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News & Insight

•2025-10-03•

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

The advanced wound care market in Mexico and Latin America is experiencing significant growth, driven by an increase in the number of injuries caused by chronic diseases, particularly diabetes. Mexico is the second largest healthcare market in Latin America, with a diabetes prevalence rate of 16.4%, and there is an urgent need for efficient chronic wound care.
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•2025-10-03•

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

According to the International Diabetes Federation (IDF), there are approximately 6.36 million people with diabetes in Thailand. However, due to the lack of effective and cost-effective drugs or medical devices for chronic wounds, the annual burden of wound care is currently estimated to exceed USD 700 million (Int Wound J. 2023 Nov 14;20(10): 3935–3938).
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•2025-07-28•

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

Oneness has received notification from the agent today that the medical device registration application of Bonvadis® for all indications has been accepted by AMMPS in Morocco.
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•2025-06-10•

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

After a three-year, three-phase application process, our product has obtained 510(k) clearances in the U.S for various acute and chronic wound indications.
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•2025-05-21•

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

Oneness has received notification from the agent today that the product topical cream received medical device marketing authorization approval for all indications in wounds under ARTG certificate number DV-2025-MC-09357-1 and with permission to be marketed in the Australia.
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•2025-05-09•

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

According to Invest India, the country’s medical device market is valued at approximately USD 11 billion and is one of the fastest-growing among emerging markets. With a projected 15% CAGR — 2.5 times the global average — the market is expected to reach USD 50 billion by 2030.
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•2025-04-23•

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

With a population of approximately 108 million and a diabetic population of approximately 11 million, Egypt's wound care market has great potential.
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•2025-04-16•

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

The demand for wound care products in Australia continues to grow steadily. According to the International Diabetes Federation Diabetes Atlas, 11th Edition (2025), the number of people living with diabetes in Australia has reached 1.69 million, reflecting a continuous rise in prevalence.
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•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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