U.S. FDA notified Oneness today that Bonvadis for partial thickness wounds, closed post-surgical wounds, and burns (1st and superficial 2nd degrees) is 510(k) cleared.

Published Date:2024-05-23

Original Link:https://www.onenessbio.com/en/news_detail295_3.htm

Statement
No	1	Date of announcement	2024/05/23	Time of announcement	07:33:08
Subject	U.S. FDA notified Oneness today that Bonvadis for partial thickness wounds, closed post-surgical wounds, and burns (1st and superficial 2nd degrees) is 510(k) cleared.
To which item it meets	paragraph 10			Date of events	2024/05/23
Date of occurrence of the event: 2024/05/23 New drug name or code: Bonvadis Indication: Bonvadis wound management medical device Planned development stages: In accordance with U.S FDA suggestion, our company will continue supplementing the required animal study data and submit the 510(k) for Bonvadis for use in full thickness chronic wounds. Current development stage: (1)File application/approved/disapproved/Each of clinical trials (include interim analysis): U.S. FDA notified Oneness today that partial thickness wounds, closed post-surgical wounds, and burns (1st and superficial 2nd degrees) is 510(k) cleared. (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: To plan for marketing and distribution. (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: i) In accordance with U.S. FDA suggestion, our company will submit the 510(k) for Bonvadis for use in full-thickness chronic wounds in 2024 H2 after supplementing the required animal study data. ii) For countries that accept the simplified registration through the US FDA 510(k), applications for multiple new indications will be submitted for market approval in 2024/25, with the goal of expanding Bonvadis’ indications in global markets. (2)Estimate responsibilities: Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is marketed. Market situation: According to the statistics of Reportlinker.com, the global market of advanced wound care products will grow at a CAGR of 6.5% and will reach 13.944 billion by 2026. To date, there have been no effective drugs or medical devices for the treatment of chronic wounds. 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)Oneness implements dual strategies of both medicinal product and medical device for development and marketing of our wound care products. Each type of product will comply with corresponding regulatory requirements to get earlier access to the markets. New drug Fespixon Cream has been approved as new drug in Taiwan, Singapore, Malaysia, and China markets. Bonvadis as a medical device has been cleared for acute wound management in the US, India, New Zealand, South Africa and Thailand. It is cleared for scar management in European Union. (2)In order to expand the intended indications, the company submitted 510(k) in accordance with the U.S. FDA’s review requirements in 2023 Q4 for partial and full thickness chronic wounds (including diabetic ulcer, pressure ulcer, and venous ulcer), post-surgical wounds, and burns, etc. The company submitted technical documents in April 2024 (review deadline set for 2024.05.22), the U.S. FDA held a conference call at 2024.05.16 and provided two suggestions: i) Given the request for additional animal study data, it is suggested for the company voluntarily withdraw the submission and resubmit it after providing supplementary animal study data. Or ii) Direct notification of rejection will be issued based on the current review results. (3)In addition to agreeing to voluntarily withdrawal of the submission as per FDA suggestion, our company proactively submitted the requested documents to the FDA (not indicating new animal study data). Today, we received notification from the FDA that Bonvadis for partial thickness wounds, closed post-surgical wounds, and burns (1st and superficial 2nd degrees) is 510(k) cleared). (4)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.