Conversion Labs Announces FDA 510(k) Submission for its Laser Therapy Hair Regrowth System
NEW YORK, Nov. 08, 2019 (GLOBE NEWSWIRE) -- Conversion Labs, Inc. (CVLB) (“Conversion Labs” or “Company”), an e-commerce and telemedicine company focused on creating and scaling proprietary health and wellness brands, today announced it has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA) for approval of its Low-Level Laser Therapy (“LLLT”) Shapiro MD Laser Cap System. The Shapiro MD Laser Cap System is a portable device intended for hair regrowth utilizing low-level laser therapy technology.
“Our submission of the 510(k) application to the FDA represents our ongoing commitment to building the Shapiro MD product line into the most robust portfolio of clinically proven/studied hair loss products in the United States,” said Stefan Galluppi, CTO and COO of Conversion Labs. “Shapiro MD now offers an over the counter shampoo, conditioner and leave-in foamer, hair-biotic supplement, generic minoxidil, finasteride, compounded prescription drugs for male and female hair loss, and, once approved, an FDA cleared laser hair regrowth product.”
“As Shapiro MD continues to mature as a brand, the team remains heavily focused on both understanding our customers and doing everything possible to maximize their experience with our company and our products,” stated Justin Schreiber, Chairman & CEO of Conversion Labs. “When our customers think about Shapiro MD, we want them to know that Shapiro MD is a trusted destination for clinically proven, over the counter or FDA-approved products for their hair loss needs. We still have work to do, but adding an FDA cleared laser cap to our product line is a big step forward. We anticipate relatively quick clearance of the FDA 510(k) submission and believe that our Laser Cap product will contribute meaningfully to revenue growth over the coming 12 months.”
About Conversion Labs
Conversion Labs, Inc. (the "Company") is an e-commerce and telemedicine company with a portfolio of proprietary online brands. In June 2019, the Company entered into a joint venture with GoGoMeds.com, to sell, dispense and ship prescription drugs directly to consumers in all 50 states. The Company’s portfolio brands market and sell over-the counter (“OTC”) and prescription health and wellness products. OTC and prescription products are marketed directly to customers with an internal advertising platform leveraging a blend of social media, search, and e-commerce services, provided by Facebook, Google, and Amazon. On October 9, 2019, the Company received LegitScript certification, a service used by government agencies around the world to verify the legitimacy of online businesses. Conversion Labs owns 51% of PDFSimpli, an online direct-response software as a service business. To learn more about our corporate strategy, brands, or for investor relations please visit www.conversionlabs.com or email us at [email protected]
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, among other thing, statements regarding the offering, the expected gross proceeds, the expected use of proceeds and the expected closing of the offering. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to develop, market and sell its products; the expected benefits and efficacy of the Company's products; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including, our current reports on Form 8-K.Source: Conversion Labs, Inc.
Released November 8, 2019