Clinical Data Reported for WAVE I and WAVE II Studies of Renal Denervation Therapy for Hypertension at Transcatheter Cardiovascular Therapeutics Conference

Kona Surround Sound® Technology Utilizes Externally-Delivered Ultrasound to Treat Drug-Resistant Hypertension

BELLEVUE, WASHINGTON AND MENLO PARK, CALIFORNIA–(BUSINESS WIRE)—OCTOBER 29, 2013.

Kona Medical announced that three month results from the WAVE II study and complete six month results for the WAVE I (first-in-man) study were presented at the Transcatheter Cardiovascular Therapeutics Conference today by Petr Neuzil, MD, of NA Homolce Hospital in Prague, Czech Republic. Data presented from WAVE II demonstrated that resistant hypertension patients treated with the Surround Sound® Renal Denervation System experienced a 19.4 mmHg drop in systolic blood pressure and 6.5 mmHg drop in diastolic blood pressure at three months (N=17). For WAVE I, patients experienced blood pressure reductions of 22 / 9 mmHg at three months and 29 / 12 mmHG at six months (N=24). For the combined studies, 73% of patients experienced a clinically significant drop in systolic blood pressure of 10 mmHg or more at three months and 81% at six months. There were no device related serious adverse events in WAVE I or WAVE II.

WAVE II utilizes a dosing pattern that reduces therapy delivery time from thirteen minutes per patient side to less than three minutes when compared with WAVE I.

The study sponsor, Kona Medical, also announced the initiation of the WAVE III study. WAVE III is evaluating the use of non-invasive ultrasound imaging to guide externally-delivered therapeutic ultrasound energy.

“Data from the WAVE I and WAVE II studies continue to indicate the effectiveness of external ultrasound as a method of renal denervation,” Dr. Neuzil reported. “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. We look forward to the future results from the WAVE III study.”

Michael Gertner, MD, founder and CEO of Kona Medical added, “I thank the WAVE I and WAVE II study teams for their commitment to this important research.”

The clinical study group included St. Vincent’s Hospital in Melbourne, Australia (Dr. Robert Whitbourn, Primary Investigator), Nemocnice NA Homolce in Prague, Czech Republic (Dr. Petr Neuzil, Primary Investigator), and St. Anne’s Hospital, Brno, Czech Republic (Dr. Zdenek Starek, Primary Investigator). Dr. Murray Esler of Baker Heart and Diabetes Institute served as norepinephrine core lab director.

About Kona Medical

Kona Medical’s Surround Sound® Renal Denervation System utilizes ultrasound, delivered from outside the body, to treat nerves leading to and from the kidney. Renal denervation has been shown in clinical studies to lead to significant and lasting reductions in blood pressure in drug-resistant hypertension patients. Kona’s non-invasive system offers the opportunity to increase patient access to renal denervation and lower healthcare costs. Kona is based in Bellevue, Washington, and Menlo Park, California.

Note: Kona Medical’s technology is investigational and is not yet for sale or approved by the US Food and Drug Administration.

Contact

Kona Medical, Inc.
John Bowers
Chief Operating Officer
(425) 558 4616
jbowers@konamedical.com