Core Insights - Hemostemix Inc. is hosting a webinar focused on its autologous stem cell therapy, ACP-01, aimed at vascular surgeons in Florida, particularly for patients suffering from chronic limb-threatening ischemia (CLTI) who have no revascularization options [1][3][4] Company Overview - Hemostemix is a leader in autologous stem cell therapy, offering VesCell™ (ACP-01) for various conditions including angina, peripheral arterial disease, and chronic limb-threatening ischemia [1][8] - The company has completed seven clinical studies involving 318 subjects, with results published in eleven peer-reviewed journals [8] - ACP-01 has shown promising clinical outcomes, including a 0% mortality rate and an 83% wound healing rate in patients followed for up to 4.5 years [8] Webinar Details - The webinar is scheduled for October 29, 2025, and will provide Florida-based practitioners with clinical knowledge and operational tools to implement ACP-01 therapy [3][5] - Attendees will receive resources such as patient screening tools and compliance checklists specific to Florida regulations [5][7] Clinical Context - Amputation rates among no-option CLTI patients are high, with 12,059 cases reported in 2023, highlighting the need for effective alternatives like ACP-01 [2] - ACP-01 is designed to stimulate angiogenesis and promote natural tissue healing using the patient's own blood-derived cells, offering a minimally invasive treatment option [2][7]

Hemostemix's Insider Lead Order of $330,000 Private PlacementOctober 07, 2025 10:05 AM EDT | Source: Hemostemix Inc.Calgary, Alberta--(Newsfile Corp. - October 7, 2025) - Hemostemix (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company") is pleased to announce a lead order of $330,000 for a non brokered private placement of up to $700,000.Purchasers may subscribe for Units at $0.11. Each Unit consists of one Common Share and one Warrant. Each Warrant may be exercised by the hold ...

Core Viewpoint - Hemostemix Inc. has filed FDA Pre-IND Application 1517 to seek regulatory feedback for a Phase I clinical trial of its lead therapy, ACP-01 (VesCell™), targeting multiple ischemic and vascular conditions, marking a significant step in its development strategy [2][3][4]. Regulatory Engagement - The filing represents Hemostemix's formal engagement with the FDA to clarify the regulatory pathway for ACP-01, aiming for expedited designations such as RMAT (Regenerative Medicine Advanced Therapy) and Fast Track [3][4][10]. - The proposed basket protocol will evaluate safety, feasibility, and early efficacy signals of ACP-01 across various high-unmet-need conditions, including peripheral arterial disease and congestive heart failure [3][6]. Real-World Evidence Integration - Hemostemix plans to incorporate systematically collected real-world evidence from Florida, where ACP-01 is legally available under SB 1768, to support its IND advancement [3][10]. - Patients treated in Florida will be monitored as if they were in a Phase I open-label clinical trial, providing standardized endpoints and data for regulatory submissions [3][10]. Market Expansion Potential - A successful basket protocol could allow Hemostemix to pursue multiple billion-dollar markets simultaneously, significantly expanding its addressable market [10]. - Positive FDA feedback could shorten timelines to pivotal trials and eventual commercialization, positioning Hemostemix as a first-mover in the autologous stem cell therapy space for ischemia and vascular dementia [10][11]. Company Background - Hemostemix is recognized as a leading autologous stem cell therapy company, having developed and patented VesCell™ (ACP-01) and completed seven clinical studies with 318 subjects [8][11]. - The company has published results demonstrating the safety and efficacy of ACP-01 in treating severe conditions, including a reported 0% mortality rate in chronic limb threatening ischemia patients over a follow-up period of up to 4.5 years [8][11].

Hemostemix to Present at Life Science Investor ForumSeptember 17, 2025 7:52 AM EDT | Source: Hemostemix Inc.Calgary, Alberta--(Newsfile Corp. - September 17, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), the leading autologous (patient's own) stem cell therapy company offering VesCell™ (ACP-01) to individuals suffering from peripheral arterial disease, chronic limb threatening ischemia, angina, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart fai ...

Core Insights - Hemostemix Inc. is set to present clinical data on its VesCell™ (ACP-01) therapy for treating Severe Angina Pectoris, highlighting its efficacy compared to current standard care options [1][2]. Clinical Study Findings - The clinical trial demonstrated significant improvements in exercise tolerance, with the six-minute walk distance increasing from 333.65 meters at baseline to 414.95 meters at 3 months and 413.25 meters at 6 months (P<0.001) [4]. - Exercise capacity, measured in Metabolic Equivalents (METs), rose from 5.62 at baseline to 6.73 at 3 months and 7.09 at 6 months (P<0.004) [4]. - Ischemia, indicated by SPECT-MIBI perfusion defects, decreased from 38.46% at baseline to 23.89% at 3 months and 21.05% at 6 months (P<0.004) [4]. - The Canadian Cardiovascular Society (CCS) angina score improved from 2.1 at baseline to 1.05 at 3 months and 1.18 at 6 months (P<0.001), indicating a reduction in chest pain severity [4][5]. Management Perspective - The CEO of Hemostemix emphasized the unique approach of using autologous stem cells to treat ischemia, highlighting the therapy's safety and significant clinical relevance [7]. - The company plans to leverage revenue from the treatment in Florida to fund a double-blind randomized clinical trial for global approval of ACP-01 [7]. Company Background - Hemostemix is an established autologous stem cell therapy company, recognized for its innovative VesCell™ (ACP-01) treatment, which has shown promise in various cardiovascular conditions [9]. - The company has completed seven clinical studies involving 318 subjects, with results published in 11 peer-reviewed journals, underscoring its commitment to research and development in the field [9].

