Showing all posts written by Brandon Smith
Mr. Smith earned his Bachelor's of Science in Biomedical Engineering at California Polytechnic University, San Luis Obispo. Mr. Smith received his J.D. from the University of San Diego School of Law where he was Editor-in-Chief of Volume 52 of the San Diego Law Review.
Mr. Smith was a summer associate with the firm in 2014 and joined the firm as an associate in 2015. Click here to read full bio
On June 16, 2022, the World Trade Organization (WTO) agreed to a partial waiver of intellectual property rights related to COVID-19 vaccines. The agreement came on the heels of an all-night negotiating session. The agreement followed years of proposals and negotiations among the WTO members.
Ultimately, the WTO members agreed to a waiver that was limited to “the subject matter of a patent required for the production and supply of COVID-19 vaccines.” The United States had previously expressed its support for a vaccine-only TRIPs waiver. Previous proposals by South Africa and India also included COVID-19 tests and treatments, as well as including access to trade secrets.
The agreement allows member countries to “authorize the use of the subject matter of a patent … without the right holder’s consent through any instrument available in the law of the Member.” However, any country making such a waiver must provide “adequate remuneration” to the patent holder.
WTO Director-General Ngozi Okonjo-Iweala praised the agreement: “[N]ow we have something in hand,” “[i]t’s really exciting now to go to those factories that are starting to set up all over the developing world and start to work with them about how this will actually be made real.”
However, the agreement did not meet with universal praise. Indian Trade Minister Piyush Goyal stated:
[W]hat we are getting is completely half baked and it will not allow us to make any vaccines. They have no intentions of allowing therapeutic and diagnostics and if at all they try to say that we are the cause for its collapse, I think we should unanimously speak to the world and tell them that no, ideally we want a holistic solution including therapeutic and diagnostics.
The full text of the agreement is available on the WTO’s website.
Surgeons at the University of Maryland School of Medicine performed the first successful porcine (pig) to human heart transplant, a procedure referred to as “xenotransplantation.” The patient, 57 year old David Bennett, was recovering and doing well three days after the procedure. The surgical team continues to monitor Mr. Bennett’s condition.
According to Bartley P. Griffith MD, a member of the surgical team that performed the xenotransplantation:
This was a breakthrough surgery and brings us one step closer to solving the organ shortage crisis. There are simply not enough donor human hearts available to meet the long list of potential recipients. We are proceeding cautiously, but we are also optimistic that this first-in-the-world surgery will provide an important new option for patients in the future.
According to organdonor.gov, “about 110,000 Americans are currently waiting for an organ transplant, and more than 6,000 patients die each year before getting one.”
The surgical team spent years refining the technique in primate studies, waiting until they saw good survival over 9-12 months without organ rejection and low infection incidence before applying for the compassionate use exemption from the FDA that allowed Mr. Bennett to receive the xenotransplantation, according to surgical team member Christine Lau MD.
The donor heart was provided by Revivicor (acquired by United Therapeutics in 2011). Ten genes in the donor heart were genetically modified, primarily to reduce the chance that Mr. Bennett’s body would reject the donor organ.
This is the second xenotransplanted organ provided by Revivicor in the last six months. In October 2021, surgeons at New York University attached Revivicor’s genetically modified porcine kidney to the blood vessels of a brain dead patient on life support without any signs of rejection for over two days. The xenotransplanted kidney functioned normally during that time period.
According to the University of Maryland School of Medicine’s press release, xenotransplants were first tried in the 1980s. However, they fell out of favor after a xenotransplantation of a baboon heart into an infant in California failed due to the immune system’s rejection of a foreign heart. In contrast, xenograft porcine heart valves have been used as valve replacements in humans for over 50 years, and xenograft valve replacements are still in use today.
This video includes more information about Mr. Bennett’s procedure and is available from the University of Maryland School of Medicine.
Baxter International Inc. (“Baxter”) has agreed to acquire Hillrom for $10.5 billion ($156 per share) in a deal expected to close in 2022. After assumption of debt, the total enterprise value of the deal is approximately $12.4 billion. The deal had been rumored for about a month before it was announced.
According to Baxter’s investor presentation, the acquisition is expected to lead to “accelerated product and digital innovation across the care continuum and care settings.”
Patients increasingly want to receive their care at home or nearby, while hospitals and other care providers are increasingly using digital health technologies to expand access, improve quality and lower costs. Baxter and Hillrom are uniting to meet the challenges of a rapidly evolving global healthcare landscape, while also creating significant value for all the stakeholders we serve.
