EMulate Therapeutics® Submits Application for CE Mark

Rapid Unit Sales of Medical Masks to Account for Incremental Revenues in the Global Market Through the COVID-19 Crisis Period

Medical facilities are highly dependent on the use of medical masks during surgeries. The availability of different versions of mask for different applications across different end-users, such as ambulatory surgical centre’s, hospitals, dental settings, etc., are expected to fuel the growth of the medical mask market throughout the forecast period.

Proximie Raises $38m Series B Funding To Accelerate Its Expansion in U.S. and European Markets

F-Prime Capital led financing, joined by Questa Capital, Eight Roads, and Maverick Ventures

RhoVac Reports to Mount Sinai Hospital in New York Join Phase IIb Study in Prostate Cancer

The participation of Mount Sinai was directly caused by the FDA approval of RhoVac's Fast Track Designation.

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.

spot_img

DON'T MISS

Related Articles