Kona Medical – 2013 Fierce 15

Kona Medical CEO Mike Gertner

Based: Bellevue, WA
Founded: 2009
CEO: Mike Gertner
Website: KonaMedical.com

The Scoop: There's been no shortage of hyperbole in the nascent market for renal denervation, as analysts forecast up to $3 billion in annual sales and med tech giants spar over data and market share abroad. But Kona Medical stands out from the hypertension-treating pack for two reasons: Unlike, say, Medtronic ($MDT) and St. Jude Medical ($STJ), it doesn't have billions in revenue to back up its development, and, unlike anyone else in the space, its device lowers blood pressure without the need for an invasive procedure.

What Makes It Fierce: The basic principles of renal denervation are pretty much universal: If you deaden nerves around the kidneys, you can effectively trick arteries to loosen up, relieving high blood pressure. The industry's heavyweights do it with radiofrequency energy, attaching nodes to a catheter and ablating nerves to bring down pressure. Startups ReCor Medical and Israel's Cardiosonic go the ultrasound route, swapping nodes for transducers in similar catheter-based procedures.

Kona Medical, on the other hand, is developing a device that can offer the same relief from drug-resistant hypertension without so much as breaking the skin. The company's Surround Sound system uses external ultrasound energy to deaden nerves, and, in 6-month results, the device charted a 29-mmHg drop in systolic blood pressure and posted no device-related serious adverse events. Those data, while early, put Surround Sound's efficacy in the same ballpark as Medtronic's Symplicity and St. Jude's EnligHTN, the space's two leaders, and if Kona can sustain the benefits in further study, it could have quite a market-disrupting technology on its hands.

The company closed a $40 million Series C over the winter, led by an undisclosed "large-cap medical technology company" and drawing funds from Essex Woodlands, Domain Associates, Morgenthaler Ventures, Western Technology Investment and BioStar Ventures. That cash will help get Kona through its CE mark-targeted studies and move the company toward commercialization. No renal denervation device has been approved by the FDA, and Medtronic is expected to hit the U.S. market first, expecting to launch Symplicity stateside in 2015.

Now, Kona is spreading out to accelerate its timelines, in August recruiting Jim Gilmore, cofounder of point-of-care ultrasound outfit SonoSite, to lead as senior vice president and oversee the development of Surround Sound. Gilmore led SonoSite's R&D efforts until Fujifilm bought the company for $995 million in 2011, and, given the history of private renal denervation developers, his experience with big exits may well be useful.

Back in 2010, Ardian was a startup with a novel approach to treating hypertension. Three years and $800 million later, its Symplicity renal denervation system is a major prong of Medtronic's future growth plans. Maya Medical picked up a CE mark for its OneShot system in early 2012, and, after signing a deal worth up to $230 million, became a division of Covidien ($COV) by midyear. Just last year, Vessix Vascular was among our inaugural Fierce 15. Now, in exchange for $425 million, the company and its V2 device are helping Boston Scientific ($BSX) CEO Mike Mahoney turn things around.

Which is to say: Big companies are buying into renal denervation, and Kona stands alone in a crowded field with its noninvasive technology.

What To Look For: With Gilmore overseeing development, Kona is plugging away on the clinical front, working to get its device on the market overseas. Beyond that, the devicemaker's long-term plans are anyone's guess. Kona has played things close to its chest since its 2009 founding, never revealing that "large" med tech benefactor and sidestepping numerous requests for an interview for this profile. Whether that's because the company is parsing a buyout offer or sitting on data that will rocket it ahead of its competitors, we'll just have to wait and see.

For more:
Kona snags ex-SonoSite exec to helm renal denervation
Covidien, Kona Medical trumpet new tech at EuroPCR
Kona Medical closes $40M round for renal denervation device
Kona Medical snags additional funding for ultrasound for hypertension

-- Damian Garde (email | Twitter)

Kona Medical – 2013 Fierce 15