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Hemostemix Announces the Incorporation of Hemostemix PR Inc: 50% Reimbursement of R&D Expenses in Cash

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Hemostemix (TSXV: HEM) (OTC: HMTXF) has incorporated Hemostemix PR Inc. in Puerto Rico as a wholly owned subsidiary. Under Puerto Rico's ACT 60 program, the company is eligible for up to 50% cash reimbursement of R&D expenses, including clinical trials and economic impact assessments.

The company identifies an annual addressable market of 8,681 Diabetic Foot Ulcers treatments in Puerto Rico, valued at USD $37,000 each. This is based on Puerto Rico's diabetes prevalence of 19-20% among adults, affecting approximately 413,400 cases.

Clinical trial results show that ACP-01, the company's precision healthcare treatment, demonstrated significant efficacy: ulcer size decreased from 1.46 cm² to 0.48 mm² within three months in CLTI patients. In heart failure trials, ACP-01 improved cardiac function by up to 24.1% in ischemic cardiomyopathy and 47.1% in non-ischemic dilated cardiomyopathy patients at 12 months.

Hemostemix (TSXV: HEM) (OTC: HMTXF) ha costituito Hemostemix PR Inc. a Porto Rico come sussidiaria interamente controllata. Sotto il programma ACT 60 di Porto Rico, l'azienda è idonea a ricevere un rimborso in contante fino al 50% delle spese di R&S, comprese le sperimentazioni cliniche e le valutazioni dell'impatto economico.

L'azienda identifica un mercato indirizzabile annuale di 8.681 trattamenti per ulcere del piede diabetico a Porto Rico, valutati a 37.000 USD ciascuno. Ciò si basa sulla prevalenza del diabete a Porto Rico, che è del 19-20% tra gli adulti, colpendo circa 413.400 casi.

I risultati delle sperimentazioni cliniche mostrano che ACP-01, il trattamento di assistenza sanitaria di precisione dell'azienda, ha dimostrato una significativa efficacia: la dimensione delle ulcere è diminuita da 1.46 cm² a 0.48 mm² nel corso di tre mesi nei pazienti con CLTI. Negli studi sulla insufficienza cardiaca, ACP-01 ha migliorato la funzione cardiaca fino al 24.1% nei pazienti con cardiomiopatia ischemica e del 47.1% nei pazienti con cardiomiopatia dilatativa non ischemica dopo 12 mesi.

Hemostemix (TSXV: HEM) (OTC: HMTXF) ha incorporado Hemostemix PR Inc. en Puerto Rico como una subsidiaria de propiedad total. Bajo el programa ACT 60 de Puerto Rico, la compañía es elegible para un reembolso en efectivo de hasta el 50% de los gastos de I+D, incluidos ensayos clínicos y evaluaciones del impacto económico.

La compañía identifica un mercado anual direccionable de 8,681 tratamientos para úlceras en pies diabéticos en Puerto Rico, valorados en 37,000 USD cada uno. Esto se basa en la prevalencia de diabetes en Puerto Rico, que es del 19-20% entre adultos, afectando aproximadamente a 413,400 casos.

Los resultados de los ensayos clínicos muestran que ACP-01, el tratamiento de atención médica de precisión de la compañía, demostró una eficacia significativa: el tamaño de la úlcera disminuyó de 1.46 cm² a 0.48 mm² en tres meses en pacientes con CLTI. En ensayos de insuficiencia cardíaca, ACP-01 mejoró la función cardíaca en hasta un 24.1% en pacientes con cardiomiopatía isquémica y un 47.1% en pacientes con cardiomiopatía dilatada no isquémica a los 12 meses.

Hemostemix (TSXV: HEM) (OTC: HMTXF)는 포르투리코에 Hemostemix PR Inc.를 완전 자회사로 설립했습니다. 포르투리코의 ACT 60 프로그램에 따라, 이 회사는 연구 및 개발(R&D) 비용, 임상 시험 및 경제적 영향 평가를 포함해 최대 50%의 현금 환급을 받을 자격이 있습니다.

회사는 포르투리코에서 연간 8,681건의 당뇨병성 발 궤양 치료 시장을 확인하고 있으며, 각각의 치료 가치는 37,000 USD입니다. 이는 포르투리코 성인의 당뇨병 유병률이 19-20%이고, 약 413,400명의 사례에 영향을 미친다는 데 기반하고 있습니다.

임상 시험 결과에 따르면, ACP-01, 회사의 정밀 보건 관리 치료는 상당한 효능을 보였습니다: CLTI 환자에서 궤양 크기가 1.46 cm²에서 0.48 mm²로 3개월 내에 감소했습니다. 심부전 시험에서, ACP-01은 허혈성 심근병 환자에서 최대 24.1%, 비허혈성 확장형 심근병 환자에서 12개월 후 47.1%의 심장 기능 개선을 보였습니다.

