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Hemostemix Appoints Renowned Vascular Surgeon and Principal Investigator, Dr. York Hsiang, as Business Consultant to Advance First Nations-Led Healthcare Partnerships
TMX Newsfile· 2026-02-03 13:55
Core Viewpoint - Hemostemix Inc. has appointed Dr. York Hsiang as a Business Consultant, aiming to enhance its operations in treating patients with severe ischemic conditions through its autologous stem cell therapy, ACP-01 [1][9]. 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), which has shown significant clinical results in treating various cardiovascular conditions [9]. - The company has completed seven clinical studies involving 318 subjects, with results published in eleven peer-reviewed publications. ACP-01 has demonstrated safety and clinical relevance, particularly for conditions like peripheral arterial disease and chronic limb threatening ischemia [9]. Appointment of Dr. York Hsiang - Dr. Hsiang, a globally respected vascular surgeon and Professor Emeritus at the University of British Columbia, has been appointed as a Business Consultant. His extensive experience in vascular surgery and clinical epidemiology positions him to guide Hemostemix in its strategic initiatives [4][5]. - Dr. Hsiang has previously served as the Principal Investigator for Hemostemix's Phase II clinical trial of ACP-01, reinforcing his credibility in the field [4][9]. Clinical Impact of ACP-01 - ACP-01 is considered a game changer for patients with critical limb threatening ischemia (CTLI), where traditional options often lead to amputation. Dr. Hsiang emphasized that he has not seen a therapy as effective as ACP-01 in his 30 years of medical practice [3][2]. - The Phase II trial results indicated a 0% mortality rate in the studied population, with 83% of patients experiencing wound healing and cessation of pain over a follow-up period of up to 4.5 years [9]. Collaboration with First Nations - Hemostemix is actively engaging with Canada's First Nations to establish healthcare initiatives that respect Indigenous sovereignty and promote local employment and capacity-building [7][8]. - The company aims to create a collaborative business plan that integrates traditional cultural healing methodologies with clinical excellence, positioning First Nations communities as centers of healing [8][11].
Hemostemix Closes $480,000 Private Placement at $0.12 per Share
TMX Newsfile· 2025-12-31 19:38
Core Viewpoint - Hemostemix Inc. has successfully closed a non-brokered private placement, raising CDN$480,000 through the issuance of 4,000,000 common shares at a price of $0.12 per share, aimed at advancing its autologous stem cell therapy initiatives [1][2]. Group 1: Financial Details - The private placement generated gross proceeds of CDN$480,000 [1]. - A total of 4,000,000 common shares were issued at a price of $0.12 per share [1]. Group 2: Use of Proceeds - The funds raised will be allocated for general working capital purposes, specifically to support regulatory, clinical, and commercialization efforts related to the ACP-01 (VesCell) therapy platform [2]. Group 3: Company Background - Hemostemix is an autologous stem cell therapy company founded in 2003, recognized as a World Economic Forum Technology Pioneer [4]. - The company has developed and patented VesCell™ (ACP-01), completing seven clinical studies involving 318 subjects, with results published in eleven peer-reviewed publications [4]. - ACP-01 has shown significant clinical relevance and safety as a treatment for various ischemic conditions, including peripheral arterial disease and chronic limb threatening ischemia [4]. Group 4: Clinical Trial Results - Hemostemix completed a Phase II clinical trial for chronic limb threatening ischemia, reporting a 0% mortality rate and 83% wound healing in patients followed for up to 4.5 years, compared to a 50% mortality rate in the general patient population [4].
