Core Insights - Hemostemix Inc. is set to showcase its innovative angiogenic cell therapy, ACP-01, at the Innovations in Wound Care Conference, emphasizing its potential to improve circulation and heal wounds for patients with advanced conditions like Peripheral Arterial Disease and Critical Limb-Threatening Ischemia [1][3] Company Overview - Hemostemix operates in the regenerative medicine sector, focusing on autologous stem cell therapies, particularly the VesCell™ (ACP-01) treatment, which has shown significant clinical success in healing chronic wounds [7] - The company has completed multiple clinical studies, demonstrating the efficacy of ACP-01 in saving limbs from amputation and improving patient outcomes [2][5] Market Potential - The wound care market in Florida is estimated to be worth $500-$600 million, with a projected growth rate of 5-6% CAGR, expected to reach $700-$800 million in the next five years [3] - The global wound care market is anticipated to exceed $20 billion by 2030, driven by increasing rates of diabetes, vascular disease, and chronic wounds [4][6] Clinical Evidence - Clinical trials have shown that ACP-01 significantly reduces ulcer size, with treated patients experiencing a decrease from a mean of 146 mm² to 0.48 mm² within three months [5] - The treatment group in clinical studies reported a 0% mortality rate and a 4.8% amputation rate, compared to a 25% amputation rate in the placebo group [5] Strategic Positioning - Hemostemix is positioned as a first-mover in the regenerative medicine space for limb salvage, with ACP-01 already available under Florida SB-1768, addressing a significant unmet medical need [6]

Core Viewpoint - Hemostemix Inc. has successfully closed the first tranche of a non-brokered private placement, raising $461,230 through the issuance of 4,193,000 units at a price of $0.11 per unit, aimed at supporting its autologous stem cell therapy, VesCell™ [1][5] Group 1: Offering Details - The offering consists of units that include one common share and one common share purchase warrant, with each warrant allowing the purchase of an additional common share at $0.15 for two years [2] - The company paid approximately $23,698.40 in cash finder's fees and issued 215,440 finder's options, each allowing the purchase of one common share at $0.15 for 24 months [4] - The offering is subject to regulatory approvals and all securities issued will have a four-month hold period under Canadian securities laws [7] Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for general working capital and to support ongoing operations, particularly the marketing and sales of VesCell™ [5] Group 3: Company Background - Hemostemix is a leader in autologous stem cell therapy, having developed and patented VesCell™ (ACP-01), and has completed seven clinical studies with 318 subjects [8] - The company has reported significant clinical outcomes, including a 0% mortality rate in a specific patient population compared to a 50% five-year mortality rate, and an 83% wound healing rate in patients followed for up to 4.5 years [8]

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].

Core Insights - Hemostemix Inc. is a leading autologous stem cell therapy company, focusing on treatments for various cardiovascular diseases, and will present at the Life Science Investor Forum on September 18, 2025 [1][2][9] - The recent passage of Florida Senate Bill 1768 allows Hemostemix to legally offer its treatment, VesCell™ (ACP-01), to patients with no other options, expanding its market reach [2][3] - The company has achieved 498 successful treatments and has a strong clinical record supported by 11 peer-reviewed publications, positioning it as a leader in the global market for autologous stem cell therapy [3][8] Company Overview - Hemostemix was founded in 2003 and has developed the patented VesCell™ (ACP-01) therapy, which is designed to treat conditions such as peripheral arterial disease and chronic limb-threatening ischemia [10] - The company has completed seven clinical studies involving 318 subjects, demonstrating the safety and efficacy of its treatments [10] - Hemostemix has received recognition as a World Economic Forum Technology Pioneer, highlighting its innovative approach in the healthcare sector [10] Clinical Evidence - The company has published 11 peer-reviewed articles that validate the safety and efficacy of its treatments, particularly for severe angina and various cardiomyopathies [8][10] - In a Phase II clinical trial for chronic limb-threatening ischemia, Hemostemix reported a 0% mortality rate and an 83% wound healing rate among patients followed for up to 4.5 years, significantly better than the typical 50% five-year mortality rate in this patient population [10]

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]

Core Insights - Hemostemix Inc. has expanded its marketing team to enhance sales efforts in Florida, focusing on the promotion of its VesCell™ therapy for various cardiovascular and podiatric conditions [1][2][6] Company Developments - The newly appointed commercial team includes experienced professionals with a strong background in the biopharmaceutical industry, aimed at effectively marketing VesCell™ to healthcare providers [2][4] - Croom Lawrence, the Chief Commercial Officer, has over 25 years of experience in biotech commercial launches, having supported over 15 blockbuster launches and generating significant returns on marketing investments for major biotech firms [4] - Sana Farooqui, the Fractional Chief Marketing Officer, will lead digital and social marketing efforts, ensuring compliance and impactful messaging [4] - Bob Branch, the Fractional Vice President of Digital Marketing & Media, brings over 20 years of experience in medical marketing, focusing on omnichannel strategies [4] Product Efficacy - VesCell™ has shown promising results in clinical trials, including improved limb circulation and reduced amputation rates for patients with Peripheral Arterial Disease (PAD) and Chronic Limb-Threatening Ischemia (CLTI) [5] - In studies involving cardiology patients, VesCell™ has demonstrated increased ejection fraction, reduced severe angina, and improved quality of life [5] - Early results suggest potential cognitive benefits in vascular dementia patients treated with VesCell™ [5] Regulatory Context - Under Florida's Right-to-Try statute, eligible physicians can offer VesCell™ to patients suffering from severe conditions, following informed consent [2][6] - Hemostemix has completed seven clinical studies involving 318 subjects, with results published in 11 peer-reviewed articles, establishing the safety and efficacy of VesCell™ [7]