13:55:52 EDT Tue 28 Jul 2026
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Hemostemix Inc.
Symbol HEM
Shares Issued 204,996,448
Close 2026-07-27 C$ 0.06
Market Cap C$ 12,299,787
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ORIGINAL: Hemostemix' Longevity Phase I Clinical Trial Leveraging VesCell(TM)'s Excellent Results

2026-07-28 12:14 ET - News Release

Calgary, Alberta--(Newsfile Corp. - July 28, 2026) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company"), an autologous (patient's own stem cells) regenerative medicine company is pleased to announce the VesCell™ Phase I Longevity Clinical Trial protocol has been drafted.

The longevity protocol represents an important milestone in Hemostemix's strategy to expand the clinical application of VesCell™ beyond the treatment of cardiovascular diseases, toward improving healthspan—the number of years people enjoy health, pain free, remaining active, strong, independent, mentally sharp and cognitively competent.

The commercial Phase I clinical trial is designed to study and leverage how VesCell™ improves multiple measures of healthspan, including patient reported quality of life, muscle mass (cardiac performance), improved cognition, immune system health, physical performance, and functional independence.

Hemostemix' Excellent Phase I Quality of Life Survey Results

In Hemostemix' ischemic Phase I cardiomyopathy study, 30 patients with paired SF-36 assessments at three and six months showed increases across all eight quality-of-life domains, with statistically significant improvements:

  • 58% improvement In Physical Functioning from 37.83 to 60.09—an increase of 22.26 points, p<0.001;

  • 92% improvement in Role Limitations due to physical health from 31.89 to 61.21—up 29.32, p<0.001;

  • 56% improvement in General Health from 34.79 to 54.57—up 19.78 points, p<0.001;

  • 48.6% improvement in Vitality from 39.58 to 58.82—up 19.24 points, p=0.001;

  • 24% improvement in Social Functioning from 60.83 to 75.42—up 14.59 points, p=0.014.

  • 30.8% improvement in the Physical Component Summary, from 30.75 to 40.21, up 9.46 points, p<0.001

SF 36 Survey and P Values Explained

The SF-36 is a validated questionnaire that measures changes in quality of life based on physical health, pain, energy, emotional well-being and ability to perform everyday activities. A result of p<0.05 means there is less than a 5% probability that the observed difference arose from random variation alone, the conventional threshold for statistical significance. In Hemostemix' clinical trials, findings less than p<0.05 provide increasingly strong evidence that the improvements were not due to chance.

Thomas Smeenk, CEO, said: "Given our results exactly mirror the requirements to win a nine figure longevity competition, a commercial VesCell™-based longevity clinical trial in healthy adults makes sense. Why wait for disease-related degeneration when VesCell™ is designed to restore circulation, cognition, increase exercise capacity, and improve the immune system by reducing inflammation?"

The Longevity trial is designed to generate clinical evidence that support participation in Healthspan competitions, some which offer up to US$101 million in prize funding to accelerate innovations that improve healthy human aging. One such competition measures longevity as increases in muscle capacity (6 minute walk test), cognition, and immune system function, which Hemostemix's results mirror.

Improved 6 Minute Walk Test as a Result of Increased Heart Function

The six-minute walk test measures the increased (decreased) distance a person can walk on a flat surface in six minutes before and after treatment. In the Phase I Angina trial, mean six-minute walk distance increased 81.3 meters post treatment at 3 months, p<0.001 and remained as an increase of 79.6 meters 6 months post treatment from baseline, p<0.001 (Tresukosol et al., 2006). In the same study, the proportion of heart that was suffering from inadequate blood circulation improved 45.3% Myocardial perfusion defects decreased 37.9% at three months, p<0.004, and decreased by 45.3% at six months from baseline, p<0.005 (Tresukosol et al., 2006). Improved cardiac function is consistent with an 80 meter improvement in the six minute walk test.

Increased Volume of Blood Ejected with Each Heart Beat

Among patients with the most severe cardiomyopathybaseline LVEF below 20% (less than 1/3 normal)mean LVEF increased approximately 94.5% relative increase from 14.6%±3.4% before treatment to 28.4%±8.0% at final follow-up. Reversal of heart disease was recorded as the movement of patients into higher LVEF% categories (better functionality) which was statistically significant at final follow-up, p<0.004. (Schubart et al., 2023).

Reversal of Heart Failure as Measured by NYHA Classification

The New York Heart Association (NYHA) classification grades heart failure from Class I, where normal activity causes no symptoms, to Class IV (end stage), where shortness of breathe and chest symptoms occur even at rest. In Hemostemix Phase I, NYHA classification decreased from Class III/IV to Class II/III at 180 days, p<0.05. "These improvements reflect substantially better daily function and fewer heart-failure symptoms" (Arom et al., 2008).

Saving a Limb is Saving a Life

As compared to a five year mortality rate of 50% in the CLTI diabetes-based patient population, the UBC and U of T reported to the 41st meeting of vascular surgeons: 0% mortality, cessation of pain, wound healing in 83% of patients followed for up to 4.5 years, as a midpoint result in Hemostemix' Phase II trial.

Next Steps

The protocol is undergoing scientific review by investigators in regenerative medicine, cardiology, neurology, longevity medicine and biostatistics before submission under The Bahamas' Longevity and Regenerative Therapies Act for all required institutional, ethics, hospital and regulatory acknowledgements and approvals.

The Company will provide additional announcements as the program advances, including:

  • Appointment of the Principal Investigator.
  • Completion of scientific review.
  • Submission under the LARTA framework.
  • Ethics, institutional and regulatory acknowledgements and approvals.
  • Clinical site activation.
  • Enrollments and sales of Longevity Therapy Convertible Debentures
  • Interim clinical and biomarker results.

About VesCell™

VesCell™ (ACP-01) is an investigational autologous regenerative cell therapy manufactured from a patient's own blood. It is designed to promote angiogenesis and improve tissue perfusion by delivering angiogenic cell precursors to areas affected by ischemia. VesCell™ has been evaluated in 11 peer reviewed publications involving 498 treated patients across multiple cardiovascular and vascular indications.

About Hemostemix

Hemostemix is an autologous stem cell therapy platform company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, is scaling and selling autologous (patient's own) blood-based stem cell therapy, VesCell™ an investigational autologous stem cell therapy developed to support circulation in areas affected by diseases of ischemia. VesCell™ is derived from a patient's own blood and evaluated through structured clinical research. Hemostemix has completed seven clinical studies of 318 subjects and published its results in eleven peer reviewed publications. ACP-01 is safe, and appears clinically relevant as a treatment for peripheral arterial disease, chronic limb threatening ischemia, non ischemic dilated cardiomyopathy, ischemic cardiomyopathy, congestive heart failure, and angina. Hemostemix completed its Phase II clinical trial for chronic limb threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science. As compared to a five year mortality rate of 50% in the CLTI diabetes-based patient population, UBC and U of T reported to the 41st meeting of vascular surgeons: 0% mortality, cessation of pain, wound healing in 83% of patients followed for up to 4.5 years, as a midpoint result. For more information, please visit www.hemostemix.com.

For further information, please contact: Thomas Smeenk, President and CEO, 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, but is not limited to, the commercial Longevity Clinical Trial based in the Bahamas. Forward-looking information is based on assumptions and involves known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied by such forward-looking information, including the risk that the restatement process and adjustments may change, or that the non-brokered private placement may not close. 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 any litigation that Hemostemix is pursuing or defending (the "Litigation"), if any; 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.sedarplus.ca. 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/306926

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