A Medical Device Daily

SynCardia Systems (Tucson, Arizona) manufacturer of the SynCardia temporary CardioWest Total Artificial Heart, reported that it has raised $10.3 million in a Series D round of funding. Highway 12 Ventures led this round of financing.

"My partners and I believe that, with the release of the Freedom driver, SynCardia can dramatically improve the quality of life for tens of thousands of people worldwide who are suffering from biventricular heart failure," said Mark Solon, managing partner of Highway 12 Ventures, who has joined SynCardia's board.

Proceeds from the financing will support the launch of two new drivers for powering the Total Artificial Heart. SynCardia said it anticipates that the Companion Driver System will receive the CE mark for use in Europe in July. The Companion Driver is designed to support Artificial Heart patients from hospital implant until their condition stabilizes. Once stable, patients will be transferred to the 12-lb Freedom discharge driver, currently under development.

"For the first time in U.S. history, stable total artificial heart patients will be able to enjoy life at home and in their community while they wait for a matching donor heart, thanks to the 12-pound Freedom discharge driver," said SynCardia President/CEO Rodger Ford.

This summer, SynCardia plans to submit an application to the FDA to conduct an IDE clinical study of the Freedom driver in the U.S. and a Design Dossier to its Notified Body for the CE mark in Europe.

The company said it also will submit a PMA supplement to the FDA for use of the Companion Driver in the U.S. In addition to the Total Artificial Heart, the Companion Driver is designed to power SynCardia's future family of pulsatile devices, including the 50 cc Total Artificial Heart, 10 cc VAD, 30 cc VAD and 60 cc VAD.

In other financing news:

• Revolutions Medical (Mount Pleasant, South Carolina) reported that it has secured financing through a $10 million dollar equity purchase agreement. The company can draw down on this equity line for up to two years at 8% discount to market price. The equity purchase agreement was arranged through Southridge Investment Group.

"We now have the access to capital we need to execute our business plan and bring our proprietary products to the market place," said Ron Wheet, CEO of Revolutions Medical.

Revolutions operates in the safety-engineered medical devices arena. Its products include the Rev Vac Safety Syringe safety blood-drawing device and the Rev Vac Safety IV Catheter.

• AFP Imaging (Elmsford, New York) reported that it has received a $1.5 million investment in growth capital and debt restructuring from BioWave Innovations and ComVest Capital.

In conjunction with the transaction, R. Scott Jones, managing director of BioWave Innovations, will assume the role of chairman of AFP Imaging. David Vozick and Donald Rabinovitch, the founders of the company, will remain on the board and will retain their roles as CEO and president of the company, respectively.

As part of the transaction, Jack Becker and Robert Blatt, current board members of AFP, will retire and Gary Jaggard, fund manager of ComVest Capital will join the company's board.

AFP Imaging is a diagnostic imaging supplier with revenues of about $30 million. It says it is a market leader with products for clinical applications in dental, medical and veterinary medicine under the brand names of AFP, Dent-X, EVA and NewTom.

• TrinityCare Senior Living (Friendswood, Texas), which develops, manages and owns faith-based senior living facilities, reported the execution of a funding agreement with a national lender for the development of a new senior living facility in the Houston metropolitan area. Funding for Trinity Terrace, an 87-unit, $10 million senior living facility in Pearland, Texas, should be available under the agreement this summer, with completion of construction anticipated by spring 2010.

"Partnering with the financial strength and expertise of this national lender and its significant relationships with HUD/LEAN process will play a key role in allowing us to achieve our expansion goals for 2009," said Donald Sapaugh, chairman/CEO of TrinityCare. He added that the company expects "funding agreements for additional new facilities to be announced in the next several weeks."