Solenic Medical Announces Successful Use of Its AMF Technology Under FDA Compassionate Use Authorization
Company to Exhibit at American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting 2025
DALLAS, Oct. 21, 2025 (GLOBE NEWSWIRE) -- Solenic Medical, a medical device company developing an innovative treatment for orthopedic implant infections, today announced the successful, FDA-authorized compassionate use of its investigational Alternating Magnetic Field (AMF) technology. The noninvasive AMF treatment was delivered as an adjunct to surgery in a patient with a serious medical condition involving a prosthetic joint infection (PJI). PJI is a debilitating and costly complication that typically requires surgical intervention, often involving 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 that the treatment has progressed positively. This case follows the completion of enrollment in Solenic’s human feasibility safety study with collected patient follow-up ranging from 6 weeks to 3 months. Again, 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,” said Bart Bandy, Solenic Medical CEO. “Looking ahead, we are also excited to connect with orthopedic surgeons attending the upcoming AAHKS meeting to discuss how we are advancing our AMF technology and our intent to bring it to more patients soon. We are committed to addressing this un-met 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 allow 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.
The Solenic Medical team will be participating in the American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting, taking place in Dallas from October 24th–25th. The company will host Booth #433, where they will engage with attending members from the orthopedic surgical community.
About Solenic Medical, Inc.
Solenic Medical, Inc. is a medical device company founded to develop and commercialize a method for treating implant infections, with their 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 the surface of medical implants. 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. For more information, please visit https://www.solenic.com.
Company Contact:
Solenic Medical, Inc.
Jose F. Guzman
VP Strategic Marketing
+1 (877) SOLEN1C (765-3612)
jose.guzman@solenic.com
Investor and Media Contact
Daniel Kontoh-Boateng
DKB Partners, LLC
Tel: +1-862-213-1398
dboateng@dkbpartners.net
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