Senseonics (NYSE:SENS) announced yesterday that real-world data from its Eversense continuous glucose monitoring system reflected strong performance and safety. The data, published in Diabetes Technology and Therapeutics, included the first 205 U.S. patients to use Germantown, Md.-based Senseonics’ Eversense system over a 90-day wear period. Zero device or procedure-related adverse events were reported with the […]
Ocular Therapeutix’s ophthalmic device gains Medicare coverage early
Ocular Therapeutix (NSDQ:OCUL) said today that the Centers for Medicare and Medicaid Services has assigned a specific and permanent reimbursement J-code for its Dextenza ophthalmic insert, which is approved for the treatment of ocular inflammation and pain following ophthalmic surgery. The code assigned to Dextenza through the Healthcare Common Procedure Coding System will become effective […]
Taris Bio, Bristol-Myers Squibb launch bladder cancer trial
Taris Biomedical has announced the dosing of the first patient in a study of its TAR-200 system plus a programmed immune checkpoint inhibitor for the treatment of muscle-invasive bladder cancer (MIBC). The TAR-200 system continuously delivers the chemotherapy drug gemcitabine in the bladder for multiple weeks. The combination with Bristol-Myers Squibb’s Opdivo (nivolumab) will be […]
Ocular Therapeutix launches Dextenza eye insert
Ocular Therapeutix (NSDQ:OCUL) yesterday announced the commercial launch of its Dextenza ophthalmic insert in the U.S. Dextenza is an ocular insert that is designed to release 0.4 mg of dexamethasone to relieve pain after ophthalmic surgery. It can deliver drugs for up to 30 days after treatment in a physician’s office. The Bedford, Mass.-based company won […]
Louisiana prisoners may get non-FDA-approved naltrexone implant
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 […]
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 […]
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