Malachi Sheahan III on CMS’s decision to expand carotid stenting coverage, and loosen CAS requirements.

Pharmaceuticals

Novo Nordisk Expands CV Pipeline with Ocedurenone Acquisition

What do you do when a blockbuster drug drives up your revenue and market cap to unprecedented levels? If you’re Novo Nordisk, you take that capital and expand your cardiovascular drug pipeline by acquiring ocedurenone from KBP Biosciences for $1.3 billion.

• Ocedurenone is a late-stage oral non-steroidal mineralocorticoid receptor antagonist (nsMRA) that has “best-in-class” potential for uncontrolled hypertension
• It’s also viewed optimistically for treating other cardiovascular and kidney diseases

Ocedurenone has nine trials to support this optimism, including…

• The BLOCK-CKD Phase 2b trial, in which ocedurenone significantly improved systolic blood pressure among patients with stage 3b/4 CKD and uncontrolled hypertension, without reports of hyperkalemia or acute kidney injury
• The ongoing CLARION-CKD phase 3 trial, which evaluates the same patient groups and outcomes across a larger multi-site study population

Novo Nordisk expects to launch additional phase 3 trials in the coming years evaluating ocedurenone’s impact on cardiovascular and kidney diseases, as it seeks to “maximize” the drug’s “full potential.”

• That combination of indications would position ocedurenone as a rival to Bayer’s nsMRA, Kerendia, which currently has FDA approval for kidney disease, but has shown benefits for hypertension and CVD.

The acquisition also closely aligns with Novo Nordisk’s strategic focus on leveraging its semaglutide windfall to expand to new serious chronic disease treatments (beyond its core focus on diabetes).

• Novo Nordisk’s other recent acquisitions looked to bolster its leadership in the weight loss segment, including Danish startup Embark Biotech and Canadian biotech Inversago Pharma in August.

The Takeaway

Semaglutide has been very good to Novo Nordisk, driving a nearly 90% market cap increase in the last year, and setting the stage for 32% to 38% in 2023 revenue growth. Novo Nordisk’s semaglutide party won’t last forever, but this acquisition strategy suggests that it will have a full chronic disease drug pipeline when that day comes.

Relying on Echo AI for Heart Failure Management

The ESC has updated its heart failure guidelines, for the first time including a guideline-directed medical therapy for heart failure with preserved ejection fraction (HFpEF). See how cardiologists are trusting echo AI to find these cases earlier in this video from Us2.ai.

Overcoming Cardiovascular Data Challenges

Aggregating multisource cardiology data is a worthy mission, but it’s often thwarted by confusion and complexity. This Change Healthcare article with Dr. Jennifer Hall, chief of data science at the American Heart Association, outlines best practices to help you overcome your cardiology data challenges and start leveraging deeper insights.

The Wire

• Ablation for HF with Afib: A single center, open label study gives some hope that catheter ablation could improve outcomes and possibly defer heart transplantation in patients with end-stage heart failure and symptomatic Afib. In the randomized study of 194 patients referred for heart transplant, the catheter ablation with guideline-directed therapy group fared better than guideline-directed therapy alone based on a primary composite endpoint including death, left ventricular assist device implantation, or urgent heart transplantation (8% vs. 30% had an event).

• GE Allia IGS Cleared: GE HealthCare announced the FDA clearance of its Allia IGS Pulse interventional angiography system. The cardiology-targeted system sports a new imaging chain featuring what GE calls a monopolar X-ray tube that is quieter and has a smaller footprint, allowing it to reach steep angulation for better views of coronary anatomy. The Allia IGS Pulse also includes GE’s MyIQ technology that enables clinicians to select from four styles with one click. 

• Radial Access Best for CHiP: A new study from Great Britain supports the increasingly common transradial access (TRA) approach in complex, high-risk percutaneous intervention procedures (CHiP). Researchers analyzed records for 137,785 procedures in high-risk patients, such as those who are older and/or have chronic kidney failure. Compared to TRA/CHiP, transfemoral access CHiP was linked to higher risks for dying, major bleeding, and MACCE (adjust odds ratio: 1.3, 2.9, 1.2).

• CMS Expands CAS Coverage: CMS officially expanded coverage for carotid-artery stenting (CAS) beyond patients with high surgical risks, now positioning it as “reasonable and necessary” for patients with symptomatic carotid artery stenosis ≥ 50% or asymptomatic carotid artery stenosis ≥70%. The expansion requires use of an FDA-approved/cleared embolic protection device, as well as pre-procedure assessments and shared decision making. Like when the CAS expansion was first proposed, some parties celebrated this expansion and others warned that it could lead to more strokes.