Hemostemix Appoints Dr. David B. Alper, to Lead Multidisciplinary Physician Education in the Use of ACP-01
TMX Newsfile· 2025-12-23 14:10
Core Viewpoint - Hemostemix Inc. has appointed Dr. David B. Alper as the Multidisciplinary Physician Education Lead and a member of its Scientific Advisory Board, effective January 2026, to enhance physician education and clinical engagement initiatives related to its stem cell therapy, VesCell (ACP-01) [1][7]. Group 1: Appointment and Role of Dr. David B. Alper - Dr. Alper will lead physician-led education and clinical engagement initiatives, starting in Florida, focusing on wound-care podiatrists and limb-preservation teams [2]. - His role includes engaging with practitioners to promote the use of ACP-01 for treating pain and ischemia related to peripheral arterial disease and diabetic foot ulcers [2]. - Dr. Alper's extensive background includes leadership roles in various national organizations related to wound care and diabetes, enhancing his credibility in the field [5][6]. Group 2: Initiatives Under Dr. Alper's Leadership - The first initiative involves clinical practice engagement in Florida, where Dr. Alper will work with podiatry practitioners to increase the adoption of ACP-01 [2]. - The second initiative focuses on engaging Deans of Clinical Education at U.S. podiatry schools to introduce ACP-01 to new graduates and faculty [3]. - The third initiative supports participation in multidisciplinary educational forums, addressing ischemic disease and integrating ACP-01 into team-based practices [4]. Group 3: Company Overview and Product Information - Hemostemix is an autologous stem cell therapy company founded in 2003, recognized as a Technology Pioneer by the World Economic Forum [8]. - The company has developed and patented VesCell (ACP-01), which has shown significant clinical results, including a 0% mortality rate in a clinical trial for chronic limb threatening ischemia, compared to a 50% mortality rate in the general patient population [8]. - Hemostemix has completed seven clinical studies involving 318 subjects, with results published in eleven peer-reviewed journals, demonstrating the safety and efficacy of ACP-01 [8].
Hemostemix Grants Stock Options
Newsfile· 2025-12-11 13:57
Core Viewpoint - Hemostemix Inc. has granted a total of 963,000 stock options to its directors, officers, employees, and consultants, subject to regulatory approval, as part of its stock option plan [1][2]. Stock Options Details - Of the 963,000 options granted, 663,000 vest immediately, while 330,000 vest 50% on December 11, 2025, and 50% on December 11, 2026 [2]. - All options have an exercise price of $0.09 per common share and an expiry date of December 11, 2030 [2]. - After this issuance, Hemostemix has a total of 19,124,694 options issued and outstanding [2]. Regulatory Exemptions - Hemostemix relied on section 5.5(b) of Multilateral Instrument 61-101 for exemption from formal valuation requirements, as no securities are listed on a specified market [2]. - The company also utilized section 5.7(a) of MI 61-101 to exempt the minority approval requirements, as the fair market value of the options granted did not exceed 25% of Hemostemix's market capitalization [2]. Company Overview - Hemostemix is an autologous stem cell therapy platform company founded in 2003, recognized as a Technology Pioneer by the World Economic Forum [3]. - The company has developed and is commercializing its patented blood-based stem cell therapy, VesCell™ (ACP-01), and has completed seven clinical studies involving 318 subjects [3]. - ACP-01 has shown significant clinical relevance and safety in treating various conditions, including peripheral arterial disease and chronic limb threatening ischemia [3]. - The Phase II clinical trial for chronic limb threatening ischemia reported a 0% mortality rate and wound healing in 83% of patients followed for up to 4.5 years [3].