Hemostemix (TSXV: HEM) (OTC: HMTXF) a constitué Hemostemix PR Inc. à Porto Rico en tant que filiale à part entière. Dans le cadre du programme ACT 60 de Porto Rico, la société est éligible à un remboursement en espèces pouvant atteindre 50% des dépenses en R&D, y compris les essais cliniques et les évaluations d'impact économique.

La société identifie un marché adressable annuel de 8 681 traitements d'ulcères du pied diabétique à Porto Rico, évalués à 37 000 USD chacun. Cela est basé sur une prévalence du diabète de 19 à 20 % parmi les adultes à Porto Rico, touchant environ 413 400 cas.

Les résultats des essais cliniques montrent que ACP-01, le traitement de santé de précision de l'entreprise, a démontré une efficacité significative : la taille des ulcères a diminué de 1,46 cm² à 0,48 mm² en trois mois chez les patients atteints de CLTI. Dans les essais sur l'insuffisance cardiaque, ACP-01 a amélioré la fonction cardiaque de jusqu'à 24,1 % chez les patients atteints de cardiomyopathie ischémique et de 47,1 % chez les patients atteints de cardiomyopathie dilatée non ischémique après 12 mois.

Hemostemix (TSXV: HEM) (OTC: HMTXF) hat Hemostemix PR Inc. in Puerto Rico als hundertprozentige Tochtergesellschaft gegründet. Im Rahmen des ACT 60-Programms von Puerto Rico ist das Unternehmen berechtigt, bis zu 50% der F&E-Kosten, einschließlich klinischer Studien und wirtschaftlicher Auswirkungen, in bar erstattet zu bekommen.

Das Unternehmen identifiziert einen jährlich adressierbaren Markt von 8.681 Behandlungen für diabetische Fußgeschwüre in Puerto Rico, deren Wert jeweils 37.000 USD beträgt. Dies basiert auf einer Diabetesprävalenz von 19-20% unter Erwachsenen in Puerto Rico, die etwa 413.400 Fälle betrifft.

Die Ergebnisse der klinischen Studien zeigen, dass ACP-01, die präzise Gesundheitsbehandlung des Unternehmens, eine signifikante Wirksamkeit aufwies: Die Geschwürgröße verringerte sich bei CLTI-Patienten innerhalb von drei Monaten von 1,46 cm² auf 0,48 mm². In Herzinsuffizienzstudien verbesserte ACP-01 die Herzfunktion um bis zu 24,1% bei Patienten mit ischämischer Kardiomyopathie und um 47,1% bei Patienten mit nicht-ischämischer dilatierter Kardiomyopathie nach 12 Monaten.

Positive
  • Eligible for 50% cash reimbursement of R&D expenses under Puerto Rico's ACT 60 program
  • Identified market opportunity of 8,681 DFU treatments at USD $37,000 each in Puerto Rico
  • Clinical trial results showed significant ulcer size reduction from 1.46 cm² to 0.48 mm²
  • Demonstrated cardiac function improvement up to 47.1% in heart failure patients
Negative
  • None.

Calgary, Alberta--(Newsfile Corp. - January 6, 2025) - Hemostemix Inc. (TSXV: HEM) (OTC: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company") is pleased to announce it has incorporated Hemostemix PR Inc., in Puerto Rico, as a wholly owned subsidiary and a domestic for profit corporation.

Under Puerto Rico's ACT 60 program, Hemostemix PR Inc. is eligible to file applications for cash reimbursement of up to 50% of its research and development expenses, including clinical trials, economic impact assessments of ACP-01 in terms of healthcare budget savings, and feasibility analyses, for example. Hemostemix PR Inc.'s first ACT 60 Application is now completed. Its submission will take place this week.

The following information highlights the healthcare drivers and financial impacts that are available to Hemostemix PR Inc., our partner CytoImmune, and the people of Puerto Rico for one of seven medical indications Hemostemix has treated safely, with clinical relevancy, and statistically significant efficacy.

Annual Addressable Market: Treatments of 8,681 Diabetic Foot Ulcers

Based on its 2020 census, Puerto Rico has a population of 3,285,874. The prevalence of diabetes in Puerto Rico (19-20%) has been increasing over the years. Various studies highlight this trend: Abarty's Health and the Puerto Rico Diabetes Association Analysis (2021) estimated a diabetes prevalence of over 19.3% among adults aged 20 and above. The International Diabetes Federation (IDF) 2021 Report estimated a diabetes prevalence of 20.1% among adults in Puerto Rico, equating to approximately 413,400 cases.

