Zelegent, Inc. Pilot Study Results Show Significant Improvement in All Study Endpoints
Outcomes data presented today at the 3rd Congress of European Otorhinolaryngology and Head and Neck Surgery in Prague, Czech Republic
IRVINE, CA (June 8, 2015) – Zelegent, Inc. (formerly Snorx, Inc.), presented clinical outcomes from its pilot clinical study today at the 3rd Congress of European Otorhinolaryngology and Head and Neck Surgery (ORL-HNS) in Prague, Czech Republic (http://www.europeanorl-hnsprague2015.com) by Dr. Yosef Krespi, Chairman of the Board of Zelegent. The clinical trial data presented included post-op and 4-6-month follow up results for the first 20 of the 45 subjects treated for snoring with the prototype version of Zelegent’s first device. The study was conducted at the New York Head and Neck Institute pursuant to a protocol approved by the Western Institutional Review Board. The endpoints included improvements in quality of life, sleep quality, and the elimination of snoring. The quantitative results, which were unveiled at 3:00 pm Central European today, showed that for the first 20 study subjects who have completed their 4-6 month follow-up visit:
Sixteen (16) of 20 subjects showed a measurable improvement in their post-procedure Epworth Sleepiness Scale score compared with their pre-procedure score. The mean score improvement was 32.2%, or 41.6% among the 16 who showed improvement. The Epworth Sleepiness Scale (ESS) was introduced in 1991 by Murray Johns, MD, of Epworth Hospital in Melbourne, Australia and has become a de-facto standard way of measuring sleep disorder severity by assessing daytime sleepiness.
Seventeen (17) of 20 subjects showed a measureable improvement in their post-procedure Snoring Outcomes Survey (SOS) score compared with their pre-procedure score. The mean score improvement was 48.8% or 58.2% among the 17 who showed improvement. The SOS is a proprietary set of seven questions devised by Drs. Yosef Krespi and David Volpi to assess specific snoring manifestations, including how the patient’s spouse or sleeping partner is being affected by the patient’s snoring.
Of the twelve (12) patients whose snoring was severe enough prior to treatment that it caused their spouses or sleeping partners to leave the bedroom during the night, nine (9) had improved enough post procedure for the spouse to stay in the same room through the night every night since the procedure.
Dr. Krespi stated that no Adverse Events were reported for the twenty (20) study subjects that received the implant and completed their follow-up visit.
Zelegent, Inc. is developing and refining the design of an innovative, minimally invasive and 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.
“We are encouraged by the initial results of our pilot clinical trial,” said Alexander K. Arrow, MD, CFA, Chief Executive Officer of Zelegent, Inc. “Our plan is to continue the post-procedure protocol at the 4-6 month mark for the remaining study subjects in the pilot study, complete design refinements of the implant and delivery device, and to initiate a multi-center study with the next generation of our device later this year.”
About Zelegent, Inc.
Zelegent, Inc. (formerly Snorx, Inc.), is a medical technology company that is developing, and plans to manufacture and market, innovative tools for physicians who treat sleep disorders. Zelegent was co-founded by two of the world’s leading authorities on sleep disorders, Dr. Yosef P. Krespi who heads the New York Head and Neck Institute Sleep Disorder Center, and Dr. David O. Volpi, founder of the eOs Sleep Network (formerly the Manhattan Sleep Center). The company’s mission is to develop 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 source of most snoring. The Zelegent tool is an investigational device only and is not for sale in the United States.
Comments are closed