Hemostemix Receives FDA Support for Its Basket Protocol Approach

Executive Summary

• Hemostemix Inc. announced successful completion of its pre‑Investigational New Drug (pre‑IND) meeting with the U.S. FDA, receiving guidance that its basket protocol approach is acceptable.
• The FDA also approved the company’s plan to collect real‑world evidence (RWE) across Florida, Canada and The Bahamas, supporting future IND filing.
• Hemostemix will incorporate the feedback into its upcoming IND submission for ACP‑01 and will provide further updates as the process advances.

Key Details

• Pre‑IND Meeting Outcome: FDA indicated that Hemostemix’s basket protocol—evaluating ACP‑01 across multiple ischemic and vascular conditions—is acceptable, provided eligibility criteria, patient heterogeneity handling, and rigorous clinical/statistical design are clearly defined.
• RWE Guidance: FDA endorsed the company’s strategy to capture real‑world data on ACP‑01 in Florida, Canada, and The Bahamas, emphasizing compliance with privacy, safety, and data integrity standards.
• Next Steps: Hemostemix will address FDA guidance in its IND submission, refine clinical practice guidelines, and continue product comparison validation studies.
• Leadership Involved: CEO Thomas Smeenk, CSO Dr. Ina Sarel, CMO Dr. Fraser Henderson, among other senior scientific and medical officers, participated in the meeting.
• Forward‑Looking Statements: The release contains forward‑looking information regarding IND filing, clinical trial plans, potential financing needs, and regulatory approvals.

Notable Quotes

“The FDA's guidance supports Hemostemix' basket protocol strategy, and collection of RWE, enabling the Company to advance across multiple ischemic diseases,” – Thomas Smeenk, CEO.
“We are incorporating the FDA's feedback in our IND submission, data models and statistical analyses of patients treated with ACP‑01.” – Thomas Smeenk, CEO.