Helius Medical shares tank on FDA denial

Helius MedicalShares in Helius Medical Technologies (NSDQ:HSDT) tanked yesterday after the company said the FDA shot down its clearance bid for the portable neuromodulation device it developed.

The Newtown, Pa.-based company’s PONS system is designed to treat neurological symptoms through electrical stimulation of nerves in the tongue. A trial of the PONS device in treating patients with chronic balance deficits from traumatic brain injuries failed to meet its efficacy endpoint in November 2017. Helius said the control group showed a significant therapeutic effect from the low-frequency pulse treatment used in that arm, skewing the study into missing the effectiveness endpoint.

Yesterday the company said that the FDA denied its application for de novo 510(k) clearance, saying the the federal safety watchdog “did not have sufficient information” to determine whether PONS treatment is better than physical therapy, based on the studies Helius used to back the application.

“We are understandably disappointed by the agency’s decision to decline our request for de novo classification and 510(k) clearance, but Helius remains committed to generating the data to pursue a de novo classification and 510(k) clearance of our PONS device in the future,” CEO Philippe Deschamps said in prepared remarks. “In addition to working on generating this new data, we will continue to focus on expanding our commercial efforts and treating patients in Canada, where we do currently have regulatory clearance.”

The news sent HSDT shares down -66.2% to a $2.10-per share close yesterday; the stock opened at $2.06 today and was off -15.2% to $1.78 apiece as of 10 a.m. Eastern.

Brainsway sets terms for $30m IPO


Brainsway this week set the terms on its forthcoming initial public offering in the U.S., saying it hopes to raise nearly $30 million.

The Jerusalem-based company, which developed a transcranial magnetic stimulation device to treat psychological disorders, said it plans to float 2.5 million American Depository shares at roughly $11.94 apiece. Each ADS is slated to represent two ordinary shares, Brainsway said; the U.S. offering price is based on the April 2 closing price of ₪21.64, or roughly $5.97, and is subject to change.

The company plans to list on the NASDAQ exchange under the symbol “BWAY,” according to a regulatory filing.

Last August, Brainsway won FDA de novo approval for its deep transcranial magnetic stimulation system with indications for treating obsessive compulsive disorder.

BRIN shares closed down -4.8% at ₪20.22 yesterday in Tel Aviv.

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FDA panel: Neuronix Alzheimer’s therapy fails to prove efficacy

An FDA advisory panel has recommended against granting de novo clearance to Neuronix’s NeuroAD system intended to slow the progress of mild to moderate Alzheimer’s disease.

NeuroAD is approved for use in Europe, Australia and Israel, but the panel found that while it met FDA safety standards, clinical studies did not prove that it is effective.

NeuroAD uses focused transcranial magnetic stimulation (TMS) to stimulate target areas of the brain responsible for cognitive functions impaired by Alzheimer’s disease, according to the Yoqneam, Israel-based company. This stimulation is designed to induce long-term potentiation, which the company said is associated with learning and memory processes, and makes these areas of the brain more receptive to cognitive training. Patients who receive the stimulation simultaneously receive such training.

Get the full story on our sister site, Medical Design & Outsourcing.

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Theranica raises $35m Series B for neuromod migraine patch

TheranicaTheranica Bio-Electronics said yesterday that it raised a $35 million Series B round for the Nerivio Migra neurostim patch it’s developing to treat migraine headache.

Netanya, Israel-based Theranica said VC shop aMoon led the round, joined by all of its existing backers, Lightspeed Venture Partners, LionBird, Corundum Open Innovation and Takoa. The company raised an unspecified amount in its seed round back in September 2016.

Theranica closed out a nearly 300-patient pivotal study last October it used to back a bid for FDA clearance that met its primary endpoint and showed “high efficacy, safety and tolerability.”

“The new funds will allow the company to mass-produce the Nerivio Migra and – once cleared by the FDA – to deliver the device to millions of migraine patients in the USA,” co-founder & CEO Alon Ironi said in prepared remarks. “They will also enable further development, targeting additional clinical syndromes. We chose to start with the USA because this is the largest single market for migraine and headache and because we were highly impressed by the readiness of the American medical community to apply drug-free, non-addictive solutions for headache and other types of pain.”

