Kelyniam Global, Inc. Receives FDA Clearance for Innovative Fusion™ BCP-PEEK Implant
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 (KLYG) ha raggiunto una tappa significativa con l'approvazione FDA 510(k) per i suoi innovativi Fusion™ Cranial and Craniofacial Implants. Gli impianti utilizzano una combinazione rivoluzionaria di Biphasic Calcium Phosphate (BCP) rinforzata con Polyether Ether Ketone (PEEK), segnando la prima approvazione FDA per questo materiale negli impianti cranici.
Il Fusion™ BCP-PEEK implant rappresenta il primo nuovo impianto nel mercato craniale da 8 anni. L'azienda può progettare, produrre e spedire questi impianti personalizzati entro 24-48 ore. La tecnologia è progettata per favorire l'integrazione ossea mantenendo durata e adattamento personalizzato, completando il portafoglio di prodotti rigenerativi esistenti di Kelyniam.
Kelyniam Global (KLYG) ha logrado un hito significativo con la aprobación FDA 510(k) para sus innovadores Fusion™ Cranial and Craniofacial Implants. Los implantes utilizan una combinación innovadora de Fosfato de calcio bicálcico (BCP) reforzado con PolieterEt er Cetona (PEEK), marcando la primera aprobación de la FDA para este material en implantes craneales.
El Fusion™ BCP-PEEK implant representa el primer nuevo implante en el mercado craneal en 8 años. La empresa puede diseñar, fabricar y enviar estos implantes personalizados en 24-48 horas. La tecnología está diseñada para promover la integración ósea mientras mantiene durabilidad y ajuste personalizado, complementando la cartera de productos regenerativos existente de Kelyniam.
Kelyniam Global (KLYG)은 혁신적인 Fusion™ Cranial and Craniofacial Implants에 대해 FDA 510(k) 승인이라는 중요한 이정표를 달성했습니다. 이 임플란트는 Biphasic Calcium Phosphate (BCP)를 Polyether Ether Ketone (PEEK)로 강화한 완벽한 조합을 활용하며, 두개골 임플란트 분야에서 이 재료의 최초 FDA 승인을 기록합니다.
Fusion™ BCP-PEEK 임플란트는 8년 만에 두개골 시장의 첫 신규 임플란트를 대표합니다. 회사는 이 맞춤형 임플란트를 24-48시간 이내에 설계, 제조 및 배송할 수 있습니다. 이 기술은 골 결합을 촉진하면서 내구성과 개인화된 적합성을 유지하도록 설계되어, Kelyniam의 기존 재생 제품 포트폴리오를 보완합니다.
Kelyniam Global (KLYG) a franchi une étape importante avec l'autorisation FDA 510(k) pour ses Fusion™ Cranial and Craniofacial Implants innovants. Les implants utilisent une combinaison révolutionnaire de Phosphate de calcium biphasique (BCP) renforcé par Polyéteréthercétoné (PEEK), marquant ainsi la première approbation FDA pour ce matériau dans les implants crâniens.
Le implant Fusion™ BCP-PEEK représente le premier nouvel implant sur le marché crânien en 8 ans. L'entreprise peut concevoir, fabriquer et expédier ces implants personnalisés en 24-48 heures. La technologie est conçue pour favoriser l'intégration osseuse tout en conservant la durabilité et un ajustement personnalisé, complétant le portefeuille de produits régénératifs existants de Kelyniam.
Kelyniam Global (KLYG) hat einen bedeutenden Meilenstein erreicht: FDA 510(k)-Freigabe für die innovativen Fusion™ Cranial and Craniofacial Implants. Die Implantate nutzen eine bahnbrechende Kombination aus Biphasic Calcium Phosphate (BCP), verstärkt durch Polyether Ether Ketone (PEEK), und markieren die erste FDA-Zulassung für dieses Material in Schädelimplantaten.
Das Fusion™ BCP-PEEK-Implantat stellt das erste neue Implantat im Schädelmarkt seit 8 Jahren dar. Das Unternehmen kann diese maßgeschneiderten Implantate innerhalb von 24-48 Stunden entwerfen, fertigen und versenden. Die Technologie soll die Knochenintegration fördern, während Haltbarkeit und passgenaue Anpassung erhalten bleiben und das bestehende regenerative Produktportfolio von Kelyniam ergänzen.
