NEXGEL and Innovative Optics US Initiate Institutional Review Board (IRB) Study in Accordance with FDA of Hydrogel Application During Laser Hair Removal
NEXGEL (NASDAQ: NXGL) and Innovative Optics US dba Vanalay have initiated an IRB study to evaluate the efficacy of NEXGEL's hydrogel in eliminating harmful particles during laser hair removal. The 30-patient study, funded by Vanalay, aims to address concerns about surgical plume, a toxic byproduct of laser procedures. NEXGEL's high-water content hydrogel may offer a solution for absorbing and capturing plume, potentially improving treatment effectiveness and reducing pain. The study, conducted by plastic surgeons at the Florida Clinical Research Center, is expected to yield top-line data in Q4 2024. This collaboration could lead to a market solution addressing regulatory compliance and clinician health concerns in the laser aesthetics industry.
- Potential new application for NEXGEL's hydrogel in the laser hair removal market
- Partnership with Vanalay, a leading supplier in the medical aesthetics industry
- Study fully funded by Vanalay, reducing NEXGEL's research costs
- Addressing a growing regulatory concern in multiple states
- Potential to improve treatment effectiveness and reduce patient pain
- Study results not guaranteed to be positive
- Regulatory approval process may be lengthy and uncertain
- Market adoption of the new application may take time
Insights
NEXGEL’s initiation of an Institutional Review Board (IRB) study to assess their hydrogel's efficacy during laser hair removal marks a significant step in addressing health concerns associated with surgical plume exposure. The key aspect here is the study's potential to demonstrate the practical benefits of NEXGEL’s hydrogel in reducing harmful airborne particles during laser hair removal procedures.
Several states have already mandated the use of plume evacuation systems, underscoring the industry's need for effective solutions. The success of this study could position NEXGEL’s hydrogel as a highly sought-after product, enhancing its market potential substantially. This is particularly impactful given the growing regulatory focus on surgical plume management.
Short-term, the completion of the study and positive results could drive increased interest and investment in NEXGEL. Long-term, if the hydrogel proves effective, it may lead to broader adoption across states and various healthcare settings, significantly boosting the company's revenue streams.
Retail investors should note the timeline, as top-line data is expected by the fourth quarter of 2024. Positive outcomes could result in considerable appreciation of NEXGEL's stock, given the regulatory and health safety implications involved.
The collaboration between NEXGEL and Vanalay to explore hydrogel applications during laser hair removal represents a strategic alliance that could disrupt the aesthetics market. The unique properties of NEXGEL’s hydrogel align well with current legislative trends mandating plume evacuation systems, indicating a strong market potential if the study results are favorable.
This trial, funded entirely by Vanalay, highlights the confidence in NEXGEL’s technology and underscores the potential commercial benefits. The ability to offer a product that not only meets regulatory requirements but also enhances the efficacy and comfort of laser hair removal procedures could position NEXGEL as a leader in this niche market.
From a market perspective, the successful outcome of this study could open new distribution channels and partnerships, enhancing the company's market share and boosting its competitive edge. Investors should watch for any announcements regarding study results and subsequent market strategies, as these could significantly impact the company's valuation and growth trajectory.
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
FAQ
What is the purpose of NEXGEL's (NXGL) IRB study with Innovative Optics US?
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