Medovex shares rose slightly today after the company announced it won regulatory approval from the Australian Therapeutic Goods Administration for its DenerveX system.
The DenerveX system uses a slowly rotating burr to remove targeted facet joint synovial membrane and radiofrequency ablation technology to destroy tissue and denude any residual nervous and synovial membrane on the joint, effectively removing sensory tissue from it, the Atlanta-based company said.
The approval is the 1st in the Asia Pacific region, Medovex said, and came ahead of its expected approval. The company said it is slated to conduct sales and product training with its Australian distributor on Sept. 17, with initial procedures anticipated for shortly after.
“We’re clearly very pleased to have received regulatory approval ahead of schedule for the marketing and sale of our DenerveX Device in Australia. This paves the way for entry into a very important area globally, Asia Pacific. Australia is a highly regarded market by many in the global medical community for the quality of care and delivery of the latest technology for the treatment of chronic disease such as facet joint pain. Since announcing receipt of CE Mark in less than just 3 months ago, we have now received orders which include countries from 3 continents, the EU, Latin America and now Asia Pacific,” prez & COO Patrick Kullmann said in a press release.
Shares in Medovex rose 1.7% today, closing at $1.17.
In July, Medovex said it sold its 1st DenerveX system, and that the device had been used in its 1st commercial procedures since winning CE Mark approval in the European Union a month prior.