Senseonics Publishes Positive Longitudinal Performance Over Multiple Sensor Insertions and Removal Cycles of the Eversense CGM System

Posted in Biotech by Medtech[y] Staff

November 21, 2019 • 2 min read

​Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and commercialization of the first and only long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, announced the publication of an assessment of the performance of multiple sequential cycles of Eversense 90 and 180-day CGM System...

Merit Medical Receives FDA Breakthrough Device Designation for WRAPSODY Endovascular Stent Graft System

Posted in Medical Device by Medtech[y] Staff

November 21, 2019 • 2 min read

​Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the Merit WRAPSODY Endovascular Stent Graft System....

Biogen Announces Enrollment Completion of Global Phase 3 Gene Therapy Study for an Inherited Retinal Disorder

Posted in Biotech by Medtech[y] Staff

November 21, 2019 • 2 min read

Biogen Inc. (Nasdaq: BIIB) announced today the enrollment of the last patient in the global Phase 3 STAR clinical study, which is evaluating the investigational gene therapy timrepigene emparvovec (BIIB111/AAV2-REP1) for the treatment of choroideremia (CHM). CHM is a rare, degenerative, X-linked inherited retinal disorder that leads to blindness....

Trevena Announces Publication of Results from Phase 3 “Real World” Safety Study for Oliceridine in The Journal of Pain Research

Posted in Biotech by Medtech[y] Staff

November 20, 2019 • 2 min read

​Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced publication of results from the Phase 3 open-label safety study (ATHENA) for IV oliceridine in The Journal of Pain Research....

CRISPR Therapeutics and Vertex Announce Positive Safety and Efficacy Data From First Two Patients Treated With Investigational CRISPR/Cas9 Gene-Editing Therapy CTX001 for Severe Hemoglobinopathies

Posted in Biotech by Medtech[y] Staff

November 19, 2019 • 2 min read

​CRISPR Therapeutics (NASDAQ: CRSP) and Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced positive, interim data from the first two patients with severe hemoglobinopathies treated with the investigational CRISPR/Cas9 gene-editing therapy CTX001 in ongoing Phase 1/2 clinical trials....