DEBx Medical receives Australian TGA approval for DEBRICHEM

Rotterdam, The Netherlands, March 19, 2021 – In early February, we finally obtained our ISO 13485:2016 certificate and our CE-certificate for DEBRICHEM. DEBRICHEM is a topical desiccantion gel for chemical wound debridement and treatment of chronic infected wounds. The CE approval allows our company to file for national registration in many countries, and in the end it lays the foundation for DEBRICHEM to be sold globally, except for the USA. 

Obtaining these certificates has turned out to be only the beginning of an intense workload for our team. Over the past month, we have activated and supported our sales and distribution network to start preparing for the launch of our product within their territory. 

It is therefore our great pleasure to announce that we received the Australian TGA approval for DEBRICHEM this morning. Another important market just opened its doors for our product. Together with our distributor, we will now start treating cases in several wound clinics in the country to get them familiar with the disruptive characteristics of our product.

Simultaneously our team will keep pushing so that the following months, we will obtain further sales approvals around the globe. For some regions, we are still looking for a distributor within wound care to support us on our mission to deliver affordable, efficient and easy-to-apply treatment of chronic wounds into daily clinical practice. 

For partnering discussions, please get in touch with our sales representatives via our contact page.

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