Hemostemix to Showcase Breakthrough Wound Healing Therapy at Innovations in Wound Care Conference Florida
Hemostemix (OTCQB: HMTXF) will present ACP-01 clinical data at the Innovations in Wound Care Conference (Dec 11–14, 2025) in Key West, Florida.
Clinical results reported include a Phase II randomized trial showing mean ulcer size fell from 146 mm2 to 0.48 mm2 (p=0.01) at 3 months, treatment-group amputation rate 4.8% vs placebo 25%, and treatment-group mortality 4.8% in that study. Hemostemix cites treatment experience across 498 subjects spanning five Phase I trials, one Phase II RCT, and one retrospective study. ACP-01 is available under Florida SB-1768. Company highlights a local non-healing wound market of $500–$600M (growing to $700–$800M) and a projected global wound care market > $20B by 2030.
Hemostemix (OTCQB: HMTXF) presenterà dati clinici ACP-01 alla conferenza Innovations in Wound Care (11–14 dicembre 2025) a Key West, Florida.
I risultati clinici riportati includono uno studio randomizzato di fase II che mostra che la dimensione media dell’ulcera è passata da 146 mm2 a 0,48 mm2 (p=0,01) entro 3 mesi, il tasso di amputazione nel gruppo di trattamento 4,8% vs placebo 25%, e la mortalità del gruppo di trattamento 4,8% in quello studio. Hemostemix cita l’esperienza di trattamento su 498 soggetti che comprendono cinque studi di fase I, un RCT di fase II, e uno studio retrospettivo. ACP-01 è disponibile nell’ambito di Florida SB-1768. L’azienda evidenzia un mercato locale di ferite non cicatrizzanti di $500–$600M (in crescita a $700–$800M) e un mercato globale previsto per le cure delle ferite superiore a $20B entro il 2030.
Hemostemix (OTCQB: HMTXF) presentará datos clínicos ACP-01 en la conferencia Innovations in Wound Care (11–14 de diciembre de 2025) en Key West, Florida.
Los resultados clínicos reportados incluyen un ensayo aleatorizado de fase II que muestra que el tamaño medio de la úlcera pasó de 146 mm2 a 0,48 mm2 (p=0,01) a los 3 meses, la tasa de amputación en el grupo de tratamiento 4,8% frente a placebo 25%, y la mortalidad del grupo de tratamiento 4,8% en ese estudio. Hemostemix cita experiencia de tratamiento en 498 sujetos que abarcan cinco ensayos de fase I, un RCT de fase II y un estudio retrospectivo. ACP-01 está disponible bajo Florida SB-1768. La compañía destaca un mercado local de heridas crónicas no cicatrizadas de $500–$600M (creciendo a $700–$800M) y un mercado global de cuidado de heridas proyectado a > $20B para 2030.
Hemostemix (OTCQB: HMTXF)가 Key West, Florida에서 열리는 Innovations in Wound Care Conference(2025년 12월 11–14일)에서 ACP-01 임상 데이터를 발표합니다.
보고된 임상 결과에는 2상 무작위 임상시험이 포함되며, 궤양 크기가 3개월 만에 146 mm2에서 0.48 mm2로 감소(p=0.01)했고, 치료군의 절단율은 4.8%였고 위약군은 25%, 해당 연구에서 치료군의 사망률은 4.8%였습니다. Hemostemix는 498명의 피실험자를 다룬 5건의 1상 연구, 1건의 2상 RCT, 1건의 후향 연구를 인용합니다. ACP-01은 Florida SB-1768에 따라 이용 가능합니다. 회사는 국소 비난성 창상 시장을 $500–$600M으로, $700–$800M으로 성장하고, 전 세계 창상 관리 시장은 2030년까지 $20B를 초과할 것으로 전망합니다.
Hemostemix (OTCQB: HMTXF) présentera les données cliniques ACP-01 à la conférence Innovations in Wound Care (du 11 au 14 décembre 2025) à Key West, en Floride.
Les résultats cliniques rapportés incluent un essai randomisé de phase II montrant que la taille moyenne de l’ulcère est passée de 146 mm2 à 0,48 mm2 (p=0,01) à 3 mois, le taux d’amputation du groupe traité 4,8% contre placebo 25%, et la mortalité du groupe traité 4,8% dans cette étude. Hemostemix cite une expérience de traitement sur 498 sujets couvrant cinq essais de phase I, un RCT de phase II et une étude rétrospective. ACP-01 est disponible sous Florida SB-1768. La société met en avant un marché local des plaies non cicatrisantes de $500–$600M (en croissance à $700–$800M) et un marché mondial des soins des plaies prévu à plus de $20B d’ici 2030.
Hemostemix (OTCQB: HMTXF) wird ACP-01-Klinikdaten auf der Innovations in Wound Care Conference (11.–14. Dez. 2025) in Key West, Florida, vorstellen.
Zu den berichteten klinischen Ergebnissen gehört eine randomisierte Phase-II-Studie, die zeigt, dass die mittlere Ulkusgröße von 146 mm2 auf 0,48 mm2 (p=0,01) reduziert wurde nach 3 Monaten, die Amputationsrate der Behandlungsgruppe 4,8% gegenüber Placebo 25%, und die Mortalität der Behandlungsgruppe 4,8% in dieser Studie. Hemostemix verweist auf Behandlungserfahrungen mit 498 Probanden, die fünf Phase-I-Studien, eine Phase-II-RCT und eine retrospektive Studie umfassen. ACP-01 ist verfügbar unter Florida SB-1768. Das Unternehmen hebt einen lokalen Markt für nicht heilende Wunden von $500–$600M (Wachstum zu $700–$800M) sowie einen prognostizierten globalen Wundversorgungsmarkt von über $20B bis 2030 hervor.
