Vascular surgeon Dr. Russell Samson in a NYT expose on the rise of unnecessary atherectomies.

Cardiology Pharmaceuticals

Lilly Diversifies Weight Loss Pipeline with Versanis Acquisition

Eli Lilly bolstered its already strong position in the white hot obesity drug segment, acquiring cardiometabolic disease biopharma startup Versanis for up to $1.92 billion.

Versanis was founded in 2021 with the specific goal of developing bimagrumab, a monoclonal antibody to activin type II receptors that directly targets fat mass by blocking activin and myostatin signaling. 

• Versanis has only raised a $70M Series A, so this “up to” $1.92B acquisition highlights the value that pharma companies are placing on weight loss leadership.

Bimagrumab is already being assessed with overweight adults in a Phase 2b trial, both as a monotherapy and when used in combination with semaglutide (Novo Nordisk’s GLP-1 Ozempic/Wegovy).

• Lilly seems particularly interested in combining bimagrumab with “incretins” (a drug class that includes Lilly’s tirzepatide… or Nordisk’s semaglutide), suggesting that this combo could further reduce fat while preserving muscle mass, leading to better overall patient outcomes.

The acquisition is also another signal that Lilly is taking a diversified approach to the high-stakes weight loss treatment segment.

• Lilly’s current GLP-1/GIP drug tirzepatide (aka Mounjaro) excelled in a recent weight loss trial, paving the way for its FDA submission for obesity (it’s already approved for T2D)
• Lilly’s investigative GCG/GLP-1/GIP drug retatrutide achieved the greatest weight loss results we’ve seen so far (24.2% at 48 weeks), plus a range of cardiometabolic improvements in a recent Phase 2 trial 
• Lilly’s pill-based investigative GLP-1 orforglipron showed similar promise last month, reducing body fat by 9.4% to 14.7% over 36 weeks

This acquisition adds a completely new weight loss mechanism to Lilly’s portfolio, although Lilly seems more focused on “the potential of bimagrumab in combination with its incretin therapies.”

The Takeaway

Lilly’s investments in weight loss (both M&A and R&D) seem justified by the massive demand we’re seeing for current GLP-1s, and the recent estimates that this segment might be worth $100B by 2030. And although bimagrumab is unproven, this high-premium acquisition would be more than justified if bimagrumab’s activin blocking capabilities combined with incretins’ glucose-lowering properties prove to be a magic combination for weight loss.

Automating Echo Amyloidosis Assessments

The University College London National Amyloidosis Centre is the world’s largest cardiac amyloidosis care provider, making their echo assessments both crucial and high-labor. See how UCL researchers used Us2.ai’s AI echo software to accurately analyze echos from 1,200 patients with ATTR Amyloidosis in 24 hours, without requiring human interaction.

Cleerly Brings the Confidence to Compete

Pro triathlete Timothy O’Donnell recently spoke on the Rich Roll Podcast about surviving a heart attack mid-race and how getting a Cleerly analysis gave him confidence to compete again. Once he confirmed his heart was ready, he returned to racing and went on to win an Ironman at the age of 42.

The Wire

• CMS’ CAS Expansion Proposal: CMS proposed expanding Medicare coverage for carotid-artery stenting (CAS) beyond patients with high surgical risks. The proposal now positions CAS as “reasonable and necessary” for patients with symptomatic carotid artery stenosis ≥ 50% or asymptomatic carotid artery stenosis ≥70%, while requiring pre-procedure assessments (neurological risk, imaging-based stenosis severity/extent) and shared decision making before performing CAS. Although some cardiologists celebrated this expansion as a “big day for carotid stenting,” others warned that it could lead to more strokes.

• Whole-Fat Dairy May Prevent CV Events: A balanced, healthy diet that includes whole-fat dairy may help prevent cardiovascular events. Analysis of almost 150k people in 21 countries, those who had a healthy diet — including whole-fat dairy — had a 14% lower risk for heart attacks and a 19% lower risk for stroke. The authors found that two daily servings of whole-fat dairy may protect against high blood pressure and metabolic syndrome.

• Infinitt Adds Us2.ai: Enterprise imaging vendor Infinitt North America announced a partnership with Us2.ai, and will add the echocardiography AI leader’s solutions to its Cardiology Suite. The alliance represents perhaps Infinitt’s first major cardiology AI partnership (it has AI partnerships in other imaging domains), while continuing Us2.ai’s rapid AI marketplace and PACS platform expansion.

• New Gene Implicated in nsBAV: Researchers identified a new gene, MIB1, that may contribute to people developing nonsyndromic bicuspid aortic valve (nsBAV), the most common congenital heart valve defect. The study involving 938 BAV patients found that the MIB1 gene, an E3-ubiquitin ligase essential for NOTCH-signal activation during heart development, was more common in nsBAV patients than controls (2% vs. 0.9%). These findings were further supported by mouse models.

