World Class Team Convened to Finalize Upcoming IDE Study Design
AUSTIN, Texas – May 1, 2007 —Spinal Restoration, an innovator in the treatment of discogenic chronic back pain, recently assembled a team of well-known and respected advisors that will make up the company’s Clinical, Scientific and Business Advisory Boards. This world-class team includes renowned researchers in the fields of disc degeneration and biomaterials as well as some of the brightest clinical minds in minimally invasive spine interventions.
Spinal Restoration assembled its Advisory Boards to finalize the design of the upcoming IDE clinical trial of the Biostat™ Disc Augmentation System, a proprietary resorbable biologic and delivery system for the treatment of discogenic chronic back pain. The ~4 million patients that suffer from this debilitating condition annually represent the single largest segment of chronic low back pain sufferers.
Dr. Kevin Pauza, one of the first clinicians to become involved with Spinal Restoration says: “The caliber of the team Spinal Restoration has assembled is impressive, and the collegial atmosphere that surrounded the Advisory Boards during these first meetings highlights the strong potential we have with Spinal Restoration. The talents of the advisors, company partners and Spinal Restoration employees are a potent combination. We already have a great start to commercializing an exciting solution for chronic lower back pain.”
Clinicians that specialize in the minimally invasive treatment of spine pain come from a variety of medical specialties including Anesthesia, Physical Medicine and Rehabilitation, Radiology, and Orthopedic Spine Surgery. Spinal Restoration has included thought leaders from each of these specialties in its Clinical Advisory Board to insure that the unique aspects of each clinical practice are considered in its product development and IDE study design.
Gary Sabins, president and CEO of Spinal Restoration adds, “Our Biostat Disc Augmentation System has great potential and will serve millions of discogenic back pain sufferers that currently have few treatment options. The scope of the problem we are dealing with demands a different, innovative approach, and that is why it’s so important that we have strong representation from multiple medical specialties. We have been able to attract a world class assembly of clinicians, academicians and scientists as advisors to this program because they believe this is a technology that can truly change back pain care.”
One of the main objectives of this meeting was to outline key steps in preparing the company for an upcoming IDE (investigational device exemption) study. The target is to begin a patient study of the Biostat Disc Augmentation System in the first quarter of 2008. The Advisory Board has a broad range of experience and includes the following members: Kevin Pauza M.D., Hyun Bae M.D., Way Yin M.D., Ralph Rashbaum M.D., Wayne Olan M.D., Stephen Hochschuler M.D., Martin MacPhee Ph.D and Jeff Lotz Ph.D. More information about each of these Advisory Board members, along with general information about Spinal Restoration can be found at www.spinalrestoration.com
About Spinal Restoration
Spinal Restoration restores patients’ lives by delivering new therapies that address unmet needs in spine health management. These therapies are minimally invasive, early interventions with clinically proven results. The company is working with a diverse, highly regarded group of clinical and scientific advisors to develop the Biostat™ Disc Augmentation System, a proprietary resorbable biologic and delivery system for the treatment of chronic disc pain. For more information, visit www.spinalrestoration.com