Ardian has completed a $47-million venture financing—one of the largest announced this year—in a sign that the market has high hopes for its breakthrough treatment for hypertension. The financing comes as the Palo Alto, California-based company is expected to release positive clinical data March 30 at the American College of Cardiology’s annual meeting in Orlando on its catheter-based treatment for hypertension, an alternative to the $50-billion pharmaceutical market aimed at addressing high blood pressure.

 

Hypertension affects one in three adults, but only half of people who are treated with medications are able to adequately control their blood pressure with these drugs. More than 1 billion people suffer from hypertension worldwide and the condition is associated with an increased risk of heart attack, heart failure, kidney disease, and death. Ardian, which emerged from work at the medical device incubator The Foundry, developed a catheter that a cardiologist can use to deliver low-level radio frequency to the nerves surrounding the renal arterial. The procedure is performed to reduce the level of activity along the sympathetic nerve, which runs between the brain and the kidney, to trigger the body’s regulatory mechanism to lower blood pressure.

 

It’s long been established that hyperactivation of the sympathetic nervous system drives the development and progression of hypertension. Ardian’s approach is rooted in troublesome surgical procedures performed in the 1930s, such surgeries became impractical with the advent of antihypertensive medications. The company’s Symplicty catheter provides a minimally-invasive approach that requires just a 40-minute outpatient procedure and has none of the troubling side effects of the surgical procedure.

 

“What we’re doing is taking that existing physiology and attacking the problem at its core—at the level of the kidney itself,” says Andrew Cleeland, president and CEO of Ardian. “Instead of a carpet bombing effect at the level of the spine where you have a lot of collateral injury, what we are doing is having a very focused and targeted solution.”

 

Clinical tests, though limited to date, have shown promising results. In a study of 50 patients who were on an average of 4.7 antihypertensive medications, researchers saw an average reduction of 27 millimeters in the systolic measure of their blood pressure over 12 months. A six point drop in systolic blood pressure by a drug is considered significant by the American Heart Association.

 

“The idea of doing an intervention for this indication is quite an interesting paradigm shift,” says Rob Whitborn, a principal investigator in the Ardian study and Director, The Cardiovascular Research Centre St. Vincent's Hospital in Melbourne, Australia. “Clearly we need to do more work, but the findings are so compelling that it really is exciting and there will be a lot of interest.”

 

Ardian said the current financing will allow Ardian to complete the clinical development of its. The company hopes to begin marketing the product in Europe by 2010 to 2011 and in the United States by 2012 to 2013.

 

The medical device maker Medtronic led the current financing round and was joined by the company’s existing investors, which include Advanced Technology Ventures, Morgenthaler Ventures, and Split Rock Partners. New investor Emergent Medical Partners also joined the round.

 

“This technology addresses a huge market, especially for the patients who are non responsive to multiple hypertension drugs,” says Hank Plain, a partner with Morgenthaler Ventures and a member of the board of Ardian. “The market is enormous, the solution is very simple, and the clinical data we’ve seen thus far is very compelling for both the efficacy and safety.”