The market for medical device connectivity is projected to reach about $2.6 billion by the year 2023, according to a report published in April 2018 by several publishers. The report states that the connectivity market for 2018 is expected to be about $940 million. This equates to a compound annual growth rate (CAGR) from 2018 to 2023 of 23.2%.
According to news articles, the report states that “[t]he growth in this market is attributed to the increasing penetration of [electronic health records] and health information exchange systems in healthcare organizations, growing focus on care quality and patient safety, healthcare IT initiatives driving the integration of medical devices with hospital information systems, and the growing need to curtail healthcare costs through a connected healthcare environment.”
From 2018 to 2023, the medical device connectivity market CAGR is estimated to be 23.2%
The report further states the medical device connectivity services segment, as opposed to the device connectivity solutions segment, is anticipated to grow at the maximal CAGR during the “outlook period” from 2018 to 2023. The report divides the technology sectors into wired, wireless, and hybrid technologies. The wireless segment is projected to register the highest CAGR during the outlook period.
The report also breaks down the relevant markets into hospitals, home healthcare, ambulatory care settings, and imaging & diagnostic centers. It finds in 2017 hospitals controlled the medical device connectivity market. The report also finds that North America is expected to grow at the highest CAGR during the outlook period, followed by Europe.
The increase in the market is attributed in the report to “growing funding towards innovative projects in the medical market, [the] need to curtail the escalating healthcare costs in the USA, the presence of a big number of healthcare IT firms, rising investments in the healthcare sector by top market players, and increasing awareness about advanced technologies.”
On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the FDA, this is the first approved artificial iris. The approval was granted to Clinical Research Consultants, Inc., and the device is marketed and developed by HumanOptics AG.
The HumanOptics website describes the CustomFlex Artificial Iris as a prosthetic iris used to treat adults and children whose iris is completely or partially missing due to congenital or traumatic aniridia, or other conditions with iris defects. Patients with aniridia experience compromised vision and also suffer from aesthetic defects of the eye. As stated by Dr. Malvina Eydelman, the approval of the CustomFlex Artificial Iris:
provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.
HumanOptics website notes that the CustomFlex Artificial Iris is made of pigmented silicone, and is customizable in size and coloration to fir the needs of each individual patient. It further describes that the artificial iris is inserted into the eye by making a small incision and inserting the folded iris into position, the iris is then unfolded and held in place by the structures of the eye, or by sutures, and mimics the function of the natural iris.
Approval of the CustomFlex Artificial Iris was performed under the compassionate use exemptions of the FDA. The approval proceeded through the premarket approval application (PMA). PMA is the FDA review of Class III medical devices, which include high-risk medical devices. Because the CustomFlex Artificial Iris was classified as a high-risk medical device according to the FDA, it required a PMA pathway in order to obtain marketing approval. This is the most stringent type of device marketing under the FDA, and according to the FDA, approval indicates that the CustomFlex Artificial Iris was shown as safe and effective for its intended uses. In addition, the CustomFlex Artificial Iris was granted Breakthrough Device designation. This program 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.
Cyberdyne, a Japan-based robotics technology company, recently announced its collaboration with Brooks Rehabilitation and the Brooks Cybernic Treatment Center to bring its Hybrid Assistive Limb (HAL®) exoskeleton to the U.S. market. According to the companies, the device is designed to help patients rehabilitate from conditions leading to lower limb disorders, including spinal cord injuries and strokes. There are currently about 200,000 people in the United States that have such injuries.
According to Cyberdyne, HAL® is the world‘s first cyborg-type robot, by which a wearer‘s bodily functions can be improved, supported and enhanced. Cyberdyne explains that wearing HAL® leads to a fusion of “man,” “machine,” and “information.” HAL works by detecting small electrical signals in the patient’s body through the use of small sensors placed on the skin. The signals are detected by HAL®, which responds with a movement at the joint. Dr. Robert McIver, the director of clinical technology at Brooks Rehabilitation, commented that patients using HAL® have seen greater functional changes in a shorter amount of time than with any other intervention method tried in spinal cord injured patients.
The press release notes that HAL® received approval and marked clearance from the U.S. Food and Drug Administration in 2017. The device was previously only available in the EU and Japan, but has been in use in Japan since 2011. In 2011, the suit was estimated to cost approximately between $14,000 and $19,000, down from the $50,000 cost for the first prototypes unveiled in 2006. The monthly rental for a HAL® suit is expected to be $1,000.
