Jing Liang on VERVE-102’s Phase 1b results.

We’ve already seen Cardiac CT volumes increase and reimbursements are on the rise as well, which means it’s time to prepare for how to handle CCTA demand. Watch this Cardiac Wire Show interview with NYU Langone Health’s Dr. Dan Karlsberg, Banner Health’s Kimberly Hatch, and Baptist Health’s Dr. Juan Batlle on how to make the most of CCTA’s volume surge. Are you ready?

Cardiology Pharmaceuticals

Verve Vaults Forward From Topline Results

Completing its pharma comeback story, Verve Therapeutics announced successful results from the Heart-2 Phase 1b Clinical Trial of its in-vivo base editing drug, VERVE-102, that targets the PCSK9 gene for reducing LDL-C.

• PCSK9 is a molecule that breaks down LDL receptors, so drugs that inhibit it force the body’s LDL receptors to work harder, which reduces LDL-C more efficiently.
• Currently there are two FDA approved PCSK9 inhibitors, Amgen’s Repatha (evolocumab) and Regeneron’s Praluent (alirocumab), both of which are injected every three months.
• VERVE-102 is different since it edits and inactivates the gene responsible for PCSK9 production, meaning a single injection could permanently lower a patient’s LDL-C levels.

VERVE-102’s topline results come from a small group of 14 patients across three different dose cohorts (weight-based cohorts of 0.3, 0.45, and 0.6mg/kg) with at least 28 days of follow-up for each participant.

• After 28 days, researchers found that a single infusion of VERVE-102 led to an average LDL-C reduction of 53% with a maximum reduction of 69% in the 0.6mg/kg dose cohort.
• The 0.3mg/kg cohort saw a 21% LDL-C reduction and a 46% PCSK9 reduction, while the 0.45mg/kg cohort saw a 41% LDL-C and 53% PCSK9 reduction.

Not only was VERVE-102’s gene editing effective, it was also safe, with no treatment-related serious adverse events and no clinically significant changes in ALT or platelets observed at any dose level.

• This stems from VERVE-102’s proprietary GalNAc-LNP delivery technology, which allows the drug to access liver cells and demonstrates a potentially best-in-class safety profile.

These successful results mark a comeback for Verve considering the adverse events that led to the discontinuation of its earlier LDL-C drug, VERVE-101.

• Now with the topline success of VERVE-102, Verve will move on to Phase 2 of Heart-2 with a fourth dose cohort of 0.7mg/kg while it awaits Eli Lilly’s PCSK9 opt-in decision.
• Under a PCSK9 collaboration agreement with Verve, Lilly can opt-in to share worldwide development expenses (33% from Lilly) and profits in the U.S. on a 50/50 basis.

The Takeaway

Although we’re still very early in the gene editing space, and even earlier in single-shot CVD treatments, a single-dose injectable for LDL-C could have a lot of appeal if the price is right, gene editing catches on, and if future trials yield similarly supportive results

An All-in-One Coronary Care Solution

See how HeartFlow ONE is transforming precision heart care as the first all-in-one CCTA pathway, combining FFRCT, stenosis, and plaque analysis in a single workflow.

The Path To Modern Enterprise Imaging is in the Cloud

Healthcare needs are changing rapidly, and some imaging systems cannot adapt to an evolving technology landscape. Explore the factors forcing imaging and IT teams to look to the cloud, and what might be holding them back in this Optum infographic.

The Wire

• AHA’s New HF Statement: The AHA published a new scientific statement for preventing heart failure that reviews the current HF risk prediction evidence and defines HF prevention strategies. The statement also highlights using cardiac biomarkers (e.g., natriuretic peptides) and echocardiography for risk reclassification and earlier detection of pre-heart failure while providing examples of evidence-based lifestyle interventions for people with HF risk factors.

