The medtech company’s implant for spinal fusion surgery recovery has gained breakthrough device designation in the US.
Cork medtech company Intelligent Implants has received Breakthrough Device Designation by the US Food and Drug Administration (FDA) for its device that monitors recovery after surgeries such as spinal fusion.
The start-up is developing a small implantable device to electrically stimulate and monitor bone growth after a procedure like spinal fusion. The device allows for the remote monitoring of a patient’s recovery in real time.
The company’s first use case of SmartFuse is in lumbar spinal fusions. It said it can help in recovery after surgery and avoid complications.
The Breakthrough Device Designation is an early stage in the process of bringing a medical device to market in the US. It allows a company to review and assess its novel device with the FDA.
It precedes other designations by the authorities such as premarket approval, 510(k) clearance and De Novo authorisation, which have various requirements for use or marketing.
“We are pleased the FDA has granted Breakthrough Device Designation for SmartFuse, a next-generation technology platform for orthopaedics.
“(The designation) underscores the urgent need for more effective treatments for patients suffering with degenerative disc disease,” the start-up’s chief executive John Zellmer said.
“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.”
Intelligent Implants is based in Cork with offices in Gothenburg and Houston. It is backed by Sean O’Sullivan’s SOSV.
Benjamin Hertzog, executive chair of Intelligent Implants, said the designation is a “strong confirmation of the disruptive potential of the SmartFuse system”.
“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,” he said.
“The industry has been talking about this paradigm for quite a while now, but with SmartFuse, the future is here.”
Disclosure: SOSV is an investor in Silicon Republic