FDA approved Solenic Medical’s Investigational Device Exemption application, authorizing the launch of a pivotal clinical trial for its SOLA-2 Alternating Magnetic Field (AMF) System in patients with periprosthetic joint infections.
The pivotal study will evaluate the safety and effectiveness of SOLA-2 in patients with infected knee replacements through enrollment at U.S. orthopedic and academic centers. 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, avoiding implant removal.
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. The study demonstrated that 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.
Bart Bandy, Chief Executive Officer of Solenic Medical, 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.”
FDA approved Solenic Medical's Investigational Device Exemption application, authorizing the launch of a pivotal clinical trial for its SOLA-2 Alternating Magnetic Field (AMF) System in patients with periprosthetic joint infections.
The pivotal study will evaluate the safety and effectiveness of SOLA-2 in patients with infected knee...
FDA approved Solenic Medical’s Investigational Device Exemption application, authorizing the launch of a pivotal clinical trial for its SOLA-2 Alternating Magnetic Field (AMF) System in patients with periprosthetic joint infections.
The pivotal study will evaluate the safety and effectiveness of SOLA-2 in patients with infected knee replacements through enrollment at U.S. orthopedic and academic centers. 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, avoiding implant removal.
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. The study demonstrated that 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.
Bart Bandy, Chief Executive Officer of Solenic Medical, 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.”
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