GE Healthcare (NYSE: GE) and Lantheus Holdings, Inc. (NASDAQ: LNTH), parent company of Lantheus Medical Imaging, Inc. have started a second Phase 3 clinical trial of flurpiridaz 18F, an investigational agent being evaluated for the detection of coronary artery disease. Flurpiridaz18F is designed as a positron emission tomography (PET) myocardial perfusion imaging (MPI) agent. The companies […]
Clinical Trials
Cerapedics launches P-15L peptide-enhanced bone graft IDE trial
Cerapedics said today it launched a new investigational device exemption trial looking to explore the safety and efficacy of its next-gen P-15L peptide enhanced bone graft in transforaminal interbody fusion surgeries. The Westminster, Colo.-based company said it has enrolled the first patients in the study, which aims to enroll a total of 364 patients with degenerative […]
J&J seeks retraction of paper critical of Pinnacle hip study
Johnson & Johnson (NYSE:JNJ) are looking to get a scholarly paper challenging the validity an internal study of its DePuy subsidiary’s Pinnacle metal-on-metal hip systems retracted, according to a Stat News report. The study and journal paper were published by Brown University’s Dr. David Egilman and accused the J&J study of “grave fraudulence,” according to the […]
Nanobiotix inks $47m financing to support nanomedicine development
Nanobiotix (PAR:NANO.PA) inked a non-dilutive financial deal with the European Investment Bank last week to support the development of its nanoparticle-based cancer therapies. The Paris, France-based company said it landed a five-year loan to borrow up to €40 million ($46.7 million) contingent upon a set of performance milestones. Get the full story at our sister site, Drug Delivery […]
Abbott launches pivotal US-based Tendyne TMVR trial
Abbott (NYSE:ABT) said today it launched a US-based pivotal clinical study of its Tendyne transcatheter mitral valve replacement system designed to treat mitral regurgitation. In the trial, the Abbott Park, Ill.-based company will explore the safety and efficacy of the system in treating patients with mitral regurgitation. Abbot touted the Tendyne as the first and only mitral […]
NanoVibronix touts trigeminal neuralgia PainShield study data
NanoVibronix (NSDQ:NAOV) yesterday released results from a study exploring the use of its PainShield device in treating patients with trigeminal neuralgia, touting improved pain relief and quality of life. The PainShield is a device designed to treat pain in nerves, muscles and joints through the delivery of localized ultrasound, the Elmsford, N.Y.-based company said. In the […]
Genentech touts positive data for tiny, refillable eye implant
Roche‘s (OTC:RHHBY) Genentech touted positive top-line data today from a Phase II study of its Port Delivery System, an eye implant designed to administer a sustained dose of ranibizumab in patients with wet age-related macular degeneration. The refillable device, which is slightly longer than a grain of rice, is intended to enable wet-AMD patients to go for […]
Hancock Jaffe wins OK from ethics committee for FIH VenoValve trial
Hancock Jaffe Laboratories (NSDQ:HJLI) said today that Colombia’s Ethics Committee at Fundación Santa Fe de Bogotá approved a first-in-human trial of its VenoValve bioprosthetic valve. The Irvine, Calif.-based company’s VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency from damage to leg vein valves […]
Medtronic launches ECG belt HF optimization trial
Medtronic (NYSE:MDT) said today it launched a new clinical trial evaluating the use of its ECG belt research system as a diagnostic tool for improving cardiac resynchronization therapy for heart failure patients. The Fridley, Minn.-based company said it has enrolled the first patients in the trial at Des Moines, Iowa’s Mercy Medical Center – West Lakes […]
Pulmatrix touts data from first-in-human trial of inhaled anti-fungal therapy
Pulmatrix (NSDQ:PULM) said today that all dosing and follow-up visits have finished for its first-in-human study of an inhaled formulation of itraconazole as a treatment of allergic bronchopulmonary aspergillosis in people with asthma. The inhaled iSperse formulation, called Pulmazole, was well-tolerated, according to the Lexington, Mass.-based company. Pulmatrix plans to launch a Phase II trial of […]
RenovoRx sets its sights on localized treatment of pancreatic cancer
People living with pancreatic cancer find themselves facing devastating odds – the five-year survival rate is in the single digits, according to the American Cancer Rate. Pursuing treatment often means dealing with the side effects of systemic chemotherapy, including hair loss, fatigue and neuropathy. Shaun Bagai and his team at RenovoRx think that their catheter could help […]