According to U.S. FDA's suggestion, the company agrees to withdraw the 510(k) for Bonvadis chronic wound and resubmit after the supplementing animal study data.

Published Date:2024-05-17

Original Link:https://www.onenessbio.com/en/news_detail288_3.htm

Statement
No	1	Date of announcement	2024/05/17	Time of announcement	10:08:58
Subject	According to U.S. FDA’s suggestion, the company agrees to withdraw the 510(k) for Bonvadis chronic wound and resubmit after the supplementing animal study data.
To which item it meets	paragraph 10			Date of events	2024/05/16
Date of occurrence of the event: 2024/05/16 New drug name or code: Bonvadis Indication: Bonvadis chronic wound medical device Planned development stages: Bonvadis has obtained 510(K) Acute wound medical device approval and is currently applying for 510(k) Chronic wound medical device. Current development stage： (1)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. (2)Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: Not applicable. (3)After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Not applicable. (4)Accumulated investment expenditure incurred: No disclosure of investment expenditure at the moment in consideration of future marketing strategies and to protect the interests of the company and investors. Upcoming development plan: (1)Scheduled completion date: In accordance with U.S FDA suggestion, our company will submit the 510(k) chronic wound medical device after supplementing the required animal study data. (2)Estimate responsibilities: Not applicable. Market situation: Not applicable Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 8 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.): (1)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 our 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 2024.H2, and commercialization arrangements will be made simultaneously. Application will not affect the company’s business. (2)According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application. New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks. The investors are advised to exercise caution and conduct thorough evaluation.