hemostemix has previously published numerous other studies proving the benefit of ACP-01, notably in the treatment of ischemia in various parts of the body. Some examples include improving ischemic cardiomyopathy patients and limb ischemia patients.

Note: NCP stands for Nerve Cell Precursor. CCP stands for Cardiac Cell Precursor. These are cultivated from the patient’s own stem cells using Hemostemix’s patented technologies.

What’s next for Hemostemix?

Apart from further studies, Hemostemix is now looking towards automating production, partnering and commercialization. The goal of improving stem cell production will help lower costs and potentially expand the business. Hemostemix also intends to advance their business development plans including possible licensing of their technology.

To help fund the above, Hemostemix recently announced a $2,750,000 Convertible Debenture offering.

Closing remarks

Hemostemix’s longer-term goal is to support a higher quality of life for all of us, a veritable “fountain of youth”, where we could boost our health yearly with our own stem cells to help repair our bodies.

Hemostemix trades on a market cap of C$19 million. Risk remains high due to the early stage, however there is truly blue sky potential if the Company can successfully license or commercialize their products in future years.




Revolutionizing the way we treat lack of blood flow diseases by using stem cell therapy

Every year modern medicine makes new breakthroughs that continue to amaze. Today’s company has a breakthrough ‘stem cell therapy,’ designed to regenerate diseased and damaged tissue, focused on patient’s with “ischemic” disease (a lack of blood flow) such as limb ischemia or ischemic heart disease (often leading to a heart attack). The company is a winner of the World Economic Forum Technology Pioneer Award.

Ischemic diseases are a huge global problem. For example, ischemic heart disease (also called coronary disease) affects around 126 million individuals, which is approximately 1.72% of the world’s population, annually. Nine million deaths per annum are caused by ischemic heart disease globally. Limb ischemia, often caused by diabetes, smoking, or age, is another huge area in need of innovative and better treatment.

Today’s company is stem cell therapy developer, Hemostemix Inc. (TSXV: HEM | OTCQB: HMTXF). Hemostemix’s stem cell therapy platform uses the patient’s own blood to harvest the stem cells and uses them in a  treatment that helps to restore circulation (blood flow) in damaged tissues.

Hemostemix’s leading product, ACP-01, has been used to treat over 500 patients, and it is the subject of a randomized, placebo-controlled, double blind trial of its safety and efficacy in patients with advanced critical limb ischemia (CLI) who have exhausted all other options to save their limb from amputation.

Hemostemix state on their website:

“Hemostemix’s proprietary platform technology is based on more than 10 years of clinical data demonstrating the ability of our autologous cell product to regenerate diseased and damaged tissue. Our efficient, scalable and cost-effective platform has the potential to generate therapies for a broad range of ischemic diseases. ACP-01, our lead clinical stage candidate, is an autologous cell therapy for the treatment of critical limb ischemia. ACP-01 is currently in a Phase 2 clinical trial in Canada and the United States.”

Note: Autologous refers to using the patient’s ‘own’ stem cells.

ACP-01 testing

Twelve patients with critical limb ischemia (CLI) and no interventional options were enrolled (10 male, 2 female, mean age 76 years) in an abstract trial test.

Hemostemix quote the results stating:

“Prior to treatment with ACP01 or placebo, 3 patients had ischemic rest pain, 8 patients had ulceration, and one patient had gangrene. Post treatment, one patient with unremitting rest pain and toe gangrene required a below knee amputation, and one patient with gangrene of the first to third toes required a forefoot amputation. Healing of ulcers and resolution of ischemic rest pain occurred in the other 10 (83%) patients. There were no clinically significant safety issues. Outcomes have been maintained for up to 4.5 years (3.5 years for 2 patients, 3 years for 1 and 1 patient died after ulcer healing secondary to congestive heart failure at 6 months).”

Hemostemix latest development for their leading product ACP-01

Hemostemix is currently working on the source document verification for their Phase II clinical trials for their lead product ‘ACP-01’ for the treatment of critical limb ischemia (CLI), peripheral artery disease (PAD), angina, ischemic cardiomyopathy, dilated cardiomyopathy and other conditions of ischemia. The document verification completion is expected to be completed by the end of 2021.

Note: Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies, followed hopefully by FDA approval.

Closing remarks

Hemostemix is revolutionizing the way we treat ischemic disease by using stem cells developed from a patient’s own blood. Abstract trials on ACP-01 led to an 83% success rate and the Company is now working towards Phase II trials.

Hemostemix is working towards revolutionizing the way we treat lack of blood flow, ischemic, diseases by using its stem cell therapy and has a market cap of C$11 million,

Further learning




Thomas Smeenk with an update on the FDA Phase II clinical trial program of the Hemostemix blood-derived, stem cell therapeutics product (ACP-01)

In a recent InvestorIntel interview, Peter Clausi speaks with Thomas Smeenk, Co-Founder, President and CEO of Hemostemix Inc. (TSXV: HEM | OTC: HMTXF) about the Phase II Clinical Trial on Hemostemix’s ACP-01 which has the potential to treat patients with severe critical limb ischemia.

In this InvestorIntel interview, which may also be viewed on YouTube (click here to subscribe to the InvestorIntel Channel), Thomas went on to say that Hemostemix is in the process of completing the source document verification. With about 60% of source documents verified, Thomas said that they expect the source document verification to be complete within the year.

To watch the full interview, click here

About Hemostemix Inc.

Hemostemix is a publicly traded autologous stem cell therapy company. A winner of the World Economic Forum Technology Pioneer Award, the Company developed and is commercializing its lead product ACP-01 for the treatment of CLI, PAD, Angina, Ischemic Cardiomyopathy, Dilated Cardiomyopathy and other conditions of ischemia. ACP-01 has been used to treat over 500 patients, and it is the subject of a randomized, placebo-controlled, double blind trial of its safety and efficacy in patients with advanced critical limb ischemia who have exhausted all other options to save their limb from amputation.

On October 21, 2019, the Company announced the results from its Phase II CLI trial abstract entitled “Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Followup” which noted healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years.

The Company owns 91 patents across five patent families titled: Regulating Stem Cells, In Vitro Techniques for use with Stem Cells, Production from Blood of Cells of Neural Lineage, and Automated Cell Therapy.

To know more about Hemostemix Inc., click here

Disclaimer: Hemostemix Inc. is an advertorial member of InvestorIntel Corp.

This interview, which was produced by InvestorIntel Corp. (IIC) does not contain, nor does it purport to contain, a summary of all the material information concerning the Company” being interviewed. IIC offers no representations or warranties that any of the information contained in this interview is accurate or complete. 

This presentation may contain “forward-looking statements” within the meaning of applicable Canadian securities legislation.  Forward-looking statements are based on the opinions and assumptions of management of the Company as of the date made. They are inherently susceptible to uncertainty and other factors that could cause actual events/results to differ materially from these forward-looking statements. Additional risks and uncertainties, including those that the Company does not know about now or that it currently deems immaterial, may also adversely affect the Company’s business or any investment therein.

Any projections given are principally intended for use as objectives and are not intended, and should not be taken,  as assurances that the projected results will be obtained by the Company. The assumptions used may not prove to be accurate and a potential decline in the Company’s financial condition or results of operations may negatively impact the value of its securities. Prospective investors are urged to review the Company’s profile on Sedar.com and to carry out independent investigations in order to determine their interest in investing in the Company.

If you have any questions surrounding the content of this interview, please email [email protected].