MedPath

Tagged News

USC Spine Center Joins Pivotal CLARITY Trial to Evaluate Nociscan for Chronic Low Back Pain

AI
  • Keck Medical Center of USC has joined the CLARITY trial to evaluate Aclarion's Nociscan technology, which uses MR Spectroscopy and AI to identify sources of chronic low back pain.
  • The randomized, multi-center CLARITY trial will enroll 300 patients across prestigious institutions including Johns Hopkins Medicine, Northwestern Medicine, and Texas Back Institute.
  • Nociscan is the first evidence-supported platform to noninvasively distinguish between painful and nonpainful discs in the lumbar spine, potentially transforming diagnosis and treatment for 266 million people worldwide with degenerative spine disease.

Imec Unveils Revolutionary Miniaturized Ingestible Sensor for Non-Invasive Gut Health Monitoring

AI
  • Imec has developed a highly miniaturized ingestible sensor measuring just 2.1cm in length and 0.75cm in diameter, three times smaller than existing capsule endoscopies, capable of monitoring gut health for up to a week.
  • The innovative device is the first to measure redox balance, a marker for oxidative stress and inflammation, alongside pH and temperature throughout the entire gastrointestinal tract without requiring unpleasant bowel preparation.
  • Following successful testing in healthy volunteers, Imec plans to evaluate the sensor in patient populations with cancer and inflammatory disorders in collaboration with Radboud University Medical Center.

Biostate AI Secures $12M Series A to Revolutionize RNA Sequencing and Molecular Diagnostics

AIPrecision MedicineOncology
  • Biostate AI has raised $12 million in Series A funding led by Accel to develop affordable RNA sequencing technology and AI-powered diagnostic models.
  • The company's proprietary BIRT and PERD technologies reduce RNAseq costs by nearly an order of magnitude, enabling researchers to run 2-3 times more samples within existing budgets.
  • Founded by former professors David Zhang and Ashwin Gopinath, Biostate AI aims to build "foundation models" for molecular medicine by analyzing billions of RNA expressions to predict disease evolution and drug responses.

Merck and imec Partner to Develop Advanced Microphysiological Systems Platform for Drug Discovery

Drug DiscoveryAI
• Merck and imec have announced a strategic partnership to develop an advanced Microphysiological Systems (MPS) platform that aims to improve drug discovery efficiency and reduce reliance on animal testing.
• The collaboration integrates organoid biology models with semiconductor hardware, incorporating biosensing and microfluidic capabilities to provide real-time insights from individual organs to multi-organ connected systems.
• The jointly developed modular system will feature standardized interfaces compatible with Merck's portfolio of stem cells and patient-derived organoids, enabling more reliable predictions of human organ responses to drug stimuli.

Persist AI Raises $12M Series A, Launches Cloud Lab to Revolutionize Pharmaceutical Formulation Development

AI
  • Persist AI has secured $12 million in Series A funding to expand its AI-driven robotics platform that reduces drug formulation development time from years to months.
  • The company's Cloud Lab platform enables pharmaceutical companies to remotely develop formulations using robotic laboratory facilities, testing 700 formulations in two months compared to the industry standard of 10-15 per month.
  • Persist AI's technology miniaturizes testing processes, requiring just 1 mL of liquid and a few milligrams of material compared to traditional methods that need 1000 mL and several grams.

Persist AI Secures $12M Series A Funding to Revolutionize Pharmaceutical Formulation Development

AI
  • Persist AI has raised $12 million in Series A funding led by Spero Ventures to expand its AI-driven robotic laboratory for pharmaceutical formulation development.
  • The company's newly launched Cloud Lab platform enables pharmaceutical companies to remotely develop and test drug formulations, reducing traditional timelines from a year to just two months.
  • Persist AI's technology supports various drug modalities including peptides, small molecules, and antibodies, with plans to build a GMP manufacturing system for long-acting injectables in collaboration with Nivagen Pharmaceuticals.

Gustave Roussy Launches UMBRELLA Trial: Using Blood-Based Tumor DNA to Revolutionize Cancer Follow-Up Care

OncologyPrecision MedicineAI
  • Gustave Roussy has initiated UMBRELLA, a groundbreaking phase III trial that personalizes post-treatment cancer monitoring based on minimal residual disease (MRD) detected through blood-based circulating tumor DNA analysis.
  • The trial will evaluate two strategies: pre-emptive immunotherapy (tislelizumab) for MRD-positive patients and reduced follow-up schedules for MRD-negative patients with non-metastatic lung, colorectal, pancreatic, and soft tissue sarcomas.
  • UMBRELLA represents the first French multi-cancer trial using MRD status for therapeutic stratification, aiming to enroll over 700 patients across 10-11 centers in a collaborative effort involving Veracyte, IntegraGen, and BeiGene.

tislelizUMaB in canceR Patients With molEcuLar residuaL Disease

NCT06332274RecruitingPhase 3
Gustave Roussy, Cancer Campus, Grand Paris
Posted 4/16/2025

FDA Approves 18 New Personalized Medicines in 2024, Marking Significant Shift in Treatment Paradigm

Drug ApprovalOncologyRare DiseaseAIReal World EvidencePrecision Medicine
  • 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.

€13.6M EU-Funded PREDI-LYNCH Project Aims to Transform Cancer Screening for Lynch Syndrome Patients

AIOncology
  • The PREDI-LYNCH project has received €13.6 million in EU funding to develop non-invasive liquid biopsy tests for early cancer detection in Lynch Syndrome carriers, addressing a critical unmet medical need.
  • Swedish diagnostics company Elypta joins 27 partners across 16 European countries in this six-year initiative (2025-2031), contributing its proprietary glycosaminoglycan-based biomarker technology.
  • With only 5% of Europe's estimated 2 million Lynch Syndrome carriers under cancer surveillance, the project aims to create affordable, accessible screening methods for colorectal, endometrial, and urothelial cancers.

IMVARIA Presents Real-World Data on FDA-Authorized AI Diagnostic Service for Pulmonary Fibrosis at ATS 2025

AI
  • IMVARIA's Fibresolve, the first FDA-authorized AI adjunctive diagnostic service for lung fibrosis, demonstrates real-world clinical utility in multi-site experiences presented at ATS 2025 Conference.
  • The AI-powered diagnostic service enables pulmonologists to evaluate suspected Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF) without workflow disruption or complex system installation.
  • IMVARIA is also presenting data on two additional AI solutions: ScreenDx for ILD assessment (FDA-cleared in 2025) and Bronchosolve, an investigational tool for lung nodule evaluation.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.