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Hemostemix Presents at TERMIS 2025, Freiburg, Germany

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Hemostemix Inc. (HMTXF) presented its clinical trial results at the TERMIS 2025 World Congress in Freiburg, Germany. The company showcased its Phase II clinical trial findings, published in JBRES, demonstrating significant improvements in ischemic tissue perfusion, pain reduction, wound healing, and limb salvage in no-option CLTI patients. The presentation also highlighted data from five heart studies investigating ACP-01 in various cardiac conditions.

CEO Thomas Smeenk emphasized the company's revenue generation of >$1 Million to date and discussed their strategy of using therapy convertible debentures sales to fund their phase III clinical trial. The company's autologous blood-based stem cell therapy, ACP-01, has completed seven clinical studies with 318 subjects, showing promising results for various cardiovascular conditions, with notably 0% mortality and 83% wound healing rates in CLTI patients.

Hemostemix Inc. (HMTXF) ha presentato i risultati del suo trial clinico al TERMIS 2025 World Congress a Friburgo, Germania. L'azienda ha mostrato i dati della fase II, pubblicati su JBRES, evidenziando miglioramenti significativi nella perfusione del tessuto ischemico, riduzione del dolore, guarigione delle ferite e salvataggio dell'arto in pazienti con CLTI senza opzioni terapeutiche. La presentazione ha inoltre illustrato dati provenienti da cinque studi cardiaci sull'ACP-01 in diverse condizioni cardiache.

Il CEO Thomas Smeenk ha sottolineato che l'azienda ha generato ricavi superiori a 1 milione di dollari fino ad oggi e ha illustrato la strategia di finanziare la fase III del trial clinico attraverso la vendita di debiti convertibili legati alla terapia. La terapia a base di cellule staminali autologhe del sangue, ACP-01, ha completato sette studi clinici con 318 soggetti, mostrando risultati promettenti per varie condizioni cardiovascolari, con un tasso di mortalità pari a 0% e un tasso di guarigione delle ferite dell’83% nei pazienti con CLTI.

Hemostemix Inc. (HMTXF) presentó los resultados de su ensayo clínico en el TERMIS 2025 World Congress en Friburgo, Alemania. La compañía mostró los hallazgos de su ensayo clínico de fase II, publicados en JBRES, que demuestran mejoras significativas en la perfusión del tejido isquémico, reducción del dolor, cicatrización de heridas y salvamento de extremidades en pacientes con CLTI sin opciones terapéuticas. La presentación también destacó datos de cinco estudios cardíacos que investigan ACP-01 en diversas condiciones cardíacas.

El CEO Thomas Smeenk enfatizó que la empresa ha generado ingresos superiores a 1 millón de dólares hasta la fecha y explicó su estrategia de financiar el ensayo clínico de fase III mediante la venta de bonos convertibles relacionados con la terapia. La terapia con células madre autólogas basada en sangre, ACP-01, ha completado siete estudios clínicos con 318 sujetos, mostrando resultados prometedores para diversas condiciones cardiovasculares, con una mortalidad del 0% y una tasa de cicatrización de heridas del 83% en pacientes con CLTI.

Hemostemix Inc. (HMTXF)는 독일 프라이부르크에서 열린 TERMIS 2025 세계 총회에서 임상 시험 결과를 발표했습니다. 회사는 JBRES에 게재된 2상 임상 시험 결과를 공개하며, 치료 옵션이 없는 CLTI 환자들의 허혈 조직 관류, 통증 감소, 상처 치유 및 사지 보존에서 유의미한 개선을 보였다고 밝혔습니다. 발표에서는 다양한 심장 질환에서 ACP-01을 연구한 5건의 심장 연구 데이터도 강조되었습니다.

CEO 토마스 스미크는 현재까지 100만 달러 이상의 수익을 창출했다고 강조하며, 3상 임상 시험 자금 조달을 위해 치료 전환사채 판매 전략을 논의했습니다. 자가 혈액 기반 줄기세포 치료제인 ACP-01은 318명의 대상자가 참여한 7건의 임상 시험을 완료했으며, CLTI 환자에서 0% 사망률과 83% 상처 치유율 등 다양한 심혈관 질환에 대해 유망한 결과를 보여주고 있습니다.

Hemostemix Inc. (HMTXF) a présenté les résultats de son essai clinique lors du TERMIS 2025 World Congress à Fribourg, en Allemagne. La société a exposé les résultats de son essai clinique de phase II, publiés dans JBRES, démontrant des améliorations significatives de la perfusion des tissus ischémiques, de la réduction de la douleur, de la cicatrisation des plaies et du sauvetage des membres chez des patients CLTI sans autre option thérapeutique. La présentation a également mis en lumière des données issues de cinq études cardiaques portant sur l’ACP-01 dans diverses pathologies cardiaques.

