SAN DIEGO--(BUSINESS WIRE)--March 22, 2004--The ATS Liquidating Trust (ATISZ.PK -- please read the disclaimer in the last paragraph of this release regarding trading under this symbol) today announced that results of a pivotal preclinical trial demonstrate the safety of Anginera(TM), its human fibroblast-based, tissue-engineered epicardial patch. Furthermore, the efficacy data within this study support previous findings and published results from prior animal studies on the ability of Anginera to positively influence left ventricular function of compromised hearts.
The primary objective of the study was to evaluate the safety of Anginera when applied to the epicardial surface of the heart in a canine model of chronic ischemia -- a condition in which heart tissue becomes damaged from inadequate blood flow.
An evaluation of the primary safety endpoints (including hemodynamic, electrocardiographic, echocardiographic, and clinical and gross pathology observations) demonstrated the safety of Anginera at all dosing levels and at all time points. Furthermore, assessment of the echocardiographic data strongly suggests a dose-dependent improvement in left ventricular function resulting from the epicardial application of Anginera.
Anginera was originally developed by Advanced Tissue Sciences, Inc. (ATS) which filed a liquidating plan of reorganization that became effective on March 31, 2003. The ATS Liquidating Trust (Trust) now holds the remaining assets of the company, including Anginera.
The Trustee believes the results of this study in conjunction with the results of prior animal studies demonstrate the safety of Anginera and support the efficacy of the technology. ATS previously announced that Anginera improved overall function of damaged heart tissue in mice while no negative effects on the function of normal heart tissue were observed. Prior to that, the company published research showing Anginera’s ability to cause mature new blood vessels to form in infarcted cardiac tissues of mice. This work was published in the October 23, 2001 issue of Circulation, the peer-reviewed journal of the American Heart Association.
Qualified prospective buyers of the Trust’s cardiovascular technology may request a copy of the full report on the Anginera trial by contacting George Kidd at Eureka Capital Markets, LLC at 414-617-9300.
When ATS announced the start of the preclinical canine trial in July of 2002, the company also planned to start a separate trial to evaluate the efficacy of Anginera in large animals. The start of the separate efficacy trial was suspended when the company filed for bankruptcy protection to ensure that ATS had sufficient funds to pay its creditors. Whether an additional animal trial is needed will be determined by the FDA and any future owner of the intellectual property rights for this technology.
The Trust hopes to sell the Anginera intellectual property rights and to distribute the resulting cash to the former stockholders of ATS, who now hold a pro rata beneficial interest in the Trust. However, a decision by the United States Patent and Trademark Office to grant a request for ex parte reexamination of Patent 4,963,489 (the “489 Patent”), which is a key patent protecting the Anginera intellectual property, could affect both the timing and amount of projected cash distributions by the Trust from the sale of its Anginera cardiovascular technology. The reexamination could also delay any Anginera sales agreement or reduce the amount potential buyers might offer. If the reexamination were to find some or all of the 489 Patent claims invalid, it could preclude any sale of Anginera by the Trust.
This release contains forward-looking statements regarding the sale of assets of ATS by the Trust pursuant to the Chapter 11 Liquidating Plan of Reorganization (“Plan”) which was confirmed by the Bankruptcy Court by a final order dated March 21, 2003 and which became effective on March 31, 2003. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The risks and uncertainties are detailed in the Plan and Disclosure Statement filed with the Bankruptcy Court. The Trust undertakes no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
As a result of the Plan, the stock of ATS was cancelled and its former stockholders now hold non-trading interests in the ATS Liquidating Trust. According to the terms of the Plan, the Interests in the ATS Liquidating Trust are not to trade and the Liquidating Trustee will only recognize as beneficiaries of the Trust those equity holders of record as of the effective date of the Plan. Any trading that may be occurring after the effective date of the Plan under the symbol “atisz.pk” or otherwise is unauthorized by the Plan and will not be recognized by the Trustee. As a result of the terms of the Plan and the order of the bankruptcy court confirming the Plan, the Securities and Exchange Act of 1934 as amended and the rules promulgated thereunder no longer apply to the Company since it has no issued stock, no shareholders, and is no longer in business. However, to the extent applicable, the above cautionary statement is made by the Trust under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts
Abe Wischnia & Associates Abe Wischnia, 619-795-2345
