The 30-patient study is designed to measure the efficacy of applying NEXGEL’s hydrogel during laser hair removal in eliminating harmful particles or plume during treatments
Several states have already either instituted or are considering surgical plume protection mandates as a requirement to contain the toxic byproduct of laser procedures
LANGHORNE, Pa., July 18, 2024 (GLOBE NEWSWIRE) -- NEXGEL, Inc. (“NEXGEL” or the “Company”) (NASDAQ: NXGL), a leading provider of medical and over-the-counter (OTC) products including ultra-gentle, high-water-content hydrogels for healthcare and consumer applications, and Innovative Optics US dba Vanalay, a leading supplier of safety products and personal protective equipment for medical, surgical and aesthetic healthcare facilities globally, today announced initiating an institutional review board (IRB) study funded entirely by Innovative Optics US dba Vanalay in accordance with the FDA, on the benefits of hydrogel application during laser hair removal.
While laser hair removal has proven to be effective in permanently removing hair, it can be associated with the release of a plume that contains airborne particles and hazardous organic compounds, which if inhaled may affect the short and long term health of professional providing the treatments. At present, well over a dozen states have enacted legislation mandating the use of plume evacuation systems in order to mitigate the hazards and risks of exposure to the plume.
The unique properties of NEXGEL’s high-water content hydrogel potentially may offer a long-needed industry-wide solution for absorbing and capturing plume during laser hair removal when applied to the surface of the skin before the procedure begins. In addition, the application of hydrogel may also allow for more effective laser hair removal, reduce the amount of pain experienced during the treatment and could be a practical solution for future that meets the requirements for regulatory compliance.
NEXGEL and Vanalay have initiated a human trial being conducted at the Florida Clinical Research Center by plastic surgeons, Dr. Barry DiBernardo of New Jersey Plastic Surgery and Dr. Jason Pozner of Sanctuary Medical Aesthetic Center in Fort Lauderdale, Florida. NEXGEL’s hydrogel will be applied to 30 patients prior to laser hair removal treatments with the primary outcome measure being the reduction of plume in the air during these procedures. NEXGEL and Vanalay expect top-line data from the study during the fourth quarter of 2024.
Adam Levy, CEO of NEXGEL, commented, “We continue to uncover a broad range of OTC and cosmetic applications for our hydrogel due to its high-water concentration and unique transdermal characteristics. The opportunity to partner with Vanalay is a tremendous testament to the strength of our core product. I would like to thank Vanalay for bringing this idea and potentially large opportunity to our attention. With the outcome of this study, we hope to bring to market a solution that can alleviate the concern of potential health problems for clinicians and their patients during these procedures. If this is indeed the case, Vanalay will be an invaluable partner in bringing the technology to market given their considerable contacts and deep understanding of the laser aesthetics market.”
