Kelyniam switches to med-tech industry, with skull implants
By OMAR FORD
Medical Device Daily Staff Writer
For years, James Ketner manufactured parts for aircraft. That was until about a couple of years ago when Ketner’s company, Kelyniam (New Britain, Connecticut), began supplying Stereolithography models to a device manufacturer. The experience served as a catalyst for Ketner and the company to shift focus to the med-tech industry.
“I saw what [other med-tech companies] were doing and I said, why would you make a mold if you’re only making one piece – a one off item,” Ketner, Kelyniam president/CEO told Medical Device Daily. “You only make a mold if you’re doing 900,000 door handles for Honda, that’s when you make a mold. I thought if we could find a bioimplantable material and machine it, I could do this thing in 24 hours, not four to five weeks.”
As a result, Ketner told MDD that Kelyniam has received FDA approval to begin commercial shipment of its Custom Skull Implants – products that are seen by many in the medical community as game-changers in the world of prosthetics.
“We’ve converted the entire company over to manufacturing this medical device,” he said.
Kelyniam Custom Skull Implants are designed and manufactured for each individual patient to correct or replace bony voids in the cranial skeleton caused by trauma or birth defects. Streamlined CAD/CAM design and manufacturing techniques allow Kelyniam to deliver patient specific implants to surgeons in as little as 24 hours from the receipt of an order.
“I think the thing that’s catching everyone off guard is how fast we can turn this around,” he said. “If you give me the CAD data by 9 a.m. I can have the product on your desk by 9 a.m. the next day.”
The relative quickness in developing the product adds to a better fit for patients, the company said.
“If you take CT scans and it takes you six weeks to get the thing implanted, it’s not going to fit as good, and you can understand why,” he said. The bone is going to move around, it’s going to start healing itself etc. But if you give me a CT scan that’s 24 hours old I can give you a piece that’s going to fit a whole lot better.”
Kelyniam began the development of these new medical devices in 2Q09. In less than two years, the company has perfected a process to quickly and accurately deliver high tolerance, patient specific custom skull implants using PEEKOPTIMA. The regulatory expertise gained during the submission process will be applied to future Kelyniam products.
According to its website, Kelyniam is capable of producing around 40 units per month and that if the firm can produce 40
units a month with its current pricing and share structure that would result in retained earnings of nearly $.18/share. The firm said it anticipated production of more than 40 units per month by the end of 2012. There are also other products in the pipeline.
Kelyniam was originally founded in 2005 and went public in 2008. Since it switched focus, the firm has made several key investments in more firmly settling into the med-device sector.
In June, the company acquired Cranston Holdings a rapid prototyping business with knowledge and expertise in Stereolithography for the medical industry.
“This acquisition will immediately add additional shareholder value by integrating Cranston’s employees and equipment into our infrastructure”, Ketner said in a release detailing the acquisition of the company “Most importantly, Cranston owns an in house developed proprietary software package that will assist us in our ISO 13485, 21 CFR 820 compliance, and that software package is now IP of Kelyniam.”
And last March, the company signed a supply agreement with Invibio (West Conshohocken, Pennsylvania), the exclusive manufacturer of implantable PEEK-OPTIMA polymer. All of Kelyniam’s Maxillofacial and Custom Cranial Implants will be made with Invibio PEEK-OPTIMA polymer.
Plans call for the company to delve deeper into the med-tech territory. It’s a path that Ketner said he didn’t mind staying on and said that the company probably would never go back to its past roots.
“I’m not going to do anything with airplanes anymore,” he said. “I’ve been there and done that. Sitting there trigging out load pads and fastener locations with your TI55 (calculator) can only last for so long. With [medical devices] it’s fun to work everyday. I’m interested and it’s fun to come into the office.”
Omar Ford, 404-262-5546
omar.ford@ahcmedia.com