As it awaits regulatory nods of approval for its heart defect test, Columbus, Ohio, medical device company CardiOx Corp. is ramping up for commercialization with a $4 million round of financing.
Two investors have already committed to the round, which CEO Larry Heaton said will fund the launch of the company’s flagship test in the first and second quarters of this year.
Its lead product is a noninvasive system for diagnosing patent foramen ovale (PFO), a hole between the left and right upper chambers of the heart that does not close as it’s supposed to soon after birth. This occurs in as many as one in four people. For most, it causes no problems, but rarely it may contribute to stroke or peripheral arterial embolization (as it did for Poison singer Bret Michaels in 2010). It’s also been studied in relation to other ailments including migraine headaches and sleep apnea.
CardiOx’s test involves the injection of a green dye into the blood and its detection by a sensor placed on the outer ear. In a phase 3 study, the company evaluated it against transesophageal echocardiography and transcranial doppler ultrasound.
The company is awaiting CE Mark and 510(k) clearance and, if all goes well, plans to launch the test in U.S. and international markets in the first and second quarters of this year. The regulatory process appears to have taken a little longer than the company expected; in 2010, it was aiming for clearance in the second and third quarters of 2011.
Heaton said a follow-on product is expected to launch later this year.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Medical device entrepreneur Philip Eggers founded CardiOx in 2006. Including the $8 million series C it closed in August 2011, the company has raised about $13.5 million since its inception, according to our calculations. Investors include Glengary LLC, LifeLine Ventures, Reservoir Venture Partners, Co-Investment Fund, Early Stage Partners, Ohio TechAngels and Northcoast Angels.
[Photo from Minneapolis Heart Institute]
