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In our unique search to find the most innovative firms in the medical device industry, we have come up with an inspiring tale of a Texas-based firm that is becoming renowned for developing cutting-edge, non-invasive treatments for metallic implants that have become infected within the body. As phenomenal as their product is, you will find their journey amazing.
This is the success story of two visionaries, both from the esteemed UT Southwestern Medical Center (UTSW). Rajiv Chopra, a Ph.D. holder, with over three decades of experience in the field of image-guided therapy, and David Greenberg, M.D., a clinically active infectious diseases (ID) physician and researcher. They both set out to find an alternative to the current standard of care for treating prosthetic joint infections. After exploring options, they settled on harnessing the power of alternating magnetic fields (AMF) and invented a revolutionary technology that is effective against biofilms on metal implants, disrupting them and eradicating the bacteria to combat periprosthetic joint infections (PJIs). In 2019, Drs. Greenberg and Chopra, together with James Y. Lancaster, then Managing Director for VIC Technology Venture Development LLC., founded Solenic Medical and exclusively licensed the technology from UTSW.
Solenic’s Alternating Magnetic Field Technology: A Quick Brief
Alternating Magnetic Field (AMF) technology kills bacteria and removes biofilm that has formed on the surface of the implant by producing magnetic fields create eddy currents on the surface of the implant which cause metallic implants to heat up even when they are inside the body. This thermal medicine complements the patient’s immune system and antibiotics to combat the infection. Research has indicated a six-order-of-magnitude decrease in biofilm when subjected to temperatures achievable by this technology but within the range of temperatures seen in other procedures. Therapeutic temperatures can be limited to less than 1mm from the implant surface.
An infected prosthetic joint with biofilm becomes more antibiotic-resistant and generally requires surgery to replace it as a curative measure. 2) An alternating magnetic field (AMF) is helpful to heat the surface of metal implants quickly and noninvasively, destroying biofilm. 3) The heat produced by the AMF exposures eliminates the extracellular polymeric substances (EPS) connected to the biofilm and destroys the bacteria. It presents a new, non-invasive approach to biofilm therapy on prosthetic joints.
AMF Technology: An All-in-one Solution for Knee and Hip Replacements
This AMF-based, non-invasive, non-contact treatment aims to address PJIs. It is a complication related to different surgeries, such as knee and hip replacements and orthopedic trauma cases requiring plates, rods, or nails. The current standard of care for chronic infections on medical implants is a two-step revision surgical operation that can be costly and risky. However, this new approach can more effectively treat pressure joint infections (PJIs).
The Impact of Solenic’s Technology
Solenic’s Technology will be helpful in the current scenarios of the aging population, longer lifespans, and sharp growth in the number of orthopedic treatments performed annually. Conventional invasive treatments for pressure injuries (PJIs) can have several drawbacks, such as the need for multiple invasive surgeries with protracted recovery periods, long antibiotic courses, and high costs that put lives at risk and cost the U.S. healthcare system billions of dollars. Because of these difficulties, around 25% of patients regretted their initial decision to replace their injured joints (Shichman I, et al., J Arthroplasty, 2023; doi:10.1016/j.arth.2023.06.015).
Ushering an Innovative Era of Effective Treatment
Initially, DAIR (debridement, antibiotics, and implant retention) is used in conventional treatment to treat prosthetic joint infections. This is done for acute PJI (symptoms for < 30 days) of a well-fixed, functional implant. DAIR aims to control the infection and protect the prosthetic joint. It does so by removing infected tissue, irrigating the joint space with antimicrobial solutions, and targeted antibiotic therapy.
Another option is a two-stage revision, which includes medically removing the contaminated implant, keeping the patient on long-term antibiotics to eradicate the infection, and surgically implanting a new prosthesis. Mostly this treatment is a successful practice. However, it is costly, needs multiple procedures, and harms patient mobility. The total number of knee and hip implants is expected to rise by 174% and 673%, respectively, over the next ten years, indicating the need for creative infection management and treatment approaches. By 2024, the estimated annual cost in the United States to treat patients with prosthetic joint infections is expected to reach an astounding $2 billion.
Significant Obstacles in Implementing Solenic’s Technology
The healthcare landscape has its set of hurdles, especially for a disruptor like Solenic. The AMF device is deployed as a rolling cart with a selection of transducers to deliver the AMF treatment.
Initially, the system could be used in the operating room as an adjunct to a surgical washout or DAIR procedure. The technology is used in this context for in-person surgical methods in the health facility, which might restrict its software to sterile surgical settings. Through in-vivo studies, they aim to demonstrate how AMF is a non-invasive, powerful medicine for infection prevention that can be utilized earlier than surgical treatment for DAIR without requiring sufferers to go through invasive remedies.
Solenic Medical’s Future Outlook
After four years of constantly developing its technology, Solenic Medical looks ahead to taking its non-invasive technology past PJIs in knee and hip replacements to shoulder, elbow, and trauma-related implants, which include plates, rods, and the spine. Each anatomical utility will require a specific transducer design to ensure the magnetic field is correctly implemented and allotted to the first-rate effect.
In addition, in the fiture AMF treatment may also be employed prophylactically in an outpatient setting, and on the days following implantation surgical treatment to prevent the opportunity of early or late implant infection.
Further research is being conducted to demonstrate that AMF technology could facilitate the osseointegration of metal implants with the host bone, as is the case with non-cemented total joint replacement, which is becoming more common in the US.
