Medical technology portfolio company Medovex said today it won CE Mark approval in the European Union for its DenerveX spinal denervation treatment system designed to treat facet joint syndrome.
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.
“We are clearly pleased to have accomplished this important milestone not just for our shareholders, but for all of those suffering from often debilitating lower back pain associated with facet joint syndrome. The CE Mark indicates a product’s compliance with applicable EU regulations and enables the commercialization of the DenerveX System in European countries. We look forward to initiating sales in the future through our already established international distribution network being able to offer surgeons, pain management specialists and patients an alternative, more cost effective and less invasive treatment option to the current surgical forms of treatment. The CE Mark is clearly the most significant milestone achieved in the company’s history to date,” prez & COO Patrick Kullmann said in a prepared statement.
The system consists of a DenerveX device kit with a single use medical device and a DenerveX Pro-40 power generator, Medovex said.
“Design, development and commercialization of our flagship patented DenerveX System has been years in the making. It was designed by surgeons for surgeons to be less invasive with faster recovery time than current surgical treatment options, and is designed to provide for a longer lasting treatment solution while offering potential savings to the health care system. We couldn’t be more pleased to have successfully reached this most important inflection point and look forward to moving into the commercialization phase of our business,” CEO Jarrett Gorlin said in a press release.
Last December, Medovex sold its Streamline IV suspension system assets to acute care focused healthcare company Skytron for an undisclosed amount.