Connecticut-based Kelyniam Global, Inc. has entered a strategic licensing agreement with Fin-ceramica faenza spa to market its hydroxyapatite cranial implant, brand named CustomizedBone Service™, in the United States.
Kelyniam Global and Fin-ceramica faenza spa Forge Partnership
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Kelyniam Global specializes in the production of custom prosthetics utilizing computer aided design and computer aided manufacturing of advanced medical grade polymers.
The hydroxyapatite cranial implant, which had been previously marketed in the U.S. by New Jersey-based Integra LifeSciences Holdings Corporation, is made of a bio-mimetic ceramic biomaterial and designed to mimic macro and micro porous hydroxyapatite, which makes up 70% human bone content. According to the company, its chemical composition and unique porous biomaterial structure of its implant support increased cell colonization and, therefore, faster recovery times.
The CustomizedBone Service™ implant is indicated for patients ages seven and up. According to Kelyniam, it has been shown to decrease rates of post-op infection incidence when compared to titanium-based implants for the same indication.
“We are extremely excited to partner with a technology leading company like Fin-ceramica,” said Kelyniam CEO Ross Bjella. “Our companies share a mutual passion of working closely with neurosurgeons to design and build complex implants for cranial and maxillo-facial applications. The CustomizedBoneä implant will give our customers another terrific option to fill a specific patient need.”
Kelyniam’s customized cranial and craniofacial implants are made from engineered bio-materials and polymers including PEEK (polyether ether ketone). The company is known for rapid, on-demand production, customized prosthetics, advanced medical grade polymers, direct collaboration with surgeons, and computer aided design and manufacturing.
Founded in 1992 in Faenza, Italy, Fin-Ceramica Faenza S.p.A., was originally a spin-off of the Institute for Science and Technology for Ceramics (ISTEC-CNR). The company designs and manufactures organic material medical devices for the repair and recovery of bone and cartilage tissues. The company combines the ceramic process tradition with biomedical innovation.
“Fin-ceramica’s unique implant is a great fit for our company, specifically because of integrative properties of hydroxyapatite and the implant’s commercial success in Europe. Our corporate cultures are very similar, both focusing on state of the art, patient focused technology that provides excellent aesthetic outcomes,” said Kelyniam’s National Sales Director Laura Reed.
Kelyniam will distribute both PEEK and CustomizedBoneä hydroxyapatite implants beginning in January 2022.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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