Sound Interventions Posts Early Data from Hypertension Trial Stony Brook, N.Y.-based Sound Interven

Sound Interventions Posts Early Data from Hypertension Trial
Stony Brook, N.Y.-based Sound Interventions Inc. has released three months’ worth of data from the company’s first-in-human clinical study, Sound-ITV, to treat resistant hypertension through the use of catheter-based ultrasound.

Hypertension is the medical term for high blood pressure. According to a report published by The American Heart Association in 2008, the exact prevalence of resistant hypertension is unknown. Clinical trials, however, suggest that it is not rare, involving perhaps 20 to 30 percent of study participants.

In the Sound-ITV trial, participants underwent office-based blood pressure measurements and 24 hour ambulatory blood pressure monitoring (ABPM) before the ultrasonic renal denervation procedure, and subsequently three months after the procedure. The office-based blood pressure measurement results showed an average decrease of -25.6/-12.5 mm Hg (millimeters of mercury). Consistent with these results, the 24-hour mean blood pressure decreased by -23.1/-11.9 mm Hg.

According to a company spokesperson, other existing studies have been unable to replicate the Sound-ITV trial’s lowered blood pressure results. Round-the-clock measurements essentially monitor subjects while they are awake, sleeping and doing normal every day activities, a method that removes the potential for human error in an office-based measurement.

“The use of 24-hour monitoring to assess results of renal denervation procedures is a more accurate measurement of effectiveness than office-based blood pressure,” agreed Vivek Reddy, M.D., of Mt. Sinai Medical Center in New York, N.Y., an advisor on the trial and a Sound Interventions equity holder. “The favorable results seen on the ABPM fortify our confidence in the efficacy of this technology.”

Patients were treated at Holmolka Hospital in Prague, Czech Republic. Patients enrolled in the study were selected based on a history of hypertension that could not be controlled with medical therapy. The Sound-ITV study was designed to evaluate the safety and effectiveness of the company’s volumetric dosimetry-controlled application of unfocused ultrasound.

“These results demonstrate the ability of Sound Interventions’ ultrasound technology to significantly lower blood pressure in patients whose blood pressure was unable to be controlled by conventional pharmaceutical therapy,” said Petr Neuzil, M.D., chairman of the department of cardiology at Holmolka Hospital.

“Prior to initiation of the Sound-ITV study, the company performed extensive in-vitro and in-vivo testing in order to perfect the ultrasound dosimetry,” explained David Smith, president and CEO of Sound Interventions. “The pre-clinical testing has demonstrated that the Sound Interventions technology is unique in its ability to ablate the target nerve fibers while sparing the arterial wall. The success of the acute procedures in the Sound-ITV Study, along with these very strong clinical results validate this research and indicate that we are well on the way to developing state-of-the-art renal denervation technology.”

Full results from the study are expected in October.

Founded in 2010, Sound Interventions is an emerging medical technology company that develops therapeutic ultrasound to treat resistant hypertension.