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Video of the Week
Cue the End Credits for This COVID-19 Test Maker
By Katie Hobbins , Managing Editor
After years of financial struggle post-COVID-19’s diagnostic boom, Cue Health seems to have begrudgingly hung the white flag of defeat, announcing recently that it would shut down operations and lay off the remainder of its employees and leadership by the end of this week, according to a report from The San Diego Union-Tribune, which first published the news.
Founded in 2010, the company saw sharp growth during the pandemic after nabbing government and private contracts for its point-of-care COVID-19 tests, raising $200 million in a 2021 IPO, and a valuation approaching $3 billion.
Post-pandemic, however, Cue has seen a steady decline of its COVID-19 testing sales. In 2023, “the company saw an 85% decrease year over year in revenue ($70.9 million) — of which its COVID-19 tests account for the majority of sales. That same year, it reported a net loss of $373.5 million,” according to previous MD+DI reporting .
Cue did see a win when it became the first company to go through the traditional regulatory process for its COVID-19 test, obtaining de novo clearance in 2023. Unfortunately, the authorization came about a month before the World Health Organization declared that the virus was no longer a public health emergency of international concern, although still a global threat.
The company has also seen multiple layoffs over the last few years. In 2022, Cue laid off 170 employees amid “economic challenges” and a decline in COVID-19 testing, and 2023 saw an additional cut of 388 people as testing demand fell further. In January 2024 , the company cut more than 200 across two rounds of layoffs, and only recently implemented an employee reduction of 230 people — 49% of its global workforce.
Additional hiccups in 2024 are the loss of two C-suite members — CEO Ayub Khattak who stepped down in March, and CFO Aasim Javed who resigned on earlier in May.
Last week, it seems Cue was hit with the straw that broke the camel’s back when FDA published a warning letter urging test users, caregivers, and healthcare providers to not use Cue Health’s COVID-19 tests for home and over-the-counter use and its COVID-19 test intended for patient care settings due to increased risk of false results.
The agency reported that after an inspection, it was revealed that Cue had made changes to these tests which reduced the reliability to detect the SARS-CoV-2 virus. FDA told users to throw away any Cue COVID-19 tests they had on hand.
With the announcement the company is shutting down operations, a WARN notice filed with the state of California detailed that at least 180 employees will be let go, with their last day being May 24. The San Diego Union-Tribune reported that laid off employees will received their final paycheck on that day covering compensation they would have received through July.
Cue did not respond to MD+DI’s request for comment.
Medtronic Finds its Backbone in the Spine Market
The Dublin-based company has seen high single-digit growth in the market.
By Omar Ford
Medtronic is benefitting from recent acquisitions in the spine market. The Dublin-based company’s executives spoke about how the mergers and the AiBLE platform helped it see high-single-digit growth in what was once a struggling franchise.
The company pointed out that after growing 6% or higher every quarter, its cranial and spinal technologies accelerated to 9% growth in the most recent reported quarter.
Brett Wall, executive vice president and president of Medtronic’s neuroscience portfolio, noted there were several reasons why growth has been steady and why it was so high in the most recent reported quarter.
“It’s a combination of this technology portfolio, including AI surgical planning, including robotics, including power and surgical instrumentation imaging and navigation - putting that all together is creating this very attractive place where very good teams and reps and groups of people want to come together to work with Medtronic,” Wall said according to a Seeking Alpha transcript of the call. “So, we have a very active program there. We're getting good contribution now, and we see that contribution continuing as we move forward.”
Historically, Medtronic has struggled in the spine market. In 2013, MD+DI reported that quarter after quarter , the medtech giant’s spine business dipped a bit further. Back then, there were several reasons surrounding the disappointing results. The reasons included pricing pressures from hospital customers, expensive acquisitions and controversy surrounding the InFuse bone-growth product.
Medtronic’s Chairman and CEO Geoff Martha said its fortunes in spine changed because of the AiBLE ecosystem. AiBLE is a digital ecosystem for neurosurgery that uses artificial intelligence tools to help surgeons plan, perform, and analyze spinal and cranial procedures. It provides a one-stop shop for spine.
“The Medtronic ecosystem, AiBLE, vs some other ecosystem, and there's not many out there, right,” Martha said touting the platform as a difference maker in spine, according to a Seeking Alpha transcript. “So that's why we keep emphasizing our installed base. It's also changing the industry structure because this takes a lot of expertise and capital to build these ecosystems. So, you don't have this long tail of tiny spine companies that are preying on docs. Those are going away. And so that's why we think this is durable. And we're - this - yes, we're investing heavily in this area and have been for years.”
A Shifting Market
Globus Medical and NuVasive took part in one of the largest spine mergers in recent history a little more than a year ago.
In 2021, Zimmer Biomet announced it was spinning out its spine business (and dental unit). That company became ZimVie. However, ZimVie struggled to find its footing post-spin in the spinal market.
Earlier this year , the company exited spine and sold the business to H.I.G. Capital for $375 million. The spine business is now being called Highridge Medical.
领英推荐
Hologic BioZorb Marker Recall Identified as Class I
By Katie Hobbins , Managing Editor
Hologic’s recall of its BioZorb Markers due to complications with the implanted device were recently identified as Class I by FDA after 71 injuries were reported as being related to BioZorb Markers. The recall is considered a correction, not a product removal.
The BioZorb marker, which was previously made by Focal Therapeutics, is an implantable radiographic marker used to mark soft tissue, like breast tissue, for future medical procedures like radiation. The device includes two components: a permanent component made of titanium and a resorbable component made of a plastic material. Meant for one-time use, BioZorb is provided sterile for implantation.
