Longeveron said today that it finished enrollment for the 1st phase of its human mesenchymal stem cell trial for Alzheimer’s disease. The company enrolled and infused 5 patients to collect safety data for its exogenously administered mesenchymal stem cells derived from adult donors’ bone marrow. After reviewing safety data, Longeveron said it plans to enroll 25 […]
Clinical Trials
Prometra micro-infusion device used to deliver meds directly to brain in epilepsy trial
Flowonix Medical and Cerebral Therapeutics said today that the 1st patients were implanted with the Prometra II programmable infusion system in a clinical trial evaluating the pump in patients with refractory epilepsy. The Address trial marks the 1st time a programmable, implantable pump has been used to deliver medication, in this case valproate, directly to […]
Ocular touts patient experience data for Dextenza implant
Ocular Therapeutix (NSDQ:OCUL) touted data today from a patient experience study of its Dextenza post-surgical pain relief implant. The study was published in Patient Preference and Adherence. The Bedford, Mass.-based company’s hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following ophthalmic surgery. After the […]
Pacira touts Phase IV study of Exparel anesthetic in total knee arthroplasty
Pacira Pharmaceuticals (NSDQ:PCRX) said today the Phase IV study of its Exparel bupivacaine liposome injection in patients undergoing total knee arthroplasty met its co-primary endpoints for postsurgical pain and opioid reduction. The anesthetic achieved statistical significance for secondary endpoints including time to 1st opioid use and the percentage of patients who did not require opioids […]
BioTime expands OpRegen dry-AMD trial with U.S. sites
BioTime Inc. (NYSE:BTX) said today that it expanded its OpRegen Phase I/IIa trial into the U.S. with 2 new trial sites. The company’s study is evaluating its OpRegen cell therapy in patients with advanced dry form age-related macular degeneration. The 2 U.S.-based trial sites will include ophthalmologists Dr. David Boyer from the Retina-Vitreous Associates Medical Group […]
Medtech stores we missed this week: March 10, 2017
The FDA and Health Canada cleared a couple medical devices while other companies touted their device studies. Here are medtech stories we missed this week but were still worth mentioning. 1. FDA clears Medela’s neonatal enteral feeding device Medela has received 510(k) clearance from the FDA to market its ENFit Low Dose Tip eternal syringes, […]
Medtronic launches DCB clinical trial for below-the-knee peripheral artery disease
Medtronic (NYSE:MDT) said today that it launched a clinical trial to evaluate the use of its In.Pact paclitaxel-coated percutaneous transluminal angioplasty balloon catheter in patients with below-the-knee peripheral arterial disease. The company treated its 1st patient in the In.Pact BTK study, performing the procedure on a patient with critical limb ischemia. “The 1st patient enrollment in […]
PolyPid touts early data for BonyPid-1000 antibiotic-eluting bone substitute
PolyPid touted interim data today from the 1st group of patients to reach the 6-month follow-up period in the clinical trial of its BonyPid-1000 doxycycline-eluting synthetic bone substitute. The Israel-based company’s clinical trial enrolled 64 patients with open tibia fractures. In this type of fracture, the bone is severely damaged and exposed, leaving it vulnerable […]
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. “Respiratory is a core […]