Biophan Technologies (West Henrietta, New York) reported last month that its TE-Bio subsidiary, acquired earlier this year, has signed an agreement with the National Aeronautics and Space Administration (NASA; Washington) to jointly develop high-density, nanoengineered thermoelectric materials toward the development of a battery to be used with implanted devices such as pacemakers, defibrillators, neurostimulators and drug pumps. The goal is to extend battery life beyond current limitations. The research, which will take place at the NASA Ames Research Center (Moffett Field, California), was originally discussed with TE-Bio. Biophan acquired a majority interest in that company in May because of its mission to develop a battery, or implantable power source, to be powered by an individual's own body heat – in other words, a biothermal battery made possible by nanotechnology.

"It's been in the works for quite some time, and it was partially the NASA interest, as well as a third-party feasibility study that we had done that caused the Biophan board to support the acquisition and the expansion into this technology space," Biophan CEO Michael Weiner told The BBI Newsletter. "Then, we also had some really good indications of interest from a number of significant industry players, all the likely suspects." Weiner said he expects to have a product on the market in two to three years, assuming everything works as hoped.

Since its founding, Biophan's mission has been to develop materials that make implanted medical devices compatible with magnetic resonance imaging. Biophan said it and its licensors have nine issued U.S. patents and more than 50 patents pending, in areas including nanotechnology (nanomagnetic particle coatings), radio frequency filters, polymer composites, and photonics. When the acquisition of TE-Bio was reported this spring, Biophan said that company was developing an implantable power system that "has the potential to provide as much as a 30-year life – a fivefold increase in service life compared to existing technology." Weiner said Biophan is not suggesting that it can make implantable devices that last for 30 years within the body, but that it could add a significant number of years to particular devices.

The agreement with NASA is adding to Biophan's mission statement and the space agency benefits from this agreement, too. It hopes to have an implantable power source device that can be used to monitor an astronaut's body function while in space. "The way it's set up right now is we're both bringing capabilities, equipment and people to the table to jointly develop," Weiner said. "We've agreed to give NASA rights for space utilization and NASA missions. They've agreed to give us an exclusive license for the medical device and commercial applications that we're interested in."

The first stage of the agreement involves Biophan purchasing equipment, which will be housed at the Ames Research Center facilities, to conduct "some specific experiments on the nanotechnology that is of mutual interest." Those experiments will be conducted by NASA scientists with help from Biophan scientists, with the two organizations sharing any data resulting from the experiments. Those experiments are designed to confirm or disappoint ""some of the expectations of the technology," Weiner said. "As the data comes in and we realize – you know, confirm or not – some of the expectations of the technology, then we'll move forward to develop it further," he said. "Then it will become a nanofabrication issue."

The idea for the biothermal battery, first introduced at the Heart Rhythm Society's (Natick, Massachusetts)Heart Rhythm 2004 Conference in San Francisco in May, had "tremendous" response from manufacturers at the show and since then, Weiner said. He said the company also has had interest expressed from makers of lab-on-a-chip devices and biosensors. Because they are so small, such devices require a very small power system. "We think that once the biothermal battery is proven and captures some market share for the first manufacturers who apply it, that it's going to make a very significant difference."

NIH unit backs RVAD development

The Department of Biomedical Engineering at the Cleveland Clinic (Cleveland, Ohio) and Kiyotaka Fukamachi, MD, PhD, have been awarded a $6.95 million contract from the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (both Bethesda, Maryland) to develop and test in clinical trials a right ventricular assist device (RVAD) for patients with congestive heart failure. Under terms of the five-year contract, researchers in the Department of Biomedical Engineering and clinicians in its Department of Thoracic and Cardiovascular Surgery will work to develop an RVAD that will benefit heart failure patients who need a more comprehensive implantable device than now available. RVADs assist the heart in pumping oxygen-depleted blood to the lungs.

This new project is an extension of the group's previous success in developing the implantable CorAide left ventricular assist device (LVAD) for patients with end-stage congestive heart failure. LVADs pump oxygen-rich blood from the heart to the rest of the body. The CorAide LVAD is an implantable continuous flow blood pump designed to serve as a "bridge" to heart transplant – or a bridge to recovery and, ultimately, an alternative to heart transplantation. That device is not yet approved in the U.S.

Fukamachi, who leads the team of biomedical engineers and researchers in the clinic's Cardiovascular Dynamics Laboratory and CorAide laboratory (housed within the clinic's Lerner Research Institute) that will develop the new device, explained the need for the RVAD for BBI. "Most heart failure patients have biventricular failure," he said. And while a large number of these people need only an LVAD support, "about 10% of the patients who require an LVAD [also] require an RVAD." Fukamachi said another 30% of these heart failure patients require long-term inotropic (drug) support for right ventricular failure. "If the CorAide LVAD can be modified and used as an RVAD, the resulting CorAide biventricular assist device would be an ideal system for patients who need additional support for their LVAD to function properly."

The use of LVADs has been increasing to serve the growing population of patients with end-stage congestive heart failure, Fukamachi said. However, since up to 40% of these patients have significant right ventricular failure that limits the benefits of LVAD therapy, he said. "We have reported a poor prognosis for patients with LVAD support who also required external RVAD support or prolonged inotropic support. A safe, implantable RVAD could save the lives of many patients with right ventricular failure."

Right ventricular failure leads to two problems: decreased forward flow and high right heart pressures that result in passive congestion of the liver, kidneys and abdominal organs. Both factors contribute to multi-organ failure, which Fukamachi described as "the leading cause of death after the implant of an LVAD." Those patients often require prolonged support with an RVAD. However, clinically available RVADs currently are not implantable devices and have several limitations, including issues with blood compatibility, infection, long-term durability, mortality and quality of life. He said other companies have RVADs at this time, but that they are external devices worn outside the body, such as Abiomed's (Danvers, Massachusetts) AB5000 or Thoratec's (Pleasanton, California) VAD system. "There are no implantable RVADs right now. That's why we are trying to develop it."

The RVAD device is being designed to be used either in conjunction with the CorAide LVAD or with other existing LVADs such as WorldHeart's (Ottawa, Ontario) Novacor system or Thoratec's HeartMate, the only such device currently approved in the U.S. for use as a destination therapy.

No Comments