UNIVERSITY OF WASHINGTON

ONWARD Medical received FDA de novo classification for its ARC-EX System, the first non-invasive technology to improve hand strength and sensation in chronic spinal cord injury patients. The system uses electrical stimulation to the spinal cord via neck electrodes, with clinical study results showing significant improvements in strength, function, and quality of life. Home use authorization is expected in mid-2025, with plans for CE Mark certification in Europe in early 2025.

AI's rapid ascent is transforming industries, including life sciences, with 65% of organizations regularly using genAI, nearly double from ten months ago. By 2025, genAI is expected to drive efficiency in drug discovery, clinical trials, and personalized treatments, with 95% of researchers anticipating AI to accelerate knowledge discovery. Key trends include multimodal AI, AI agents, intuitive search, and AI-powered consumer experiences. The Deloitte report projects a top 10 biopharma company could capture $5–7 billion in peak value by scaling AI over five years, emphasizing high-value, low-complexity initiatives to build momentum.

Machine learning helps define personalized 'normal' blood test ranges, improving disease diagnosis and predicting future health risks by analyzing individual patient data over time, moving beyond one-size-fits-all reference intervals.

FDA approves FemPulse's EVANESCE-II trial for its wearable FemPulse Ring, a bioelectronic device offering mild electrical nerve stimulation as a non-invasive alternative to pharmaceutical treatments for overactive bladder (OAB). The trial will compare the device's efficacy with tolterodine. Previous trials showed the device safe, comfortable, and effective, with potential for EU commercial availability by 2025.

Parse Biosciences expands Evercode BCR for mouse studies, enabling full-length BCR sequencing and whole transcriptome profiling, enhancing antibody discovery and immunological research.

A study by Mass General Brigham reveals that CBC setpoints are unique to each patient, suggesting a personalized approach could improve health assessment and early disease diagnosis.

FemPulse™ received FDA IDE approval for EVANESCE II trial, testing its FemPulse Ring™ for overactive bladder (OAB) treatment. The device offers a non-surgical, patient-managed neuromodulation therapy, aiming to provide an alternative to medications and invasive treatments. FemPulse also advances in EU MDR process, targeting 2025 commercial availability.

Adding palbociclib to standard therapy significantly improved progression-free survival (PFS) in HR-positive, HER2-positive metastatic breast cancer patients, with a median PFS of 44.3 months vs. 29.1 months in the control group. The study suggests palbociclib may become a new standard of care, despite manageable toxicity.

FemPulse received FDA IDE approval for its overactive bladder therapy, enabling the EVANESCE II trial. The FemPulse Ring, a vaginally-inserted, removable device, aims to provide continuous neuromodulation without surgery. The company plans to confirm it as a first-line alternative to medications, addressing their limited efficacy and side effects.

Amgen's scientists, trained by Nobel laureates, drive groundbreaking research. Christy Tinberg, cited in the 2024 Chemistry Nobel Prize, exemplifies this, having developed a novel computational method for protein design. Other Amgen researchers trained by Nobel winners include Shane Caldwell, Robert Vernon, Kate Ashton, and more, contributing to advancements in protein design, drug discovery, and diagnostics.