June 18, 2019
FDA Accepts for Filing the Humanitarian Device Exemption Application For EMulate Therapeutics™ Hælo™ Pediatric System
Regulatory milestone involves device to treat diffuse midline glioma in children
SEATTLE (PRWEB) JUNE 18, 2019
EMulate Therapeutics, Inc., a clinical-stage therapeutic device company developing non-invasive treatments for cancers and other serious diseases, announced it has received notice that the US Food and Drug Administration (FDA) accepted for filing the EMulate Therapeutics application for Humanitarian Device Exemption (HDE) for the Hælo Pediatric system. The FDA granted the 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), in children.
Chris Rivera, EMulate Therapeutics President and Chief Executive Officer, made the announcement stating, “This is another important step for our company. Upon the HDE approval anticipated later this year, we will be able to begin commercialization of the Hælo Pediatric system in the US to treat DMG. Most importantly, we are on our way to providing a potential treatment for children with this aggressive and uniformly fatal condition.”
Donna Morgan Murray, Chief Regulatory Officer for EMulate, stated, “DMG, including DIPG, is an ultra-rare brain tumor that primarily effects children between the ages of 5 and 10 years of age. The median survival is less than 1 year following diagnosis. It is gratifying that we have the potential to bring this new and unique treatment to children suffering from this devastating disease.”
About EMulate Therapeutics
Headquartered in Seattle, EMulate Therapeutics is a clinical-stage therapeutic device company. EMulate has invented and patented a groundbreaking technology that utilizes precisely targeted ultra-low radiofrequency energy (ulRFE®) to specifically regulate metabolic pathways on the molecular and genetic levels – without chemicals, radiation or drugs – delivered via a simple-to-use non-sterile, non-invasive, non-thermal, non-ionizing investigational device. The company’s goal is to transform disease treatment on a global scale with ulRFE, which can potentially be applied to a wide range of medical conditions as well as to veterinary medicine and non-medical applications. EMulate’s initial focus is on the treatment of patients with brain cancer, who are not well served by conventional standard of care therapies, which often result in poor outcomes and devastating side effects. Pre-clinical work is focused on exploring new applications in oncology. In addition, EMulate’s Voyager system for adults with glioblastoma is an investigational medical device in clinical development.
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