NEW BRITAIN, Conn.--(BUSINESS WIRE)--Kelyniam Global, Inc. (Pinksheets: KLYG), an emerging medical device manufacturing company, announced today it has completed its filing process with the Central Contractor Registration (CCR) and has received approval to sell its revolutionary Custom Skull Implants in veteran and military hospitals across the country and world. CCR is the primary supplier database for the U.S. federal government and all vendors have to be registered before the award of a contract or agreement.
According to a story in USA Today, Pentagon officials estimate that up to 360,000 Iraq and Afghanistan veterans have suffered traumatic brain injuries. Many of these brave wounded have damaged or missing portions of their skulls and require cranial implants to be surgically implanted as part of their course of treatment.
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 been approved to market our Custom Skull Implants to our Veteran’s and military hospitals,” said James Ketner, president and founder of Kelyniam. “Our fighting men and women deserve the finest medical care available and we are confident our implants will greatly improve the quality of life of these wounded warriors.”
Kelyniam Custom Skull Implants have been successfully implanted in patients around the country including its first military patient earlier this month. Feedback from surgeons performing these surgeries has been extremely positive and they have all been ecstatic regarding the quality and fit of the implants and the incredibly fast turnaround time.
Mr. Ketner added, “We recently officially launched our products on October 3rd at the CNS (Congress of Neurological Surgeons) show in Washington D.C. and had very favorable responses from surgeons and distributors, especially regarding our lead times. We are on track for a great year in 2012, and believe we will make or exceed our earnings estimates for year-end 2012.”
About Kelyniam Global, Incorporated
Kelyniam Global (Pinksheets: KLYG), Inc. specializes in the use of CAD/CAM technology to provide patient specific custom implants to assist medical professionals by allowing them to operate more effectively, improve patient care, and reduce health care costs by providing the highest quality products available with today's technology. The company is continually researching and developing new products and processes to help patients live more active and productive lives.
Please visit our website at www.kelyniam.com for more information.
Except for historical information contained in this release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this release, words such as "anticipate," "believes," "estimate," "expect," "should," "intend," "projects," "objective" and "appears" and similar expressions, as they relate to the Company or its management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of the Company's management, as well as assumptions made by and information currently available to the Company's management. Among the factors that could cause actual results to differ materially are the following: the effect of business and economic conditions; the impact of competitive products and pricing; capacity and supply constraints or difficulties; product development, commercialization or technological difficulties; the regulatory and trade environment; the impact of reimbursement rates and coverage; and the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to revise any forward-looking statements as a result of future events or developments.