Intelligent Implants aims to help patients 'grow' or fix the spine
Spinal surgery is a field of medicine not for the faint of heart even in the best of times, but Intelligent Implants has raised $8.7 million to make spinal operations less painful.
The company's smart implants are being used for the first time in spinal fusion surgery, where two or more vertebrae are permanently joined to improve stability, correct deformities or reduce pain. More than a million such operations are performed worldwide, but they are usually considered a last resort due to the risk of complications or persistent pain after surgery.
Intelligent Implants uses wireless implantable electronics to stimulate, control and monitor bone growth. The company notes that the current state of postoperative care potentially involves long-term dependence on physical therapy and/or painkillers. Intelligent Implants is pushing the market to adopt a more technologically advanced solution.
The company's active smart implants are not the first devices in this category. Everyone is familiar with pacemakers and cochlear implants, which became available in the 1950s and 1970s, respectively. Intelligent Implants' innovation lies in creating a solution that requires no wires or batteries. The device is placed between the vertebrae using the same standard surgical procedure as existing inactive implants.
The device is then powered from an external source via induction, much like a phone can use a wireless charging pad. This creates an electric field that stimulates and guides bone growth.
“I wish this surgery on no one, but if you need to have it, we must make sure the results are as good as possible”
The electrodes used for stimulation can also serve as sensors. The device consists of a standard orthopedic implant with the addition of "some extra magic." In this case, the magic is a set of electrodes that can be used for neuromodulation to promote bone growth, plus some antennas and electronics to control all of it.
After surgery, patients wear a spinal brace to keep the spine in the correct position. The brace is a convenient place to store the power supply and device controls. According to Zellmer, smart implants gain their sensing control almost as a side effect of stimulating bone growth. He explains that the device can measure impedance (the complex resistance between two circuit nodes). The spine does not work very well at first, so as the graft material is gradually replaced by bone in the body, the electrical signature changes, and during this process you can measure bone growth.
The company's product, called SmartFuse, received the FDA (U.S. Food and Drug Administration) Breakthrough Device designation. The government agency considers that the "device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases." The company explained that to join this program, it completed trials in large animals (sheep), which showed three times greater bone growth and reduced fusion time by 50%.
The CEO noted that it is quite unusual to receive Breakthrough Device status based on preclinical data. Most devices receive it because results are based on human trials. Company employees "held a big dance party in the office when they got the news."
So far, Intelligent Implants has used sheep for its trials, as sheep and goats are the most commonly used animals in orthopedic research. The company plans to conduct its first human clinical trials in 2023.
“After a family member suffered a serious injury, we decided to tackle this complex problem. We knew our solution would only work if the company's team had deep domain expertise and long-term commitment, and if we could adapt our technology to surgeons' current practices (standards of care). We are now more than halfway to bringing our SmartFuse product to market, and the FDA decision confirms that this approach was the right one”
The company took part in the SOSV HAX technical program (a startup development program) before it ended. It raised $5.2 million from the EIC Accelerator (European Innovation Council), with participation from SOSV, and another $3.5 million from a group of Swedish angel investors.
“We met SOSV partner Bill Liao back in 2015, and he has supported us ever since. That is a long time for a venture firm, and they have done truly amazing work both in helping us with operations and in providing support at every stage. I think it's impressive: we are doing something very complex here. This is a Class III device, an implantable device with a stimulation system. What we are doing is completely new, and bringing this into orthopedics shows our vision and intuition”
SOSV Managing Partner Bill Liao said: "Building implantable technology is as difficult as it gets, and Intelligent Implants has moved forward with remarkable consistency. We are proud to keep supporting them on this path to help millions of patients and serve a market that will reach $9 billion in a few years."
