2011-06-30
Invibio® Biomaterial Solutions, the market leader in providing PEEK-based biomaterial solutions to medical device manufacturers around the world, announced today that, commencing this summer, Kelyniam Global, Inc. (KLYG) will have commercially available Custom Skull Implants (CSI), manufactured using Invibio’s patented PEEK-OPTIMA® polymer. Kelyniam, an emerging medical device manufacturer, recently received its FDA 510(k) clearance to market cranial implants.
Designed and manufactured on a patient-by-patient basis, Kelyniam CSI rely on the exceptional strength, bone-like modulus, radiolucency, purity, versatility and guaranteed supply of high quality PEEK-OPTIMA polymer. The Kelyniam CSI is intended to correct or replace bony voids in the cranial skeleton caused by trauma or birth defects while promoting a better anatomic fit versus conventional reconstruction methods and materials.
Invibio’s PEEK-OPTIMA polymer features:
- Over a decade of implantation history and use in nearly 3 million implanted devices
- Natural radiolucency and compatibility with medical imaging techniques to allow healing site visualization without artifacts
- Bone-like mechanical properties, exceptional strength and excellent durability
“We chose PEEK-OPTIMA because the product has a long safety record, is compatible with our manufacturing environment and is consistently available on short notice should our customers demand it,” said James Ketner, Kelyniam president & CEO.
Figure 1: The Kelyniam CSI, made with PEEK-OPTIMA polymer, offers improved anatomical fit, faster turnaround and the potential for reduced operating time.
Streamlined CAD/CAM design and PEEK-OPTIMA processing techniques enables Kelyniam to deliver patient-specific implants in as little as 24 hours from the receipt of CT scans, thus significantly shortening the time between trauma and implantation. Less waiting time means healing can begin more quickly, promoting greater patient satisfaction, shorter hospital stays and minimizing the potential need for subsequent hospital admissions.
A wide range of commercially available fixation systems can be used to attach the Kelyniam CSI to native bone, enabling surgeons to use their preferred fixation device. Because each Kelyniam CSI is created on 3D software and can be surgeon modified before the design is cut, the resulting implant is closely fitted to the defect. Further surgeon modifications are generally not needed and, according to American Journal of Engineering and Applied Sciences operating room time can be reduced by as much as 85% with customized skull implants.
About Kelyniam Global, Incorporated
Kelyniam Global (OTC: 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 contact Kelyniam at: 1-800-280-8192 (toll free U.S.) or 1-860-352-2949 (International), info@kelyniam.com, or visit our website at www.kelyniam.com for more information.
Forward-Looking Statements
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.
About Invibio
Invibio is a global leader providing high performance biomaterials, advanced technical research and consultative solutions to medical device manufacturers across a wide range of markets. The company provides medical device manufacturers with PEEK-OPTIMA polymer and compounds, MOTIS® polymer, ENDOLIGN® composite and PEEK-CLASSIX® polymer for the development of long- and short-term implantable medical devices.
Please contact Invibio at: +484 342 6004 (Americas) +44 (0) 1253 898 000 (Europe & Asia Pacific), info@invibio.com, or www.invibio.com for more information.
Invibio Media Contact:
Susan Skrudland
224-764-2125