This article has been updated to clarify the BioCorRx’s role in the program. The Louisiana Department of Corrections is working with BioCorRx (OTC:BICX) to offer soon-to-be-released inmates an opioid addiction treatment implant that has not been approved by the FDA. The implant, which contains a compounded form of naltrexone, is one of several medication-assisted options being […]
Implants
Intersect ENT wins preliminary CMS reimbursement code
Shares in Intersect ENT (NSDQ:XENT) got a boost yesterday on news that the Centers for Medicare and Medicaid Services (CMS) had assigned the company’s Sinuva corticosteroid-eluting sinus implant a preliminary J-code. Intersect ENT stock, which had been bumping along just under $30 per share last week, jumped to $33.13 per share at Monday’s market open, […]
Ocular Therapeutix doses first wet-AMD patient in implant trial
Ocular Therapeutix (NSDQ:OCUL) said today that it dosed the first patient in a study of its OTX-TKI tyrosine kinase inhibitor implant. The Phase I trial is slated to assess the bioresorbable device’s safety, durability and tolerability in people with wet age-related macular degeneration. The company’s investigational product is a bioresorbable hydrogel fiber implant formulated with a […]
BioCorRx wins $5.6m grant for sustained release naltrexone implant
BioCorRx (OTC:BICX) announced this month that it won a two-year grant from the NIH’s National Institute on Drug Abuse to support the development of its sustained release naltrexone implant for the treatment of opioid use disorder. The grant includes $2.8 million for Feb. 1, 2019 to Jan. 31, 2020, followed by $2.8 million for the second […]
Senseonics touts first U.S. trial implant of 180-day CGM
Senseonics (NYSE:SENS) said yesterday that its Eversense XL 180-day continuous glucose sensor was implanted into the first participant of a trial designed to support a pre-market application to the FDA. The company’s 180-patient Promise trial is slated to study the safety and efficacy of the Eversense device in people with diabetes over 180 days. Senseonics also […]
Reva touts first implant of Fantom Encore bioresorbable scaffold in Italy
Reva Medical (ASX:RVA) touted this week the first implant of its newly-launched Fantom Encore bioresorbable scaffold in Italy. The company’s third-generation coronary bioresorbable scaffold features a thin strut profile and Reva’s Tyrocore polymer. “The patient I treated today was young, only 53 years old, and a perfect candidate for bioresorbable scaffolds,” Antonio Colombo of the Columbus […]
Senseonics reports mixed Q3 results
Shares in Senseonics (NYSE:SENS) fell today after the medical device maker missed EPS expectations but met sales estimates on Wall Street with its third quarter financial results. The Germantown, Md.-based company posted a net loss of -$31.9 million on sales of $5.2 million for the 3 months ended Sept. 30. Quarterly net losses were up 83% on […]
Ocular Therapeutix shares fall after Q3 earnings miss
Shares in Ocular Therapeutix (NSDQ:OCUL) fell today after the company missed EPS estimates on Wall Street with its third-quarter financial results. The Bedford, Mass.-based company posted a net loss of -$15 million on sales of $498,000 for the 3 months ended Sept. 30. Sales for the quarter were down -5% compared with the same period last year. Earnings […]
Senseonics wins another FDA approval for its implantable CGM
Senseonics (NYSE:SENS) said this week that it won another FDA approval for its implantable continuous glucose monitoring system, giving nurse practitioners and physicians assistants the ability to implant and remove the Eversense device. When the product was first approved by the FDA in June, only trained physicians were allowed to conduct the sensor insertion and removal […]
MicroPort’s drug-eluting stent performs well in European study
MicroPort Scientific’s Firehawk rapamycin target eluting coronary stent performed comparably to Abbott’s Xience stent family in a study just published in The Lancet. The TARGET AC multi-center, randomized controlled trial enrolled 1,653 patients at 21 clinical study sites in Europe. Firehawk met the trial’s non-inferiority primary endpoint of target lesion failure rate at 12 months of 6.1% versus […]
