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SmartFuse · Project

Wireless Bio-Electrical Implants to Prevent Spinal Fusion Surgery Failures

healthTestedTRL 6

Imagine a spinal implant that acts like a smart battery and sensor in one. It uses tiny electrical pulses to nudge bone to grow faster and stronger, similar to how a pacemaker helps a heart. It also sends a wireless signal to a doctor's device to show exactly how the healing is progressing without needing extra X-rays.

By the numbers
18%
failure rate of spinal fusion surgeries due to non-union
1cc
maximum volume of enclosed electronics
The business problem

What needed solving

Spinal fusion surgeries have an 18% failure rate because vertebrae sometimes fail to fuse. This leads to severe complications and the need for costly, painful revision surgeries.

The solution

What was built

A wirelessly powered TLIF cage implant with embedded electronics and a matching ECAP external IoT device for data and power transmission.

Audience

Who needs this

Orthopedic implant manufacturersSpinal surgeonsMedical IoT device developersHospital procurement departments
Business applications

Who can put this to work

Medical Device Manufacturing
enterprise
Target: Orthopedic implant manufacturer

If you are an implant manufacturer dealing with high revision rates due to non-union — this project developed a wirelessly powered bio-electrical stimulation system that reduces the 18% failure rate of spinal fusions. It integrates electronics into a PEEK and titanium cage to accelerate bone growth.

Digital Health
mid-size
Target: IoT healthcare software provider

If you are a software provider dealing with a lack of real-time post-surgical data — this project developed an ECAP external electronics unit that provides real-time feedback on bone healing progress. This allows for remote monitoring of the patient's recovery process.

Specialized Surgery
SME
Target: Private spinal surgery clinic

If you are a clinic dealing with devastating complications from failed spinal fusions — this project developed the SmartFuse system that controls the formation of new bone. This ensures a higher success rate for patients who have no other options for relief.

Frequently asked

Quick answers

What is the cost or price of the system?

Based on available project data, specific pricing is not mentioned, but the design was intentionally developed to maintain cost-effectiveness and manufacturability.

Can this be produced at an industrial scale?

Yes, the project developed novel construction techniques for PEEK and titanium components to allow for cost-effective manufacturing of the high-strength cages.

What is the IP or licensing status?

The project utilizes a proprietary, wirelessly powered bio-electrical stimulation system, though specific patent numbers are not listed in the provided data.

What is the timeline for market entry?

The system is intended for a first-in-human (FIH) clinical study in mid 2024, followed by a pivotal study for market approvals.

How does the system integrate with existing hospital workflows?

It integrates via an ECAP external electronics unit with a mobile data connection, allowing physicians and caregivers to receive real-time feedback on healing.

Consortium

Who built it

The project is led by a single Swedish SME, Intelligent Implants Sweden AB. With a 100% industry ratio and no university or research partners, the project is lean and focused entirely on commercial product development and clinical translation.

How to reach the team

Contact Intelligent Implants Sweden AB regarding the SmartFuse clinical pilot trial

Next steps

Talk to the team behind this work.

Contact us to explore licensing opportunities for bio-electrical stimulation implants.

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