Solenic Medical, Inc.
Solenic Medical Inc. is pioneering a non-invasive solution for infected metallic implants using patented alternating magnetic field (AMF) technology. Their mission is to eradicate biofilms on implant surfaces, effectively treating a common and costly surgical complication, with the goal of replacing risky and expensive revision surgeries and transforming the standard of care.
Industries
Nr. of Employees
small (1-50)
Solenic Medical, Inc.
College Station, Texas, United States, North America
Products
First‑generation investigational AMF knee system
Investigational, non‑contact device system designed to deliver alternating magnetic fields to compatible metallic knee implant components to thermally target biofilm in an operating room setting.
First‑generation investigational AMF knee system
Investigational, non‑contact device system designed to deliver alternating magnetic fields to compatible metallic knee implant components to thermally target biofilm in an operating room setting.
Services
Early feasibility clinical trials under IDE
Conduct and manage FDA-approved investigational device studies for AMF treatment of total knee implant infections, including site coordination and patient enrollment in limited-scope trials.
Preclinical GLP large‑animal testing and translational research
Design and execution of GLP-compliant large-animal studies and preclinical experiments to evaluate AMF efficacy, safety, and combination therapies for implant-associated infections.
Regulatory and quality system advisory for medical devices
Advisory services in quality management system development and regulatory strategy for device development and submissions based on internal regulatory experience.
Early feasibility clinical trials under IDE
Conduct and manage FDA-approved investigational device studies for AMF treatment of total knee implant infections, including site coordination and patient enrollment in limited-scope trials.
Preclinical GLP large‑animal testing and translational research
Design and execution of GLP-compliant large-animal studies and preclinical experiments to evaluate AMF efficacy, safety, and combination therapies for implant-associated infections.
Regulatory and quality system advisory for medical devices
Advisory services in quality management system development and regulatory strategy for device development and submissions based on internal regulatory experience.
Expertise Areas
- Orthopedic implant infection treatment
- Clinical trial design and execution (IDE/early feasibility)
- Medical device electromagnetic engineering
- Preclinical large‑animal implant models
Key Technologies
- Alternating magnetic field (AMF) induction heating
- Electromagnetic coil and field shaping
- Thermal dosimetry and computational modeling
- Infrared thermal imaging