WaveForm Technologies said today that it has finished four clinical trials of its continuous glucose monitoring system and that it expects to win CE Mark clearance for the device this year. The WaveForm CGM system is designed to be worn for 14 days and includes a sensor insertion tool, a small sensor wire, a polymer […]
Clinical Trials
Medtronic touts therapy delivered via SynchroMed pump in patients with post-stroke spasticity
Medtronic (NYSE:MDT) touted data today showing that intrathecal baclofen therapy delivered via the company’s SychroMed II infusion pump performed better than the conventional treatment for patients with severe post-stroke spasticity. The medtech titan’s SynchroMed II pump is the only device approved in the U.S. for ITB therapy. The Sisters study pitted Medtronic’s ITB therapy against oral […]
Svelte Medical launches pivotal trial for drug-eluting stent-on-a-wire
The first patient has been enrolled in Svelte Medical System‘s Optimize pivotal trial, which is designed to evaluate the safety and efficacy of Svelte’s drug-eluting stent integrated delivery system and rapid exchange platforms. The 2,000-person trial comes in the wake of a first-in-man trial for Svelte’s product and a study comparing the system with Medtronic‘s […]
Eyenovia sets range for IPO
N.Y.-based startup Eyenovia updated its regulatory filings to reveal that it plans to offer 2.73 million shares priced between $10 – $12 apiece in its initial public offering. The 7-person company, which is developing a device to deliver small doses of drugs to the eye, is applying to list on the Nasdaq exchange under the […]
GenSight to launch trial of gene therapy, visual stimulation device combo in UK
The UK’s Medicines and Healthcare Regulatory Agency has approved GenSight Biologics’ (EPA:SIGHT) application to combine gene therapy and a wearable optronic visual stimulation device in patients with retinitis pigmentosa. The first-in-man Phase I/II trial is designed to study the safety and tolerability of GenSight’s GS030 combination therapy in three groups of three patients each. GS030’s gene […]
Glaukos touts Ph2 glaucoma trial for drug-eluting intraocular implant
Glaukos (NYSE:GKOS) touted data today from a Phase II trial of its travoprost intraocular implant in a 12-month cohort of glaucoma patients. The company’s iDose device is placed during a micro-invasive procedure and filled with a special formulation of travoprost – a drug used to reduce intraocular pressure. The implant continuously delivers therapeutic levels of travoprost […]
Novaliq enrolls first patient in Ph2 dry eye disease trial
Novaliq said today that it has begun randomizing patients in a Phase II trial of its product candidate for dry eye disease. Patients with evaporative dry eye disease caused by Meibomian gland dysfunction have impaired tear film lipid layers, according to the specialty pharma company, and treatment options for these patients are limited. Novaliq’s NOV03 […]
KemPharm launches pivotal efficacy trial for extended-release ADHD prodrug
KemPharm (NSDQ:KMPH) has launched a pivotal efficacy trial of its extended-release prodrug product for the treatment of attention deficit hyperactivity disorder in children. The company’s classroom-style study is designed to support a potential label for KP415 that would include both early-onset and long duration treatment effect for ADHD. The 140-patient trial is slated to wrap up […]
Kala Pharma reveals mixed Ph3 data for dry eye disease drug
Kala Pharmaceuticals (NSDQ:KALA) shares dropped -28% today after the company revealed mixed results from two Phase III trials of its dry eye disease drug, KPI-121. In its Stride 1 trial, the company’s drug met statistical significance for the primary endpoint of conjuctival hyperemia change from baseline to day 15, as well as the primary endpoint of […]
BioCardia files 2nd FDA IDE bid for CardiAMP chronic myocardial ischemia, refractory angina study
BioCardia (NSDQ:BCDA) said today it filed for a second FDA investigational device exemption to launch a trial of its CardiAMP cell therapy for treating chronic myocardial ischemia and refractory angina as it seeks a second indication. The San Carlos, Calif.-based company’s CardiAMP therapy uses autologous cells to treat chronic myocardial ischemia, and is designed to stimulate […]