Larry Boy, << here's my 1st peak at atis >>
Attached is partial press release. Finding clients and clinics
seems to be the gamble. Can they generate clinical interest/income??? I've boxed out 2 areas that get my attention, negatively that is.
The Company will initially focus on a small number of centers, while working with the Health Care Financing Administration (HCFA) and other payors to address reimbursement. Under a Treatment IDE, companies are allowed to recover the costs of manufacturing and distributing the product.
Advanced Tissue Sciences is a tissue engineering company utilizing its proprietary core technology to develop and manufacture human tissue products for tissue repair and transplantation. The Company, through its joint venture with Smith & Nephew plc, currently has two products on the market, TransCyte(TM) (formerly Dermagraft-TC(R)), for full and partial-thickness burns, and Dermagraft for the treatment of diabetic foot ulcers (currently available in Canada and the United Kingdom). In addition to TransCyte and Dermagraft, the Company is also developing products for cartilage and cardiovascular applications.
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The matters discussed in this press release involve risks and uncertainties. In particular, the Company will need to successfully complete an additional controlled clinical trial of Dermagraft in the treatment of diabetic foot ulcers and submit a revised premarket
approval application to the FDA. No assurance can be given that the Company will successfully complete the additional clinical trial, the
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clinical trial will be completed within any specific timeframe, that the data from the trial will be statistically significant or otherwise consistent with the results of the Company's earlier pivotal trial or that the Company will obtain FDA or other regulatory approvals of Dermagraft (or that any such approvals will be obtained on a timely basis). In addition, there can be no assurance the
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Company will successfully enroll centers and patients, or obtain
adequate reimbursement, if any, under the Treatment IDE. These and
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other risks are detailed in the Company's publicly available filings with the Securities and Exchange Commission including the Company's Annual Report on Form 10-K for the year ended December 31, 1997. Actual results may differ materially from those currently anticipated as a result of such risks.
Larry |