Hemostemix Inc. Announces FDA Pre-IND Meeting and NBPP of $960,000
Newsfile· 2025-12-10 16:17
Core Points - Hemostemix Inc. has announced a Pre-IND meeting with the FDA scheduled for January 16, 2026, to discuss its basket clinical trial protocol for ACP-01, aimed at treating various ischemic conditions [2][6] - The company is also conducting a non-brokered private placement to raise up to $960,000 through the issuance of 8,000,000 common shares at a price of $0.12 per share [3][6] FDA Pre-IND Meeting - The FDA meeting will focus on a unified ischemia-based mechanism of action for ACP-01, which targets multiple ischemic conditions [2][6] - Hemostemix plans to present its clinical rationale, manufacturing platform, and regulatory pathway to advance towards FDA clearance for its Phase I clinical trial [2][6] Non-Brokered Private Placement - The private placement aims to raise $960,000, with all securities subject to a four-month hold period [3][6] - The financing is pending final approval from the TSX Venture Exchange [3][6] CEO Comments - The CEO emphasized the significance of the FDA meeting in advancing a unified clinical trial program for ischemia [4][6] - The company has a precedent for Phase I clinical trials, citing the approval of Lantrida based on similar data [4][6] Use of Proceeds - Proceeds from the private placement will be utilized to advance FDA regulatory preparations, clinical operations expansion in Florida, The Bahamas, and Canada, and general corporate working capital [10]
Hemostemix Welcomes Shaune Harding, OStJ, RN as Director of Patient Care & Clinical Operations
Newsfile· 2025-12-04 14:10
Core Insights - Hemostemix Inc. has appointed Shaune Harding as the Director of Patient Care & Clinical Operations, enhancing its patient-centric healthcare model [1][2][3] Company Overview - Hemostemix is a leader in autologous stem cell therapeutics, particularly for ischemic diseases, and has been operational since 2003 [4] - The company has developed and patented VesCell™ (ACP-01), a blood-based stem cell therapy, and has completed seven clinical studies involving 318 subjects [4] - Hemostemix has published results in eleven peer-reviewed publications, demonstrating the safety and clinical relevance of ACP-01 for various ischemic conditions [4] Appointment of Shaune Harding - Shaune Harding brings over 30 years of clinical and management experience, which will be utilized to improve the personalized care experience in The Bahamas, Florida, and Canada [2] - Her role will ensure long-term continuity of care for patients treated with VesCell and facilitate the capture of patient data for regulatory approval of ACP-01 [2] Patient Care Operations - The responsibilities of the new Director include onboarding new patients, reviewing medical records, and mapping patient health journeys from assessment to multi-year follow-up [6] - Continuous monitoring of patient data will be conducted, including metrics on heart rate, activity, and sleep, using approved wearable devices [6] - Monthly follow-up meetings will support goal setting and adherence to healthcare journeys, along with adverse event monitoring and compliance with regulatory obligations [6]
Hemostemix Featured at Innovations in Wound Healing 2025, Key West, December 11-14
Newsfile· 2025-12-03 19:05
Core Insights - Hemostemix Inc. is participating in Innovations in Wound Healing 2025, showcasing advancements in regenerative medicine for cardiovascular diseases, particularly Chronic Limb-Threatening Ischemia (CLTI) [1][2] - The company emphasizes the efficacy of its treatment, ACP-01, which has shown significant clinical trial results, including a 0% mortality rate and 83% limb preservation in treated patients over 4.5 years [3][10] - The recent enactment of Florida SB 1768 allows for the legal availability of ACP-01 to patients suffering from Peripheral Arterial Disease (PAD) and related conditions [4] Company Overview - Hemostemix is an autologous stem cell therapy platform company founded in 2003, recognized as a Technology Pioneer by the World Economic Forum [10] - The company has developed and patented VesCell™ (ACP-01), completing seven clinical studies with 318 subjects and publishing results in eleven peer-reviewed journals [10] - ACP-01 is positioned as a safe and clinically relevant treatment for various cardiovascular conditions, including PAD and CLTI [10] Clinical Evidence - Clinical studies indicate that ACP-01 effectively regenerates microvascular circulation, restores function, and improves quality of life for patients with severe ischemic peripheral arterial disease [2][3] - A study published by the University of Toronto reported that patients treated with VesCell experienced a significant reduction in ulcer size, from a mean of 146 mm² to 0.48 mm² within three months [3] - The treatment group showed a significantly lower rate of amputations and deaths compared to the placebo group, highlighting the treatment's effectiveness [3] Industry Context - The traditional approach in cardiovascular care has been to delay treatment until conditions worsen, which can lead to irreversible damage [8] - Hemostemix advocates for early intervention to restore circulation, arguing that timely treatment can enhance patient quality of life and reduce healthcare costs [9] - The company aims to change the standard of care in vascular treatments, promoting regenerative options before patients face severe complications [9]
