Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

In Brief: Advanced Tissue Sciences

This article was originally published in The Gray Sheet

Executive Summary

Advanced Tissue Sciences: Premarket approval application submission for the firm's Dermagraft-TC engineered human dermal tissue planned for "the first half of 1996," the company announces Dec. 19. The La Jolla, California company says its 65-patient pivotal clinical trial comparing Dermagraft to cadaver skin for the treatment of severe burns has yielded "statistically significant results" with respect to the trial's primary endpoint -- "the ability of the coverings to adequately prepare the wound beds for successful autograft take." In June, FDA notified ATS that its PMA would receive expedited review ("The Gray Sheet" June 12, In Brief)...
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT005237

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel