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.”
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.
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.
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.
On July 19th, 2018, the United States Department of Veterans Affairs (VA) and IBM Watson Health announced an extension of their ongoing partnership to interpret cancer data in patients.
According to the press release, the partnership was originally announced two years ago with the goal of providing precision care for veterans. Oncologists and pathologists receive tumor samples from patients nationwide. The DNA is sequenced from these samples. Watson then interprets the genomic data and identifies relevant mutations. Once the mutations are identified, Watson suggests potential targeted treatment options. Watson accomplishes this by cross-referencing the findings against medical literature on potential and FDA approved therapies.
The partnership builds upon other genomic efforts by the VA. One such program is the VA’s Million Veteran Program. Starting in 2011, this program aimed to create a massive medical and genomic database by collecting blood samples from 1 million volunteers. The VA noted that by taking baseline and subsequent readings based on military experiences, health and lifestyles, the information contained in the database could hold the key to preventing and treating diseases.
According to press releases, the VA currently treats 3.5% of the United State’s cancer patients. This makes the VA the largest health care provider treating cancer in the United States. According to the National Cancer Institute, in 2018, an estimated 1,735,350 new cases of cancer will be diagnosed in the United States.
In its press release, Dr. Kyu Rhee, chief health officer for IBM Watson Health. “It is incredibly challenging to read, understand and stay up-to-date with the breadth and depth of the medical literature, and link them to relevant mutations for personalized cancer treatments. This is where AI can play an important role in helping to scale precision oncology, as demonstrated in our work with VA, the largest integrated health system in the U.S.”
Envision Healthcare Corporation (“Envision”) recently announced an agreement to be acquired by KKR & Co. L.P. (“KKR”) for about $5.5 billion in cash. The transaction is valued at $9.9 billion, including the assumption or repayment of debt. The transaction remains subject to regulatory and shareholder approvals, but is expected to close in the fourth quarter of 2018.
Envision, based on Nashville, TN, is a national physician staffing company and provider of physician services, including post-acute care and ambulatory surgery. KKR is a global private equity firm headquartered in New York, NY. The agreement to acquire Envision follows KKR’s 2017 acquisition of American Medical Response, an ambulance business subsidiary of Envision, for $2.4 billion.
It has been reported that other private equity firms including a consortium of Carlyle Group LP and TPG global competed for Envision. According to a report by Bain & Co., the value of private equity deals in healthcare across the globe reached $42.6 billion in 2017, up 17% from $36.4 billion in 2016.
Regarding its acquisition of Envision, Jim Momtazee, Head of KKR’s Health Care investment team states:
Envision has a very strong reputation for delivering high-quality, patient-focused care through its network of 25,000 clinical professionals at thousands of hospitals, surgery centers and alternate sites of care across the country. We are excited to partner with the outstanding team lead by Chris Holden to help build upon the strong foundation in place and accelerate Envision’s growth going forward.
According to its website, SafeAir specializes in smoke evacuating diathermy pencil products. Diathermy pencils are used in electrosurgical procedures such as cauterization. Such procedures generate smoke, and SafeAir’s Smoke Pencil products have an integrated smoke evacuation function to remove such surgical smoke from its source.
The acquisition of SafeAir AG is highly complementary to the Surgical business of Stryker’s Instruments division , and strengthens our smoke evacuation portfolio in both the U.S. and Europe.
Regarding how this acquisition fits into Stryker’s medical device portfolio, Mr. Scannell went on to report:
This acquisition aligns with Stryker’s focus of providing solutions that result in a higher quality of care and level of safety for both healthcare professionals and patients.
Stryker’s forthcoming acquisition may indicate the company’s understanding of the growing smoke evacuation system market that is expected to grow at a compound annual growth rate of 5.6% and reach $180M within 18 months.
President Donald Trump’s 25 percent tariffs on Chinese imports went into effect on July 6, a move that, according to industry experts, could have wide-ranging effects on American medical device manufacturers. In early April, RBC Capital Markets estimated the proposed tariffs could cost the entire medical device industry up to $1.5 billion each year. A more recent survey conducted by the Medical Imaging and Technology Alliance (MITA), an organization that represents medical imaging and radiopharmaceutical manufacturers, projected that the tariffs will cost American medical manufacturers more than $138 million this year. According to MITA, CT scanners and other radiographic imaging devices could be impacted the most by the new tariffs.
