DataMeds Applauds FDA's Proposed Interim Access Policy for Compounding Using Certain Peptides and Provides Corexa Health's Peptides Roadmap

Corexa Health's three divisions - pharmacy, distribution, and tech & hub - positioned to serve the emerging compounded peptide market

TAMPA, FL - DataMeds AI, Inc. (NASDAQ:MEDS) ("DataMeds AI," "DataMEDS SI," "DataMEDS," or the "Company"), a healthcare company leveraging its Health IT and physical infrastructure together with its super intelligence platform EinsteinRxTM and smart contracts platform PharmacyChainTM, today applauded the issuance of a new policy proposal by the U.S. Food and Drug Administration (FDA) entitled "Interim Access Policy for Compounding Using Certain Peptides." The new proposed policy comes less than three months following the recommendation from FDA's Pharmacy Compounding Advisory Committee (PCAC) to loosen restrictions on the use of six peptides. The U.S. compounding pharmacy market is expected to grow from $18 billion in 2025 to over $34 billion annually by 2035, according to Precedence Research.

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Concurrently, the Company's pharmacy-focused subsidiary Corexa Health provided a roadmap for how it intends to capitalize on the improving peptides regulatory landscape.

"We were very pleased to see FDA begin to act on PCAC's recommendations so quickly," said Gerald Commissiong, Interim Co-CEO of DataMEDS. "Corexa Health has three separate pharmacy-focused divisions to address key needs within the independent pharmacy space as it relates to the tremendous potential opportunities that peptides provide to improve human health and provide greater choice for consumers, in addition to the business opportunity for pharmacies."

"Corexa Pharmacy is a 503A compounding pharmacy and intends to begin to fill prescriptions for peptides eligible for compounding under FDA's interim policy once it goes into effect. We have initiated a thorough review of potential providers of suitable drug substance and intend to formalize contracts with appropriate partners in the coming weeks in preparation for what we anticipate will be significant demand. Because we expect the peptide market to be predominantly cash pay initially, there appears to be a significant opportunity for Corexa Pharmacy to benefit with reduced exposure to PBM clawbacks and other insurance-related reimbursement challenges. Our Corexa Distribution division is licensed in all 50 states and is positioned to serve as a channel for independent pharmacies to be able to access compliant sources of peptide drug substance so that they can meet the demand of their local communities. Our 40,000 square foot warehouse in Lakeland, Florida is able to purchase products on a wholesale basis for sale to pharmacies, as well as serve as a third-party logistics (3PL) provider for peptide manufacturers seeking a strategically located warehouse solution that can deliver products to pharmacies in all 50 states. We intend to work closely with prospective peptide manufacturing partners, as well as our network of 6,500+ independent pharmacies to help improve peptide access for patients throughout the country, especially in rural areas."

"Our Corexa Tech & Hub division presents potentially the most compelling opportunity for growth and value creation, especially given the recent launch of the Health Lives Here mobile application," noted Mr. Commissiong. "Due to the nature of the hub receiving the prescriptions from physicians and routing them to Corexa Pharmacy or a local pharmacy of the patient's choosing, the hub is positioned to see significant growth as physicians increasingly become the conduit for consumers to procure peptides eligible for compounding. Our Electronic Benefits Verification (EBV) offering will be able to keep patients, providers and pharmacies up-to-date on any changes in insurance coverage for peptides."

The Company sees the forthcoming peptide market opportunity as central to its growth plans, and as reinforcing its emerging business model of providing access to telemedicine, laboratory and pharmacy services via the Health Lives Here mobile application that also allows for the purchase of suitable medical foods and dietary supplements that complement prescribed medications. DataMEDS intends to initially focus its peptides marketing towards patients who have historically obtained peptides through the grey market. The Company recently licensed technology tailored for patient on FDA approved GLP-1 receptor agonist drugs, and is building programs designed to help them succeed in their health and wellness journeys using patent-protected platform licensed from REBOOT. DataMEDS believes it is uniquely positioned in the telehealth space to use technology to help GLP-1 patients set, track and meet their goals as a result of the REBOOT license.

For more information, visit www.datamedsai.com or contact James Lambert, Vice President at Rubenstein Public Relations, at jlambert@rubensteinpr.com or at 212-805-3024.