كيليانْيَام غلوبال (KLYG) حققت إنجازاً مهماً بقبول FDA 510(k) لأجهزة Fusion™ الجمجمية وجراحة الوجه الجمجمية المبتكرة Fusion™ Cranial and Craniofacial Implants. تستخدم الزرعات مزيجاً ثورياً من فوسفات الكالسيوم ثنائي الطور (BCP) المعزز بـ بوليإيثير إيثر كيتون (PEEK)، وهو أول اعتماد من FDA لهذه المادة في الزرعات القحفية.
يمثل جهاز Fusion™ BCP-PEEK أول جهاز جديد في سوق الجمجمة خلال 8 سنوات. يمكن للشركة تصميم وتصنيع وشحن هذه الزرعات المخصصة خلال 24-48 ساعة. تم تصميم التكنولوجيا لتعزيز الاندماج العظمي مع الحفاظ على المتانة والملاءمة الشخصية، مكملةً لمحفظة منتجات Kelyniam الترميمية القائمة.
Kelyniam Global (KLYG) 已在 FDA 510(k) 批准方面取得重要里程碑，推出其创新的 Fusion™ 颅骨与颅面植入物。这些植入物采用开创性组合：双相磷酸钙（BCP）与聚醚醚酮（PEEK）增强，是该材料在颅骨植入物中的首次获得FDA批准。
Fusion™ BCP-PEEK 植入物是 8 年来颅骨市场的第一款新植入物。公司可以在 24-48 小时 内设计、制造并发货这些定制植入物。该技术旨在促进骨结合，同时保持耐用性和个性化贴合，补充Kelyniam现有的再生产品组合。
- First FDA-approved BCP-PEEK material for cranial implants in the US
- First new implant in cranial/craniofacial market in 8 years
- Rapid 24-48 hour manufacturing and shipping capability
- Enhanced bone integration properties while maintaining durability
- None.
This 510(k) clearance marks the first time the FDA has approved this material for use in cranial and craniofacial implants, representing a significant milestone in implant technology. The Fusion™ BCP-PEEK implant is the first totally new implant launched in the cranial and craniofacial market in 8 years.
"Kelyniam's achievement as the first company in the
Designed for custom applications , the Fusion™ BCP-PEEK material meets critical neurosurgery needs where precise, patient-specific solutions are essential for treating traumatic injuries, defects from tumor resections, or congenital anomalies. As with Kelyniam's PEEK implants, Fusion™ BCP-PEEK custom implants can be designed, manufactured and shipped to surgeons within 24-48 hours, ensuring timely care for patients in need.
Ross Bjella, Chairman and CEO, added, "Kelyniam continues to deliver cutting-edge technology to neurosurgeons. This unique implant is an important part of our regenerative product line, which includes our CustomizedBone™ (hydroxyapatite) implant from Finceramica, SpA, and the Osteopore range of products."
About Kelyniam Global, Inc. Kelyniam Global, Inc. specializes in rapidly producing custom cranial and craniofacial implants using biocompatible materials. By partnering with neurosurgeons worldwide, the company delivers high-quality, patient-specific solutions with a quick turnaround time. Dedicated to innovation in regenerative medicine, Kelyniam continues to enhance neurosurgical care. For more information, visit www.kelyniam.com .
Forward-Looking Statements This press release contains forward-looking statements under Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements involve risks and uncertainties that may cause actual results to differ from projections. Investors should not place undue reliance on these forward-looking statements.
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SOURCE Kelyniam Global Inc
FAQ
What FDA clearance did Kelyniam Global (KLYG) receive in September 2025?
How long does it take Kelyniam to manufacture and ship custom Fusion™ BCP-PEEK implants?
What makes Kelyniam's Fusion™ BCP-PEEK implants unique in the market?
What conditions can Kelyniam's Fusion™ BCP-PEEK implants treat?
What other regenerative products does Kelyniam offer besides Fusion™ BCP-PEEK implants?