The Trump Administration’s original tariff list included more than 1,300 items, of which 30 were finished medical device products, including pacemakers, ultrasounds, CT scanners, needles, catheters, radiation therapies.
Patrick Hope, Executive Director of MITA stated:
“These tariffs on imaging products or their components will harm the American medical technology sector’s ability to stay competitive and will adversely affect the U.S. economy in ways that could compromise patient access to care. Though the Administration has stated that it will implement an exemption process, we have not yet seen any information about how or when it will do so. Policymakers should act quickly to ensure that patient access to innovative life-saving technology is not compromised.”
MITA has commented to U.S. Trade Representatives that many medical imaging products undergo “inter-company transfers,” meaning the products are imported from a manufacturer in China to a facility in the U.S., where they are transformed and re-exported, sometimes to China. In these cases, the tariffs present a major disincentive to manufacturing the products in the United States.
MITA hopes it can convince U.S. Trade officials to develop a “robust exemption process” for medical imaging products and components. Patrick Hope stated:
“[W]hile we are encouraged that the Administration has shown openness to making adjustments to the list, we first need a clear explanation of the process we should use to make our case to the government to ensure that American innovation can continue to thrive.”
Although AdvaMed, an international trade association for medical technology, claims to have successfully lobbied to remove some types of medical devices from the tariff list, an AdvaMed representative declined to reveal which devices had been removed.
Senseonics recently received Premarket Approval from the Food and Drug Administration (FDA) for its Eversense® Continuous Glucose Monitoring (CGM) System. According to Senseonics, the Eversense® CGM System is the first and only implantable device to allow for continuous blood-glucose monitoring for as long as three months.
The Eversense ® CGM system includes an implantable glucose sensor, a wearable transmitter, and the Eversense Mobile App. Senseonics advertises the sensor as utilizing fluorescent, glucose indicating polymer technology to measure glucose in the interstitial fluid. According to Senseonics, measurements from the sensor are conveyed to the wearable transmitter, which wirelessly communicates with the Eversense Mobile App to display real-time glucose measurements, trends, and alerts.
Commenting on the FDA approval, Senseonics President and CEO Tim Goodnow stated:
“With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way.”
Medtronic recently announced that the U.S. Food and Drug Administration (FDA) has approved its Deep Brain Stimulation (DBS) Clinician Programmer and Activa Programming Application. Medtronic’s DBS Clinician Programmer is presently being launched in Europe and is expected to be launched in the United States before the end of July 2018.
DBS therapy involves the delivery of electrical stimulation to specific areas of the brain using a surgically-implanted device. About 125,000 Medtronic Activa devices are implanted globally. Medtronic’s Activa DBS system is used as therapy for neurological diseases including Dystonia and Parkinson’s disease.
The Activa Programming Application is designed for use with the Samsung Galaxy Tab S2 tablet. According to Medtronic’s press release, the purpose of the application is to “enhance the clinical programming experience, streamline workflows and provide actionable information to support neurologists and neurosurgeons in their treatment of patients.” The programmer is expected to have an immediate impact on thousands of patients’ post-implant care. For example, the programmer will allow the service life of certain Activa rechargeable implantable neurostimulators to be extended by 6 years, giving patients about 15 years between device replacement surgeries.
Dr. Mohammad Maarouf, associate professor, head of the Department of Stereotaxy and Functional Neurosurgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Germany stated that the programmer’s “intuitive, visual interface and task-based workflow makes daily use easier, saving [him] time to focus on what’s most important-[his] patients.”
According to Medtronic’s press release, Medtronic’s DBS Clinician Programmer is also approved for use with the Activa DBS systems for treating refractory epilepsy, which will be launched in the United States later this year.
On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including digital health technologies and diagnostic tests that could provide novel solutions to detecting, treating and preventing addiction, addressing diversion and treating pain.”
FDA Commissioner Scott Gottlieb stated that “[m]edical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis.” Medical devices can be used to address opioid addiction by, for example, effectively addressing local pain syndromes in order to supplant the use of systemic opioids and reduce the use of opioids. “New digital technology products and diagnostic tests could help in the opioid addiction fight by detecting, treating, and preventing addiction; addressing diversion of the opioid supply chain to illicit use; and treating pain,” the FDA said.