According to USPTO public records, Cyberdyne is a listed assignee of a number of U.S. Patents, including, 9,943,458 and 8,773,148, as well as design patents D749,227, and D786,446. Cyberdyne notes that the International Patent Application relevant to HAL® was accredited as a Notable Invention by the World Intellectual Property Organization (WIPO).
According to the Straits Times, QT Vascular, a Singapore-based medical device company, reached an asset purchase and option agreement to sell its intellectual property rights to some of its non-drug coated coronary products, such as its Chocolate XD® and Glider™, to Teleflex Life Sciences Unlimited Company and Teleflex Incorporated (“Teleflex“). The agreement gives Teleflex the option to purchase QT Vascular’s drug coated product, the Chocolate Heart, which is still being developed.
Under the agreement, Teleflex may pay up to $98.4 million in cash—$26.2 million for the non-drug coated coronary products, $65.6 million for the drug coated coronary product, and up to an additional $6.6 million upon the achievement of certain sales revenue milestones. According to the Straits Times, the total value of the deal may be greater than $100 million, which exceeds QT Vascular’s market value of $36.3 million as of May 23, 2018.
Eitan Konstantino, CEO of QT Vascular, stated:
We are excited that Teleflex, one of the world’s leading medical device companies, chose to acquire our coronary products and to obtain a license to our extensive coronary IP portfolio. We will work closely with Teleflex’s team to bring our pioneering drug coated coronary product, Chocolate Heart™, to the US market.
According to QT Vascular’s press release, the deal is pending approval by its shareholders. As reported in the Straits Times, QT Vascular and Teleflex are also negotiating other business agreements, including supply agreements related to the products QT Vascular is selling to Teleflex.
The press release states that QT Vascular will independently continue its development of other products, such as a planned Investigational Device Exemption clinical trial of its differentiated drug coated percutaneous transluminal angioplasty balloon (Chocolate Touch®) in the U.S.
This deal follows the January 2018 announcement of QT Vascular’s sale of its non-drug coated Chocolate® PTA balloon catheter to Medtronics for $28 million.
The FDA announced 510(k) clearance for Inari Medical’s FlowTriever device for the treatment of pulmonary embolism (“PE”). According to Inari, the FlowTriever system is the first thrombectomy device cleared for the treatment of PE. The FlowTriever had previously been cleared for treatment of the peripheral vasculature.
Inari announced that the PE specific clearance was based on the results from the FlowTriever Pulmonary Embolectomy (“FLARE”) study. Principal investigator Dr. Thomas Tu presented the results of the FLARE study at an April 27, 2018 Scientific Session of the Society for Cardiovascular Angiography and Interventions in San Diego, CA. In a press conference, Dr. Tu stated that the FlowTriever “potentially has the chance to reduce bleeding complications, [and] to reduce total hospital and ICU length of stay.” Dr. Tu also emphasized that the FlowTriever compared favorably with other techniques for treating PE and that FlowTriever employs a “purely mechanical approach which avoids the use of thrombolytic drugs and [the] resulting risk of of bleeding complications” associated with other techniques. Co-principal investigator Dr. Victor Tapson touted the results as “an exciting advancement in the treatment of acute pulmonary embolism patients” because “[u]ntil now, there has not been an approach to rapidly restore flow to reverse right heart strain without the use of thrombolytic drugs and their inherent risk of bleeding complications.”
A recent article from the American College of Cardiology estimates that approximately 100,000 hospitalized patients each year die of causes related to PE. The article discusses other treatments for PE, including anticoagulants and inferior vena cava filters. The article also discusses other percutaneous approaches for treatment of PE such as “1) thrombus fragmentation with a rotating pigtail catheter; 2) aspiration thrombectomy; 3) rheolytic thrombectomy; and 4) suction embolectomy.”
The FlowTriever is a mechanical device designed “to treat vascular occlusions due to an embolis[m].” The FlowTriever catheter has a self-expanding retriever with three “disks” for engagement and retraction of clots. The retriever is designed to self-expand with a clot, engaging the clot and trapping it between the disks. The clot is retracted into an “aspiration guide catheter,” allowing for synchronized aspiration and mechanical retraction of the clot. Additional information on the FlowTriever is available in the video below from Inari Medical.
