BioCardia
Overview
Products
Pipeline
Publications & Talks
Patents
Press & News
Scientific Advisors

Press Releases

Thoratec Corporation Announces Equity Investment in Emerging Heart Failure Technology - BioCardia Is Developing Tools for Delivery of Biotherapeutic Compounds to the Heart

Pleasanton, CA., March 30th 2004 - PRNewswire-FirstCall Thoratec

Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, said today that it has made an equity investment in BioCardia, Inc., which is developing tools to enable the local delivery of biotherapeutics to the heart.

BioCardia, which is privately held and based in South San Francisco, CA, has developed the Helical Infusion Catheter System, which offers a unique, corkscrew-shaped needle delivery platform. The system, which has a Device Master File residing with the FDA, has performed well in preclinical studies and initial results from early human safety studies have been positive. BioCardia is initiating three biotherapeutic clinical studies of two cell therapies and a gene therapy for different significant unmet cardiovascular indications.

Under terms of the investment documents, Thoratec will partner with BioCardia to explore opportunities for developing devices for the surgical delivery of biotherapeutics, have limited exclusive rights to negotiate the distribution, licensing or purchase of surgical delivery technology developed by BioCardia and through an observational board seat be able to review relevant clinical data accumulated by BioCardia through their multiple trials. Financial terms of the investment are not being disclosed.

"This is an excellent opportunity for Thoratec to greatly expand its knowledge base of a wide range of cell-based therapies for heart failure, including those that may represent a future potential adjunctive therapy to heart assist devices. We believe that our joint efforts in this area may complement Thoratec's ongoing efforts in the development of assist devices as a Destination Therapy or Bridge to Recovery," said D. Keith Grossman, president and chief executive officer of Thoratec.

"BioCardia has developed what appears to be leading-edge technology in this emerging area and has built an extensive patent portfolio," he continued.

The Helical Infusion Catheter technology is based on original pacemaker lead fixation technology and enables the needle to be affixed in the heart muscle, providing a consistent dosage while preventing cell migration, leakage and back flow.

"We are delighted to be partnering with Thoratec as we enter this new frontier in the treatment of heart failure," said Peter Altman, PhD, CEO and Chairman of BioCardia. "They have established a clear leadership position in the assist device area, not only with approved products, but also those under development, and we look forward to combining our technology resources to develop new surgical solutions for those patients suffering from heart failure," he continued.

Thoratec is a world leader in products to treat cardiovascular disease with its Thoratec(R) VAD (Ventricular Assist Device) and HeartMate(R) LVAS (Left Ventricular Assist System) implanted in more than 6,600 patients suffering from heart failure. The HeartMate is the first and, to date, only device approved by FDA for Destination Therapy, the treatment of heart failure patients who are not eligible for a heart transplantation.

In addition, the company is developing the HeartMate II, the company's next generation device designed to provide long-term support for patients who are in end-stage heart failure. Thoratec has recently initiated clinical studies for the device in the U.S. and Europe. The company's HeartMate III is currently in preclinical studies.

Thoratec's product line also includes the Vectra(R) vascular access graft for patients undergoing hemodialysis. Additionally, its International Technidyne Corporation (ITC) division supplies blood testing and skin incision products. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's web sites at http://www.thoratec.com or http://www.itcmed.com.

BioCardia is a world leader in the emerging field of biointerventional cardiology, developing locally delivered biotechnology product solutions for patients suffering from heart failure, ischemia, and infarction. BioCardia's established catheter delivery technologies enable the potential of therapeutic protein, gene, and cell based therapies currently in development. BioCardia markets the BioCardia (R) Universal Deflectable Tip Guide Catheter product family and is engaged in clinical trials of biotherapeutic agents both independently and with partner organizations. BioCardia is headquartered in South San Francisco, California. For more information, visit the company's website at http://www.biocardia.com.

The portions of this news release that relate to future plans, events or performance are forward-looking statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to the results of clinical trials, regulatory approval processes, healthcare reimbursement and coverage policies and acquisition activities. These factors, and others, are discussed more fully under the heading, "Risk Factors," in Thoratec's 10-K for the fiscal year ended January 3, 2004, and other filings with the Securities and Exchange Commission. Actual results, events or performance may differ materially. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.


For more information, contact: Investor Relations, BioCardia, Inc. 650-624-0900, .