Corporate ProfileAdvanced Tissue Sciences, Inc.
Officers:
Primary Business: Biopharmaceuticals(NASDAQ Symbol: ATIS) Advanced Tissue Sciences, Inc. is a leading tissue engineering company engaged in the development of living human tissue products for therapeutic applications. The Company is primarily focusing its efforts on skin, cartilage and cardiovascular products. Utilizing principles of cell biology, biochemistry and polymer science, the Company has developed and is applying its patented core technology which permits living human cells to be cultured ex vivo in a manner that allows the cells to develop and assemble into a functioning three-dimensional tissue. The Company has successfully replicated a variety of human tissues and has a number of products under various stages of development. Advanced Tissue Sciences' objective is to redefine tissue repair and transplantation by developing, manufacturing and marketing products produced through tissue engineering. The Company's product strategy is to utilize its patented core technology to develop multiple products which address unmet therapeutic needs or offer improved, cost-effective alternatives to current treatment modalities. By building on its base of scientific knowledge through the continued application of its core technology, the Company believes it will achieve significant synergies in the development, clinical testing and manufacture of successive tissue products. In addition, the Company is focusing its development programs on products which are currently being or are expected to be regulated as medical devices. Medical devices are generally subject to a shorter regulatory approval process than biologics or pharmaceuticals. The Company is developing marketing and reimbursement strategies, establishing a direct sales organization and pursuing strategic alliances, to market future commercial products. Leading the Company's product development efforts are therapeutic skin products that address the bum and diabetic foot ulcer markets. These products, based on Dermagraft®, a three-dimensional living human tissue designed by the Company as a temporary or permanent replacement for human dermis, were developed to treat conditions where the dermis (the inner skin layer) has been injured or destroyed, such as in severe bums and chronic skin ulcers. The dermis is essential to normal skin function and healing and, unlike the epidermis (the outer skin layer), does not regenerate into normal tissue after injury. The Company has two lead products currently in pivotal clinical trials, a temporary covering for severe bums ("Dermagraft-TC™") and a dermal replacement product ("Dermagraft-Ulcers") for treating diabetic foot ulcers. The Company expects to submit a premarket approval ("PMA") application to the Food and Drug Administration ("FDA") for Dermagraft-TC in the first half of 1996 and for Dermagraft-Ulcers to treat diabetic foot ulcers in late 1996. The FDA has notified the Company that the PMA applications for both products will receive expedited review.
Advanced Tissue Sciences Inc.Number of employees: 150Advanced Tissue Sciences (ATIS), a leading tissue engineering company, has developed a proprietary core technology to manufacture human tissues and organs for transplantation. Current products in development focus on skin, cartilage and cardiovascular tissues. Additional products in development include bone, tendon and vascular grafts. The Company's lead product for the treatment of diabetic foot ulcers is currently in pivotal clinical trials both in the United States and in France, and a PMA is expected to be submitted in 1996. Dermagraft-TC, for the treatment of severely burned patients, is also in pivotal clinical trials in the U.S. The FDA has notified ATIS that they intend to review its Dermagraft-TC PMA in an expedited manner. ATIS expects to submit a PMA for Dermagraft-TC during the first half of 1996. The Company has a worldwide 50/50 joint venture with Smith & Nephew of the UK for the joint development and marketing of engineered human cartilage for ortho pedic applications. Smith & Nephew with annual sales revenue in excess of $1.5 bil lion, owns the world's leading arthroscopy company (Smith & Nephew Endoscopy) and the fourth largest orthopedic company (Richards). ATIS is also conducting extensive research in the cardiovascular area in order to develop tissue engineered heart valves, blood vessels and stents. The Company has received a $5 million equity investment and research funding from St. Jude Medical, the world leader in the manufacturing and marketing of mechanical heart valves.
|