Kelyniam Global Renews Licensing Agreement with Finceramica, Unlocking Access to Valuable Pipeline Products
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 (OTC: KLYG) rinnovato il proprio accordo di licenza con Finceramica Faenza per tre anni, estendendo l'accesso al portafoglio di biomateriali di Finceramica tra cui SINTlife (un innesto riassorbibile di idrossiapatite di magnesio in pasta iniettabile) e il sistema di realtà aumentata Surgery V-Connect.
Il rinnovo concede a Kelyniam diritti di distribuzione negli Stati Uniti ampliati e accesso esclusivo ai prodotti in pipeline, posizionando l'azienda per entrare nei mercati ortopedici e ricostruttivi, e si cita l'aspettativa che SINTlife potrebbe ottenere l'approvazione FDA entro due anni, mirando ai mercati descritti come circa 10 volte il settore attuale degli impianti craniali personalizzati.
Kelyniam Global (OTC: KLYG) renovó su acuerdo de licencia con Finceramica Faenza por tres años, ampliando el acceso al portafolio de biomateriales de Finceramica, incluyendo SINTlife (un injerto de hidroxiapatita de magnesio resorbible en forma de pasta injectable) y el sistema de realidad aumentada Surgery V-Connect.
La renovación otorga a Kelyniam derechos de distribución ampliados en Estados Unidos y acceso exclusivo a productos en desarrollo, posicionando a la empresa para ingresar a los mercados ortopédicos y reconstructivos, y cita la expectativa de que SINTlife podría obtener la aprobación de la FDA dentro de dos años, dirigido a mercados descritos como aproximadamente 10 veces el sector actual de implantes craneales personalizados.
Kelyniam Global (OTC: KLYG)은 Finceramica Faenza와의 라이선스 계약을 3년 연장하여 Finceramica의 생체재료 포트폴리오에 대한 접근을 확대했습니다. 여기에는 SINTlife (주입 가능한 퍼티 형태의 재흡수 가능한 마그네슘 하이드록시아파타이트 이식물) 및 Surgery V-Connect 증강 현실 시스템이 포함됩니다.
갱신은 미국 내 배포 권한을 확대하고 파이프라인 제품에 대한 독점 접근권을 부여하며, 회사를 정형외과 및 재건 시장으로 진입시킬 수 있게 하고, SINTlife가 FDA 승인을 2년 이내에 받을 수 있다는 기대를 밝히며, 현재 맞춤 두개골 임플란트 부문의 약 10배 규모로 설명된 시장을 겨냥합니다.
Kelyniam Global (OTC : KLYG) a renouvelé son accord de licence avec Finceramica Faenza pour trois ans, élargissant l'accès au portefeuille de biomatériaux de Finceramica, y compris SINTlife (une greffe résorbable à base d'hydroxyapatite de magnésium sous forme de pâte injectable) et le système de réalité augmentée Surgery V-Connect.
Le renouvellement accorde à Kelyniam des droits de distribution élargis aux États-Unis et un accès exclusif aux produits en pipeline, positionnant l'entreprise pour pénétrer les marchés orthopédiques et reconstructifs, et indique une attente selon laquelle SINTlife pourrait obtenir l'approbation FDA dans un délai de deux ans, ciblant des marchés décrits comme environ 10 fois le secteur actuel des implants crâniens personnalisés.
Kelyniam Global (OTC: KLYG) hat seine Lizenzvereinbarung mit Finceramica Faenza um drei Jahre verlängert und den Zugang zum Biomaterialportfolio von Finceramica erweitert, einschließlich SINTlife (ein resorbierbares Magnesium-Hydroxyapatit-Transplantat in injizierbarer Paste) und dem Surgery V-Connect Augmented-Reality-System.
Die Verlängerung gewährt Kelyniam erweiterte Vertriebsrechte in den USA und exklusiven Zugang zu Produkt-Pipelines, positioniert das Unternehmen für den Eintritt in Orthopädie- und Rekonstruktionsmärkte und verweist darauf, dass SINTlife innerhalb von zwei Jahren die FDA-Zulassung erhalten könnte, mit einem Zielmarkt, der etwa dem 10-Fachen des aktuellen Nischenmarktes für individuelle Schädelimplantate entspricht.
