Zelegent, Inc. Launches Multi-Center Snoring Reduction Trial
First Patients in the S.I.LE.N.C.E. Trial Underwent Elevoplasty Procedures Last Friday
IRVINE, CA (March 13th, 2017) – Zelegent, Inc., a clinical-stage medical technology company developing innovative tools for otolaryngologist sleep specialists, today announced the beginning of enrollment in its multi-center pivotal snoring reduction trial, the S.I.LE.N.C.E. study. The trial will evaluate the safety and efficacy of Snoring Intervention via Elevoplasty™ in a Non-surgical Clinical Environment (S.I.LE.N.C.E.).
The company’s first six clinical sites to receive Investigational Review Board (IRB) approval to begin enrollment are St. Elizabeth’s Medical Center in Boston, MA, the Medical University of South Carolina in Charleston, SC, ChicagoENT in Chicago, IL, the Entrust Medical Group in Orange, CA, and Park Avenue Sinus & Sleep Center and Staten Island University Hospital in New York, NY. The seventh and eighth centers, Cedars-Sinai Medical Center in Los Angeles, CA, and the Tibor Rubin VA Medical Center in Long Beach, CA, are pending IRB approval. The first two patients in the trial underwent Elevoplasty procedures last Friday, March 10th. The trial is expected to enroll 60-100 patients.
“We see the Elevoplasty procedure as a potentially important new alternative for non-apneic patients suffering from routine snoring who seek to both avoid wearing a nighttime appliance and avoid major surgery,” said Dr. Peter Catalano, MD of St. Elizabeth’s Medical Center. “We anticipate meeting or exceeding our enrollment goals quickly.”
Zelegent, Inc. is developing an innovative, minimally-invasive, advanced medical device that will be intended for use by otolaryngologist sleep specialists to perform an in-office, outpatient procedure that requires no general anesthesia, and that may alleviate snoring by shortening, suspending, and stiffening a patient’s soft palate.
“Initiation of the multi-center S.I.LE.N.C.E. Study fulfills our first major 2017 milestone.” said Alexander K. Arrow, MD, Chief Executive Officer of Zelegent, Inc. “We are optimistic that, if the clinical results of this pivotal, multi-center trial are consistent with the results obtained in our single-center pilot trial, the data will support a regulatory submission to the U.S. Food and Drug Administration later this year.”
About Zelegent, Inc.
Zelegent, Inc. (formerly Snorx, Inc.), is a medical technology company developing innovative tools for physicians who treat sleep disorders. The company’s mission is to develop, manufacture, and commercialize a novel, minimally-invasive, advanced medical device to be used by sleep specialist otolaryngologists to treat snoring by shortening, suspending, and stiffening the patient’s soft palate. The clinical technique, Elevoplasty™, is an office-based procedure designed to be less invasive than today’s surgical options.
The Elevo™ Kit is an investigational device only and is not for sale in the United States.
For updates, find Zelegent online at www.zelegent.com, or
Zelegent™ and Silence is Healthy™ are trademarks of Zelegent, Inc. Zelegent is part of the EvoNexus family of companies.
For further information, please contact:
Alexander K. Arrow, MD, CFA
Chief Executive Officer
5151 California Ave., Suite 150
Irvine, CA 92617