CANTON, Conn., Nov. 10, 2025 /PRNewswire/ -- Kelyniam Global, Inc. (OTC: KLYG), a leader in custom cranial and craniofacial implants, today reported financial results for the third quarter ended September 30, 2025.

Q3 2025 Financial Highlights (Compared to Q3 2024)

   -- Year-to-date revenue of $2,186,491, compared to $2,492,607, a decrease of 
      12.3%. 
 
   -- Gross profit of $1,695,496, compared to $1,956,714, a decrease of 13.3%, 
      primarily due to the revenue headwinds offset by stable material costs. 
 
   -- Operating loss of $(162,373), compared to operating income of $273,248, 
      reflecting increased investments in sales support and regulatory costs 
      associated with the new Vestakeep$(R)$ product. 

"Sales have faced headwinds this year from a slow distributor ramp-up and temporary market share shifts, but through Q3, we're steadily catching up to 2024 levels and building a stronger foundation for sustainable growth," said Ross Bjella, CEO of Kelyniam Global. "The cranial implant sector remains robust, with competitors with overall market projections showing expansion from $1.43 billion in 2024 to over $1.5 billion in 2025. We're capitalizing on this by aggressively adding distributors in untapped markets, where we see tremendous opportunity to capture demand for our rapid-turnaround, custom solutions."

Key Strategic Developments in Q3 2025

   -- FDA Clearance for Vestakeep(R): Received 510(k) clearance for this novel 
      resorbable bi-calcium phosphate implant, expanding Kelyniam's portfolio 
      into regenerative applications and addressing unmet needs in craniofacial 
      reconstruction. 
 
   -- Hospital Approvals Pipeline: The Kelyniam product line is under Value 
      Analytics review approval at six major U.S. hospitals, including two 
      Level 1 trauma centers, potentially adding up to $500,000+ in annual 
      recurring revenue. 
 
   -- KLYG uplists to OTCID status on OTC Markets Group Platform. This 
      designation underscores Kelyniam's commitment to financial transparency 
      and compliance. 

Kelyniam's complete unaudited financial results for Q3 2025, including detailed segment breakdowns and cash flow statements, are available on the company's website at www.kelyniam.com.

About Kelyniam Global, Inc.

Kelyniam Global, Inc. (OTC: KLYG) 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, hospitals, and payors 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.

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SOURCE Kelyniam Global Inc

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November 10, 2025 15:56 ET (20:56 GMT)