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CeraPedics L.L.C. to Present at Windhover Information and Medtech Insight's ''In SPINE'' Conference.


DALLAS -- CeraPedics L.L.C. will be presenting at 9:55 a.m. at Windhover Information and Medtech Insight's Inaugural "IN SPINE" Event, taking place November 11, 2004 at the Westin Stonebriar Resort in North Dallas.

CeraPedics L.L.C. is a privately-held orthopedic company focused on the development of osteobiologic products incorporating P-15(TM). Based on its P-15 technology platform, CeraPedics is currently developing bone substitutes and a coating for orthopedic implants.

P-15 is a synthetic small peptide attachment factor that mimics the cell-binding domain of Type-I collagen, the organic component of autograft autograft: see transplantation, medical.  bone. In the body, this cell-binding domain is intimately involved in the binding and migration of cells and initiates the cascade of events leading to new bone formation. CeraPedics' products incorporate P-15 that is identical to the naturally occurring cell-binding domain of Type-I collagen. The company possesses the exclusive world-wide orthopedic rights to its P-15 technology through the University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). .

CeraPedics' first product, CerOss P-15, is the first and only bone substitute using small peptide technology to mimic the organic component of autograft bone. The product is comprised of anorganic bone mineral (ABM ABM: see guided missile.

ABM - Asynchronous Balanced Mode
) to which the P-15 is bound. To improve the handling of the material, the combination of ABM/P-15 is suspended in an inert hydrogel hy·dro·gel
n.
A colloidal gel in which the particles are dispersed in water.



hydrogel

a gel that contains water.

hydrogel Wound care A polymer absorptive wound dressing. See Dressing.
. CerOss P-15 is currently under consideration by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
.

Peer-reviewed clinical studies in the oral cavity oral cavity
n.
The part of the mouth behind the teeth and gums that is bounded above by the hard and soft palates and below by the tongue and the mucous membrane connecting it with the inner part of the mandible.
 found the active ingredient of CerOss P-15, the ABM/P-15 particles, demonstrated superior efficacy to demineralized bone matrix (DBM (DeciBels below 1 Milliwatt) A measurement of power loss in decibels using 1 milliwatt as the reference point. A signal received at 1 milliwatt yields 0 dBm. A signal at .1 milliwatt is a loss of 10 dBm. See deciBel and dBA. ) and synthetic bone substitutes. In addition, a large animal spine study and human pilot study for non-union fracture repair Fracture Repair Definition

Fracture repair is the process of rejoining and realigning the ends of broken bones. This procedure is usually performed by an orthopedist, general surgeon, or family doctor.
 suggest the P-15 bone substitute has efficacy at least equivalent to autograft bone. Based on these studies, CeraPedics believes that CerOss P-15 should be superior to allografts allografts (al´graf´ts),
n.pl the transplantation of tissue between genetically nonidentical individuals of the same species.
 and synthetics, and be at least equivalent to autograft in orthopedic applications.

In addition to the bone substitute development program, CeraPedics is evaluating the coating of metallic orthopedic implants with P-15. In-vitro results demonstrate that P-15 immobilized on a titanium (Ti) surface creates a more hospitable surface for bone to implant integration. Additional in-vivo studies are planned to confirm the in-vitro results.

In 2003, an independent source valued the U.S. market for bone substitutes at nearly $500 million, representing year-over-year growth of 50%. CerOss P-15 will target spine and trauma procedures which make up over 80% of the bone substitutes market.

In addition, the P-15 coating could be used on a variety of orthopedic implants including artificial discs, interbody cages, pedicle pedicle /ped·i·cle/ (ped´i-k'l) a footlike, stemlike, or narrow basal part or structure.

ped·i·cle
n.
1. A constricted portion or stalk.

2.
 screws and other implants.

To learn more about CeraPedics and its P-15 technology, please visit the company's website www.cerapedics.com.

About Medtech Insight

Medtech Insight's medical technology investment conferences are considered the premier forum for senior executives in the investment and medical technology community to preview emerging medtech companies in need of funding, acquisition and/or strategic partnership. Medtech Insight, which was recently acquired by Windhover Information Inc. (www.windhover.com), publisher of IN VIVO in vivo /in vi·vo/ (ve´vo) [L.] within the living body.

in vi·vo
adj.
Within a living organism.



in vivo adv.
: The Business & Medicine Report, and Start-UP: Windhover's Review of Emerging Technologies, offers a wide variety of products and services for the medical technology executive. In addition to conferences, the company publishes the "medtech insight" newsletter, a monthly publication covering the latest trends and innovations in the medical technology industry, as well as analyses of medtech markets through its Reports group, and offers custom consulting and market research. To register for the "IN SPINE" conference or for more information on Medtech Insight, please call Scott Pantel at 949-219-0150 or 888-290-2225 toll-free in the U.S., e-mail sales@medtechinsight.com, or visit http://www.medtechinsight.com/inspine-01.html.
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Publication:Business Wire
Date:Nov 1, 2004
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