Current Health is the developer of an AI-powered upper-arm wearable and related software platform that measures a patient’s respiration, pulse, oxygen saturation, temperature, and movement. The real-time measurement device received Class II clearance from the FDA for post-acute care, marking the first time that an end-to-end, passive RPM wearable and platform has received clearance from the agency.
In discussing the agreement between Best Buy and Current Health, Christopher McCann, CEO of Current Health stated:
Over the coming decade, significantly more healthcare can be delivered in the home. We started Current Health to make that exciting transition radically easier for healthcare providers to achieve . . . Best Buy has unparalleled physical reach, world-class supply chain logistics, and trusted support services–allowing us to provide a high-touch consumer experience, at scale. We’re excited to join with Best Buy Health to move safe and effective healthcare into the home globally.
This acquisition will continue Best Buy’s investment in consumer-side health care technologies. For example, Best Buy previously acquired GreatCall Inc. (now Lively Inc.), a personal emergency response subscription service, for $800 million in 2018 and acquired Critical Signal Technologies, Inc., a senior-focused remote patient monitoring provider, for $125 million in 2019. The significant investment into the healthcare technology space for the consumer electronics company follows what Best Buy sees as a major growth opportunity. In a March 2021 earnings call, Corie Berry, CEO of Best Buys, stated, “We plan to invest in people, product development and the ongoing development of our health technology platform and our data analytics and intelligence engines.” Deborah Di Sanzo, President of Best Buy Health, further elaborated by stating:
The future of consumer technology is directly connected to the future of healthcare. We have the distinct expertise in helping customers make technology work for them directly in their homes and by combining Current Health’s remote care management platform with our existing health products and services, we can create a holistic care ecosystem that shows up for someone across all of their healthcare needs.
Alpha Tau Medical Ltd. (“Alpha Tau”) is a medical technology start-up focused on the research, development, and commercialization of its Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) treatment for solid cancerous tumors. On October 8, 2021, Alpha Tau announced that it received FDA Breakthrough Device Designation for using Alpha DaRT to treat recurrent glioblastoma multiforme (GBM). GBM is an aggressive, often incurable form of cancer responsible for malignant brain tumors.
According to the FDA, the goal of its Breakthrough Devices Program is to “provide patients and health care providers with timely access to  medical devices by speeding up their development, assessment, and review.”
“As GBM is such a terrible disease, it is critical that we find new solutions for these patients, and we are thrilled that receipt of the FDA’s Breakthrough Device Designation will allow us to expedite our clinical collaborations with leading cancer centers in the U.S. and across the world, and to bring new hope for GBM patients. I am very proud of our team and our collaborators who have worked hard to extend the use of Alpha DaRT to GBM and have already accomplished so many amazing things. This is fantastic news for Alpha Tau and fantastic news for so many GBM patients around the world.”
Alpha DaRT works by first inserting a “seed” into a cancerous tumor. The seed then releases high-energy alpha particles that destroy the tumor while sparing the healthy tissue around it.
This is the second FDA Breakthrough Device Designation Alpha Tau has received. In June 2021, Alpha Tau announced the FDA’s designation of Alpha DaRT for treating squamous cell carcinoma, a type of skin cancer.
NeoChord Announces Successful Completion of First-in-Human Procedure with its Mitral Chordal Repair Technology
NeoChord, Inc. (“NeoChord”) announced on October 4, 2021 that it successfully completed a first-in-human procedure with the NeXuS Transcatheter Mitral Chordal Repair (TMVr) device NeoChord is developing. NeoChord also reported that the patient has been discharged from the hospital and is back to a normal lifestyle.
In a press release David Chung, President and Chief Executive Officer of NeoChord expressed enthusiasm for their achievement. “On behalf of our entire organization, I want to thank the collective team of physicians for bringing this first-in-human procedure to success. Coupled with our successful, clinical experience with the transapical device, this transcatheter milestone further establishes NeoChord as the leader for beating heart, off-pump mitral chordal repair, providing another tool for the Heart Teams to offer patients a surgically-proven technique with an interventional approach.”
