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Hemostemix Inc. Announces FDA Pre-IND Meeting and NBPP of $960,000
Calgary, Alberta--(Newsfile Corp. - December 10, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HM...
About this update from Hemostemix Inc
[{"type":"text","content":"Hemostemix Inc. Announces FDA Pre-IND Meeting and NBPP of $960,000Calgary, Alberta--(Newsfile Corp. - December 10, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) (\"Hemostemix\" or the \"Company\"), the leading autologous (patient's own) stem cell therapy company offering VesCell™ (ACP-01) to individuals suffering from vascular dementia, angina, ischemic cardiomyopathy, congestive heart failure, non-ischemic dilated cardiomyopathy, pain, total body ischemia, peripheral arterial disease and chronic limb threatening ischemia, with ACP-01 at Doctors Hospital, Nassau, The Bahamas, is pleased to announce two major corporate developments:The U.S. Food and Drug Administration (FDA) has scheduled Hemostemix's basket protocol Pre-IND meeting for January 16, 2026; andSubject to TSXV approval, the Company announces a non-brokered private placement of up to $960,000.FDA Schedules Hemostemix Basket Protocol Pre-IND MeetingThe FDA has scheduled Hemostemix's Pre-IND meeting for January 16, 2026 to review the Company's basket clinical trial protocol for the treatment of ischemia, including:Vascular dementiaIschemic cardiomyopathyPeripheral arterial disease (PAD)Generalized ischemiaThe basket protocol unifies these conditions under a single ischemia-based mechanism of action for ACP-01. 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.Non-Brokered Private Placement (NBPP)The Company announces a non-brokered private placement of up to $960,000, consisting of the issuance of 8,000,000 common shares at a price of $0.12 per share, with no warrants.All securities issued will be subject to a four-month hold period in accordance with applicable securities laws and TSX Venture Exchange (\"TSXV\") policies. The financing is subject to final TSXV approval.CEO Comment\"The FDA Pre-IND meeting brings us closer to a unified ischemia-based clinical trial program,\" stated Thomas Smeenk, CEO. \"It makes sense to address ischemia in multiple indications, given our success rate in these conditions as published in 11 peer reviewed articles. Why a Phase I clinical trial? First, Lantrida, an allogenic stem cell treatment, was approved on phase I only data. That is a precedent. Second, we can charge patients to be studi...