Blog Articles

Cryoablation Competition Heats Up

Atrial fibrillation (AF), a common heart rhythm disorder, is often treated with cardiac ablation. Cardiac ablation uses RF (heating) or cryothermal (cooling) energy to scar the areas of the heart muscle that are responsible for the abnormal heart rhythm. Abbott Laboratories, Boston Scientific, and Biosense Webster (a subsidiary of Johnson & Johnson), each offer RF ablation catheters. According to one analyst, however, Medtronic is the first company to launch a cryoablation device and currently has reign over the cryoablation market. Recent developments suggest competition in cryoablation is now ramping up.

“The cryoablation market is set for disruption as Adagio Medical, Boston Scientific and a number of other smaller companies enter the space to challenge the market dominance of Medtronic’s devices.” -Sheryl Tang, senior analyst for medical devices at GlobalData.

GlobalData estimates cryoablation catheters make up approximately 27% of the global electrophysiology ablation catheters market, with the cryoablation catheter market growing at a Compound Annual Growth Rate (CAGR) of 5%. GlobalData expects small companies with successful devices in the cryoablation space to be prime acquisition targets for large companies looking to obtain a place in the cryoablation market and to secure a stronger position in the wider electrophysiology ablation market.

Laguna Hills, California-based Adagio Medical, Inc., appears to be one such small company with a cryoablation device. The company recently announced that it successfully treated its first patients with its One Shot+™ catheter. Adagio Medical describes its cryoablation platform as using continuous and uninterrupted flow of the cryogen through the catheter, allowing ultra-low temperature cryoablation catheters with diameters smaller than  2 millimeters.

In July of this year, Boston Scientific announced a definitive agreement to acquire Cryterion Medical Inc., a privately-held company developing a single-shot cryoablation platform for the treatment of AF. According to a recent article, the Cryterion cryoablation system uses a balloon catheter, mapping catheter, and steerable sheath. The Cryterion cryoablation system is not available for sale. However, a clinical study of the Cryterion cryoablation system is reportedly being conducted in Europe, with a CE Mark submission expected in early 2019. Boston Scientific plans to submit an investigational device exemption (IDE) application to the U.S. Food and Drug Administration (FDA), with patient enrollment expected to begin in 2019.

It remains to be seen whether Biosense Webster or Abbott Laboratories has interest in acquiring a company in the cryoablation space. If either company decides to do so, Adagio Medical may be a target for acquisition.

Abbott Obtains FDA Approval for HeartMate 3 Device

Abbott announced on October 19, 2018 that its HeartMate 3 Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. Physicians now can offer the HeartMate 3 system to patients not eligible for a transplant. The HeartMate 3 LVAD can serve as a permanent implant, allowing patients to live with the device for the rest of their lives.

The MOMENTUM 3 study, which included more than 1,000 patients with New York Heart Association (NYHA) Class IIIB or IV heart failure and which followed patients for a short-term endpoint of six months and a long-term endpoint of two years, supported HeartMate 3’s FDA approval. It was reported that during the study, patients with the HeartMate 3 LVAD had a survival rate of 82.8 percent at two years. It was also reported that the rate of suspected pump thrombosis (clotting of blood) remained low, at 1.1 percent, at two years and that the stroke rate was low, at 10 percent, at two years.

According to Abbott, the HeartMate 3 uses magnetic levitation technology. This technology has been designed to reduce trauma to the blood passing through the pump.

FDA Approves Marketing of Self-Fitting Hearing Aid

The U.S. Food and Drug Administration recently announced approval for Bose to market their Bose Hearing Aid.  According to the press release, the Bose Hearing Aid, which was approved through the FDA’s De Novo premarket review pathway, is the first approved hearing aid that can be self-fit and adjusted by a user.

Malvina Eydelman, M.D., the Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices at the FDA’s Center for Devices and Radiologic Health commented:

“Today’s marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device. The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.”

According to the press release, clinical studies found the self-fitting Bose Hearing Aid to yield comparable outcomes relative to those found using a professional fitting.   The press release also reported that users generally preferred self-adjusted settings over those selected by a professional.

