NEXGEL and Innovative Optics US Initiate Institutional Review Board (IRB) Study in Accordance with FDA of Hydrogel Application During Laser Hair Removal
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.”
About NEXGEL, Inc.
NEXGEL is a leading provider of healthcare, beauty, and over-the-counter (OTC) products including ultra-gentle, high-water-content hydrogels. Based in Langhorne, Pa., the Company has developed and manufactured electron-beam, cross-linked hydrogels for over two decades. NEXGEL brands include Silverseal®, Hexagels®, Turfguard®, Kenkoderm® and Silly George®. Additionally, NEXGEL has strategic contract manufacturing relationships with leading consumer healthcare companies.
About Innovative Optics
Innovative Optics, established in Maple Grove, Minnesota in 1993, has grown to become a leading supplier of safety products and personal protective equipment for medical, surgical and aesthetic healthcare facilities globally.
Our line of laser safety items includes laser loupe protection, laser glasses, IPL glasses, patient goggles, disposable eye shields, and laser barriers. We believe our job is to help educate and determine the best safety solutions for the needs of a broad scope of healthcare producers and the patients in their care.
Forward-Looking Statement
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (which Sections were adopted as part of the Private Securities Litigation Reform Act of 1995). Statements preceded by, followed by or that otherwise include the words “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “project,” “prospects,” “outlook,” and similar words or expressions, or future or conditional verbs, such as “will,” “should,” “would,” “may,” and “could,” are generally forward-looking in nature and not historical facts. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the Company's actual results, performance, or achievements to be materially different from any anticipated results, performance, or achievements for many reasons. The Company disclaims any intention to, and undertakes no obligation to, revise any forward-looking statements, whether as a result of new information, a future event, or otherwise. For additional risks and uncertainties that could impact the Company's forward-looking statements, please see the Company's Annual Report on Form 10-K for the year ended December 31, 2022, including but not limited to the discussion under “Risk Factors” therein, which the Company filed with the SEC and which may be viewed at http://www.sec.gov/.
Investor Contact:
Valter Pinto, Managing Director
KCSA Strategic Communications
212.896.1254
Valter@KCSA.com
Released July 18, 2024