Stratasys (NSDQ:SSYS) said today it began enrollment for patients in its 3DHeart study, which aims to explore the use of patient-specific 3D printed models in pre-operative planning for pediatric heart surgery. The 3DHeart study will focus on pediatric congenital heart patients requiring complex two-ventricle repairs, with a primary endpoint of cardiopulmonary bypass time with secondary […]
Clinical Trials
Stem cell transplants could improve insulin independence in T1D
Researchers from the City of Hope demonstrated that some patients with Type I diabetes can be cured, at least temporarily, with a stem cell transplant. The team’s work was published in Frontiers in Immunology. The trial enrolled 21 patients and found that autologous hematopoietic stem cell transplantation increased C-peptide levels and induced insulin independence in patients with […]
Glenmark wins FDA nod for Phase II study of nebulized tiotropium bromide
Glenmark Pharmaceuticals said today that the FDA approved its Investigational New Drug application for a Phase II study of its nebulized tiotropium bromide. The Mahwah, N.J.-based company plans to enroll 155 patients with mild to moderate chronic obstructive pulmonary disease and evaluate its GSP 304 formulation as a daily maintenance treatment for bronchospasm. Get the full story […]
Stryker halts enrollment early in Trevo study on high probability of success
Stryker (NYSE:SYK) said today that it’s putting an early stop to enrollment in a clinical trial of its Trevo anti-stroke device after a review board decided there’s a high probability of success for the study. Kalamazoo, Mich.-based Stryker paid $135 million for Concentric Medical and its Trevo clot retriever back in 2011. The device is […]
Virta Health looks to reverse, not treat, Type II diabetes
Virta Health, founded by physicians and scientists from Stanford, MIT and Harvard, launched today with the goal to reverse Type II diabetes using its technology platform to enable personalized remote care. The company provides physician supervision, health coaches, an app and biomarker tracking tools, as well as a personalized nutrition plan for its patients in […]
Terumo’s MicroVention touts low adverse composite outcomes in HydroCoil study
Terumo Corp. (TYO:4543) subsidiary MicroVention today released results from a study of its HydroCoil embolic system, touting that the trial met its primary and secondary endpoints and showed low adverse composite outcomes. The 513-patient prospective, randomized, controlled trial aimed to explore the use of the HydroCoil embolic system for treating endovascular aneurysms compared to bare platinum coils, […]
Study: Dextera touts shorter hospital stays for MI lobectomy procedures using its MicroCutter stapler
Dextera Surgical (NSDQ:DXTR) today released data from a small study of patients who underwent microlobectomy procedures utilizing its MicroCutter surgical stapler, touting hospital stays at least 2 days lower than open lobectomy procedures. “The interest in the presentation at the meeting reflects the global interest in technologies like the MicroCutter 5/80 that enable less invasive approaches […]
Mast Therapeutics subsidiary advances trial for inhaled sodium nitrite solution
Mast Therapeutics (NYSE:MSTX) said today that its subsidiary Aires Pharmaceuticals inked a deal with the University of Pittsburgh related to its phase 1/2 open-label proof-of-concept trial for the company’s AIR001 inhaled sodium nitrite solution in patients with cystic fibrosis. The study will evaluate the nebulized drug as a treatment of Pseudomonas aeruginosa infection in CF […]
Study evaluates drug-device combo therapy for deep vein thrombosis
A National Institutes of Health-sponsored study found that most patients with deep vein thrombosis should be treated with anticoagulant drugs alone, without a procedure-based intervention. However, the same study showed that a minimally-invasive catheter-director therapy, pharmacomechanical catheter-directed thrombolysis, provided greater initial pain relief and could prevent disability in DVT patients. The research was presented today […]
InGeneron raises $20m in Series D for regenerative stem cell therapies
InGeneron said today that healthcare provider Sanford Health invested $20 million in the company’s Series D financing round. The Houston, Texas.-based company said the funding will be used to support the clinical programs for its stem cell injections in patients with rotator cuff and venous ulcer tears. “This significant investment demonstrates Sanford’s commitment to be […]
7 medtech stories we missed this week: March 3, 2017
Several clinical study results were published this week, while other companies reached distribution deals. Here are 7 medtech stories we missed this week but were still worth mentioning. 1. Health Canada approves Ventripoint’s complete heart analysis system for 2D ultrasounds Ventripoint Diagnostics received a license from Health Canada for its new VMS-Plus machine and the 4-chamber […]