Kelyniam Global Secures Exclusive U.S. License for Evonik's VESTAKEEP® Fusion Biomaterial in Cranial Implants

Rhea-AI Summary

Kelyniam Global (OTC: KLYG) secured an exclusive U.S. license from Evonik to market VESTAKEEP® Fusion, a bi-calcium phosphate–infused PEEK material, for cranial, craniofacial, and maxillofacial implants.

The agreement provides two years of exclusivity with an option to renew and names Modern Plastics as the distributor to ensure supply. Kelyniam said the material's osteoconductive properties support bone growth and integration and that the license expands its regenerative product lineup alongside existing options from Finceramica and Osteopore.

Positive

• 2-year exclusive U.S. license to market VESTAKEEP Fusion
• Adds a bioceramic-infused PEEK to regenerative cranial portfolio
• Distribution secured through Modern Plastics for supply continuity

Negative

• Exclusivity is time-limited to two years, requiring renewal to extend protection
• No financial terms disclosed for the license or expected revenue
• Faces competition from established regenerative options like Finceramica and Osteopore

News Market Reaction

-2.71%

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-2.71% News Effect

On the day this news was published, KLYG declined 2.71%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

CANTON, Conn., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Kelyniam Global, Inc. (OTC: KLYG), a leader in custom cranial and craniofacial implants, today announced it has secured an exclusive U.S. license from Evonik Industries AG to market VESTAKEEP® Fusion, a bi-calcium phosphate-infused PEEK material, for cranial, craniofacial, and maxillofacial implants. This agreement grants Kelyniam two years of exclusivity with the option for renewal upon mutual agreement.

The license enhances Kelyniam's regenerative product lineup by incorporating VESTAKEEP® Fusion's osteoconductive properties, that promote human bone growth and integration. Distributed through Modern Plastics, a trusted long-term supplier of PEEK materials, this partnership leverages a proven relationship to ensure reliable access and supports Kelyniam's growth in advanced neurosurgical solutions.

This strategic move adds significant value for shareholders by expanding Kelyniam's regenerative medicine portfolio alongside established regenerative options like Finceramica's CustomizedBone (hydroxyapatite) and Osteopore's polycaprolactone products, positioning the company to meet increasing demand for innovative, patient-focused cranial reconstruction.

“We’re proud to introduce VESTAKEEP® Fusion as the latest addition to Kelyniam’s portfolio of innovative cranial and craniofacial solutions,” said Desiree Webb, Chief Operating and Revenue Officer at Kelyniam Global. “Pre-clinical studies have shown that PEEK-containing BCP demonstrates superior osteointegration, and the Fusion BCP implant showcases our ongoing commitment to delivering regenerative technologies that improve patient outcomes and advance the standard of care.”

About Kelyniam Global, Inc.

Kelyniam Global, Inc. (OTC: KLYG) a United States based company, designs, manufactures, and distributes custom cranial and craniofacial implants using advanced biocompatible materials. Renowned for its industry-leading 24-48 hour delivery, Kelyniam partners with surgeons and hospitals to optimize clinical outcomes and reduce costs in neurosurgery. For more information, visit www.kelyniam.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements, including projections for 2026 revenue growth, distributor expansion impacts, and the effects of recent partnerships and clearances, involve risks and uncertainties that could cause actual results to differ materially from those anticipated. Such risks include market competition, regulatory delays, distributor performance variability, economic pressures on healthcare spending, and supply chain disruptions, as detailed in Kelyniam's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Kelyniam undertakes no obligation to update these statements except as required by law.

SOURCE Kelyniam Global, Inc. Investor Contact: (860) 590-3034 | info@kelyniam.com

FAQ

What did Kelyniam announce on November 13, 2025 regarding VESTAKEEP Fusion (KLYG)?

Kelyniam announced an exclusive U.S. license from Evonik to market VESTAKEEP Fusion for cranial and craniofacial implants with two years of exclusivity.

How long is Kelyniam's exclusivity for VESTAKEEP Fusion (KLYG)?

The license grants Kelyniam two years of exclusivity in the U.S., with an option to renew by mutual agreement.

Will Kelyniam have reliable access to VESTAKEEP Fusion material (KLYG)?

Yes; distribution is arranged through Modern Plastics, a long-term PEEK supplier, to support reliable access.

What clinical benefit does VESTAKEEP Fusion offer for cranial implants (KLYG)?

The material is a bi-calcium phosphate–infused PEEK that Kelyniam says promotes osteoconduction and bone integration based on preclinical data.

Does the announcement include financial terms or revenue guidance for Kelyniam (KLYG)?

No; the announcement does not disclose license fees, pricing, or revenue guidance.

How does VESTAKEEP Fusion position Kelyniam among competitors like Finceramica and Osteopore (KLYG)?

Kelyniam positions VESTAKEEP Fusion as an addition to its regenerative lineup alongside Finceramica (hydroxyapatite) and Osteopore (polycaprolactone) products.