CANTON, CT >> Kelyniam Global (KLYG), a maker of custom cranial and craniofacial implants, announced today that it has received premarket approval from the Food and Drug Administration (FDA) for a new 510(k) application that allows for unique modifications to their PEEK cranio-maxillofacial implant product line.
This approval means Kelyniam can now sell the only approved PEEK cranial implant with an integrated fixation system (IFS). IFS Tabs© can eliminate the need for cranioplasty plates, saving hundreds of dollars per procedure. Surgeons can determine where the fixation tabs are placed around the implant to ensure a precise fit.
The comprehensive 510(k) application included additional modifications that are now only available on Kelyniam’s PEEK implants. Eric Boyea, Director of Quality and Regulatory Affairs, said, “Kelyniam has a proven process for 510(k) submissions and worked closely with the FDA to ensure the review process went smoothly. We are excited about this approval because surgeons can now request Kelyniam implants to include a temporal cutback to help streamline implantation by reducing the need for difficult dissection when needed. Surgeons also have the option to include perfusion holes to allow communication with the subgaleal space when needed.”
Dr. Mark Smith, Kelyniam’s VP of Business Development said, “I know from first-hand experience and from discussions with colleagues just how much easier and faster securing the implant is with the IFS Tabs©.”
“Our distributor partners have been eagerly waiting for this approval,” said Laura Reed, Kelyniam’s National Sales Director. “These unique enhancements, many which are now only approved for Kelyniam implants, will differentiate our products in the market. In addition, these new features can be included within our current 24-hour turnaround time.”
Ross Bjella, Kelyniam’s Chairman and CEO, said, “Kelyniam has once again proven our ability to work closely with surgeons and the FDA to bring innovative products to the market. Our commitment to providing unique products that meet or exceed customer needs is evident in this comprehensive application.”
Kelyniam expects to start shipping the enhanced implants in June.
Kelyniam Global 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 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.