BrainsWay Deep TMS System Receives FDA Clearance for OCD Treatment

Israel-based BrainsWay recently announced the de novo FDA clearance of its Deep Transcranial Magnetic Stimulation (TMS) system for treatment of obsessive compulsive disorder (OCD).

According to the press release, the BrainsWay Deep TMS system was previously cleared for treatment-resistant major depressive disorder in 2013, and this month’s de novo clearance is the second indication granted for the device, and marks the first clearance of a non-invasive device for treatment of OCD.  The BrainsWay press release further notes that the Deep TMS system’s H7-coil targets the anterior cingulate cortex, which is known to play a role in the pathophysiology of OCD.  BrainsWay stated that Deep TMS treatment, which uses changing magnetic fields to stimulate nerve cells in the brain, is non-invasive and has been shown to be safe and well-tolerated by patients.

BrainsWay plans to offer its OCD treatment both in new installations and as an upgrade to its existing systems.  Addressing the broad future applicability of the Deep TMS system, BrainsWay president and CEO Yaacov Michlin said:

This clearance further establishes Deep TMS as a platform technology that will provide treatments for additional psychiatric indications, subject to successful completion of our currently ongoing multi center studies and regulatory approvals.

FDA Approves First Generic Epinephrine Autoinjectors

The United States Food and Drug Administration recently announced approval for Teva Pharmaceuticals to market generic epinephrine autoinjectors.  According to the press release, Teva’s autoinjectors are the first generic versions of Mylan’s EpiPen® and EpiPen Jr ® to receive FDA approval.

Food Allergy & Research reports that as many as 15 million people in the U.S. have food allergies, which results in about 200,000 needing emergency medical care per year.  Commenting on the approval, U.S. FDA Commissioner Scott Gottlieb stated:

This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.

Analyst reports indicate wholesalers are not expecting to receive the generic epinephrine autoinjectors from Teva for several months.  A Teva spokesperson commented that the company “is applying its full resources to this important launch in the coming months and is eager to being supplying the market.”  Currently, Mylan’s EpiPen® 0.3 mg autoinjector 2-pack sells for about $697 at HealthWarehouse.com.  Teva has not yet indicated the price of its generic autoinjector.

 

 

 

FDA to Strengthen Cybersecurity Oversight

In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the premarket review process for medical devices. In particular, the report suggests including cybersecurity documentation as a criterion in the FDA’s Refuse-To-Accept (RTA) checklist, using presubmission meetings to address cybersecurity questions, and including cybersecurity as an element of the FDA’s Smart template.

The FDA has been ramping up its cybersecurity review lately to deal with increased cybersecurity concerns. For example, a ransomware attack caused an Indiana hospital to shut down its system. Other cyberattacks may have gone undetected.

Currently, the FDA reviews documentation that manufacturers submit regarding cybersecurity as part of the premarket submissions. The FDA uses this information to consider known cybersecurity risks and threats when reviewing submissions that deal with networked medical devices. The FDA may request additional information from applicants when submissions require clarification or when cybersecurity documentation is lacking. In view of these requests, the FDA regularly approves manufacturers on cybersecurity issues when sufficient documentation is provided.

For example, in one review of a glucose monitoring system, an FDA reviewer did not find “any information on how the manufacturer included cybersecurity in the device’s design,” according to the report. “The FDA reviewer explained that the device relied heavily on users to protect against cybersecurity threats by using antivirus software and enabling firewalls. The FDA reviewer requested that the manufacturer update its hazard analysis to address the missing information. The manufacturer did so, and FDA found the update to be acceptable.”

Because of examples like this, the report suggests using cybersecurity documentation as an element in the FDA’s RTA checklist. The RTA checklist is a screen against incomplete applications. Were cybersecurity part of these checklists, failure by a manufacturer to provide adequate cybersecurity documentation could prevent the FDA to accept the submission for substantive review.

The report also suggests that the FDA use presubmission meetings to address cybersecurity-related questions. These meetings serve as a way for manufacturers to ask the FDA specific questions, such as whether the submission satisfies the FDA’s standards. During these meetings, the FDA can include cybersecurity as part of the discussion, which may reduce the amount of time for the FDA review.

