Medical Device Dailys

PARIS — A high-powered, heavily financed French start-up developing an artificial heart for use in late-stage heart failure has brought on board two heavyweight senior executives from the European cardiovascular medtech industry to help develop the market for its device.

Carmat (Velizy, France), a spin-off from the European space and defense group EADS (Leiden, the Netherlands), announced that the CEO of Sorin (Milan, Italy), André-Michel Ballester, and the former VP for Medtronic's (Minneapolis) cardiac rhythm management, Peter Steinmann have joined its board.

The acting CEO of Carmat, Michel Finance, was also named to the Carmat board.

"We are delighted that messieurs Ballester and Steinmann have agreed to join CARMAT as independent board members to help us successfully develop the most advanced total artificial heart in the world," said Carmat chairman Jean-Claude Cadudal.

Created in November, 2008, Carmat expects to implant up to 20 artificial hearts in patients in 2011 (Medical Device Daily, Nov. 3, 2008).

Another board member and the chief scientific officer for the company, Alain Carpentier, MD, spent 15 years and €15 million ($21.4 million) at EADS where he was given carte blanche to develop the technology behind the new implantable heart.

Spinning out the technology to Carmat was the first step toward bringing the device to market, Carpentier told MDD, saying "We are moving from pure research to clinical applications."

The device holds the unique distinction of being pre-approved by the French Agency for Healthcare Product Safety (AFSSAPS) for implantation in "life-threatened patients with no other available treatment options," meaning a patient who otherwise might drop dead of a massive heart attack.

The French innovation agency OSEO awarded the company transferring the technology from the labs to the market some €33 million in grants and loans, the largest amount of funding ever awarded to a start-up.

And the new company raised in excess of €7 million ($10 million) in a first financing round, with €5 million from Truffle Capital (Paris) and €2.25 million from EADS and the Fondation Alain Carpentier.

"It's nice to have more cash than you plan to burn," Dr. Philippe Pouletty, the managing director of Truffle, told MDD.

"We have not done any detailed market studies," he said, adding the partners believe simply that if the implanted heart results in low survival rates and a low quality of life for the patients, then the market prospects will be low.

A specialist in cardiovascular surgery devices, Ballester heads the Sorin Group, one of the leading provider of medical devices for cardiovacular diseases that reported revenues of €643.2 million ($919.2 million) for 2008.

Steinmann held various senior management positions in Europe and Canada for 20 years within world-leading multinationals, including Johnson & Johnson (New Brunswick, New Jersey) and most recently served as vice-president for Western Europe at Medtronic.

The prototype for the implantable heart, shaped like a human heart and mimics the dynamics of heart pressures and flows, has been tested in animals for sensitivity to activity and orientation, such as standing or lying down.

The device runs off a belt-mounted battery pack for five hours with built-in software allowing it to be remotely monitored and diagnosed.

The Carmat prototype is patented and the device is now undergoing pre-clinical testing and fine-tuning, with the next milestone to be a design freeze ahead of evaluation, Pouletty said.

3 UK companies benefit from seed funding

Three companies that have recently been spun out of Leicester University's (Leicester, UK) Space Research Centre are the first businesses in the East Midlands to benefit from a new Germinator Programme' European funding that helps early-stage healthcare businesses become self supporting.

BioAstral, Gamma Technologies and Spectral-ID have all developed technologies in the field of space research, which, with the help of funding and other support worth £90,000 from the Germinator Programme, are now being adapted for the bioscience and medical sectors.

Engineers at BioAstral have developed a fluorescence detector based on cryogenic super-conducting tunnel junctions (STJs) that will be used to improve the imaging of microarrays, which are used in the discovery and testing of drugs.

Gamma Technologies is currently prototyping a handheld Mini Gamma Ray Camera for clinical applications in intensive care and operating theatres. Primary focus will be sentinel lymph node imaging, but the camera is anticipated to have wider clinical applications including intra-operative tumor location, thyroid morphology and lacrimal drainage.

Finally, Spectral-ID has developed a detector that can be used find counterfeit high-value goods including pharmaceuticals. A laboratory-based prototype has been built and used in blind trials to discriminate between samples of counterfeit and genuine products obtained from major manufacturers.

The Germinator Programme, managed by Medilink East Midlands and BioCity Nottingham, is intended to fund entrepreneurial support for new companies, paying for a business expert to work with the companies for up to nine months, plus access to research data and business incubator services at the university.