Raymedica has received FDA approval to begin enrolling patients in a US clinical study to evaluate the potential benefits of its HydraFlex™ Nucleus Arthroplasty System™, a new non-fusion technology for the treatment of degenerative disc disease.

Implanted via an Anterior lateral RetroPeritoneal Approach (ARPA), the HydraFlex device is designed to replace the diseased nucleus potentially providing pain relief and maintaining disc height. The HydraFlex device is designed with the Company’s same proprietary pre-formed contained hydrogel technology that has been implanted in over 4,000 patients over the past 10 years.

The HydraFlex Nucleus Arthroplasty System has distinct design features that provide a more anatomic contoured shaped device for greater fit and fill; a softer core with a larger footprint to potentially reduce the risk of subsidence; and faster hydration to allow faster stabilization in comparison to the Company’s pioneering PDN-SOLO® design. The HydraFlex NAS™ incorporates new co-functioning instrumentation that is designed to provide repeatable/reproducible intra-discal sizing with consistent placement of the device during implantation. The ARPA permits a more thorough consistent nucleus cleanout, the ability to repair the annular incision, and is a less destabilizing approach. This device and system approach is collectively designed to potentially improve clinical performance.

For more information on spine surgeons participating in the FDA approved clinical evaluation on the HydraFlex™ Nucleus Arthroplasty System™ Technology, please refer to the following investigator websites:

US CLINICAL TRIAL TRAINED SURGEONS

Reginald J. Davis, M.D., FACS, Baltimore, MD, USA
Study Coordinator: Jackie Murphy, RN (Tel: 443-849-4282)
http://www.gbmc.org/gbna/links.cfm

Kenneth A. Pettine, M.D., Loveland, CO, USA
Study Coordinator: Gina Klapproth, RNFA (Tel: 800-795-5487)
http://www.rmsas.com/3_clinicaltrial3.html

John S. Thalgott, M.D., Las Vegas, NV, USA
Study Coordinator: Madilyne Fogarty, (Tel: 702-878-4382)
http://www.cdsslv.com

Rick B. Delamarter, M.D., Santa Monica, CA, USA,
Study Coordinator: Lacey Feldman (Tel: 310-449-6584)

Additional candidate information on this latest treatment option in Nucleus Arthroplasty™ is located at www.hydraflexnas.com