Invibio Provides Our Readers Information On Their New Composite Material ENDOLIGN
BY ARIELLA P. GOLOMB, MD, SEPTEMBER 25, 2006
Invibio, principal supplier of PEEK polymer, an increasingly important material used in orthopedic applications, announced earlier this month the launch of a new device material, ENDOLIG(TM) composite, a biocompatible carbon fiber reinforced thermoplastic material. On their website, the company highlights the benefits of this new material, including its mechanical strength, imaging compatibility, biocompatibility, FDA and CE approvals and sterilization tolerance.
Michael Callahan, president of Invibio responds to HealthpointCapital's further questions about ENDOLIGN.
HC: What will be the first orthopedic applications of Endolign? Is it currently being used in any products?
MC: Regulatory approval has already been received for implantable orthopaedic devices composed of ENDOLIGN. Current applications include translaminar pins and spine cages (KIMBA) from Signus.
HC: When would a manufacturer decide to use PEEK-Optima versus Endolign? Is there a difference in regards to load bearing indications? What is the difference in the pricing structure between the two?
MC: ENDOLIGN composite material offers superior strength and stiffness compared with PEEK-OPTIMA polymer and is an excellent replacement for applications that traditionally use metals, such as cobalt chromium alloys, titanium alloys and stainless steel. Orthopedic applications that need to withstand high sustained or cyclic loads, including total hip and knee replacement devices, are good candidates for ENDOLIGN. Because of their significantly different properties, ENDOLIGN and PEEK-OPTIMA are designed for different applications and we do not anticipate competition between the two.
Cost varies as it is determined by device configuration, size, and production volume, which effect the composition of the ENDOLIGN product.
HC: How does the load bearing indication for Endolign compare to that for other intervertebral spacers?
MC: ENDOLIGN spacers are exceptionally strong compared with unfilled PEEK OPTIMA polymer and allograft alternatives. The continuous carbon fibers significantly enhance the mechanical properties of the PEEK-OPTIMA matrix resulting in a composite that displays exceptional stiffness, tensile strength and fatigue behavior compared to metals. Additionally, the strength and other mechanical properties of ENDOLIGN can be tailored by modifying the orientation of the carbon fibers.
Translaminar pins, intermedullary nails/screws,
and osteosynthesis plates/screws from Icotec AG.
HC: What is the barrier to entry for other PEEK manufacturers- is it your IP protection, or is it manufacturing/distribution relationships?
MC: ENDOLIGN is a proprietary product and its development has required significant investment to ensure the stringent quality and process controls required for manufacturing of implantable biomaterials.
HC: When do you expect to launch in the Asia-Pacific medical market?
MC: ENDOLIGN was launched in the Asia-Pacific market at the same time as the U.S.
For more information on Invibio check out HealthpointCapital's previous interview with Mike Callahan President of Invibio, where he discusses PEEKs emergence as a leading biomaterial and Invibio’s collaboration with OEMs and our previous blog entry about Invibio's expansion into the Asia Pacific market.
