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Qureight's AI-Powered Synthetic Control Arms Validate Efficacy of Avalyn's Inhaled Pirfenidone for Rare Lung Disease

AIRare Disease
  • Qureight achieved a world-first breakthrough by using AI-powered synthetic control arms to replace human placebo groups in lung disease research, demonstrating significant clinical efficacy for Avalyn's inhaled pirfenidone (AP01) in treating idiopathic pulmonary fibrosis.
  • The innovative approach generated over 10,000 randomly sampled control groups from real-world IPF patient data, with results showing statistically significant reduction in lung capacity decline over 48 weeks compared to the 100mg AP01 dose.
  • This groundbreaking methodology addresses critical ethical and practical challenges in rare disease trials by reducing study costs, duration, and the need for placebo assignments in high-mortality conditions like IPF.
  • The technology leverages deep-learning analytics and quantitative image analysis to create digitally-twinned synthetic controls that more closely match treated patients' baseline disease states than traditional randomized placebo comparisons.

Isomorphic Labs Appoints Dr. Ben Wolf as Chief Medical Officer, Establishes US Operations

AIDrug Discovery
  • Isomorphic Labs, the AI-first drug discovery company, has appointed Dr. Ben Wolf as Chief Medical Officer to lead translation of AI-driven discoveries into clinical medicines.
  • Dr. Wolf brings nearly 20 years of biopharmaceutical experience, including expertise in precision oncology and advancing therapeutics from discovery through regulatory approval.
  • The company has established a new US presence in Cambridge, Massachusetts, following a $600 million external investment round earlier this year.
  • The appointment positions Isomorphic Labs to advance its AI drug design engine across multiple therapeutic areas and drug modalities into clinical development.

VSA Announces Acquisition of AI Clinical Development Company HopeAI to Transform Drug Development Timelines

AI
  • TCTM Kids IT Education Inc. (VSA) has signed a letter of intent to acquire HopeAI, an AI company specializing in clinical trial optimization that has helped pharmaceutical partners reduce development timelines by up to 2.5 years.
  • HopeAI's proprietary platforms have demonstrated significant impact by reducing Phase 3 trial sample sizes by up to 20% and enabling 24-hour responses to FDA feedback through AI-powered clinical development solutions.
  • The acquisition addresses a critical industry need, as pharmaceutical companies spent over $200 billion on clinical development in 2024 alone, with average development cycles taking 9 years.

Hera Biotech Acquires HeraFem Point-of-Care Cervical Cancer Diagnostic with 91% Sensitivity

AI
  • Hera Biotech has acquired HeraFem, a point-of-care cervical cancer diagnostic device that achieves 91% sensitivity for detecting CIN2+ lesions using electrical and optical spectroscopy with AI algorithms.
  • The acquisition expands Hera Biotech's platform beyond endometriosis to address cervical cancer, which causes approximately 350,000 global annual deaths with 94% occurring in low- and middle-income countries.
  • HeraFem eliminates the need for sample collection and provides immediate, same-visit diagnosis, addressing limitations of traditional Pap tests that have 55-80% sensitivity for detecting high-grade lesions.
  • The company has secured distribution partners and pre-orders across Central and South America while pursuing U.S. regulatory pathways to scale commercialization globally.

Xlife Sciences Expands Asian Footprint Through Strategic Partnerships in Digital Health and Precision Oncology

AI
  • Xlife Sciences AG has signed strategic partnerships with Korean companies Huraypositive Corp. and OncoMASTER Inc. to accelerate digital health and precision oncology innovation across Asia.
  • The collaboration leverages OncoMASTER's AI-powered platform built on clinical data from over 10,000 advanced cancer patients, representing the largest such dataset in Asia.
  • The partnership aims to bridge academic innovation with clinical translation while enabling Korean companies to access European commercialization opportunities through Xlife Sciences' network.
  • This marks a significant expansion of Xlife Sciences' international presence, focusing on personalized healthcare solutions and AI-driven cancer treatment prediction technologies.

