Tagged News
Basil Systems Secures $11.5M to Revolutionize Life Sciences Decision-Making with AI
• Basil Systems has raised $11.5 million in funding led by Golden Ventures, with participation from Hearst Ventures and Argosy Capital, to expand its AI-powered product lifecycle intelligence platform.
• The company has built BasilLink, the largest indexed dataset in life sciences with over 600 million records, providing real-time insights for regulatory submissions, clinical planning, and post-market surveillance.
• Already utilized by four of the five largest global medical device companies and in trials with major pharmaceutical firms, Basil's platform aims to transform fragmented regulatory and clinical data into actionable intelligence.
EMPOWER CAD Study Confirms Benefits of IVL-First Strategy in Female Patients with Calcified Coronary Lesions
• The EMPOWER CAD study, the first prospective real-world PCI trial focused exclusively on female patients with complex calcified coronary artery disease, demonstrated high procedural success rates with Shockwave's intravascular lithotripsy.
• Women with coronary artery calcification have historically experienced poorer outcomes than men and are typically underrepresented in clinical trials, making this study particularly significant for addressing gender disparities in cardiovascular care.
• The 30-day results showed 86.9% procedural success with minimal complications, offering a promising alternative to traditional calcium modification treatments like rotational or orbital atherectomy that carry higher complication risks in female patients.
Real-World Data Confirms Trikafta's Long-Term Efficacy as Gold Standard in Cystic Fibrosis Treatment
• New real-world evidence presented at ATS 2025 validates Trikafta (elexacaftor/tezacaftor/ivacaftor) as an effective long-term therapy for cystic fibrosis patients with at least one F508del mutation.
• The study by Sutharsan and colleagues provides valuable insights into laboratory markers while demonstrating sustained clinical benefits across various outcomes in this patient population.
• These findings further establish Trikafta's position as the gold standard treatment in long-term cystic fibrosis care, reinforcing its therapeutic value for patients.
Cordis Launches 10,000-Patient Global Registry for SELUTION SLR Drug-Eluting Balloon
• Cordis has initiated the SELUTION Global Coronary Registry, which will track real-world outcomes of their sirolimus-eluting balloon in up to 10,000 patients worldwide for five years.
• The registry complements five ongoing randomized trials and builds on positive peripheral experience data, positioning SELUTION SLR as a next-generation technology that delivers sustained drug release without permanent implants.
• A distinguished steering committee of international interventional cardiologists will oversee the registry, including Dr. Ajay Kirtane from Columbia University as chairman.
FDA Approves 18 New Personalized Medicines in 2024, Marking Significant Shift in Treatment Paradigm
• The FDA approved 18 new personalized medicines in 2024, representing 38% of all newly approved therapeutic molecular entities across multiple treatment areas including cancer and Alzheimer's disease.
• Six new gene and cell-based therapies for rare genetic diseases and cancers were authorized, alongside expanded indications for 11 diagnostic testing systems and the first-ever expanded indication for an approved gene therapy.
• Personalized medicines now constitute at least 25% of drug approvals for the past decade, a substantial increase from less than 10% ten years ago, demonstrating the healthcare system's shift away from one-size-fits-all approaches.
VESALIUS-REAL Study Reveals Critical Gaps in Cardiovascular Care Despite Available Treatments
• The VESALIUS-REAL study of 278,000 high-risk patients found 70% did not receive lipid-lowering therapy after heart attacks or strokes, and 88% had no treatment intensification within a year.
• Half of cardiovascular event patients never received follow-up LDL-C testing, and among those tested, 82% failed to achieve guideline-recommended cholesterol goals despite available treatments.
• Amgen is working to address these care gaps through initiatives including free LDL-C testing at CVS MinuteClinics, partnerships with cardiology organizations, and the LATTICE Consortium to accelerate implementation science.
Biodesix Presents New Data Showing Nodify Lung® Tests Improve Pulmonary Nodule Management
• New study of over 350,000 patients reveals significant gaps in lung nodule management, with approximately two-thirds receiving no clinical work-up after nodule discovery.
• Research presented at ISPOR 2025 shows concerning rates of mismanagement, with 60% of biopsies performed on benign nodules and 35% of malignant nodules receiving only follow-up CT scans.
• Real-world data from a safety-net hospital demonstrates how Biodesix's Nodify Lung® testing can guide clinical decisions through actionable results in pulmonary nodule risk stratification.
Elevated Lipoprotein(a) Linked to Higher Risk of Recurrent Cardiovascular Events in Landmark Study
• A landmark study of over 273,000 individuals with atherosclerotic cardiovascular disease found that every increase in lipoprotein(a) levels is associated with higher risk of recurrent cardiovascular events.
• Patients with very high Lp(a) levels (≥300 nmol/L) faced a 45% increased risk of subsequent cardiovascular events compared to those with low levels (<15 nmol/L), with slightly higher risks observed in Hispanic and Black individuals.
• High-impact LDL cholesterol-lowering therapies, particularly PCSK9 inhibitors, may help mitigate the harmful effects of elevated Lp(a) levels, suggesting important treatment implications for high-risk patients.
Colorectal Cancer Leads in Real-World Data Volume, But Oncology Trials Need Modernization
• Phesi's analysis of 167 million patient records reveals colorectal cancer has the largest volume of real-world data with nearly six million records, outpacing breast, lung, liver, and prostate cancers.
• Despite the wealth of available data, oncology clinical trials continue to suffer from inefficiencies, with trial design and execution failing to keep pace with advances in biomarker science and patient profiling.
• Experts urge a shift toward "precision oncology" using AI and clinical data science to optimize patient profiles, programs, protocols, and operations plans to accelerate drug development.
Nationwide Study Confirms Safety of LUMASON® Ultrasound Enhancing Agent in Echocardiography
• A comprehensive real-world study analyzing over 11.4 million patients has validated the safety profile of ultrasound enhancing agents (UEAs) in echocardiographic procedures, with LUMASON® showing very low rates of serious complications.
• The research, published in the Journal of the American Heart Association, demonstrated that LUMASON® use was associated with reduced odds of short-term mortality compared to unenhanced echocardiograms.
• No significant differences in safety profiles were observed before, during, or after the COVID-19 pandemic, reinforcing the consistent reliability of LUMASON® across varying healthcare environments.