Clinical Pipeline
Anasonic is dedicated to advancing its Low-Intensity Pliant Ultrasound (LIPUS) technology through rigorous clinical research. Our clinical pipeline reflects our commitment to validating the safety and efficacy of LIPUS for chronic kidney disease (CKD) treatment and expanding its applications to other medical conditions.
Preclinical Research
Several peer-reviewed papers have been published detailing the preclinical results, supporting the potential of LIPUS as a viable CKD treatment.
Clinical Trials
Exploratory Clinical Trials
- Objective: To evaluate the safety, tolerability, and preliminary efficacy of LIPUS in human CKD patients.
- Design: Open-label, single-arm studies involving a small group of patients to monitor immediate and short-term effects of the therapy.
- Location: Seoul St. Mary’s Hospital
Milestone:
- Clinical trial approval by MFDS (JUL. 2024)
- IRB approval for clinical trials at Seoul St. Mary’s Hospital and Eunpyeong St. Mary’s Hospital (JUN. 2024)
- Completion of the first exploratory clinical trial (JUN. 2025)
- Completion of the second confirmatory/approval clinical trial (JUN. 2026)
Confirmatory Clinical Trials
- Objective: To confirm the efficacy and safety of LIPUS in a larger, more diverse patient population and to provide robust data for regulatory submissions.
- Design: Multicenter, randomized, controlled trials comparing LIPUS treatment with standard care.
- Locations: Multiple leading medical centers worldwide
Trial Phases
- Exploratory Trials (2024): Initial human trials to evaluate safety and efficacy, showing promising results in improving GFR and reducing inflammation.
- Confirmatory Trials (2025-2026): Larger-scale trials aimed at confirming the findings from exploratory trials and securing regulatory approval for widespread clinical use.
Future Directions
Ongoing and Planned Studies
Anasonic is continuously expanding its research efforts to explore new applications and further validate LIPUS technology. Future studies will focus on:
Expansion to Other Conditions
- Investigating the efficacy of LIPUS in treating other chronic conditions such as cardiovascular diseases and neurodegenerative disorders.
Long-Term Efficacy and Safety
- Conducting long-term follow-up studies to ensure sustained benefits and monitor any potential late-onset effects.
Pediatric Trials
- Exploring the use of LIPUS in pediatric patients with CKD to provide early intervention and improve long-term outcomes.
Regulatory Approvals
Anasonic is committed to achieving regulatory approvals for LIPUS technology across multiple regions.
We are working closely with regulatory agencies to meet the necessary standards and bring this innovative treatment to patients worldwide.