Ardian (Palo Alto, California), a privately held developer of the Symplicity, a catheter-based medical device to treat hypertension, reported receiving one of the largest financing rounds in the medical technology sector in the last six months, with a raise of $47 million.

The funding round was led by device powerhouse Medtronic (Minneapolis). Joining Medtronic in the new funding round are Ardian's three existing investors: Advanced Technology Ventures, Morgenthaler Ventures and Split Rock Partners, as well as new investor Emergent Medical Partners.

With this latest funding, the company has raised about $66 million since its inception in 2003. Ardian was the eighth company created by medical device incubator The Foundry (Menlo Park, California).

Andrew Cleeland, president/CEO of Ardian, told Medical Device Daily that he attributes the company's ability to raise such a substantial funding round in lean times to its management team and to "some good early clinical results pointing in a promising direction."

"We are thrilled to have attracted this strong team of investors and appreciate the confidence they have shown in funding the development of this clinically important technology," he said. "We are particularly encouraged to have Medtronic as a new partner, and see their investment as a validation of our exceptional early clinical results, as well as the potential of our treatment for such a pervasive and complex disease."

Perhaps even more telling of the company's potential is the investment by Emergent Medical Partners, led by the legendary Thomas Fogarty, MD, a renowned Stanford (Palo Alto, California) cardiovascular surgeon and founder of Bacchus Vascular (Santa Clara, California).

"Dr. Fogarty is a legend in the cardiovascular field, and having him make an investment speaks volumes for the promise of this technology," said Cleeland, who noted that this latest funding will be used for clinical development, including in the U.S. The system already has the CE mark.

Of course the market potential for a more effective treatment for hypertension (high blood pressure) is quite appealing. The condition affects about one-third of the developed world's adult population, and is the most commonly diagnosed condition in the U.S. It significantly increases the risk of heart attack, stroke, heart failure and chronic kidney disease.

It is the single most common contributor to death worldwide. In the U.S. alone, high blood pressure affects about 73 million people, only two thirds of whom are treated. Close to half of all people with hypertension in treatment are not currently reaching their target blood pressure.

Only 35% of hypertensive patients are satisfactorily controlled with medication, the most common form of treatment for the condition. A major contributor to the development and perpetuation of hypertension is hyper-activation of the sympathetic nervous system. The Symplicity catheter system is designed to disrupt the renal sympathetic nerves by means of a simple 40-minute procedure, thereby reducing sympathetic activation and hence blood pressure.

The system consists of a 5 Fr, single-use catheter with a radio frequency (RF) monopolar electrode at the distal tip which is placed in the renal artery via the femoral artery. Low power RF energy is then delivered via the catheter through the vessel wall to disrupt the sympathetic renal nerves.

According to Cleeland, the company's initial goal is to reduce a patient's blood pressure generally in conjunction with their existing medication, with the hope that one day as the technology evolves, more people will be able to eliminate their medication altogether. He noted that just a 5 mmHg reduction in blood pressure would result in a 14% decrease in stroke, a 9% decrease in heart disease and a 7% decrease in death. A 20 mmHg decrease in systolic blood pressure, he added, would nearly halve heart disease-related death.

One area that Cleeland acknowledged has not been fully researched yet is the possible need for a reoperation as the effects of the procedure potentially lessen over time. He said the company is hoping to prove the durability of the procedure with its current clinical trial, and he expects its effectiveness at the very least to stretch out "over a number of years."

Cleeland noted that Henry Krum, MD, of the Alfred Hospital/Monash University (Melbourne, Australia), is to present the early clinical experience on the first 50 patients of the company's 80-patient clinical trial with the Symplicity at the upcoming American College of Cardiology's (Washington) annual meeting in Orlando, Florida. The presentation will be part of a late-breaking clinical trials session scheduled for March 30.

Simultaneous to the ACC presentation by Krum, The Lancet will publish an online version of the data.

In other financing news, Boston Scientific (Natick, Massachusetts) said that Moody's Investors Service has raised the company's rating outlook to stable from negative. In addition, Moody's upgraded Boston Sci's U.S. public bond rating to Ba1 from Ba2 and its liquidity rating to SGL-2 from SGL-3, while affirming its corporate credit rating at Ba1.

Moody's said the revised rating outlook reflects: 1) improved covenant cushions provided by recent amendments to the company's bank facility; 2) generally steady market share for key drug-eluting stent (DES) and cardiac rhythm management (CRM) products, and 3) ongoing debt repayment and cost-savings initiatives.

Moody's noted that Boston Scientific has been able to retain market share in the drug-eluting stent arena while rebuilding its cardiac rhythm management presence with new product launches.

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