Mitral regurgitation is believed to affect more than 2 million individuals and to be the most common valvular disorder in the United States. According to some studies, mitral regurgitation is prevalent in more than 10% of adults over the age of 75. NeoChord notes that, if left untreated, mitral regurgitation may lead to chronic heart failure – the leading cause of hospitalization in the U.S. and Europe.
This first-in-human procedure was performed at the University Hospital of Bordeaux in France in collaboration with the Universitätsmedizin Mainz Germany. According to Thomas Modine, MD, University Hospital of Bordeaux and Ralph Stephan von Bardeleben, M.D., Universitätsmedizin Mainz, who both co-led the procedure, “the ability to replace a ruptured native chord by precisely placing suture in the mitral leaflet and securing with an anchor contributed to a very safe procedure.”
Azeem Latib, M.D., leading cardiologist from New York USA closely involved in the development of the TMVr device and procedure believes that “minimally invasive transcatheter chordal repair offers the promise of driving surgical-like results by maintaining the physiologic construction of the mitral valve, translating to better long-term outcomes.”
NeoChord is a privately-held medical technology company focused on beating heart mitral valve repair in patients suffering from mitral valve regurgitation.
The United States Department of Justice announced that medical device company Affordable Healthcare Solutions, LLC has pleaded guilty to charges related to unapproved prescription hyaluronic acid medical devices, as reported by a press release dated September 28, 2021. The devices are “intended for the treatment of pain in osteoarthritis of the knee that must be injected by a doctor or other qualified health care professional.” The company was sentenced for “Receiving Adulterated Devices in Interstate Commerce and Delivery for Pay with Intent to Defraud or Mislead, in violation of 21 U.S.C. §§ 331(c) and 333(a)(2).”
21 U.S.C. § 331(c) prohibits “[t]he receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.” According to the facts admitted during the plea, special agents with the United States Food and Drug Administration (FDA) located and seized foreign-market Supartz, Euflexxa, Synvisc, Synvisc-One, and Orthovisc that were adulterated for lacking FDA approval for distribution and use in the United States.
According to the press release, a review of the devices seized from Affordable Healthcare Care Solutions confirmed various differences between the outer box and carton labels, patient information brochures, and instructions for use between the FDA-approved labeling for Supartz, Orthovisc, Synvisc, Synvisc-One, and Euflexxa versus the labeling included with the unapproved versions being distributed by Affordable Healthcare Solutions. While discussing the seizure, Special Agent in Charge, Justin C. Fielder, emphasized that the “FDA regulates the manufacturing and distribution of medical devices to help ensure the safety of American patients.”
As a result of the plea agreement, Affordable Healthcare Solutions pleaded guilty to a felony, was fined, and was ordered to forfeit $837,000 worth of devices seized by the special agents. Juan Antonio Gonzalez, Acting United States Attorney for the Southern District of Florida, announced the felony guilty plea and stated:
Medical device suppliers whose greed leads them to disregard FDA protocols and approval processes put the public in danger. . . . These are serious crimes and, in our district, companies that put profit over patient safety will be held accountable.
Boston Scientific Corp. has agreed to acquire Devoro Medical Inc. in a deal expected to close this year. Boston Scientific previously held a 16% equity stake in Devoro Medical and now agrees to acquire the remaining 84% stake for $269M. Boston Scientific also agrees to pay up to $67M more if Devoro Medical clears certain regulatory and clinical milestones.
Devoro Medical is the developer of the WOLF Thrombectomy® Platform–a technology platform that “targets and rapidly captures blood clots using finger-link prongs that retrieve and remove thrombi in the arterial and venous systems.”