Finally, the report recommended that cybersecurity be a stand-alone element in the FDA’s Smart template. A dedicated section on cybersecurity could allow FDA reviewers to explain the results of their review regarding cybersecurity in a standard format.

The FDA has agreed with these recommendations and has begun taking steps to implement them, such as by including cybersecurity in the Smart template. The FDA also said that it “intends to update the RTA checklist and the accompanying guidance to specifically identify cybersecurity as an item in the checklist during the next update of these items.” The FDA is also currently considering new rules that may require submission of software as part of a premarket submission.

Medical Device Market Returns and Recent Industry Activity

The medical device and related markets have shown some growth recently.  For example, IHI, an iShares U.S. Medical Devices ETF, has a total return of about 24% year-to-date in 2018.   In the same time period, the S&P 500 has a return of about 8%.  The IHI fund has an average annual return in the last ten years of about 14% compared to about 10.7% for the S&P 500According to MarketWatch, the IHI fund invests in “medical-products companies that deliver the tubes, pumps and tools that are necessary to make medical facilities function. . . .  While some of the products offered by these companies are indeed high-tech, such as artificial heart valves, many are less glamorous, such as catheters and blood-pressure cuffs. But despite their flash, these items are staples, and medical offices and hospitals nationwide remain big revenue sources for these companies.”

MarketWatch further reports that ETFs related to healthcare in general have “more than tripled the returns of the S&P 500 this year.”  For example, the largest healthcare ETF by funds, XLV, is reportedly up 10% this year, and the IBB fund is up about 330% over the last ten years. Other healthcare-related funds reported to be outperforming the S&P 500 year-to-date in 2018 include the following:

  • Janus Henderson Obesity ETF “SLIM,” up 20%;
  • iShares U.S. Healthcare Providers ETF “IHF,” up 22%,
  • Invesco DWA Healthcare Momentum ETF “PTH,” up 23%;
  • the Ark Genomic Revolution Multi-Sector ETF “ARKG,” up 23%;
  • the SPDR S&P Health Care Equipment ETF “XHE,” up 27%; and
  • the Invesco S&P SmallCap Health Care ETF “PSCH,” up 40%.

There has been some activity and forecasts in the medical device market recently reported.  Some forecasts include the market for medical device connectivity projected to reach about $2.6 billion by the year 2023.  The global market for “IoT” (internet of things) medical devices is projected to grow at a compound annualized growth rate (CAGR) of about 25% from 2018 to 2023.   For the same period, the market for anesthesia-related devices is expected to have a CAGR of about 6.4%.  The global market for retinal surgery devices is reported as “likely to exceed $3 Billion by 2025, almost double from its current level in 2017.”  The global market for brachytherapy devices is reportedly predicted to rise at 4.2% CAGR from 2017 to 2022.

Some examples of recent medtech funding and M&A activity have included: CytoSorbents, a critical-care immunotherapy company that specializes in blood purification, received a research award of up to $3 million from the NIH.  Irvine-based Endologix, provider of solutions for aortic disorders, reportedly recently took out a $210.5 million convertible loan facility.  Urotronic, developer of a drug-coated balloon catheter for treating urethral strictures in men, reportedly raised $20 million in an equity offering involving 7 investors.  410 Medical Inc. a Durham, North Carolina-based company focused on technologies for resuscitation of critically ill patients, reportedly recently raised $3.1 million in financing.

FDA Grants Breakthrough Status to Dthera Sciences’ Alzheimer’s Therapeutic

On August 23, 2018, Dthera Sciences announced that the Food and Drug Administration granted Breakthrough Therapy designation to its Alzheimer’s disease therapeutic device. According to the FDA, Breakthrough Therapy designation is intended to help patients have more timely access to breakthrough technologies that provide treatment for diseases for which no approved treatment exists or which offer significant advantages over existing treatments. A therapy that receives Breakthrough Therapy designation will be reviewed within 60 days of receipt.

