Calgary, Alberta — January 16, 2026 — Leads & Copy — Hemostemix Inc., an autologous stem cell company focused on treating pain from various conditions, has announced the successful completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA).
The FDA has indicated that Hemostemix’s basket protocol approach for evaluating ACP-01 across multiple ischemic and vascular-related conditions is acceptable, pending the inclusion of well-defined eligibility criteria, appropriate handling of patient heterogeneity, and rigorous clinical and statistical design. The company intends to address the FDA’s guidance in its IND submission, clinical practice, and guidelines.
The company also received guidance on its plan to capture ACP-01 real-world data (RWE) in Florida, Canada, and The Bahamas. According to the announcement, this supports the collection of RWE structured in a manner consistent with FDA’s publications, addressing patient privacy, safety, and data integrity.
Hemostemix’ team at the pre-IND meeting included CEO Thomas Smeenk; Chief Scientific Officer Dr. Ina Sarel; Chief Medical Officer, Professor of Neurosurgery, and neurosurgeon Dr. Fraser Henderson; transplant surgeon, cardiologist and stem cell researcher Dr. Ernst von Schwarz; and neurologist Dr. William Shankle.
CEO Thomas Smeenk stated that the FDA’s guidance supports Hemostemix’s basket protocol strategy and collection of RWE, which will enable the company to advance across multiple ischemic diseases. Hemostemix is incorporating the FDA’s feedback into its IND submission, data models, and statistical analyses of patients treated with ACP-01.
The company is proceeding with the filing of its IND, including the submission of product comparison validation studies, and will provide updates throughout the process.
Hemostemix, founded in 2003, is an autologous stem cell therapy platform company and a World Economic Forum Technology Pioneer Award winner. The company has developed, patented, is scaling and selling its autologous blood-based stem cell therapy, VesCell™ (ACP-01). According to the release, Hemostemix has completed seven clinical studies of 318 subjects and published its results in eleven peer-reviewed publications, with ACP-01 demonstrating safety, clinical relevance, and statistical significance as a treatment for various conditions.
Hemostemix completed its Phase II clinical trial for chronic limb threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science. Data reported to the 41st meeting of vascular surgeons showed 0% mortality, cessation of pain, and wound healing in 83% of patients followed for up to 4.5 years, compared to a five-year mortality rate of 50% in the CLTI patient population.
For further information, please contact: Thomas Smeenk, President, CEO EM: tsmeenk@hemostemix.com / PH: 905-580-4170
Source: Hemostemix Inc.
