Kelyniam Global, Inc. (Pinksheets: KLYG), an emerging medical device manufacturing company that recently was granted FDA 510(k) approval, announced today that it has begun commercial shipment of its Custom Skull Implants (CSI). Kelyniam CSI's are seen by many in the medical community as a game-changer in the world of medical prosthetics.
“We are confident our innovative technology, superior form, fit, and function will greatly enhance patient outcomes and empower surgeons by providing them with more and better treatment options than our competitors.”
Kelyniam Custom Skull Implants (CSI) 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 enable Kelyniam to deliver patient specific implants to surgeons in as little as 24 hours from the receipt of an order. The ability to provide custom implants quickly and accurately can reduce the time between trauma and implantation and provides surgeons additional treatment options.
"We are very excited to have begun commercial shipment of our state-of-the-art Custom Skull Implants," said James Ketner, president and CEO of Kelyniam. "We are confident our innovative technology, superior form, fit, and function will greatly enhance patient outcomes and empower surgeons by providing them with more and better treatment options than our competitors."
Kelyniam uses Invibio's PEEK-OPTIMA® for all of its custom implants. More about Kelyniam's innovative use of PEEK-OPTIMA can be found at the following link: http://www.plasticstoday.com/articles/peek-empowers-custom-designed-skull-implants0706201101
"We initially became involved with the medical device industry back in 2008 when we were supplying Stereolithography (SLA) models to a device manufacturer," said Ketner. "When we saw how those implants were being made, we decided that a better manufacturing process could be used to deliver a higher tolerance product and faster deliverable turnaround time. We were producing around 40 units per month when we were making the models, and if we can produce 40 units a month with our current pricing and share structure, that would result in retained earnings of approximately $.18/share. We anticipate production of more than 40 units per month by the end of 2012. We also have other products in development we believe will add additional revenues and earnings."
The company also intends on becoming fully reporting with the Securities and Exchange Commission once earnings dictate a share price that will allow the company to move to a higher exchange such as the AMEX or NASDAQ.
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