MicroMed Technology, Inc. today announced it has received conditional approval from the Food and Drug Administration (FDA) to begin its pivotal multi-center clinical study of the MicroMed DeBakey Ventricular Assist Device (VAD). The clinical trial will take place at approximately 20 sites with an estimated 178 treated and control subjects.

"The team at MicroMed has worked hard these past five years to further develop the ancillary systems which support the technology originally conceived by NASA," commented Dallas Anderson, CEO and President of MicroMed. "Commencement of the multi-center trial in the U.S. is an important milestone in our corporate history and is validation of our goal to provide lifesaving treatment options to patients with congestive heart failure."

Smaller than any other LVAD on the market, the MicroMed DeBakey VAD(R) has been implanted in 85 patients to date and is significantly ahead of its competitors in the regulatory pathway. Measuring just 1" x 3" and weighing less than four ounces, the MicroMed DeBakey VAD is a miniaturized axial flow heart-assist pump 1/10 the size of currently marketed VADs. Due to its small size, the implantation surgery is less invasive than with larger LVADs, reducing operating time, tissue disruption and is expected to have a lower incidence of infection and perioperative bleeding.

The Phase III pivotal trial represents an extension of the feasibility trial, which began in June 2000 at the Methodist Hospital in Houston, Texas. The trial, which is expected to begin shortly as sites are sanctioned, will be used to collect and evaluate data about the VAD and its effectiveness as a bridge to heart transplant therapy.

"We are very appreciative of the FDA to approve the MicroMed DeBakey VAD for a multi-center pivotal clinical trial," said Dr. Michael E. DeBakey and Dr. George P. Noon, co-principal investigators. "Completion of this trial would lead to the availability of a new life saving technology at heart centers across the United States." Dr. DeBakey is Chancellor Emeritus of the Baylor College of Medicine and Director of the Methodist DeBakey Heart Center in Houston and also Chairman of the MicroMed Medical Advisory Board.

CHF afflicts 15 million people worldwide. Heart transplants are traditionally the only treatment hope for most late-stage CHF patients; however, due to a lack of donor hearts, only 2,500 transplants are performed each year. Patients waiting for a heart transplant are usually implanted with a VAD to keep them alive until a donor can be found. VADs are currently marketed as a bridge to heart transplant but MicroMed believes VADs have the potential to be used as an alternative to heart transplant in the near future.

The MicroMed DeBakey VAD is an axial flow heart assist device capable of pumping in excess of 10 liters of blood per minute. It provides rest to the heart muscle by taking over the pumping action for the diseased heart. Over time, with the support of the pump, a small percentage of patients could have the possibility of regaining all or a portion of the heart's native strength and function, referred to as a bridge-to-recovery. Bridge-to-recovery and alternative-to-transplant indications will increase the VAD market potential dramatically, from approximately $120 million to a projected market of $2-4 billion annually.