Mr. Thomas Smeenk reports
HEMOSTEMIX INC. ANNOUNCES FDA PRE-IND MEETING AND NBPP OF $960,000
Hemostemix Inc. has seen two major corporate developments:
- The U.S. Food and Drug Administration has scheduled Hemostemix's basket protocol preinvestigational new drug application meeting for Jan. 16, 2026.
- Subject to TSX Venture Exchange 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 Jan. 16, 2026, to review the company's basket clinical trial protocol for the treatment of ischemia, including:
- Vascular dementia;
- Ischemic cardiomyopathy;
- Peripheral arterial disease;
- 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 1 basket clinical trial of ACP-01.
Non-brokered private placement
The company announces a non-brokered private placement of up to $960,000, consisting of the issuance of eight million common shares at a price of 12 cents 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 policies. The financing is subject to final TSX-V approval.
Chief executive officer 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 1 clinical trial? First, lantrida, an allogenic stem cell treatment, was approved on phase 1 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 percentage (ICM), wound healing (PAD), reduction of pain (general ischemia, ICM plus 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," Mr. 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 Inc.
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, has patented, is scaling and is 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 11 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 2 clinical trial for chronic limb-threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science. As compared with a five-year mortality rate of 50 per cent in the CLTI patient population, University of British Columbia and University of Toronto reported to the 41st meeting of vascular surgeons: 0 per cent mortality, cessation of pain and wound healing in 83 per cent of patients followed for up to 4.5 years as a midpoint result.
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