• LUMA’s FDA Clearance: LUMA Vision received FDA clearance for its VERAFEYE Visualization Platform that uses catheter-based imaging to provide real-time visuals of cardiac anatomy. The VERAFEYE platform enables two and four-dimensional, 360-degree visualization with imaging depths up to 120mm away from the catheter to improve clinician precision during electrophysiology and structural heart procedures. The system also comes with magnetic tracking and can be used for guiding navigation of third-party catheters.

• Elixir Medical Debuts IVL in EU: Adding yet another player to the intravascular lithotripsy (IVL) market, Elixir Medical received the CE mark for its LithiX Hertz Contact system. The LithiX device uses metal hemispheres across the surface of a semi-compliant balloon to create localized points of contact with vascular calcium and then create fractures using physical force. This method is different from other IVL systems that use sound waves to break up calcium and helps minimize vessel tissue injuries.

• Cellino + Karis Bio: Cellino partnered with Karis Bio to industrialize the first clinical-stage autologous induced pluripotent stem cell (iPSC)-derived therapy for PAD and CAD. The iPSC therapy works by generating new blood vessels in ischemic organs with the patient’s cells to restore blood flow and repair damaged tissues. The collaboration aims to accelerate the development of Karis’ iPSC-EC therapy by using Cellino’s Nebula biomanufacturing system to scale production of autologous iPSCs.

• Pfizer Abandons GLP-1 Candidate: Pfizer is throwing in the towel on its oral GLP-1 danuglipron which was being investigated for chronic weight management. Although Pfizer’s dose-optimization studies for danuglipron met their pharmacokinetic objectives and the overall frequency of liver enzyme elevations was in-line with other GLP-1 drugs, a single asymptomatic study participant experienced drug-induced liver injury. After reviewing all clinical data generated for danuglipron and recent input from regulators, Pfizer decided to discontinue development.

• MetaVia’s GLP-1 Entry: In other GLP-1 news, MetaVia released positive topline results from its Phase 1 clinical trial for DA-1726. MetaVia’s DA-1726 is a dual oxyntomodulin analog agonist that works like a GLP-1 for treating obesity, and a 32mg dose led to a mean body weight reduction of -4.3% after four weeks. DA-1726 also led to a maximum waist circumference reduction of 3.9 inches and mean reduction of 1.6 inches after 33 days of use.

• ACC & MedAxiom’s Five Year Plan: The ACC announced its five-year Strategic Plan focused on transforming care delivery in new areas. As part of this initiative, the ACC and its subsidiary, MedAxiom, partnered on a series of care transformation resources including new operational architectures for specific clinical objectives, patient populations, and non-clinical determinants of health. The duo will work on implementation strategies for team-based care, AI-enabled clinicians, and health systems.

• FIRE1 IVC Monitor’s Safety: Results from a JACC Heart Failure study suggest FIRE1’s Norm implantable IVC monitor could help safely track changes in intravascular fluid volume for detecting HF. The study tracked the first 50 patients to receive the Norm device and found that it safely delivered accurate IVC data after six months. Median daily adherence was 96% per patient and more than 7.4k transmissions were successfully sent from the sensor to the cloud.

• ABCVM’s Next Moves: Following the ABMS’ denial of the American Board of Cardiovascular Medicine taking over cardiologist certification, the ABCVM held a town hall at ACC.25 to discuss next steps. ABMS has since clarified it had doubts about ABCVM’s financial sustainability and disagreed on what basis cardiologists should be recertified. However, ABMS received more than 1,000 “uniformly positive” comments from cardiologists about the independent board and said it would allow ABCVM to reapply after 24 months.

• Mavacamten Doesn’t Help nHCM: Bristol Myers Squibb’s mavacamten (CAMZYOS) fell flat in its impact on nonobstructive HCM in the Phase 3 ODYSSEY-HCM trial, suggesting that the disease truly isn’t comparable to obstructive HCM. Mavacamten didn’t meet its dual primary endpoints of changes in patient KCCQ score and peak oxygen consumption compared to placebo at 48 weeks of follow-up. This directly contradicts dramatic changes in QoL and exercise capacity in patients with obstructive HCM found in trials for mavacamten and Cytokinetics’ aficamten.

