Washington's Kona Medical is pressing forward with its novel approach to renal denervation, releasing solid data as it develops a non-invasive device to lower blood pressure in patients with drug-resistant hypertension.
Kona unveiled results from its two ongoing studies of Surround Sound, finding an average systolic blood pressure reduction of 29 mmHg at 6 months in WAVE I, and a three-month drop of 19.4 mmHg in WAVE II, a study using a new dosing pattern that reduces therapy time from 13 to three minutes.
Those data put Kona and its ultrasound-powered renal denervation system in the same ballpark as offerings from some of the industry's largest players, though Surround Sound's studies so far are smaller and shorter than those sponsored by Medtronic ($MDT), St. Jude Medical ($STJ) and Boston Scientific ($BSX). However, the 2013 Fierce 15 winner has something its big-name competitors lack: a system that promises to treat hypertension without so much as breaking the skin.
Kona is yet to win a CE mark for the device, and the company is still plugging away in clinical trials, setting out plans for WAVE III, which will use non-invasive ultrasound imaging to guide Surround Sound's external ablation, investigator Petr Neuzil said.
"The great promise of this technology is the opportunity to treat hypertension patients outside the cath lab, without the use of catheters, invasive instruments or radiation," Neuzil said in a statement. "We look forward to the future results from the WAVE III study."
Kona closed a $40 million venture round last year to support Surround Sound's development, and, this month, the company snagged a $10 million investment earmarked to help get the device on the market in China.
- read the announcement
Special Report: FierceMedicalDevices' 2013 Fierce 15 - Kona Medical