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Aficamten Scores for nHCM, Mother’s CVD, and Cordella’s Efficacy
By Viktor Zarev
May 7, 2026
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“Robin Williams famously said that cocaine is God’s way of saying you’re making too much money. Worrying about your VO2 max might be the same.”

Adam Cifu, MD

Today’s top story is the culmination of a conversation we’ve been having for the last 18 months. It’s quite stunning to see just how good the science backing aficamten is.

As always, thanks for reading!

-Vik

Cardiology Pharmaceuticals

Aficamten, ACACIA-HCM, and the Road to the First nHCM Drug

The question of how to treat non-obstructive hypertrophic cardiomyopathy has long perplexed researchers and pharmaceutical developers alike, but topline results from Cytokinetics’ Phase 3 ACACIA-HCM trial suggest MYQORZO (aficamten) could be the answer.

  • HCM is commonly characterized by thickened heart muscle that struggles to relax, but in the non-obstructive form, this enlarged tissue doesn’t block blood leaving the heart.
  • Since there’s no “obstruction” to remove or chemically treat, clinicians have to rely on off-label symptom management that often falls short.

For Cytokinetics, aficamten already saw success in obstructive HCM, so the hypothesis of ACACIA-HCM was simple – can the drug help patients with the more common, non-obstructive form?

To test this, researchers randomized 516 patients with symptomatic nHCM to receive either aficamten or placebo for 36 weeks and the results were a success across the study’s endpoints.

  • For the primary endpoint, aficamten led to significant improvements compared to placebo in KCCQ scores (11.4 vs. 8.4) and peak VO2 (0.64 vs -0.03).
  • Aficamten also led to statistically significant improvements in NYHA class and NT-proBNP levels.

To understand how important those results are, the only other HCM drug, Bristol Myers Squibb’s CAMZYOS (mavacamten) failed to improve symptoms and pVO2 in the ODYSSEY-HCM trial for nHCM.

  • As such, if ACACIA-HCM can lead aficamten to an expanded approval for non-obstructive HCM, it would be the sole therapeutic for 60% of diagnosed HCM patients.

Wall Street’s reaction also underscored the importance of these study results…

  • Cytokinetics’ stock surged roughly 14% on the news.
  • Meanwhile BMS shed 2%.

However, the trial also highlighted the need for careful monitoring.

  • While no new safety issues emerged, 10% of participants on aficamten experienced a drop in LVEF to below 50%, compared to just 1% in the placebo group.

The Takeaway

Cytokinetics’ MYQORZO already showed better outcomes than the competition in oHCM, but it seems like the drug could be headed toward dominance in non-obstructive HCM as well. That’s a win for HCM patients, the majority of whom still don’t have a pharmaceutical option, and an obvious win for Cytokinetics.

The Power of AI in Cardiovascular Imaging

Cardiac labs are under more pressure than ever to deliver more with greater speed and precision. Hear from Tony Gallagher, Director of Noninvasive Cardiology at Baptist Health Lexington about how Siemens Healthineers’ ACUSON Origin is reshaping daily practice and transforming the future of echocardiography.

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Merge & Us2.ai for Accessible Cardiac AI

AI isn’t the future anymore, it’s an irreplaceable feature for cardiac imaging. Dive deeper into how Merge & Us2.ai are integrating FDA-cleared algorithms with advanced imaging systems to help clinicians focus on what matters most – their patients.

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Earlier Detection, Better Outcomes

When it comes to heart disease, early detection is crucial to a patient’s long-term health. Learn more about how Fujifilm helps clinicians achieve that with the Lisendo 880 cardiovascular ultrasound system’s unique solutions that detect early abnormalities seen in heart failure, while offering insight into cardiac functions and groundbreaking hemodynamic analysis.

