Hemostemix's Boots on the Ground in Florida October Update

Core Insights - Hemostemix Inc. is advancing its autologous stem cell therapy, VesCell™ (ACP-01), in Florida, focusing on patients with chronic limb-threatening ischemia (CLTI) and related conditions, leveraging the newly enacted Florida Senate Bill 1768 [1][2][4] Group 1: Legislative Framework - Florida Senate Bill 1768 establishes a progressive framework for regenerative medicine, allowing licensed physicians to administer unapproved stem-cell therapies for pain management and wound care, provided safety and ethical standards are met [2] - The statute offers a pathway for no-option CLTI patients to access potentially life-saving therapies like ACP-01 [2] Group 2: Company Initiatives - Hemostemix is implementing a "Boots on the Ground" initiative to enhance patient access to ACP-01, which includes educational webinars for vascular surgeons across Florida [1][4] - The company has deployed a dedicated sales and outreach team to engage with vascular surgeons and podiatrists in major Florida cities, focusing on education about SB 1768 and establishing clinic partnerships [6][7] Group 3: Physician Education and Training - A specialized curriculum is being developed to train physicians on ACP-01 protocols, patient consent standards, and monitoring practices, ensuring compliance with SB 1768 [8] - Hemostemix is conducting Grand Rounds presentations at the University of Florida to review clinical trial results and promote ethical integration of ACP-01 [5][4] Group 4: Patient Access and Community Engagement - The company is expanding compassionate-use access for CLTI patients under SB 1768, facilitating treatment for those with severe pain and non-healing wounds [9] - Educational materials are being created for patients to inform them about regenerative options and the benefits of ACP-01 in pain relief and wound healing [11] Group 5: Clinical Research and Results - Hemostemix has completed seven clinical studies involving 318 subjects, demonstrating the safety and efficacy of ACP-01 for various cardiovascular conditions [12] - The Phase II clinical trial for chronic limb-threatening ischemia 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% mortality rate in this patient population [12]