European market leading implant now available in the U.S.
COLLINSVILLE, CT., December 23, 2021 — Kelyniam Global, Inc. (OTC: KLYG), a leading manufacturer of custom cranial PEEK implants today announced that it has entered into a strategic licensing agreement with Fin-ceramica faenza spa to market the company’s hydroxyapatite patient specific implant. This bio-mimetic ceramic biomaterial is based on macro and micro porous Hydroxyapatite (HA), a major (70%) component of human bone. The specific bio-mimetic chemical composition combined with an elevated interconnected porosity play a role in the perimetral osteointegration process.
The innovative CustomizedBone Service™ implant is indicated for use in adult and pediatric patients (for children 7 years of age and above). The highly bio-compatible material, shows a reduced post-op infection incidence compared to titanium-based implants.
“We are extremely excited to partner with a technology leading company like Fin-ceramica,” said Ross Bjella, Kelyniam’s CEO, “Our companies share a mutual passion of working closely with neurosurgeons to design and build complex implants for cranial and maxillo-facial applications. The CustomizedBone™ implant will give our customers another terrific option to fill a specific patient need.”
Kelyniam will distribute the implant through its active salesforce of more than 50 representatives starting in January.
Representatives will carry both PEEK (polyether ether ketone) and hydroxyapatite products. The CustomizedBone™ implant was previously marketed in the U.S. by Integra Lifesciences.
Laura Reed, Kelyniam’s National Sales Director said, “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.”
Gabriele Esposito, Finceramica’s Global Marketing & Sales Director said “It is a really important agreement for Finceramica. We are very proud to collaborate with a specialized company in cranioplasty like Kelyniam”.
“Based on the large experience and success we have in EMEA markets with Relevant Clinical Data to support Product safety and efficacy, we are confident that this partnership with Kelyniam will allow the development of the CustomizedBone™ in U.S.” said Giorgia Conti, Finceramica’s International Product Manager.
Fin-Ceramica Faenza S.p.A. stands for Italian excellence. Established in 1992 in Faenza (Italy) as a spin-off of the Institute for Science and Technology for Ceramics (ISTEC-CNR), it was later taken over by the Tampieri Financial Group, which, though active in completely different sectors, understood its great added value and invested heavily to boost its growth. Finceramica combines the tradition of ceramic processes with the innovation of the biomedical field. It designs and manufactures medical solutions from organic material for the repair and regeneration of bone and cartilage tissues. The chemical composition and porous structure of the the biomaterials lead to its colonization from the human cells. This contributes to a speedier recovery. Concerning cancer care, CustomizedBone™ implants make it possible to perform cancer extirpation and cranial cavity reconstruction during the same surgery, thus optimizing resources. Finceramica boasts a wealth of international experience, focusing on niches of excellence worldwide.
Kelyniam Inc., 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 maxillo-facial implants for patients requiring the reconstruction of cranial and certain facial structures. Kelyniam works directly with surgeons, health systems and payors to improve clinical and cost-of-care outcomes.
As a cautionary note to investors, certain matters discussed in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such matters involve risks and uncertainties that may cause actual results to differ materially, including the following: changes in economic conditions; general competitive factors; the Company’s ability to execute its service and product sales plans; changes in the status of ability to market products; and the risks described from time to time in the Company’s SEC reports.
Contacts: Ross Bjella, CEO or Terrance Kurtenbach, CFO
(800) 280 – 8192