Hemostemix and FireFly Neuroscience's Brain Network Analytics (BNA(TM)) Engage to Complete Phase 1 Vascular Dementia Clinical Trial of ACP-01
Hemostemix (TSXV: HEM) and Firefly Neuroscience (NASDAQ: AIFF) have announced a collaboration to conduct a Phase 1 clinical trial studying ACP-01 as a treatment for vascular dementia. The trial will evaluate brain wave activity in up to 100 patients using Firefly's FDA-Cleared BNA™ platform.
The study will assess patients before treatment and at 3 and 6-month intervals post-treatment. Hemostemix will leverage Firefly's database of 77,000 EEG brain scans across twelve disorders. The trial's primary endpoints include safety assessment, ACP-01 delivery feasibility via intrathecal injection, dosage safety, and tolerability.
Secondary endpoints encompass cognitive functional assessment, clinical dementia rating, quality of life assessment, and MRI analyses of brain volume and blood flow. The exploratory endpoint will use Firefly's BNA™ readout at specified intervals to objectively evaluate ACP-01's efficacy in treating vascular dementia.
Hemostemix (TSXV: HEM) e Firefly Neuroscience (NASDAQ: AIFF) hanno annunciato una collaborazione per condurre un trial clinico di Fase 1 che studierà l'ACP-01 come trattamento per la demenza vascolare. Lo studio valuterà l'attività delle onde cerebrali in un massimo di 100 pazienti utilizzando la piattaforma BNA™ approvata dalla FDA di Firefly.
Lo studio valuterà i pazienti prima del trattamento e a intervalli di 3 e 6 mesi dopo il trattamento. Hemostemix utilizzerà il database di Firefly contenente 77.000 scansioni EEG su dodici disturbi. Gli endpoint primari dello studio includono la valutazione della sicurezza, la fattibilità della somministrazione dell'ACP-01 tramite iniezione intratecale, la sicurezza del dosaggio e la tollerabilità.
Gli endpoint secondari comprendono la valutazione delle funzioni cognitive, la classificazione clinica della demenza, la valutazione della qualità della vita e le analisi MRI del volume cerebrale e del flusso sanguigno. L'endpoint esplorativo utilizzerà il readout BNA™ di Firefly a intervalli specificati per valutare obiettivamente l'efficacia dell'ACP-01 nel trattamento della demenza vascolare.
Hemostemix (TSXV: HEM) y Firefly Neuroscience (NASDAQ: AIFF) han anunciado una colaboración para llevar a cabo un ensayo clínico de Fase 1 que estudiará el ACP-01 como tratamiento para la demencia vascular. El ensayo evaluará la actividad de las ondas cerebrales en hasta 100 pacientes utilizando la plataforma BNA™ aprobada por la FDA de Firefly.
El estudio evaluará a los pacientes antes del tratamiento y a intervalos de 3 y 6 meses después del tratamiento. Hemostemix aprovechará la base de datos de Firefly que contiene 77,000 escaneos de EEG en doce trastornos. Los objetivos primarios del ensayo incluyen la evaluación de la seguridad, la viabilidad de la entrega de ACP-01 a través de inyección intratecal, la seguridad de la dosis y la tolerabilidad.
Los objetivos secundarios abarcan la evaluación de la función cognitiva, la calificación clínica de la demencia, la evaluación de la calidad de vida y los análisis de MRI del volumen cerebral y el flujo sanguíneo. El objetivo exploratorio utilizará la lectura BNA™ de Firefly en intervalos específicos para evaluar objetivamente la eficacia del ACP-01 en el tratamiento de la demencia vascular.
헤모스테믹스 (TSXV: HEM)와 파이어플라이 신경과학 (NASDAQ: AIFF)는 혈관성 치매 치료제로서 ACP-01을 연구하는 1상 임상 시험을 수행하기 위한 협력을 발표했습니다. 이 시험은 Firefly의 FDA 승인 BNA™ 플랫폼을 사용하여 최대 100명의 환자에서 뇌파 활동을 평가할 것입니다.
연구는 치료 전과 치료 후 3개월 및 6개월 간격으로 환자를 평가합니다. 헤모스테믹스는 12개 질환에 걸쳐 77,000개의 EEG 뇌 스캔 데이터베이스를 활용할 것입니다. 시험의 주요 목표는 안전성 평가, 경막외 주사를 통한 ACP-01 전달 가능성, 용량 안전성 및 내약성을 포함합니다.
2차 목표는 인지 기능 평가, 임상 치매 등급, 삶의 질 평가 및 뇌 용적과 혈류의 MRI 분석을 포함합니다. 탐색적 목표는 Firefly의 BNA™ 판독값을 특정 간격으로 사용하여 혈관성 치매 치료에 대한 ACP-01의 효능을 객관적으로 평가합니다.
