Intelligent Implants, a medtech company based in Cork, Ireland, has developed the SmartFuse TLIF cage, a spinal implant intended to enhance bone healing and reduce rates of non-union following spinal fusion surgery. The implant is equipped with electrodes that are designed to enhance bone growth, as well as provide a means of monitoring bone healing.
A significant proportion of spinal fusion surgeries fail, leading to complications including pain and the requirement for corrective procedures. In many cases, spinal fusion fails because of non-union, where the vertebrae do not fuse. The SmartFuse TLIF cage implant is intended to tackle this by providing electrical stimulation, which the company reports can significantly enhance bone healing.
The SmartFuse implant received Breakthrough Device Designation from the FDA in 2021, and Intelligent Implants is aiming for a first-in-human study soon. The technology may also have potential in other orthopedic applications beyond the spine.
Medgadget had the opportunity to speak with Ben Hertzog, CEO of Intelligent Implants, about the technology.
Conn Hastings, Medgadget: Please give us an overview of failed spinal fusion surgeries and the consequences they have for patients and healthcare systems.
Ben Hertzog, Intelligent Implants: There are over 600,000 spinal fusion surgeries in the US every year (~ 1.5M worldwide) to treat degenerative disc disease. This is an invasive and costly procedure, sometimes cited as the costliest surgical procedure in the US. When it works, spinal fusion can be a game-changer for patients suffering from chronic back pain. However, we still see an unacceptably high rate of non-union (ie, when the vertebrae fail to fuse). It is estimated that 10-40% of spinal fusion procedures result in failed fusion, with an estimated $ 16B of associated economic waste in the US alone. The “soft costs” of failed fusions are even higher. Failed fusion is frustrating for the surgeon but can be devastating for the patient, often resulting in significant pain (lasting months and often requiring opioids), complex revision surgery (often with poor outcomes), lost work, and generally diminished quality of life.
Medgadget: What do you think is needed to remedy the high failure rates in spinal fusion surgery?
Ben Hertzog: There are something like 500 different implants approved for use in spinal fusion, yet we are still dealing with these high rates of non-union in high-risk and complex cases. There have been amazing advances in materials and implant design, but nothing has dramatically improved outcomes yet. Biologics, such as Bone Morphogenic Protein (BMP), have been shown to grow significantly bone, but they have also struggled to improve outcomes in clinical use. In addition, they are very expensive and involve ongoing debates regarding complications. We believe new technologies are needed that can both accelerate and control bone growth. This is our mission at Intelligent Implants.
Medgadget: What inspired the company to develop a smart spinal implant?
Ben Hertzog: The genesis of our company starts with our co-founders Dr. Rory Murphy (Neurosurgeon, Barrow Brain and Spine, Phoenix AZ) and our CTO, Erik Zellmer, Ph.D. They realized there was an opportunity to do something interesting by applying the concepts and technology of neurostimulation (the focus of Erik’s Ph.D.) to orthopedics and spinal fusion. This idea eventually became the SmartFuse system.
Medgadget: Please give us an overview of the SmartFuse system and how it works.
Ben Hertzog: SmartFuse is a wirelessly enabled, active implant technology that uses an array of electrodes to stimulate, control, and monitor bone growth. The system is comprised of an implant to deliver local electrical stimulation to accelerate bone growth, an external “wearable” to wirelessly power and communicate with the implant, and a cloud-based physician portal and patient App.
Medgadget: How did the idea for the implant come about? How did you realize that electrical stimulation could enhance spinal healing?
Ben Hertzog: Electric signals are part of nature and core to our physiology. We have known for many decades that electrical signals play a crucial role in the body’s process of creating new bone. In fact, it is also known that if an external electrical signal is applied in the appropriate manner, we can stimulate the formation of bone. What our company has done is applied neurostimulation principles and advanced micro-electronic design to create the first wireless implant that can deliver this electrical stimulation directly to the site where the new bone is needed, and do it in a way that we have precise control over that stimulation.
Medgadget: What type of data does the implant generate, and how can it help clinicians make treatment decisions?
Ben Hertzog: In addition to stimulation, we can also use the implant to measure the electrical properties of the surgical site. The electrical properties of the mature (healed) bone are quite different than that of the immediate post-operative surgical site, so by measuring these properties, over time, we can actually detect the new bone being formed and present this data to the surgeon in a way that is indicative of healing. Our SmartFuse Cloud system enables the physician to access the data in real-time. We can also track patient compliance and system status. Overall, we can provide the surgeon with an unprecedented view into the patient’s post-operative journey, including how well they are healing. We believe this ability to accelerate bone growth AND monitor healing and patient compliance has the potential to improve outcomes dramatically.
Medgadget: How has the system performed so far in reducing non-union and enhancing bone healing?
Ben Hertzog: We have demonstrated in a chronic, large animal (ovine) model of spinal fusion that SmartFuse can increase the quantity of new bone by 3X and improve the quality of that bone versus a standard (eg, unstimulated) control.
Medgadget: Congratulations on receiving Breakthrough Device Designation for the SmartFuse System. What is next for the technology?
Ben Hertzog: As a company, our big focus right now is all on getting the SmartFuse system into the clinic for a first-in-human study for spinal fusion. We see SmartFuse as a platform technology that can be applied to almost any orthopedic implant where you want to accelerate and monitor healing. We are working on other orthopedic indications in addition to the spine.