Intersect ENT(NSDQ:XENT) said today that it won FDA approval for its Propel Contour steroid-releasing implant for the treatment of chronic sinusitis in the frontal and maxillary sinsuses. The Menlo Park, Calif.-based company’s portfolio of steroid-releasing implants are used in patients undergoing ethmoid, frontal or maxillary surgeries to treat chronic sinusitis. Get the full story at […]
Clinical Trials
E-Qure wins FDA nod to expand chronic wound treatment device trial
Chronic wound treatment device developer E-Qure said today it won FDA approval to expand and launch a pivotal trial of its Bio-electrical Signal Therapy Device chronic wound treatment device. The New York-based company said its Bio-electrical Signal Therapy device is designed for non-invasively treating hard-to-heal chronic wounds, including pressure ulcers, diabetic foot ulcers, venous stasis ulcers and […]
Children’s National Health System highlights novel approach for cell therapy
Children’s National Health System touted data today from a Phase I dose-ranging study evaluating a cell therapy approach in patients with blood and bone marrow cancers for whom stem cell transplantation hasn’t worked. Results from the Resolve trial showed that 78% of patients responded to multi-tumor-associated antigen specific lymphocytes (TAA-L) treatment and 44% of patients […]
GlaxoSmithKline, Innoviva tout data for Relvar Ellipta inhaled drug combo
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) touted data today from a non-inferiority lung function study evaluating its inhaled, once-daily corticosteroid/long-acting beta2 agonist combination therapy in patients with asthma. The study showed that patients with well-controlled asthma could switch from the twice-daily Seretide Accuhaler to the companies’ once-daily Relvar Ellipta therapy without compromising lung function. Get the full story […]
Penumbra: Stroke study shows aspiration system equal to stent retrievers
Penumbra (NYSE:PEN) touted data from the Aster trial evaluating its aspiration system compared to a stent retriever as a first-line thrombectomy approach for acute ischemic stroke. The data showed that the company’s direct aspiration, first-pass technique (Adapt) compared favorably with a stent retriever – 85.4% of patients treated with Penumbra’s aspiration system met the study’s […]
Meril’s bioresorbable, drug-eluting vascular scaffold
Meril Life Sciences has developed a drug-eluting, bioresorbable vascular scaffold that the body can slowly degrade and wash away. The company’s MeRes100 is made of biodegradable polymers, PLLA and PDLLA. Sirolimus, a commonly-used immunosuppressant found in drug eluting stents, is embedded in the scaffold’s coating. The company designed the struts of the device to be just […]
LifeBond launches pivotal LifeSeal sealant trial
Tissue repair-focused developer LifeBond said today it launched a pivotal study of its LifeSeal surgical sealant kit, set to explore the use of the sealant in patients undergoing colorectal anastomosis. The Israel-based company’s LifeSeal surgical sealant kit includes a specific gastrointestinal sealant designed to minimize staple-line leakage during gastrointestinal resection procedures. “LifeBond’s team is committed to bringing […]
Orthocell touts CelGro nerve regeneration study
Orthocell (ASX:OCC) touted interim data today from an ongoing clinical study of its CelGro collagen soft tissue repair device for peripheral nerve regeneration. Researchers are evaluating the safety, tolerability and effectiveness of CelGro in surgery with patients who have suffered injury to 1 or more peripheral nerves in the hand and upper limb. The company said that […]
Boston Scientific touts no deaths, low PVL rates in Lotus TAVR trial
Boston Scientific (NYSE:BSX) this week presented new data from the Respond extension study of its Lotus transcatheter aortic valve replacement with its Depth Guard technology, touting no deaths and low rates of paravalvular regurgitation. Data from the study was presented at the Cardiovascular Research Technologies CRT 2017 annual meeting in Washington D.C. The 50-patient Respond Extension […]
TiGenix, Takeda highlight data for cell therapy in patients with Chron’s disease
Takeda (TYO:4502) and TiGenix (EBR:TIG) today touted long-term data from its phase III Admire-CD trial evaluating its suspension of allogenic expanded adipose-derived stem cells, Cx601, in patients with Chron’s disease. The study showed that Cx601 maintained long-term remission of treatment refractory complex perianal fistulas over 52 weeks. The randomized, phase III trial compared Cx601 to […]
Insulet touts Omnipod Horizon hybrid closed-loop system in patients with T1D
Insulet (NSDQ:PODD) touted data today from the 1st feasibility study of its Omnipod Horizon hybrid closed-loop system in patients with Type 1 diabetes. Data from the study showed that the Omnipod automated glucose control algorithm performed well, with minimal hypoglycemia, and that it was safe. The Billerica, Mass.-based company enrolled 24 patients with Type 1 diabetes […]