Hemostemix Receives FDA Support for Its Basket Protocol Approach

Core Insights - Hemostemix Inc. has successfully completed its pre-Investigational New Drug (pre-IND) meeting with the U.S. FDA, which is a significant step for the company in advancing its autologous stem cell therapy for various ischemic conditions [1][5]. Company Overview - Hemostemix is an autologous stem cell therapy platform company founded in 2003, recognized as a World Economic Forum Technology Pioneer. The company has developed and patented VesCell™ (ACP-01), a blood-based stem cell therapy [7]. - The company has conducted seven clinical studies involving 318 subjects, with results published in eleven peer-reviewed publications. ACP-01 has shown safety and clinical relevance as a treatment for several conditions, including peripheral arterial disease and chronic limb threatening ischemia [7]. FDA Guidance and Protocols - The FDA has provided guidance on Hemostemix's basket protocol approach, which is deemed acceptable provided it includes clearly defined eligibility criteria and rigorous clinical design. This protocol aims to evaluate ACP-01 across multiple ischemic and vascular-related conditions [3]. - The FDA also supported the company's plan to capture real-world evidence (RWE) for ACP-01 in jurisdictions such as Florida, Canada, and The Bahamas, emphasizing the importance of patient privacy and data integrity [4]. Next Steps and Regulatory Milestones - Hemostemix is moving forward with the filing of its IND, which will include product comparison validation studies. The company plans to release updates throughout this process [6]. - The CEO of Hemostemix, Thomas Smeenk, stated that the FDA's guidance will enable the company to advance its strategy across multiple ischemic diseases, incorporating FDA feedback into their IND submission and data models [5].