Cork, Ireland, Gothenburg, Sweden & Houston, Texas (May 28, 2021) — Intelligent Implants Ltd (II), a development-stage, medical device company with offices in Cork, Ireland, Gothenburg, Sweden and Houston, Texas has announced today that its SmartFuse® system has received Breakthrough Device Designation by the US Food and Drug Administration (FDA).
Intelligent Implants SmartFuse technology is a wirelessly enabled orthopedics platform that has been designed to remotely stimulate, control, and monitor bone growth. The goal of the SmartFuse system is to accelerate bone growth and provide remote monitoring of the patient to support real-time clinical decision-making. The first indication for the SmartFuse system will be for use in lumbar spinal fusions.
FDA Breakthrough Device designation is granted to certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal is to give patients and doctors timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval. The Breakthrough Devices Program offers device companies an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help companies receive feedback from the FDA and identify areas of agreement in a timely way. Recipients can also expect prioritized review of their submission and potential Medicare reimbursement through the Medicare Coverage of Innovative Technology payment pathway.
“We are pleased the FDA has granted Breakthrough Device designation for SmartFuse, a next-generation technology platform for orthopedics. It underscores the urgent need for more effective treatments for patients suffering with degenerative disc disease,” said John Zellmer, Chief Executive Officer. “We look forward to working closely with the FDA through future clinical trials and review processes for SmartFuse. We expect to benefit from additional FDA input during premarket development as well during the submission process and through an expedited review once the submission is filed. Our goal is to bring this important new technology to a patient population with a significant unmet medical need.”
“Breakthrough Device Designation is a strong confirmation of the disruptive potential of the SmartFuse System, “said Benjamin Hertzog, Executive Chairman of Intelligent Implants. “I believe that SmartFuse represents the future of medical devices, where we have smart implants designed to not only provide a therapeutic benefit, but to also provide data to support real-time clinical decision making throughout the duration of therapy. The industry has been talking about this paradigm for quite a while now, but with SmartFuse, the future is here.”