FDA warns against unapproved concussion diagnosis devices

FDAThe FDA today warned consumers against using medical devices purported to assess head injuries, saying tht only five companies are cleared to market such devices in the U.S. and that they should only be used by physicians.

“The FDA has identified several manufacturers that were marketing medical devices for concussion diagnosis, treatment or management without the FDA’s approval or clearance,” the federal safety watchdog said. “To date, there are a limited number of medical devices that have been approved or cleared by the FDA to aid in diagnosis, treatment or management of head injury, including suspected concussion and other traumatic brain injuries. Additionally, the FDA has not approved or cleared any devices that can assess or diagnose a head injury, including suspected concussion and other traumatic brain injuries without an evaluation by a health care provider.”

“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own. Using such devices can result in an incorrect diagnosis after a head injury that could lead a person with a serious injury to return to their normal activities instead of seeking critical medical care, putting them at greater danger,” added Center for Devices & Radiological Health director Dr. Jeffrey Shuren. “Products being marketed for the assessment, diagnosis, or management of a head injury, including concussion, that have not been approved or cleared by the FDA are in violation of the law. The FDA routinely monitors the medical device market and became aware of violative products being marketed to consumers. The FDA has alerted companies to our concerns and asked them to remove such claims. We will continue to monitor the marketplace for devices making these unsubstantiated claims and are prepared to take further action if necessary.”

Synchron’s thought-to-text tech starts clinical trial

Synchron’s Stentrode technology is designed to restore communication to people with paralysis. (Image from Synchron)

Synchron said it has begun the first clinical trial for its neural interface technology designed to restore communication to people with severe paralysis.

The trial will measure the safety of the company’s “thought-to-text” technology by assessing its Stentrode implant in combination with BrainOS software and the stability of high-fidelity signals from the brain to external communications technologies.

Stentrode was designed to be small and flexible enough to safely pass through curving blood vessels in a procedure called cerebral angiography, eliminating the need for open brain surgery, according to Campbell, Calif.-based Synchron. By using blood vessels to deliver the technology to the brain, the technique may reduce risk of brain tissue rejection of the device, which has been a significant problem for other techniques, the company said. BrainOS is a modular training software powered by artificial intelligence that enables patients to control assistive technologies directly through thought.

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

Silk Road Medical clears $109m in IPO

Silk Road MedicalSilk Road Medical (NSDQ:SILK) said yesterday that it cleared just more than $109 million in its initial public offering, including a fully subscribed underwriters option.

The $20-per-share flotation grossed $120 million, Sunnyvale, Calif.-based Silk Road said. The company is developing a neuroprotection and stent system called Enroute as an aid to transcarotid artery revascularization procedures. Silk Road’s estimated net proceeds of $109.1 million are earmarked for sales force expansion, new clinical trials, increasing its international footprint and potentially for acquisitions.

president & CEO Erica Rogers told MassDevice.com last week that Enroute is designed to be a less-invasive alternative to carotid endarterectomy. It’s engineered to temporarily reverse blood flow during shunting to prevent debris from entering the brain, Rogers told us.

In their first day of trading April 4, SILK shares gained 80.9% on the IPO price, opening at $33.15 apiece and rising as high as $39.51 before closing at $36.18 each. The stock closed down -2.3% at $34.99 per share yesterday.

Silk Road Medical upsizes IPO

Silk Road MedicalSilk Road Medical today boosted the size of its pending initial public offering to as much as $120 million.

When it registered the IPO in March, Silk Road said it could fetch as much as $86 million. But last week the Sunnyvale, Calif.-based company cut the range, saying it planned to float nearly 4.7 million shares at $15 to $17 apiece, for gross proceeds of $70.5 million to $79.9 million.

Today Silk Road said it plans to offer 6 million shares at $19 to $20 a piece, which would deliver gross proceeds of $114 million to $120 million. The company developed the Enroute transcarotid stent and neuroprotection system to treat carotid artery blockages before they cause a stroke.

Silk Road has said it plans to use the cash to expand its sales force and operations, increase R&D including new clinical trials, expand internationally and possibly acquire new ventures or technologies.

The company said it plans to list under the “SILK” symbol on the NASDAQ exchange.

Silk Road has raised at least $104 million since 2015, when it first won 510(k) clearance from the FDA for Enroute in carotid stenting and angioplasty procedures. Pre-market approval for high-risk patients followed in May of that year.

Teva wins EU nod for Ajovy migraine prophylactic

Teva Pharmaceuticals logo - updated

Teva (NYSE:TEVA) said yesterday that it won EC Marketing Authorization for its Ajovy pre-filled syringe injection meant to serve as a prophylaxis for migraines in adults who experience at least four migraine days per month.

The Israel-based company said that Ajovy is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide ligand and blocks its binding to the receptor.

Read the whole story on our sister site, Drug Delivery Business News

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NexStim wins Health Canada approval for NBS, NexSpeech

Nexstim

Nexstim said today that it won approval from Health Canada for its NBS system and NexSpeech devices.

The Helsinki-based company’s NBS system and NexSpeech comprise a diagnostic device intended for the non-invasive localization of the brain areas that control motor and speech functions. The devices are used by neurosurgeons for surgical planning prior to brain tumor operations or in treating treatment-resistant epilepsy, Nexstim said.

