Asepticys(TM) Files 510k Submission with U.S. FDA seeking Marketing Clearance for Novel TriFlect(TM) Disinfection Technology Following Successful Completion of Clinical Trial Requirements
ALEXANDRIA, Va., April 8, 2019 /PRNewswire/ -- Asepticys LLC, a leading innovator and developer of anti-infective pharmaceutical and consumer healthcare products, today announced the successful completion of multi-site human clinical trials for Asepticys' novel contact lens care solution containing TriFlect™ technology, and the submission of its 510k application to the U.S. Food and Drug Administration (FDA). The clinical trials involved over 320 patients at 12 sites across the United States. Asepticys' 510k application with the FDA marks a significant milestone towards commercial launch in the coming year of its first product using the ground-breaking TriFlect™ technology.
"Eye infection with contact-lens wearers is a growing problem," stated Dr. Rebecca Metzinger, Chief of Ophthalmology at the Southeast Louisiana Veterans Healthcare System. "According to figures from the Center for Disease Control1, over one-third of the nearly 41 million adults wearing contact lenses each year have sought medical attention for an infection associated with the use of their lenses. So it's not a surprise that clinicians at the Asepticys trial sites were incredibly enthusiastic about the performance of this newly developed TriFlect™ technology, as it provides a new standard for rapid disinfection of dangerous bacteria while increasing convenience for the patient."
"TriFlect™ technology is a breakthrough in disinfection that's poised to disrupt and become a new benchmark in the $1 billion U.S. contact lens care market," said Todd Rands, Chief Executive Officer at Asepticys. "The successful human clinical trials represent a major milestone for Asepticys. Once we have final marketing clearance from the FDA, we will quickly move forward with the commercial launch of this disruptive new product."
"There hasn't been enough innovation to combat the constantly evolving microbial threats all around us," added Mr. Rands. "Asepticys' highly effective TriFlect™ technology is fueling a pipeline of promising new infection-fighting products that raise the standards for safety and health in our homes and hospitals."
Asepticys develops Rx pharmaceuticals and OTC consumer healthcare products that provide fast-acting and broad-spectrum topical infection control against all major classes of pathogens – bacteria, fungal, viral, and amoeba. Utilizing its novel and patent-protected biocidal compound – called TriFlect™ Technology – the company is rapidly building a platform of topical anti-infective products that target and eliminate serious pathogenic infections. The company's technology is poised to disrupt the market for infection control, improving the lives of millions of patients. For more information, visit www.asepticys.com.
1 Cope JR, et al. Contact lens wearer demographics and risk behaviors for contact lens-related eye infections – United States, 2014. Centers for Disease Control and Prevention (CDC), MMWR Morb Mortal Wkly Rep. 2015;64(32):865-70.
c: (917) 763-6036
(Trademarks are the property of their respective owners)
View original content to download multimedia:http://www.prnewswire.com/news-releases/asepticys-files-510k-submission-with-us-fda-seeking-marketing-clearance-for-novel-triflect-disinfection-technology-following-successful-completion-of-clinical-trial-requirements-300825369.html