The deal is the latest in a series of moves by Baxter, including extending a multi-year strategic agreement with Amazon Web Services, and acquiring certain assets related to PerClot Polysaccharide Hemostatic System from CryoLife.
The Hillrom acquisition is the largest in an already busy year for medical device mergers and acquisitions. Other notable acquisitions this year include Steris’ acquisition of Cantel Medical for $4.6 billion; Roche’s acquisition of GenMark Diagnostics for $1.8 billion; and Boston Scientific’s acquisitions of Lumenis’ surgical business and Preventice Solutions. As of late July, mergers and acquisitions in the medical device field were on pace to exceed last year’s performance.
Medtronic recently announced that it received clearance from the FDA and CE Mark approval for its LINQ II insertable cardiac monitor (ICM). The announcement notes that ICMs “are small, subcutaneously implanted devices offering continuous ambulatory electrocardiogram monitoring” and that in particular, ICMs focus on detecting and managing subclinical atrial fibrillation. Articles have noted that recently some ICM’s have expanded their monitoring capabilities to assist with home monitoring of COVID-19 patients.
The LINQ II system purports to offer remote programming and remote patient management that allow system optimization without the patient visiting the hospital. Rob Kowal, M.D. Ph.D, the chief medical officer of Medtronic’s Cardiac Rhythm and Heart Failure division touted this as an advantage of the LINQ II system in view of the COVID-19 environment:
[T]he LINQ II system offers patients a seamless way to experience ongoing connectivity between their device and their physician, while reducing the need for in-office visits.
Medtronic advertises the LINQ II as delivering the lowest published rate of false positives as compared to other ICM devices. Medtronic asserts that this increased accuracy will allow clinicians to spend approximately 33% less time reviewing ICM transmission, thereby streamlining their workflows. The LINQ II also purports to offer up to a 4.5 year lifespan, a 50% increase from the three year average lifespan of ICM’s reported in 2018. According to Medtronic, the LINQ II system also includes Medtronic’s MyCareLink Heart mobile app to automatically transfer data from the LINQ II to their physician. For patients who cannot use a cell phone, Medtronic notes that it offers a dedicated MyCareLink Relay Home Communicator.
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.
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.
The FDA recently cleared the first medical device accessory for the Apple Watch — AliveCor’s KardiaBand. According to AliveCor, the Kardiaband is a mobile, real-time electrocardiogram (EKG) reader that can record an EKG within 30 seconds and display the results on the Apple Watch or iPhone. In conjunction with the KardiaBand, AliveCor is introducing “SmartRhythm, a new feature within the Kardia app for the Apple Watch.”
Portable EKG readers for smart phones are not new; several are on the market already. However, none of them can tell the patient when to take an EKG. The KardiaBand solves that problem. The combination of the KardiaBand and SmartRhythm will use the Apple Watch’s sensors “to continuously evaluate the correlation between heart activity and physical activity,” and alert the user to take an EKG using the KardiaBand when the “heart rate and activity are out of sync.” According to Dr. Eric Topol, director of the Scripps Translational Science Institute,
[The KardiaBand] is continuously monitoring your heart rate to let you know if something is potentially off track. That’s the big difference.
AliveCor eplains that the Kardia app will display the results of the EKG on the Apple Watch and alert the patient if atrial fibrillation (Afib) is detected. If necessary, the results of the EKG can be emailed directly to a physician. Dr. Topol believes that this technology will “markedly increase the number of EKGs taken,” which will potentially save lives, because Afib often goes undetected.
The news of KardiaBand’s approval comes within days of Apple’s announcement of the Apple Heart Study in conjunction with Stanford Medicine, which will investigate the detection of Afib using the sensors already embedded in the Apple Watch. However, in a recent interview, AliveCor’s CEO, Vic Gundotra, distinguished the KardiaBand from the heart rate and activity sensors already found on the Apple Watch:
Apple might be able to say ‘oh your heart rate is high’ …but what does that mean? Does that mean you should go to the hospital? And if you go to the hospital what are they going to do?. Any doctor will say ‘ok come in, let’s get an EKG reading.’ . . . It’s not possible to diagnose atrial fibrillation without FDA clearance. That is a big, big play.
AliveCor touts the FDA’s approval of KardiaBand as a reason patient’s can be confident in the results of AliveCor’s mobile real-time EKG technology. In another interview, Mr. Gundotra stated
The average consumer doesn’t know what a normal sinus rhythm looks like or what atrial fibrillation looks like. Yet the FDA has cleared our individual algorithms. The consumer can have confidence that this is FDA-cleared. And frankly, we have the clinical studies to prove it.
