Zelegent was born of the brainstorm of two of the world’s foremost authorities on snoring pathology and treatment. Dr. David Volpi, one of New York City’s foremost snoring specialists and head of eOs Sleep, formerly the Manhattan Snoring and Sleep Center, and Dr. Yosef Krespi, the Director of the Center for Sleep Disorders, and the NYHNI Professor of Clinical Otolaryngology, Columbia University, dreamed up a novel tool. It would allow sleep specialist otolaryngologists to perform a simple, elegant, office-based interventional procedure that alleviates the airway obstructive symptoms of snoring. It would do this by acting on the soft palate, the anatomic cause of most snoring, rather than the base of the tongue. They called their creation “Snorx.”
Schematic showing the original concept conceived by Krespi and Volpi for a simple office-based procedure to shorten the soft palate of snoring patients
In December 2014, Drs. Krespi read in a press release that the former President and COO of dental laser company Biolase, Inc., Alexander Arrow, was leaving after having managed the company through an unusual turnaround and brought in a new management team. What Dr. Arrow immediately saw in Drs. Krespi’s and Volpi’s Snorx was an alternative to all the unpopular or ineffective snoring interventions available today, because it avoided the three main limitations of snoring interventions: that they either (a) require a patient to wear something in their mouth at night, or (b) involve painful surgery, or (c) work by moving the base of the tongue forward, which misses the anatomic cause of most snoring. It took only about a week of due diligence for Dr. Arrow to be convinced to join the new company as CEO, incorporated as Snorx, Inc. in January 2015.
Dr. Arrow set about to build Snorx, Inc. into a significant and valuable commercial enterprise. He began by screening and interviewing prospective component suppliers for the proprietary curved needle and handle, the novel implantable resorbable palate suspension implant, and kitting and packaging. He recruited a conscientious and reliable regulatory executive, David Humbert, to be the new company’s VP of Regulatory and Clinical Affairs. He began recruiting a Clinical Advisory Board.
By February 2015, the Snorx procedure had been performed in some 28 patients in the New York Head and Neck Institute (NYHNI) with encouraging initial results.
In March 2015, institutional investors began to take notice about the progress the company was making toward what is arguable the largest opportunity in the ENT space, and investment discussions heated up. Vendor planning and selection intensified. The company’s quality system and Standard Operating Procedures (SOPs) became to take shape.
Zelegent CEO Alexander Arrow, MD on the day the Company moved in to its new office space in EvoNexus in Irvine, California
In April 2015, the company received word that it had been accepted into the prestigious EvoNexus technology company incubator. Dr. Arrow moved the company into its new office space on May 8th. The new higher-profile of the company attracted more attention, including from noted branding expert Dean Del Sesto of Breviti to Snorx, which lead to an engagement to re-name the product, and along with it, the company. This lead to the re-naming of Snorx, Inc. into Zelegent, Inc. on May 12, 2015, with the name Snorx being retired for good. Zelegent’s “z” beginning is reminiscent of sleep, it rhymes with intelligent and sounds somewhat like elegant, and the “ent” at the end is a catchy solute to the clinical specialty for whom the company’s products are designed.
Also in April Dr. Arrow succeeded in recruiting a new VP of Engineering, Joe Paraschac, might be the only engineer in the world with an extensive background in all of the three most important fields for the development and refinement of Zelegent’s lead product: Suture Handling, Needle Design, and surgical treatment of Sleep Disorders. Joe is the inventor of 30 issued medical device patents, including 12 in the field of sleep apnea and one related to suture handling. He is simply meant to be part of Zelegent.
In May, in EvoNexus, Zelegent completed the five-month process of recruiting a “dream team” of advisors for its Clinical Advisory Board. The five sleep disorder specialists, Drs. Peter Catalano, Michael Friedman, Boyd Gillespie, Sam Mickelson, and Tucker Woodson, constitute some of the most influential and sought-after practitioners in the field. Zelegent is fortunate to be guided by these thought leaders of the field in matters relating to clinical development and physician preference matching.
In June 2015, the company unveiled its first set of pilot clinical trial results at the 3rd Congress of European Otorhinolaryngology and Head and Neck Surgery (ORL-HNS) in Prague, Czech Republic. Dr. Krespi gave the presentation, which 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 the device. The endpoints included improvements in quality of life, sleep quality, and the elimination of snoring.
Today, the young company is entering its pre-commercialization stage and anticipates filing its first 510(k) applications in 4Q 2017, and beginning commercial sales in 2018.
Zelegent Chairman Yosef Krespi, MD unveiling the results to Zelegent’s pilot clinical trial in Prague, Czech Republic
CAUTION — Investigational device. Limited by Federal (or United States) law to investigational use.