ReCor Medical, an emerging medical device company, disclosed today updated data for the REDUCE First-In-Man clinical study of its PARADISE (Percutaneous Renal Denervation System) ultrasound platform for achieving renal denervation. PARADISE, which is CE-marked, is designed to treat patients with 'resistant' hypertension ("HTN"), a major risk factor for cardiovascular disease.
“These updated clinical data will boost our momentum as we make ready to launch PARADISE in Europe.”
Preliminary F-I-M clinical data for PARADISE were reported previously at the "TRenD 2012" transcatheter renal denervation scientific meeting by cardiologist Thomas A. Mabin, M.D., Vergelegen Medi-Clinic, South Africa. The updated PARADISE data show that systolic blood pressure was reduced by a statistically significant average of 36 mm Hg in 8 patients at 90-days follow-up. The scientific literature demonstrates that only a 5 mm Hg reduction in BP results in a 14% decrease in stroke, a 9% decrease in heart disease, and a 7% decrease in mortality.
"Our PARADISE system is designed to offer a minimally invasive ultrasound therapy to resistant hypertension patients to help reduce their blood pressure," said Mano Iyer, CEO, ReCor Medical. "These updated clinical data will boost our momentum as we make ready to launch PARADISE in Europe."
PARADISE includes a 6 French-compatible catheter with a cylindrical transducer that emits ultrasound energy circumferentially, allowing for a rapid and highly efficient renal denervation procedure. The advantage of PARADISE is its ability to uniformly denervate all the way around the arterial wall while simultaneously cooling the endothelium, to help enable a safe, consistent, and fast renal denervation procedure.
These updated data were disclosed for the first time to corporate and other investors during a conference call today sponsored by Sanford C. Bernstein & Co., the sell-side research unit of AllianceBernstein L.P. Sanford C. Bernstein was founded in 1967 as an investment-management firm for private clients. Sanford Bernstein is consistently among the most highly ranked independent sell-side research teams, according to industry surveys conducted by third-party organizations.