Toronto, Ontario--(Newsfile Corp. - March 3, 2025) - DiagnaMed Holdings Corp. (CSE: DMED) (OTCQB: DGNMF) ("DiagnaMed", "DMED", or the "Company"), a leading provider of cutting-edge technology solutions for the hydrogen and life sciences industries, today announced in a significant advancement for rare disease research, the Company has been granted Orphan Drug Designation (ODD) for molecular hydrogen in the treatment of amyotrophic lateral sclerosis (ALS) by the U.S. Food and Drug Administration (FDA). This designation underscores the potential of molecular hydrogen as a novel therapeutic option for ALS patients and highlights ongoing efforts to address unmet medical needs in rare disease communities.
ALS is a progressive neuromuscular disease that attacks nerve cells responsible for controlling voluntary muscle movement, leading to paralysis and, ultimately, respiratory failure, and has a life expectancy of only two to six years after diagnosis. Currently, there is no known cure for ALS. ALS affects approximately 50,000 people in the U.S. and Europe, with over 5,000 new cases diagnosed annually. With limited treatment options available, the FDA's recognition of molecular hydrogen as an orphan drug offers hope to patients and families impacted by this debilitating illness.
Molecular hydrogen, a small molecule with antioxidant and anti-inflammatory properties, has shown early promise in preclinical studies for its ability to mitigate oxidative stress and inflammation-key factors implicated in ALS progression. The FDA's decision paves the way for DiagnaMed to accelerate its discovery and development programs with molecular hydrogen.
One of DiagnaMed's strategic initiatives regarding hydrogen is to unlock the medical potential of molecular hydrogen for neurodegenerative diseases and brain health conditions (press release). The Company's commercialization strategy involves partnering with specialty pharmaceutical companies to fund the development of its medical programs involving molecular hydrogen.
Letter of Intent with Revive Therapeutics Ltd (CSE: RVV) (OTCQB: RVVTF) ("Revive")
DiagnaMed and Revive have entered into a non-binding letter of intent (LOI), dated February 28, 2025, with Revive to acquire the full rights to DiagnaMed's intellectual property (the "Acquired Assets") pertaining to molecular hydrogen for ALS (the "Acquisition"). The final terms of the Acquisition will be agreed to by the parties after the completion of due diligence by Revive. The Acquisition is expected to close on or before March 31, 2025, subject to customary closing conditions, including but not limited to, the negotiation and execution of a definitive agreement.
Fabio Chianelli, Chairman and CEO of DiagnaMed, commented:
"Receiving orphan drug designation from the FDA is a significant milestone for DiagnaMed and validates the promise of molecular hydrogen as a potential treatment for ALS. We are excited to partner with Revive Therapeutics to advance this program and meet the urgent needs of the ALS community."
The Orphan Drug Designation provides DiagnaMed with key incentives, including tax credits for clinical trial costs, exemption from certain FDA fees, and the potential for seven years of market exclusivity upon approval. These benefits are designed to encourage the development of therapies for rare diseases that might otherwise lack sufficient commercial interest.
About DiagnaMed
DiagnaMed Holdings Corp. (CSE: DMED) (OTCQB: DGNMF) delivers innovative technology solutions for the cleantech and life sciences industries, with a focus on hydrogen production and AI-driven drug discovery and diagnostics. Visit DiagnaMed.com.
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