Transdermal Delivery Solutions said today the clinical trial of its Testagen Hypospray has entered its pivotal phase. The Testagen TDS is designed for testosterone replacement through transdermal absorption through a spray-on delivery system. “We are pleased to reach this milestone and expect our progress with the technology to accelerate rapidly from here. As with any […]
Clinical Trials
Ocular Therapeutix launches another pivotal for Dextenza eye drug-device combo
Ocular Therapeutix (NSDQ:OCUL) said today that it launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication. Bedford, Mass.-based Ocular Therapeutix has had mixed results with Dextenza, formerly known as OTX-DP, which is designed to deliver sustained dosage of dexamethasone over 4 weeks, using a hydrogel plug […]
Intersect ENT touts sinus-implant study results
Intersect ENT (NSDQ:XENT) said today results from 3 clinical studies of its Propel, Resolve and Nova products showed positive results. The data was presented at the American Rhinologic Society’s annual meeting in Dallas. Each of the studies evaluated steroid releasing sinus implants placed in minimally invasive in-office procedures to reduce inflammation for patients with chronic […]
Intersect ENT's Propel study meets endpoint
Intersect ENT (NSDQ:XENT) said a new study of its Propel mini steroid-releasing sinus implant used after frontal sinus surgery met the primary endpoint in a clinical trial. The Propel device is already approved for use in the ethmoid sinuses, behind the bridge of the nose, in conjunction with sinus surgery to treat symptoms of chronic sinusitis, […]
Bellerophon plunges on failed cardiac implant trial
Bellerophon Therapeutics (NSDQ:BLPH) said today that its bioabsorbable cardiac matrix failed to meet both the primary and secondary endpoints in a 303-patient clinical trial, sending its share price down nearly -63% today. BCM is a liquid medical device injected into the coronary artery leading to the damaged area of a heart, and is designed for use after […]
Intersect Ent launches Nova sinus implant trial
Intersect ENT (NSDQ:XENT) said yesterday it enrolled the 1st patient in a trial of its Nova bioabsorbable steroid releasing sinus implant. The implant is designed to prop open the sinuses and deliver anti-inflammatory medication after surgical interventions, the Menlo Park, Calif.-based company said. “Clinical evidence to date has shown that Propel and Propel mini meaningfully […]
Diabetes: Medtronic furthers the quest for an artificial pancreas
Medtronic (NYSE:MDT) and Intarcia Therapeutics were in the spotlight at the American Diabetes Assn.’s annual scientific sessions conference in Boston last week, revealing new medical device developments in the fight against diabetes. Medtronic took center stage, announcing new developments for its artificial pancreas program, touting positive data from a user study of its MiniMed 640g and revealing plans to collaborate […]
Avedro application needs more work, FDA says
Massachusetts ophthalmic devices maker Avedro has some issues to address before the company can move forward with an FDA New Drug Application for its light-based cross-linking product for treatment.
Covidien launches 2 trials to support its Stellarex drug-device combo
Echo Therapeutics readies Prelude SkinPrep for clinical trials
Echo Therapeutics Inc. (OTC:ECTE) reached a milestone with one of its two flagship products, the Prelude SkinPrep system, which is ready for clinical trials examining its use in dispensing lidocaine.
The Franklin, Mass.-based company, which is also developing a needle-free glucose monitoring system called the Symphony tCGM, said its development work on the Prelude system is complete and it’s ready for a study in the “near term.”
