Welcome to our dedicated page for Kelyniam Global news (Ticker: KLYG), a resource for investors and traders seeking the latest updates and insights on Kelyniam Global stock.
Kelyniam Global Inc. (KLYG) specializes in advanced cranial implant solutions that combine precision engineering with clinical insights. This news hub provides investors and medical professionals with essential updates on the company's technological advancements, regulatory milestones, and market developments.
Access real-time announcements about FDA-cleared innovations, partnership agreements with healthcare systems, and financial performance reports. Our curated collection includes press releases detailing new biocompatible materials, manufacturing process improvements, and clinical trial outcomes relevant to custom prosthetics.
Key updates cover earnings disclosures, intellectual property acquisitions, and strategic collaborations with neurosurgical teams. Bookmark this page to monitor Kelyniam's progress in developing CAD/CAM-engineered implants that enhance surgical precision while reducing hospital costs.
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.
Kelyniam Global (OTC: KLYG) reported Q3 2025 results for the quarter ended Sept 30, 2025. YTD revenue was $2,186,491, down 12.3% versus $2,492,607 in 2024; gross profit fell to $1,695,496, down 13.3%. The company recorded an operating loss of $162,373 versus operating income of $273,248 a year earlier, citing higher sales support and regulatory costs tied to the Vestakeep® product.
Key developments: FDA 510(k) clearance for Vestakeep®, a resorbable bi-calcium phosphate implant; six major U.S. hospitals are in Value Analytics review; and KLYG uplisted to OTCID on OTC Markets.
Kelyniam Global (OTC: KLYG) reported Q3 2025 results for the quarter ended Sept 30, 2025. YTD revenue was $2,186,491, down 12.3% versus $2,492,607 in 2024; gross profit fell to $1,695,496, down 13.3%. The company recorded an operating loss of $162,373 versus operating income of $273,248 a year earlier, citing higher sales support and regulatory costs tied to the Vestakeep® product.
Key developments: FDA 510(k) clearance for Vestakeep®, a resorbable bi-calcium phosphate implant; six major U.S. hospitals are in Value Analytics review; and KLYG uplisted to OTCID on OTC Markets.
Kelyniam Global (OTC: KLYG) renewed its licensing agreement with Finceramica Faenza for three years, extending access to Finceramica's biomaterials portfolio including SINTlife (a resorbable magnesium hydroxyapatite graft in injectable putty form) and the Surgery V-Connect augmented reality system.
The renewal grants Kelyniam expanded U.S. distribution rights and exclusive access to pipeline products, positions the company to enter orthopedic and reconstructive markets, and cites an expectation that SINTlife could receive FDA clearance within two years, targeting markets described as roughly 10x the current custom cranial implant sector.
Kelyniam Global (KLYG) has achieved a significant milestone with FDA 510(k) clearance for its innovative Fusion™ Cranial and Craniofacial Implants. The implants utilize a groundbreaking combination of Biphasic Calcium Phosphate (BCP) reinforced with Polyether Ether Ketone (PEEK), marking the first FDA approval for this material in cranial implants.
The Fusion™ BCP-PEEK implant represents the first new implant in the cranial market in 8 years. The company can design, manufacture, and ship these custom implants within 24-48 hours. The technology is designed to promote bone integration while maintaining durability and personalized fit, complementing Kelyniam's existing regenerative product portfolio.
Kelyniam Global (OTC:KLYG), a manufacturer of custom cranial implants, has announced that CFO Terrance Kurtenbach will present at the Life Sciences Virtual Investor Forum on September 18th, 2025, at 10:00 EDT.
The company will showcase its product portfolio, including the exclusively licensed CustomizedBone hydroxyapatite implant from Finceramica Spa and the OsteoStrip and Osteoplug product lines from Osteopore. Kelyniam aims to establish itself as a leader in regenerative options for U.S. surgeons.
Investors can participate in this interactive online event and schedule one-on-one meetings with management on September 18th (PM), 19th, and 22nd.
Kelyniam Global (OTC:KLYG), a manufacturer of custom cranial and craniofacial implants, has achieved an uplisting to the OTCID market tier on the OTC Markets Group platform. This upgrade reflects the company's commitment to transparency and compliance with financial reporting requirements.
The OTCID status distinguishes KLYG among OTC companies, requiring regular financial reporting and compliance with strict criteria. CFO Terrance Kurtenbach highlighted that this achievement could attract a broader investor base while supporting long-term growth. The company continues to focus on expanding its product portfolio, including PEEK cranial implants with patented fixation and regenerative products.
Kelyniam Global (OTC: KLYG), a manufacturer of custom cranial and craniofacial implants, reported challenging Q2 2025 financial results. The company experienced a 20.2% decrease in revenue to $1,364,432 compared to Q2 2024, with gross margin declining 18.1% to $1,090,691.
The company shifted from an operating profit of $172,093 in Q2 2024 to an operating loss of $59,869 in Q2 2025. Despite these challenges, management highlighted improved Q2 performance compared to Q1, attributing slower periods to the unpredictable nature of the cranial implant market. The company maintains its competitive advantage through 24-48 hour delivery of custom implants for rush cases.
Kelyniam Global (OTC: KLYG), a custom cranial implant manufacturer, reported challenging Q1 2025 results with revenue declining 34.7% to $624,910 from $957,447 in Q1 2024. The company posted an operating loss of $(140,556) compared to a profit of $123,599 in the prior year. To address these challenges, Kelyniam appointed Alex Rivero as National Sales Director and plans to add 10 new distributors in 2025.
The company announced a significant three-year distribution agreement with Osteopore Ltd. to distribute their bioresorbable products in the U.S., including Osteostrip®, Osteoplug®, and Osteomesh®. This partnership, along with Finceramica, positions Kelyniam as a leader in regenerative medicine for cranial surgery while maintaining their commitment to 24-48 hour custom implant delivery.
Kelyniam Global (OTC:KLYG), a custom cranial implants manufacturer, reported record financial results for 2024. The company achieved total revenue of $3,328,382, marking a 24.6% increase from $2,672,357 in 2023. Operating income improved significantly to $277,037 from a loss of ($239,166), representing a $515,203 improvement.
The company's EBITDA turned positive at $322,824 compared to a loss of $189,758 in 2023. Key operational achievements included expanding to 15 new hospitals, completing an FDA audit with minor observations, and sponsoring the Skull Base 360 wet lab at the University of Maryland. The company plans to focus on strengthening partnerships, in-licensing products, and pursuing organic growth in 2025, with significant investments planned in sales and business development activities.
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