DePuy Synthes, a part of the Johnson & Johnson Medical Devices Companies, announced recently that it has signed a definitive agreement to acquire the assets of Medical Enterprises Distribution, LLC, which includes the automated ME1000™ Surgical Impactor tool used in hip replacement surgery. The two companies had previously formed an exclusive agreement to co-market the hip application of the ME1000™. The financial terms of the acquisition are not being disclosed. The transaction is expected to close in the second quarter of 2018.
According to Medical Enterprises, the ME1000™ delivers constant, stable energy that is designed to automate bone preparation, implant assembly and positioning in total hip arthroplasty (THA). DePuy Synthes said that the company plans to develop and broaden the surgical impactor technology for a range of orthopaedic surgery procedures.
“The acquisition of assets of Medical Enterprises Distribution is a key example of going beyond the implant to provide complete solutions to achieve better outcomes.” – Ciro Roemer, Company Group Chairman of DePuy Synthes
The hip replacement global market was $6.5 billion in 2015 and is predicted to reach $9.1 billion by 2025. The global market for all joint replacements is expected to reach $30 billion by 2025. Other companies in the joint replacement markets include Zimmer Biomet, Smith & Nephew, and Stryker.
In the recent press release, DePuy Synthes also announced an exclusive marketing agreement with JointPoint Inc. to co-market a hip navigation system for analysis of implant selection during THA. Earlier this year, DePuy Synthes announced the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery for total and partial knee replacement. In discussing the Orthotaxy acquisition, Ciro Roemer, Company Group Chairman of DePuy Synthes, said “Our goal is to bring to market a robotic-assisted surgery technology that is an integral part of a comprehensive orthopedics platform, delivering value to patients, physicians and healthcare providers across the episode of care.” Other companies in the joint replacement market are likely seeking to create comprehensive orthopedic platforms as well.
According to an Apple press release, iPhone users will now be able to store and view their medical records on their phones as part of a new feature found in iOS 11.3. Although many patients are already familiar with clinic-specific patient portals, Apple’s new Health Records feature is said to allow patients to download their medical records from a variety of hospitals and clinics, and consolidate those records on their iPhone.
According to Apple, the Health Records feature can be found in Apple’s Health app on updated devices. The Health Records feature allows participating hospitals and clinics to transfer medical information to a users device. The patient’s medical record data will be stored along with their own patient-generated data in the consolidated Health app. Users will be able to view recorded allergies, clinical vitals, conditions, immunizations, lab results, medications, procedures, and similar information. Users will also be notified whenever their data is updated, such as when lab results are received.
Apple notes that in the past, patients’ medical records were held in multiple locations, requiring patients to log into each care provider’s website and piece together the information manually.
The press release notes that data within the Health Records feature will be encrypted and protected with the user’s iPhone passcode. Moreover, no health record data passes through Apple’s network. Instead, Apple relies on Fast Healthcare Interchangeability Resources (FHIR) and related application programming interfaces (APIs) to transmit the data from a hospital or clinic’s electronic health record (EHR) system directly to a user’s device over an encrypted connection.
As a result, Apple maintains that it does not create, transmit, or receive any protected health information for or on behalf of a covered entity or business associate. Nevertheless, if a user chooses to sync their health data with iCloud, the data will be encrypted in transit and for storage on Apple’s servers.
With the push to provide patients with their digital health information comes a push for FHIR, solidifying the technology’s viability as a solution to the federal mandate that providers allow patients to access electronic versions of their health records
Apple notes that at this time, around 40 hospitals and clinics are participating, including Johns Hopkins, Cedars-Sinai, Penn Medicine, UC San Diego Health, and Geisinger Health System.
3D printing specialist Materialise recently received FDA 510(k) clearance for its Mimics inPrint software. Mimics inPrint is said to use to create 3D anatomical models from medical image data and output those models to a 3D printer at the point-of-care. The physical models created with Mimics inPrint assist practitioners with patient diagnostics, consultation, and planning complex procedures. According to a company press release, Mimics inPrint is already used by 16 of the top 20 hospitals to provide personalized patient care at the point-of-care.
In the press release, Materialise CEO Wilfried Vancraen stated:
Materialise has nearly three decades of experience in developing certified medical solutions that create a better and healthier world. The FDA clearance for our Mimics inPrint software will support the adoption of 3D planning and printing in U.S. hospitals and the creation of point-of-care 3D printing facilities.
According to Frank J. Rybicki, MD, PhD and Chief of Medical Imaging at Ottawa Hospital:
This milestone for Materialise serves as a benchmark for the clinical implementation of 3D printing for physicians creating 3D models at the point-of-care.
