Hemostemix's Boots on the Ground in Florida October Update
Hemostemix (OTCQB: HMTXF) is expanding patient access to its autologous angiogenic-cell therapy ACP-01 in Florida under Senate Bill 1768, which allows licensed physicians to deliver unapproved stem-cell–based treatments for pain and wound care with safety and consent safeguards. The company has deployed a Florida field team, run webinars since August, and will present Grand Rounds at the University of Florida on November 12, 2025.
Key activities include physician training, streamlined compassionate-use access for Rutherford 4–5 CLTI patients, IRB review for a Basket trial, and patient education materials.
Hemostemix (OTCQB: HMTXF) sta ampliando l'accesso dei pazienti alla sua terapia autologa a cellule angiogenetiche ACP-01 in Florida in conformità con la Senate Bill 1768, che consente ai medici autorizzati di fornire trattamenti a base di cellule staminali non approvati per la gestione del dolore e la cura delle ferite, con salvaguardie di sicurezza e consenso. L'azienda ha schierato un team sul campo in Florida, ha tenuto webinar dall'agosto e terrà Grand Rounds presso l'Università della Florida il 12 novembre 2025.
Le attività chiave includono formazione dei medici, accesso semplificato all'uso compassionevole per pazienti Rutherford 4–5 CLTI, revisione IRB per uno studio Basket e materiali educativi per i pazienti.
Hemostemix (OTCQB: HMTXF) está ampliando el acceso de los pacientes a su terapia autóloga de células angiogénicas ACP-01 en Florida conforme a la Senate Bill 1768, que permite a médicos titulados administrar tratamientos a base de células madre no aprobados para el manejo del dolor y el cuidado de heridas, con salvaguardas de seguridad y consentimiento. La empresa ha desplegado un equipo en el campo en Florida, ha realizado seminarios web desde agosto y presentará Grand Rounds en la Universidad de Florida el 12 de noviembre de 2025.
Las actividades clave incluyen la formación de médicos, un acceso más ágil para uso compasivo para pacientes Rutherford 4–5 CLTI, revisión IRB para un ensayo Basket y materiales educativos para los pacientes.
Hemostemix (OTCQB: HMTXF)은 플로리다에서 자가 혈관 형성 세포 치료제 ACP-01에 대한 환자 접근을 확장하고 있으며, 이는 안전 및 동의 보장을 갖춘 통증 및 상처 관리용 승인되지 않은 줄기세포 기반 치료를 허용하는 SB 1768 법에 따라 진행됩니다. 회사는 플로리다 현지 팀을 배치하고 8월부터 웨비나를 진행했으며 2025년 11월 12일에 플로리다 대학교에서 Grand Rounds를 발표할 예정입니다.
주요 활동에는 의사 교육, Rutherford 4–5 CLTI 환자들을 위한 연민적 이용의 간소화된 접근, Basket 시험에 대한 IRB 심의, 그리고 환자 교육 자료가 포함됩니다.
Hemostemix (OTCQB: HMTXF) étend l’accès des patients à sa thérapie autologue à base de cellules angiogéniques ACP-01 en Floride, conformément à la Senate Bill 1768, qui autorise les médecins licenciés à administrer des traitements à base de cellules souches non approuvés pour la gestion de la douleur et les soins des plaies, avec des garanties de sécurité et de consentement. L’entreprise a déployé une équipe sur le terrain en Floride, organise des webinaires depuis août et présentera des Grand Rounds à l’Université de Floride le 12 novembre 2025.
Les activités clés comprennent la formation des médecins, un accès facilité à l’utilisation compassionnelle pour les patients Rutherford 4–5 CLTI, l’examen par le comité IRB pour une étude Basket et des supports éducatifs pour les patients.
Hemostemix (OTCQB: HMTXF) erweitert den Zugang von Patienten zu seiner autologen angiogenen Zelltherapie ACP-01 in Florida gemäß Senate Bill 1768, der lizenzierten Ärzten erlaubt, nicht genehmigte zellbasierte Behandlungen bei Schmerz- und Wundversorgung mit Sicherheits- und Einwilligungsschutz anzubieten. Das Unternehmen hat ein Florida-Feldteam eingesetzt, Webinare seit August abgehalten und wird am 12. November 2025 Grand Rounds an der University of Florida präsentieren.