In a statement made to TechCrunch, Joanne Berhiaume, a spokesperson for Bose, stated:

“Now, the De Novo grant by the FDA validates that Bose technologies can be applied to help people with mild to moderate hearing impairment take control of their hearing. We look forward to bringing affordable, accessible and great sounding solutions to the millions of people who could benefit from hearing aids but don’t use them.”

FDA & DHS Coordinate Efforts to Address Cybersecurity

The U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership between the agencies and “stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities.”

The agreement formalizes a long-standing relationship by developing a new framework for greater coordination and cooperation. As part of the new framework, specific responsibilities have been assigned to the FDA and the National Protection and Programs Directorate (NPPD), a component of the DHS. The following table provides a breakdown of the responsibilities outlined in the agreement:

FDA Responsibilities NPPD Responsibilities
1. Coordinate and participate in regular, ad hoc, and emergency coordination calls to enhance mutual awareness of vulnerabilities and threats 1. Serve as central medical device vulnerability coordination center
2. Provide NPPD with draft public releases to facilitate coordination of messaging 2. Participate in regular, ad hoc, and emergency coordination calls with FDA to enhance mutual awareness of vulnerabilities and threats
3. Comment in a timely manner on NPPD draft advisories and alerts 3. Confer with entities providing sensitive information prior to sharing any CCI, trade secret, or PCII-protected vulnerability or product information with the FDA
4. Assess the risk to health and patient harm when potential impact is disputed 4. Coordinate with FDA on the content of alerts and advisories to be published by DHS
5. Submit requests to NPPD for independent third-party technical assistance to analyze and test medical systems 5. Maintain technical capabilities to support requests for independent third-party analysis regarding the impact of vulnerabilities
6. Share non-trade secret information to resolve disputes of risk, impacts, and communication 6. Publish healthcare and public health related alerts and advisories

In summary, the DHS will serve as the central coordination center and interface with appropriate stakeholders, and the FDA will provide technical and clinical expertise regarding medical devices.

FDA Commissioner Scott Gottlieb, M.D., during his discussion of the new agreement, addressed the FDA’s continued commitment to confront cybersecurity risk, while also recognizing the need for increased coordination between government agencies:

The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns . . . But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone. Every stakeholder has a unique role to play in addressing these modern challenges. That’s why this announcement is so important.

This agreement is not the first time a government agency has reached out to the FDA in an effort to strengthen medical device cybersecurity. As previously reported on the KnobbeMedical blog, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General recommended earlier this year that the FDA include cybersecurity review as a greater part of the premarket review process for medical devices (e.g., through the inclusion of a Refuse-To-Accept checklists). This new FDA-DHS agreement is another example of continuing attempts to address ongoing medical device cybersecurity risks.

Benchmarking Quality Assurance

Best Practices, LLC recently released a study that provides insights into the amount of resources pharmaceutical and medical device companies allocate to ensure their products meet quality and regulatory standards.  The study includes aggregate and anonymized data from 31 large medical companies, including Fisher & Paykel Healthcare, ResMed, Smith & Nephew, and Medtronic, among others.  The majority of the surveyed companies operate primarily in the medical device field, but the data also includes results from diagnostic and pharmaceutical companies.

According to Best Practices, the study benchmarks the amount resources spent on quality assurance systems, regulatory affairs, and post-market surveillance of products. One exemplary finding was that, for the average company, the resources expended on the combined quality and regulatory systems amounted to nearly 8% of all company FTEs (full-time employee equivalence).  The report further observes that more resources should be spent on the quality assurance system as company revenues increase to maintain consistent quality practices during expansion of operations.

Other sections of the report include data and analysis regarding the particulars of quality assurance systems including the number of CAPAs, NCEs, field actions, change requests, and FDA warning letters reported by individual companies.  The study also includes data on the volume and duration of complaints received through post-market surveillance and benchmarks the amount of employee time spent addressing theses complaints.

The complete study is available for purchase through Best Practices, LLC.

