Mr. Thomas Smeenk reports

HEMOSTEMIX RECEIVES FDA SUPPORT FOR ITS BASKET PROTOCOL APPROACH

Hemostemix Inc. has successfully completed its preinvestigational new drug (pre-IND) meeting with the United States Food and Drug Administration (FDA).

Hemostemix' team included Thomas Smeenk, chief executive officer; Dr. Ina Sarel, Chief scientific officer; Dr. Fraser Henderson, chief medical officer, professor of neurosurgery and a practising neurosurgeon; Dr. Ernst von Schwarz, a triple board-certified transplant surgeon, cardiologist and renowned stem cell researcher; and Dr. William Shankle, a neurologist specializing in the prevention, diagnosis and management of vascular dementia and Alzheimer's.

Basket protocol

The FDA provided guidance indicating that the company's basket protocol approach is acceptable, subject to the inclusion of clearly defined eligibility criteria, appropriate handling of patient heterogeneity, and rigorous clinical and statistical design. The basket protocol is designed to evaluate ACP-01 across multiple ischemic and vascular-related conditions that share common underlying pathophysiology, while maintaining clinically meaningful cohort definitions and appropriate analytical methods. Hemostemix will address the FDA's guidance in its IND submission; in its clinical practice, and guidelines.

Real world evidence (RWE)

The company also received the FDA's guidance on its plan to capture ACP-01 real-world data in jurisdictions such as Florida, Canada and The Bahamas. The guidance supports the collection of RWE that is structured in a manner consistent with FDA's publications, which addresses patient privacy, safety and data integrity.

Next regulatory milestones

"The FDA's guidance supports Hemostemix's basket protocol strategy, and collection of RWE, enabling the company to advance across multiple ischemic diseases," stated Thomas Smeenk, chief executive officer. "We are incorporating the FDA's feedback in our IND submission, data models and statistical analyses of patients treated with ACP-01," Mr. Smeenk said.

Hemostemix is proceeding with the filing of its IND, including the submission of product comparison validation studies. The company will news release updates throughout the process.

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, 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 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 II 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, wound healing in 83 per cent of patients followed for up to 4.5 years, as a midpoint result.

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