Dthera Sciences chief executive officer Edward Cox stated:

We commend the FDA for recognizing this significant unmet medical need as well as the critical importance of providing innovative new treatments to patients with Alzheimer’s and their caregivers.

According to Dthera Sciences, the therapeutic device, termed DTHR-ALZ, is a prescription digital therapeutic for patients with Alzheimer’s disease. The device digitally delivers ReminX, a reminiscence therapy, to patients with Alzheimer’s disease and automatically optimizes the therapy using biofeedback. Reminiscence therapy is a behavioral intervention that involves introduction of familiar pictures, music, or other materials to help patients reminisce about past experiences.

According to the press release, Alzheimer’s disease is a neurodegenerative disease that is among the ten leading causes of death in the United States. In addition, it is one of the most financially costly diseases. According to Dthera Sciences, DTHR-ALZ mitigates the symptoms of agitation and depression associated with Alzheimer’s disease with minimal investment of time and resources.

Boston Scientific Buys Venous-Stent Maker VENITI

Boston Scientific recently announced an agreement to acquire privately-held VENITI, Inc. for $160 million. According to the press release, VENITI submitted a pre-market approval application with the U.S. Food and Drug Administration in June 2018 for the VICI stent system for treating obstructive venous disease. The VICI stent system received CE Mark approval in 2013.

According to the press release, venous obstructive disease affects more than 1.1 million people in the United States and Western Europe annually. Jeff Mirviss, Senior Vice President and President of Peripheral Interventions at Boston Scientific, commented:

Along with our leading AngioJet thrombectomy platform and venous product pipeline, we look forward to meeting the needs of physicians treating both chronic and acute venous disease.

According to the Worcester Business Journal, Boston Scientific announced over $1.5 billion in acquisitions this year alone. Other notable Boston Scientific acquisitions in 2018 include Millipede ($540m), NxThera ($306m), nVision Medical Corporation ($275m), Claret Medical ($270m), and Cryterion Medical ($202m).

Boston Scientific expects the acquisition of VENITI to be immaterial to adjusted earnings per share (EPS) in 2018 and 2019, and accretive thereafter. Nonetheless, shares of Boston Scientific opened trading the day of the announcement up more than 3 percent.

BioSig Technologies Receives FDA 510(k) Clearance for Its Noninvasive Electrophysiology Information System

The Los Angeles-based medical device company BioSig Technologies, Inc. announced in a press release the FDA 510(k) clearance of its PURE EP System, which is designed to aid electrophysiology procedures, such as cardiac ablation for treating atrial fibrillation.

According to the company’s website, existing cardiac signal acquisition technology results in loss of vital information in the signal.  The company states that the PURE EP system incorporates “proprietary hardware and software . . . designed to effectively eliminate noise, artifact and baseline wander in real-time to present clearer signals during EP studies and catheter ablation” and “developed to enhance clinical decision making by revealing the most important parts of the signals.”

Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. commented:

Our PURE EP System is the culmination of many years of scientific research and business development efforts. It is our goal to provide tangible benefits to electrophysiologists and improve the current standards of EP procedures in the clinical setting.  We are excited to bring the advanced platform to the U.S. market.

According to a previous BioSig press release about the completion of a private placement, an FDA 510(k) application for the PURE EP system, the company’s first product, was submitted in late March 2018.  According to public records, BioSig is the listed assignee of, among others, a pending U.S. patent application directed to “evaluation of electrophysiology systems.”

According to that press release, BioSig has raised approximately $11,000,000 in 2018.  The company also announced that it expects to be trading on Nasdaq in 2018.

MaxQ-AI Files for IPO

MaxQ-AI (previously known as MedyMatch) recently filed for an $8 million IPO.  According to Nasdaq, MaxQ-AI filed confidentially on February 13. The prosepectus filed with the SEC describes MaxQ-AI as “a clinical stage artificial intelligence, or AI, company specializing in improving diagnostic accuracy through deep learning technology.”  MaxQ-AI is currently classified as an “emerging growth company” under the 2012 JOBS Act (meaning it had revenues of less than $1.07 billion last fiscal year).  MaxQ-AI’s CEO is Gene Saragnese.

