Fox News Radio and ongoing clinical studies…

I was on a number of Fox News Radio programs and wanted to get a list of the ongoing studies I mentioned:

Migraine study can be found here:

Stroke study can be found here:

Bravemind/PTSD study can be found here: https://clinicaltrials.gov/ct2/show/NCT02246972

Tinnitus study has completed enrollment but a new study will be open soon:

Nuviant Medical Receives €3.4M from BioWin to Further Advance Closed Loop Neurostimulation System for E-Health Initiative

Company Plans to Grow Its Wallonia Team with 25-30 New Hires in Three Years

Liege, Belgium, Jan. 8, 2015 — Nuviant Medical (“Nuviant” or “the Company”) announced that its CardiaX Project was awarded a €3.4 million research grant from the Walloon Region government in coordination with the region’s health competitiveness cluster Biowin. This grant will support continued development of digital healthcare solutions related to implantable medical devices.

Nuviant joined the Walloon Region Consortium in 2013 via its wholly-owned subsidiary, Rosellini Scientific Benelux (RSB).  It has benefited from consortium partnerships with iSTAR Medical, the Catholic University of Louvain, and the University of Liege as well as collaboration with other Wallonia-based companies including Medi-Line, Lambda-plus, IOL, and recently the new Creative Wallonia supported WeLL (Wallonia E-health Living Labs).  The Company has expanded its manufacturing capacity in Belgium by opening an office in Liege, which includes a new ISO Class 6 cleanroom, and by hiring five full-time employees.  Over the next three years, the Company  plans to transfer moremanufacturing operations to Belgium and to hire 25-30 additional employees.

“The support we have received from the Walloon Region as well as our neighboring partners has expedited our ability to develop advanced e-health solutions for patients suffering from neurological diseases.  It is our belief that a more holistic approach to the application of neurostimulation which includes signals from the heart will usher in a new era of neurotechnological advances.  Belgium has been a world leader in these innovations for a number of years.” stated Nuviant’s Chairman and Managing Director of RSB, Hartmut Spitaels.  “The Walloon Region has solidified an environment that facilitates the design, manufacturing, and testing of our implantable systems.”

Minister Marcourt ‘s administration has approved another Biowin innovation project in digital healthcare, one of the key strategic spearheads of his tenure, as he believes this will have major benefits for the economy.  The Biowin-supported CardiaX program aims to incorporate digital healthcare with key actors in the Liege area.  Nuviant Medical, the project sponsor, is currently transferring its manufacturing of implantable devices to the Region.  This will enhance the know-how and economic activity for some high-tech medical device companies in the Region. The supply-revenue that would come to the Liege-based suppliers would be of significant value once the innovation gets commercially deployed.

As Vice-president of the Government of Wallonia and the Federation Wallonie-Bruxelles and Minister of Economy, Jean-Claude Marcourt, wishes to highlight the success of the Cardiax project which is born in the heart of collaborations initiated by the Biowin cluster: “This profitable collaboration between two renowned industrial partners i.e. [RSB] and Istar Medical, in perfect connection with two regional academic associations, namely the Catholic University of Louvain and the University of Liège, demonstrates once again that strong innovative ecosystems strengthen the policy of competitive clusters I launched 8 years ago. This policy leads on high added-value projects.”

The Minister underlines that “the setting up of joint research projects is more and more integrated in the DNA of new science businesses operating in Wallonia.  It is a good omen for the economical development but also for the prosperity of employment in our region.”

About Nuviant Medical

Nuviant is developing implantable neurostimulation systems for the relief of various chronic diseases and disorders. Nuviant’s first product, the Synapse™ system, has received the CE Mark for certain movement disorders. Nuviant intends to use the product in additional human clinical studies and prepare it for commercialization in select world markets. Nuviant Medical has produced and tested its device in accordance with FDA Good Manufacturing Practices in its 10,000 square foot state of the art cleanroom. For more information on Nuviant Medical, please visit our website at www.nuviantmedical.com.


Source Article: Fierce Medical Devices

A trial at the U of M is helping stroke victims regain their strength

The trial involves a surgical implant permanently placed onto the vegus nerve in the neck and another device similar to a pacemaker in the chest. The devices are then stimulated, with a push of a button, during physical therapy to try and wake up dormant neurons and help strengthen connections to the brain — all in hopes of improving struggling movements.

Stroke Rehab“It’s like rehabilitation or physical therapy — with a boost,” said Dr. Teresa Kimberly who is leading the trial sponsored by the medical device company Microtransponder.

At the beginning of the trial, Diane Larson couldn’t unscrew the top off her soda bottle, but today it’s much easier.

“As a physical therapist I’ve never seen anyone at her stage in recovery makes as big a gain as she has,” Dr. Kimberly.

Larson is thankful the study, and the physical therapy that came with it, have pushed her to work on basic movements.

“I never considered myself handicapped and that was good it gave me reason,” Larson said of the therapy.

