ABIOMED CEO Explains Information Policy for Initial Human Trial of AbioCor Replacement Heart.

Business Editors and Health/Medical Writers

DANVERS, Mass.--(BW HealthWire)--Aug. 6, 2001

In advance of its Annual Meeting in Boston on August 8, 2001, ABIOMED, Inc. (NASDAQ:ABMD) today released the text of a letter to the Company's stakeholders from Dr. David M. Lederman, Chief Executive Officer.

Dear shareholders, employees, clinical partners and their patients:

A very important and perhaps historical medical event took place on July 2, 2001. A patient, in consultation with his wife and family, agreed to be part of the first human trial of a revolutionary and potentially very important new medical device - the AbioCor(TM) Implantable Replacement Heart. Because our information policies for the clinical trial have been the subject of substantial discussion in the media, including strong support but also some criticism, I want to explain to you how we arrived at them and why we are committed to them.

As founder of ABIOMED, Inc. and initial member of the technical team that developed the AbioCor heart, I long ago made a commitment that our human clinical trials would give very high priority to the interests and quality of life of each patient. To accomplish that, we developed communications policies for our clinical trials that put the patients first. We have been extremely pleased by the initial patient's early experience, but we have been equally gratified that his confidentiality has been maintained and that he and his family have been able to live through this experience in dignity and relative peace.

The success of the AbioCor is not dependent on it being able to simply pump blood. Rather, success will depend on the replacement heart's ability to allow quality of life to continue even after the natural heart fails. In our view, quality of life involves not only the medical status of the patient and the technical performance of the replacement heart, but also the personal and spiritual dignity of the patient. That is why we invested a great deal of time and resources into deciding how to conduct the trials, and made those decisions with the same care that we devoted to the replacement heart's technical capabilities.

Personal quality of life means living a full life with mental capacities intact and free of pain or discomfort. It also means, among other things, that every action, clinical development, personal detail and change in medical status - typically the most private information for any person - is not broadcast in a play-by-play manner reminiscent of a sporting event. For us, spiritual quality of life includes being able to live in dignity and privacy without the public spotlight and on-lookers gawking at every move. We are all looking forward to the day when the patients and their families feel that they are ready and decide to share their experience with the public at large.

ABIOMED did not just make up this notion of quality of life. For the past twenty years we carefully studied the successes and failures of prior human clinical studies of breakthrough devices. We consulted ethicists, physicians, and government officials. Most of all, we spoke with patients facing end-of-life as a result of heart failure.

The result was a set of patient protection measures and ethical guidelines that I believe to be among the most thorough and effective ever implemented for a medical device trial. We set up an Independent Patient Advocacy Council with an irrevocable trust funded by ABIOMED for the duration of the initial clinical trial. Members of the Council, who are experienced in counseling end-of-life patients, are available to give patients and their families advice totally independent of the interests of ABIOMED, the hospital, or the clinical team. In cooperation with our clinical partners and consultants we developed detailed informed consent documents that are as open, complete and understandable as we know how to make them.

We prepared in advance to do all that was possible to insure that communications and media relations were patient-centered, not publicity-centered. Working with all of our participating clinical trial sites and their surgical and medical teams before the trial began, we established ground rules intended to guarantee the patient's complete anonymity and maximum privacy. We also thought it was important to insulate the clinical teams, as well as the many ABIOMED technical personnel providing onsite support to those teams, from the distractions and turmoil attendant to close daily scrutiny. To this end, we have resisted demands for daily or real time release of patient information. Based on our constructive interaction with responsible local, national and international journalists, I believe that our intentions have by and large earned us the respect and cooperation of the media.

Some objectors have argued that our policies are wrong because "the public has a right to know" about the patient and the progress of the clinical trial. It is certainly true that the public, the larger medical community, and the media all have an understandable interest in the replacement heart and the initial patients, and ultimately a right to know about the clinical trial and the technology being tested. But we absolutely reject the notion that any public purpose or right is served by releasing information minute by minute, day to day, or even week to week, in a manner that compromises the rights, the feelings, or the dignity of the patient and the patient's family. No one has anything to gain by having this information a day, a week, or even a month earlier. Public curiosity, and the appeal of what is admittedly a fascinating human interest story, does not constitute a right. It certainly cannot override the privacy right of the patient and his family. Our policies, consistent with the obligations we have to the FDA, other clinical sites, and the medical community, have in fact made plentiful information available in a clear, reasonably timely and responsible manner.