Hemostemix (OTCQB: HMTXF) سيقدّم بيانات ACP-01 السريرية في مؤتمر Innovations in Wound Care (11–14 ديسمبر 2025) في كي ويست، فلوريدا.
تشمل النتائج السريرية المبلغ عنها تجربة عشوائية مزدوجة التعمية من المرحلة II تُظهر أن متوسط حجم القرحة انخفض من 146 مم2 إلى 0.48 مم2 (p=0.01) عند 3 أشهر، ومعدل البتر في مجموعة العلاج 4.8% مقابل الدواء الوهمي 25%, والوفيات في مجموعة العلاج 4.8% في تلك الدراسة. تشير Hemostemix إلى خبرة علاج مع 498 مريضاً تغطي خمس تجارب مرحلة I، وتجربة عشوائية محكومة من المرحلة II، وإحدى الدراسات الاستعادية. ACP-01 متاح بموجب Florida SB-1768. تؤكد الشركة وجود سوق محلي للجروح غير القابلة للشفاء يتراوح بين $500–$600M (ينمو إلى $700–$800M) وسوق عالمي للعناية بالجروح يتجاوز $20B بحلول 2030.
- Ulcer size reduced from 146 mm2 to 0.48 mm2 (p=0.01) at 3 months
- Treatment-group amputation rate 4.8% vs placebo 25% in Phase II trial
- 498 subjects treated across multiple trials and studies
- ACP-01 available under Florida SB-1768
- Florida non-healing wound market: $500–$600M (projected $700–$800M)
- Treatment-group reported one death (4.8%) in the Phase II study
- Regulatory access noted only under Florida SB-1768 (geographic limitation)
Calgary, Alberta--(Newsfile Corp. - November 18, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), a leader in regenerative medicine, will attend the Innovations in Wound Care Conference from December 11-14, 2025 in Key West, Florida. The company will highlight its world-leading angiogenic cell therapy, ACP-01, which regenerates circulation, heals ulcers, alleviates pain, and improves quality of life for patients with advanced wound care needs including Peripheral Arterial Disease, Critical Limb-Threatening Ischemia (CLTI).
Last week, Hemostemix completed a Grand Rounds presentation at the University of Florida Department of Vascular Surgery, featuring Dr. Fraser Henderson, Neurosurgeon. The session reviewed clinical insights from the treatment of 498 subjects including across five Phase I trials, one Phase II double-blind randomized controlled trial, and one retrospective study. Four of Hemostemix' studies detailed wound healing that saved limbs from amputation, including the double blind randomized phase II trial of no option CLTI subjects:
- Henderson et al. (J Biomed Res Environ Sci, 2024): Published ulcer size in the treated group decreased from a mean of 146 mm2 to 0.48 mm2 (p = 0.01) by 3 months (wound size reduced from the size of a wild strawberry to the size of one grain of sand). There was no significant decrease in the size of the ulcers of the placebo group (p < 0.54). At one year there were no complications related to treatment. The treatment group had one amputation (
4.8% ) and one death (4.8% ); the placebo group had 2 amputations (25% ) and 1 death (12.5% ). - Mutirangura et al. (Journal of the Medical Association of Thailand, 2009): Reported
83.3% of treated had clinically significant improvement of adequate circulation at the distal limb for the complete healing. - Szabo et al. (Cytotherapy, 2013): At 2-year follow-up in the control group:
20% mortality and75% required major amputations; in the treated group:0% mortality, and70% of limbs saved from amputation. At 3-month follow-up, the change in hemodynamic parameters showed a significant increase in the treated group over the control group. - Misskey et al. (UBC & University of Toronto 2023): Healing of ulcers and resolution of ischemic rest pain occurred in the other
83% patients.
Why It Matters: ACP-01 is currently available under Florida SB-1768. Up to 500,000 Floridians live with pain associated with non-healing wounds - a
Watch the CLTI Grand Rounds Replay on YouTube
Quote from Thomas Smeenk, President & CEO:
"Our mission is simple yet profound: to treat pain, heal wounds that otherwise will not heal, save limbs and improve patients' quality of life. ACP-01 is the world's leading therapy for regenerating circulation and healing wounds where traditional options have failed. We are proud to share our clinical success and collaborate with physicians at the Innovations in Wound Care Conference to advance patient care."
Investor Highlights:
Hemostemix operates in a global wound care market projected to exceed
Media Contact:
Thomas Smeenk
President & CEO, Hemostemix Inc.
+1 (905) 580-4170
www.hemostemix.com
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 financing of the Company related to 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.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/275002
FAQ
When and where will Hemostemix (HMTXF) present ACP-01 data at the Innovations in Wound Care Conference?
What were the key Phase II ACP-01 results Hemostemix (HMTXF) reported on Nov 18, 2025?
How many patients have been treated with ACP-01 across Hemostemix studies?
Is ACP-01 commercially available and where can it be used now?
What market opportunity did Hemostemix cite for non-healing wounds in Florida and globally?