Materialise describes itself as having 27 years of 3D printing experience and according to USPTO public database records is currently the assignee of 34 issued patents and 106 patent applications dating from 2004 to the present.
More than two and a half years after the China Food and Drug Administration (CFDA) formally approved its first three-dimensional (3D) printed medical device for mass production, a hip implant co-developed by Peking University’s Third Hospital and AK Medical, the agency has issued a draft guidance on the regulatory requirements for approval of 3D printed devices. The new guidance, titled “Guidelines for the Technical Review of Custom Additive Manufacturing Medical Device Registration,” proposes that “[t]he process of production and verification of custom-built additive-produced medical devices should, in particular, control the testing of printing equipment, processes, post-processing, raw materials and final products, as well as cleaning, packaging and sterilization.”
Although the CFDA is open to consultation on the guidance until March 30, the existing draft would require 3D device applicants to provide at least (1) a product name according to its scope and design for classification and standardization purposes; (2) a description of the product including the chemical composition of each component; (3) clinically relevant model specifications; (4) the scope of the application and contraindications; (5) the product’s research and development background with a comparison to similar products; and (6) research data on product performance with supplementary material characterization.
This development is in line with increased attention to 3D printing technology by regulatory authorities worldwide. In December 2017, the U.S. Food and Drug Administration (FDA) published its guidance titled “Technical Considerations for Additive Manufactured Medical Devices,” which provided the agency’s initial thoughts on 3D printing, including important considerations for design, manufacturing, device testing, and premarket approval. This initial non-binding document was published as “a type of guidance that serves as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance,” and identified the significant issues that the FDA was likely to emphasize in future regulations. Similarly, Australia’s Therapeutic Goods Administration (TGA) opened consultation on the topic in November 2017.
KnobbeMedical.com was recently named as a “Top 30 Medical Device Blog” by Feedspot. KnobbeMedical made the list along with other respected medtech industry blogs including MassDevice and MDDI Online based on several stated factors including online search rankings and quality and consistency of posts.
KnobbeMedical is a cooperative portal for entrepreneurs, executives, clinicians, researchers, investors, and corporate board members who are exploring a start-up, joint venture or spin-off in the medical device industry.
On March 23, Auris Health, Inc. announced FDA clearance for the Monarch Platform, Auris’ new system for robotic endoscopy. According to Auris Health, the Monarch Platform “integrates the latest advancements in robotics, micro-instrumentation, endoscope design, sensing, and data science into one platform.”
Josh DeFonzo, Auris’ Chief Strategy Officer, noted some challenges with endoscopy and need of better control for endoscopic systems:
Endoscopy requires a lot of skill, but also you’ve got to be very facile in maneuvering a device – a device that’s anywhere from approximately a meter to, in the case of colonoscopy, three meters long.
According to Bloomberg Businessweek, the Monarch Platform, instead of the traditional, antiquated one-handed interface requiring twist and control maneuvers, features robotic arms that doctors can control using a controller that on the surface resembles a game console controller. DeFonzo further stated that “Auris’ system allows for more direct control through a game-like controller.”
Dr. Fred Moll, CEO of Auris Health, Inc., said in an interview that Auris is currently focused on lung cancer for two reasons: (1) lung cancer is the deadliest cancer in the world; (2) lung provides a perfect “proving ground” because it comprises a complex network of tunnels. According to Dr. Moll, the Monarch not only can navigate nimbly through the lung, but also can improve over time thanks to its navigation software.
Auris Health, Inc. is led by CEO Dr. Fred Moll, also known for his Da Vinci Surgical System, a top-selling surgical robot used in laparoscopic surgeries. According to DeFonzo, the company anticipates a limited launch of the Monarch across the U.S. and commencement of its pilot studies later this year.
Technology has advanced significantly since the development of the earliest robotics platforms used in medicine. The Monarch platform is designed to address the limitations of current technology with the introduction of a new era of flexible robotics. With this FDA clearance, we intend to deliver on the promise of improving patient care, starting with earlier and more accurate diagnosis of pulmonary nodules. We envision additional uses for the technology across future endoscopic clinical indications.
Theranos Charges Provide Perspective for Medical Device Companies, Biotechnology Companies, and Investors
Theranos describes itself as a privately held technology company based in Palo Alto focused on developing lab-on-a-chip technology for blood testing. By 2014, Theranos raised more than $400 million and had an estimated value of $9 billion.
