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 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. 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: 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.
