Today, Bonvadis is 510(k) cleared by the U.S. FDA for full-thickness chronic wounds, marking a significant milestone in international commercialization.

Published Date:2025-06-10

Original Link:https://www.onenessbio.com/en/news_detail361_1.htm

Statement
No	1	Date of announcement	2025/06/10	Time of announcement	19:25:42
Subject	Today, Bonvadis is 510(k) cleared by the U.S. FDA for full-thickness chronic wounds, marking a significant milestone in international commercialization.
To which item it meets	Subparagraph 10			Date of events	2025/06/10
1. Date of occurrence of the event:2025/06/10 2. New drug name or code: Bonvadis 3. Indication: Wound Dressing 4. Planned development stages: NA 5. Current development stage: (1) File application/approved/disapproved/Each of clinical trials (include interim analysis) results/occurrence of other major events affecting new-drug research and development: a. In August 2022, Bonvadis obtained U.S. FDA 510(k) clearance for substantial equivalence as a medical device for acute wound indications, granting its U.S. market approval. b. In May 2024, Bonvadis obtained U.S. FDA 510(k) clearance for indications including partial-thickness wounds, closed post-surgical wounds, and 1st and superficial 2nd degree burns, granting its U.S. market approval. c. Today, Bonvadis received U.S. FDA 510(k) clearance for full-thickness chronic wound indications, granting its U.S. market approval. The indications cleared by the U.S FDA including full- and partial-thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers. d. After a three-year, three-phase application process, Bonvadis has obtained 510(k) clearances in the U.S for various acute and chronic wound indications. (2) Once disapproved by competent authority, having each of clinical trials (include interim analysis) results less than statistically significant sense, or occurrence of other major events affecting new-drug research and development, the risks and the associated measures the Company may occur: Not applicable. (3) After obtaining official approval from competent authority, the results (include interim analysis) of statistically significant sense, or the occurrence of other major events affecting new-drug research and development, the future strategy: Conduct international market sales and promotion. (4) Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. 6. Upcoming development plan: (1) Scheduled completion date: Not applicable. (2) Estimated responsibilities: Oneness shall pay the licensor sales royalties at a certain percentage according to the licensing contract once the product is commercialized. 7. Market situation: The global advanced wound care products market has a compound annual growth rate (CAGR) of 15.7%, with no effective or economically viable treatment drugs or medical devices currently available for chronic wounds. 8. Any other matters that need to be specified (If an event occurs or is resolved by a company that is publicly offered or above, 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) Our company’s wound care product, ON101, adopts a dual-track strategy as both a pharmaceutical and medical device. Following a set plan and targeting specific markets, we have been applying for market access step-by-step. For the indication of full-thickness wounds, the product has already obtained market approval in three key markets: Saudi Arabia, Australia, and the United States. (2) Oneness is simultaneously pursuing commercialization in key global markets, adopting a flexible strategy and actively expanding through exclusive licensing, distribution, and co-marketing partnerships. (3) Unlike typical medical devices, Bonvadis has, over the past three years, established extensive clinical use cases internationally in wound care and gained scientific recognition for its therapeutic efficacy. It ranks among the top in the latest global meta-analysis on treatments for diabetic foot ulcers. (4) Gaining full-thickness wound indications 510(k) clearance in the U.S. is a key milestone, supporting further development of international commercialization. (5) 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. 9. 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.