Hemostemix's Pitch to Wall Street: ACP-01 Vascular Dementia Trial will Generate $5,365,000, Capture Data, as a Phase 1 Clinical Trial
Hemostemix (HMTXF) has announced a Phase 1 clinical trial for treating Vascular Dementia with ACP-01, targeting up to 100 patients. Each patient will pay USD $37,000 for the treatment, potentially generating USD $3.7M (CAD $5.36M) in revenue.
The trial will evaluate the safety, tolerability, and preliminary efficacy of intrathecal ACP-01 injection directly into cerebrospinal fluid. Primary endpoints include safety assessment and ACP-01 delivery feasibility, while secondary endpoints focus on cognitive function, dementia rating, and quality of life measurements.
The study will utilize FireFly's BNA™ technology for brain activity monitoring, comparing results against their FDA-cleared database of 77,000 EEG brain scans. The company reports a successful case study of a patient treated with ACP-01 showing positive results 10 years post-treatment.
Hemostemix (HMTXF) ha annunciato uno studio clinico di Fase 1 per il trattamento della demenza vascolare con ACP-01, mirando a coinvolgere fino a 100 pazienti. Ogni paziente pagherà 37.000 USD per il trattamento, generando potenzialmente 3,7 milioni di USD (5,36 milioni di CAD) di entrate.
Lo studio valuterà la sicurezza, la tollerabilità e l'efficacia preliminare dell'iniezione intratecale di ACP-01 direttamente nel liquido cerebrospinale. Gli obiettivi primari includono la valutazione della sicurezza e la fattibilità della somministrazione di ACP-01, mentre gli obiettivi secondari si concentrano sulla funzione cognitiva, la valutazione della demenza e le misurazioni della qualità della vita.
Lo studio utilizzerà la tecnologia BNA™ di FireFly per il monitoraggio dell'attività cerebrale, confrontando i risultati con il loro database approvato dalla FDA di 77.000 scansioni EEG. L'azienda riporta un caso studio di successo di un paziente trattato con ACP-01 che ha mostrato risultati positivi 10 anni dopo il trattamento.
Hemostemix (HMTXF) ha anunciado un ensayo clínico de Fase 1 para tratar la demencia vascular con ACP-01, dirigido a hasta 100 pacientes. Cada paciente pagará 37,000 USD por el tratamiento, generando potencialmente 3.7 millones de USD (5.36 millones de CAD) en ingresos.
El ensayo evaluará la seguridad, tolerabilidad y eficacia preliminar de la inyección intratecal de ACP-01 directamente en el líquido cefalorraquídeo. Los objetivos primarios incluyen la evaluación de la seguridad y la viabilidad de la administración de ACP-01, mientras que los objetivos secundarios se centran en la función cognitiva, la calificación de demencia y las mediciones de calidad de vida.
El estudio utilizará la tecnología BNA™ de FireFly para el monitoreo de la actividad cerebral, comparando los resultados con su base de datos aprobada por la FDA de 77,000 escaneos EEG. La empresa informa de un estudio de caso exitoso de un paciente tratado con ACP-01 que mostró resultados positivos 10 años después del tratamiento.
Hemostemix (HMTXF)는 ACP-01로 혈관성 치매를 치료하기 위한 1상 임상 시험을 발표했으며, 최대 100명의 환자를 대상으로 합니다. 각 환자는 치료를 위해 37,000 USD를 지불하며, 이는 잠재적으로 370만 USD(536만 CAD)의 수익을 창출할 수 있습니다.
이번 시험은 ACP-01을 뇌척수액에 직접 주입하는 것의 안전성, 내약성 및 초기 효능을 평가할 것입니다. 주요 목표는 안전성 평가 및 ACP-01 투여 가능성이며, 부차적 목표는 인지 기능, 치매 평가 및 삶의 질 측정에 초점을 맞춥니다.
이 연구는 FireFly의 BNA™ 기술를 사용하여 뇌 활동을 모니터링하며, 77,000개의 EEG 뇌 스캔에 대한 FDA 승인 데이터베이스와 결과를 비교합니다. 이 회사는 ACP-01로 치료받은 환자의 성공 사례를 보고하며, 치료 후 10년이 지난 후 긍정적인 결과를 보였다고 전했습니다.
Hemostemix (HMTXF) a annoncé un essai clinique de Phase 1 pour traiter la démence vasculaire avec ACP-01, visant jusqu'à 100 patients. Chaque patient paiera 37 000 USD pour le traitement, générant potentiellement 3,7 millions USD (5,36 millions CAD) de revenus.
L'essai évaluera la sûreté, la tolérance et l'efficacité préliminaire de l'injection intrathécale d'ACP-01 directement dans le liquide céphalorachidien. Les objectifs principaux incluent l'évaluation de la sécurité et la faisabilité de l'administration d'ACP-01, tandis que les objectifs secondaires se concentrent sur la fonction cognitive, l'évaluation de la démence et les mesures de qualité de vie.
L'étude utilisera la technologie BNA™ de FireFly pour le suivi de l'activité cérébrale, comparant les résultats avec leur base de données approuvée par la FDA de 77 000 scans EEG. L'entreprise rapporte une étude de cas réussie d'un patient traité avec ACP-01 montrant des résultats positifs 10 ans après le traitement.