Hemostemix Starts its Roll-up of Cardiology Practices, Acquiring its First Two
Newsfile· 2025-11-26 21:21
Core Insights - Hemostemix Inc. has initiated its strategy to acquire cardiology practices, starting with two prominent cardiologists in the Dominican Republic, Dr. Roberto Manuel Fernandez-de-Castro and Dr. Hector Rosario Figueroa, for 2,000,000 shares each [1][11] - The long-term strategy aims to integrate profitable medical practices to enhance the commercialization of ACP-01 treatments, creating a sustainable patient flow for the company [2][6] - The two cardiologists have extensive experience, having treated over 200 patients with ACP-01, positioning them as key figures in the company's expansion efforts [3][7] Company Strategy - The acquisition of these practices is part of a broader plan to establish a clinical and commercial presence internationally, with a focus on patient treatment flow and increasing practitioner engagement [2][6] - Hemostemix aims to replicate its business model across various markets, including Florida, Puerto Rico, and Canada, leveraging the expertise of the acquired cardiologists [6][7] Clinical Expertise - Dr. Fernandez-de-Castro and Dr. Figueroa will contribute their expertise in treating various cardiovascular conditions, including Angina, Ischemic and Dilated Cardiomyopathy, Congestive Heart Failure, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, and Vascular Dementia [5][4] - Their established reputations and patient bases in the Dominican Republic are expected to facilitate the implementation of ACP-01 therapy [4][5] Financial Aspects - The TSXV has approved an extension for a non-brokered private placement, allowing Hemostemix to raise funds at $0.11 per unit, with total gross proceeds of $461,230 raised to date [8] - Each unit consists of one common share and one warrant, with the potential for additional shares to be acquired at $0.15 per share [8] Company Background - Hemostemix is an autologous stem cell therapy platform company, recognized for its development of VesCell™ (ACP-01), which has shown promising results in clinical studies for various cardiovascular diseases [9] - The company has completed seven clinical studies involving 318 subjects, demonstrating the safety and efficacy of ACP-01 [9]
Dr. William R. Shankle to Advance ACP-01 as a Treatment for Vascular Dementia
Newsfile· 2025-11-20 14:00
Core Insights - Hemostemix Inc. is advancing ACP-01, an autologous stem cell therapy, for the treatment of vascular dementia, with Dr. William R. Shankle leading the Phase I clinical trial [1][8][10] Company Overview - Hemostemix Inc. specializes in autologous stem cell therapies, particularly VesCell™ (ACP-01), targeting various conditions including vascular dementia, chronic limb threatening ischemia, and congestive heart failure [1][12] - The company has completed seven clinical studies involving 318 subjects and has published results in eleven peer-reviewed publications [12] Clinical Trial Details - The Phase I clinical trial protocol for ACP-01 has been submitted to an Institutional Review Board (IRB) for ethical review, with revisions made based on initial comments [9][10] - Dr. Shankle is reviewing a patient database of approximately 500 individuals diagnosed with cognitive impairment to identify up to 30 patients for the trial [10] Dr. William R. Shankle's Background - Dr. Shankle has over 35 years of medical practice, focusing on cognitive disorders and has been involved in numerous clinical programs and public education initiatives [2][3] - He is the founder of The Shankle Clinic and has held leadership roles at the University of California, Irvine, contributing to advancements in the understanding of vascular dementia [3][4] ACP-01 and Vascular Dementia - ACP-01 is designed to promote angiogenesis and microvascular repair, addressing the vascular underpinnings of vascular dementia [5][8] - The therapy has shown safety and clinical relevance in treating other conditions, with significant outcomes reported in previous studies [12]
Hemostemix Closes CDN$280,594 Private Placement
Newsfile· 2025-11-18 22:07
Core Insights - Hemostemix Inc. has received conditional approval from the TSX Venture Exchange for a non-brokered private placement amounting to CDN $280,594, involving the issuance of 2,244,752 Common Shares at a price of CDN $0.125 per share [1][2] Company Overview - Hemostemix is a leading autologous stem cell therapy company, founded in 2003, specializing in VesCell™ (ACP-01) for various cardiovascular conditions [4] - The company has completed seven clinical studies involving 318 subjects, with results published in 11 peer-reviewed publications [4] - ACP-01 has shown significant clinical relevance and safety as a treatment for conditions such as peripheral arterial disease and chronic limb threatening ischemia, with a reported 0% mortality rate in a specific patient population over 4.5 years [4] Use of Proceeds - The proceeds from the private placement will be allocated to general working capital purposes, supporting ongoing operational expenses and business development activities [2] Regulatory Compliance - All securities issued in connection with the offering are subject to a four-month hold period under Canadian securities laws [3]