Navigation Links
FDA Accepts for Filing the Humanitarian Device Exemption Application For EMulate Therapeutics™ Hælo™ Pediatric System
Date:6/18/2019

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.

Media Relations Contact:
Dennis Kroft
dkroft(at)emulatetx.com
201-602-8354

Read the full story at https://www.prweb.com/releases/fda_accepts_for_filing_the_humanitarian_device_exemption_application_for_emulate_therapeutics_hlo_pediatric_system/prweb16385042.htm.


'/>"/>
Source: PRWeb
Copyright©2019 Vocus, Inc.
All rights reserved


Related medicine news :

1. Dr. Kevin Hogan Accepts New Patients with Missing Teeth for Dental Implants in Mt. Pleasant, SC, to Support Self Improvement Month
2. Periodontist, Dr. Curry Leavitt Accepts New Patients for All-on-4® Dental Implants in Las Vegas, NV
3. Newly Appointed President of Wisdom Natural Brands® Accepts Prestigious Recognition
4. Dr. Kim Ross Recognizes Stroke Awareness Month, Accepts New Patients with Periodontal Disease Annapolis, MD
5. East LA Dental Office, Smiles LA, Now Accepts New Patients With a Special Promotion
6. New Vitae Wellness and Recovery Now Accepts Waivers for Payment
7. The Nanotechnology Startup Challenge in Cancer Accepts 28 Teams to Launch Startups from Unlicensed NIH Inventions
8. Dr. Mason Miner Now Accepts New Patients from Cortez, CO, for Minimally-Painful Infant Frenectomy Laser Treatment
9. Dr. Frederick Thurston Now Accepts New Patients From Winter Haven, FL, In Need of Dental Implants
10. Dr. Joseph Gaspari Now Accepts New Allentown, PA Patients for Dental Implants
11. Dr. Kenneth Peavy Now Accepts New Gum Disease Patients From Greensboro, NC for Laser Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/23/2019)... ... July 23, 2019 , ... ... Las Vegas, a multidisciplinary pain management approach will be examined, helping healthcare professionals ... suffering with chronic or acute pain. These minimally invasive techniques are designed to ...
(Date:7/23/2019)... , ... July 23, 2019 , ... Shady Grove ... today the grand opening of its newest full-service fertility and in vitro fertilization (IVF) ... The new full-service location offers access to two leading, board certified reproductive endocrinologists, a ...
(Date:7/23/2019)... ... ... Spa Marbella at Mission Inn Resort & Club has unveiled a new menu ... derived from natural ingredients. , Whether guests elect to make a day of it ... , A six-hour, head-to-toe immersion provides female guests with the best of everything ...
(Date:7/21/2019)... ... July 22, 2019 , ... Surgical facelifts might be the gold ... face, but not everyone wants or needs surgery, according to cosmetic surgeon Dr. Richard ... Pa. , “For women and men who can’t tolerate the downtime associated with a ...
(Date:7/19/2019)... COLUMBUS, Ohio (PRWEB) , ... July 19, 2019 ... ... leadership team with the appointment of Nathan Okuley as its Director of Marketing ... strategy for the next phase of the company’s rapid growth while furthering the ...
Breaking Medicine News(10 mins):
(Date:7/23/2019)... ... July 23, 2019 , ... Breathe Life , ... Hamnett Hill , Partner at Diagram Ventures , has joined its board of ... of building and scaling early-stage technology businesses to the Breathe Life board at a ...
(Date:7/23/2019)... ... July 23, 2019 , ... Power T Handle, ... benefited from the Power T Handle, which increased surgical efficiencies and reduced surgeon ... by Christopher Ames, MD, Director of Spinal Deformity and Spine Tumor Surgery, University ...
(Date:7/19/2019)... ... July 19, 2019 , ... The new studies ... novel non-invasive transdermal (over-the-skin) technology, which is the leader in the field of ... clinical evidence obtained by Circularity over the past six years. The clinical work ...
Breaking Medicine Technology: