Thu, Nov 20, 2008
Dr. Marvin Slepian is co-founder of SynCardia.
More Photos (2):

Business

Heart maker poised for profit

firm's pace picks up

With tighter business focus, new implant 'driver' on the way, SynCardia forecasts profitability in '06
By Thomas Stauffer
ARIZONA DAILY STAR
Tucson, Arizona | Published: 01.21.2006
The CEO of the Tucson-based company that makes the only FDA-approved total artificial heart told investors Friday that 2006 will be the year that SynCardia Systems Inc. turns the corner from a life-saving science project to a profitable business.
The privately held SynCardia, which produces the CardioWest temporary total artificial heart, should see sales of $14.9 million and profit of about $6 million this year, CEO Rodger Ford told investors at a meeting held at the Arizona Inn.
A key aspect to the company's expected growth is development of a more portable pneumatic "driver" to power the Cardio-West hearts, Ford said. The company plans to submit a more portable driver to the U.S. Food and Drug Administration for approval by next month.
In addition, the 5-year-old company has the goal of adding two hospitals a month to the list of heart centers implanting the CardioWest hearts into patients.
SynCardia currently services two transplant centers in the United States — Tucson's University Medical Center and the Cleveland Clinic— and seven other centers worldwide.
Implanted in patients to keep them alive until they receive human donor hearts, Cardio-West hearts evolved from the 1980s-era Jarvik-7, one of the first artificial hearts implanted in a human. There are currently just 37 drivers available worldwide to supply power and air to CardioWest hearts, units inherited from Symbion, the company started by Dr. Robert Jarvik.
Known as "Big Blues" for their light blue exterior finish and their filing-cabinet-sized dimensions, the old 500-pound drivers will be replaced by 20-pound units about the size of a microwave oven, if approved by the FDA.
SynCardia has spent more than four years acquiring newer, more portable driver technology from Europe and recently licensed technology for a new driver unit from a German company, MEDOS Medizintechnik AG.
Twenty-one of the new drivers are currently undergoing durability testing in Houston, said SynCardia co-founder Dr. Marvin Slepian.
The development and approval by U.S. and European regulatory agencies of the new driver represents a sea change for SynCardia, said Stuart Williams, director of the University of Arizona's Biomedical Engineering Program and a longtime developer of medical devices.
"That's been one of the critical issues for SynCardia, so they're really addressing a major next step in getting these new drivers established," Williams said.
The goal of signing on two new transplant centers a month sounds reasonable, given the epidemic nature of congestive heart failure and the lack of competition, he said.
"They really don't have any true competitors at this time in the field of a totally implantable heart," Williams said.
Though medical science has progressed to where many people can be kept alive with their own native hearts through procedures and therapy until a human donor heart is available, there will always be a segment of people whose hearts have failed to the point where a temporary artificial heart will be a life-saving stopgap, he said.
An investor at the meeting said he was not surprised by Ford's assessment of SynCardia's profitability.
"Syncardia has moved from being a company run by founders and creators to a company that's now partnered by those founders and creators to true business people who can take this product to its profitable and best use around the world," said Duff Hearon, chairman of the Ashland Group investing firm.
The 2005 hirings of Ford, who founded AlphaGraphics Printshops of the Future, and David Mackstaller, a co-founder with Ford of Anthem Equity Group Inc., a real estate and investment company, signaled to Hearon that SynCardia was progressing to the next level as a business, Hearon said.
"Those are two of the premier business executives in our state or anywhere for that matter," he said. "That's why this is a year I think will be very exciting as SynCardia becomes a profitable venture."
SynCardia sold 52 Cardio-West hearts at about $100,000 each last year. The company is projecting sales of 170 Cardio-West hearts in 2006, said Steven Langford, vice president of manufacturing and support.
About 550 patients have received CardioWest hearts or earlier versions since 1985.
● Contact reporter Thomas Stauffer at 573-4197 or tstauffer@azstarnet.com