About DataMeds AI, Inc. (DBA DataMeds SI)

DataMeds SI (NASDAQ: MEDS) is a healthcare company that focuses on the vertical integration of technology, pharmacy, pharmaceutical-adjacent and telemedicine business units through its Health IT platforms to deliver a better experience for consumers and providers. Headquartered in Tampa, Fla., DataMEDS incorporates the super intelligence platform EinsteinRxTM and blockchain-enabled smart contracts platform PharmacyChainTM into the Health Lives Here mobile application, and its Corexa Pharmacy provides pharmacy dispensing and related services, including the distribution of products developed by Tollo Health. DataMEDS has licensed patented GLP-1 patient management technology from REBOOT, a subsidiary of Data Health Partners. The Company's Helomics Corporation subsidiary operates a CLIA-certified laboratory in Pittsburgh offering the ChemoFx® Assay.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and are not predictions of actual performance. Forward-looking statements include, without limitation, statements regarding FDA's proposed Interim Access Policy for Compounding Using Certain Peptides, including whether, when and in what form the policy is finalized or takes effect, which peptides will be eligible for compounding under it, and whether FDA modifies, narrows, suspends or withdraws the policy or changes its enforcement priorities; the Company's ability to identify, qualify and contract with suppliers of peptide drug substances that meet applicable regulatory and quality requirements, and the timing, cost and terms of any such agreements; the ability of Corexa Pharmacy to compound and dispense peptides in compliance with Section 503A of the Federal Food, Drug, and Cosmetic Act, applicable USP standards, and the pharmacy laws and board of pharmacy requirements of each state in which it dispenses; the ability of Corexa Distribution to obtain and maintain the wholesale distribution and third-party logistics licenses required in each state and to secure peptide manufacturer and pharmacy customers; physician prescribing of, and patient demand for, compounded peptides, and the pricing the Company is able to achieve in a cash-pay market; competition from other compounding pharmacies, outsourcing facilities, telehealth platforms and manufacturers of FDA-approved products; the anticipated growth in prescription volume routed through the Corexa Tech & Hub division and the Health Lives Here application; whether, when and to what extent third-party payors provide coverage for peptides, and the ability of the Company's Electronic Benefits Verification offering to track such coverage; the Company's ability to market peptide-related offerings, including to patients taking GLP-1 receptor agonist drugs, in compliance with FDA, FTC and state requirements; safety, adverse event or product quality issues associated with compounded peptides, and related product liability, regulatory, enforcement and reputational risks; the anticipated growth of the compounding pharmacy and peptide markets; the Company's relationships with NFL Alumni Health and Tollo Health, including related-party transactions; the Company's anticipated business strategy, operating plans and growth opportunities; the Company's ability to maintain compliance with Nasdaq listing standards; the Company's liquidity, capital resources and ability to fund operations; the Company's ability to maintain compliance with Nasdaq listing standards, the development of a proprietary blockchain and the development of provider-network features, the creation of the Health Lives Here pharmacy network, the success of the NFL Alumni Health partnership, the companies' proposed transaction with DataVault AI Inc. (NASDAQ: DVLT), Scilex Holding Company, EOS Holdings and HealthBridge Advisors (controlling shareholder of Tollo Health, LLC); the satisfaction or waiver of closing conditions applicable to any of the foregoing; the receipt of stockholder approval and any other required approvals; the Company's anticipated business strategy, operating plans and growth opportunities; the integration of telemedicine, pharmacy, laboratory, wearable-device, artificial intelligence, blockchain and data-management technologies; the proposed development, commercialization and expansion of EinsteinRx AI, PharmacyChain, Health Lives Here and related platforms; the anticipated growth of the market for Long COVID products and related treatment approaches; the companies' ability to empower patients to access, manage, control or monetize health data; the anticipated benefits of the companies' technology platforms, strategic relationships and business combinations; the Company's capitalization, outstanding securities, lock-up arrangements, public float and registration statements. Actual results may differ materially from those expressed or implied in these forward-looking statements due to a number of risks and uncertainties, including those described under "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to update or revise any forward-looking statements, except as required by law.

DataMeds AI Media Contact

James Lambert, Vice President
Rubenstein Public Relations
Phone: 212.805.3024
Email: jlambert@rubensteinpr.com

DataMeds AI Investor Contact

Investor Relations: IR@datamedsai.com

Additional Contact:

David Shapiro
B2i Digital, Inc.
+1 212-579-4844
david@b2idigital.com

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SOURCE: DataMEDS AI, Inc.

This release was published on openPR.