At KweHealth, we are pioneering a new era in regenerative science by advancing exosome therapeutics as our core platform and developing complementary cell therapies alongside them. Our mission is to deliver transformative therapies for some of the most intractable diseases that modern medicine struggles to treat—including neurodegenerative disorders, chronic pain, wound healing, orthopedic conditions, and musculoskeletal disorders.

We believe breakthroughs happen through collaboration. That’s why we partner with researchers, clinicians, and institutions who share our vision of advancing regenerative medicine. Whether in early-stage research or clinical trials, we provide not only access to our novel products but also comprehensive support to accelerate your journey from concept to clinic.

  • We provide expert guidance through the complex regulatory landscape:

    • Expert Guidance: Deep expertise in IND/IRB submissions and case reports, with applications prepared to meet the highest regulatory standards.

    • Customized Solutions: Tailored submission strategies that align with the unique needs of your study.

    • Streamlined Process: Efficient, well-organized workflows designed to minimize delays and accelerate approvals.

    • Documentation Support: Comprehensive preparation, formatting, and organization of all required paperwork.

    • Ongoing Communication: A partner every step of the way, ensuring clarity, transparency, and responsiveness.

  • We bring a science-first, regulation-ready mindset to product development:

    • Cutting-Edge Expertise: Insights from seasoned professionals in CMC, product characterization, and regulatory strategy.

    • Comprehensive Characterization: Access to advanced analytical techniques for in-depth profiling of product quality, safety, and behavior.

    • Robust CMC Strategy: Development of optimized formulations, manufacturing processes, and stability protocols—aligned with FDA and global standards.

    • Regulatory Compliance: Guidance on IND, NDA, and BLA submissions, supported by FDA-approved third-party partners.

    • Tailored Solutions: Flexible services designed for biotech startups, clinics, hospitals, or pharmaceutical companies.

    • Contracted Medical Science Liaisons: Subject matter experts available to help communicate your product’s MOA and value to KOLs and healthcare providers.

  • We integrate AI, biomarker analysis, and advanced analytics to help you demonstrate safety and efficacy with precision:

    • Biomarker-Driven Assessments: Using biomarker insights to evaluate therapeutic impact on specific patient populations and disease backgrounds.

    • Predictive Analytics: Forecasting patient responses and outcomes to inform smarter trial design.

    • Prescriptive Analytics: Guiding optimal strategies for product use and trial execution.

    • Data Visualization & Discovery: Transforming complex datasets into actionable insights.

    • Data Integration & Quality: Ensuring accuracy, consistency, and reliability across multiple data sources.

Partner With Us

If you are a researcher or clinician working on innovative clinical trials or research programs, KweHealth is ready to collaborate. Together, we can navigate the path from discovery to clinical impact—accelerating the development of regenerative therapies that redefine what’s possible in medicine.

Our Collaborative Focus

We are particularly interested in supporting projects targeting:

  • Neurodegenerative disorders (e.g., Parkinson’s, Alzheimer’s, ALS, MS)

  • Chronic pain and difficult-to-treat neurological conditions

  • Wound healing and tissue regeneration

  • Orthopedic and musculoskeletal repair

By combining exosome-based therapeutics, cellular therapies, and advanced analytics, KweHealth provides collaborators with the tools, expertise, and regulatory support needed to bring transformative therapies closer to patients.