Twin Health Raises $53 Million to Scale AI-Powered Digital Twin Platform for Metabolic Disease Management

AI
  • Twin Health secured $53 million in funding led by Maj Invest to expand its AI digital twin platform for metabolic health management into Fortune 500 enterprises and health plans.
  • The company's platform creates personalized metabolic models using biomarker data and has demonstrated significant clinical outcomes, with over 90% of diabetic subjects achieving type 2 diabetes reversal in clinical trials.
  • Twin Health operates on a performance-based care model where clients only pay when members achieve measurable clinical results such as improved A1C levels or weight loss.
  • The technology addresses the growing use of GLP-1 medications by providing personalized pathways to reduce long-term dependence on costly diabetes drugs.

Multimodal AI System Demonstrates Superior Survival Prediction for Hepatocellular Carcinoma Immunotherapy

AI
  • A novel multimodal fusion (MMF) system combining CT imaging-based deep learning with clinical features achieved C-index values of 0.74 for overall survival and 0.69 for progression-free survival in predicting outcomes for unresectable hepatocellular carcinoma patients receiving immune checkpoint inhibitors.
  • The MMF system outperformed traditional assessment methods by 29.8% for overall survival prediction compared to mRECIST criteria and demonstrated consistent risk stratification across diverse clinical subgroups in a multicenter validation study of 859 patients.
  • Biological analysis revealed the system's predictions correlate with key molecular pathways including PI3K-Akt signaling and tumor suppressor genes like GCK, providing mechanistic insights into immunotherapy response patterns in hepatocellular carcinoma.

A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

NCT04102098Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 12/31/2019

Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors

NCT03821935Active, Not RecruitingPhase 1
AbbVie
Posted 2/21/2019

Ellipsis Health Raises $45M Series A to Launch Sage, AI Care Manager with Emotional Intelligence

AI
  • Ellipsis Health secured $45 million in Series A funding led by Salesforce, Khosla Ventures, and CVS Health Ventures to advance AI-powered care management solutions.
  • The company unveiled Sage, an emotionally intelligent AI Care Manager that adjusts its tone and approach based on patient emotional states and mental health needs.
  • Sage leverages patented vocal biomarker technology trained on millions of clinical patient calls to support complex patients who drive majority of healthcare costs.
  • The AI platform integrates with Salesforce Health Cloud to address staffing shortages and reduce operating costs while maintaining high-quality patient engagement.

Viz.ai Receives First FDA Clearance for AI-Powered Subdural Hemorrhage Measurement Technology

AI
  • Viz.ai has received FDA 510(k) clearance for Viz Subdural Plus, the first comprehensive AI solution for quantifying subdural hemorrhages on CT scans.
  • The technology automatically measures volume, thickness, and midline shift of subdural collections, streamlining what has traditionally been a manual process.
  • Chronic subdural hematoma is projected to become the most common cranial neurosurgical condition, with approximately 60,000 new cases annually by 2030.
  • The AI tool is particularly valuable for guiding treatment decisions in elderly patients and those on anticoagulants, especially for MMA embolization procedures.

Iom Bioworks Secures Rs 4 Crore Seed Funding to Advance AI-Powered Gut Microbiome Healthcare Platform

AI
  • Bengaluru-based deep science startup Iom Bioworks raised Rs 4 crore in seed funding led by Inflection Point Ventures to develop personalized gut microbiome healthcare solutions.
  • The company has achieved significant early traction with over 500 customers in its first year and secured two granted patents with two more in advanced stages.
  • The startup's AI-powered platform uses large-scale knowledge graphs and advanced modeling to provide personalized health recommendations based on individual gut bacterial composition.
  • Funding will be used to strengthen infrastructure, scale scientific and commercial teams, expand marketing efforts, and secure global intellectual property rights.

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