Vertex Pharmaceuticals (Nasdaq:VRTX) announced today that the FDA lifted the clinical hold placed on the Phase 1/2 trial of VX-880. Boston-based Vertex designed VX-880 as a stem cell-derived fully differentiated pancreatic islet cell replacement therapy for people with type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemia. It could potentially restore the body’s ability […]
Clinical Trials
GlucoTrack provides positive update on next-gen glucose monitor
GlucoTrack (Nasdaq:GCTK) announced today that its second-generation glucose monitor device has shown promising results in analyses. Rutherford, New Jersey-based GlucoTrack — formerly known as Integrity Applications (Nasdaq:IGAP) — earlier this year completed lab testing of the non-invasive GlucoTrack 2.0 clinical prototype system and has observed better-than-expected accuracy and performance with the technology. According to a […]
GI Dynamics EndoBarrier meets endpoints in diabetes, obesity study
GI Dynamics today announced the results of a study of its EndoBarrier system that met efficacy and safety endpoints. Boston-based GI Dynamics designed its EndoBarrier endoscopically delivered device therapy as a non-surgical, alternative treatment for type 2 diabetes and obesity for patients who do not have adequate control of their conditions through their current medication and […]
Data shows cost benefits with Pear Therapeutics digital therapeutic for opioid use disorder
Pear Therapeutics (Nasdaq:PEAR) today shared real-world data highlighting low costs with its reSET-O prescription digital therapeutic (PDT). Boston-based Pear Therapeutics’ reSET-O represents the only FDA-authorized PDT for the treatment of opioid use disorder (OUD). According to a news release, results from a 12-month, real-world data study of reSET-O demonstrated reduced healthcare resource utilization and associated […]
Early study supports experimental hydrogel injection for chronic low back pain
A study demonstrated that an experimental hydrogel formulation was safe and effective in substantially relieving chronic low back pain. Research presented at the Society of Interventional Radiology Annual Scientific Meeting in Boston supported the hydrogel, which was injected into spinal discs in an effort to relieve chronic low back pain caused by degenerative disc disease […]
Data supports Beta Bionics’ iLet bionic pancreas
Beta Bionics announced today that a trial of its iLet bionic pancreas met key endpoints, including reduced HbA1c. Dr. Roy W. Beck and clinical investigators presented the results of the multi-center, randomized Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT) at the American Diabetes Association (ADA) 82nd Scientific Sessions in New Orleans. Read: The biggest stories […]
Pear Therapeutics reports positive real-world data for chronic insomnia treatment
Pear Therapeutics (Nasdaq:PEAR) today announced real-world data from a trial of its Somryst prescription digital therapeutic (PDT). Data showed that Somryst, the only FDA-authorized PDT for treating chronic insomnia, achieved significant reductions in symptoms of insomnia, anxiety and depression severity both immediately following treatment and at six-months follow-up. Boston-based Pear Therapeutics presented results at the […]
First patient enrolled in MedAlliance’s drug-eluting balloon trial
MedAlliance announced today that the first patient was enrolled in a trial of its Selution SLR sirolimus-eluting balloon. Last month, the company received FDA investigational device exemption (IDE) for the Selution SLR drug-eluting balloon, which it designed to provide a controlled sustained drug release, similar to a drug-eluting stent. The FDA IDE BTK (below-the-knee) Selution4BTK […]
The biggest stories from the American Diabetes Association (ADA) 2022 Scientific Sessions
For the 82nd time, the American Diabetes Association (ADA) Scientific Sessions convened to highlight all the innovations within the diabetes technology space. Major players like Dexcom, Medtronic, Abbott, Insulet and more continue to plug along, while companies like Bigfoot Biomedical, One Drop and others shared data backing the technology that they bring to the table. […]
Sernova touts data on implantable cell pouch for treating insulin-dependent diabetes
Sernova announced clinical data supporting the potential of its Cell Pouch system as a “functional cure” for insulin-dependent diabetes. London, Ontario-based Sernova designed its proprietary Cell Pouch system as an implantable and scalable medical device that forms a natural environment in the body for long-term survival and function of therapeutic cells that release necessary proteins […]
