The EMA's Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion on Sensorion SA's application seeking orphan drug designation for OTOF-GT, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss.
The therapeutic validity of RNA editing tools in vivo remains largely unknown in disease models both in terms of RNA editing efficacy and therapeutic improvement of disease-related symptoms. In recent work, scientists from the Institute of Neuroscience at the Chinese Academy of Sciences and colleagues evaluated RNA correction therapy in a mouse model that recapitulates the phenotype of human dominant-inherited deafness.
The U.S. FDA’s rule for over-the-counter (OTC) hearing aids was several years late coming out, but the rule has nonetheless proven controversial from the outset. Two members of the U.S. Senate have blasted device makers for what they allege is interference with the rulemaking process via “astroturf” campaigns to prod hearing aid users to influence the agency’s final rule.
Aerin Medical Inc.’s funding nosed up to $190.5 million with its latest venture capital round, which brought in $60 million in fresh cash. The provider of noninvasive solutions for chronic nasal conditions plans to use the funds to ramp up commercialization and expand market access to its Vivaer and Rhinaer products. New investor Ally Bridge Group led the round with support from returning major investors KCK Medtech, Questa Capital and Orbimed.
Lyra Therapeutics Inc.’s $100.5 million private placement has investors moving to the tune of the ear, nose and throat specialty therapeutics company. Lyra’s stock (NASDAQ:LYRA) jumped from early April trading in the $4.20 range to $6.02 with the announcement April 8 of the pending placement. The stock shot up again on April 13 when the placement finalized and surged in after-hours trading, ultimately spiking over $7 shortly after the opening bell April 14.
Medtronic plc has launched a single-use device for outpatient-based treatment of chronic, obstructive Eustachian tube dysfunction (ETD). Medtronic’s FDA-approved Nuvent system is a manually controlled balloon catheter for insertion into the Eustachian tube canal. Once pressurized, the balloon expands and dilates the Eustachian tube canal to relieve symptoms of ETD.
Several recent studies highlight the rapidly expanding applications for neuromodulation using bioelectronic devices. A pair of articles in the Journal of the American Heart Association and Journal of the American College of Cardiology focused on the benefits to patients with heart failure and those at risk of post-operative atrial fibrillation, respectively. A study published in Brain Stimulation found that 85% of tinnitus patients experienced resolution of their symptoms when using a neuromodulation device.
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