August 28, 2019
EMulate Therapeutics, Inc., a clinical-stage therapeutic device company developing non-invasive treatments for cancers and other serious diseases, announced it has submitted an application for a CE Mark in the European Union (EU) to commercialize its Voyager ulRFE® system for treatment of patients with brain cancer – both recurrent and newly diagnosed glioblastoma (GBM).
EMulate Therapeutics President and Chief Executive Officer Chris Rivera, made the announcement stating, “This submission for the CE Mark is an important milestone for the company, which upon approval will enable commercialization not only in the EU, but in other geographies as well. Our research and commercialization teams have worked diligently over the years to develop this unique medical device. The Voyager platform has the potential to treat a number of forms of cancers and other serious diseases in children and adults.”
“We are very excited about this submission toward the CE Mark for Voyager in the EU,” stated Donna Morgan Murray, Chief Regulatory Officer for EMulate Therapeutics. “Upon approval, the commercialization process will begin throughout the EU, and treatment can commence for patients with recurrent and newly diagnosed GBM.”
EMulate received ISO 13485:2016, a prerequisite for a CE Mark, in May of this year; as well as receiving MDSAP (Medical Device Single Audit Program) certification in July, which is pertinent to registration in other geographies.
EMulate recently announced it had received notice that the US Food and Drug Administration (FDA) accepted for filing the EMulate Therapeutics application for Humanitarian Device Exemption (HDE) for its Hælo™ Pediatric system, based on the Voyager platform. The FDA granted a Humanitarian Use Device (HUD) designation for the Hælo Pediatric system in March 2018 to treat diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), as well as other cancer indications in children.