Cardiovascular Weekly News - October 2nd 2025

Cardiovascular Update: CardiAMP cell therapy, GBD special report, EU steps up CVD strategy and More

From CardiAMP cell therapy topline data showing major exercise tolerance gains and angina reductions, to sex-specific insights on hidden myocardial infarction causes from Mayo Clinic, and AI-driven plaque analysis winning payer clearance in the US—this week’s highlights reveal groundbreaking advances in cardiovascular diagnostics, treatment, and global health strategy.

In Today’s Newsletter

💉 CardiAMP cell therapy roll-in topline (BioCardia) [1] [22 Sep 2025]

https://cardiovascularnews.com/biocardia-announces-top-line-data-from-trial-of-cardiaamp-cell-therapy-procedure/
Context: Open-label roll-in cohort in chronic myocardial ischemia with refractory angina; 6-month primary endpoint; all on GDMT.
Key point: Company reports improved exercise tolerance and fewer angina episodes; no treatment-emergent MACE (endpoint specifics beyond direction not independently detailed).
Implication: May influence prescriber choice and payer reviews pending full data.

🫀 Hidden causes of MI differ by sex (Mayo Clinic / JACC) [2] [US • 23 Sep 2025]

https://nypost.com/2025/09/23/health/new-study-finds-hidden-causes-of-heart-attacks-that-are-often-overlooked-or-misdiagnosed/
Context: 15+ years; 1,474 heart attacks analyzed.
Key point: In women <65, >50% of MIs linked to nontraditional causes (e.g., embolism, SCAD); atherosclerosis explains fewer events than in men; misdiagnosis common.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧠 AI plaque analysis cleared + payer win (HeartFlow) [3] [US • 24 Sep 2025]

https://cardiovascularnews.com/hearflows-next-generation-plaque-analysis-algorithm-gains-us-fda-clearance/
Context: US FDA 510(k) for next-gen Plaque Analysis; Cigna coverage effective Oct 1; company cites IVUS agreement and improved detection vs prior algorithm.
Key point: Only FDA-cleared AI tool for plaque quantification per company; expected to guide CAD risk assessment and management.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.

🌍 GBD special report: CVD = 1 in 3 deaths [4] [24 Sep 2025]

https://cardiovascularnews.com/one-in-three-deaths-globally-linked-to-cardiovascular-disease/
Context: GBD 1990–2023 across 204 countries; JACC special report.
Key point: CVD remains top cause of deaths and DALYs; ~80% of CVD DALYs attributable to modifiable risks; large cross-country variation.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧬 Multi-omics/genetics to cut CVD deaths? (BGI Genomics) [5] [25 Sep 2025]

https://www.eurekalert.org/news-releases/1099733
Context: Press framing on AI-driven multi-omics risk tools; cites EJPC projections and large-scale genetics research.
Key point: Source argues genetic screening + multi-omics may improve risk prediction and target therapy; quantitative impact claim framed directionally.
Implication: Signals pipeline investment and modality expansion.

🇪🇺 EU steps up CVD strategy [6] [EU • 26 Sep 2025]

https://www.medscape.com/viewarticle/european-union-steps-fight-against-cardiovascular-disease-2025a1000ptb
Context: Movement toward an EU Cardiovascular Health Plan; JACARDI collaboration; tighter air-quality rules; risk-factor policies (tobacco, sugar, sodium).
Key point: Focus on prevention, early detection, equity, and environmental determinants; regulatory actions in development/implementation.
Implication: Introduces competition that may affect pricing and formulary access.

🌏 WHO South-East Asia World Heart Day note [7] [South-East Asia • 29 Sep 2025]

https://www.who.int/southeastasia/news/detail/29-09-2025-world-heart-day
Context: SEAHEARTS resolution progress; protocol-based management scaling; ongoing barriers in enforcement and access.
Key point: ~90M people on protocol-based care for HTN/diabetes (as of Jun 2025); significant premature CVD mortality persists.
Implication: May expand screening, initiation, and follow-up at scale.

