Ortec International Inc announced that the clinical data from its recently concluded pivotal (final stage) clinical trial evaluating the use of its Composite Cultured Skin (CCS) for facilitating wound closure of split thickness skin donor site wounds in burn patients achieved statistical significance for its primary endpoint, time to 100 percent wound closure.

Statistical significance was achieved, as well, for secondary endpoints, including time to "readiness for recropping" (the ability to reharvest the donor site). CCS treated sites also demonstrated significantly better cosmetic outcome at 3 months and 6 months subsequent to application (based on both the Vancouver and Hamilton scar score) than the control treated sites. No significant differences between CCS treated sites and the control with respect to infection, blistering, break down of the treatment site, or itching was noted.

The data generated from this trial will serve to support Ortec's Pre-Market Approval Application (PMA), which if approved, will allow Ortec to commercially market CCS for the donor site wound indication, estimated to be a market in excess of $100 million. Ortec expects to file the PMA with the Food And Drug Administration (FDA) by mid-January.

The prospective controlled randomised multi-center pivotal clinical trial comparing Ortec's CCS with the control dressing, a standard of care treatment for donor site wounds, showed that use of CCS on donor site wounds accelerated wound closure and the time to readiness to recrop by an average (median) of six days (p=<0.002), an acceleration of approximately 30 percent over standard of care.

The trial was conducted at 12 clinical sites involving 82 patients, followed for 24 weeks post application, with each patient serving as his own control. Each patient received both CCS and the control dressing in a matched pairs design, wherein each patient had two designated donor sites. All patients included in the trial sustained burns with a total body surface area (TBSA) of at least 10 percent and up to 80 percent.

Commenting on the pending filing of the donor site PMA, Steven Katz Ortec's president and CEO said, "Achievement of this milestone is truly a significant one for Ortec. The filing of our company's first PMA is another step along the continuum of what we believe will be a number of meaningful PMA filings and impact milestones over the course of the next two years."