Cardiogenesis Corp., an Irvine medical device maker, is looking to a twist on its core product to help weather a rough spot.
That is if the Food and Drug Administration approves it.
Cardiogenesis is awaiting word from the FDA on its Pearl 5.0 robotic medical device that is used to treat angina, or a build up of plaque in the arteries throughout the heart.
Pearl is an “advanced version of the device that was approved in 1999 with a standard surgical approach,” said Richard Lanigan, Cardiogenesis’ president.
The company is banking on the new device to stop its recent revenue slip and to regain some clout after suffering a delisting of its stock and departure of its chief executive in the past year and a half.
Cardiogenesis submitted its application to the FDA in May and hopes it will get a decision on Pearl by November, Lanigan said.
Pearl works by sending laser energy to areas of a patient’s heart muscle that don’t receive adequate blood flow. The laser stimulates new microvessel growth. Pearl works with the company’s Solargen 2100S laser console and uses surgical robots, which the company said provides more maneuverability for doctors and is less invasive for patients.
The idea for Pearl being used in this surgical procedure to treat angina first came about three years ago, Lanigan said.
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Pearl 5.0: FDA reviewing robotic medical device |
Cardiogenesis, in federal filings, said it believes its only direct competitor is PLC Medical Systems Inc., a Franklin, Mass.-based company that has worked in the past with Edwards Lifesciences Corp., the Irvine heart valve maker.
Separately, Cardiogenesis is working on delivering patient-derived stem cells through laser therapy to speed recovery in heart surgery.
The company received European regulatory approval for that technique and has treated some 25 patients in Europe and the Middle East. It is planning a formal study in Europe, Lanigan said.
Even with stem cell work, Lanigan emphasized that Cardiogenesis is not a biotechnology company.
Cardiogenesis, formerly known as Eclipse Surgical Technologies Inc., moved to Irvine from Foothill Ranch last October.
The company came to Orange County in 2001 from Sunnyvale in the Bay area.
Cardiogenesis has 35 workers and outsources its manufacturing.
In the second quarter, the company posted a loss of $255,000 on revenue of $2.4 million.
The device maker’s revenue fell 45% from a year earlier, largely because of lower equipment sales including a significant drop in revenue for the disposable handpiece part of the laser technology.
Its target market is cardiothoracic surgeons and traditional cardiologists.
Cardiogenesis has faced its share of challenges.
Through Dec. 31, it had an accumulated deficit of $170.1 million. Its former chief executive, Michael Quinn, left the company last July in the wake of what Cardiogenesis called “conduct that the executive committee believes violated the terms of his employment agreement” in a federal filing.
Quinn’s departure came after Cardiogenesis lost its listing on the over-the-counter Bulletin Board stock exchange. The delisting came after the company didn’t file its 2005 annual report and its first-quarter report in 2006. It now trades on the low-profile Pink Sheets exchange.
But it hopes to change that, Lanigan said.
In addition to looking to trade on a larger exchange, Lanigan said that the device maker is concentrating on “creating its future” through improved operating performance, quarter-to-quarter profitability and achieving milestones with key products,things he said the company believes will improve its valuation on Wall Street and lead it to eventually seek listing on a higher profile stock exchange.
“Obviously, we know that being on the Pink Sheets is not desirable in any way, but we think that the way to (achieve a higher profile) is by focusing our business and driving our business,” said Lanigan, who’s been with Cardiogenesis since 1997 and was previously the company’s senior vice president and general manager of research and business development.
