Glucagon-like peptide-1(Bristol Myers Squibb Co. /Saint Nazaire Assets/)

Medtronic Chief Scientific, Medical and Regulatory Officer Dr. Laura Mauri drills into GLP-1 drug trial results to estimate their impact across the portfolio. The impact of glucagon-like peptide-1 (GLP-1) drugs like Ozempic and Wegovy on medtech manufacturing is one of the biggest uncertainties heading into 2024. Industry leaders like Medtronic, Stryker and Intuitive have faced questions from investors about whether these weight loss drugs will reduce demand for certain medical devices and procedures. Despite a portfolio spanning some of the fields that would seem likely to be affected — such as cardiovascular, diabetes, surgical and neurovascular — Medtronic Chair and CEO Geoff Martha recently said the drugs won’t impact his company’s growth in the medium or long term, aside from a temporary, modest impact to baratric procedures. That assertion is based on “extensive, science-based work,” Martha said on the company’s second-quarter earnings call. “The areas that we get questions on — type 2 intensive, hypertension, AFib, obesity — besides the fact these are just woefully underpenetrated from a medtech perspective, we’ve done all the analysis,” he said. To offer more detail, Martha asked Medtronic SVP and Chief Scientific, Medical and Regulatory Officer Dr. Laura Mauri to explain how the world’s largest device manufacturer estimated its exposure to GLP-1 drugs — a process that other device developers could apply to their own portfolios. How Medtronic updated its cardiovascular models to account for GLP-1 drugs Mauri and her team used data from the SELECT trial for Novo Nordisk’s semaglutide GLP-1 drug in obese patients with a history of cardiovascular disease. (SELECT is a forced acronym for “Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity.”) Novo Nordisk released headline results from that trial in August 2023, showing a reduction in major adverse cardiovascular events. In November, the drugmaker offered more detailed data at the American Heart Association (AHA) Scientific Sessions 2023 and published them in the New England Journal of Medicine. “The SELECT trial results that were presented at AHA gave us a lot more detail beyond the top line that we heard about back in August, to really look at the endpoints, look at the drug adherence and understand the details of the trial results,” Mauri said. Those more detailed results supported Medtronic’s hypothesis that the drugs will have a negligible effect on cardiovascular procedure volumes, she said. “First, the number needed to treat was much higher. And that means it’s setting a higher bar for treatment compared with other things that are used in guidelines,” Mauri said. “And then we saw that there was a lack of effect on cardiovascular death, and that’s something that if it had been present would have spurred more adoption. And the lack of that is important, because it will not spur the wide adoption and coverage that we might have been looking at if that had been positive.” The only effect on the composite endpoint was non-fatal myocardial infarction, not stroke or cardiovascular death, she said. And nearly a third of patients stopped using the drugs due to nausea and gastrointestinal side effects. “Clearly we know from practice that rates of adherence are even lower, and that results in lower treatment effects,” Mauri said. She also called out a couple of interesting findings from the trial: “The higher BMI population didn’t seem to have as much benefit, and there was no significant treatment effect in the North American subgroup, which is certainly something that we’ll want to understand better going forward.” Medtronic already models cardiovascular procedure volumes across the U.S., so Mauri’s team used the prevalence of obesity for each of those procedure populations. They then applied “a range of penetration and adherence assumptions [for GLP-1 drugs] all the way up to including what we’ve seen over time with statins, which are really well tolerated and freely available and part of guidelines for the past 30 years.” “And then we also input, obviously, the risk reductions seen in each of the endpoints from the SELECT trial or literature based on weight loss to look at treatment effects,” Mauri continued. “And the bottom line is that the reduction to [total addressable market] growth over the next 10 to 30 years is really negligible on the cardiovascular procedure outlook.” GLP-1 drugs and Medtronic’s diabetes business Medtronic EVP and Diabetes Operating Unit President Que Dallara offered some details on how her business has studied the potential impact of GLP-1 drugs on products like the MiniMed 780G automated insulin delivery (AID) system. “There’s some evidence from SELECT that would say there may be a slowdown in the pre-diabetic population towards insulin dependency, and maybe some in type 2 come off insulin, but we believe this number to be very small and more than offset by the fact that there is low penetration of type 2 using AID,” Dallara said. “When you look at the funnel of 3 to 4 million who require basal insulin, 25 million noninsulin type 2s, as well as the over 100 million prediabetic population, it doesn’t change our point of view on the long-term size of the market as well as the growth rates,” she continued. What Medtronic’s analysis doesn’t include Mauri said the company’s projections don’t include potential offsets of rapid growth in underpenetrated markets or new markets such as renal denervation or pulsed-field ablation. The analysis also doesn’t include the potential benefits of GLP-1 drugs for medical device developers. Stryker officials, for example, have said the drugs may allow obese patients to lose weight ahead of joint replacement surgeries that they otherwise wouldn’t qualify for due to the potential for complications. From the perspective of Medtronic’s cardiovascular business, “there’s potential upside for patients and procedure growth because of the potentially longer survival or lower BMI that makes a greater funnel of patients eligible for cardiovascular procedures,” Mauri said.