 

 

 

 

 

FDA Launches ‘Quik’ 510(k) Review Pilot Program

The Food and Drug Administration (FDA) recently unveiled the Quality in 510(k) (“Quik”) Review pilot program, aimed at reducing the time it takes to review moderate-risk medical devices by one-third.  The pilot, dubbed as “a Turbo Tax for information submitted in 510(k)s,” by FDA Commissioner Scott Gottlieb, will allow device manufacturers to submit premarket notifications electronically using “eSubmitter” software, as long as the device is classified under one of the specific product codes included in the pilot program and is not a combination product.  In addition to lower risk devices, the pilot program includes some higher risk Class II devices, such as surgical lasers, certain endoscopic equipment, and certain imaging devices (e.g., MRI and stationary X-rays).

The FDA’s stated goal is to review 510(k) applications for devices that meet the eligibility requirements within 60 days, rather than the typical 90 days for traditional applications.

FDA Commissioner Scott Gottlieb also commented:

“As technology evolves, patients have the opportunity to access more innovative medical devices that can help improve their health. To advance that progress, the FDA must also modernize its own review and submission process to make sure that our programs continue to be efficient, consistent and scientifically rigorous.”

Apple’s Latest Watch Receives FDA Approval For ECG Functionality

Since its first release in 2015, the Apple Watch has continued to evolve and incorporate more health- and fitness-tracking capabilities. The latest version of Apple’s Watch—Series 4—features a larger display screen, thinner case, a new interface, and, according to Apple “revolutionary health capabilities.” These health capabilities include electrocardiogram (ECG) functionality, which has been granted approval by the U.S. Food and Drug Administration. Also incorporated into the latest version of the Watch, according to Apple, are a new accelerometer and gyroscope that allow for fall detection.

Jeff Williams, Apple’s chief operating officer, stated:

The completely redesigned Apple Watch Series 4 continues to be an indispensable communication and fitness companion, and now with the addition of groundbreaking features, like fall detection and the first-ever ECG app offered directly to consumers, it also becomes an intelligent guardian for your health.

Apple notes that its Series 4 Watch allows wearers to place their finger on a dial for 30 seconds and receive a heart rhythm classification, which can identify if the wearers’ heartbeat is following a normal or irregular pattern. Irregular heart beat patterns, often referred to as Atrial fibrillation, increase the risk of heart complications. Recordings of such heart rhythm information are stored in a Health app and can be shared with physicians via a PDF file.

Some commentators believe the fall detection capabilities of Apple’s Series 4 Watch may prove significantly valuable, especially for elderly wearers. The Series 4 Watch is said to incorporate a new accelerometer and gyroscope which measure up to 32 g-forces and utilizes “custom algorithms to identify when hard falls occur.” The Watch also analyzes trajectory of the wearer’s wrist and the impact of accelerations, and sends an alert to the wearer after a fall event. Such alert can be dismissed or used by the wearer to make an emergency call to a healthcare provider. According to Apple, if the Watch senses a lack of movement for one minute after the alert notification, an automatic emergency call is made and a message is sent to emergency contacts along with location data.

 

First CBD Drug Receives FDA Approval

The FDA recently announced its approval of GW Pharmaceutical’s Epidiolex drug, described as the first ever plant-derived cannabinoid medicine in the United States.  The announcement notes that Epidiolex contains a highly purified form of cannabidiol (CBD), one of many cannabinoids derived from cannabis plants.  CBD, however, lacks the psychoactive properties of its more famous cousin, tetrahydrocannabinol (THC).  The FDA approved the use of Epidiolex for the treatment of seizures associated with several rare forms of epilepsy in patients 2 years and older.

According to public databases, GW Pharmaceuticals is the listed assignee of seven issued patents for methods of treating various epileptic and other medical conditions using CBD, as well published filings in Europe, Canada, Japan, and the United Kingdom.

Although CBD is an active ingredient of an FDA approved drug, CBD is still considered a Schedule 1 controlled substance under the federal Controlled Substances Act and cannot yet be placed for sale on the market. As a part of its approval of Epidiolex, the FDA has sent a recommendation to the Drug Enforcement Agency to reschedule CBD to a less-controlled schedule.  The DEA must act on this recommendation within 90 days of the original approval, although the DEA is not under any obligation to reschedule marijuana or any of its components, including CBD.  Nevertheless, observers have noted that the FDA’s approval of a CBD-based drug is at odds with the requirement that a Schedule 1 substance have “no currently accepted medical use in treatment.”