We have also heard that our unwillingness to allow unfettered access to every detail of the clinical trial on a real time basis will somehow compromise the integrity of the trial. This is nonsense. ABIOMED has worked very closely with the FDA, and our participating institutions and physicians to make sure that information is accurately recorded, reviewed, and appropriately shared. The research record and ultimately the public record is being maintained at the highest level of integrity. Premature release of partial clinical information is more a threat than a safeguard to research integrity. Our research methods, records, and findings will be subject to the highest level of scrutiny by regulatory agencies, institutional review boards, peer organizations, medical journals, and individual researchers. We began the process of sharing detailed information about the trial with the clinical community at the first AbioCor Grand Rounds held in Boston on Saturday, July 28, and will continue to regularly share information through such events, presentations at medical society meetings, and peer reviewed publications.

Some have argued that funding from the National Heart, Lung and Blood Institute (NHLBI) to ABIOMED for preclinical development of the AbioCor replacement heart creates an obligation to give freer public access to real time information about the clinical trial. ABIOMED has often acknowledged and reiterates the critical role of NHLBI funding in allowing us to come as far as we have. We are proud to be a party to what we think is a model for public-private partnership in advanced medical technology development in the United States. But again, our debt to federal funding does not create an obligation to provide patient information on demand to the public. As recipients of federal contracts, our obligations began and continue with our best effort to fulfill the terms of our contracts and to accurately report on our progress and results to the funding agency. The agency, in this case the NHLBI, is responsible for reporting the results of its contracting activity to the Congress and to the public, and it has done so through a variety of mechanisms. No one has any legitimate grounds for complaint on this score.

Some have opined that our information policy is designed to protect ABIOMED's financial interest, to control the dissemination and mitigate the effects of bad news. This argument betrays a profound lack of understanding about how ABIOMED approaches its fiduciary responsibility. As a public company, ABIOMED does have a responsibility to act in the best interests of our shareholders. In that regard, we work to become a profitable company and to increase our shareholder value. In my view, continued growth of shareholder value will be attained by successful patient-centered conduct and completion of the AbioCor trial, gaining FDA approval to market the replacement heart, and managing the company's existing business operations in an efficient and effective manner. Our goals are best achieved by avoiding hype, by setting reasonable expectations, and behaving in a scrupulously honest way. Anything that lessens the integrity of the clinical trial diminishes our ability to achieve our objectives. And in our calculus, the very worst thing we could do would be to appear to try to hide a negative event.

Some of the decisions that we have made for the AbioCor clinical trial are ethically complex and subject to debate and refinement. We have and continue to welcome discussions concerning elements of our informed consent, conflicting views about how to deal with the issue of advanced medical directives, and the like. Frankly, I am disappointed that some academic commentators have opted to air their criticisms in the media while declining invitations to engage in a direct dialogue with us. We have had a few vocal critics, particularly with regard to our news release policy, but the vast majority of physicians and medical ethicists have been strongly supportive. Most important for us, the patient and his family have been supportive and appreciative.

A patient should not have to sacrifice privacy and quality of life in order to be part of a process that potentially gives them, and hopefully to tens of thousands of others, extended quality of life. I am confident that by championing the patient's interest we also champion the public interest and lay the strongest foundation for our corporate success. This may be frustrating to some, but its good public policy, good business policy, and good personal policy.

As shareholders, we recognize that elements of this healthy public debate may be confusing. And, we understand that you need to be, and should be, kept informed of our progress in this important AbioCor initial clinical trial. We have spent considerable time and effort preparing for this clinical trial. We are using our experience to minimize trial delays and maximize probability of success. We look forward to communicating with you on a timely basis as we reach important milestones and other significant events in the clinical trial and urge you to evaluate opinions on our progress based on what is in the overall interest of the patients. By focussing on the patients in this trial, we help ourselves succeed.

Sincerely,

David M. Lederman, Ph.D.

Chairman and Chief Executive Officer

Based in Danvers, Massachusetts, ABIOMED, Inc. (pronounced "AB'-EE-O-MED") is a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. The Company's AbioCor Implantable Replacement Heart is to be implanted in patients enrolled as part of an initial clinical trial conducted under an Investigational Device Exemption from the United States Food and Drug Administration. The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial. ABIOMED currently manufactures and sells the BVS(R), a heart assist advice for the temporary support of all patients with failing but potentially recoverable hearts.