HEMOSTEMIX RECEIVES FDA SUPPORT FOR ITS BASKET PROTOCOL …
Jan 16, 2026 · Hemostemix completed its Phase II clinical trial for chronic limb threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science.
Hemostemix Inc. Announces FDA Pre-IND Meeting and NBPP of …
Dec 18, 2025 · Hemostemix will present its clinical rationale, manufacturing platform, and regulatory pathway, to advance toward FDA clearance of its Phase I basket clinical trial of ACP-01.
Hemostemix Receives FDA Support for Its Basket Protocol Approach
Jan 16, 2026 · "The FDA's guidance supports Hemostemix' basket protocol strategy, and collection of RWE, enabling the Company to advance across multiple ischemic diseases," stated Thomas …
Hemostemix (TSXV:HEM) Completes Pre-IND Meeting with FDA
Jan 18, 2026 · Hemostemix completed its Phase II clinical trial for chronic limb threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science.
FDA signals support for Hemostemix basket protocol approach
Jan 19, 2026 · Regulatory commentary and a community submission note that Hemostemix received favorable engagement from the FDA for its basket protocol strategy, according to a public post.
Hemostemix Receives FDA Support for Its Basket Protocol Approach
Jan 16, 2026 · Hemostemix will address the FDA's guidance in its IND submission; in its clinical practice, and guidelines. The Company also received the FDA's guidance on its plan to capture ACP-01 real …
Hemostemix Inc. Announces FDA Pre-IND Meeting and NBPP of …
Dec 10, 2025 · Hemostemix will present its clinical rationale, manufacturing platform, and regulatory pathway, to advance toward FDA clearance of its Phase I basket clinical trial of ACP-01.
Hemostemix Receives FDA Support for Its Basket Protocol Approach
Jan 16, 2026 · 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.
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FDA backs Hemostemix: regulator signals support for basket protocol
Jan 18, 2026 · BioBriefs delivers the industry’s 10 must-know updates, every morning. Hemostemix received formal support from the U.S. Food and Drug Administration for its basket protocol approach, …