Intelligent Implants Secures $8.7M Funding for Spine Growth Technology

Advancements in Spinal Fusion Surgery: Intelligent Implants Secures €7.5 Million

Spinal surgery represents a significant medical undertaking, and Intelligent Implants has recently secured €7.5 million ($8.7 million) in funding to refine and improve the process. The company is focused on developing smart implants specifically for spinal fusion surgery.

The Challenge of Spinal Fusion

Spinal fusion surgery involves the permanent connection of two or more vertebrae to enhance stability, correct deformities, or alleviate pain. Over a million of these procedures are performed globally each year. However, it’s often considered a last resort due to potential complications and the possibility of persistent post-operative pain.

Intelligent Implants' Innovative Approach

Intelligent Implants is pioneering a new approach by utilizing wireless, implantable electronics. These devices are designed to stimulate, monitor, and guide bone growth during the fusion process. Current post-operative care often relies heavily on physical therapy and pain medication, a reliance the company aims to reduce.

A Novel Design: Wirelessly Powered Implants

While implantable devices like pacemakers have existed for decades, Intelligent Implants’ innovation lies in its wire and battery-free design. The SmartFuse implant is positioned between vertebrae using standard surgical techniques, mirroring existing implant procedures.

The implant receives power through external induction, similar to wireless phone charging. This induced electric field actively stimulates and directs bone growth, promoting a more robust fusion.

CEO's Vision for Improved Patient Outcomes

“I don’t wish this surgery on anyone, but if you have to do it, we have to make sure that the outcomes are as good as they can be,” states John Zellmer, CEO of Intelligent Implants, highlighting the company’s commitment to patient well-being.

Beyond Stimulation: Integrated Sensing Capabilities

The electrodes used for stimulation also function as sensors. The implant combines a conventional orthopedic implant with advanced technology, including electrodes for neuromodulation to encourage bone growth, antennas, and control electronics.

Patients typically wear a spinal corset after fusion surgery to maintain proper alignment. This corset conveniently provides a location for the device’s power and control units.

Monitoring Bone Growth Through Impedance Measurements

Zellmer explains that the sensor functionality is a beneficial byproduct of the bone growth stimulation. The device performs impedance measurements; as bone tissue replaces the graft material, the electrical signature changes, allowing for precise monitoring of the fusion process.

FDA Breakthrough Device Designation

The company’s SmartFuse product has received a Breakthrough Device designation from the FDA. This signifies the agency’s belief that the device offers a more effective treatment for debilitating conditions.

Extensive pre-clinical trials on sheep demonstrated promising results, showing three times more bone growth and a 50% reduction in fusion time.

A Rare Achievement: Pre-Clinical Breakthrough Designation

“It is pretty uncommon to get a Breakthrough Device Designation based on pre-clinical data,” Zellmer notes, as most designations are based on human trials. The team celebrated this significant milestone upon receiving the news.

Progressing Towards Human Clinical Trials

To date, Intelligent Implants has conducted trials using sheep and goats, common animal models for orthopedic research. The company plans to initiate its first human clinical trials in 2023.

Driven by Personal Experience and Expertise

“After a family member suffered from poor outcomes we decided to tackle this hard problem. We knew our solution would only work if our team had strong domain knowledge, long-term commitment and if we could fit our technology into the current practices (standard-of-care) of surgeons,” Zellmer shared, emphasizing the personal motivation behind the company’s work.

Funding and Support

The company successfully closed its seed round, raising €4.5 million ($5.2 million) from the EU’s EIC Accelerator and SOSV, alongside an additional €3 million ($3.5 million) from Swedish angel investors.

SOSV partner Bill Liao has been a long-term supporter of Intelligent Implants, providing operational guidance and investment support since 2015.

A Visionary Approach to Implantable Technology

“I think that is spectacular: We are doing something really hard here. This is a Class 3 device, an active implantable device with a stimulation system. What we are doing is totally new, and bringing that into the orthopedics field shows vision and guts,” Zellmer added.

Bill Liao, general partner at SOSV, stated, “Creating implantable technology is about as hard as it gets, and Intelligent Implants have been tremendously steady in its progress. We are proud to keep supporting them on this journey to help millions of patients and serve a market poised to reach $9B in a few years.”