FDA Approves Study on Magnetic Field Treatment for Periprosthetic Joint Infections

Solenic Medical has earned U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to conduct a pivotal clinical trial evaluating its SOLA-2 Alternating Magnetic Field (AMF) System in patients with periprosthetic joint infections (PJI).

The approval is a major value-building milestone for Solenic, allowing the company to start a clinical study that could support future FDA marketing authorization for potentially the first non-invasive treatment to help eradicate biofilm on infected orthopedic implants. The pivotal study will evaluate SOLA-2’s safety and effectiveness in patients with infected knee replacements through enrollment at national orthopedic and academic centers and is expected to serve as the foundation for future regulatory submissions.

“FDA IDE approval marks a pivotal milestone for Solenic Medical and validates years of scientific and clinical development,” Solenic Medical CEO Bart Bandy said. “We believe SOLA-2 has the potential to fundamentally transform how periprosthetic joint infections are treated and generate the positive clinical evidence needed to bring a potentially paradigm-shifting technology to patients, physicians, and healthcare systems worldwide.”

Periprosthetic joint infections are among the most serious and costly complications in orthopedics, with hip, knee, and shoulder PJI imposing an estimated global healthcare cost burden of more than $6 billion annually, with projections exceeding $15 billion per year by 2035. These infections often require multiple surgeries, prolonged hospitalization, extended antibiotic therapy, and, in many cases, implant removal and replacement. Despite this clinical and economic burden, treatment options are limited, and meaningful failure rates have remained relatively unchanged for decades. SOLA-2 leverages Solenic’s proprietary AMF technology to precisely heat the outer surface of metallic implants and disrupt bacterial biofilms, the underlying driver of implant infections, thereby avoiding implant removal.

“Periprosthetic joint infection remains one of the most challenging problems in arthroplasty care,” said Antonia Chen, M.D., chair and professor, Department of Orthopedic Surgery; president, American Association of Hip and Knee Surgeons; and Solenic Medical Advisory Board member. “A non-invasive technology designed to safely target biofilm on the entire implant surface would represent an important advancement in infection therapy for patients and surgeons, particularly if it reduces the need for more invasive procedures.”

Solenic previously evaluated the SOLA-2 AMF System in an early feasibility study involving adult patients diagnosed with knee implant infection undergoing debridement, antibiotics, and implant retention, also known as DAIR. The study demonstrated the SOLA-2 performed as intended with no device-related adverse events and helped inform the design of the FDA-authorized pivotal trial, which represents the next major step in Solenic’s clinical and regulatory development pathway. 

Periprosthetic joint infections occur when bacteria colonize the area around an artificial joint implant. These infections can be difficult to treat because bacteria may form biofilm on implant surfaces, making them more resistant to antibiotics and host immune response. Current treatment options often involve prolonged antibiotics, surgical debridement, implant retention in selected patients, or staged revision surgery involving implant removal and replacement.

Solenic Medical is a clinical-stage medical technology company developing non-invasive solutions for metallic implant-associated infections. The company’s proprietary Alternating Magnetic Field (AMF) platform, SOLA-2, addresses one of the most challenging problems in modern orthopedics: biofilm-related infections. This approach addresses a critical unmet need in orthopedics, crucial for an aging population and increased patient volumes undergoing total joint procedures. Additional metallic implant applications have been identified and protected under patent. SOLA-2 is an investigational device and has not been approved for commercial use.