– FDA Advisory Committee voted to recommend easing compounding restrictions for six peptides, including Epitalon and Semax, late last week –
– These two peptides have attracted growing scientific interest for their potential neuroprotective and cognitive-supportive properties –
– Collaboration represents a significant step toward making precision cognitive care more measurable, scalable, and clinically actionable –
KENMORE, N.Y. and LOS ANGELES, July 28, 2026 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly”) (NASDAQ: AIFF), an Artificial Intelligence ("AI") company advancing precision neuroscience, and Next Health, a global leader in health optimization and longevity, today announced a strategic partnership to launch a novel precision cognitive health platform integrating Firefly’s AI-powered, U.S. Food and Drug Administration (“FDA”)-cleared EEG/ERP brain biomarker technology with personalized cognitive peptide protocols. The initiative aims to provide physicians with objective measures of brain function to help personalize, monitor, and optimize emerging cognitive therapies.
The announcement follows last week's recommendation by an FDA Advisory Committee to add six therapeutic peptides—including Epitalon and Semax—to the list of bulk drug substances eligible for pharmacy compounding. While the recommendation is not binding and requires further FDA action, it represents an important regulatory milestone that could broaden physician access to these emerging peptide therapies.1
Epitalon and Semax have each drawn growing attention in the scientific literature for their potential neuroprotective and cognitive-supportive properties. While additional clinical research remains ongoing, both peptides have been studied for potential applications in the evolving field of precision cognitive medicine.2,3
By combining objective EEG-based biomarkers with personalized therapeutic protocols, the collaboration seeks to replace subjective assessments of cognitive health with data-driven clinical decision-making. The collaboration establishes a scalable framework for integrating objective brain biomarker assessments into routine longevity and cognitive care, helping lay the foundation for broader adoption of quantitative neurodiagnostics in precision medicine.
“Founded over a decade ago, Next Health pioneered the clinical longevity category before longevity was a mainstream concept,” said Greg Lipschitz, Firefly’s Chief Executive Officer. “Today, it is the globally recognized leader in biomarker-driven, proactive health optimization, operating with a trusted consumer brand, extensive provider network, and clinical infrastructure that took more than a decade to build. Likewise, we believe Firefly has established a differentiated position through our FDA 510(k)-cleared, AI-powered EEG/ERP platform. Unlike traditional symptom-based approaches, Firefly provides objective neurological biomarkers that can guide treatment decisions. As new peptide therapies, like Epitalon and Semax, continue to capture global attention, and as interest in objective brain health measurement and cognitive therapeutics accelerates, we believe combining Firefly's quantitative brain biomarkers with Next Health's clinical expertise has the potential to redefine how cognitive health is measured, personalized, and monitored.”
“Next Health represents the vanguard of the longevity revolution—where cutting-edge medical technology, luxury hospitality, and proactive health optimization converge to redefine the future of wellness,” commented Dr. Darshan Shah, Founder & Chief Executive Officer of Next Health. “Our comprehensive functional medicine approach to health is data-driven and defined by not merely the absence of disease, but the abundance of vitality. Firefly's FDA-cleared brain wave analytics technology complements that by enabling clinicians to objectively measure brain function before, during and after treatment. Objective brain mapping has the potential to become an important component of personalized cognitive medicine, helping clinicians better understand, personalize, and monitor emerging peptide therapies.”
The initiative is expected to leverage Next Health's rapidly expanding network of longevity clinics. The companies intend to collaborate on developing standardized clinical protocols integrating Firefly's FDA-cleared EEG/ERP platform with provider-guided peptide therapies and expect to provide updates as key milestones are achieved.
Notes and Sources
1 Neither Epitalon nor Semax is approved by the FDA for any use, and the Advisory Committee’s recommendation addresses only compounding eligibility—it does not constitute an FDA determination regarding the safety or efficacy of either peptide.
2 Araj SK, Brzezik J, Mądra-Gackowska K, Szeleszczuk Ł. Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties. Int J Mol Sci. 2025 Mar 17;26(6):2691. doi: 10.3390/ijms26062691. PMID: 40141333; PMCID: PMC11943447.
3 Radchenko AI, Kuzubova EV, Apostol AA, Mitkevich VA, Andreeva LA, Limborska SA, Stepenko YV, Shmigerova VS, Solin AV, Korokin MV, Pokrovskii MV, Myasoedov NF, Makarov AA. The Potential of the Peptide Drug Semax and Its Derivative for Correcting Pathological Impairments in the Animal Model of Alzheimer's Disease. Acta Naturae. 2025 Oct-Dec;17(4):110-120. doi: 10.32607/actanaturae.27808. PMID: 41479572; PMCID: PMC12755871.
About Firefly Neuroscience
Firefly Neuroscience, Inc. (NASDAQ: AIFF) is an Artificial Intelligence ("AI") company advancing precision neuroscience, applying AI and large-scale electrophysiological data to give clinicians a more complete, objective picture of how an individual patient's brain is functioning. Firefly's proprietary database now consists of over 200,000 EEG/ERP brain scans, making it the world's largest known standardized EEG/ERP repository. Firefly's EEG-based, AI-driven, and FDA-510(k)-cleared Evoke System has the potential to transform diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, ADHD, and PTSD.
Please visit www.fireflyneuro.com for more information.
About Next Health
Next Health is the world’s most comprehensive health optimization brand, utilizing a Medicine 4.0 model to combine diagnostics, longevity therapies, and preventative medicine. With a mission to empower individuals through data-driven healthcare, Next Health continues to expand its footprint both nationally and internationally. Some of its top services include the following:
- Precision IV Therapy: Featuring NAD+, Glutathione, and NR
- Biomarker Testing with 1-1 provider consultations
- Regenerative and Peptide Therapies
- Wellness Technology: Hyperbaric Oxygen Chamber, Infrared LED Bed & Sauna, Cryotherapy, and VISIA Skin Analysis
- Hormone and Weight Optimization
- Advanced Treatments: EBOO Ozone Therapy and Therapeutic Plasma Exchange
- Executive Physicals, including a full-body MRI
Please visit www.next-health.com for more information.
Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" for purposes of the federal securities laws concerning Firefly, including statements regarding the anticipated benefits, scope, and results of the collaboration between Firefly and Next Health, and statements regarding Next Health’s business, clinic network, and expansion plans. These forward-looking statements include express or implied statements relating to Firefly's management team's expectations, hopes, beliefs, intentions, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Firefly will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Firefly's control) and other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the FDA does not take further action consistent with the Advisory Committee’s recommendation, or takes longer than currently anticipated to do so; the fact that Epitalon and Semax are not approved by the FDA and their safety and efficacy for any indication have not been established; risks related to Firefly’s reliance on Next Health and other third parties to develop, market, and commercialize the initiative; the risk that Next Health does not achieve its stated clinic expansion targets; and those other factors described under the heading "Risk Factors" in the reports and other filings of Firefly with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of Firefly's assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. It is not possible to predict or identify all such risks. Forward-looking statements included in this press release only speak as of the date they are made, and Firefly does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Investor & Media Contact
Stephen Kilmer
(646) 274-3580
stephen.kilmer@fireflyneuro.com
