Tucson-based biomedical company SynCardia Systems Inc. soon may be in a major business expansion its owners say would put it in a category with two other local biomed giants - Ventana Medical Systems and Sanofi-aventis — in the fight against the nation’s top two killers, heart disease and cancer.
Privately-held SynCardia, developer of the only FDA-approved bridge-to-transplant artificial heart, has purchased Houston-based publicly-held MicroMed Cardiovascular, which has a promising FDA-approved pediatric ventricular assist device (VAD) and another for adults in clinical trials.
|
|
SynCardia acquired MicroMed after Rodger Ford, president and CEO of SynCardia, and David Mackstaller, vice president of development of SynCardia, created a new company, E-Wilson LLC, as a special purpose entity to own MicroMed Shares.
As of Aug. 28, E-Wilson had acquired 97.5 percent of outstanding MicroMed shares and took the company private. In exchange, E-Wilson agreed to invest up to $10 million in MicroMed over the next two years.
The acquisition puts SynCardia and MicroMed under the same ownership. Ford says it gives the owners what they consider to be the best tools to provide a full spectrum of solutions to patients suffering from heart disease.
Visualizing a continuum of solutions for heart disease patients as a funnel, Mackstaller said the VAD would be a solution at the wide side of the funnel, providing a device that would augment blood flow through the heart for the many patients suffering from congestive heart failure. The SynCardia bridge-to-transplant CardioWest temporary total artificial heart device (TAH-t) would be at the narrow end of the funnel, providing a life-saving "bridge to transplant" for patients with such severe heart failure that the only answer is a heart transplant.
Eventually, Ford said, the owners may make the business a publicly-traded entity. At this point, however, it has not been determined whether SynCardia and MicroMed will be combined into one company with a new name, and work remains before the owners can take full advantage of the technologies the two companies offer in heart disease solutions.
While already approved for use in Europe, the MicroMed adult VAD, known as the HeartAssist 5, remains in clinical trials in the United States with no indication of when FDA approval might come. But the device, which uses a NASA-developed rotary blood pump that increases the cardiac output of a patient with a failing left ventricle (heart failure), appears to offer some major advantages over a competing device that already has U.S. FDA approval—Thoratec’s HeartMate II.
While most available VADs are large, heavy and must be planted in the abdominal area, increasing chances of bleeding and infection, only the MicroMed HeartAssist 5 and the Thoratec HeartMate II are small enough to be planted above the diaphragm in the pericardial space.
But the HeartAssist 5 is lighter — weighing just 92 grams versus HeartMate II’s 145 grams — and only the HeartAssist 5 has an exclusive flow probe that measures blood flow 24/7 so that effectiveness of the device is constantly monitored.
Once the HeartAssist 5 achieves FDA approval, it is anticipated it could capture a significant share of that business, especially if it is seen as a device with advantages over the HeartMate II.








Comments