Oneness Biotech announced on March 12 that its flagship wound care product, Bonvadis, has officially received its Quality Management System certificate (Market Authorization) from the European Compliance Museum (ECM). This grants Bonvadis legal access to all 27 EU member states, covering a comprehensive range of indications.

• Broad Clinical Utility: The approval spans acute wounds (lacerations, burns), chronic wounds (diabetic foot ulcers, pressure sores), and scar management.
• Dual-Track Strategy: Oneness Biotech is tackling the US$300 billion global wound care market through a unique "Drug-Device Dual-Track" regulatory strategy. With the EU puzzle piece now in place, the company is positioned to accelerate licensing negotiations with international distributors.
• 2026 Outlook: Oneness Biotech’s international business unit will immediately launch commercialization plans across Europe, tailoring market entry based on regional healthcare reimbursement environments.

Resource: 合一全球佈局再傳捷報！Bonvadis 傷口醫材獲歐盟 27 國上市許可