Her partner Brent Bunkowske agrees about Larson’s improvement, “In reality I got my girl back, it’s just a miracle, I just think it’s a miracle.”

Just half way through Madson doesn’t know for sure whether he’s part controlled part of trial or if he’s getting the real thing, but based on huge strides he’s made in just a few weeks the VNS stroke trial looks to be very promising.

“I couldn’t even grab things when I first came here,” Madson said. “I’m just thankful that I got into this study.”

This is a pre-FDA trial, meaning there is a long way to go before this will hit the mainstream. The U of M  is looking for more people to participate in the trial.


Source Article: Fox9

Nuviant Medical Awarded $175k NIH SBIR Grant to Develop Treatment for Dysphagia

Company plans to use proprietary neuromodulation system for superior laryngeal nerve stimulation

DysphagiaCOLUMBIA, Mo., Dec, 15, 2015 /PRNewswire-iReach/ — Nuviant Medical (“Nuviant” or “the Company”) announced today that it was awarded a National Institutes of Health Small Business Innovative Research (SBIR) grant to apply its neuromodulation system to superior laryngeal nerve (“SLN”) stimulation for the treatment of neurogenic dysphagia.  This therapy involves stimulation that selectively facilitates swallowing in patients with dysphagia, thus restoring quality of life and mitigating both morbidity and mortality.

Dysphagia refers either to difficulty with the initial phases of a swallow or to the sensation that foods or liquids are obstructed in passage from the mouth to the stomach.  As many as 15 million Americans (approximately 60-80% of all patients with neurodegenerative diseases) suffer from dysphagia, with nearly 600,000 Americans newly diagnosed each year.  This condition is primarily caused by neurological diseases such as Parkinson’s disease, amyotrophic lateral sclerosis, stroke, dementia, muscular dystrophy, and cerebral palsy. Nuviant is currently developing its SynapseTM deep brain stimulation (DBS) system for the treatment of neurological diseases and expects to integrate the SLN therapy into its product line.

Dysphagia is highly correlated with malnutrition and aspiration pneumonia, which results in poor quality of life and contributes considerably to increased morbidity and mortality. Current treatments for this debilitating and life-threatening condition are limited to diet modifications (e.g., thickened liquids), behavioral adaptations (e.g., tucking the chin when swallowing), and other palliative interventions (e.g., feeding tubes) as efforts to extend survival. Despite being a major source of morbidity and mortality, there are few treatment options.

“I am thrilled to collaborate with Nuviant to further develop their technology and potentially provide a restorative treatment option for these patients,” said co-investigator Teresa Lever, Ph.D., assistant professor of otolaryngology at the University of Missouri School of Medicine, who will be leading the study with Principal Investigator Dr. Navid Khodaparast of Nuviant.  Dr. Lever continued, “Through the past few decades, there has been slow advancement in available therapies for this clinically significant problem.  We are pushing to deliver the implantable neuromodulation solution that could enhance the lives of these high-risk patients.”

“If this research garners successful results, we are confident that integrating this therapy with our existing DBS platform will provide a welcomed and much needed solution for patients with neurological diseases and neurogenic dysphagia,” said Nuviant CEO Will Rosellini. “As our field progresses and more treatment options are found with neurostimulation, multi-application and possibly single-implant systems will be the obvious choice for co-morbidity management.”

About Nuviant Medical, Inc. – Nuviant Medical is a medical device company that is developing implantable neurostimulation systems for the relief of various chronic diseases and disorders.  The Synapse™ system is the only system that can stimulate across 16 independent channels while simultaneously recording neural signals.  Synapse previously received CE approval for adjunctive alleviation therapy of movement disorder symptoms and is being further developed for commercialization in Europeand the US.  For more information on Nuviant Medical, please visit our website at www.nuviantmedical.com

Source Article: http://finance.yahoo.com/news/nuviant-medical-awarded-175k-nih-215600358.html

MicroTransponder Clinical Trial Results Published in Stroke after Company Completes a $5.5M Round of Funding


MicroTransponder, Inc., (www.microtransponder.com) a privately-held medical device company, is pleased to announce that its successful stroke rehabilitation clinical trial has been published in the prestigious academic journal Stroke. The manuscript, titled “Safety, Feasibility and Efficacy of Vagus Nerve Stimulation (VNS) Paired with Arm Rehabilitation Following Ischemic Stroke” reports clinical results from a paired VNS therapy for stroke patients with significantly reduced upper limb mobility. This condition can incapacitate the patient and impede the ability to perform daily tasks required for independent living. Stroke is a peer-reviewed academic journal that is published monthly by the American Heart Association.

The VNS stroke trial was conducted at two stroke centers in the United Kingdom. The principal investigator for the study, Dr. Jesse Dawson from Glasgow University, said, “We saw dramatic improvements in our patients over the 6-week treatment period after using the paired VNS therapy.  Numerous patients were able to resume daily activities like driving, swimming, grocery shopping, cooking, and taking care of young children.  What was particularly encouraging is that these results were obtained by chronic stroke patients who, on average, had their strokes over 1.8 years ago.  This is very difficult patient group to treat.”