As reported by CNN, Theranos’ investors included high profile individuals such as Larry Ellison (Oracle), current Secretary of Education Betsy DeVos, and Rupert Murdoch. Additionally, Theranos’ Board of Directors has included at one point: Secretary of State Henry Kissinger, Secretary of State George Schultz, Senator Bill Frist, Senator Sam Nunn, and current Secretary of Defense James Mattis.
According to the SEC’s complaint, Elizabeth Holmes and Ramesh Balwani “raised more than $700 million from late 2013 to 2015 while deceiving investors by making it appear as if Theranos had successfully developed a commercially-ready portable blood analyzer that could perform a full range of laboratory tests from a small sample of blood.” The complaint further alleges that Theranos “modif[ied]
commercially-available analyzers and [ran] misleading demonstrations” and made false or misleading statements to the Department of Defense.
Theranos and Holmes have neither admitted nor denied the allegations. According to an SEC press release, Theranos and Holmes have agreed to settle the fraud charges levied against them. Reportedly, the settlement includes Holmes paying a $500,000 penalty and being barred from serving as an officer or director of a public company for the next 10 years.
While Theranos was not a publicly traded company, Steven Peikin, the Co-Director of the SEC’s enforcement division stated the actions make “clear that there is no exemption from the anti-fraud provisions of the federal securities laws simply because a company is non-public, development-stage, or the subject of exuberant media attention.”
As reported by the Silicon Valley Business Journal: “In depositions filed as part of a lawsuit by an investor last year, former Secretary of State George Schultz and retired U.S. Navy Admiral Gary Roughead said they didn’t feel qualified to question the technology. They said they were unaware that Theranos’ equipment could not run all the tests being touted by Holmes — even as news reports started appearing that suggested its capabilities were exaggerated.”
A fundamental principle of corporate law is the role of the Board of Directors. Under Delaware General Corporation Law §141(a), “The business and affairs of every corporation organized under this chapter “shall be managed by or under the direction of a board of directors….” While the Directors do not directly manage the day-to-day responsibilities of running a corporation, they are ultimately responsible for the management of the corporation.
A Board of Directors may rely on the Business Judgment Rule, which is a presumption that, in making business decisions, the directors of a corporation acted on an informed basis and in good faith that the actions taken were in the best interest of the company and its shareholders. However, a Board of Directors must operate with a Duty of Care, wherein the Board of Directors should make informed decisions by assuming an active role throughout the entire decision-making process.
While the culpability of the Board of Directors may be debated, news articles have discussed the merits of choosing Board members with expertise in the technology field of interest and utilizing experts with experience in that technology field to conduct due diligence before making investments.
According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO Stroke Platform. According to PR Newswire, Viz.AI’s LVO Stroke Platform is the “first artificial intelligence triage software” and its approval begins “a new era of intelligent stroke care begins as regulatory approval.” The Viz.AI LVO Stroke Platform, according to the U.S. Food and Drug Administration press release, is a clinical support software designed to analyze Computerized Tomography (CT) scans, identify suspected large vessel blockage, and send a notification to specialist of a potential stroke in patients sooner.
According to the Centers for Disease Control and Prevention, strokes are the fifth leading cause of death in America. A stroke occurs when the blood vessels in the brain are damaged, compromising the necessary blood flow to the brain. There are many types of strokes and can often lead to brain damage, long term disability, and death. A CT scan can show the location and extent of the damage to the brain to diagnose the stroke as well as the type of stroke that has occurred.
Viz.AI is a healthcare company based in San Francisco and Tel Aviv, dedicated to “expand Direct-to Intervention care” which “advances information about treatable patients straight to the interventionalist.” Neurosurgeon and CEO of Viz.Al, Dr. Chris Mansi stated in a press release:
“The Viz.ai LVO Stroke Platform is the first example of applied artificial intelligence software that seeks to augment the diagnostic and treatment pathway of critically unwell stroke patients.”
According to the FDA press release, Viz. AI Contact application was granted De Novo premarket review, which is a “regulatory pathway for new types of medical devices that are low to moderate risk and have no legally marketed predicate device to base a determination of substantial equivalence.” This is a new regulatory classification, “which means that subsequent computer-aided triage software devices with the same medical imaging intended use may go through the FDA’s premarket notification (510 (k)) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”
The Viz.AI Contact application is one example of what the FDA calls “clinical decision support software (CDS). CDS includes technology that aids in diagnosing and identifying treatment plans. CDS includes “technology has the potential to enable providers and patients to fully leverage digital tools to improve decision making.” The FDA is currently creating a regulatory framework for CDS to provide guidance and encourage developers in this field.