The results of a recent study showed a 4-fold increase in Afib detection when using AliveCor’s mobile 30-second EKG technology. That same study showed that when using mobile EKG technology, such as the KardiaBand or AliveCor’s other device, fewer cases of Afib went undiagnosed.
The KardiaBand is available on AliveCor’s website for $199.
On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™. The myBETAapp joins the growing field of medical mobile applications, which the FDA predicts will reach 1.7 billion smartphone or tablet users by 2018.
According to Bayer, the myBETAapp connects their BETACONNECT autoinjector (for delivering BETASERON®, a therapeutic agent for multiple sclerosis) to a patient’s mobile device or computer, and the BETACONNECT Navigator functions as a tool to view data uploaded by the myBETAapp.
According to the myBETAapp user instructions, the application will:
- Display scheduled injections according to an injection routine
- Allow the user to determine when an injection is scheduled
- Display suggested injection sites based on the injection sites shown in the prescribing information for BETASERON®
- Display a monthly calendar of recorded, missed, and scheduled injections
- Transfer and sync data recorded by the autoinjector to the corresponding injection in the calendar
- Send a notice to record injection data to the patient via email
In the press release, Bayer describes the myBETAapp and BETACONNECT Navigator as allowing further connection between the patient and the healthcare team by, with the patient’s permission, providing access to the patient’s injection history. The application is also advertised as providing further connectivity to a BETA Nurse for patients enrolled in BETAPLUS®, Bayer’s patient support program.
According to Dr. Kantor, President Emeritus, Florida Society of Neurology:
The myBETAapp and BETACONNECT Navigator work cohesively together to support communication and connection between people living with relapsing remitting multiple sclerosis and their BETA Nurse and health care team.
Bayer reports that the myBETAapp will be available for free download from the Apple app store, Google Play Store, or Betaseron.com by mid-July 2017.
Healthcare apps are becoming a greater part of everyday life. The increasing prominence and functionality of these apps has lead to the question of when healthcare apps should be regulated as medical devices. In the United States, the FDA has issued some guidance on how it will treat healthcare-related apps. However, the FDA’s guidance only provides a list of examples of what constitutes a medical device, leaving the app developers to try and analogize their new apps to the examples or interpret the statutory language.
The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has attempted to simplify the regulatory determination for app developers by updating its guidance on classifying health apps as medical devices. As part of the update, the MHRA published a”step-by-step interactive PDF” to assist app developers in determining whether their app will be regulated.
According to the press release, “[a]pp users can use this guidance to check if their health app is a medical device.” The goal of the update is to “aid developers in navigating the regulatory system so they are aware what procedures they need to have in place to get a CE mark which indicates acceptable safety standards and performance, and what their reporting responsibilities are when things change or go wrong.” John Wilkinson, MHRA’s Director of Medical Devices stated:
Where apps or stand-alone software make a diagnosis or recommend a treatment, people should check for CE-marking before using their apps and developers should make sure they are complying with the appropriate medical device regulations.
To further MHRA’s goal of assisting app developers with CE marking regulation, the interactive PDF provides a flow chart to help app creators determine whether their app could potentially be classified as a medical device.
The interactive PDF also provides additional flow charts for determining whether an app has a medical purpose and whether an app works directly with in vitro diagnostic (IVD) data. Additionally, the interactive PDF also sets forth the “essential requirements” that app developers must meet in the event their app is classified as a medical device. MHRA has inserted explanatory comments into these requirements section that give simple examples or a brief interpretation of the regulatory text. MHRA also provided links in the PDF where app developers can go for additional guidance.
The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. According to the press release, the goal of these new regulations is to:
mak[e] sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit [from] innovative health care solutions in a timely manner.
The press release notes that the draft regulations will accomplish these goals by strengthening the rules on placing devices on the market and tightening surveillance once they are available. Regarding the agreement, Edith Schippers, Minister of Health of the Netherlands and President of the EU Council stated:
The deal reached will improve patients’ health and it will help to enhance the quality of life of disabled persons. It will also ensure a level playing field for the 25 000 medical devices manufacturers in the EU, many of which are SMEs and which employ more than half a million persons.
The medical industry recognises the importance of these updated regulations. The implementation will require substantial resources from all stakeholders, including industry. It is thus essential to keep the overarching goals of patient safety and innovation in mind during the translation into implementable rules.
If the Parliament’s ENVI Committee (i.e., the Committee on Environment, Public Health and Food Safety) and the EU Council confirm the agreement later this year, the new rules will apply three years after publication for medical devices and five years after publication for in vitro diagnostic medical devices. A draft of the new regulations is not yet available, but the press release provides the following notable details on the expected content.
