Tele: 561.316.3330
Breaking Medical Device News

Friday, October 15, 2021
HomeFDARheOx System for Chronic Bronchitis: FDA Approves Commencement of Pivotal Trial

RheOx System for Chronic Bronchitis: FDA Approves Commencement of Pivotal Trial

February 22, 2021

RheOx System is designed to deliver non-thermal pulsed energy to the airways in the lungs to reduce mucus-producing cells, thereby improving the cough and mucus symptoms of chronic bronchitis.

Building upon the positive results of previous studies, the RheSolve Trial is a double-blind, randomized, sham-controlled study in COPD patients with moderate to severe chronic bronchitis. The study will randomize 270 subjects in a 2:1 ratio at up to 40 US centers and up to 10 international centers.

The trial will assess the safety and efficacy of the RheOx System when used to treat the symptoms of chronic bronchitis. The primary efficacy endpoint is the change from baseline to 6 months in the COPD Assessment Test (CAT) score.

“Chronic bronchitis is a debilitating disease which results in symptoms that impact the quality of life which commonly persist following guideline-based medical treatment. Our collaboration with the COPD Foundation to bring forward the CAT score as a meaningful patient-reported measurement helped enable a study design centered on an outcome reflecting the patient’s experience,” said Frank Sciurba, MD, Professor of Medicine in the Division of Pulmonary and Critical Care Medicine at the University of Pittsburgh, and Co-Principal Investigator. “Prior feasibility study results suggest that Bronchial Rheoplasty using RheOx is well-tolerated, reduces symptoms, and may significantly improve quality of life for patients. We look forward to studying this therapy in a larger, blinded, randomized trial.”

“With the approval of this rigorously designed trial, we are ready to commence enrollment at major medical centers across the United States,” said Jonathan Waldstreicher, MD, CEO of Gala Therapeutics. “This is a significant milestone towards bringing a breakthrough therapy to millions of chronic bronchitis patients in the US.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy