Oneness Biotech Co., Ltd. announced that Bonvadis has obtained 510(K) Acute wound medical device approval and is currently applying for 510(k) Chronic wound medical device. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Bonvadis has obtained 510(K) Acute wound medical device approval and is currently applying for 510(k) Chronic wound medical device. Upcoming development plan: Scheduled completion date: In accordance with U.S FDA suggestion, company will submit the 510(k) chronic wound medical device after supplementing the required animal study data.

The company submitted technical documents in April 2024 in accordance with the U.S. FDA's review requirements in November 2023. The U.S. FDA temporarily notified the company to hold a conference call last night and requested additional animal study data. The company responded to the FDA's suggestion and will withdraw the application.

After completing the animal study and obtaining the data this year, the company will resubmit the 510(k) chronic wound medical device application. The regulatory authority will conduct the final review. Bonvadis is one of the wound medical devices developed by company.

It has obtained 510(k) approval for acute wound indications. After supplementing animal study data as required by the U.S FDA, the chronic wound application will be submitted in second half of 2024 and commercialization arrangements will be made simultaneously. Application will not affect the company's business.

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