⚙️ First-in-human smart heart implant (Relief Cardiovascular) [8] [Georgia • 30 Sep 2025]

https://www.massdevice.com/relief-cardiovascular-first-human-smart-heart-implant/
Context: Feasibility study; transcatheter implant in the vena cava; combines hemodynamic monitoring with adaptive decongestion therapy.
Key point: Initial implants completed; patients discharged home; system syncs data to cloud; intended for diuretic-resistant HF congestion.
Implication: Signals pipeline investment and modality expansion.

🧪 CityUHK “DNA surgery” program funding [9] [Hong Kong • 30 Sep 2025]

https://www.eurekalert.org/news-releases/1100246
Context: RAISe+ Scheme grant; genome editing tools + engineered LNP delivery; two candidates (liver / cardiovascular) entering IND-enabling.
Key point: Team targets “one-and-done” somatic genome editing; preclinical NHP work completed; aims for early clinical testing.
Implication: Signals pipeline investment and modality expansion.

💊 SOUL: oral semaglutide CV & limb outcomes (subanalysis) [10] [01 Oct 2025]

https://www.medscape.com/viewarticle/oral-semaglutide-reduces-major-adverse-cardiovascular-and-2025a1000q9a
Context: Double-blind CVOT in T2D with ASCVD/CKD; PAD subgroup prespecified.
Key point: Reduced MACE overall; MALE lower vs placebo regardless of PAD status; PAD subgroup effects require cautious interpretation (statistical uncertainty noted).
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

CVD burden remains immense and uneven; modifiable risks dominate [4].
Diagnostic and policy shifts (AI plaque analysis; EU plan; SEAHEARTS) may move care upstream [3,6,7].
Interventions span cells to cities: autologous cell therapy, genome editing, device-based decongestion, and environmental policy [1,6,8,9].
Sex-specific etiologies and PAD comorbidity highlight personalization needs in cardiometabolic care [2,10].
Payer and regulatory milestones can rapidly expand access to novel diagnostics/therapies [3,6].

📢 Stay Ahead in Cardiovascular Research!

✅ Contact LucidQuest at info@lqventures.com for strategic guidance on Cardiovascular innovations and research.

FAQ

What did BioCardia actually report in its CardiAMP roll-in cohort?

Directional topline: improved exercise time and fewer angina episodes at 6 months, with no treatment-emergent MACE reported in the open-label cohort on GDMT; full peer-review pending [1].

How does HeartFlow’s newly cleared tool differ from prior versions?

Company cites a next-gen algorithm, expanded nomogram, 3D plaque visualization, and higher plaque-detection performance vs its first-gen tool; Cigna coverage begins Oct 1 across lines of business [3].

Which nontraditional MI causes were emphasized in younger women?

Spontaneous coronary artery dissection (SCAD) and embolic etiologies featured; study highlights under-recognition and misdiagnosis risks in women under 65 [2].

What is the EU planning beyond clinical care?

A comprehensive cardiovascular health plan with prevention, early detection, equity, environmental measures (air quality), and product regulations (tobacco/nicotine, nutrition) under development/implementation [6].

What does the SOUL subanalysis suggest for patients with PAD?

Oral semaglutide’s MACE reduction was not statistically modified by PAD status; MALE were lower overall vs placebo, with subgroup estimates requiring cautious interpretation [10].

What is Relief Cardiovascular’s “smart heart” implant designed to do?

Provide pressure-guided, adaptive decongestion via a vena cava valve while continuously monitoring hemodynamics; early feasibility implants completed with home discharge reported [8].

Entities / Keywords

BioCardia; CardiAMP cell therapy; refractory angina; chronic myocardial ischemia • Mayo Clinic; JACC; SCAD; embolism; sex differences in MI • HeartFlow; Plaque Analysis; AI; IVUS; Cigna coverage; 510(k) • Global Burden of Disease; JACC; DALYs; modifiable risk factors • BGI Genomics; multi-omics; polygenic risk; EJPC • European Commission; EU Cardiovascular Health Plan; JACARDI; Ambient Air Quality Directive • WHO South-East Asia; SEAHEARTS; protocol-based HTN/diabetes care • Relief Cardiovascular; transcatheter implant; heart failure congestion • CityUHK; CRISPR; genome editing; eLNPs; IND enabling • Novo Nordisk; semaglutide; SOUL; PAD; MALE; MACE.