SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities and Exchange Act of 1934
OCTOBER 14, 1996
Date of Report
(Date of earliest event reported)
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ADVANCED TISSUE SCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Delaware 0-016607 14-1701513
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(State or other jurisdiction of (Commission (I.R.S. Employer
incorporation or organization) File No.) Identification No.)
10933 North Torrey Pines Road, La Jolla, California 92037
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (619) 450-5730
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Item 5. Other Events
On October 14, 1996, Advanced Tissue Sciences, Inc. (the "Company") issued a
press release containing information on the results of its pivotal clinical
trial in the United States of Dermagraft (R) in the treatment of diabetic
foot ulcers. The Company also reported that it is preparing, and plans to
submit, a Premarket Approval (PMA) application for Dermagraft for the treat-
ment of diabetic foot ulcers in December 1996. The press release is attached
hereto as Exhibit 28.
Item 7. Exhibits
Exhibit
Number Description
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28 Press Release of the Company dated October 14, 1996
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
ADVANCED TISSUE SCIENCES, INC.
Date: October 23, 1996 By: /s/ Arthur J. Benvenuto
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Arthur J. Benvenuto
Chairman and Chief Executive
Officer
EXHIBIT 28
For Information Contact:
Marie C. Burke John H. Robinson
Director, Corporate Communications Chief Executive
Advanced Tissue Sciences, Inc. Smith & Nephew plc
619/450-5802 011-44-171-836-7922
FOR IMMEDIATE RELEASE
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DERMAGRAFT (R) SHOWS STATISTICAL SIGNIFICANCE IN THE TREATMENT OF DIABETIC
FOOT ULCERS; PMA TO BE SUBMITTED IN DECEMBER
La Jolla, Calif., October 14, 1996 - Advanced Tissue Sciences, Inc. (Nasdaq:
ATIS) and Smith & Nephew plc announced that statistical significance
(p value = 0.01) was reached for the primary endpoint of their pivotal trial
of Dermagraft in the treatment of diabetic foot ulcers. After discussions
with the Food and Drug Administration (FDA), Advanced Tissue Sciences
reported that it is preparing, and plans to submit, a Premarket Approval
(PMA) application for Dermagraft for the treatment of diabetic foot ulcers
in December of this year. Advanced Tissue Sciences and Smith & Nephew
entered into an agreement to form a joint venture for the worldwide commer-
cialization of Dermagraft for the treatment of diabetic foot ulcers in April
of this year. The estimated U.S. market opportunity for this indication
potentially exceeds $1 billion.
In the pivotal clinical trial, Dermagraft was applied weekly for up to eight
weeks and, in all other respects, Dermagraft-treated patients received the
same treatment as the control patients. The primary endpoint in the study was
complete wound closure at the end of twelve weeks. Following a pre-PMA
meeting with the FDA, Advanced Tissue Sciences indicated the PMA submission
would include Dermagraft product used in the pivotal trial meeting
specifications consistent with the product the Company intends to
commercialize. There were 281 patients enrolled in the pivotal trial
resulting in 240 evaluable patients, the majority of which were included in
determining statistical significance of the primary endpoint (p value = 0.01).
With respect to complete healing, a difference of approximately 20% was found
between the Dermagraft patients treated with this product and the control
group. In addition, these patients achieved complete healing significantly
faster with Dermagraft than with the control treatment (p value = 0.01). Data
from the trial is expected to be presented at the Advanced Wound Care
Symposium in New Orleans in April 1997.
Arthur J. Benvenuto, Chairman and Chief Executive Officer stated, "The success
of the Dermagraft trial represents a significant achievement and confirms our
belief that bioengineered human tissue can provide solutions to important
medical problems. Our efforts with Smith & Nephew are now focused on the
submission of a well-prepared PMA application to support the FDA in their
expedited review of Dermagraft, and in putting our sales and marketing plans
into place. The combined capabilities of Smith & Nephew and Advanced Tissue
Sciences represent a powerful partnership in tissue engineering."
"As a leading company in wound healing, we are delighted that these results
for Dermagraft will reinforce our position at the forefront of technology,"
commented John H. Robinson, Chief Executive of Smith & Nephew. "With Smith &
Nephew's international strength in this area, we are already preparing for a
potential launch in the second half of 1997 in the U.S. and the U.K., with the
roll-out continuing during 1998 as quickly as regulatory permission is
received."
Advanced Tissue Sciences is a tissue engineering company utilizing its
proprietary core technology to develop and manufacture human tissue
replacement products for tissue repair and transplantation. Advanced Tissue
Sciences currently has two products in pivotal clinical trials for skin tissue
applications and is developing products for cartilage and cardiovascular
applications.
-more-
<PAGE>
Smith & Nephew is a leading worldwide healthcare company with a highly
successful track record in developing, manufacturing and marketing a wide
variety of innovative and technologically advanced tissue repair products,
primarily in the areas of bone, joints, skin and other soft tissue. They have
extensive marketing and distribution capabilities, with an established sales
force in more than 90 countries.
THE DISCUSSION CONTAINED IN THIS PRESS RELEASE REGARDING REGULATORY FILINGS,
APPROVAL OF PRODUCTS AND THE COMMERCIALIZATION OF PRODUCTS INVOLVES RISKS AND
UNCERTAINTIES. NO ASSURANCE CAN BE GIVEN THAT ANY PMA APPLICATION SUBMITTED
BY THE COMPANY WILL BE ACCEPTED FOR FILING, THAT THE COMPANY WILL SUCCESSFULLY
GAIN FDA APPROVAL, THAT THE COMPANY WILL BE ABLE TO MANUFACTURE COMMERCIAL
QUANTITIES OF DERMAGRAFT AT A REASONABLE COST OR THAT IT WILL MARKET ANY SUCH
PRODUCTS. THESE AND OTHER RISKS ARE DETAILED IN PUBLICLY AVAILABLE FILINGS
WITH THE SECURITIES AND EXCHANGE COMMISSION SUCH AS ADVANCED TISSUE SCIENCES'
FORM 10-K AND IN A REGISTRATION STATEMENT ON FORM S-3 (FILE NO. 333-01185).
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