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The Wire

  • Maternal Heart Disease: Adding to a trend of maternal cardiac health studies, new data suggests that a mother’s heart disease significantly increases her child’s congenital heart disease (CHD) risk. Among 14k mothers and 15k children studied, children whose mothers had adult congenital heart disease (ACHD) faced a 71% higher risk, while those whose mothers acquired heart disease (AHD) faced a 38% risk. ACHD correlated with preterm births, whereas AHD was linked to genetic abnormalities.
  • Cordella PA Shows Clinical Results: Two-year PROACTIVE-HF data showed that Edwards Lifesciences’ (formerly Endtronix’s) Cordella Pulmonary Artery sensor system helps maintain low heart failure event rates (0.89/patient) for patients with NYHA Class III symptoms. While the study found that HFrEF patients experienced higher event rates than the HFpEF cohort (1.0 vs. 0.8), health status still improved regardless of ejection fraction. The study’s authors suggest that remote monitoring of vital signs and seated mPAP offers an effective management strategy for high-risk patients.
  • PaceAid’s Visual CPR Assist: New Jersey-based start-up, PaceAid launched a single-use visual guide to fix the stress gap in CPR timing. Created by veteran respiratory therapist Colleen McGowan, the device provides clear cues for compressions and rescue breaths to counter cognitive load during high-pressure cardiac arrests. With four models covering infant to adult care, PaceAid serves as a visual metronome for the heart. The company’s 2025 hospital trials also confirm it boosts clinician confidence and adherence.
  • Cook Medical’s Catheter Recall: The FDA finalized a Class I recall for Cook Medical’s Centimeter, Aurous, and Beacon Tip sizing catheters. Per the recall, these devices risk cracking or breaking mid-procedure, potentially causing lethal vessel injury or device fragmentation. While no injuries have been reported yet, the structural failure was deemed a high-stakes hazard. Cook Medical has ordered an immediate halt to all sales and usage, requiring all affected inventory to be returned.
  • Lilly’s Indiana Investment: Eli Lilly invested another $4.5B (now totaling $21B) into its Lebanon, Indiana campus, opening its first dedicated genetic medicine plant and prepping the largest API site in U.S. history. This expansion will secure its U.S. production for blockbuster drugs like Mounjaro and its newly oral weight-loss pill, Foundayo. Lilly also says that by 2027, this hub will be the primary engine for its next-gen metabolic and genetic pipeline.
  • RelayPro’s Lethal Release Failure: The FDA issued an Early Alert for Bolton Medical’s RelayPro Thoracic Stent Graft after a stuck delivery system led to three deaths. This manifested as a disconnected proximal clasp which prevented the graft from releasing, forcing high-risk conversions to open surgery. Regulators are urging surgeons to consider alternatives since if the apex holder slides without resistance during a procedure, the device is already failing.
  • Medtronic’s Mitral Upgrade: Medtronic launched the Mosaic Neo mitral bioprosthesis following its FDA-approval for robotic and minimally invasive surgery. Building on Medtronic’s Mosaic platform, the Neo features a lower profile, reduced stent protrusion to protect the LVOT, and a “cinch” mechanism for smoother delivery. The device also comes with enhanced fluoroscopic visibility and new small-incision sizers, to simplify complex replacements for the 20k Americans treated annually.
  • MGB’s PRS Risk Test: Mass General Brigham developed and validated a new polygenic risk score (PRS) test that targets eight heart conditions, which could identify high-risk patients that traditional metrics miss. Validated on 300k individuals, the test found that those in the top 10% genetic risk category faced a 3.7x higher risk for coronary disease. MGB developed the risk score to be EHR-integrated, enabling earlier intervention and acting as a genetic early-warning system, though researchers still need to improve the tool’s limited ancestral diversity.
  • Cardiologists’ Malpractice Risk: Cardiologists might not be among the medical specialists at highest risk of being sued for malpractice in a new AMA survey, but their risk is still real. Among 26 specialties, cardiology ranked ninth, with 15% of cardiologists saying they had ever been sued in their career (ob/gyn doctors were at the top at 60%). Thankfully, only 0.4% of cardiologists said they had been sued in the previous year. On the positive side, the proportion of physicians reporting malpractice claims fell in 2024 compared to 2016 (29% vs. 34%).
  • Medical Liability Premiums Rise: Perhaps not surprisingly, medical liability premiums continued to rise in another AMA survey on medical malpractice. The proportion of premiums that rose in 2025 was up sharply compared to 2018 (40% vs. 14%), and premiums rose for the past seven years, a trend not seen since the medical malpractice crisis of the early 2000s. Premiums tended to be lower in states that have caps on non-economic damages. The report stated that further premium increases could limit patient access to care.
  • Fewer Doctors Planning to Quit: In another sign of the easing healthcare burnout crisis, a new survey found that fewer physicians are planning to quit their current practice compared to a few years ago. Ina JAMA Network Open study, researchers surveyed 37.1k U.S. physicians, finding that the percentage who intended to leave fell in 2024 compared to 2022 (15% vs. 20%), and the percentage who wanted to reduce their hours also dropped (23% vs. 26%).

Beyond the Calcium Score with Circle CVI

The coronary artery calcium score has been the non-invasive gold standard for a quick look at heart disease risk, but it only tells part of the story. Learn more about how Circle Cardiovascular Imaging is using AI-enabled coronary plaque analysis to redefine heart risk beyond what a CAC score can tell us.

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The Nature of Raw ECG Signals

Raw ECG recordings are inherently affected by noise, motion artifacts, and variability in signal acquisition. Read more about how Monebo has focused on transforming raw cardiac signals into reliable, clinically meaningful insight for over two decades.

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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.

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The Resource Wire

  • Staying ALERT with Tempus: Undertreatment and time to treatment of valvular heart disease are among the biggest challenges health systems face today, but Tempus’ AI-driven EHR notifications can change that. Read the results of Medtronic and Tempus’ ALERT trial which found that delivering data directly to providers resulted in a 40% relative increase in life-saving valve procedures. 
  • CMR Access Is Broken — Here’s How to Fix It​: Cardiac MRI is one of the most powerful tools for diagnosing heart disease, yet it’s still out of reach for many patients. Download Vista AI’s new infographic to see what’s holding CMR adoption back—and how AI and automation can help make gold-standard imaging more accessible than ever.
  • Heart failure places enormous strain on our healthcare systems and patients: There are 3.7 million US patients with HFpEF or HFmrEF, with prevalence only expected to rise. To learn more about the heart failure landscape and Bayer’s commitment to addressing patient unmet need, watch the video here.
  • Merge Hemo Ranks 2026 Best in KLAS: Merge Hemo ranked 2026 Best in KLAS for cardiology hemodynamics, marking the 14th year it’s been named a category leader. Find out more about why Merge’s strategy of a modular, unified imaging solutions portfolio continues to dominate the KLAS rankings, year in, year out.

The Industry Wire

  1. CMS to provide $50/mo GLP-1 access for Medicare beneficiaries.
  2. HHS encourages doctors to consider lifestyle changes, not drugs, for depression. 
  3. Pennsylvania sues AI company after chatbot posed as licensed doctor.
  4. Hospitals face growing fallout from ACA coverage cliff.
  5. Judy Faulkner shares keys to Epic’s success in Freakonomics interview.
  6. Are blue zones real? Answering that question is harder than ever.
  7. HCA VP of care transformation steps down.
  8. Eko Health and Boehringer Ingelheim team up to help dogs live longer.
  9. Atrium Health, WakeMed merger faces delay.
  10. Trump’s immigration policies are fueling brain drain.