ATLANTA, Nov. 7 /PRNewswire/ -- Under the leadership and advisement of Dr. Randal Betz and industry veteran Lew Bennett, SpineMedica Corporation has assembled 12 of the nation’s top orthopedic-spine and neurological surgeons to sit on their Physician Advisory Board (PAB). These surgeons are committed to helping the company develop an artificial disc implant for use in total disc replacement procedures in the lumbar spine.
On October 2, 2005, in Orlando, Florida, the company convened the first meeting of the PAB to review and discuss SaluDisc(TM), the Company’s proprietary artificial disc replacement device.In addition to physicians in attendance, Lew Bennett, who co-founded Howmedica and helped build Sofamor Danek, also facilitated the PAB meeting,” rather than “founder of Howmedica and Sofamor Danek” as originally issued inadvertently.
Made from a hydrogel, SaluDisc is a novel disc replacement product currently in development and preclinical testing for treatment of lumbar degenerative disease -- one of the largest disease aliments of our aging society. PAB members discussed SaluDisc’s biomemetic properties -- such as its flexion and extension durability and its ability to adjust to weight distribution -- and offered SpineMedica engineers various design options. From the meeting it was clear that SaluDisc’s prototype design was acceptable and that the device would require only minor adjustments before final testing.
The company already has extensive bench and preclinical data with their lumbar disc prototype. In addition, clinical experience with the Salubria extends back four years and over 1000 cases in the knee and is approved for use in the US as a nerve sheath or cuff.
Dr. Randal Betz is well-recognized by his peers as a skilled leader of product development think-tanks, has served in leadership positions in several professional spine societies, and is considered an innovator in spine surgery. Of SaluDisc, Dr. Betz states, “The major benefits of SaluDisc over other total discs is that it is a very strong material, is customizable to individual patients’ size and bone density, has less associated risk and in the event that revision is necessary, is potentially much easier to revise.”
This first PAB meeting marks a major milestone for SpineMedica, since the Company aims to have SaluDisc in clinical trials in patients with lumbar degenerative disease in the near future, following final preclinical testing. From the information obtained at the meeting, SpineMedica’s team of engineers is currently refining the existing SaluDisc and plans to perform these additional bench and preclinical studies, as recommended by the PAB, in the last quarter of 2005.
In August, 2005, SpineMedica completed a license agreement with SaluMedica, LLC for the world-wide, exclusive rights to use a revolutionary new biomaterial called Salubria(R) in spinal applications. The company and the PAB believes Salubria is ideally suited for use as an artificial disc, to be indicated for patients who would otherwise receive a spinal fusion. The product is not yet approved by the US FDA.
About SpineMedica Corp:
SpineMedica, a Florida corporation, is a development stage company that is focused on commercializing medical device technologies for application in the spine and chronic back pain. SpineMedica’s goal is to acquire promising technologies in this field through licensing arrangements and develop and commercialize such technologies based on its expertise.
This release contains forward-looking statements with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed.
Actual results could differ materially from those currently anticipated due to a number of factors, including risks relating to the need for additional capital and the uncertainty of additional funding; the early-stage products under development; uncertainties relating to clinical trials; success in the clinical development of any products; dependence on third parties; future capital needs; and risks relating to the commercialization, if any, of the Company’s proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).
Salubria(R) is a registered trademark of SaluMedica, LLC.
SaluDisc(TM) is a proprietary trademark of SpineMedica Corp.
SpineMedica Corporation
CONTACT: Maria Steele, SpineMedica Corporation, +1-850-269-0000
Web site: http://www.spinemedica.com/