SOURCE: Protein Polymer Technologies, Inc.

February 21, 2006 09:08 ET

Spine Wave Notifies Protein Polymer Technologies of FDA Approval to Conduct U.S. Clinical Trials

Patient Enrollment for NuCore™ Injectable Nucleus IDE Clinical Trial Begins

SAN DIEGO, CA -- (MARKET WIRE) -- February 21, 2006 -- Protein Polymer Technologies, Inc. (OTC BB: PPTI) today announced that it has been notified by Spine Wave, Inc., that approval for an Investigational Device Exemption has been received from the U.S. Food and Drug Administration (FDA). This allows Spine Wave to conduct a pilot human clinical trial to investigate the safety and effectiveness of the company's NuCore™ Injectable Nucleus.

NuCore™ Injectable Nucleus, based on PPTI's patented tissue adhesive technology, is an injectable protein polymer formulation for repair of spinal discs damaged as a result of injury or aging. Injected in a liquid form, the NuCore material rapidly cures to a gel that has physical properties which mimic those of the natural nucleus. The companies are engaged in a program to develop and commercialize PPTI's technology for certain spinal and orthopedic applications. PPTI manufactures the NuCore material for Spine Wave's clinical trials.

"The FDA's approval to conduct clinical trials of NuCore™ Injectable Nucleus in the U.S. is a true affirmation of our core technology," said William N. Plamondon III, Chief Executive Officer of PPTI. "There is an unmet medical need for improved treatment options of low back pain. We believe this new technology provides surgeons a minimally invasive option for treating patients who suffer from back pain caused by damaged or degenerated discs."

NuCore™ Injectable Nucleus offers the potential to intervene early in the disc degeneration process and provide relief from chronic low back pain. Avoiding spinal fusion as a last resort treatment for disc degeneration disease would be of tremendous benefit to patients, since fusion destroys the natural function and mobility of the spine.

Back pain is the leading cause for healthcare expenditures in the United States. According to the American Academy of Orthopaedic Surgeons, treatment for back pain costs an estimated $100 billion a year in medical costs, lost working days and workers compensation. More than 31 million Americans wrestle with bouts of low back pain at any given time. One third of all Americans over the age of 18 had a back problem in the past five years severe enough for them to seek medical treatment.

Spine Wave has enrolled patients in microdiscectomy studies of NuCore Injectable Nucleus in four countries: Switzerland, Australia, Germany and the United States, and expects to expand enrollment of this and other studies in the first half of 2006.

About Protein Polymer Technologies, Inc.

Protein Polymer Technologies, Inc. is a biotechnology company that discovers and develops innovative therapeutic devices to improve medical and surgical outcomes. The Company focuses on developing technology and products to be used for soft tissue augmentation, tissue adhesives and sealants, wound healing support and drug delivery devices. Protein Polymer Technologies' proprietary protein-based biomaterials are uniquely tailored to optimize clinical performance and contain no human or animal components that could potentially transmit or cause disease. The company is headquartered in San Diego, California. For additional information about the company, please visit www.ppti.com.

To date, PPTI has been issued twenty-six U.S. Patents on its core technology with corresponding issued and pending patents in key international markets.

About Spine Wave

Spine Wave is a medical device company 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™ Injectable Nucleus, the StaXx™ FX Fracture Repair System, the StaXx™ XD Expandable Device, and several products in development.

This press release contains forward-looking statements that are based on management's views and expectations. Actual results could differ materially from those expressed here; further, the Company is not obligated to comment specifically on those differences. Risks associated with the Company's activities include raising adequate capital to continue operations scientific and product development uncertainties, competitive products and approaches, continuing collaborative partnership interest and funding, regulatory testing and approvals, and manufacturing scale up. The reader is encouraged to refer to the Company's 2004 Annual Report Form 10-KSB, and 10KSB/A and other recent filings with the Securities and Exchange Commission, copies of which are available from the Company, to further ascertain the risks associated with the above statements.

Contact Information

  • Media Contact:
    Bryan deCastro
    (631) 495-9177

    Carole Boucard
    (954) 370-2524
    Creative Public Relations

    Investor Contact:
    Erin Davis
    (858) 558-6064 x 120
    Protein Polymer Technologies, Inc.