“Theranica’s vision and current stage align well with the investment strategy of our late stage fund,” added aMood partner Todd Sone. “Theranica’s innovative migraine device combines excellent clinical efficacy, safety and tolerability, together with advanced digital technologies to maximize the benefit for patients.”

“This new partnership with aMoon, together with the on-going support from our existing investors, gives Theranica the fuel to commercialize the product, bring it to the masses and ultimately improve migraine therapy worldwide, by turning this innovative, non-invasive, drug-free solution into the first line of treatment,” co-founder & chairman Dr. Shimon Eckhouse said.

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Cala Health licenses MGH-developed neuromod tech

Cala Health

Cala Health said this week it inked a deal to license technology from Partners Healthcare and its affiliate Massachusetts General Hospital intended to improve the company’s non-invasive neuromodulation platform for investigating and treating chronic diseases.

The licensed technology was developed from research on transcutaneous vagus nerve stimulation and respiratory-gated vagal afferent nerve stimulation at a research lab in the MGH, the Burlingame, Calif.-based company said.

“This collaboration with MGH’s cutting-edge research team provides a clear opportunity to accelerate development of wearable neuromodulation therapies for many chronic diseases. By working together, our combined team can discover, develop and deliver breakthrough therapies for patients living with these conditions,” founder & CEO Kate Rosenbluth said in a press release.

As part of the licensing agreement, the original inventors of the technology will work with Cala Health as advisors on its development, the company said.

“This collaboration is the result of years of research and development on the links between brain and cardiac function, and our team is excited to be working with an established company that has experience taking new devices through clinical studies and regulatory clearance,” Women, Heart and Brain Global Initiative exec director Jill Goldstein of Harvard Medical School said in a prepared release.

“There is a great need to offer effective therapies that are not based on drugs or invasive implants. Non-invasive neuromodulation may help address that need,” said Vitaly Napadow of Massachusetts General Hospital and Harvard Medical School said in prepared remarks.

In December, Cala Health launched a clinical trial of the latest version of its wearable neurostimulator for treating essential tremor, eyeing extended use of the wrist-worn device.

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FDA issues ‘leap-frog’ guidance on brain/computer interfaces

A researcher instructs a patient on how to move an artificial hand using a brain/computer interface device.

FDA has issued draft guidance for developers of devices to help amputees and people with paralysis regain mobility or their sense of touch.

FDA defines brain/computer interface (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. The guidance proposes that non-clinical device testing can be used to demonstrate that potential risks have been mitigated before beginning a clinical study. It also provides detailed recommendations on preparing to submit an application for an investigational device exemption.

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Axonics Modulation Technologies slides on misses Q4, 2018 earnings

Axonics Modulation TechnologiesAxonics Modulation Technologies (NSDQ:AXNX) took a hit after it posted fourth-quarter and 2018 losses that exceeded the consensus forecast on Wall Street.

The company is developing a sacral nerve stimulation device to treat incontinence.

Irvine, Calif.-based Axonics said yesterday that its losses grew 95.6% to -$9.6 million, or -50¢ per share, on sales of $494,000 for the three months ended Dec. 31, 2018, compared with the same period in 2017. Analysts on The Street were expecting losses of -32¢ on sales of $220,000.

Full-year losses also grew, rising 86.0% to -$32.5 million, or -$4.64 per share, on sales growth of 452.3% to $707,000 compared with 2017. Analysts were looking for losses of -1.59 per share on sales of $440,000.

“We view the generation of $0.5 million of revenue in the fourth quarter, serving a handful of customers with a small team of sales professionals, to be a harbinger of things to come. We are seeking measurable market share gains in 2019 from our two primary markets in Europe, the United Kingdom and the Netherlands. The accounts we have secured in these markets are exceeding our expectations in terms of the percentage of SNM implants using the Axonics system. Moreover, we now have the only SNM device with full-body MRI labeling, an advantage that should aid us in gaining further traction,” CEO Raymond Cohen said in prepared remarks. “Our primary focus continues to be gaining FDA approval in the shortest possible timeframe. To that end, and based on interaction with the FDA, we determined our best course of action was to further enrich our current literature-based PMA with the full cohort of Artisan-SNM study data as well as the full-body MRI data. As we advance our regulatory strategy, we continue to press forward on our initiative to be fully prepared to execute a broad, fully staffed U.S. launch upon FDA approval. We are building a world-class team and have been pleased that many experienced neuromodulation and urology professionals view Axonics as an attractive place to work that represents an exciting career opportunity. Overall, we are making excellent progress on our key operational objectives.”