According to Robert Ochs, acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, “(This) software device could benefit patients by notifying a specialist earlier thereby decreasing the time to treatment. Faster treatment may lessen the extent or progression of a stroke.”
According to PR Newswire, the Israeli Ministry of Health has granted initial approval to Tel-Aviv-based Kanabo Research for their VapePod vaporizer product as a medical device. PR Newswire notes that with this approval, Israel has become the first country in the world to grant medical device approval for a “vaporizer for the use of medical cannabis extracts and formulations.” High Times, a cannabis-related publication, goes further to say that this is the first certification of marijuana “‘paraphernalia’ as an accepted medical device.”According to Israel21c, Kanabo claims that the approved vaporizer will provide for “more effective, consistent, and accurate dosing and delivery methods than currently accepted medical cannabis treatment methods.” Cannabis administration “has long frustrated doctors due to lack of precise dosage” according to The Jerusalem Post. It reports that Kanabo says the VapePod will solve this problem with its “consistent and accurate gauge.” Moreover, The Jerusalem Post notes that many medical cannabis patients inhale by smoking, and that vaporizers “reduce health risks and make inhalation more effective.”
Israel21c also reports that Kanabo’s next version of the approved VapePod – the VapePod MD, will “monitor patient usage and gather usage data for caregivers, doctors and research applications. PR Newswire reports that Kanabo has initiated pre-clinical trials and is “achieving impressive results in early findings” with their targeted formulations for sleep disorders that are designed to be used with the approved VapePod. Kanabo also has two patents pending which are directed to the formulations according to PR Newsire.
Kanabo Research was founded in 2016 and currently employs 12 people according to The Jerusalem Post. Co-Founder and CEO of Kanabo Research Avihu Tamir had this to say about the future of the company: “We expect that due to the transition of most of the cannabis consumers to the use of vaporizers, our company is projected to reach $10 million in sales within three years in the Israeli market, while the Israeli cannabis market is expected to reach $100 million in sales within three years. The Israeli market is a platform to deliver our technology to global markets in North America and Europe.”
The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). According to an FDA news release, the approved test is the first direct-to-consumer test to report on three specific BRCA1 and BRCA2 breast cancer gene mutations.
According to the news release, BRCA1 and BRCA2 are human genes that produce tumor suppressor proteins. Mutations of these genes may interfere with the production or functioning of the proteins and are linked to an increased risk of female breast and ovarian cancers. About 12% of women in the U.S. population will develop breast cancer sometime during their lives. However, according to the National Cancer Institute, a recent large study estimated that about 72% of women who inherit a harmful BRCA1 mutation will develop breast cancer by the age of 80. Similarly, about 69% of women who inherit a harmful BRCA2 mutation will develop breast cancer by age 80. Because mutations of the BRCA1 and BRCA2 genes may be passed down to future generations, genetic testing for breast cancer risk has become more common.
23andMe offers genetic testing directly to consumers. Traditionally, genetic testing was only available through healthcare providers: an individual would request tests from a healthcare provider, the healthcare provider would order tests from a laboratory, collect and send the samples, and interpret the test results before passing them onto the individual. In contrast, direct-to-consumer genetic testing allows consumers to order and perform genetic tests without needing to interact with a healthcare professional. 23andMe has previously offered direct-to-consumer tests for the purposes of discovering an individual’s ancestry. However, this new FDA approval indicates expansion of genetic testing services to other applications.
Although the FDA approval of 23andMe’s test is positive, the FDA expressly noted certain caveats regarding the test. Specifically, the FDA clarified that the test only detects three out of more than 1,000 known BRCA mutations and that only a small percentage of Americans carry one of the three mutations. A negative result therefore does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk. Additionally, the FDA is establishing criteria, called special controls, which set forth the agency’s expectations in assuring the test’s accuracy and performance. Though this test may be a precursor for exciting possibilities on the horizon, the FDA warned that this limited test should not completely replace consultations with a health care professional.
Cyberdyne, Inc. recently announced FDA marketing approval for its Medical HAL [Hybrid Assistive Limb] therapeutic device and services. Cyberdyne describes itself as a Japanese company founded by Professor Yoshiyuki Sankai of the University of Tsukub and is traded publicly on the Tokyo Stock Exchange. The press release notes that Medical HAL has received previous marketing approval in Japan and the European Union.
