of the



Salons D&E, Grand Ballroom

Gaithersburg Hilton Hotel

620 Perry Parkway, Gaithersburg, Maryland

July 17, 2001


Panel Acting Chair:                                                                          Executive Secretary:

Susan Galandiuk, MD                                                                                                             David Krause, PhD



10:00 am                Closed Session


10:30 am                Call to Order


Conflict of Interest and Opening Remarks

David Krause, PhD, Executive Secretary


Panel Introductions

Susan Galandiuk, MD, Acting Chairman


Update Since the Last Meeting

Stephen P. Rhodes, MA, Branch Chief, Plastic and Reconstructive Surgery Devices Branch

11:00 am                Open Public Comment (up to 30 minutes)


11:30 am                Applicant Presentation, Ortec International, Orcel™ Composite Cultured Skin


Introduction/Product Indication

Costa Papastephanou, PhD, President,


Product Technology/Manufacturing

Mel Silberklang, PhD, VP Research and Development


Summary of Clinical Safety

Steven Peltier, VP Clinical and Regulatory Affairs


Clinical Discussion on Donor Sites

John Griswold, MD, Clinical Investigator


Protocol Overview

Steven Peltier


Clinical Results

Paul Glat, MD, Clinical Investigator


Statistical Results

Kazem Kazempour, PhD, Consultant

Summary and Conclusions

Steven Pelteir


12:30 pm                Lunch


 1:30 pm                FDA Presentation


Preclinical and Technical

Sam Arepalli, PhD, Lead Reviewer, Division of General and Restorative Devices



Roxolana Horbowyj, MD, Division of General and Restorative Devices


FDA Questions

Dr. Sam Arepalli


2:30 pm                 Panel Deliberations and Address FDA Questions


Panel Lead Reviewers


Clinical: Joseph V. Boykin, Jr., MD


Statistical: David L. DeMets, PhD


3:00 pm                 Additional Open Public Comments (up to 30 minutes)


3:30 pm                 FDA Summation


Sponsor Summation


4:00 pm                 Concluding Panel Deliberations and Vote


 5:00 pm                Adjournment