According to it’s website, MaxQ-AI focuses on “artificial intelligence driven diagnostic tools.”  Its goal is “to deliver A.I. based patient specific clinical decision support applications to improve quality outcomes and reduce healthcare costs.”  MaxQ-AI says this will reduce the misdiagnosis rate in the medical industry.  MaxQ-AI is currently focused on “continuing to build out capability in the acute care ER setting with a natural extension into trauma.”

MaxQ-AI recently received CE mark approval for its Accipio software platform, which is used for “detection of intracranial hemorrhage” by analyzing non-contrast head CT images.  In addition, MaxQ-AI received a “breakthrough device” designation from the FDA for its Accipio software platform.  According to the prosepectus, MaxQ-AI has not submitted the Accipio products for FDA approval, but plans to do so in the third quarter 2018.

Last year, MaxQ-AI unveiled partnerships with GE Healthcare, Samsung, and IBM.  According to the press releases, each of these companies plans to integrate the Accipio software into existing technology.

MaxQ-AI’s IPO comes on the heels of the busiest quarter for IPOs in three years, according to MarketWatch.  In the second quarter of 2018, sixty companies raised $13.1 billion in IPOs.

Cyberattacks and the Value of Medical Data

On July 20, 2018, SingHealth, a Singapore healthcare institution consisting of four public hospitals, five national specialty centers and a network of nine polyclinics, reported that it had been the target of a cyberattack resulting in the information of around 1.5 million individuals being compromised.

This is not an isolated incident as statistics compiled from the U.S. Department of Health and Human Services (HHS) indicate that more breaches involving healthcare data were reported in 2017 than any other year since records first started being published. In Experian’s 2018 Data Breach Industry Forecast, Experian noted that from January through June of 2017, 233 healthcare data breach incidents were reported to HHS, the media or state attorney generals. For the 193 attacks for which there are numbers, 3,159,236 patient records were affected. In a 2016 Data Breach Industry Forecast, Experian predicted that healthcare companies remain one of the most targeted sectors by attackers, driven by the high value that compromised data can command on the black market, along with the continued digitization and sharing of medical records.

Forbes reported that, on the black market, the going rate for a social security number is 10 cents and a credit card number is 25 cents, while electronic medical health records could be worth hundreds or even thousands of dollars because such medical data contains a wealth of exploitable information, such as names, addresses, work history, family member names, financial information, as well as more sensitive information relating to medical history.

 

FDA Announces Innovation Challenge for Devices to Prevent and Treat Opioid Use Disorder

The Food and Drug Administration (FDA) has announced a medical device innovation challenge to help address opioid abuse and misuse.  With the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, the FDA intends to encourage development of medical devices that will help to combat the ongoing opioid crisis.

According to the announcement, diagnostic and therapeutic devices at any stage of development are eligible for submission to the Challenge.  The FDA also indicates that currently marketed devices may be submitted if developers are interested in demonstrating that their device has an improved benefit-risk profile as compared to opioids in the management of pain.  Non-limiting examples of suitable medical devices provided by the FDA include diagnostic devices that identify patients at increased risk for addiction, opioid-sparing or opioid-replacement therapies for acute or chronic pain, and devices that monitor the use and prevent diversion of prescription opioids.

According to the announcement, Challenge submissions should describe:

  • The novelty of the medical device/concept,
  • The development plan for the medical device,
  • The development team, and
  • The anticipated benefit of the device used by patients and the impact on public health as compared to other available alternatives.

The FDA has indicated that they will work directly with selected applicants during a collaboration phase to accelerate the development and review of new devices, similar to the process under the existing Breakthrough Devices Program.  The announcement also reports that selected devices will also be granted Breakthrough Device designation without requiring a separate application.  Challenge applications will be accepted through September 30, 2018.  The FDA will be hosting a webinar on July 25, 2018 to provide further information.

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.