OptMed Inc. receives clearance from the U.S. Food & Drug Administration (FDA) for its 510(k) TearRepair™ Liquid Skin Protectant

PR Newswire · 10/16 16:07

NEW YORK, Oct. 16, 2024 /PRNewswire/ -- OptMed, Inc. proudly announces it has received a letter from the U.S.Food & Drug Administration (FDA) clearing its 510(k) TearRepair™ Liquid Skin Protectant.

TearRepair™ Liquid Skin Protectant is a non-cytotoxic, methylidene malonate based, rapid-drying liquid barrier film for the protection of the skin. It is applied as a liquid and dries within minutes, adhering to the contours of the skin to form a transparent flexible film. TearRepair™ will wear off naturally and is provided sterile. 

Ervin Braun, OptMed CEO commented, "This is a significant and important milestone for our company. OptMed will aggressively move forward to commercialize TearRepair™. Braun added, "OptMed's proprietary methylidene malonate platform technology provides the company flexibility to further develop new product options to protect skin as well as address acute, surgical, and chronic wounds like lacerations, incisions, open wounds, and potentially internal applications."

Optmed, Inc. has been developing a completely new and revolutionary medical adhesive for over 10 years, whose chemistry, methylidene malonate, is unlike any other chemistry offered to the market and indeed may be integral to revolutionizing surgical procedures in the future. 

OptMed, Inc. is a privately held medical device company that is engaged in the development, manufacturing, and commercialization of methylidene malonate-based products. With this FDA clearance, Optmed now can offer a line of skin protectants and topical surgical adhesives. While this is a significant milestone for the company, Optmed's future steps include pursuing the internal surgical adhesive market with its proprietary polymer chemistry.

For more information contact:

Ervin Braun

CEO - OptMed

M:(203) 273-7450

E-Mail: ebraun@optmed.com 

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SOURCE Optmed, Inc.