UPDATED April 24, 2019, with comment from NeuroSigma. NeuroSigma won de novo clearance from the FDA last week to put the first medical device for treating attention-deficit hyperactivity disorder on the U.S. market. Los Angeles-based NeuroSigma makes the Monarch eTNS system, which is designed to deliver mild electrical signals through a forehead patch to stimulate […]
NeuroSigma touts preliminary eTNS traumatic brain injury trial results
NeuroSigma Systems today released preliminary data from a trial of its Monarch trigeminal nerve stimulation system designed to treat combat veterans with traumatic brain injuries, citing improvements in memory, anxiety and brain activity. The results were presented at the North American Neuromodulation Society’s meeting in Las Vegas, the company said. The trial was performed at the Veterans […]
NeuroSigma wins CE Mark for eTNS ADHD system
NeuroSigma Systems said today it won CE Mark approval in the European Union for its Monarch eTNS system to treat attention-deficit/hyperactivity disorder in adults and children 7 and older. Los Angeles-based NeuroSigma said it is the 1st and only non-drug treatment for ADHD approved in the European Union. “ADHD is estimated to affect up to […]
Epilepsy device developer NeuroSigma withdraws IPO
UCLA-spun out NeuroSigma Systems withdrew its plans for an initial public offering that could have brought the company as much as $50 million for its noninvasive system to treat drug-resistant epilepsy. NeuroSigma is developing the Monarch eTNS system, which delivers mild electrical signals through a forehead patch to stimulate branches of the trigeminal nerve. The […]
UCLA spinout NeuroSigma seeks $50m in IPO
NeuroSigma aims to reap as much as $50.2 million in its upcoming initial public offering for the UCLA spinout’s noninvasive system to treat drug-resistant epilepsy.
NeuroSigma plans to sell 3.6 million shares on the NASDAQ exchange for between $13 and $15 each, reserving the symbol NSIG, according to a regulatory filing.
IPOs: ReWalk and NeuroSigma prepare to hit the public market
Two medical device makers are preparing initial public offerings for the coming weeks, breaking up a spree of biotech IPOs that have dominated the market.
NeuroSigma wins an FDA green light for Phase III clinical trials
NeuroSigma is one step closer to bringing its epilepsy treatment to U.S. markets with FDA approval to begin its Phase III clinical studies.
Currently only available for investigational use in the U.S., NeuroSigma’s Monarch eTNS system is already on the shelves in Europe and Canada. Earlier studies have shown a 50% reduction in seizures for 2/5 of epilepsy patients treated, NeuroSigma said.
CircuLite, NeuroSigma land CE Marks
The European Union granted CE Mark approval to a pair of medical device companies, CircuLite and NeuroSigma, for their technologies designed to treat heart failure, epilepsy and depression.
Boston Scientific CFO Jeffrey Capello joins board of OvaScience | Personnel Moves
Boston Scientific (NYSE:BSX) executive vice president and chief financial officer Jeffrey Capello joined the board of directors at OvaScience, a Boston, Mass.-based start up developing infertility treatments.
Capello began working at Boston Scientific in 2008, landing the CFO seat in 2010. He oversees the company’s global finance, information systems, business development and corporate strategy functions.
Cardiosolutions raises $3.3M | Funding Roundup
Cardiosolutions Inc. landed about half of what it hopes will amount to a $6.5 million fundraising round, pulling in $3.3 million from eight un-named investors, according to a regulatory filing.
The Stoughton, Mass.-based company is a spinout from contract manufacturer STD Med, which early last year bought a new, 32,000-square-foot cleanroom to house Cardiosolutions and sister firm Spirus Medical Inc.
NeuroSigma spinout NSVascular looks to commercialize UCLA stent technology
NeuroSigma Inc. spun out NSVascular Inc. to develop two stent lines using thin-film nitinol technology developed at the University of Calif.-Los Angeles under an exclusive licensing agreement.
Los Angeles-based NeuroSigma said its new subsidiary plans to develop one type of stent to treat brain aneurysms and another to treat peripheral artery disease.
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