AXNX shares closed down -3.2% at $20.75 apiece yesterday and were down -3.0% to $20.22 each today in late-morning activity.

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Inspire Medical wins more Blue Cross Blue Shield coverage

Inspire Medical SystemsFive more Blue Cross Blue Shield health plans have extended coverage to Inspire Medical Systems’ (NYSE:INSP) sleep apnea therapy, the company said today.

These plans and the effective dates of their coverage are:

    • Independence Blue Cross, in Pennsylvania, March 4, 2019;
    • Blue Cross Blue Shield of Louisiana, Feb. 20, 2019;
    • Wellmark, in Iowa and South Dakota, Jan. 1, 2019;
    • HealthNow New York, April 1, 2019
    • BCBS of Kansas City, March 1, 2019.

Together, these plans provide coverage for approximately 8.5 million members. Thirteen BCBS plans covering about 25 million members have issued coverage policies for the company’s technology since a January 7 BCBSA Evidence Street report said there is sufficient evidence to determine that Inspire therapy results in a meaningful improvement in net health outcomes for patients meeting specified criteria.

The Maple Grove, Minn.-based company’s technology is a closed-loop, pacemaker-like system designed to stimulate nerves to keep airways open during sleep to treat obstructive sleep apnea.

“We continue to work with many payers across the U.S. to develop positive coverage policies of Inspire therapy,” said Inspire president & CEO Tim Herbert in a prepared statement. “The specific plans we are announcing today are in important target geographic areas where there are a significant number of implanting physicians. These positive coverage policies will now provide enhanced access to Inspire therapy, and we remain committed to making Inspire more accessible to more patients in the future.”


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FDA clears Axilum Robotics’ system for TMS positioning

(Image from Axilum Robotics)

Strasbourg, France-based Axilum Robotics said today that it has received 510(k) clearance from FDA for its TMS-Cobot TS MV, indicated for the spatial positioning and orientation of the treatment coil of the MagVenture TMS Therapy system.

Transcranial magnetic stimulation (TMS) is a non-invasive neurostimulation technique. Its approved and potential applications range from neuroscience research to the treatment of drug-resistant neurological or psychiatric diseases.

Get the full story on our sister site, Medical Design & Outsourcing.


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Axonics wins expanded MRI-safe CE Mark approval for r-SNM system

Axonics Modulation Technologies

Axonics Modulation Technologies (NSDQ:AXNX) said today that it won expanded CE Mark approval clearing its r-SNM Sacral Neuromodulation system for use with 1.5T and 3T full body magnetic resonance imaging.

The Irvine, Calif.-based company touted the r-SNM as the only implantable SNM system to have received full-body labeling in the EU.

“Without this labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator surgically explanted prior to the MRI scan, resulting in an additional surgery for the patient and additional costs to patients and the healthcare system. This authorization of full-body MRI scans in Europe is another important milestone for Axonics, differentiating our technology from the competitive system and further demonstrating the foresight of our engineers and our commitment to invest the time and capital to provide the best possible SNM solution for patients, clinicians and the healthcare system. As announced on February 12, Axonics submitted complete test data to the U.S. FDA for the purpose of gaining Conditional Full Body Magnetic Resonance Imaging labeling approval in the U.S,” CEO Raymond Cohen said in a prepared statement.

“This is a game changer. Full-body MRI labeling is critical to patients who need, or may anticipate needing, magnetic resonance imaging. This new expanded labeling eliminates a major concern for both groups of patients and will allow more patients to choose SNM to treat their urinary and bowel dysfunction without compromising their quality of life,” chief medical officer Dr. Karen Noblett said in a press release.

Earlier this month, Axonics said that it submitted an amendment to the FDA premarket approval application for its implantable r-SNM System 1 Sacral Neuromodulation device seeking full-body magnetic resonance imaging labeling.

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