Hemostemix's Boots on the Ground in Florida
Hemostemix (OTCQB: HMTXF) has launched its face-to-face sales program in Florida for its VesCell™ (ACP-01) autologous stem cell therapy. The initiative focuses on Miami, Naples, and Tampa, leveraging Florida's SB 1768 law that allows advanced cell therapies for patients with life-threatening conditions who have exhausted standard treatments.
The company has treated 498 patients across seven clinical studies involving 318 subjects, resulting in 11 peer-reviewed publications. Clinical results show significant improvements in treating conditions like peripheral arterial disease, with ulcer size reduction from 1.46 cm² to 0.48 mm² in treated groups. The therapy has also demonstrated positive outcomes in treating chronic stable angina and improving cardiac function.
Hemostemix (OTCQB: HMTXF) ha avviato il suo programma di vendita diretta in Florida per la terapia autologa con cellule staminali VesCell™ (ACP-01). L’iniziativa è focalizzata su Miami, Naples e Tampa, sfruttando la legge della Florida SB 1768 che consente terapie cellulari avanzate per pazienti con patologie potenzialmente letali che hanno esaurito i trattamenti standard.
L’azienda ha trattato 498 pazienti in sette studi clinici che hanno coinvolto 318 soggetti, con la pubblicazione di 11 articoli peer-reviewed. I risultati clinici mostrano miglioramenti rilevanti in condizioni come la malattia arteriosa periferica, con una riduzione della dimensione delle ulcere da 1,46 cm² a 0,48 mm² nei gruppi trattati. La terapia ha inoltre dimostrato esiti positivi nel trattamento dell’angina stabile cronica e nel miglioramento della funzione cardiaca.
Hemostemix (OTCQB: HMTXF) ha puesto en marcha su programa de ventas presenciales en Florida para su terapia autóloga con células madre VesCell™ (ACP-01). La iniciativa se centra en Miami, Naples y Tampa, aprovechando la ley de Florida SB 1768 que permite terapias celulares avanzadas para pacientes con condiciones potencialmente mortales que han agotado los tratamientos estándar.
La compañía ha tratado a 498 pacientes en siete estudios clínicos que involucraron a 318 sujetos, con 11 publicaciones revisadas por pares. Los resultados clínicos muestran mejoras significativas en el tratamiento de afecciones como la enfermedad arterial periférica, con una reducción del tamaño de las úlceras de 1,46 cm² a 0,48 mm² en los grupos tratados. La terapia también ha mostrado resultados positivos en el tratamiento de la angina estable crónica y en la mejora de la función cardíaca.
Hemostemix (OTCQB: HMTXF)는 자가 줄기세포 치료제 VesCell™(ACP-01)의 플로리다 지역 대면 영업 프로그램을 시작했습니다. 이 이니셔티브는 마이애미, 네이플스, 탬파에 중점을 두고 있으며, 표준 치료를 소진한 생명을 위협하는 질환 환자에게 첨단 세포 치료를 허용하는 플로리다 법안 SB 1768을 활용합니다.
회사는 7건의 임상 연구에서 총 318명을 대상으로 498명의 환자를 치료했으며, 11건의 동료 평가 논문을 발표했습니다. 임상 결과는 말초 동맥 질환 등에서 유의한 개선을 보여주었으며, 치료군의 궤양 크기가 1.46 cm²에서 0.48 mm²로 감소했습니다. 이 치료법은 만성 안정형 협심증 치료 및 심장 기능 개선에서도 긍정적인 결과를 보였습니다.
Hemostemix (OTCQB: HMTXF) a lancé son programme de ventes en personne en Floride pour sa thérapie autologue par cellules souches VesCell™ (ACP-01). L’initiative cible Miami, Naples et Tampa, tirant parti de la loi de Floride SB 1768 qui autorise les thérapies cellulaires avancées pour les patients atteints de pathologies potentiellement mortelles ayant épuisé les traitements standard.
La société a traité 498 patients au sein de sept études cliniques impliquant 318 sujets, aboutissant à 11 publications évaluées par des pairs. Les résultats cliniques montrent des améliorations significatives pour des affections telles que la maladie artérielle périphérique, avec une réduction de la taille des ulcères de 1,46 cm² à 0,48 mm² dans les groupes traités. La thérapie a également démontré des effets positifs dans le traitement de l’angine stable chronique et l’amélioration de la fonction cardiaque.
Hemostemix (OTCQB: HMTXF) hat sein Präsenzvertriebsprogramm in Florida für die autologe Stammzelltherapie VesCell™ (ACP-01) gestartet. Die Initiative konzentriert sich auf Miami, Naples und Tampa und nutzt das floridianische Gesetz SB 1768, das fortschrittliche Zelltherapien für Patienten mit lebensbedrohlichen Erkrankungen erlaubt, die alle Standardbehandlungen ausgeschöpft haben.
