Oneness Biotech announced on the 23rd that it has received notification from the U.S. Food and Drug Administration (FDA) approving its Bonvadis wound dressing for certain indications. The product has been granted 510(k) clearance for use on partial-thickness wounds, post-surgical wounds, and burns (first and superficial second-degree).
For the application of Bonvadis for full-thickness chronic wounds, Oneness Biotech will follow FDA recommendations and submit additional required animal study data. The company plans to resubmit the 510(k) application in the latter half of this year.
Oneness Biotech stated that for countries accepting FDA 510(k) streamlined registration, they will apply for new indication approvals for Bonvadis wound dressing between 2024 and 2025, aiming to expand its international market reach.
According to a market research report by Reportlinker.com, the global advanced wound care products market is expected to grow at a compound annual growth rate (CAGR) of 6.5%, reaching $13.944 billion by 2026. Notably, there are currently no effective treatments or medical devices for chronic wounds.
Oneness Biotech is employing a dual strategy of drug and device development to accelerate market access in multiple countries. The new drug Fespixon has already received approval in Taiwan, Singapore, Malaysia, and China. The Bonvadis wound dressing has obtained 510(k) clearance in the U.S., as well as in India, New Zealand, South Africa, and Thailand for acute wound indications. Additionally, it has received medical device approval for scar treatment in the European Union.
To further expand its product indications, Oneness Biotech submitted a 510(k) application in Q4 2023 for various new indications, including partial-thickness and full-thickness chronic wounds (such as diabetic ulcers, pressure sores, and venous ulcers), post-surgical wounds, and burns. The FDA review period for these submissions was set to conclude by May 22, 2024. During a teleconference on May 16, 2024, the FDA provided two recommendations: to supplement the application with additional animal study data or face potential non-approval.
Following the FDA's advice, Oneness Biotech agreed to withdraw its application temporarily to provide the necessary animal study data. Concurrently, the company proactively submitted the requested documentation that did not include new animal study data. Today, Oneness Biotech received FDA notification that Bonvadis has been granted 510(k) clearance for partial-thickness wounds, post-surgical wounds, and burns (first and superficial second-degree).
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