Solenic Medical’s investigational Alternating Magnetic Field (AMF) technology has been used for the first time in a U.S. Food and Drug Administration (FDA)-authorized compassionate use case, the company announced. The noninvasive AMF treatment was delivered as an adjunct to surgery in a patient suffering from a prosthetic joint infection (PJI).

PJI is a debilitating and costly complication that typically involves surgery, often requiring complex, aggressive procedures. In severe cases, PJI can lead to amputation or death at rates comparable to many well-known cancers.

The compassionate use of the Solenic AMF treatment was performed in collaboration with the patient’s care team. No device-related adverse events have been reported to date, and on-going patient monitoring has indicated the treatment has progressed positively. This case follows enrollment completion in Solenic’s human feasibility safety study with collected patient follow-up ranging from six weeks to three months. No device-related adverse events have been reported to date from that study.

“We are highly encouraged to see the continued progress in the compassionate use patient’s recovery,” Solenic Medical CEO Bart Bandy said. “We are committed to addressing this unmet need and bring to market an effective, non-invasive new standard of care for patients with this challenging condition, recognizing that global joint replacement procedures are projected to grow at a record pace over the next five years.”

This compassionate use case was made possible through FDA’s Expanded Access program, which allows patients with a serious or immediately life-threatening disease or condition, and without satisfactory alternatives, to access investigational products. FDA’s authorization was specific to this single patient and is not indicative of broader approval or availability. The Solenic AMF technology (Sola2 AMF Knee System) is an investigational device and has not received FDA marketing authorization for commercial use.

Solenic Medical Inc. is developing and hopes to commercialize a method for treating implant infections, with an initial focus on prosthetic joint infections (PJI). Solenic will leverage the unique properties of alternating magnetic fields (AMF) generated from non-invasive technology to neutralize biofilm on medical implant surfaces. This non-invasive treatment addresses a major complication of various surgeries, such as knee and hip replacements, as well as in trauma-related implants such as plates and rods. This is particularly important given an aging population and the rapid increase in the number of these procedures being performed every year, according to the company.