Oneness Biotech announced a major milestone in its global commercialization of innovative medical devices, with the U.S. Food and Drug Administration (FDA) granting market approval for Bonvadis cream for full-thickness chronic wound indications. The approved indications include full-thickness and partial-thickness wounds, post-surgical wounds, first- and superficial second-degree burns, as well as chronic wounds such as diabetic foot ulcers, venous ulcers, and pressure sores—effectively covering both acute and chronic wound indications in the U.S. market.

Oneness Biotech CEO Cheng Shu-Ling stated that ON101, formulated with proprietary plant-derived extracts, benefits from a dual-path strategy as both a new drug and a medical device for global market expansion. The U.S. FDA's approval, which encompasses all three major types of chronic wounds in addition to burns and surgical wounds, not only enables regulatory cross-application for other FDA-recognized markets but also signifies strong regulatory endorsement with the final full-thickness wound indication. This greatly enhances the company’s position in ongoing global licensing and commercialization discussions.

Bonvadis, the company’s innovative wound care medical device, first received U.S. FDA approval for acute wound indications in 2022. After three years of continued development, Oneness obtained approval for partial-thickness chronic wounds in early 2024 and has now successfully received approval for full-thickness chronic wounds.

Cheng emphasized that the U.S. is the world’s largest market for wound care products, yet there remains a lack of effective treatments for chronic wounds. With no approved new drugs currently available for these conditions, demand for medical devices has grown steadily in recent years, especially as artificial dermis products remain prohibitively expensive.

Following its initial approval and launch in Taiwan, the new wound care product has since secured regulatory approvals in China, Singapore, and Malaysia. It is also undergoing substantive review processes in Indonesia, Vietnam, and the Philippines. In other regions, Oneness is pursuing medical device pathways to accelerate commercialization. The company has also completed major global quality certifications—including FDA QSR 820 CFR, GMP, MDSAP, and ISO 13485—laying a solid foundation for its international market deployment.

Resource: 合一醫材通過美國全皮傷口適應症上市許可