Hemostemix (HMTXF) hat eine Phase-1-Studie zur Behandlung von vaskulärer Demenz mit ACP-01 angekündigt, die bis zu 100 Patienten umfassen soll. Jeder Patient wird 37.000 USD für die Behandlung zahlen, was potenziell 3,7 Millionen USD (5,36 Millionen CAD) an Einnahmen generieren könnte.
Die Studie wird die Sicherheit, Verträglichkeit und vorläufige Wirksamkeit der intrathekalen Injektion von ACP-01 direkt in die Gehirn-Rückenmarks-Flüssigkeit bewerten. Die primären Endpunkte umfassen die Sicherheitsbewertung und die Machbarkeit der ACP-01-Verabreichung, während die sekundären Endpunkte sich auf die kognitive Funktion, die Demenzbewertung und die Lebensqualitätsmessungen konzentrieren.
Die Studie wird die BNA™-Technologie von FireFly zur Überwachung der Gehirnaktivität nutzen und die Ergebnisse mit ihrer von der FDA genehmigten Datenbank von 77.000 EEG-Gehirnscans vergleichen. Das Unternehmen berichtet von einer erfolgreichen Fallstudie eines Patienten, der mit ACP-01 behandelt wurde und 10 Jahre nach der Behandlung positive Ergebnisse zeigte.
- Revenue generation of USD $3.7M from trial participants
- Successful 10-year follow-up case study showing positive results
- Access to FireFly's extensive database of 77,000 EEG brain scans
- Company has safely treated 498 patients for cardiovascular disease
- Patients must pay USD $37,000 each for treatment, which may limit enrollment
- Early-stage Phase 1 trial with unproven efficacy
- Revenue dependent on achieving full enrollment of 100 patients
Calgary, Alberta--(Newsfile Corp. - March 17, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or "HEM"), an autologous angiogenic stem cell company that has safely treated 498 patients for various forms of cardiovascular disease, pitched the treatment of Vascular Dementia with ACP-01 to Wall Street.
"The specificity of ACP-01 in promotion of angiogenesis, the molecular up-regulation of brain neurotrophic factors, and specific chemokines, strongly suggest ACP-01 may be efficacious as a treatment for vascular dementia," stated Dr. Fraser Henderson, neurosurgeon, CMO, Hemostemix Inc.
"Designed as Phase 1 clinical trial for up to 100 patients who meet the inclusion criteria, and who will each pay Hemostemix USD
The clinical trial of 100 patients will add to Firefly's proprietary database of 77,000 EEG brain scans across twelve disorders. The scans may objectively prove that intrathecal injection of ACP-01 is a safe, efficacious, and a clinically relevant treatment for vascular dementia. In January 2025, Firefly highlighted two impactful studies that demonstrated the utility of its AI-based BNA™ advanced Resting Electroencephalograms (EEG) and Cognitive EEG (ERP) data analytics. As illustrated by the two studies, Firefly's BNA™ system uniquely provided objective measures of the efficacy of treatment and cognitive change.
Design of Hemostemix's Vascular Dementia Phase I Clinical Trial of ACP-01
The Phase 1 clinical trial will evaluate the safety, tolerability, and preliminary efficacy of intrathecal injection of ACP-01 directly into the cerebrospinal fluid of subjects who suffer from vascular dementia.
Primary endpoints include incidence of safety and adverse events; feasibility of ACP-01 delivery via intrathecal injection; safe dosage; and tolerability.
Secondary endpoints include cognitive functional assessment; global clinical dementia rating; quality of life assessment; and, standardized MRI metric analyses of brain volume and blood flow.
Exploratory endpoints include FireFly's BNA™ readout pre-treatment and at 3-months, and 6-months post-treatment.
How Hemostemix Plans to Use BNA™ in its Phase I Vascular Dementia Clinical Trial
Firefly's BNA™ technology will be used pre-treatment as an assessment, and post-treatment to record brain activity at resting state and during the performance of visual and auditory cognitive tasks. The wide range of functional brain measures will be compared against Firefly's FDA-cleared age-matched normative database. Each score will be assessed relative to the relevant reference normal range. The analyses will compare the change in different brain measures over time within the treated population, relative to the expected normative change over a range of six months based on Firefly's database.
Quality of life and brain function will be measured with the BNA™ assessment.
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 therapies that include angiogenic cell precursors (ACP-01), later neural cell precursors (NCP-01), and cardiomyocyte cell precursors (CCP-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
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 use of FireFly's BNA™ technologies, the sales of ACP-01 as a treatment for vascular dementia, including the commercialization of ACP-01. 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 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; 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/244840
FAQ
What is the expected revenue from Hemostemix's (HMTXF) Vascular Dementia trial?
How many patients will be enrolled in HMTXF's Phase 1 Vascular Dementia trial?
What technology will HMTXF use to monitor treatment effectiveness in the Vascular Dementia trial?
What are the primary endpoints of HMTXF's Vascular Dementia Phase 1 trial?
