OsteoWeld is transforming musculoskeletal health through innovation
We have already developed the underlying technology for the SutureWeld and Alpha Nail implants which consists of an ultrasonic generator, a first-generation ultrasonic handpiece and first-generation implants. The handpiece has been developed to be limited re-use and give surgeon interface feedback.
We are at Technology Readiness Level (TRL) 5 with initial 510K US regulatory approval, with further development programmes planned.
We are currently preparing a Seed Investment Round to attract the required funding towards market launch of the first product: SutureWeld. The investment will support finalising the design and set-up manufacturing of the OsteoWeld generator and the SutureWeld instrumentation and implants, ISO certification and further FDA / 510k approvals for US market launch. The Seed Investment Round is expected to close in H1 2022 allowing us to launch the SutureWeld in the US market by 2023.
In April 2021 we were awarded a €100k Stepping Stone Fund convertible loan, and in July 2021 were awarded a £500k SMART award by Innovate UK. The grant will support a research project, run in collaboration with the University of Birmingham, to develop our next-generation SutureWeld instrumentation and implant. The project will focus on both implant material and design as well as developing the instrumentation to be user friendly and as sustainable as possible.
We are working towards ISO 13485:2016 Medical Devices Quality Management Systems and ISO 14001:2015 Environmental Management Systems certification as part of our commitment to innovation, patient safety and sustainability.