• Million Hearts Model Reduces Events: When CMS reimbursed providers for proactive CV risk assessments and providing care to address those risks, it modestly reduced CV events without increasing healthcare costs. CMS’s Million Hearts Model program paid healthcare organizations to evaluate and treat fee-for-service beneficiaries aged 40 to 79 years. Within five years, participating patients with medium or high CVD risks had a lower probability of experiencing a first-time CVD event (-0.3 pct points) or either a CVD event or CVD death (-0.4 pct points), with similar Medicare costs as non-participants.

• Ventricle Health’s Seed Round: Value-based home care startup Ventricle Health landed $8M in seed funding to expand its heart failure management model across the US. Ventricle aims to give patients access to home and virtual cardiology appointments within as little as three days, while reducing patients’ annual heart failure medical costs by “at least 30-50%” through guideline-directed therapy management and reducing readmissions. The company is already supporting ACOs, primary care practices, and their payer partners in the Mid-Atlantic, Texas, Ohio, and Florida.

• The Case For Dihydropyridine Safety: An American Physiological Society journal study supports the safety of dihydropyridines (Ca2+channel blockers), which are widely used for hypertension. Some have questioned their use, thinking that they activate store-operated Ca2+ entry in fura-2-loaded nonexcitable cells, triggering vascular remodeling and worsening heart failure. But the researchers found that concentrations of Ca2+ channel blockers in patients do not activate store-operated Ca2+ entry and say the class should still be recommended.

• Evident Vascular Exits Stealth: Intravascular ultrasound startup Evident Vascular exited stealth mode, landing $35M in Series A funding and detailing plans to develop an AI-enabled IVUS platform. As its name suggests, the Evident Vascular platform will focus on peripheral vascular interventions, which is notable given that most IVUS platforms prioritize coronary procedures. Evident plans to leverage its peripheral vascular-optimized design to drive growth with PVI procedures, an area where IVUS has long been underutilized.

• Tight Glucose Control Safe in ICU: In a randomized multicenter NEJM study of 9,230 ICU patients with no early parenteral nutrition, outcomes were similar for those with glucose targets that were liberal (>215 mg per deciliter) and tight (80 to 110 mg per deciliter). Patients with liberal and tight glucose targets also had similar 90-day mortality rates (10.1% vs. 10.5%), while both had low rates of severe hypoglycemia (0.7% and 1%). Other key markers like time to hospital discharge and need for respiratory support were also similar.

• InfoBionic Series D: Just days after the FDA clearance of its MoMe ARC virtual cardiac telemetry solution, InfoBionic secured a Series D funding round (value unspecified) to drive its domestic growth and international expansion. InfoBionic’s new MoMe ARC remote cardiac monitoring solution combines its third generation ECG monitoring tech and a new Bluetooth diagnostic 6-lead sensor, to support a wider range of patient and clinical use cases.

• Distressed Hospital M&A: Kaufman Hall’s Q3 Healthcare M&A Report found that acquisition activity is regaining momentum as health systems continue consolidating in pursuit of long-term sustainability. The quarter’s 18 M&A moves easily eclipsed Q3 2022 (10) and Q3 2021 (7), although the challenges of the last two years were apparent in one of the report’s metrics: over one-third of the M&A transactions was driven by financial distress, well above historical benchmarks.

Making the Leap to Outsource Post-Processing

Interested in how to outsource cardiac image post-processing, but not sure where to start? PIA walks you through how to assess and compare vendors, understand pricing models and payment options, and outline your requirements to identify vendors who meet your clinical needs. 

Cleery’s Best AI Award

Cleery came out on top at HLTH 2023’s Digital Health Awards, where it was named winner of the Best Use of AI in Health Tech category. That’s quite an accomplishment given that there were over 450 competing AI companies, and a testament to how it’s using AI to “revolutionize the identification and prevention of heart disease.”

The Resource Wire

• 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.

• Do you know how many patients with high CVD risks are in your chest CT archive? See how the Stanford Health Care System used Bunkerhill Health’s Incidental CAC algorithm to screen its previous non-gated chest CTs, identify patients with coronary calcium, and get them on statins.

• Atrial fibrillation is often difficult to characterize with an automated algorithm due to the changing waveform morphology, system, or muscle noise. This is especially true given the size constraints of ambulatory devices to detect AFib. See how Monebo’s Kinetic AF ECG Algorithm overcomes these size limitations without sacrificing accuracy.

• Gain in-depth knowledge of fluoroscopic anatomy and cutting-edge imaging techniques with renowned expert, Dr. Nicolo Piazza. This five-session master class is happening now through November. Register now!