TEXAS – July 29, 2020 – Solenic Medical, a developer of a device that uses alternating magnetic fields to treat a prosthetic joint infections (PJI) announced today that it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). Breakthrough Designation is reserved for devices or technologies that may provide for more effective treatment of life-threatening or irreversibly debilitating conditions in order to give patients timely access. The patent-pending technology exclusively licensed from University of Texas Southwestern Medical Center (UTSW) offers an approach for the eradication of biofilm on metallic implants with the advantage of being a completely non-invasive treatment of PJI. Initially targeting the metallic components of knee implants, this product is the first in the company's pipeline of treatments for most metallic medical implants including knees, hips, elbows, trauma devices and more.
James Y. Lancaster, CEO of Solenic Medical, said, “I am pleased with the work of our team that has allowed us to demonstrate our product’s merit and to be recognized as a Breakthrough Device. This designation provides us with priority review and access to designated FDA team members throughout the development and marketing authorization process. This technology meets a significant need for solutions to prosthetic joint infections that risk the mobility of our growing aging population. As patients live longer with their artificial joints, the chance of infection has increased along with the number of patients having multiple implants in their lifetime.”
Each year in the United States, over 1 million total knee and hip replacements are performed, and these operations are projected to increase by 637% and 174% respectively by the year 2030. Prosthetic joint infections (PJI) is one of the most serious complications in the field of arthroplasty. Currently, treatment of PJI can involve a two-stage revision requiring two additional surgeries and weeks of antibiotic treatment. While it can be effective, the two-stage revision procedure has a high failure rate, poses significant morbidity to high-risk patients, is associated with a negative impact on quality of life, and is very expensive. The projected total annual cost to treat patients with PJIs in the U.S. in 2020 is a staggering $1.6 billion, representing a major cost to the healthcare system. The challenges are even greater for open wound trauma patients with a typically high infection risk over 30%.”
A major impediment to effective treatment of PJI is the presence of biofilm, a thin film produced by bacteria that forms a protective shield around the joint and impairs the effectiveness of both antibiotics and the immune system. Biofilm is associated with infections of many widely used medical implants such as catheters, mechanical heart valves, intrauterine devices and trauma implants as well as prosthetic joints. The inability to eradicate biofilm is the primary reason that surgical replacement of an implant remains the standard of care for the treatment of PJI and other implants such as trauma plates and rods.
James Y. Lancaster, CEO of Solenic Medical, said, “The Breakthrough Device designation is a key step in this year’s path to market. Another key step underway right now is a large animal trial at the University of Utah to test the latest version of the device and transducer combination. Thanks to the FDA designation things will move rapid fire with a series of safety studies to finish the year at UTSW as well as many rounds of software simulations on various medical implant models. We have a lot to do, but we will go into 2021 with a lot of momentum towards a target of our first human patient in early 2022.”
About Solenic Medical, Inc.
Solenic Medical, Inc. is a medical device company founded to develop and commercialize a method for treating prosthetic joint infections (PJI). Solenic will leverage the unique properties of alternating magnetic fields (AMF) generated from external coils to eradicate 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. Solenic Medical, Inc. is a VIC Technology Venture Development™ portfolio company. For more information, please visit https://www.solenic.com