Das Unternehmen hat 498 Patienten in sieben klinischen Studien mit insgesamt 318 Probanden behandelt und 11 Peer-Review-Publikationen vorgelegt. Klinische Ergebnisse zeigen deutliche Verbesserungen bei Erkrankungen wie peripherer arterieller Verschlusskrankheit, mit einer Verringerung der Geschwurgroße von 1,46 cm² auf 0,48 mm² in den behandelten Gruppen. Die Therapie zeigte außerdem positive Ergebnisse bei der Behandlung von chronischer stabiler Angina und der Verbesserung der Herzfunktion.
- None.
- Still requires ongoing FDA engagement for full regulatory approval
- Limited to patients who have exhausted standard-of-care treatment options
Calgary, Alberta--(Newsfile Corp. - August 26, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), an 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 failure, and total body ischemia, under Florida's SB 1768, announces the launch of its face-to-face sales program, with boots on the ground in Miami, Naples, and Tampa, Florida.
Florida's law authorizes the use of advanced cell therapies such as VesCell™ in patients with life-threatening or severely debilitating conditions who have exhausted standard-of-care treatment options. To drive rapid adoption, Hemostemix is executing a "boots on the ground" strategy, led by Thomas Smeenk, CEO, and Croom Lawrence, CCO, who are meeting directly with clinicians, clinic owners, and former Phase II clinical trial investigators, across the state.
"Florida is one of the most advanced U.S. jurisdictions for right-to-try and compassionate use access," said Thomas Smeenk, CEO of Hemostemix. "By putting boots on the ground, we're ensuring physicians and clinic leaders have direct engagement with our leadership team as we expand access to VesCell™ for patients in need."
"Our priority is building deep relationships with the clinical community, many of whom already have firsthand experience with ACP-01 from earlier trials," added Croom Lawrence, CCO. "Florida represents a significant opportunity to align world-class expertise with our mission to bring VesCell™ to those with no remaining treatment options."
Scientific and Clinical Results
Hemostemix has treated 498 patients and completed seven clinical studies of 318 subjects, resulting in 11 peer-reviewed publications that validate the safety and efficacy of VesCell™. This evidence base is now being leveraged to establish a statewide network of treatments in participating clinics.
The Florida rollout strategy includes data collection for FDA Engagement: All Results add to the Company's safety and efficacy profile to obtain Regulatory Approval.
- Direct engagement with podiatrists, cardiologists, and vascular specialists.
- On-site meetings with former Phase II trial sites to transition trial experience into clinical adoption.
- Educational outreach to clinic owners and healthcare providers on patient eligibility, treatment protocols, and data collection (outcomes of treatments).
- Ongoing follow-ups with regulators, including the FDA, with respect to the data generated from treatment outcomes.
A New Chance to Live Better, Longer
Under Florida's Right-to-Try statute SB 1768, physicians-including podiatrists, cardiologists, vascular surgeons, and other specialists treating no-option patients-can now offer VesCell™ (ACP-01) to patients suffering in pain from:
- Peripheral Arterial Disease (PAD)
- Chronic Limb-Threatening Ischemia (CLTI)
- Angina
- Ischemic Cardiomyopathy
- Non-Ischemic Dilated Cardiomyopathy
- Congestive Heart Failure
- Total Body Ischemia
Clinical Results to Date
- Podiatrists & Vascular Surgeons
- In three published trials, including Phase II, VesCell™ generated new blood vessels, restored circulation, healed ulcers, and reduced rates of amputation.
Ulcer size in the treated group decreased from a mean of 1.46 cm2 (the size of a wild strawberry) to 0.48 mm2 (p = 0.01) (the size of a grain of sand) by 3 months. There was no significant decrease in the size of the ulcers of the placebo group (p < 0.54).
To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/5065/263935_4dbb1d5964bbd9af_002full.jpg
- Cardiologists and Thoracic Surgeons
- In three published studies of 41, 106, and 53 subjects, respectively, VesCell™ was safe, and clinically relevant. It improved overall ejection fraction significantly, improved exercise capacity and quality of life.
- In the treatment of chronic stable angina (24 subjects), VesCell™ reduced severe angina symptoms, improved exercise capacity, improved six minutes walk test results, and generated clinical improvement in all patients.
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). A recent peer-reviewed article in Cells (June 29, 2025) provides the scientific foundation for how ACP-01 and NCP-01 may enhance brain-computer interface performance by reducing inflammation, fostering angiogenesis and synaptic plasticity, and potentially extending implant longevity. Hemostemix has completed seven clinical studies of 318 subjects and published its results in 11 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 Company's boots on the ground sales strategy 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.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/263935
FAQ
What conditions can Hemostemix's VesCell™ (HMTXF) treat?
What are the clinical results of Hemostemix's VesCell™ therapy?
How many patients has Hemostemix (HMTXF) treated with VesCell™?
Where is Hemostemix (HMTXF) launching its sales program in Florida?
Who is eligible for Hemostemix's VesCell™ treatment in Florida?