Both the NBS system and NexSpeech use navigated Transcranial Magnetic Stimulation to better allow for personalized, accurate and reproducible stimulation of specific areas of the brain, the company said.

Nexstim said that it has already inked a distribution agreement with a Canadian distribution company to bring both systems to the market in the region, according to a press release.

Earlier this week, Nexstim said that it won FDA 510(k) clearance for a new, shorter treatment protocol for its Navigated Brain Therapy transcranial magnetic stimulation system intended to treat major depressive disorder.

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BrainScope completes large-scale BrainScope One mTBI validation study

Brainscope

BrainScope said today that it completed a validation study of its BrainScope One device designed to assess head injuries, exploring its ability to assess mild traumatic brain injuries in adolescent and young adult populations.

The Bethesda, Md.-based company ‘s FDA-cleared BrainScope One device is a multi-modal device designed to aid in the objective and rapid assessment and triage of head injury patients, and can assess the “full spectrum of brain injury” including concussions and brain bleeds.

BrainScope said that the study included data from nearly 1,700 subjects and more than 4,000 evaluations performed between 2015 and 2019. In the study, researchers aimed to create and validate an objective, personalized capability to assess concussions and readiness to return to activities in males and females between the ages of 13 and 25.

“These large studies add important information to the understanding of the pathophysiology of concussion, leading to better assessment capabilities which can improve short and long-term outcomes of head-injured patients,” chief scientific officer Leslie Prichep said in a prepared statement.

The company said that it released preliminary results related to concussion assessment capabilities for potential severity and the likelihood of prolonged recovery in the journal Computers in Biology and Medicine in January. Results from the study indicated highly significant differences in the BrainScope EEG-based biomarker at the time of injury between 177 concussed patients and controls with no significant differences at when Return-to-Play was clinically determined.

BrainScope added that progressive recovery over time was also objectively demonstrated, and that results supported the hypothesis that some of the more severely injured subjects may have been allowed to return to play too soon.

“We are extremely pleased to have concluded these substantial clinical studies over 4 years, the results of which are extremely exciting as we work in the near-term through appropriate regulatory processes to bring important new concussion assessment capabilities to the market. In particular I want to thank the U.S. Department of Defense, the NFL, GE, and BrainScope investors for their financial support of this major initiative which has yielded such excellent results,” CEO Michael Singer said in a press release

The company said that $9.9 million in funding for the study came from the U.S. Department of Defense. The trial was also supported by private funding and by funds from the NFL-GE Head Health Challenge.

In January, BrainScope said that it won FDA clearance to include a new indication language for its BrainScope One concussion assessment device.

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LivaNova’s CMS vagus nerve depression device trial must include sham arm

LivaNova

A new U.S. Centers for Medicare & Medicaid Services trial of LivaNova‘s (NSDQ:LIVN) Vagus Nerve Stimulation Therapy system intended to treat treatment-resistant depression will require a sham-control arm, doubling the subject population LivaNova originally expected.

The trial, which the London-based company won clearance from CMS for last month, will allow coverage for the VNS devices through a Coverage with Evidence Development framework.

As revealed last month, the trial will be double-blinded, randomized and feature a follow-up of at least one year, the company said.

New data, revealed in a posting on Clinicaltrials.gov, indicate that the trial will seek 1,000 subjects with an estimated start date of this July. LivaNova said last month that it only planned to include 500 subjects in the trial of the device.

All subjects in the trial will be implanted with the VNS system, though subjects in the sham-control arm will not have the device activated for the first 12 months. After the initial trial, patients in the sham arm will be allowed to join the open-label, prospective and longitudinal portion of the study where they will tracked out to five years.

The primary endpoint of the trial will be mainly monitored through scoring on the Montgomery Åsberg Depression Rating Scale, as well as disability assessments, adverse event monitoring and a selection of other physical and mental health assessment criteria.

Last November, CMS proposed a launch of a clinical trial of the VNS system to explore its ability to treat Treatment-Resistant Depression.

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FDA clears shorter protocol for Nexstim’s NBT TMS depression treatment

Nexstim

Nexstim said today that it won FDA 510(k) clearance for a new, shorter treatment protocol for its Navigated Brain Therapy transcranial magnetic stimulation system intended to treat major depressive disorder.

The Helsinki-based company said that the FDA cleared the system for a Theta Burst Stimulation treatment protocol, which is much shorter than its previously cleared treatment protocol.

The newly cleared protocol for the NBT system takes only 3 minutes per session, significantly shorter than the 37-minute standard treatment protocol the company won FDA clearance for in November 2017.

Nexstim said that a large multi-center clinical trial of the new protocol showed it to be non-inferior to the standard protocol, and said that the new, shorter treatment will improve both patient access and treatment experiences for patients. The company added that the shorter protocol will also improve efficiency and ease of use for TMS treatment centers.

“The FDA clearance of the much shorter Theta Burst Stimulation protocol for our NBT system is important as we continue to commercialize the device in the United States. The new protocol will deliver multiple benefits for both our customers and the patients they treat. This approval reflects Nexstim’s continuing investment in our navigated TMS technology to ensure that more and more patients in the U.S. can gain access to this unique, personalized and reproducible approach to treating MDD,” chair & CEO Martin Jamieson said in a press release.

Last November, Nexstim said that it pulled the trigger on a 30-to-1 reverse split of its stock as the company looks to reduce its share capital.

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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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