MARROW-TECH RECEIVES APPROVAL TO FURTHER EXPAND DERMAGRAFT(TM) CLINICAL TRIALS
MARROW-TECH RECEIVES APPROVAL TO FURTHER EXPAND
DERMAGRAFT(TM) CLINICAL TRIALS
LA JOLLA, Calif., Nov. 6 /PRNewswire/ -- Marrow-Tech Inc. (NASDAQ-NMS: MAROA) today announced it has received approval from the Food and Drug Administration (FDA) to expand clinical trials of Dermagraft(TM) -- the company's living dermal replacement product -- from 12 to 24 burn centers.
Marrow-Tech began clinical trials of Dermagraft for the treatment of burn patients at the University of California, San Diego Medical Center in January 1991 under an Investigational Device Exemption (IDE). To date, more than 30 patients have been treated with Dermagraft at 10 burn centers across the country. Preliminary clinical results were presented on Oct. 19 at the International Symposium on Wound Healing and Wound Management in Chicago. The patients will be followed clinically to determine long-term graft outcomes and additional patients continue to be enrolled in the study.
Concurrently, three leading wound care centers are participating in clinical trials of Dermagraft for the treatment of chronic venous skin ulcers under a supplemental IDE. The company also plans to file for supplemental approval to treat patients with decubitus ulcers (pressure sores) by the end of this fiscal year.
Marrow-Tech is engaged in the growth of the human tissue outside the body. The company is developing its proprietary three- dimensional cell culture system for potential therapeutic and laboratory applications.
/CONTACT: Alana B. Wheeler of Marrow-Tech, 619-450-5714/
(MAROA) CO: Marrow-Tech Inc. ST: California IN: MTC SU: KJ-AL -- SD008 -- 1793 11/06/91 14:09 EST