According to Boston Scientific’s press release:
“The addition of the WOLF platform advances our efforts to ensure physicians have the right tools to improve procedural efficiencies,” said Jeff Mirviss, executive vice president and president, Peripheral Interventions at Boston Scientific. “Clot management remains a core focus of our business, and upon commercialization, this highly differentiated technology will complement and expand our offerings to a full suite of interventional strategies for thromboemboli, which also includes the EkoSonic™ Endovascular System (EKOS) and the AngioJet™ Thrombectomy System.”
Boston Scientific plans to accelerate development of the WOLF platform following its acquisition of Devoro Medical, according to Michael R. Jaff, D.O., its Chief Medical Officer and Vice President of Clinical Affairs, Technology and Innovation, Peripheral Interventions.
This deal is the latest in a series of acquisitions this year by Boston Scientific. In January, Boston Scientific agreed to acquire cardiac wearables company Preventice Solutions for $925M. In March, Boston Scientific agreed to acquire the global surgical business of Lumenis LTD for $1.07B. And, in June, Boston Scientific agreed to acquire cardiac ablation device maker Farapulse for $295M.
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.
The orthopedic industry traditionally sees significant levels of intellectual property litigation activity, and this year has been no different. One source of this activity comes from Conformis who has continued to assert patents directed towards surgical planning and patient specific instruments and implants. In 2021, Conformis filed three new complaints, settled one case, and continued another litigation. These cases have involved various companies, including DePuy Synthes, Exactech, Bodycad, Wright Medical, and Medacta.
Decisions and settlements have also been reached in several additional lawsuits relating to diverse technologies, such as bone plates, knee implants, and pedicle screws. TriMed, Arthrex, Medacta, and Zimmer are some of the companies that have been parties to these lawsuits. Alternative forums, including the use of Inter Partes Review, have also continued to play significant roles for both patent holders and challengers.
Several attorneys from Knobbe Martens – including Andrew Douglas, Jessica Achtsam, Michael Christensen, Kregg Koch, Christy Lea and Sabing Lee – presented a webinar on August 26, 2021, to discuss notable decisions from recent orthopedic and spine intellectual property litigations. The webinar was prepared in anticipation of the 2021 Annual Meeting of the American Academy of Orthopaedic Surgeons and the 36th Annual Meeting of the National Association of Spine Specialists and included topics such as:
- an analysis of claim types asserted by Conformis against patient specific implant and instrument technologies and how these claims have been enforced against and challenged by many prominent orthopedic companies;
- how statements made by a patent holder can limit the scope of their claims in litigation;
- how small companies can leverage their patents to derive licensing revenue;
- trade secret issues that can arise at industry meetings;
- how prolific doctor inventors have built and enforced large patent portfolios;
- remedies for IP disputes outside the United States; and
- strategies for using patents defensively as part of a countersuit strategy.
The full webinar is available for viewing at this web link.
Medical Device Trade Secret Not Publicly Disclosed via Patenting, Displaying, and Selling Covered Product, 7th Cir. Affirms
Can certain specific medical device details remain company know-how or protected trade secrets even if patents are pursued on the medical device? Consider the Seventh Circuit’s commentary in its August 9, 2021 decision upholding a preliminary injunction in the Life Spine, Inc. v. Aegis Spine, Inc. case. The preliminary injunction prohibits Aegis from selling or marketing its competing AccelFix product (shown below, right) until the case is resolved on the merits.
Aegis argued in appealing the preliminary injunction that the district court erred in concluding that information about the ProLift device could remain a protected trade secret after Life Spine patented, displayed, and sold the device to hospitals and surgeons. However, the Seventh Circuit held that “Aegis does not come close to showing that [the district court’s] finding was clear error.” The Seventh Circuit stated that Aegis had not proven that Life Spine’s patent materials disclose the “exact dimensions and measurements of every ProLift component.” In addition, the Seventh Circuit stated that “those who attend ProLift displays do not have unfettered access to the device” and that “the only purchasers of the ProLift are hospitals and surgeons, who purchase the device for use in scheduled surgeries.”