Zu den Schlüsselaktivitäten gehören die Schulung von Ärzten, vereinfachter Zugang zur mitfühlenden Nutzung für Rutherford 4–5 CLTI-Patienten, IRB-Überprüfung für eine Basket-Studie und patientenbezogene Bildungsmaterialien.
Hemostemix (OTCQB: HMTXF) يوسّع وصول المرضى إلى علاجه الذاتي بالخلايا الوعائية ACP-01 في فلوريدا وفقًا لقانون Senate Bill 1768، الذي يتيح للأطباء المصرّحين تقديم علاجات مبنية على الخلايا الجذعية غير المعتمدة لإدارة الألم ورعاية الجروح مع ضمانات السلامة والموافقة. قامت الشركة بنشر فريق ميداني في فلوريدا، عقدت ندوات عبر الإنترنت منذ أغسطس، وستقدّم Grand Rounds في جامعة فلوريدا في 12 نوفمبر 2025.
تشمل الأنشطة الرئيسية تدريب الأطباء، وتيسير الوصول إلى الاستخدام التعاطفي لمرضى Rutherford 4–5 CLTI، ومراجعة IRB لدراسة Basket، ومواد توعوية للمرضى.
- SB 1768 enactment enables physician delivery of ACP-01 in Florida
- Florida field team met dozens of vascular surgeons and podiatrists
- Grand Rounds set for Nov 12, 2025 at University of Florida
- Streamlined compassionate-use access for Rutherford 4–5 CLTI patients
- SB 1768 curriculum trains physicians on consent and monitoring standards
- None.
Calgary, Alberta--(Newsfile Corp. - October 30, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), the leading autologous (patient's own) stem cell therapy company offering VesCell™ (ACP-01) to no-option individuals suffering from pain related to angina, peripheral arterial disease, chronic limb threatening ischemia, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia, today announced major progress in Florida as it builds upon the success of its weekly webinar series, which since August has drawn strong interest from vascular surgeons statewide. These efforts mark the next phase of the Company's "Boots on the Ground" initiative, accelerating patient access to ACP-01, Hemostemix's autologous angiogenic-cell-precursor therapy for chronic limb-threatening ischemia (CLTI), pain relief, and wound healing, under Florida Senate Bill 1768 (SB 1768).
Florida Opens the Door to Compassionate Innovation
SB 1768, enacted this year, establishes one of the most forward-looking regenerative-medicine frameworks in the United States. It empowers licensed Florida physicians to deliver unapproved stem-cell-based therapies specifically for pain management and wound care, provided safety, consent, and ethical safeguards are met. For no-option CLTI patients-those suffering severe ischemic pain and non-healing wounds at risk of amputation-this statute provides a pathway to receive potentially limb-saving therapies such as ACP-01.
Hemostemix's approach centers on physician enablement and statutory compliance, including licensure verification, disclosure of expected outcomes, adverse-event reporting, and integration with ongoing clinical protocols.
"SB 1768 beacons compassionate innovation, tackling pain and wounds in CLTI and similar conditions," said Thomas Smeenk, CEO of Hemostemix. "Pain defines ACP-01's indications-from heart failure, angina, and cardiomyopathy to wound care and CLTI-while cognition defines our dementia work. Our Florida expansion ensures physicians can provide ACP-01 safely, effectively, and ethically under state law, transforming lives while upholding regulatory integrity."
Grand Rounds at the University of Florida - November 12, 2025
As part of its educational leadership in regenerative medicine, Hemostemix will headline a Grand Rounds presentation at the University of Florida in Gainesville on November 12, 2025, led by Dr. Fraser Henderson Sr., Neurosurgeon.
The University of Florida, Gainesville - a principal investigator site in Hemostemix's FDA-authorized randomized phase II clinical trial - played a key role in evaluating ACP-01 for the treatment of critical limb ischemia. This upcoming session will review Hemostemix's Phase I and II clinical trial results across CLTI, ischemic and dilated cardiomyopathy, and angina. The event underscores the Company's commitment to physician education, ethical integration of ACP-01 under SB 1768, and collaboration with Florida's medical community.
