Truspine Technologies PLC

The Company is developing revolutionary and uniquely disruptive technologies

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Truspine Technologies Plc

TruSpine Technologies Plc was incorporated on 8 December 2014. On 7 May 2020, a resolution was passed approving a reduction of capital whereby the share premium account of the Company was cancelled by an amount of £2,250,000. The Company re-registered as a public limited company on 28 May 2020. On 20 August 2020 the Company was admitted to the Aquis Stock Exchange Growth Market with the issue of 3,700,442 new ordinary shares raising gross proceeds of circa £1.4m. Since then, the Company has raised a further £2,589,240 through the subscription of 80,201,031 new ordinary shares to date and a further £186,573 in convertible loan notes.

The Company is developing disruptive technologies for use in the spinal stabilisation market, commencing with the following three devices:

-        Cervi-LOK - for the cervical and upper thoracic spine

-        Faci-LOK - for the lumbar and lower thoracic spine, and

-        GRASP Laminoplasty - a treatment for decompression of the spinal cord.

These devices represent a potentially significant development in spinal fixation, by providing stabilisation while not altering the bony spinal anatomy of patients through the use of screws, staples or other devices which currently dominate the spinal market.

The 510(k) application Cervi-LOK was submitted during 2023. There has been regular contact with the FDA and as part of the interaction the FDA has raised a number of points it wishes us to address as part of the process. As would be expected the level of detail, data, and evidence is of a very high standard. We are at present in the process of collating this additional information together. Once this is complete, we can request an interim meeting to ensure all of our additional information and data is exactly what they require, if not beyond that. Where necessary we will conduct additional testing and studies to bring this unique innovation to the market, which could be a game changer for patients and surgeons alike.

The Company signed Heads of Terms for a European partnership with HD Hospital Device S.R.L ("HD"), a long-established medical device business in Italy. The signed Heads of Terms outlines a plan for TruSpine and HD to work together on research and development, developing a European business plan to include potential distribution and manufacturing agreements, subject to agreement on final commercial terms between the two companies. A key element to the strategic partnership strategy will be working with HD, firstly to seek approval for its products and then to develop a commercial business plan.

The Company plans to commence further development work on its other two products in due course, and to review how the intellectual property portfolio of the Company can be expanded over time.

The Company acquired the Patents relating to its technologies from Professor Frank Boehm, (the inventor of the Technologies) pursuant to the IP Sale Agreement. Details of the Patents are set out in paragraph 6 of Part I and details of the IP Sale Agreement are set out at paragraph 9.1 of Part IV in the Company’s Admission Document. The Company protects the intellectual property in its technologies and any future application thereof by submitting patent applications in each country in which it intends to operate. This is an active and ongoing process with new applications being filed to cover revised design, usage and application of the Technologies.

The Global Spinal Devices Market is currently estimated to be worth USD$13.3 billion and is expected to grow at a compound annual growth rate of 5.4 per cent from 2024 to 2030. North America is the single largest and most mature market accounting for around 48.3 per cent of the total global revenues. (Source: the Global Spinal Devices Market Report 2023).

It is important to note that the Products have not yet been used on live patients, as they are still subject to regulatory clearance and approvals by the relevant national medical regulators.

Cervi-LOK and Faci-LOK are spine stabilisation devices used in the fusion of the cervical, thoracic and lumbar spine respectively.  They differ from existing methods of vertebrae stabilisation as they are non-intrusive. Cervi-LOK and Faci-LOK clamp onto specific landmarks of the vertebrae bones rather than requiring fixation with screws.

 The minimally invasive products represent a potentially significant development in spinal fixation, fusion and laminoplasty techniques, providing stabilisation without altering the bony spinal anatomy by requiring screws, staples or other such attachments which dominate the current technologies and irreversibly alter the anatomy of the spine. The Company’s philosophy is one of “preserving nature’s design”, and as such, the devices have been designed to be safe, fast and easy to implant, as well as being minimally intrusive. The Company aims to be one of the first spinal companies to offer single use sterile packaged implants and instruments, which will position the Company favourably, especially in the ambulatory surgical centres in the USA.

 The Directors believe that the Company’s technologies will fill a gap in the market due to its relative health advantages (for example through not altering the patient’s anatomy) as well as its overall lower cost per procedure (resulting from the reduced requirement for fluoroscopy, shorter surgery time and faster patient recovery time). The Company’s technologies cause minimal tissue disruption allowing the normal spine anatomy to remain intact and therefore aids the spinal stabilisation and fusion process.

 The Company has a phased product development strategy and following the submission of the 510(k) to the FDA and subject to regulatory clearance, it plans to commence initial product marketing of Cervi-LOK. The overall aim is to establish the Company’s products as the “go-to solutions” for the spinal stabilisation and fusion market. In addition to the three flagship products, the Company also has a pipeline of additional and complementary IP and product offerings at an early stage of development.

Initially the Company is seeking to obtain clearance for use of its products in the United States. For the products to be lawfully marketed and sold in the United States, they are required to have “clearance” from the FDA. The Company has initially sought FDA clearance for its Cervi-LOK product. The FDA is responsible for protecting the public health in the United States by (amongst other things) ensuring the safety, efficacy, and security of medical devices.

The Company’s products are classified as “Class II” Medical Devices under the FDA’s device classification system and therefore require FDA 510(k) clearance, which does not require clinical studies prior to clearing the devices for marketing and sales. The FDA 510(k) clearance process compares a product to a “predicate device”, measuring safety, function and strength. Under the notion of “substantially equivalent”, if a device performs in testing at least as well as the accepted predicate device, FDA 510(k) clearance will be granted.

Major company analysis in the spinal devices market currently identifies a high number of competitors, who are able to benefit from scale economies. However, these existing competitors’ technologies still utilise invasive technologies like lateral mass and pedicle screws and therefore TruSpine should be well placed to compete within the spinal stabilisation market because, crucially, its products do not alter the bony anatomy of patients.