(via TheNewswire)
Vancouver, British Columbia, Canada – TheNewswire - September 9, 2025 – PanGenomic Health Inc. (“PanGenomic Health” or the “Company”) (CSE: NARA, FSE:LL30) is pleased to announce that its wholly-owned subsidiary, Mindleap Health Inc. (“Mindleap Health"), is developing a real-world evidence (“RWE”) platform for the Complementary & Alternative Medicine (“CAM”) market.
“With profound changes taking place in the U.S. Food and Drug Administration and National Institutes of Health by Robert F. Kennedy Jr., the Secretary of Health and Human Services 1 , we believe there is a significant opportunity to develop a global evidence-based platform that collects information about the efficacy of non-pharmaceutical approaches to health and wellness”, said Robert Nygren, Executive Chair of PanGenomic Health and newly-appointed President of its wholly-owned subsidiary Mindleap Health. “These changes in the U.S. now complement decades-long advocacy efforts by the World Health Organization for national health authorities to adopt greater use of CAM solutions as a means to lower healthcare costs and improve health outcomes globally.” 2
On July 25, 2025 the Company announced the development of the NaraCare.AI platform for personalized health products, which will leverage insights and functionality developed from the Company's Nara mental health app, Mindleap telehealth platform and Mujn diagnostic tools and will utilize leading large language model (“LLM”) platforms. The Mindleap telehealth platform is designed to provide consumers with online access to an extensive library of wellness content and with telehealth access to a broad range of alternative health practitioners. The Company further announced on August 19, 2025 that its Agenta Health eCommerce site will be the springboard for the NaraCare.AI platform. The Agenta Health eCommerce site can be accessed at www.agentahealth.store.
The new Mindleap RWE platform will collect and analyze health data from a broad range of traditional and non-traditional sources, including clinical research studies from Western and non-Western countries, long-documented history of human use and evidence of modern use. Leveraging leading LLM platforms that can analyze these health datasets, the Mindleap RWE platform will aim to support an expanded interpretation of the “substantial evidence” standard needed to support health claims. First established by the FDA for new drug approvals in 1962, the substantial evidence standard has recently expanded beyond traditional randomized, double-blind studies to include some real-world evidence of drug candidate efficacy. 3 The goal of the Mindleap RWE platform will be to become a trusted source of information about non-pharmaceutical health solutions.
Insights from the Mindleap RWE platform will be utilized within the NaraCare.AI platform to support its personalized product recommendation functionality for consumers and also be available on a subscription basis to manufacturers, distributors, retailers, researchers and health practitioners interested in understanding the level of evidence that exists for Complementary & Alternative Medicine health and wellness solutions. Mindleap Health expects to launch the Mindleap RWE platform in the first quarter of 2026.
References:
1 “FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program”, Food and Drug Administration and National Institutes of Health, May 2025
https://www.fda.gov/news-events/press-announcements/fda-and-nih-announce-innovative-joint-nutrition-regulatory-science-program
“FDA Advances Rare Disease Drug Development with New Evidence Principles”, Food and Drug Administration, September 2025
https://www.fda.gov/news-events/press-announcements/fda-advances-rare-disease-drug-development-new-evidence-principles
2 “WHO Traditional Medicines Strategy 2002–2005”, World Health Organization, 2002 https://www.who.int/publications/i/item/WHO-EDM-TRM-2002.1
“WHO Traditional Medicines Strategy 2014–2023”, World Health Organization, 2013 https://www.who.int/publications/i/item/9789241506096
3 “FDA and Clinical Drug Trials: A Short History”, Food and Drug Administration, 2008
https://www.fda.gov/media/110437/download
“FDA’s Historical Use of “Real World Evidence””, Food & Drug Law Institute, 2018
https://www.fdli.org/2018/08/update-fdas-historical-use-of-real-world-evidence /
About Mindleap Health
Mindleap Health is a provider of holistic health and wellness information. To learn more about Mindleap Health’s products and services: www.mindleap.com or email: support@mindleap.com
About PanGenomic Health
PanGenomic Health is a precision health company that has developed a self-care digital platform to deliver personalized, evidence-based information about natural treatments. Registered as a British Columbia benefit company, PanGenomic Health's mission is to promote alternative health solutions tailored to the health profile of each individual. To learn more about PanGenomic Health’s products and services: www.pangenomic.com or email: info@pangenomic.com.
For more information, please contact:
Fairfax Partners Inc. Daniel Southan-Dwyer, President +1 604 366 6277 connect@fairfaxpartners.ca | |
This news release includes certain statements that may be deemed “forward-looking statements”, including statements respecting the services to be provided by PanGenomic Health and the consideration to be paid to PanGenomic Health. The use of any of the words “anticipate”, “continue”, “estimate”, “expect”, “may”, “will”, “would”, “project”, “should”, “believe” and similar expressions are intended to identify forward looking statements. Although PanGenomic Health believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because PanGenomic Health can give no assurance that they will prove to be correct. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. These statements speak only as of the date of this News Release. Actual results could differ materially from those currently anticipated due to a number of factors and risks including various risk factors discussed in PanGenomic Health’s disclosure documents which can be found under PanGenomic Health’s profile on www.sedarplus.ca. These risk factors include the possibility of delays in PanGenomic Health’s development efforts, PanGenomic Health not having sufficient financial resources to complete its development efforts in a timely manner and other risks, including those that may be outside of the control of PanGenomic Health. Except as required under applicable securities legislation, PanGenomic Health undertakes no obligation to publicly update or revise forward-looking statements.
The Canadian Securities Exchange has neither approved nor disapproved the information contained herein and does not accept responsibility for the adequacy or accuracy of this news release.
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