Hemostemix (TSXV: HEM) et Firefly Neuroscience (NASDAQ: AIFF) ont annoncé une collaboration pour réaliser un essai clinique de Phase 1 étudiant l'ACP-01 comme traitement de la démence vasculaire. L'essai évaluera l'activité des ondes cérébrales chez jusqu'à 100 patients en utilisant la plateforme BNA™ approuvée par la FDA de Firefly.
L'étude évaluera les patients avant le traitement et à des intervalles de 3 et 6 mois après le traitement. Hemostemix utilisera la base de données de Firefly, qui contient 77 000 scans EEG à travers douze troubles. Les principaux objectifs de l'essai comprennent l'évaluation de la sécurité, la faisabilité de l'administration de l'ACP-01 par injection intrathécale, la sécurité du dosage et la tolérance.
Les objectifs secondaires englobent l'évaluation fonctionnelle cognitive, l'évaluation clinique de la démence, l'évaluation de la qualité de vie et les analyses IRM du volume cérébral et du flux sanguin. L'objectif exploratoire utilisera la lecture BNA™ de Firefly à des intervalles spécifiés pour évaluer objectivement l'efficacité de l'ACP-01 dans le traitement de la démence vasculaire.
Hemostemix (TSXV: HEM) und Firefly Neuroscience (NASDAQ: AIFF) haben eine Zusammenarbeit angekündigt, um eine Phase-1-Studie durchzuführen, die ACP-01 als Behandlung für vaskuläre Demenz untersucht. Die Studie wird die Gehirnwellenaktivität bei bis zu 100 Patienten mithilfe der von der FDA zugelassenen BNA™-Plattform von Firefly bewerten.
Die Studie wird die Patienten vor der Behandlung sowie nach 3 und 6 Monaten nach der Behandlung evaluieren. Hemostemix wird die Datenbank von Firefly mit 77.000 EEG-Gehirnscans über zwölf Störungen nutzen. Die primären Endpunkte der Studie umfassen die Sicherheitsbewertung, die Durchführbarkeit der ACP-01-Verabreichung durch intrathekale Injektion, die Dosissicherheit und die Verträglichkeit.
Die sekundären Endpunkte umfassen die Beurteilung der kognitiven Funktionen, die klinische Demenzbewertung, die Lebensqualitätsbewertung und die MRI-Analysen des Gehirnvolumens und des Blutflusses. Der explorative Endpunkt wird Fireflys BNA™-Auswertung in festgelegten Intervallen verwenden, um die Wirksamkeit von ACP-01 bei der Behandlung von vaskulärer Demenz objektiv zu bewerten.
- Partnership with established companies (Bright Minds, Novartis, Takeda)
- Access to extensive database of 77,000 EEG brain scans
- FDA-cleared BNA™ platform technology
- Potential to set objective standard for vascular dementia treatment
- existing data on ACP-01 in dementia treatment
- Early-stage Phase 1 trial with uncertain outcomes
- Complex trial design requiring multiple assessment points
Insights
Firefly Neuroscience's collaboration with Hemostemix represents a strategic expansion of its BNA technology into vascular dementia research. The agreement positions Firefly to collect valuable brain activity data from up to 100 patients undergoing Hemostemix's ACP-01 treatment, with measurements at baseline, 3-months, and 6-months post-treatment.
This partnership adds to Firefly's growing portfolio of collaborations with established pharmaceutical companies (including Novartis and Takeda), enhancing its credibility in the healthcare sector. By leveraging its proprietary database of 77,000 EEG brain scans across twelve disorders, Firefly can provide objective measurement capabilities that strengthen the clinical trial's scientific value.
From a technology application perspective, this collaboration demonstrates the versatility of Firefly's FDA-cleared BNA platform. The company's AI-driven analytics will measure cognitive changes and treatment efficacy through advanced EEG analysis, potentially establishing Firefly's technology as a standard assessment tool for neurodegenerative conditions.
While the financial terms remain undisclosed, this partnership model offers Firefly a relatively low-risk opportunity to demonstrate its technology's utility in a new therapeutic area. The data generated could enhance Firefly's AI algorithms and normative databases regardless of the trial's ultimate outcome, adding long-term value to its core technology assets.
This Phase 1 trial represents an innovative application of Firefly's BNA technology to objectively measure changes in brain function following stem cell therapy. The study design includes comprehensive endpoints: primary safety measures, cognitive functional assessments, and Firefly's proprietary BNA readouts as an exploratory endpoint.
Notably, Firefly's technology provides critical differentiation for this clinical trial through its ability to objectively quantify neurological changes. By comparing patient data against Firefly's age-matched normative database, the trial can potentially identify subtle improvements that standard cognitive assessments might miss. This addresses a significant challenge in dementia research - the need for sensitive, objective measurement tools.
