Calgary, Alberta--(Newsfile Corp. - August 12, 2026) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company") is pleased to announce the appointment of Prof. Dr. Ernst von Schwarz, MD, PhD, FESC, FACC, FSCAI, as Principal Investigator of Hemostemix' VesCell™ (ACP-01) longevity clinical trial.
The study is designed to investigate whether Hemostemix' VesCell™ can improve measurable dimensions of longevity including cardiovascular health associated with health-span (healthy active aging), improvements in muscle function as measured by the six minute walk test, cognitive function, and immune system improvement as measured by decreased inflammation.
About Prof. Dr. Ernst von Schwarz
Dr. von Schwarz brings more than three decades of cardiovascular, academic and regenerative-medicine experience to the study. Triple board certified as a transplant surgeon, cardiologist and physician-scientist at Cedars-Sinai Medical Center and UCLA, Dr. von Schwarz has published more than 150 scientific papers, including as co-author of Hemostemix' retrospective study evaluating transcatheter implantation of VesCell in patients with ischemic and non-ischemic cardiomyopathy. He joined Hemostemix' Scientific Advisory Board in 2022; and, he joined Phase II investigator Dr. York Hsiang in Hemostemix' educational webinar, When Standard Heart Treatment Isn't Enough, May 2026.
Most recently, Dr. von Schwarz is the featured expert in HeartCode, a powerful and emotionally charged documentary that details how most heart-related deaths are preventable, and how longevity is achievable. "There is an important connection between cardiovascular health and longevity: our organs cannot remain healthy without adequate circulation," said Dr. von Schwarz. "The VesCell™ data to-date supports a properly designed longevity study, to measure whether cardiovascular function, physical capacity, quality of life and other objective markers of health-span can be preserved and improved; and, I look forward to answer these questions rigorously," he said.
From Restoring Circulation to Extending Health-span: Longevity
The Longevity trial is designed to generate clinical evidence that support participation in health-span 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 as defined by the 6 minute walk test, improved cognition and immune system function, which Hemostemix' clinical results mirror.
For example, in the study co-authored by Dr. von Schwarz, subjects with a left ventricle ejection fraction below 20% improved from a mean LVEF of 14.6% before treatment to 28.4% at final follow-up, representing a 94.5% relative improvement (p < 0.003), which is consistent with improvement in Subjects' six minute walk test.
Improved 6 Minute Walk Test and Improved Heart Function: 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 at 6 months 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).
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' 41 patient Phase I, NYHA classification decreased from Class IV/III to Class III/II at 180 days, p<0.05, reflecting substantially better daily function and fewer heart-failure symptoms (Arom et al., 2008).
In Hemostemix' Phase I ischemic 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:
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.
"Dr. von Schwarz is uniquely qualified to lead this study because his career sits precisely at the intersection of cardiovascular medicine, regenerative medicine and longevity," said Thomas Smeenk, CEO. "Combined with his work on HeartCode, Dr. von Schwarz is recognized as an expert who details how to extend healthy, fully functional life well past age 100! That is a very significant global business for Hemostemix," Smeenk said.
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 & CEO
Hemostemix Inc.
Email: tsmeenk@hemostemix.com
Phone: 905-580-4170
Forward-Looking Information
This news release contains forward-looking information within the meaning of applicable Canadian securities legislation, including statements concerning the proposed longevity clinical trial, its design, regulatory approvals, commencement, enrollment, endpoints and potential clinical applications of VesCell™ (ACP-01). Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. There can be no assurance that the proposed clinical trial will commence as contemplated, receive required approvals, achieve its proposed endpoints or demonstrate safety or efficacy for any indication. Readers should not place undue reliance on forward-looking information.
VesCell™ (ACP-01) remains investigational, and statements regarding its potential applications should not be interpreted as establishing safety or efficacy for longevity or any indication not authorized by the applicable regulatory authority.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/309315
The study is designed to investigate whether Hemostemix' VesCell™ can improve measurable dimensions of longevity including cardiovascular health associated with health-span (healthy active aging), improvements in muscle function as measured by the six minute walk test, cognitive function, and immune system improvement as measured by decreased inflammation.
About Prof. Dr. Ernst von Schwarz
Dr. von Schwarz brings more than three decades of cardiovascular, academic and regenerative-medicine experience to the study. Triple board certified as a transplant surgeon, cardiologist and physician-scientist at Cedars-Sinai Medical Center and UCLA, Dr. von Schwarz has published more than 150 scientific papers, including as co-author of Hemostemix' retrospective study evaluating transcatheter implantation of VesCell in patients with ischemic and non-ischemic cardiomyopathy. He joined Hemostemix' Scientific Advisory Board in 2022; and, he joined Phase II investigator Dr. York Hsiang in Hemostemix' educational webinar, When Standard Heart Treatment Isn't Enough, May 2026.
Most recently, Dr. von Schwarz is the featured expert in HeartCode, a powerful and emotionally charged documentary that details how most heart-related deaths are preventable, and how longevity is achievable. "There is an important connection between cardiovascular health and longevity: our organs cannot remain healthy without adequate circulation," said Dr. von Schwarz. "The VesCell™ data to-date supports a properly designed longevity study, to measure whether cardiovascular function, physical capacity, quality of life and other objective markers of health-span can be preserved and improved; and, I look forward to answer these questions rigorously," he said.
From Restoring Circulation to Extending Health-span: Longevity
The Longevity trial is designed to generate clinical evidence that support participation in health-span 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 as defined by the 6 minute walk test, improved cognition and immune system function, which Hemostemix' clinical results mirror.
For example, in the study co-authored by Dr. von Schwarz, subjects with a left ventricle ejection fraction below 20% improved from a mean LVEF of 14.6% before treatment to 28.4% at final follow-up, representing a 94.5% relative improvement (p < 0.003), which is consistent with improvement in Subjects' six minute walk test.
Improved 6 Minute Walk Test and Improved Heart Function: 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 at 6 months 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).
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' 41 patient Phase I, NYHA classification decreased from Class IV/III to Class III/II at 180 days, p<0.05, reflecting substantially better daily function and fewer heart-failure symptoms (Arom et al., 2008).
In Hemostemix' Phase I ischemic 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.
"Dr. von Schwarz is uniquely qualified to lead this study because his career sits precisely at the intersection of cardiovascular medicine, regenerative medicine and longevity," said Thomas Smeenk, CEO. "Combined with his work on HeartCode, Dr. von Schwarz is recognized as an expert who details how to extend healthy, fully functional life well past age 100! That is a very significant global business for Hemostemix," Smeenk said.
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 & CEO
Hemostemix Inc.
Email: tsmeenk@hemostemix.com
Phone: 905-580-4170
Forward-Looking Information
This news release contains forward-looking information within the meaning of applicable Canadian securities legislation, including statements concerning the proposed longevity clinical trial, its design, regulatory approvals, commencement, enrollment, endpoints and potential clinical applications of VesCell™ (ACP-01). Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. There can be no assurance that the proposed clinical trial will commence as contemplated, receive required approvals, achieve its proposed endpoints or demonstrate safety or efficacy for any indication. Readers should not place undue reliance on forward-looking information.
VesCell™ (ACP-01) remains investigational, and statements regarding its potential applications should not be interpreted as establishing safety or efficacy for longevity or any indication not authorized by the applicable regulatory authority.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/309315