Protein Polymer and Spinal Wave Expand R&D Relationship for Developing
Unique Spinal Disk Repair Product
SAN DIEGO, April 3 -- Protein Polymer Technologies,
Inc. (OTC Bulletin Board: PPTI) and Spinal Wave, Inc. today announced the
expansion of the contractual research and development relationship between
the two companies. Spinal Wave is a private company formed last year by PPTI
and Windamere Venture Partners to develop and commercialize an injectable
protein-based formulation for the repair of Spinal discs damaged either
by injury or aging. Based on PPTI's proprietary tissue adhesive technology,
the initial product under development has the potential to be utilized in
a number of Spinal procedures including discectomy and the treatment of
chronic low back pain.
Under the amended Supply and Services Agreement, PPTI
on behalf of Spinal Wave is proceeding with preclinical safety and performance
studies of the device to support Spinal Wave's filing of an Investigational
Device Exemption with the FDA to obtain approval to initiate human clinical
testing. PPTI estimates it will receive from Spinal Wave approximately $1.5
million in R&D payments over the next year, exclusive of the preclinical
study costs. During the subsequent period leading to regulatory marketing
approvals, PPTI's contractual responsibilities include the supply of product
to be used in clinical testing and preparation for commercial manufacturing
operations. Spinal Wave is responsible for clinical testing, regulatory approvals,
and commercialization.
Back pain is the leading cause for healthcare expenditures
in the United States. According to a 2000 Viscogliosi Bros., LLC, Spinal
Industry report, back pain results in more than $50 billion in direct and
indirect medical expense. Despite the invasive surgery associated with many
Spinal procedures, such as Spinal fusion, the worldwide Spinal market represents
more than $2 billion in revenues, growing at a rate of over 25% annually.
It is the fastest growing major segment of the orthopedic industry.
In many instances, Spinal fusion is a procedure of last
resort, since it destroys the natural function and mobility of the Spinal
by replacing the shock absorbing intervertebral disc with metal and/or bone.
Currently, there are no approved products to replace or restore the function
of the invertebral disc that has degenerated, nor to intervene in the degenerative
process. Using PPTI's patented technology, Spinal Wave and PPTI are developing
a product (the Injectable Disc Nucleus) designed to restore natural disc
function by replacing or augmenting the natural disc nucleus that has degenerated
or that has been surgically removed in a discectomy procedure. The product
has the potential to be used independently in minimally invasive outpatient
procedures as well as in combination with traditional open procedures.
Protein polymers are synthetic proteins created "from
scratch" through chemical DNA (gene) synthesis and produced in quantity
by bacteria through large-scale fermentation. As a result, protein polymers
are capable of uniquely combining specified biological, chemical, and physical
properties of natural proteins which make up the body's own tissues, while
containing no human or animal components that could potentially transmit
or cause disease. They can also be processed into a wide variety of different
materials (such as films, fibers, adhesives, and gels), while retaining
these properties. PPTI pioneered the development of this technology and
now holds 21 U.S. patents on the design, composition of matter, and production
of protein polymers, with corresponding international applications in major
markets.
Protein Polymer Technologies, Inc. (PPTI), is a San DiegoÐbased
company focused on developing products to improve medical and surgical outcomes.
From its inception in 1988, PPTI has been a pioneer in protein polymer design
and synthesis, developing an extensive portfolio of proprietary biomaterials.
In addition to the Spinal disc repair product being developed with Spinal
Wave, PPTI is conducting pilot clinical studies of both a urethral bulking
agent for the treatment of stress urinary incontinence and a dermal contouring
agent for cosmetic surgery and dermatology. Other targeted products include
tissue adhesives and sealants for general surgical use, scaffolds for wound
healing and tissue engineering, and depots for local drug delivery.