According to Bloomberg, “accepted companies will get to work more closely with the FDA’s review offices than usual to help get their products approved. Products that qualify as breakthrough devices under food and drug law will receive that designation without the sponsor needing to submit an application, the agency said. A breakthrough device designation can reduce the time and cost to get a product to market that addresses life-threatening or irreversibly debilitating diseases.”
The innovation challenge is open to any product in any stage of development. The challenge also is open to developers of currently marketed devices who can show that their devices have an improved benefit-risk profile compared to opioid use in pain management. The FDA anticipates “that applicants will eventually submit one or more formal applications to the FDA, such as an investigational device exemption, De Novo, premarket clearance (510(k)) or premarket approval application.”
This innovation challenge is part of the FDA’s plan to aid in the opioid crisis and supports several overarching goals of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis. On April 20, 2018, the agency also released the first of two new draft guidances intended to aid industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence.
J&J Accepts Platinum Equity’s $2.1B Offer for its LifeScan Subsidiary; Receives Offer for Advanced Sterilization Products Subsidiary
On June 12, 2018, Johnson & Johnson announced acceptance of an offer from Platinum Equity, a private investment firm, to acquire its diabetic monitoring unit, LifeScan, for approximately $2.1 billion. In response to the acquisition, Platinum Equity Chairman and CEO Tom Gores said
We are committed to putting our financial resources and global operating expertise to work in support of the company’s core mission to improve the quality of life for people living with diabetes.
LifeScan offers blood glucose monitoring products to patients for the care of diabetes under the OneTouch brand. According to the press release, LifeScan business earned approximately $1.5 billion in revenue in 2017. Platinum Equity previously reported that LifeScan President Valerie Asbury would continue leading the business.
In February 2018, Bloomberg reported that Johnson & Johnson was seeking to sell off its sterilization products division for as much as $2 billion. The selling price has increased as Johnson & Johnson announced on June 6, 2018, receipt of a binding offer from Fortive Corp. to acquire Advanced Sterilization Products (ASP), a division of Ethicon Inc., for approximately $2.8 billion. If accepted, Johnson & Johnson indicated it expects the proposed transaction to close no later than early 2019.
ASP sells sterilization products under the STERRAD and CYCLESURE brands. ASP’s high level disinfection products are sold under the EVOTECH brand. Johnson & Johnson reported that ASP earned approximately $775 million in revenue in 2017.
The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in April 2018, but the program was updated in response to requested public input. The FDA expects to roll out a finalized version of the program by December 2018 and to have a pilot test available in 2019.
With the precertification program, the FDA hopes to streamline the certification of “mobile apps” and other software that is used to “treat, diagnose, cure, mitigate, or prevent disease or other conditions,” or so-called software as a medical device (SaMD), according to the updated program description. While software in a medical device (SiMD) is not currently part of the program, the FDA hopes to include SiMD and software that is an accessory to hardware in the future. The program will allow certain organizations that can demonstrate a “culture of quality and organizational excellence” to streamline their oversight of SaMD.
The update clarifies that not all software is subject to regulatory review even if it has some connection to the medical industry. In particular, the update notes that non-device software is exempt, such as software that is intended for (1) for administrative support, (2) for maintaining or encouraging a healthy lifestyle, (3) to serve as electronic patient records, (4) for transferring, storing, converting formats, or for displaying data, or (5) to provide certain limited clinical decision support.
According to the update, organizations “of all sizes” can qualify. The FDA makes clear that startups and smaller companies can apply and receive precertification. Two levels of precertification exist. Level 1 precertification allows an organization to develop and market “lower risk” software without review while also streamlining review of higher risk software. This level would be awarded to an organization that demonstrates excellence in product development but may have a “limited track record” in “developing, delivering, and maintaining” products in the healthcare market. Level 2 precertification allows “lower and moderate risk” software to be developed and marketed without review and allowing streamlined review of other software. This level is awarded to those organizations with a track record in demonstrating high quality software products.
In determining what amount of review is required for “lower risk” and “moderate risk” SaMD, the FDA looks at (1) the risk category of the product, (2) the level of precertification of the organization, and (3) the extent of the changes the software relative to an existing device. Under either level of precertification, “minor changes” require no review by the FDA.
The FDA is looking to update additional aspects of the precertification program, including how it relates to substantially equivalent device review. The FDA is currently requesting comments on the program.
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.