Regarding the patent materials, a figure of which is shown below, the Seventh Circuit noted that “Life Spine’s patent did not disclose the precise specifications of the ProLift” devices. The Seventh Circuit recognized that such dimensions could only be learned by someone who has access to the device and sophisticated measurement technology. As for public displays, the Seventh Circuit noted that Life Spine representatives supervise those who attend ProLift displays as they handle the devices.
Regarding sales of the ProLift device, the Seventh Circuit noted that Life Spine or its distributors ship the ProLift in sealed boxes and that the surgeries are overseen by Life Spine representatives or distributors. The Seventh Circuit further noted that “it seems doubtful that the hospitals or surgeons purchasing the device . . . would secretly unpackage the device [and] measure all its components with specialized measurement technology” and that it “seems even more unlikely that a device would be removed from a patient’s body and then reverse engineered.”
Following this decision, the case will return to the United States District Court for the Northern District of Illinois to continue on the merits.
According to an article published in Nature Biotechnology, Harvard and MIT researchers invented a face mask for detecting SARS-CoV-2, the virus that causes COVID-19, via a user’s breath. Instead of relying on a lab, the personal device uses sensors that use wearable freeze-dried cell-free (wFDCF) technology. This technology contains the same molecules that cells use to recognize and manipulate nucleic acids and proteins. According to MedGadget, unlike previous iterations of this technology which store living cells in “tiny aquariums”, wFDCF technology prevents any issues with leakage due to breakage.
To use the mask, a user presses a button on the mask to release water onto reactive wFDCF sensors. MedGadget reports that results are given within 90 minutes and can be displayed on the inside of the mask for privacy purposes. According to the scientific article, the wFDCF technology first cleaves viral particle samples in order to release the viral RNA. Next, target genes located in the viral RNA are amplified via reverse transcription–recombinase polymerase amplification, in order to amplify the sequence that encodes for the spike protein. A lateral flow assay strip is then used to display visual results similar to a pregnancy test.
“We have essentially shrunk an entire diagnostic laboratory down into a small, synthetic biology-based sensor that works with any face mask, and combines the high accuracy of PCR tests with the speed and low cost of antigen tests,” said researcher Peter Nguyen. “In addition to face masks, our programmable biosensors can be integrated into other garments [e.g., lab coats] to provide on-the-go detection of dangerous substances including viruses, bacteria, toxins, and chemical agents.”
MIT News reports that the device can also swap in sensors for other pathogens, including influenza, Ebola, and Zika, or sensors they have developed to detect organophosphate nerve agents.
Genetic Engineering and Biotechnology News reports that the research team is “actively searching for manufacturing partners who are interested in helping to enable the mass production of the face mask diagnostic for use during the COVID-19 pandemic, as well as for detecting other biological and environmental hazards.” The article reports that the authors have already submitted provisional patent applications for the technology.
The original article was published in Nature Biotechnology on June 28, 2021, and is available here.
According to the FDA, the medical device industry experienced significant supply chain disruptions during the COVID-19 pandemic. Such disruptions caused shortages of PPE, ventilators, diagnostic testing, and other medical devices. As Janet Woodcock, M.D., the Acting Commissioner of Food and Drugs, acknowledges in her July 21, 2021 statement:
“the pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices.”
Woodcock also explains the steps being taken by the FDA to avoid such shortages in the future. One step includes a request for $21.6 million to fund a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP). This funding request is part of the FDA’s request for $97 million to support its core safety programs. Woodcock explains “the funding will provide, for the first time, resources to establish a permanent program for U.S. supply chain resilience for medical devices.” RSCSPP’s goal is to prevent and mitigate the supply chain issues like those experienced during the pandemic while reducing dependence on foreign medical devices.
Additionally, the FDA is looking to expand its authority to prevent future shortages. The FDA seeks broader authority “to obtain supply disruption notifications for critical devices.” Broader authority has also been requested to require manufacturers to develop and share risk management plans. The FDA plans to work with Congress to ensure the FDA has the resources and authority needed to advance these initiatives.