Research analysts covering Kelyniam Global.
Recent press releases and 8-K filings for KLYG.
Kelyniam Global Announces Q3 2025 Financial Results and Strategic Developments
KLYG
Earnings
Product Launch
Demand Weakening
- Kelyniam Global reported a 12.3% decrease in year-to-date revenue to $2,186,491 for Q3 2025 compared to Q3 2024, resulting in an operating loss of $(162,373), down from an operating income of $273,248 in the prior year.
- The company attributed the financial decline to revenue headwinds from a slow distributor ramp-up and temporary market share shifts, alongside increased investments in sales support and regulatory costs for its new Vestakeep® product.
- Strategically, Kelyniam Global received FDA 510(k) clearance for Vestakeep®, expanding its product portfolio, and has its product line under review at six major U.S. hospitals, with potential for over $500,000 in annual recurring revenue.
- The company also achieved OTCID status on the OTC Markets Group Platform, underscoring its commitment to financial transparency.
Nov 10, 2025, 8:55 PM
Kelyniam Global Receives FDA Clearance for Fusion™ BCP-PEEK Implant
KLYG
Product Launch
- Kelyniam Global, Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Fusion™ Cranial and Craniofacial Implants.
- These implants are crafted from a unique combination of Biphasic Calcium Phosphate (BCP) reinforced with Polyether Ether Ketone (PEEK), marking the first time the FDA has approved this material for use in cranial and craniofacial implants and representing the first totally new implant launched in the cranial and craniofacial market in 8 years.
- The Fusion™ BCP-PEEK implants are designed for custom applications to encourage bone integration while providing exceptional durability and personalized fit, and can be designed, manufactured, and shipped to surgeons within 24-48 hours.
Sep 18, 2025, 3:23 PM
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