There's been a lot of noise in recent weeks around GLP-1 drugs and their ripple effect on medtech , but Abbott CEO Robert Ford said the concerns are overblown. In fact, Ford maintained an optimistic tone Tuesday morning when he discussed the potential relationship between GLP-1 drugs and medtech. Initially approved to treat diabetes, glucagon-like peptide-1 (GLP-1) drugs are also showing a lot of promise for weight loss. There are already two GLP-1 drugs approved for weight loss: Liraglutide (Saxenda) and semaglutide (Wegovy). ttsz / iStock via Getty Images GLP-1 drugs can make the stomach empty slower so patients feel satisfied with smaller amounts of food, and they can tell the brain there is food in the stomach to suppress appetite and cravings. The drugs are designed to mimic a protein that the body makes naturally when we eat. When used for weight management, these medications pump the breaks on appetites and the rate at which food exits the stomach. As a result, people on these medications eat less because they are thinking less about food and are satisfied with smaller portions. Ford cited a recent analysis of Abbott's U.S. user base that showed a growing number of the company's continuous glucose monitoring (CGM) sensors are using GLP-1 medications in combination with Libre CGM sensors as part of a combination therapy approach for managing their diabetes. On average, those customers using both Libre and GLP-1 drugs exhibited a higher rate of use for both products as they are wearing Libre sensors more often and taking GLP-1 drugs more frequently compared to other Libre customers in the United States. "This increase in use or better compliance is a positive sign that these users are taking an even more active role in managing their diabetes," Ford said during the company's third-quarter earnings call. "While we traditionally think of therapy choices as having to compete against one another, this is a good example of a complementary relationship between two products that both help optimize the treatment of diabetes." The CEO acknowledged that there is plenty of investor angst over the potential medtech impact from GLP-1 drugs, but he said this angst is probably driven more by people with a bit less "domain knowledge" in medtech and that they seem swayed by headlines touting recently published studies on the new class of medications. This hype is generating fear about the potential reduction in certain medtech market sizes long term, and that fear is impacting valuations in medtech, Ford said. "I understand that new technologies will naturally cause us to think differently about the future, and I think early on those initial thoughts about the future are generally impacted more by emotion than facts and data, and I think that's what you're seeing right now today as it relates to GLP-1 and medtech markets," he said. Ford encouraged analysts to think about the bigger picture in terms of how many people are expected to be on a GLP-1 drug in the next five years, which he estimated to be about 10 million to 15 million people. "That's a real small fraction of the size of these medical device markets that we're talking about," he said. Ford estimates there's about half a billion people with diabetes, another half a billion people with cardiovascular disease, and there's also some overlap of people with diabetes and cardiovascular disease. He also pointed out that it's not uncommon for patients to be prescribed medication either before or after a medical procedure, and it's not uncommon for physicians to use multiple tools in combination to help patients manage their diabetes. Over time, data from tools like Libre sensors may even be used to help evaluate the effectiveness of GLP-1 drugs. "With the portfolio with a diverse portfolio that Abbott has where we look at healthcare across the full spectrum from nutrition to diagnostics to treatment, I think that this then provides the company with an opportunity to further explore where we can bring value to patients that are using these drugs," Ford said. Another point he made regarding GLP-1 drugs is side effects. As with most drugs, there are side effects of taking these medications, including a loss of muscle mass over time. That's an area Abbott has experience in with the nutrition side of its business. "So, we've got an opportunity here to be able to develop whether it's a nutritional product or other products that can help address one of the side effects, which is muscle mass loss," Ford said. "...Bottom line, I think it's fantastic science, it's fantastic biology, this is great for public health in the short term, and I think the concerns are overblown." Longer term, say about 15 years to 20 years out, Ford said he sees a lot of unanswered questions still regarding GLP-1 drugs and their impact in medtech.