RF-EOI-24-003
Accelerating spinal fusion with implantable electronics
Layperson summary
One in seven patients undergoing surgery to fuse a worn spine experiences a delay or failure in bone healing. This results in prolonged pain, poor function, and redo surgery. We have invented a miniature electronic device that can be embedded within an orthopaedic implant. Our device controllably accelerates bone growth around the implant, and wirelessly monitors the healing response. Our pre-clinical and animal trials show that bone grows twice as fast around implants with our device. We have designed a prototype spinal fusion implant, our first of many clinical applications. ORUK support will fund design iteration of this prototype and its accompanying surgical instruments, and mechanical safety and usability testing. We have our first patent filing, a commercial and regulatory strategy, and industry engagement. This work is the next step towards a first-in-human clinical trial in 2026.
Aim of your proposed research
Our device delivers electromechanical stimuli to amplify bone’s innate healing response. Our animal-trial prototype showed that the device accelerates bone growth at the implant-bone interface, while wirelessly transmitting data related to this effect. Our first human-scale prototype is a lumbar spinal fusion implant with our device embedded at its core. The aims of the proposed research are to 1) iterate on its design, 2) manufacture 16 beta prototypes and undertake mechanical safety testing, and 3) characterise the new device’s electromechanical performance relative to our animal-trial prototype results.
Your research methodology
Development under an ISO13485 Quality Management System (QMS) co-implemented with Imperial’s MedTechONE team will consist of:
1) Iteration of our alpha prototype based on feedback from a formative usability study at the North American Spine Society annual meeting (NASS, October 2024), following IEC62366;
2) Pilot production of sixteen beta-prototype implants outsourced to our ISO13485-compliant manufacturing partners;
3) Electrical characterisation using electric field probes;
4) Mechanical characterisation using laser doppler vibrometry and acoustic measurement;
5) Biological characterisation using in vitro cell models and ex vivo organ models;
6) Safety testing to IEC60601.
Impact of your proposed research
Our technology will accelerate bone growth for faster, more reliable healing around spinal fusion implants. We expect to halve time-to-fusion and drastically reduce non-union, currently up to 12 months and 1 in 7 respectively. This ORUK-supported research will progress us from Technology Readiness Level 4 (TRL4, proven in a large-animal trial) to TRL5 (ready for clinical trials) with a first-in-human device that is usable, robust, and effective. While our first product is for spinal fusion, our bone-growth acceleration technology will be relevant to 15m patients per year across orthopaedics; future embodiments will include cementless knee arthroplasty and fracture fixation systems.
Are you a start-up?
Yes
Research activity area follow definitions provided in UKCRC Health Research Analysis 2022
Treatment Development
Amount requested (£)
£100,000
Duration (months)
12 months
Start date
01-01-2025
Is there an external research partner?
No
Is there an Intellectual Property (IP) linked to this research?
Yes
If so, who owns and maintains this patent?
Owned by Imperial College, exclusively licensed to and maintained by Embed Biotech Limited, automatic assignment on exit or business criticality.
Will you be testing on animals?
No
Have you previously received funding from ORUK?
No