Since the Company's inception, United States government agencies, particularly the National Heart, Lung and Blood Institute (''NHLBI''), have provided significant support to the Company's product development efforts. The Company seeks funding from third parties to support its research and development programs and generally limits the use of its own funds until the scientific risk is reduced. In addition, the Company intends to pursue collaborative relationships to develop and commercialize the Company's non-cardiac assist technologies.
The Company's primary dental product (the "PerioTemp") is a device used for screening early periodontal disease through the measurement of small temperature differences around the pockets where teeth meet the gums.
The Company is in early stages of distribution of its cardiovascular product. Current emphasis has been on developing the U.S. market via a direct sales force. The BVS is marketed outside the U.S. through a third-party distribution network.
The Company's common stock is traded and listed on the Nasdaq National Market, under the symbol "ABMD". The Company conducts operations from facilities, located approximately 15 miles north of Boston on Route 128 in Danvers, Massachusetts.
The BVS 5000 Temporary Artificial Heart System Product Description
What is the BVS 5000?
The BVS 5000 is an external cardiac support system capable of completely supporting a patient's circulation. Sophisticated automation makes the BVS extremely simple to use and allows clinical staff to focus their efforts on caring for the patient, not the technology. The BVS delivers pulsatile flow to the vital organs, ensuring that these critical systems receive the perfusion necessary to maintain function during the support period. Since becoming the first cardiac support system to gain FDA approval in 1992, the BVS has rapidly established itself as the new standard of care for patients in ventricular failure. Open heart centers around the world consider it the treatment of choice for profound, postcardiotomy ventricular failure.
The BVS 5000... Designed to meet the specific needs of patients suffering profound ventricular failure. A life-saving alternative to current treatment therapies. More cost-effective than historical treatment options that are less effective. The only FDA-approved and reimbursable product for postcardiotomy support. Supported by a team of specialists dedicated to clinicians, their patients, and the BVS 5000.
How does the BVS 5000 compare to conventional therapies?
Traditionally, ventricular failure is treated with a combination of inotropic drugs and the intra-aortic balloon pump. While this therapy has saved lives, its effectiveness is limited to patients who require only partial support and it is not sufficient for patients in complete ventricular failure. Centrifugal pumps have also been used for cardiac support, despite their original design for short-term use in the operating room. The non-pulsatile flow they produce severely restricts the time patients can safely remain on support, and additional medical personnel are required to provide constant monitoring and ensure that the pump is operating correctly.
The BVS offers an alternative: life-saving support without the end-organ complications, expensive medical therapies, overuse of hospital resources, and extended hospital stays often caused by conventional approaches.
How does the BVS 5000 advance the standard of cardiac care?
(1) Unique dual-chamber blood pumps mimic the function of the natural heart, allowing continuous gravity drainage of the heart and safe ventricular decompression. (2) Pulsatile flow perfuses vital organs and tissues as nature intended. When organ function is sustained, the heart has ample time and opportunity to recover, without costly complications. (3) BVS system flow and rate automatically adjust as the patient's hemodynamic status changes, eliminating time-consuming management of the device and the associated time and expense of extensive staff training.
How can the BVS 5000 reduce costs while improving outcomes?
The treatment of patients requiring more aggressive cardiac assist with intra-aortic balloon pumps or centrifugal pumps is extremely costly. High costs are directly related to complications of end-organ dysfunction that result in expensive therapies, poor utilization of hospital resources and long lengths of stay. By employing a therapy specifically designed to treat profound ventricular failure, consumption of critical care resources can be reduced while outcomes are improved. The decision to purchase the BVS 5000 reallocates resources away from an ineffective method of treatment and toward definitive, state of the art care. The BVS 5000 provides patients with the best chance for survival and recovery, while helping hospitals attain the important goal of reducing or containing costs.
ABIOMED WINS $8.5+ MILLION FEDERAL CONTRACT TO QUALIFY ITS ARTIFICIAL HEART FOR HUMAN TRIALS
Danvers, MA., Sept. 16, 1996 -- ABIOMED, Inc. (pronounced "AB-EE-O-MED"), (NASDAQ - ABMD) announced today that it has won a $8.5+ million contract from the National Heart, Lung and Blood Institutes (NHLBI) to complete readiness testing of its battery-powered implantable total artificial heart, in preparation for human trials. The evaluation for technical merit was conducted by a peer review committee of experts selected by NHLBI and by NHLBI staff members. While the base technology has been under development since 1977, ABIOMED's present electric artificial heart configuration has been under development for the past nine years in collaboration with the Texas Heart Institute (THI) in Houston, Texas.
"We are obviously delighted with the NHLBI decision," said Dr. David M. Lederman, the Company's President and Chief Executive Officer. "This contract places ABIOMED firmly on the forefront of the race to develop an optimum solution to the shortage of donor hearts for the tens of thousands of patients facing end-stage cardiac failure every year. We are committed to bring our product to the clinic before the year 2000." "Moreover," he added, "our artificial hearts will save lives at an affordable cost to society. We anticipate that the cost of our synthetic hearts will be comparable to moderately-priced automobiles, lower than the current costs associated with heart transplants and, unlike transplants which are available to only a small fraction of potential recipients (about 2,300+ donor hearts in the US every year), they will be available to all who need it."
The ABIOMED heart, which can pump more than 10 liters per minute, has been designed to fit most of the US adult population and is expected to allow recipients to lead normal, productive, quality lives. The major component, which is the size of a medium-sized grapefruit, will be implanted in the cavity left by removal of the natural heart and there will be no physical connections across the skin to the outside world. Electrical power for the heart will be transmitted into the body without skin punctures. Physiological information will be accessible to attending physicians via wireless transmission when the patients visit the hospital for examination or over telephone lines from any other location. To the casual observer, the only noticeable feature will be an external battery carried by the artificial heart recipient (see purse in illustration).
The artificial heart consists of two blood pumps that are analogs of the natural heart's two pumping chambers (the left and right ventricles, respectively). These pumps and their valves are made from Angioflex�, (an ABIOMED biomaterial) and are powered by a sealed miniaturized hydraulic pump/motor system. The artificial heart's beat rate and output are controlled with state-of-the-art miniaturized electronics and the heart adjusts automatically to meet the varying demands of the body in the same manner as the natural heart. Like the natural heart, the ABIOMED artificial heart is quiet in operation and can be heard only using a stethoscope.
In contrast to implantable left ventricular assist devices, which provide support only to the left ventricle of the heart and require the diseased heart to remain in place, and which are currently either in early clinical trials or have been approved as temporary bridging devices to transplantation, the ABIOMED artificial heart is designed to completely replace the diseased heart, both physically and functionally.
The NHLBI contract provides funding support for up to four years and represents the final federally-funded phase for this important national program. Over the past three years, ABIOMED concentrated on completion of system design and developmental testing of a device intended for five year reliability.