PharmaSonics Inc has initiated SPLASH (Sonotherapy Prevention of Late Arterial in-Stent Hyperplasia), a new Phase II trial to study the company's Intravascular Sonotherapy System for the reduction of the rate of restenosis in patients with failed coronary stenting, so-called "in-stent restenosis." SPLASH complements the ongoing SWING (Sound Wave Inhibition of Neointimal Growth) trial, the Phase II pivotal trial of Sonotherapy to prevent restenosis in native coronary lesions immediately following stent implantation, so-called de novo stenting. Sonotherapy employs a selective spectrum of therapeutic ultrasound, delivered through a standard catheter after stent implantation or revascularization.

"If the clinical trial establishes the effectiveness of Sonotherapy in the treatment of in-stent restenosis, I believe it will be the first-line therapy most physicians will be choosing for the treatment of this problem," commented Jeffrey Moses, Director of Interventional Cardiology for Lenox Hill Heart and Vascular Institute, and principal investigator for SPLASH.

"We believe SPLASH will establish Sonotherapy as the therapy of choice for in-stent restenosis, due to its simplicity, ease of use and the fact that extra catheter lab staff are not required," explained Menahem Nassi, President and CEO of PharmaSonics. "Ultrasound energy may provide an important alternative to use of radioactive isotopes, which have significant complexity in terms of handling and administration to the patient. We believe the data from the two trials -- SPLASH, for treatment of occluded stents, and SWING, for de novo stenting -- will lead to the availability of a single option the cardiologist can use to treat both types of occurrences."

The FDA approval for the SPLASH and SWING trials was based on early results for SILENT, the FDA-approved Phase I registry trial of Sonotherapy. The nine-month (final) results for SILENT will be presented at the upcoming Transcatheter Cardiovascular Therapies (TCT) meeting, being held September 11-16 in Washington, DC.

The SPLASH and the SWING trials are examining the role of Sonotherapy in reducing the incidence of restenosis for the more than one million patients per year worldwide who will be treated with a coronary stent. Restenosis occurs after stenting when the body's healing response results in an over-proliferation of smooth muscle cells.

The SPLASH trial is designed to evaluate the long-term safety and clinical efficacy of Sonotherapy in patients being treated for in-stent restenosis (re-narrowing occurring within a stent already implanted) in a single native coronary artery. The first SPLASH case was recently performed in Michigan by Dr. Kevin Wolschleger at Spectrum Health.

SPLASH is a prospective, randomized, double blind clinical trial with 600 patients at more than 50 cardiac centers across the U.S., Canada and Europe. Patients may have stent lengths of 15mm to 50mm.