In a press release issued the same day as the approval of Epidiolex, the FDA Commissioner Scott Gottlieb, M.D. stressed that the approval was not a recognition of cannabis or any of its components as medicines.  The press release notes that approval of Epidiolex was based on controlled clinical trials evaluating a highly purified form of CBD for treatment of specific conditions, manufacturing under consistent quality controls, and the creation of a reliable dosage form.  Nevertheless, the Commissioner encouraged continued clinical research into cannabis related drugs and noted programs and guidances intended to facilitate and expedite development and review of drugs to address unmet medical needs.

Apple Watch Receives Clearance from FDA as an Over-the-Counter ECG-monitoring Device

On September 12, 2018, Apple released its new Apple Watch Series 4 with a new ECG app that can take an electrocardiogram (ECG). Apple’s new Apple Watch Series 4 has been granted De Novo classification by the FDA, which allows Apple to provide its Series 4 Apple Watches as an over-the-counter ECG-monitoring device.

Jeff Williams, Apple’s chief operating officer, noted Apple’s continued desire to make Apple Watch a more useful healthcare device for the public:

“The completely redesigned Apple Watch Series 4 continues to be an indispensable communication and fitness companion, and now with the addition of groundbreaking features, like fall protection and first-ever ECG app offered directly to consumers, it also becomes an intelligent guardian for your health.”

According to Apple, Apple Watch Series 4 is designed to intermittently analyze heart rhythms in the background and look for any irregular heart rhythm, such as atrial fibrillation (AFib). If a user’s heart rate exceeds or falls below a specified threshold, Apple Watch Series 4 can generate an alert. Electrical impulses are analyzed to generate ECG waveform and to determine AFib classification, which are automatically stored in Apple Watch’s Health app.

AliveCor received FDA clearance for its KardiaBand application for use with the Apple Watch last November. KardiaBand’s press release indicates that it includes a wearable band and a monitoring system integrated to Apple Watch.

However, according to The Verge, there are some important caveats to the FDA’s grant of de novo classification. First, both the ECG app and the irregular rhythm notification feature are not intended for people under the age of 22. Second, the irregular rhythm notification feature is not intended for people who have previously been diagnosed with atrial fibrillation. Moreover, the FDA does not intend to replace existing diagnostic methods and treatments for atrial fibrillation with Apple Watch. The FDA clearly states that “the feature is not intended to replace traditional methods of diagnosis or treatment.”

 

FDA Expresses Priorities for Clinical Trial Efficiency, Artificial Intelligence

The FDA has announced new goals to help modernize its procedures and respond to new technologies.  In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials for medical devices and develop standards for new technologies like artificial intelligence.

According to Gottlieb, clinical trials “are becoming more costly and complex to administer” while “new technologies and sources of data and analysis make better approaches possible.”  In order to take advantage of these better approaches, Gottlieb pointed to the FDA’s Breakthrough Devices Draft Guidance, which proposes streamlined procedures to develop flexible clinical trial designs for important medical devices.  This will allow the FDA to “evaluate . . . innovative devices more efficiently.”  Six breakthrough devices have already been cleared using this program.

Additionally, Gottlieb discussed the FDA’s new goal of enabling the use of “real-world evidence” to support decisions to approve devices.  According to Gottlieb, “[r]eal world evidence can help answer questions that are relevant to broader patient populations or treatment settings where information may not be captured through traditional clinical trials.”  The FDA is helping to design several proof-of-concept trials that utilize real-world evidence.

Finally, Gottlieb discussed the FDA’s role in dealing with new and emerging technologies.  In particular, Gottlieb discussed artificial intelligence, which “holds enormous promise for the future of medicine.”  Medical artificial intelligence models are currently in development and the FDA recently approved an AI algorithm for detection and treatment of distal radius fractures.  According to Gottlieb, the FDA is exploring ways to handle and evaluate the kinds of data that are relevant to AI performance and safety, hoping to “enable a transparent benchmarking system for AI algorithm’s performance.”

Gottlieb concludes that the FDA has “undertaken a comprehensive effort to make sure that our organization and policies are as modern as the technologies we’re being asked to evaluate, and that we’re able to efficiently advance safe, effective new innovations.”

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.