From a clinical validation perspective, this study strengthens Firefly's position as its BNA system will be used to measure both cognitive change and quality of life outcomes. The company's recent announcement of two studies demonstrating BNA's utility in measuring treatment efficacy reinforces the scientific rationale for this application.
While the trial's primary focus is Hemostemix's ACP-01 therapy, Firefly stands to benefit regardless of the treatment outcome. A successful trial would validate BNA as an assessment tool for vascular dementia, while even a negative result would generate valuable neurological data to enhance Firefly's database. This positions the company to potentially develop condition-specific assessment protocols that could be marketed to clinicians and pharmaceutical companies developing dementia therapies.
A growing body of clinical evidence supports the use of Firefly's FDA-Cleared BNA(TM) platform to study ACP-01 as a treatment for vascular dementia
Calgary, Alberta--(Newsfile Corp. - March 6, 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, including vascular dementia, announces its collaboration with Firefly Neuroscience, Inc. (NASDAQ: AIFF) ("Firefly"), an Artificial Intelligence ("AI") company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders.
Hemostemix and Firefly will study brain wave activity in up to 100 patients before and after treatment with ACP-01 at baseline, 3-months, and 6-months post-treatment (the "Phase 1").
Hemostemix's Phase 1 clinical trial of vascular dementia is in line with Firefly's collaborations with globally recognized companies, such as Bright Minds, Novartis and Takeda. Through the collaboration, Hemostemix will leverage Firefly's proprietary database of 77,000 EEG brain scans across twelve disorders. Hemostemix and FireFly will work together to generate an exploratory endpoint to objectively prove that intrathecal injection of ACP-01 is a safe, preliminarily efficacious, and clinically relevant treatment for vascular dementia.
"Listen to a Patient treated with ACP-01 for Vascular Dementia 10 Years Post-Treatment," stated Thomas Smeenk, CEO, Hemostemix. "Mrs. L lost her daily function-abilities and was to be admitted to a long-term care facility. Ten years after ACP-01 treatment, in 12 minutes, she discussed her career path, family-raising-time, wonderful second marriage, ability to drive, and the benefits of ACP treatment including no longer suffering from ocular migraines. Then she scheduled a lunch appointment with the physician who treated her for vascular dementia, to celebrate her cognitive health ten years post treatment," Smeenk continued. "With BNA™'s readouts of ACP's impacts, I predict Hemostemix and Firefly will set the objective standard for the successful diagnoses and treatment of vascular dementia. Families who have a loved-one who are suffering from vascular dementia may contact me (tsmeenk@hemostemix.com), to understand the assessment, inclusion and exclusion criteria," Smeenk said.
"We are proud that BNA™ continues to be at the forefront of EEG innovation, and we agree with Hemostemix that its study of ACP-01 dose response in subjects suffering from vascular dementia has the potential to exemplify how our proprietary technology may transform complex brain data into actionable insights for clinicians and researchers," said Greg Lipschitz, Executive Chairman of Firefly. "
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
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 enhanced BNA™ system uniquely provided objective measures of the efficacy of treatment and cognitive change.
How Hemostemix Plans to Use BNA™ in its Phase I Vascular Dementia Clinical Trial
Firefly's BNA™ technology will be used in pre- and post -treatment to record brain activity at resting state and during the performance of visual and auditory cognitive tasks. The recorded electrophysiological data is automatically cleaned and analyzed by Firefly's proprietary BNA™ platform. A 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 Firefly BNA™ assessment.
"There is limited data on the use of ACP-01 in dementia; however, 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 , CMO, Hemostemix.
About Firefly
Firefly (NASDAQ: AIFF) is an Artificial Intelligence ("AI") company developing innovative solutions that improve brain health outcomes for patients with neurological and cognitive disorders. Firefly's FDA-510(k) cleared Brain Network Analytics (BNA™) technology revolutionizes diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has built a comprehensive database of brain wave tests, secured patent protection, and achieved FDA clearance. The Company is launching BNA™ commercially, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as medical practitioners for its clinical use.
Brain Network Analytics was developed using artificial intelligence and machine learning on Firefly's extensive proprietary database of standardized, high-definition longitudinal electroencephalograms (EEGs) of over 17,000 patients representing twelve disorders, as well as clinically normal patients. BNA™, in conjunction with an FDA-cleared EEG system, can provide clinicians with comprehensive insights into brain function. These insights can enhance a clinician's ability to accurately diagnose mental and cognitive disorders and evaluate the therapy or drug that is best suited to optimize a patient's outcomes of treatment.
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.sedar.com. 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.
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FAQ
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