Kelyniam Global (OTC: KLYG) قامت بتجديد اتفاقية الترخيص مع Finceramica Faenza لمدة ثلاث سنوات، موسعة الوصول إلى محفظة المواد الحيوية لدى Finceramica بما في ذلك SINTlife (غرَف عظمية قابلة للامتصاص من هيدروكسي أباتيت المغنيسيوم في شكل عجينة قابلة للحقن) ونظام الواقع المعزز Surgery V-Connect.
يمنح التجديد لـ Kelyniam حقوق توزيع موسعة في الولايات المتحدة والوصول الحصري إلى المنتجات في خط الأنابيب، مع وضع الشركة في موقع يسمح لها بالدخول إلى أسواق العظام والتجديد، مع الإشارة إلى توقع بأن قد يحصل SINTlife على موافقة FDA خلال عامين، مستهدفاً أسواق تُوصف بأنها تقارب 10 أضعاف قطاع زراعات الجمجمة المخصصة الحالي.
- Three-year licensing extension with Finceramica
- Exclusive U.S. access to SINTlife and other biomaterials
- Pipeline diversification into orthopedic and reconstructive markets
- Commercial expansion hinges on SINTlife FDA clearance
- No financial terms disclosed for the licensing extension
CANTON, Conn., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Kelyniam Global, Inc. (OTC: KLYG), a leading manufacturer of custom cranial and cranio-maxillofacial implants, today announced the renewal of its licensing agreement with Finceramica Faenza S.p.A., an innovative Italian biomaterials company. The three-year extension strengthens the longstanding partnership, granting Kelyniam expanded access to Finceramica's advanced product portfolio, including SINTlife, a next-generation fully resorbable synthetic graft made of substituted magnesium hydroxyapatite nanocrystals, available in injectable putty form, Surgery V-Connect a Smart Augmented Reality System and other products
SINTlife product is expected to receive FDA clearance within 2 years, targeting markets estimated to be 10 times larger than the current custom cranial implant sector.
This renewal not only secures Kelyniam's position as a key U.S. distributor but also positions the company for significant expansion into high-growth areas of regenerative medicine. By leveraging Finceramica's proprietary technologies, Kelyniam aims to diversify its offerings beyond its patented cranial implants, addressing broader needs in orthopedic and reconstructive surgery.
"We are thrilled to extend our collaboration with Finceramica, a partnership that has already delivered innovative solutions for patients undergoing cranial reconstruction," said Ross Bjella, CEO of Kelyniam Global. "This renewal provides us with exclusive access to groundbreaking biomaterials like SINTlife, which will open doors to expansive markets in bone regeneration. We're excited about the mutual benefits—Finceramica gains a dedicated long-term distributor in the U.S., while Kelyniam secures a pipeline of unique products that could transform our growth trajectory by 2029 and beyond."
Michele Desogus, CEO of Finceramica Faenza S.p.A., echoed the enthusiasm: "Renewing our agreement with Kelyniam underscores our shared commitment to advancing regenerative surgery through innovative biomaterials. For Finceramica, this partnership ensures a strong, reliable presence in the U.S. market, allowing us to bring SINTlife to patients who need them most. We're mutually excited about the opportunities ahead, as Kelyniam's expertise in custom implants complements our cutting-edge technologies, paving the way for collaborative success in larger, high-impact markets."
The agreement highlights the strategic alignment between the two companies, with Finceramica benefiting from Kelyniam's established U.S. distribution network and regulatory experience, while Kelyniam gains entry into multimillion-dollar markets projected for rapid growth. This positions Kelyniam to capitalize on the evolving demand for advanced biomaterials in orthopedic applications.
About Kelyniam Global, Inc. Kelyniam Global, Inc. (OTC: KLYG) specializes in the rapid production of custom prosthetics utilizing computer-aided design and computer-aided manufacturing of advanced medical-grade polymers. The company develops, manufactures, and distributes custom cranial and craniofacial implants for patients requiring the reconstruction of cranial and certain facial structures. Kelyniam works closely with surgeons, health systems, and payors to improve clinical and cost-of-care outcomes.
About Finceramica Faenza S.p.A. Finceramica Faenza S.p.A. is an Italian company that develops, manufactures, and commercializes innovative therapeutic solutions in the biomedical field, focusing on regenerative surgery for bone and cartilage defects. Part of the Tampieri Financial Group, Finceramica combines traditional ceramic processes with biomedical research to create advanced biomaterials that mimic natural tissue structures.
For more information, please contact: Kelyniam Global, Inc. Investor Relations (860) 590-3034 info@kelyniam.com
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