Spine Applications

Low back pain is the leading cause for healthcare expenditures in the United States, resulting in more than $50 billion in direct and indirect medical expense, and products used to treat it are the fastest growing major segment of the orthopedic industry, with a market of $2.1 billion in revenues and a growth rate of more than 25% annually, according to a February 2000 Viscogliosi Bros., LLC., Spine Industry Analysis Series report. The leading surgical treatments for spine include spinal fusions, discectomies, and laminectomies, but the market for disc replacement and repair is expected to grow more rapidly than other treatments as new products are approved over the next five years.

PPTI is a technology partner with Spine Wave, Inc. PPTI owns 2.4 million shares of Spine Wave, Inc. common stock. PPTI used its patented tissue adhesive technology to create Spine Wave’s NuCore™ intervertebral disc repair material. PPTI manufactured the NuCore™ material for Spine Wave’s clinical trials.

The spine supports about one-half of the body’s weight while maintaining highly flexibility and mobility. The spinal disc is like a jelly-filled tire between the bony vertebrae, a key component providing for flexibility and acting as a shock absorber. It has no blood supply and thus is not able to repair itself. Exposure to heavy loads or extreme twisting motions can cause tears in the outer portion of the disc, allowing the jelly-like material (the nucleus) to extrude. Additionally, with age the disc degenerates. The injury to or degeneration of the disc results in fundamental changes in its mechanical properties and also impacts surrounding tissues in a variety of ways, which can result in persistent pain.

Currently, there are no satisfactory treatments available for the treatment of chronic low back pain due to damaged or deteriorated discs. In extreme cases, a spinal fusion may be performed to limit the mobility of the joint. However, this procedure requires invasive surgery, restricts mobility, and leads to further degeneration of the spine.

A number of products are in development and/or approved in the U.S., ranging from complete replacement with an artificial disc to implantation of “pillows” within the disc space. Spine Wave and PPTI believe an injectable product that can be used in an outpatient procedure, avoiding surgery required for implants and thus minimizing additional damage to the disc and/or surrounding structures will be a preferred approach. Collaborative feasibility studies have demonstrated that the injectable disc nucleus product has physical properties mimicking those of the natural nucleus; is able to withstand the large, cyclical forces seen by the human spine; and resists expulsion under high loads due to its adherence to the disc wall.

Spine Wave’s NuCore™ Injectable Nucleus device, 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. Spine Wave has enrolled patients in Degenerative Disc Disease and microdiscectomy studies of the NuCore™ Injectable Nucleus device in four countries: Switzerland, Australia, Germany and the United States.

PPTI created this core technology and manufactured the product for Spine Wave, Inc.’s U.S. and European trials. Spine Wave has transitioned to CMC Biopharmaceuticals to manufacture the recombinant protein for NuCore™ Injectable Nucleus for commercial in-market supply, thus proving PPTI’s ability to transfer their core technology to commercial production.