In the press release, Cyberdyne explained that Medical HAL “is considered to be an innovative cybernic treatment device that attends to actually improve and regenerate the function of the patient’s own brain-nerve-physical systems, instead of an orthosis that physically supports the patient to walk or a robot that repeatedly performs specific movements for its patients.” The press release further describes Medical HAL as designed as an exoskeletal aid that attaches to a patient’s limb to assist their movement. Rather than providing movement to the limb through preprogramed algorithms or artificial intelligence, Medical HAL is controlled through nerve signals received with bioelectric sensors attached to the patient’s body. These bioelectric sensors attach at various places on the body, including the lower spine, legs, and arms. The sensors are designed to sense specific nerve signals sent from the patient’s brain to muscles in the limb. These signals can then be translated into specific motions in the exoskeletal aid that assist natural movement of the limb.
Current testing and research is being conducted that uses Medical HAL as an aid for retraining patients with severe nerve damage through physical therapy. According to the press release, retrained nerves and limbs can function similarly to the way they functioned before nerve damage. One example of a positive patient outcome relates to a patient who injured his spine and lower back, leaving one leg paralyzed. After treatment and training for several months with the Medical HAL device, he was able to improve control over that leg and eventually walk with the aid of a walker.
According to public USPTO databases, patents and publications listing Cyberdyne as the assignee include the following: “Wearing-Type Movement Assistance Device,” “Electrodes For Biopotential Measurement, Biopotential Measuring Apparatus, And Biopotential Measuring Method,” and “Ambulation Training Device And Ambulation Training System.”
According to Bloomberg, Apple, Inc. is currently developing an electrocardiogram (also known as an EKG or ECG) feature in its smartwatch products. A report from Bloomberg and other sources have stated that the unit in development requires users to squeeze the frame with two fingers to send a weak electrical current to the heart to pick up signals. The electrical current is used to track a user’s electrical heart signals in order to determine if there are any abnormalities such as irregular heart beats. The Verge states that “[s]ensors and data gathered from minor electric currents sent up the arm and across the chest to the user’s heart would measure data typically gathered by electrodes on the skin.” This would let users obtain a constant stream of EKG data that could then better inform doctors with diagnosis and treatment at an early stage. The CDC indicates that abnormal heart beats can increase the risk of strokes and heart failures in individuals.
The article notes that Apple’s current Watch has a basic heart rate monitor, but the company has increasingly trying to use advanced sensors to “predict future afflictions, rather than simply collect historical data about the body. An EKG would make it easier to establish the health of a user’s heart, and potentially spot some cardiac problems early.”
The article further notes that this development is not surprising as Apple has already given up marketing its smartwatch as a luxury watch. When it was first released in 2015, the Apple Watch was largely marketed as a high-end fashion piece. As the “second and third generations went on sale, the focus shifted to health and fitness, with Apple adding alerts for abnormal heart rate spikes.” Apple has now been focusing on using the Watch as a medical device. According to Jeff Williams, Apple’s chief operating officer, “[t]here’s tremendous potential to do on-device computing, to do cloud computing as well and to take that learning, and through machine learning, deep learning and ultimately artificial intelligence, to change the way health care is delivered . . . [w]e can’t think of anything more significant than this.”
Apple has already launched a new study in partnership with Stanford University that will track Apple Watch users’ heart rhythms for irregularity. The Federal Drug Administration also has cleared the Apple Watch’s first medical device accessory, an EKG reader built into a watch strap from medical device company AliveCor.
According to Bloomberg, the “health industry’s size has made it attractive for tech giants seeking new growth markets. U.S. health spending is forecast to grow from almost $3.5 trillion in 2016 to $5.5 trillion by 2025” according to data compiled by Bloomberg. Other corporate giants such as Google parent Alphabet Inc. already have two health-care divisions, while Amazon.com Inc. has for almost two decades been looking at ways to get into the pharmaceutical industry.
One of the largest hurdles for these companies to enter the medical-device market has been the the strict testing requirements imposed by the U.S. Food and Drug Administration. However, in September 2017, the FDA announced that it has chosen nine tech companies to participate in a pilot program (FDA Pre-Cert) to help tech companies bypass some regulations that have hindered health software and products release.