Core Viewpoint - Hemostemix Inc. has received approval from the TSX Venture Exchange for a debt settlement involving the issuance of common shares at a price of $0.20 per share to settle CDN$400,000 of indebtedness [1][2][3] Group 1: Debt Settlement Details - The company will issue a total of 2,000,000 common shares to certain creditors at a deemed price of $0.20 per share [2] - The shares will be subject to a statutory hold period of four months and one day, in accordance with applicable securities laws [2] - The debt settlement is subject to acceptance by the TSX Venture Exchange and will not create a new control person [3] Group 2: Company Overview - Hemostemix is a leading autologous stem cell therapy company, founded in 2003, specializing in VesCell™ (ACP-01) for various cardiovascular diseases [1][4] - The company has completed seven clinical studies involving 318 subjects, with results published in 11 peer-reviewed publications [4] - Recent studies indicate that ACP-01 is safe and effective, showing a 0% mortality rate in chronic limb threatening ischemia patients, compared to a 50% mortality rate over five years in the general patient population [4]

Core Insights - Hemostemix Inc. is launching a face-to-face sales program in Florida to promote its autologous stem cell therapy, VesCell™ (ACP-01), targeting patients with severe conditions who have exhausted standard treatment options [1][2][3] Company Strategy - The company is implementing a "boots on the ground" strategy, with leadership directly engaging clinicians and clinic owners across Florida to facilitate the adoption of VesCell™ [2][3] - The focus is on building relationships with the clinical community, leveraging prior trial experiences to enhance treatment access [3] Scientific and Clinical Results - Hemostemix has treated 498 patients and completed seven clinical studies involving 318 subjects, resulting in 11 peer-reviewed publications that validate the safety and efficacy of VesCell™ [4] - Clinical results show significant improvements, such as a reduction in ulcer size from a mean of 1.46 cm² to 0.48 mm² in treated patients [10] Regulatory Engagement - The Florida rollout strategy includes data collection to support FDA engagement, enhancing the company's safety and efficacy profile for regulatory approval [5] - The Right-to-Try statute SB 1768 allows physicians to offer VesCell™ to patients suffering from various severe conditions, including Peripheral Arterial Disease and Chronic Limb-Threatening Ischemia [6][7] Treatment Outcomes - VesCell™ has demonstrated the ability to generate new blood vessels, restore circulation, and heal ulcers, with a reported wound healing rate of 83% in patients followed for up to 4.5 years [11][13] - In studies, VesCell™ improved overall ejection fraction, exercise capacity, and quality of life for patients with chronic stable angina [12]

A New Chance to Live Better, Longer Under Florida's Right-to-Try statute (SB 1768), physicians-including podiatrists, cardiologists, and all specialists treating pain and no-option patients suffering from PAD, CLTI, angina, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, and congestive heart failure can offer VesCell™, Hemostemix's patented ACP-01 therapy, to qualifying patients, following informed consent. Croom Lawrence, Chief Commercial Officer: With over 25 years of biotech commercial laun ...

Company Overview - Hemostemix is an autologous stem cell therapy platform company founded in 2003, recognized as a World Economic Forum Technology Pioneer [2] - The company has developed and patented VesCell™ (ACP-01), a blood-based stem cell therapy, and is scaling its production and sales [2] - Hemostemix has completed seven clinical studies involving 318 subjects, with results published in 11 peer-reviewed publications [2] Clinical Achievements - ACP-01 has shown safety and clinical relevance as a treatment for various conditions, including peripheral arterial disease and chronic limb threatening ischemia [2] - The Phase II clinical trial for chronic limb threatening ischemia reported 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 [2] Recent Developments - Hemostemix has contracted Empire Market Ventures to enhance market awareness and investor engagement [1] - Empire Market Ventures specializes in strategic communications and market intelligence, providing tailored solutions for emerging companies [1] - The partnership aims to position Hemostemix for long-term success in capital markets [1]

Core Viewpoint - Hemostemix Inc. has increased the size of its previously closed non-brokered private placement from $2,969,600 to $3,000,000, following additional subscriptions received after the original closing date [1][2]. Group 1: Offering Details - The Offering now includes a total of 3,000,000 additional units at a price of $0.10 per unit [2]. - Each unit consists of one common share and one common share purchase warrant, with the warrant allowing the holder to acquire an additional common share at an exercise price of $0.15 for 24 months [3]. - An acceleration clause is included, allowing the Company to expedite the expiry of the warrants if the common shares' closing price exceeds a weighted average of $0.185 for 10 consecutive trading days [3]. Group 2: Financial Aspects - The Company paid cash finder's fees totaling $100,032 and issued 1,000,320 finder's options, each allowing the purchase of one common share at an exercise price of $0.15 for 24 months [4]. - Proceeds from the Offering will be used to repay CD1 at a 50% discount to face value ($1,250,000) and for general working capital to support ongoing operational expenses, including marketing and sales of VesCell™ [5]. Group 3: Related Party Transactions - The Offering is classified as a "related party transaction" under Multilateral Instrument 61-101, with directors Mr. Peter Lacey and Mr. Loran Swanberg participating directly and indirectly [6]. - The Company will file a material change report regarding the related party transaction on SEDAR+ [6]. - The transaction was approved by the board of directors, including disinterested directors, and no special committee was established [6]. Group 4: Shareholder Impact - Prior to the Offering, Mr. Lacey owned 9,316,937 common shares, representing 6.14% of the total shares [9]. - After subscribing to 15,000,000 units, Mr. Lacey's ownership increased to 24,316,937 common shares, representing 13.40% of the total shares on a non-diluted basis [9].