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Arch Therapeutics Presents Corporate Update at the LD Micro Invitational on Tuesday, June 6, 2017
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FRAMINGHAM, MA -- (Marketwired) -- 06/06/17 -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of novel liquid, gel and solid hemostatic and wound care devices, today presented a corporate update at the LD Micro Invitational at the Luxe Sunset Boulevard Hotel in Los Angeles, California.
"This has been an exciting period for Arch," said Terrence W. Norchi, President and CEO of Arch Therapeutics, Inc. "As previously announced, we expect to file for a 510(k) allowance mid-year for AC5™ designed for external use. If the 510(k) filing is allowed by the FDA, we expect that the benefit will be significant in terms of business opportunity and technology validation. We have invested significant time and effort into accelerating our plans for this regulatory application in the US, and we continue to concentrate resources on this objective. We are currently working to scale up production while evaluating and developing further indications. We expect to have commercial product available in 2018."
The 510(k) pathway enables Arch to submit a regulatory application to the FDA for external use sooner than would be possible by solely relying on the premarket approval application ("PMA") pathway. The Company still plans on taking the products being developed for internal use through the PMA process. The ability to employ the 510(k) regulatory pathway for an external use product has been an important development, and it may significantly shorten the timeframe for obtaining regulatory allowance to market a product in the US, which potentially presents a significantly greater commercial opportunity compared to Europe.
Dr. Norchi indicated that in Europe, the Company continues to work with its supply chain partners to complete the obligations required to submit an application for a CE Mark. The Company is also evaluating the impact from recent changes to the European Medical Device Regulations on the timing of a CE Mark filing and approval and, in particular, the degree to which these recent changes may affect the Company's ability to submit a CE Mark application in 2017 as previously announced. Arch anticipates providing a further update when a definitive filing date is determined and plans to file for such approval as soon as reasonable and possible.
Norchi added, "In addition, the Company has made progress on its preclinical pipeline, which includes several product applications with high unmet medical needs. These include applications for chronic cutaneous wounds, burns, surgical adhesions, gastrointestinal anastomoses and ophthalmology.
"Arch was also recently notified that the Japanese Patent Office issued a favorable trial decision to maintain in its entirety an issued patent that had been disputed and which we previously exclusively licensed from the Massachusetts Institute of Technology."
Dr. Norchi concluded, "We believe that our current cash on hand will meet our anticipated cash requirements into the third quarter of Fiscal 2018."
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