Key Actions Driving ACP-01 Access in Florida
Dedicated Sales and Outreach Team
Led by Chief Commercial Officer Croom Lawrence, Hemostemix deployed its Florida-focused field team that has met with dozens of vascular surgeons, and podiatrists, in Miami, Tampa, Orlando, Jacksonville, Naples, Boca Raton since August. These sessions focus on SB 1768 education, patient screening, and referral workflows, resulting in several emerging clinic partnerships.Physician Training Programs
A dedicated SB 1768 curriculum trains physicians on ACP-01's protocols for pain and wound outcomes, patient-consent standards, and monitoring of patients as if they are in an open label phase 1 clinical trial. The in-person discussions emphasize scope adherence, documentation, legal and ethical transparency.Compassionate-Use Access Expansion
Under SB 1768's pain/wound provisions, Hemostemix has streamlined access for Rutherford 4-5 CLTI patients with intractable pain and wounds, while fielding interest for its Basket clinical trial now under IRB review.Collaborative Network Building
Hemostemix is establishing formal ties with Florida's vascular surgeons to coordinate success-story documentation, adverse-event reporting, and compliance tracking per SB 1768.Patient and Community Education
SB 1768-information materials are now being developed for patients exploring regenerative options. The educational content highlights ACP-01's track record in pain relief and wound healing for CLTI.
Operational Infrastructure and Momentum
With boots on the ground, Hemostemix's Florida operations will include:
Ongoing grand rounds presentations.
Outreach via social media to patients who suffer in pain with CLTI.
Clinical liaisons coordinating patient eligibility and regulatory documentation.
Ongoing webinars and in-person sessions for physician engagement and patient education.
ABOUT HEMOSTEMIX
Hemostemix is an autologous stem cell therapy platform company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, is scaling and selling autologous (patient's own) blood-based stem cell therapy, VesCell™ (ACP-01). Hemostemix has completed seven clinical studies of 318 subjects and published its results in eleven peer reviewed publications. ACP-01 is safe, clinically relevant and statistically significant as a treatment for peripheral arterial disease, chronic limb threatening ischemia, non ischemic dilated cardiomyopathy, ischemic cardiomyopathy, congestive heart failure, and angina. Hemostemix completed its Phase II clinical trial for chronic limb threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science. As compared to a five year mortality rate of
For further information, please contact: Thomas Smeenk, President, CEO & Co-Founder: EM: tsmeenk@hemostemix.com / PH: 905-580-4170
Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Information: This news release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information in relation to the treatment of CLTI in Florida and the completion of the treatment of pain related to angina, peripheral arterial disease, chronic limb threatening ischemia, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia with Angiogenic Cell Precursors (ACP-01) in furtherance of sales of VesCell™ (ACP-01), and the commercialization of ACP-01 via the sale of compassionate treatments under Florida SB 1768. There can be no assurance that such forward-looking information will prove to be accurate. Actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix's current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the underlying value of Hemostemix and its Common Shares; the successful resolution of any litigation that Hemostemix is pursuing or defending (the "Litigation"); the results of ACP-01 research, trials, studies and analyses, including the analysis being equivalent to or better than previous research, trials or studies; the receipt of all required regulatory approvals for research, trials or studies; the level of activity, market acceptance and market trends in the healthcare sector; the economy generally; consumer interest in Hemostemix's services and products; competition and Hemostemix's competitive advantages; and, Hemostemix obtaining satisfactory financing to fund Hemostemix's operations including any research, trials or studies, and any Litigation. Forward-looking information is Subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: the ability of Hemostemix to complete clinical trials, complete a satisfactory analyses and file the results of such analyses to gain regulatory approval of a phase II or phase III clinical trial of ACP-01; potential litigation Hemostemix may face; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in Hemostemix's markets and the markets in which it expects to compete; lack of qualified, skilled labour or loss of key individuals; and risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, disruptions to economic activity and financings, disruptions to supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession or depression; the potential impact that the COVID-19 pandemic may have on Hemostemix which may include a decreased demand for the services that Hemostemix offers; and a deterioration of financial markets that could limit Hemostemix's ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in Hemostemix's disclosure documents on the SEDAR website at www.sedarplus.ca. Although Hemostemix has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of Hemostemix as of the date of this news release and, accordingly, it is Subject to change after such date. However, Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.
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FAQ
What does Florida Senate Bill 1768 mean for Hemostemix (HMTXF) patients?
When and where will Hemostemix present clinical results for ACP-01 (HMTXF)?
Which CLTI patients are prioritized for compassionate access to ACP-01 under HMTXF's Florida program?
What physician resources is Hemostemix (HMTXF) offering in Florida under SB 1768?
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