Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis. Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma […]
Orthopedics
OsteoRemedies wins FDA nod for Remedy Spectrum GV hip spacer and bone cement
OsteoRemedies recently announced that it has received FDA clearance for its Remedy Spectrum GV hip spacer system and Spectrum GV bone cement. The system is designed to give surgeons a broad spectrum of treatment options with both Gentamicin and Vancomycin. “We are very proud to have the first FDA cleared dual-antibiotic spacer system and bone […]
Flexion reports data from Phase II bilateral osteoarthritis trial
Flexion Therapeutics (NSDQ:FLXN) touted data today from a Phase II trial assessing the bilateral dosing of its extended-release triamcinolone acetonide injection in people with bilateral osteoarthritis. The study found that bilateral injections of Flexion’s Zilretta therapy resulted in lower plasma concentrations of triamcinolone acetonide compared to immediate-release triamcinolone acetonide in crystalline suspension (TAcs). The company also […]
Genentech wins FDA nod for subcutaneous formulation of arthritis drug
Roche‘s (OTC:RHHBY) Genentech reported this week that the FDA approved the subcutaneous formulation of tocilizumab for the treatment of active systemic juvenile idiopathic arthritis in patients two years and older. The U.S. agency approved the intravenous formulation of Actemra for the same indication in 2011. Systemic juvenile idiopathic arthritis affects roughly 30,000 children in the U.S., according […]
Medtech stories we missed this week: August 3, 2018
From Esaote launching its new ultrasound device to Nipro’s Infraredx launching in Japan, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Esaote launches new ultrasound devices Esaote announced in an Aug. 2 press release that it has launched its new MyLab X7, MyLab X6 and MyLab X5 ultrasound systems. […]
Anika tops sales, EPS estimates with Q2 results
Anika Therapeutics (NSDQ:ANIK) reported its second-quarter financial results today, topping sales and earnings estimates on Wall Street. The Bedford, Mass.-based company posted profits of $10 million, or 69¢ per share, on sales of $30.5 million for the 3 months ended June 30, for bottom-line loss of -11% on sales loss of -9% compared with the same […]
Medtech stories we missed this week: July 13, 2018
From Angiodroid receiving CE Mark approval to Masimo launching its vital signs app, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Angiodroid wins CE Mark for Angiopulse IABP Angiodroid announced in a July 11 press releasethat it has received CE Mark approval for its AngioPulse intra-aortic balloon pump […]
Anika swings to a loss in Q1
Shares in Anika Therapeutics (NSDQ:ANIK) fell in premarket activity today after the company missed expectations on Wall Street with its first-quarter results. The Bedford, Mass.-based company swung to a net loss of -$6.7 million, or -46¢ per share, on sales of $21.3 million for the 3 months ended March 31, down -9.1% compared with the same […]
Medtech stories we missed this week: April 27, 2018
From DuPuy Synthes’s spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. DePuy Synthes launches spinal implants DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed to […]
Flexion touts interim data from Ph3 trial of osteoarthritis injection
Flexion Therapeutics (NSDQ:FLXN) this week touted updated, interim results from an ongoing Phase IIIb study evaluating the safety and tolerability of repeat administration of its osteoarthritis injection, Zilretta. The company’s injectable suspension is an extended-release formulation of triamcinolone acetonide designed for patients with osteoarthritis of the knee. Top-line results from Flexion’s trial showed that 95% of […]
