NeuroSigma, an epilepsy treatment company, has withdrawn its plans for its initial public offering through which it was expecting to raise $50 million.
On Friday, the Los Angeles company quietly pulled back its regisration statement with the Securities & Exchange Commission.
On Monday, a gentleman who answered the phone said NeuroSigma is not commenting on reasons for withdrawal.
In filing for an IPO last August, the company explained that it has developed the Monarch eTNS system, a non-invasive external trigeminal nerve stimulation system to be used as an adjunctive therapy to drug-resistant epilepsy and major depressive disorder whose disease is not controlled by one kind of treatment alone.
The eTNS is a disposable patch that a patient can wear on the forehead to administer the therapy by themselves at home during sleep with the help of a pulse generator. The pulse generator is the size of a cell phone. The product is approved in Canada, EU and Australia, and NeuroSigma is developing a second generation of the therapy.
In January, FDA granted a Humanitarian Use Device designation to the eTNS system, considered to be the first step in obtaining a HUD exemption.
"Our eTNS system may become an attractive adjunctive treatment for many children with Lennox-Gastaut Syndrome. It is a non-invasive neuromodulation system that these children and their families can use in the home if an HDE is approved," said Ian Cook, M.D., NeuroSigma's Chief Medical Officer in a press release at the time. "Many patients still suffer from the symptoms of this devastating condition despite best current medical practice. We have already begun collecting the human clinical data necessary to apply for the HDE," said Ian Cook, NeuroSigma's Chief Medical Officer."
Meanwhile,NeuroSigma is progressing along its path to also leverage TFN(thin film nitinol)-based endovascular devices. In May the Mayo Clinic reported that NeuroSigma's TFN flow diverter had achieved good results in 13 rabbits with simulated aneurysms.
"The current first generation flow diverters typically take many weeks or months to achieve complete aneurysm occlusion, even after placement of multiple devices. In contrast, NeuroSigma's TFN flow diverter has thus far shown rapid aneurysm occlusion after placement of a single device," said Colin Kealey, Director of Advanced Development and Medical Affairs at NeuroSigma in a May news release.
The initial registration statement which spelled out NeuroSigma's plans for an IPO had, however, very litle information on this stent technology.
Arundhati Parmar is senior editor at MD+DI. Reach her at [email protected] and on Twitter @aparmarbb
[Photo Credit: iStockphoto.com user Elenarts]
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