Developer of innovative solution for sinus surgery, SinuSys Corp., is to initiate a U.S. clinical trial studying the company’s proprietary Restora™ technology platform. The system incorporates a steroid-eluting spacer which is designed to even out the post-insertion delivery of steroid drugs, thereby avoiding inflammatory response and clinical consequences of a single bolus.
Background
The Restora spacer is made of a non-resorbable rate-controlled membrane that delivers a steady dose of an anti-inflammatory agent (steroid) over a period of seven days. Because of its ability to locally and consistently deliver the drug, SinuSys says it has the potential to mitigate systemic use of steroids, which have been shown to be a health risk for patients. Restora also provides mechanical support which, in combination with the steroid elution should prevent nasal tissue scarring and inflammation post-FESS.
The newly announced, double-blind randomized trial will evaluate the investigational SinuSys technology in up to 50 patients with chronic rhinosinusitis. The study will compare the Restora device with the current standard of care, its primary endpoint being reduction in inflammation and scarring as measured by the Lund-Kennedy score at one month post-procedure. Secondary endpoints include the incidence of post-operative interventions and formation of synechiae (scarring of nasal tissue) at one month as well as and other outcomes measurements, including SNOT (Sino-Nasal Outcome Test) 22, evaluated at three months post-procedure.
The trial is sponsored by Dr. Peter Catalano at St. Elizabeth’s Medical Center in Boston and Dr. Mahmoud Ghaderi at Mercy Hospital in Philadelphia, with Dr. Catalano serving as principal investigator.
Investigator comments
“I look forward to evaluating this new, easy to use sinus spacer which promises to deliver a more predictable dose of a therapeutic agent during the time when its presence is most important to the healing process,” said Dr. Catalano.
Company comments
“We developed Restora at the request of leading physicians, who asked for a safe, mechanically robust and bio-inert spacer with longer and more stable drug delivery, with a view towards improving upon the current therapy today,” said SinuSys Chief Executive Officer Thomas Schreck. “While this study is adjunctive to surgery, the SinuSys Restora technology platform also offers the potential to enable a stand-alone procedure for virtually any patient requiring local drug delivery. This drug-infused device was developed based on the company’s many years of institutional experience working with drug delivery technology.”
Source: SinuSys Corporation
published: October 13, 2015 in: Clinical Studies/Trials, ENT