We are a clinical-stage medical device company, incorporated in the State of Delaware in 2007, focused on the development and commercialization of novel surgical adhesives for the localized treatment of patients with external and internal wounds. Our proprietary technology platform is based on a chemistry called methylidene malonate (“MM212”), a biocompatible polymer originally designed for drug delivery which has been extensively tested for biocompatibility and adhesive properties in topical and internal applications. MM212-based surgical adhesives have unique versatile properties which include strong bonding properties, the ability to bond to tissues in wet environments, elastic properties and biocompatibility with human tissues. Our initial product candidates, BondEase® Topical Skin Adhesive (“BondEase”) and TearRepair Liquid Skin Protectant (“TearRepair”), are biocompatible tissue adhesives for topical applications. BondEase was designed as a topical adhesive for the closure of acute incision and laceration wounds and TearRepair was designed as a topical skin protectant for fragile and damaged skin, such as for skin tears of the elderly.
In December 2015, we received clearance from the U.S. Food and Drug Administration (“FDA”) to market BondEase in the United States. However, we have not yet started to market and sell BondEase, as we needed first to scale up its manufacturing process and make certain improvements to ease the delivery of the adhesive on the wound. We have now completed the scale up of the manufacturing process and the product improvements for BondEase, which included changes to the manufacturing process of the active component within the monomer formulation, the composition of the monomer and activator formulations, and changes to device design. We have evaluated the improved BondEase product and have determined that it is substantially equivalent to the device that received FDA clearance, and we believe that no additional animal studies or human clinical trials will be required by the FDA. We anticipate that we will file a new application with the FDA to obtain clearance to market BondEase in the United States within three months of the completion of this offering.
We are also planning to file an application with the FDA within three months of the completion of this offering to obtain clearance to market TearRepair in the United States. We are also at the early stage of development of our adhesive platform for two additional clinical indications to protect chronic wounds and to seal internal wounds and organ leakage. These two clinical applications are unique as there are currently no surgical adhesives approved for chronic wounds and very few adhesives approved for internal wounds, and we believe these few adhesives have serious shortcomings. We believe that our chemistry with unique mechanical performance in a wet environment and its safety profile could make these two clinical applications potential candidates for the treatment of chronic wounds, internal wounds and organ leakage.
**Note: We have not yet generated any revenue from product sales. We have a history of net losses and an accumulated deficit. Our net loss for the 12 months ended March 31, 2022, was $3.86 million.
(Note: OptMed, Inc. filed its S-1/A dated July 26, 2022, with updated financial statements through March 31, 2022, but still no terms for its IPO. OptMed, Inc. filed its S-1 (prospectus) on June 15, 2022.)
|Industry:||Medical device - Surgical adhesives|
|Address||745 Fifth Avenue, Suite 500 New York, New York 10151|
|Phone Number||(646) 898-2004|
|View Prospectus:||OptMed, Inc.|
|Revenues||$0 mil (last 12 months)|
|Net Income||$-3.86 mil (last 12 months)|
|Price range||$0.00 - $0.00|
|Est. $ Volume||$23.0 mil|
|Manager / Joint Managers||EF Hutton|
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|Quiet Period Expiration Date:||Available only to Subscribers|
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