The U.S. Food and Drug Administration has announced approval of Banyan Biomarkers, Inc.’s Banyan BTI (Brain Trauma Indicator) under the FDA’s De Novo premarket review pathway. According to the press release, Banyan BTI is the first in vitro diagnostic blood test for the evaluation of mild traumatic brain injuries (mTBI), commonly referred to as concussions, authorized for marketing by the FDA.
According to Banyan Biomarkers, more than 90 percent of patients presenting to the emergency department with mTBI receive a negative CT scan. Banyan BTI purports to identify two brain-specific protein biomarkers that rapidly appear in the blood after a brain injury, providing information to assess patients with suspected mTBI. According to the FDA, availability of a blood test for concussions will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients.
With respect to approval of Banyan BTI, FDA Commissioner Scott Gottlieb, M.D. stated:
“A blood-testing option for the evaluation of mTBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests.”
On March 5, 2018, Boston Scientific announced its acquisition of EMcision, a privately held company in the United Kingdom and Canada. According to Boston Scientific, this acquisition will expand its range of medical devices in the field of minimally invasive endoluminal procedures as alternatives to conventional surgery. According to Art Butcher, Senior Vice President and President of the Endoscopy Division of Boston Scientific:
As we continue to search for ways to treat pancreaticobiliary cancers, we also seek to improve the quality of life for patients living with a cancer diagnosis today. We are committed to exploring innovative options to help increase the chance of earl diagnosis, improve treatment and advance the ability to remove cancers located in challenging areas of the gastrointestinal tract.
According to EMcision, EMcision was founded by an internationally renowned surgeon and medical device inventor, Professor Nagy Habib, and has developed proprietary medical devices utilizing RF technology for applications such as percutaneous procedures, and open, laparoscopic, vascular, and endoscopic surgeries. EMcision’s devices help patients with advanced cancers located in challenging areas of the gastrointestinal tract for whom surgery is not an option.
EMcision’s website states that EMcision’s flagship product, the Habib™ EndoHPB, is a novel endoscopic bipolar radiofrequency (RF) probe that was the world’s first endoscopic device for tumour ablation via ERCP. The Habib™ EndoHPB has been cleared by the U.S. Food and Drug Administration (FDA) and received CE mark from the EU. EMcision devices are currently being sold in 38 countries around the world and used in most of the top cancer centers in the United States.
With regards to the acquisition, Cherif Habib, EMcision’s outgoing CEO, stated: “By partnering with Boston Scientific, we will continue delivering on our mission of improving the quality of life of cancer patients on much larger scale. Boston Scientific has the resources and the know-how to further improve our technology, expand clinical indications and make it available to may more patients.” According to Yahoo Finance, Boston Scientific’s Endoscopy division revenues rose 14.8% year over year to $436 million in the last reported quarter.
On February 20, 2018, Johnson & Johnson Medical Devices Companies announced the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery technologies, including a differentiated robotic-assisted surgery solution. According to Johnson & Johnson, this technology is currently in early-stage development for total and partial knee replacement, and the Johnson & Johnson Medical Devices Companies plan to broaden its application for a range of orthopaedic surgery procedures.
Orthotaxy was founded in Grenoble, France, in 2009 by robotics entrepreneur Stéphane Lavallée and has focused on surgical planning software that allows surgeons to plan implant placement on preoperative CT or MRI images. Orthotaxy has also developed patient-specific surgical guides that enable surgeons to insert surgical instruments and perform surgery in accordance with a planned strategy.
Orthotaxy currently has 3 pending published patent applications: U.S. Patent App. Nos. 14/667,623, 15/032,223, and 15/032,225. The ’623 application and the ’223 application are directed to methods for constructing a patient-specific surgical guide (e.g., element 1 in FIG. 4 of the ’623 application reproduced below) based on a patient’s 3-D medical image.
The ’225 application is directed to a method for planning a surgical intervention that comprises computing and displaying a pseudo-radiographic images along with the representation of an implant in a patient’s anatomical structure, as illustrated in FIG. 2 of the ’225 application reproduced below.
Regarding the acquisition, Company Group Chairman Ciro Roemer stated: “Our goal is to bring to market a robotic-assisted surgery technology that is an integral part of a comprehensive orthopaedics platform, delivering value to patients, physicians and healthcare providers across the episode of care. The team at Orthotaxy has significant expertise and passion in developing this platform, and we aspire to bring to market a differentiated technology that helps improve clinical outcomes and increases patient satisfaction.”
According to Johnson & Johnson, financial terms of the acquisition will not be disclosed.