Calgary, Alberta -
Newsfile Corp. - December 10, 2025 -
Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company"), the leading autologous (patient's own) stem cell therapy company offering VesCell™ (ACP-01) to individuals suffering from vascular dementia, angina, ischemic cardiomyopathy, congestive heart failure, non-ischemic dilated cardiomyopathy, pain, total body ischemia, peripheral arterial disease and chronic limb threatening ischemia, with ACP-01 at Doctors Hospital, Nassau, The Bahamas, is pleased to announce two major corporate developments:
- The U.S. Food and Drug Administration (FDA) has scheduled Hemostemix's basket protocol Pre-IND meeting for January 16, 2026; and
- Subject to TSXV approval, the Company announces a non-brokered private placement of up to $960,000.
FDA Schedules Hemostemix Basket Protocol Pre-IND Meeting The FDA has scheduled Hemostemix's Pre-IND meeting for January 16, 2026 to review the Company's basket clinical trial protocol for the treatment of ischemia, including:
- Vascular dementia
- Ischemic cardiomyopathy
- Peripheral arterial disease (PAD)
- Generalized ischemia
The basket protocol unifies these conditions under a single ischemia-based mechanism of action for ACP-01. Hemostemix will present its clinical rationale, manufacturing platform, and regulatory pathway, to advance toward FDA clearance of its Phase I basket clinical trial of ACP-01.
Non-Brokered Private Placement (NBPP) The Company announces a non-brokered private placement of up to $960,000, consisting of the issuance of 8,000,000 common shares at a price of $0.12 per share, with no warrants. All securities issued will be subject to a four-month hold period in accordance with applicable securities laws and TSX Venture Exchange ("TSXV") policies. The financing is subject to final TSXV approval.
CEO Comment "The FDA Pre-IND meeting brings us closer to a unified ischemia-based clinical trial program," stated Thomas Smeenk, CEO. "It makes sense to address ischemia in multiple indications, given our success rate in these conditions as published in 11 peer reviewed articles. Why a Phase I clinical trial? First, Lantrida, an allogenic stem cell treatment, was approved on phase I only data. That is a precedent. Second, we can charge patients to be studied (treated) and followed. Third, we can publish the interim results and end points, comparing improvements in cognition (vascular dementia), LVEF% (ICM), wound healing (PAD), reduction of pain (general ischemia, ICM + PAD), and improvement in quality of life (all indications) for all participants. Plus, it generates a protocol for all patients who are treated, who do not meet inclusion criteria. Thus we study every patient treated with ACP-01 to generate the scientific basis for its approval," Smeenk said.
Use of Proceeds Proceeds will be used to advance:
- FDA regulatory preparations and meeting execution
- Clinical operations expansion in Florida, The Bahamas and Canada
- General corporate working capital
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™ (ACP-01). Hemostemix has completed seven clinical studies of 318 subjects and published its results in eleven peer reviewed publications. ACP-01 is safe, clinically relevant and statistically significant 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 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 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 the Phase I basket protocol...