Based on the successful trial results, MicroTransponder is conducting a 20-patient follow up study.  The initial sites will be in Dallas, Texas, Houston, Texas, Minneapolis, Minnesota, and Glasgow, UK.  Enrollment is now open and the sites are seeking stroke patients who have recently had a stroke and are still experiencing upper limb movement limitations, although they must still have some movement in their limb. More information is available at www.vnsstroketrial.com.

The Vivistim® System has been developed to treat stroke patients that experience upper limb deficit following their stroke.  It consists of a small implanted battery and wires that internally connect to the vagus nerve in the neck. During the rehabilitative therapy, the patient receives a small amount of neurostimulation to the vagus nerve to strengthen the neural pathways in the brain.  This paired treatment method is based on years of neuroscience research published in peer-reviewed academic journals.  Vagus nerve stimulation has been utilized by 100,000 patients over the past 21 years to control their epilepsy. More information can be found on www.MicroTransponder.com.

The Company also announced that it had closed a $5.5 Million round of funding that was led by Green Park & Golf Ventures in order to commercialize MicroTransponder’s stroke and tinnitus therapy in Europe in 2016 and complete additional clinical studies. The $5.5 Million round of funding was led by Texas based Green Park & Golf Ventures, who also led the last round of financing.  This round included investment from both existing investors, including the UT Horizon fund, as well as new investors.  “We saw great clinical progress in the past two years at MicroTransponder, stated Dr. Clay Heighten, partner at Green Park & Golf Ventures. “We think that both the stroke and the tinnitus therapies have a large potential market, due to the significant numbers of patients whose lives are severely disrupted by these conditions and the lack of sufficient treatment options.”

The publication of our stroke clinical trial in Stroke is an honor for MicroTransponder.  Frank McEachern, CEO of MicroTransponder, states, “We appreciate the outpouring of support and recognition we have received from the clinicians in the stroke community.  Most stroke related innovation is focused solely on acute care and the stroke community is eager for alternatives for their chronic stroke patients with motor deficits, especially for those patients who may have had their strokes years ago.  Our Vivistim® therapy offers our patients the opportunity to return to free independent living and reduce or eliminate the constant care they currently require, often from their spouse or adult child.”


About MicroTransponder, Inc.

MicroTransponder Inc. (www.microtransponder.com) is a medical device development company with a strong neuroscience research focus.  The Company’s mission is to restore freedom and dignity for patients suffering from neurological disease. An experienced team of scientists and engineers has developed and continue to expand neurostimulation programs to treat various forms of neurological diseases, including post stroke motor rehabilitation and tinnitus. MicroTransponder has a substantial neurostimulation focused R&D program, which is able to quickly translate scientific discoveries into clinical therapies.


Read Source Article Here

Nuviant Medical, Inc. Converts Debt in Preparation of Form 10 Filing

DALLAS, Oct. 15, 2015 /PRNewswire-iReach/ — Nuviant Medical Inc. (“Nuviant” or “the Company”) announced today that debtholders from a previous Medtronic intellectual property acquisition have recently converted into common stock alongside an infusion of new capital from existing investors. The transaction values the Company at $48 million in advance of a Form 10 filing with the U.S. Securities and Exchange Commission expected early 2016. The Company is now debt-free and has existing government contracts to support development through the end of 2016.


Read Full Press Release Here

Team Wins DARPA Grant to Explore Potential Treatment for PTSD


A federal agency has awarded a four-year grant that could result in funding of up to $6.4 million to the Texas Biomedical Device Center at UT Dallas to study a potential new therapy for individuals who suffer from post-traumatic stress disorder (PTSD).

Read Full Press Release Here

Med device maker secures $3.8M to cure tinnitus


MicroTransponder Inc., an Austin-based medical device company, has secured $3.8 million in new capital as part of a $5.5 million funding round, with the money coming from a group of 18 investors.

Read Full Press Release Here

Good News for Tinnitus Sufferers

The Sounds of Silence: Science-based tinnitus therapeutics are finally coming into their own.

Stop the Ringing

Read Full Article Here

Rosellini Scientific, LLC Receives $790,000 Fast Track SBIR, Names Ron Conquest Chief Operating Officer

Company Plans to Develop Proprietary Nanocomposite Balloon for Drug Delivery

DALLASAug. 11, 2015 /PRNewswire-iReach/ — Rosellini Scientific, LLC (“RS” or “the Company”) an operational investment company, announced today that it received a Fast Track SBIR to develop a micro-perforated nanocomposite balloon for intravascular anti-restenotic drug delivery.  RS is an operational investment company that specializes in the development of advanced medical device concepts at the intersection of implantable electronics, nanotechnology, and personalized medicine.

Read Full Press Release Here