Expected Impact of Draft Regulations on Device Manufacturing
- “[F]urther tighten the rules for the independent bodies that are responsible for assessing medical devices before they can be placed on the market”
- “[S]trengthen the surveillance of these so-called notified bodies by national authorities”
- Give the notified bodies “the right and duty to carry out unannounced factory inspections”
- Manufacturers will be responsible for “the follow-up of the quality, performance and safety of devices placed on the market”
- “Manufacturers and other economic operators will have clear responsibilities, for instance on liability, but also on registering complaints on devices”
- Improved availability “of clinical data on devices”
- Strengthen the protection for “patients participating in clinical investigations”
- Increased checks by experts for certain high risk devices
Expected Impact of Draft Regulations on Transparency and Traceability
- Creation of a central database for “all relevant information”
- “It will cover economic operators, notified bodies, market surveillance, vigilance, clinical investigations and certificates”
- “It will provide patients, healthcare professionals and the public with comprehensive information on products available in the EU”
- “Patients who are implanted with a device will be given key information on the product, including any precautions which might need to be taken”
On February 12, 2016, the FDA issued draft guidance for the use of ultrahigh molecular weight polyethylene (UHMWPE) in orthopedic devices. The draft guidance is open for public comment for the next 90 days. According to the draft guidance, the recommendations apply to “class II and class III devices intended for orthopedic applications.” The guidance applies to four types of UHMWPE materials: conventional UHMWPE, highly crosslinked UHMWPE (XLPE), Vitamin E highly crosslinked UHMWPE (VEPE), and non-conventional UHMWPE.
The draft guidance provides FDA recommendations on the “information and testing to submit in pre-market notifications (510(k)s), de novo requests, premarket approval (PMA) applications, humanitarian device exemptions (HDEs), and investigational device exemptions (IDEs).” The draft guidance provides recommendations on reporting material characterization, biocompatability, and shelf life when submitting those documents. A brief summary of some of these recommendations follows.
[The FDA recommends characterizing] the following properties of the material: crosslink density, trans-vinylene index (TVI), oxidation index (OI), crystallinity, melting temperature, and free radical concentration. If the measured values lie within the normal range, determined by comparison to literature (i.e., for de novo, PMA, HDE, or IDE) or a predicate device with the same intended use (i.e., 510(k)), no additional information will typically be requested. However, for some properties, FDA recommends that certain results be achieved.
The draft guidance provides examples of properties where certain results should be achieved. The draft guidance notes that some properties “are comparative in nature. When submitted in a 510(k), the results should be compared to a predicate device with the same intended use.”
For Class II devices, if the subject device has identical UHMWPE materials and manufacturing processes as a predicate device, with the same type and duration of patient contact, [the FDA] recommend that you identify the predicate device as part of your biocompatibility evaluation in lieu of providing specific testing.
For other class II devices, de novos, and class III devices, the guidance directs the applicant to evaluate the device’s material based on Blue Book Memorandum #G95-1.
The FDA recommends not packaging “UHMWPE materials containing unstable free radicals in air-permeable packaging because shelf-aging may degrade the mechanical properties of UHMWPE.”
Allergan recently announced that it has completed its acquisition of AqueSys. AqueSys is a privately held company, headquartered in Orange County, California, focusing on “commercializing implantable devices that will significantly improve the treatment of glaucoma, . . . the world’s leading cause of irreversible blindness.”
According to the press release, Allergan’s acquisition of AqueSys is an all-cash transaction that includes a $300 million up front payment with potential milestone payments contingent on the development of XEN45, AqueSys’ leading product. Allergan states that the acquisition of “XEN45 adds to Allergan’s strong late-stage eye care pipeline, with therapies in development to treat glaucoma, dry eye disease, age-related macular degeneration (AMD) and diabetic macular edema (DME).” Allergan reports that final FDA 510(k) clearance of the XEN45 is expected in late 2016 or early 2017.
The acquisition of AqueSys and XEN45 is highly complementary to our leadership position in eye care and underscores our commitment to develop and commercialize treatments that advance care and add value for ophthalmologists and their patients. The treatment of glaucoma is increasingly shifting to dropless therapies given the challenges of patient compliance. The XEN45 device provides a minimally invasive approach to lowering IOP [intraocular pressure] for physicians and their patients seeking new ways to treat glaucoma that go beyond conventional eye drop treatments.
According to its website, Allergan is a multi-billion dollar global pharmaceutical company, which focuses on six therapeutic areas: dermatology and aesthetics; CNS; eye care; women’s health and urology; GI and cystic fibrosis; and cardiovascular and infectious disease. Allergan’s global headquarters are in Dublin, Ireland while its U.S. headquarters are in Parsippany, New Jersey.