Hologic announced the recall after reports of complications and adverse events (AEs) connected to the implanted devices. Such complaints included pain, infection, rash, device migration, device erosion, seroma, discomfort, feeling the device in the breast, and the need for additional medical treatment to remove the device. Currently, there have been no reports of death associated with the recall.
On March 13, Hologic sent all affected customers an Important Medical Device Safety Notification requesting that patients contact a healthcare provider if they experience any adverse events following the placement of a BioZorb marker and discuss the risks and benefits of implanting the device. The letter also requested that healthcare providers be aware of any reported serious AEs following BioZorb Marker implantation, to continue monitoring patients who have the implants, and report any issues associated with the device.
This is just the latest chapter in an ongoing saga of issues concerning the Hologic BioZorb markers in 2024. In February, FDA announced through a safety communication that it was advising patients and healthcare providers to be aware of potential risks of serious complications when using the BioZorb Marker and BioZorb LP Marker devices. In the communication, the agency highlighted reports and published literature describing SAEs in patients who were implanted with the device in breast tissue.
At the time of the notice, FDA wrote that it had received reports of SAEs in patients undergoing breast conservation procedures like lumpectomy. These complications, in part, could be related to the BioZorb Makers extended resorption time of several years, according to FDA. Additionally, it was reported that similar AEs were seen in literature, including the device breaking through the skin of the nipple and moving out of position from where it was initially implanted. Consequences of such migration could lead to potential breakthrough of the chest cavity or blood vessels, which could be life-threatening and impact future targeting of radiation to the intended site.
"Hologic and the FDA issued a safety notification in February to help ensure patients and healthcare providers had the most up-to-date information regarding BioZorb," a Hologic spokesperson told MD+DI. "The recent administrative classification of the Safety Notification posted on the FDA’s website was an expected step in the regulatory process. BioZorb continues to be offered and used safely and successfully with patients undergoing radiation treatment following breast conserving surgery. Patient safety is, and has always been, our top priority."
The Importance of USP Class VI Testing
By Patrick Dick , Technical Sales
The United States Pharmacopeia (USP) group is a non-government, non-profit organization that sets the standards for the production of drugs (for both humans and animals), food ingredients, and dietary supplements. The USP organization typically is concerned with and sets the standards for purity, quality, strength, and consistency in biotechnology and pharmaceutical endeavors.
The standards set by the USP group are published in the USP-NF, a combined effort by the two compendia. The National Formulary (NF) is a list of formulas for preparations of commonly used pharmaceutical drugs within the United States. The USP-NF contains the standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. These standards are enforceable by the United States Foods and Drug Administration (USFDA).
The USP has six different classes of standards for plastics to test the biological reactivity of various types of plastic materials in vivo, or inside the body. These classes are used to certify materials with Class I being the simplest certification, and Class VI being the most rigorous and frequently requested certification.
The 3 biocompatibility tests
The tests required to pass a USP Class should help to determine how biocompatible the material will be. The aforementioned tests include a systemic injection test, an intracutaneous test, and the implantation test. The systemic injection and intracutaneous test will be able to determine the systemic and biological responses by the single injection of the sample material, while the implantation test will be able to determine the response of living tissue to the sample material.
The first test, the systemic injection test, is used to study any acute toxicity of the sample material. To determine acute toxicity, extracts from an alcohol saline solution, polyethylene glycol solution, 0.9% sodium chloride solution, and sesame oil are used as the control injection. The variable injection uses the same extraction solutions that are exposed to the sample material. All extraction solutions are injected into mice and then studied for behavioral changes and weight changes over the course of three days.
The second test, the intracutaneous test, uses the same extraction solutions as Test 1 but instead is looking for visual impacts to the injection site. All the extractions are injected into the skin of a rabbit along its spinal column and monitored for 72 hours looking for signs of erythema (reddening of the skin) and edema (swelling). To pass this portion of the test, the injection sites are graded on a scale of 0 (no sign of reddening or swelling) to 4 (severe reddening or swelling) and must achieve a score of 1 or lower on both tests.
The final test is a muscle implantation test to determine any reaction of living tissue to a test material. Control samples of high-density polyethylene rods as well as rods of the sample material are surgically implanted into a rabbit’s muscle tissue and then monitored for seven days. After the week, the rabbit is euthanized and the implantation sites are investigated looking for signs of tissue damage such as hemorrhages, necrosis, discoloration, and/or infection. If the implantation site shows no sign of damage, the sample material is considered to have passed this test.
Class VI testing extends beyond plastics
This rigorous form of biological compatibility testing helps to keep in-vivo parts and other biotechnology safe for human and animal use. While this test was originally designed for plastics, any material can be subject to USP Class VI certification.
For example, SilcoTek works with many pharmaceutical, medical device manufacturing, and medical packaging companies. The company takes customers' metal parts and, using a high-temperature chemical vapor deposition (CVD) process, deposits an ultra-thin, amorphous silicon-based surface coating. Those who employ this service typically require a bioinert, low surface energy coating called Dursan that helps to impede protein adhesions and assist in corrosion protection. While those surface improvements are helpful in these industries, the coating technology would be useless without a USP Class VI certification.
SilcoTek was able to send their Dursan-coated samples to the US Pharmacopeia group’s appointed lab and have all three of the required tests performed using the sample materials, easily passing each of them. The Dursan coating process makes stainless steel surfaces inert to numerous chemicals as well as creates a non-stick surface for the release of proteins, plastics, and many other materials.
Manufacturers interested in learning more about USP Class VI testing can visit www.usp.org or reach out to the author of this article. For manufacturers interested in learning more about SilcoTek’s CVD coating technology: Please visit www.SilcoTek.com or contact the author directly at [email protected] .
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