Healthcare Industry News:  compression fracture 

Devices Neurosurgery Orthopaedic

 News Release - June 28, 2006

Spine Wave Begins Patient Enrollment in NuCore(TM) Injectable Nucleus Degenerative Disc Disease Feasibility Study

SHELTON, Conn.--(HSMN NewsFeed)--June 28, 2006--Spine Wave, Inc. announced today that it has begun patient enrollment in a second arm of a feasibility IDE clinical trial studying the company's proprietary NuCore(TM) Injectable Nucleus for the treatment of Degenerative Disc Disease (DDD). Earlier this year, the Company announced that it had begun the first arm of an IDE clinical trial of the NuCore(TM) Injectable Nucleus for use as an adjunct to microdiscectomy.

DDD is a gradual process that occurs as an individual ages, causing low back pain for millions of people. In this IDE study, the surgeon will make a small incision and then use a needle to inject the NuCore(TM) Injectable Nucleus into the damaged disc. The NuCore(TM) material is injected in a liquid form which rapidly cures to a gel.

Hyun W. Bae, M.D., a spine surgeon on staff at St. John's Hospital and Century City Doctors Hospital in Los Angeles, is the Principal Investigator in this arm of the IDE study. "I am excited to begin treating patients in this study," stated Dr. Bae. "This procedure holds great promise for millions of Americans who suffer from back pain caused by disc degeneration. We currently can either fuse the discs together or implant an artificial disc to provide relief for patients. This new procedure allows a surgeon to use a needle to inject the NuCore(TM) material and in so doing, 'pump up' the nucleus that separates the vertebrae and cushions the spine. It may be performed as an outpatient procedure and be more suitable for the patient who is not yet a candidate for major spine surgery."

The NuCore(TM) Injectable Nucleus was developed in conjunction with Spine Wave's technology partner, Protein Polymer Technologies Inc (PPTI). Spine Wave holds an exclusive license to 26 patents and other patent applications pending in the United States and internationally in the fields of Spine and Orthopedics. The NuCore(TM) Injectable Nucleus was developed to replace the degraded nucleus inside the disc. The NuCore(TM) Injectable Nucleus is an injectable, 100% synthetic recombinant protein hydrogel designed to mimic the natural nucleus and restore the spine's natural biomechanics.

Spine Wave has now enrolled patients in DDD and microdiscectomy studies of the NuCore(TM) Injectable Nucleus in four countries: Switzerland, Australia, Germany, and the United States.

About Spine Wave

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. In January 2006, Spine Wave closed a series C financing and raised $36.5 million, bringing the total funds raised to date to $90 million. For more information, visit Spine Wave's website at www.spinewave.com.


Source: Spine Wave

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