BETA
Clinical-stage medical device developer investigating alternating magnetic fields as an adjunct treatment for infected orthopedic implants.
Solenic Medical is an Addison, Texas medical device developer led by CEO Bart Bandy. It develops SOLA-2, an alternating magnetic field platform intended to address bacterial biofilm on metallic orthopedic implants.
External coils generate magnetic fields intended to produce controlled heating at the implant surface and disrupt biofilm. The technology is being studied alongside established infection treatment. In the AMPLIFY knee-implant trial, all participants receive debridement, antibiotics and implant-retention surgery; SOLA-2 is evaluated as an additional intervention, rather than as a proven replacement for surgery or antibiotics.
Solenic announced FDA authorization to initiate a pivotal investigation in June 2026. The AMPLIFY registry’s October 2026 update lists recruiting status and a planned enrollment of 165. The company previously disclosed a US$5.1 million Series A round led by Johnson & Johnson Innovation–JJDC in June 2023.
SOLA-2 remains investigational and is not approved for commercial use. Solenic announced FDA Investigational Device Exemption authorization for its pivotal study in June 2026; this authorizes clinical investigation rather than commercial sale. [4][1][2]
AMPLIFY (NCT07700927) includes an initial open-label sentinel stage followed by a randomized sham-controlled stage. All participants receive debridement, antibiotics and implant-retention surgery plus pathogen-appropriate antibiotics. Its October 30, 2026 registry update lists recruiting status and estimated enrollment of 165; the planned sample size is not a count of treated patients. [4][1][2]
Latest recorded source review: 2026-11-06.
Scope: selected product families.
No commercially marketed product portfolio has been established in the reviewed material.
External-coil system designed to create controlled heating at a metallic implant surface to target biofilm. AMPLIFY evaluates its use in adults with knee periprosthetic joint infection as an adjunct to debridement, antibiotics and implant retention. [4]
Investigational · AMPLIFY clinical studyThe registry update describes a staged investigation with planned enrollment of 165 participants. [1]
Solenic announced the appointment of the Shockwave Medical founder as chairman of its board. [6]
The company announced FDA authorization to initiate a clinical investigation of SOLA-2 for periprosthetic joint infections. [2]
The financing was led by Johnson & Johnson Innovation–JJDC, with ShangBay Capital and Highpoint Ventures participating. [6]
Accessed 11/06/2026