Le PDG Thomas Smeenk a souligné que la société a généré à ce jour plus d’un million de dollars de revenus et a expliqué leur stratégie de financement de l’essai clinique de phase III par la vente d’obligations convertibles liées à la thérapie. La thérapie à base de cellules souches autologues à partir du sang, ACP-01, a complété sept études cliniques impliquant 318 sujets, montrant des résultats prometteurs pour diverses affections cardiovasculaires, avec notamment un taux de mortalité de 0 % et un taux de cicatrisation des plaies de 83 % chez les patients CLTI.

Hemostemix Inc. (HMTXF) präsentierte seine klinischen Studienergebnisse auf dem TERMIS 2025 Weltkongress in Freiburg, Deutschland. Das Unternehmen stellte die Ergebnisse seiner Phase-II-Studie vor, die in JBRES veröffentlicht wurden und signifikante Verbesserungen bei der ischämischen Gewebeperfusion, Schmerzlinderung, Wundheilung und Gliedmaßenrettung bei Patienten mit therapieresistentem CLTI zeigten. Die Präsentation hob zudem Daten aus fünf Herzstudien hervor, die ACP-01 bei verschiedenen Herzerkrankungen untersuchen.

CEO Thomas Smeenk betonte, dass das Unternehmen bisher Einnahmen von über 1 Million US-Dollar erzielt hat, und erläuterte die Strategie, die Phase-III-Studie durch den Verkauf von therapie-konvertierbaren Schuldverschreibungen zu finanzieren. Die autologe, blutbasierte Stammzelltherapie ACP-01 hat sieben klinische Studien mit 318 Probanden abgeschlossen und zeigt vielversprechende Ergebnisse für verschiedene Herz-Kreislauf-Erkrankungen, mit bemerkenswerten 0 % Sterblichkeit und 83 % Wundheilungsrate bei CLTI-Patienten.

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Freiburg, Germany--(Newsfile Corp. - May 20, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF), a leading Phase III clinical-stage biotechnology company developing autologous stem cell therapies for cardiovascular diseases, is presenting its groundbreaking clinical trial results and regenerative medicine innovations today at the Tissue Engineering and Regenerative Medicine International Society (TERMIS) 2025 World Congress in Freiburg, Germany.

Hemostemix's presentation highlights the company's clinical pipeline, and its innovation to finance the company non dilutively from the forward sale of therapy convertible debentures to no-option patients who can be treated compassionately under exemption in certain jurisdictions.

Among the key results shared is the publication of Hemostemix's Phase II clinical trial findings in the Journal of Biomedical Research & Environmental Sciences (JBRES), which demonstrated statistically significant improvements in ischemic tissue perfusion, pain reduction, wound healing, and limb salvage in no-option CLTI patients.

Hemostemix is also showcasing data from five pivotal heart studies investigating ACP-01 in patients with ischemic and non-ischemic cardiomyopathy, congestive heart failure, and angina. These studies have been published in leading peer-reviewed journals, including Stem Cell Research & Therapy.

"Presenting at TERMIS 2025 is a tremendous opportunity to share our company's asymmetric investment opportunity, stated Thomas Smeenk, CEO. I am highlighting our >$1 Million revenues to-date, our forecast of ramp-up from sales of TSX approved therapy convertible debentures to no-option patients who agree to be followed for one year, and explain how these cashflows will fund our phase III clinical trial," Smeenk said.

Hemostemix's presentation at TERMIS 2025 reflects its commitment to innovation, evidence-based clinical research, and advancing ACP-01 as a new standard of care for patients suffering from peripheral arterial disease, chronic limb threatening ischemia, angina, ischemic heart disease, non ischemic dilated cardiomyopathy and vascular dementia.

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, ACP-01. Hemostemix has completed seven clinical studies of 318 subjects and published its results in nine 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 60% in the CLTI patient population, UBC and U of T reported to the 41st meeting of vascular surgeons: 0% mortality, cessation of pain, wound healing in 83% of patients followed for up to 4.5 years, as a midpoint result. For more information, please visit www.hemostemix.com.

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 sales of its lead product ACP-01, the commercialization of ACP-01 via the sale of compassionate treatments under Special Access Programs. 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/252711

FAQ

What clinical trial results did Hemostemix (HMTXF) present at TERMIS 2025?

Hemostemix presented Phase II clinical trial results showing statistically significant improvements in ischemic tissue perfusion, pain reduction, wound healing, and limb salvage in no-option CLTI patients, along with data from five heart studies investigating ACP-01 in various cardiac conditions.

What is the success rate of Hemostemix's ACP-01 therapy in CLTI patients?

According to reports presented to the 41st meeting of vascular surgeons, ACP-01 showed 0% mortality and 83% wound healing in patients followed for up to 4.5 years, compared to the typical 60% five-year mortality rate in CLTI patients.

How many clinical studies has Hemostemix completed for ACP-01?

Hemostemix has completed seven clinical studies involving 318 subjects and published results in nine peer-reviewed publications.

How is Hemostemix funding its Phase III clinical trial?

Hemostemix is funding its Phase III trial through the sale of TSX-approved therapy convertible debentures to no-option patients who agree to be followed for one year, having generated over $1 Million in revenues to date.
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