• FDA Clears Echo AI App: French software developer DESKi received FDA 510(k) clearance for HeartFocus, a new AI application for guiding healthcare professionals in performing echocardiography exams. HeartFocus enables staff – including novices – to perform cardiac ultrasound exams with just a few hours of training, and the application was supported by a clinical trial in which 100% of novice-conducted scans with HeartFocus met diagnostic standards.

Cardiology AI: From Research to Clinical Practice

Explore how AI algorithms are reshaping cardiology with insights from Tempus’ recent webinar, featuring Dr. David Ouyang of UCLA and Cedars-Sinai, alongside Tempus’ Dr. John Pfeifer and Dr. Brandon Fornwalt. This expert panel dives into how AI can bridge diagnostic gaps, enhance patient outcomes, and streamline workflows for conditions like AFib and pulmonary hypertension. Read the full recap to glimpse the future of AI-driven cardiology.

Explore Vitrea Advanced Visualization

Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow

Ready for More Precise ECG Monitoring?

Monebo designs, develops, and licenses complex ECG algorithms for use in a wide variety of monitoring applications. If you’re a medical device developer, monitoring center, or system integrator see why Monebo might be right for you.

The Resource Wire

• AI-Echo for Cardiac Amyloidosis: Despite advancements in cardiac imaging, cardiac amyloidosis remains significantly underrecognized and underdiagnosed. Discover how Us2.ai’s deep learning diagnostic algorithm uses echocardiography and apical 4-chamber DICOM images to detect CA.

• The New Way to CMR: Cardiac MRI is infamous for its complexity and backlogs, but it doesn’t need to be that way. See how Vista.ai’s Vista Cardiac solution automates and simplifies image acquisition so all technologists can perform a CMR scan with quality, consistency, and efficiency.

• Addressing Coronary Artery Disease: Learn how the AGENT™ Drug-Coated Balloon provides a new treatment option for in-stent restenosis in the U.S. Rx Only. (Sponsored by Boston Scientific)

• Cut Waste with GE HealthCare’s Inventory Management: Want to make your hospital’s inventory practices more efficient? Tune in to this webinar on how GE HealthCare’s data-driven insights can optimize inventory management and reduce cardiac procedure times by 30-45 minutes.

• Relieving The Burden of Post-Processing: With the advent of advanced imaging technologies like CCTA come added burdens to technologists and diagnostic imaging centers. See how PIA can relieve the burden of post-processing, saving you time while helping your bottom line.

• A New Era of Precision and Efficiency: Ready to enhance your cardiovascular imaging precision and efficiency? See how Circle Cardiovascular Imaging’s new cvi42 6.1 platform is bringing CT and MR imaging under a single platform.

• Merge Still Best in KLAS: Merge Cardio and Merge Hemo continued their KLAS hot streak, ranking Best in KLAS 2025 for Cardiology and Hemodynamics for the 10th and 13th years. Discover the user enhancements and software improvements that led to Merge Cardio and Merge Hemo’s latest wins. 

• Innovating AFib Care: The first manifestation of AFib is often stroke, but many hospitals aren’t set up to coordinate these patients’ post-stroke care. See how UCSD is leveraging Viz.ai’s Viz Connect solution to simplify neuro and EP collaboration in this HRX 2024 interview.

The Industry Wire

1. Measles cases could be underreported as outbreak swells in Texas. 
2. CDC considers ending universal COVID vaccine recommendations.
3. Humana suffers Medicare Advantage star ratings setback.
4. UnitedHealthcare’s CEO wants to fix the company’s image. 
5. Remote patient monitoring doesn’t always work. 
6. Abbott to expand manufacturing to the U.S. following tariffs. 
7. HHS layoffs could be illegal. 
8. Trump plans to address the ‘pill penalty’ of drug pricing. 
9. UnitedHealth will enter DOJ mediation over Amedisys deal. 
10. Physician compensation up 3.6% in 2024, but not for all specialties.