• Proposed MPFS Cuts Earn Calls for Reform: CMS proposed new lower rates for the 2024 Medicare Physician Fee Schedule (MPFS), prompting calls to reform how Medicare rates are set. The proposed rule calls for a 3.36% downward adjustment in payment rates, continuing a trend that has seen a 26% decline since 2001. Physician groups and legislators say Medicare’s rate-setting system is “broken” due to requirements like budget neutrality, and are urging Congress to step in.

• The End of Appropriate Use Criteria? In what might be seen as a more positive MPFS development, CMS is proposing a “pause” to efforts to require referring physicians to use appropriate use criteria (AUC) for ordering a range of exams and procedures. AUC was supposed to go into effect in 2021 as part of an effort to reduce unnecessary care, but CMS has postponed the deadline several times.

• Entresto Reduces HF Anemia Risks:  New analysis of PARADIGM-HF study outcomes found that the neprilysin-inhibiting effects of Novartis’ Entresto (sacubitril/valsartan) may lower the risk of anemia and improve overall outcomes in heart failure patients. Of 8,239 participants (1,677 anemic), HFrEF patients were 30% less likely to develop anemia when taking the ARNI Entresto compared to the ACE inhibitor enalapril, while also reducing the risk of cardiovascular death or heart failure hospitalization in patients with and without anemia (-16% & -12%).

• Private-Practice Medicine Plummets: The share of physicians in private practice continues to plummet, falling 13 percentage points in the last decade and nearly 30 points over the past three decades. That’s according to a new AMA report that found the share of doctors in private practice dropped from 2012 to 2022 (60.1% to 46.7%), noting that private-practice rates were close to 76% in the 1980s.

• The Cost of Private Equity: In (perhaps) related news, a new report highlighted the rapid growth of physician practice acquisitions by private equity, from 75 deals in 2012 to 484 deals in 2021. That growth apparently comes at the expense of healthcare costs, which rise when a single PE firm has more than 30% market share in a metropolitan area. Cardiology care costs grew 8.7% in areas with >30% PE-ownership, which was still far smaller than price increases seen in gastroenterology (18.2%), OB/GYN (16.3%), and dermatology (13.3%).

• Coronary Calcium’s Gut Microbe Link: In a new study in Circulation, researchers from Sweden found a link between coronary artery calcification (CAC) on CT scans and gut bacteria. As part of the SCAPIS study, researchers scanned almost 9k people aged 50-65 without known heart disease. CAC was found in 40.3% of participants, who had 64 species of CAC-associated gut bacteria, including some bacteria that was also associated with inflammation markers in the blood. 

• Rock Health H1 2023 Funding Recap: Rock Health’s H1 2023 digital health funding report confirmed that we’re in a new market cycle, and it’s time to buckle up for fewer rounds and smaller checks. First half US digital health funding totaled $6.1B across 244 rounds, revealing a downward trend in Q2 ($2.5B across from 113 rounds), and a continued emphasis on mega rounds (12 >$100M rounds in H1). Cardiology digital health startups have typically been well represented in Rock Health’s reports, although none were mentioned this time around. For a deeper dive, here’s Digital Health Wire’s coverage.

Optimizing Your Post-Processing Workflow

The growth of cardiac CT and CMRI volumes and continued shortages in the imaging technologist workforce can mean big challenges for imaging organizations. Join this Cardiac Wire Show starring Precision Image Analysis’ Jim Canfield and Cleveland Clinic’s Scott D. Flamm, MD, MBA to see how outsourcing cardiac image post-processing can solve this problem, while improving efficiency, accuracy, and standardization.

Register Now: Current TAVR Trends for Bicuspid Anatomy on July 17.

Join our expert faculty for a live, case-based discussion on July 17 at 7:30 p.m. ET. Over the course of 90 minutes, we will discuss strategies for bicuspid cases and contemporary sizing methods. Register now!

The Resource Wire

• There’s plenty of short term benefits to cardiology data analytics, but it’s just as important for providers to make sure they’re ready for the future of cardiology analytics. This Change Healthcare article with Dr. Jennifer Hall, chief of data science at the American Heart Association, examines what technology leaders can do today to facilitate their future advancements in cardiovascular data and analytics. 

• HeartFlow’s new RoadMap Analysis solution allows CT readers to accurately, efficiently, and consistently identify stenoses in the coronary arteries. See how RoadMap Analysis’ visual and quantitative insights into the narrowing of all major coronary arteries helps readers evaluate coronary CT angiograms before determining the need for an FFRCT.

• Noise and artifacts can make automated ECG analysis less reliable than what’s required for the exacting standards of cardiac safety trials. Monebo’s Kinetic Intervals ECG Algorithm provides precise interval measurements between any two points on the ECG waveform, allowing clinicians to utilize data they can trust.