The annual incidence of foot ulceration in patients with diabetes varies between 1.2% and 3.0%, a mean of 2.1% per year (Diabetes Journals). At the mean, Hemostemix estimates its annual total addressable market in Puerto Rico for diabetic foot ulcers (DFUs) treatment is approximately 8,681 cases at USD $37,000 each. The lifetime risk of developing a foot ulcer for patients with diabetes is estimated to be between 19% and 34% (RACGP, 78,546 - 140,556 cases). The 2024 Canadian Institute for Health Information study, Equity in diabetes care: A focus on lower limb amputation, highlighted that in Canada, 31,220 hospitalizations cost $750 Million annually; however, the report noted, that cost reflected a fraction of the total system costs associated with diabetic foot ulcers and amputations.

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DFU Before Treatment

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After Treatment with Hemostemix ACP-01

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We presented these figures and our solution to Puerto Rico's Governor Elect during her campaign" stated Thomas Smeenk, CEO. "Together with the Government, our partner CytoImmune, and physicians who may treat under special access programs, ACP-01 may heal ulcers, mitigate pain for no-option diabetic foot ulcer patients, and save the healthcare budget 4-5 years of hospitalization costs per patient treated. Leveraging our Phase II results, we will complete an economic analysis of the significant cost savings for the healthcare system of Puerto Rico. ACT 60 is why Puerto Rico is the best jurisdiction in the world to complete clinical trials and R&D," Smeenk said.

Globally, 236 million suffer from peripheral arterial disease. 23 million degenerate into chronic limb threatening ischema ("CLTI"), and face a 60% mortality rate in five years. In contrast, the University of Toronto and University of British Columbia posted their interim results during Hemostemix's Phase II randomized double blind clinical trial that 83% of patients followed for up to 4.5 years experienced healing of ulcers and resolution of ischemic rest pain.

Precision Healthcare (ACP-01) Regenerates Circulation and Restores Quality of Life

ACP-01 is sourced from the patient's blood and cultured in the patient's serum. It is demonstrated to be safe, clinically relevant, and statistically effective. For example:

  • In the Journal of Biomedical Research & Environmental Science, February 2024, The Company's phase II chronic limb threatening ischemia (CLTI) clinical trial results detailed that ulcer size decreased significantly in the treated group from a mean of 1.46 cm² to 0.48 mm², p = 0.01 within three months.
  • In the Journal Stem Cell Research & Therapy, October 2023, the Company published its seventh peer reviewed study. This was the third independent study of ACP-01 as a treatment for end stage heart failure (53 subjects). Two previous clinical trials of ischemic cardiomyopathy and non ischemic dilated cardiomyopathy( 106 subjects, 41 subjects), achieved clinically relevant results that were statistically significant. For example, in 53 subjects, ACP-01 regenerated and improved cardiac function by up to 24.1% at 12 months in ischemic cardiomyopathy subjects; and, up to 47.1% at 12 months in non ischemic dilated cardiomyopathy subjects.

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About Hemostemix

Founded in 2003, Hemostemix is a clinical-stage biotechnology company and winner of the World Economic Forum Technology Pioneer Award. The Company has developed and patented a blood-based stem cell therapeutics platform that includes angiogenic cell precursors (ACP), neuronal cell precursors (NCP), and cardiomyocyte cell precursors (CCP)

For more information, visit www.hemostemix.com. Or, contact: Thomas Smeenk, President & CEO tsmeenk@hemostemix.com. Phone: 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 Program, and social media programs targeted to generate sales. 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 the 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 Hemostemis 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/236101

FAQ

What is the potential market size for HMTXF's diabetic foot ulcer treatment in Puerto Rico?

HMTXF has identified an annual addressable market of 8,681 Diabetic Foot Ulcer treatments in Puerto Rico, valued at USD $37,000 each, based on the region's 19-20% diabetes prevalence.

How effective is HMTXF's ACP-01 treatment in clinical trials for ulcer reduction?

In Phase II clinical trials, ACP-01 significantly reduced ulcer size from 1.46 cm² to 0.48 mm² within three months in chronic limb threatening ischemia patients.

What R&D benefits does HMTXF receive through Puerto Rico's ACT 60 program?

Through Puerto Rico's ACT 60 program, HMTXF is eligible for cash reimbursement of up to 50% of its research and development expenses, including clinical trials and economic impact assessments.

What improvement in cardiac function did HMTXF's ACP-01 show in heart failure patients?

ACP-01 improved cardiac function by up to 24.1% in ischemic cardiomyopathy patients and up to 47.1% in non-ischemic dilated cardiomyopathy patients at 12 months.

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