As Nexeon MedSystems Inc. has been racking up grant funding, the Dallas-based company recently began offering its shares on the OTC Market.

Nexeon announced last week that it has received a Phase I Small Business Research Innovation grant from the National Heart, Lung, and Blood Institute to collaborate with researchers at the Oregon Health & Science University in the development of a neurostimulation therapy for asthma.

The grant is based on the merits of its proposed development plan for a unique asthma treatment related to airway constriction, according to Nexeon. The NHLBI is part of the National Institutes of Health.

“I’m proud of our management team for implementing and delivering on innovative financing strategies in much the same fashion as our engineers do.”
Will Rosellini

The company said the therapy would be a second-line defense used by patients whose current medications don’t treat their asthma sufficiently.

It’s the latest in a string of major announcements in recent months for Nexeon, which said in late September that its shares would begin trading on the OTC Market under the ticker symbol NXNN. The Securities and Exchange Commission declared Nexeon’s S-1 Registration Statement effective in June.

“We filed a Form 10, which is typically reviewed by the SEC,” Nexeon CEO Will Rosellini told Benzinga. It’s a way to go public that is an alternative to the traditional IPO path.

Essentially, that means that Nexeon is “volunteering to have the reporting obligations of a public company,” Rosellini said.

“I’m proud of our management team for implementing and delivering on innovative financing strategies in much the same fashion as our engineers do,” Rosellini said in a release. “Our next step is to uplist to a major exchange, we hope to accomplish this as soon as possible.”

That announcement came as Nexeon was finalizing development of its deep brain stimulation system to treat symptoms associated with Parkinson’s disease, according to a release.

Nexeon is seeking European regulatory approval for its deep brain neurostimulation system, and the company plans a 2018 European commercial launch of the product with a Food and Drug Administration premarket approval trial enrolling at the same time.

Nexeon is in final stages of product development prior to European regulatory approval submission for its deep brain neurostimulation system for the treatment of symptoms associated with Parkinson’s disease. [Image courtesy of Nexeon MedSystems, Inc.]

NEXEON IS INVOLVED IN MULTIPLE CLINICAL TRIALS

In announcing its NHLBI grant, Nexeon said that more than 300 million people worldwide live with asthma — 20 million in the U.S. and 10 million in Europe.

Studies underway seek to demonstrate the ability of both auricular Vagus Nerve Stimulation (aVNS) and Vagus Nerve stimulation (VNS) to induce improved airway responses that are predictive of a clinically meaningful outcome in humans. 

VNS is an FDA-approved treatment for epilepsy and depression, and researchers around the globe are demonstrating the effects of VNS across various neurological disorders including stroke, tinnitus, headaches, arthritis, obesity, and other conditions.

“We are excited to expand the utilization of either external or implantable neurostimulation solutions for the treatment of various disorders,” Roselinni said in a release. “With both implantable Vagus Nerve and external auricular Vagus Nerve stimulation systems, we are able to pursue the optimal therapy for patients without biasing one system or the other.”

“With both implantable Vagus Nerve and external auricular Vagus Nerve stimulation systems, we are able to pursue the optimal therapy for patients without biasing one system or the other.”
Will Rosellini

Rosellini — a former minor league baseball player in the Arizona Diamondbacks system — previously founded Microtransponder, which is developing Vagus Nerve stimulation to relieve motor impairment following a stroke.

Nexeon said it’s involved in multiple clinical trials with its Auricular Vagus Nerve stimulator and is in the process of finalizing development of its state-of-the-art implantable neuromodulation system.

In August, Nexeon announced that it had been awarded a two-year, Phase II Small Business Research Innovation grant from the NHLBI for development of a nanocomposite drug-eluting balloon technology and other intellectual property related to precision medicine.

That Phase II grant will fund up to $600,000 of critical preclinical research and process development activities, Nexeon said.

In May, Nexeon came in second in the Health Wildcatters’ Health Innovation Pitch Competition at the 10th Annual Healthcare Dealmakers Conference.

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