Healthcare Industry News:  PEEK 

Devices Surgery Orthopaedic FDA

 News Release - May 4, 2006

Spine Wave Announces StaXx(TM) XD FDA 510(k) Clearance

SHELTON, Conn.--(HSMN NewsFeed)--May 4, 2006--Spine Wave announced today that the Company received FDA 510(k) clearance to market the StaXx(TM) XD Expandable Device. The innovative expandable PEEK spacer, indicated for use as a Vertebral Body Replacement device, will be the first commercial product that the Company will release into the U.S. market.

"We are excited to bring the StaXx(TM) XD System to the US market and to begin building our US distribution," said Mark LoGuidice, Chairman and CEO of Spine Wave. "Surgeon response to the StaXx(TM) XD PEEK spacer, and in particular, the implant's in situ expansion and distraction capabilities, has been very encouraging."

Scott Kitchel, M.D., Assistant Clinical Professor of Orthopedic Surgery at Oregon Health and Sciences University added, "I have been working with the Company for several years developing this technology. I believe that the StaXx(TM) XD's in situ distraction offers unique advantages not available with one-piece, monolithic implant designs and I am eager to begin using the system."

Spine Wave expects to complete a StaXx(TM) XD limited US release this summer with a broad market launch in the fall. Mr. LoGuidice commented, "We are in the process of aggressively recruiting a world class sales organization in preparation for the full market launch. We anticipate having a robust product portfolio and the StaXx(TM) XD System is simply the first of many products that we plan to leverage through our distribution."

About Spine Wave:

In January, Spine Wave closed a series C financing and raised an additional $36.5 million, bringing the total funds raised to date to $90 million. The Company is focused on the development and marketing of clinical solutions for three of the largest and fastest growing spinal market segments: nuclear replacement and augmentation, vertebral compression fracture repair and spinal fusion. The company's product portfolio includes the NuCore(TM) Injectable Nucleus, the StaXx(TM) FX Fracture Repair System, the StaXx(TM) XD Expandable Device, and several additional products in development. For more information, visit Spine Wave's website at www.spinewave.com.



Source: Spine Wave

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