Kelyniam Global, Inc., (KLYG), a maker of patient specific craniofacial and skull implants, announced the submission of its third 510(k) application to the FDA to expand their line of custom implants.
“The 510(k) submission is the result of our significant investments in research and development and in the quality infrastructure to successfully pursue regulatory applications,” said Director of Quality and Regulatory Affairs, Eric Boyea. “Kelyniam is now positioned to acquire or develop new products and document the regulatory pathway most likely to result in an approval.”
The company is seeking approval for a patent-pending implant design that includes a unique fixation system and other elements specific to Kelyniam’s custom implants. The new implants are designed to be available within 24 hours of receiving a patient-specific CT scan, as are the rest of Kelyniam’s product line. Orders received by 11:00 AM can be delivered to a hospital by 11:00 AM the next business day.
Vice President of Sales and Business Development, Dr. Mark Smith said, “The features of this new product were specifically requested by our customers. We worked closely with leading neurosurgeons around the country to understand their needs and where other products on the market fell short. We expect strong demand for this product upon FDA approval.”
Kelyniam Global, Inc., uses 3D printing, state-of-the-art additive manufacturing and CNC technology to create custom implantable prosthetic plates and medical models utilizing advanced medical grade biomaterials. The company develops, manufactures, and distributes custom craniofacial and skull implants for patients requiring the reconstruction of cranial and non-load bearing facial structures. Kelyniam works directly with surgical sales representatives, distributors, 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.