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News & Insight

•2025-04-10•

Oneness has submitted 510(k) application of Bonvadis® for full thickness wound indications to the U.S. FDA.

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. 
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•2025-04-03•

The medical device registration application of Bonvadis® for all indications of wounds has been accepted by Brazil ANVISA. 

The demand for wound care products in Brazil is showing steady growth. According to a market report, the Brazilian wound care market is expected to reach USD 545.1 million by 2030, with a compound annual growth rate (CAGR) of 3.6%. The main drivers of this growth are improvements in healthcare infrastructure and the rising incidence of chronic wounds, particularly diabetic foot ulcers (DFUs). According to the International Diabetes Federation, there are 15.7 million adults with diabetes in Brazil, with a prevalence rate of 10.5%, the highest in Latin America. The continuous rise in diabetes prevalence is contributing to the increase...
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•2025-03-25•

Oneness Biotech Co., Ltd., has been granted the Brazil Good Manufacturing Practice (B-GMP) certification for Bonvadis® from Brazil ANVISA.

Oneness received the notification today from the agent that our product has passed the Brazilian Good Manufacturing Practice (B-GMP) certification according to the Brazilian Official Announcement (DOU) issued by ANVISA.
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•2025-03-18•

The medical device registration application of Bonvadis® for all indications in wounds has been accepted by UAE MOHAP. 

The advanced wound care market in the Middle East is showing stable growth, primarily driven by the increasing number of chronic wound cases, particularly DFU. Data indicates that the advanced wound care market in the Middle East is expected to reach USD 4.8 billion by 2028, with a compound annual growth rate (CAGR) of 5.8%. The rising prevalence of diabetes remains a key factor driving market growth, leading to an increased demand for innovative wound care solutions.
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•2025-02-15•

Oneness Listed in the S&P Global Sustainability Yearbook

Oneness Listed in the S&P Global Sustainability Yearbook for the Third Consecutive Year, Ranking Among the Top 10 in the Global "Pharmaceuticals Industry" for 2025
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•2025-01-29•

Oneness Biotech Co., Ltd., had been granted with MDSAP (Medical Device Single Audit Program) certification for medical device quality management system.

Oneness has received notification from the Notified Body, confirming that we comply with the MDSAP (Medical Device Single Audit Program) quality management system standards. The MDSAP certificate has been issued with the certificate number: MDSAP 803792
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•2025-01-28•

Oneness Granted with MDSAP Certification for Its Quality System

Oneness Biotech Co., Ltd., had been granted with MDSAP (Medical Device Single Audit Program) certification for medical device quality management system.
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•2024-11-04•

Bonvadis® topical cream received medical device marketing authorization approval for all indications in wounds for Saudi Arabia.

According to the International Diabetes Federation (IDF), the population of Saudi diabetic patients are more than 4 million people. The number of DFU patients is approximately 500,000. Current treatments in Saudi Arabia are mostly traditional remedies, and the incidences of ulcer infection and amputation are relatively high.
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•2024-05-23•

Bonvadis® Cleared as A Medical Device by US FDA.

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.
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