Investors

2022

TruSpine Technologies plc, (AQSE: TSP) the medical device company focused on the development of its pioneering "screwless," spinal (vertebral) stabilisation systems, reports its full year results for the year ended 29 March 2021.

The Annual Report and Financial Statements for the year ended 29 March 2021 will shortly be available on the Company's website.  Copies of the Annual Report and Financial Statements will be posted to shareholders shortly.

This announcement contains inside information for the purposes of the UK Market Abuse Regulation and the Directors of the Company are responsible for the release of this announcement.

Enquiries:

CHIEF EXECUTIVE'S STATEMENT

I am pleased to report that in spite of the many challenges presented by Covid-19, TruSpine Technologies plc was able to continue with its IPO plans and was successfully admitted to the Aquis Stock Exchange Growth Market on 20 August 2020 raising gross proceeds of circa £1.4m.

The proceeds are principally being used to progress the development of the Company's pioneering spinal stabilization products, with a specific focus on completing the FDA submission for its first product to market, the Cervi-LOK. TruSpine is excited to announce the decision to commission our regulatory consultant, Emergo, to prepare and file a submission requesting that the FDA examine the CerviLOK to be designated as a "Breakthrough Device."  This category was introduced by the FDA a few years ago and confers on a product recognition that it fulfills a number of exacting criteria.  Our research shows that only a few spinal devices have received this most distinguished designation. 

During the year, product development has progressed well significantly, both with the Cervi-LOK implant and the instrumentation, which will all be sterile packed and single use. Aside from the general strengthening and expansion of the Company's IP, the pre-submission to the FDA for the Cervi-LOK product was also completed. The Company subsequently received written feedback confirming the pathway for additional testing and validation of the product ahead of making the full 510(k) FDA submission for clearance.

As disclosed in the Company's Admission Document, the Company acquired the patents relating to its Technologies from Professor Frank Boehm, (the inventor of the Technologies) pursuant to the IP Sale Agreement. 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$10.2 billion and is expected to grow at a compound annual growth rate of 3.1 per cent. to 2026. North America is the single largest and most mature market accounting for around 55 per cent. of the total global revenues. The largest single sector of the global spinal device market is the spinal stabilisation sector, which is currently estimated to be worth USD$7.1 billion. This sector is estimated to grow at a compound annual growth rate of approximately 3 per cent. per annum, with the minimally invasive spine surgery component of the spinal stabilisation sector estimated to grow at a rate of approximately 6.9 per cent. This is specifically the market sector in which the Company's Products will be positioned. The Company has a phased product development strategy and is planning, subject to regulatory clearance, to commence initial product marketing of Cervi-LOK in the USA. 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.

The Company continues to be in a pre-revenue development phase and remains loss making at this stage of its development. The loss before taxation for the year was £651k (2020: £344k) after administrative expenses of £645k (2020: £341k). The R&D tax credit was £107k (2020: £162k) bringing the loss after tax to £544k (2020: £182k). Development spend for the year was £426k (2020: £225k).

Consolidated net assets at 29 March 2021 amounted to £2.746 million (2020: £1.694 million) including cash and cash equivalents of £543.5k (2020: £135k).

A number of changes to the Management have occurred during the year as TruSpine realigned and strengthened its leadership team for the IPO and next phase of its growth. This included the appointment of an additional non-executive director Nikunj Patel and Anthony Swoboda as Vice President of Sales and Marketing for North America both in June 2021.

On behalf of the Board, I would also like to thank all shareholders for their support, and TruSpine's staff and commercial partners for their hard work during the year.

We are a lean and progressive company with a suite of products and IP that have the potential to provide a potential quantum shift in patient treatment within the Spinal Fixation market, and with our IPO now recently completed we are very well positioned in terms of funding and corporate profile. The board therefore looks to the future with confidence.

Ian Roberts
Chief Executive

STRATEGIC REPORT

The Directors present their Strategic Report on the Group for the year ended 29 March 2021.

Review of the business and future developments

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 Acquis Stock Exchange Growth Market with the issue of 3,700,442 new ordinary shares at the IPO raising gross proceeds of circa £1.4m. In March 2021 the Company raised a further £620,500 through the subscription of 6,205,000 new ordinary shares.

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 Company is seeking to obtain regulatory clearance from the US Food and Drug Administration ("FDA") for its Cervi-LOK product in 2022. Once this has been achieved the Company will concentrate on further development work on its other two products and will subsequently seek clearance for Faci-LOK and GRASP Laminoplasty.

The Company has made a Pre-Submission to the FDA for its Cervi-LOK product and has received written feedback which provides it with a pathway for testing and validation of the product ahead of making the full 510(k) FDA submission for clearance for Cervi-LOK, in-house and independently, and are currently developing all of our regulatory documentation and Quality Management Systems, ready to complete our submission to the FDA for a 510(k) Clearance. 

Once a 510(k) application has been submitted, the FDA's decision to provide clearance normally takes up to 90 days, following which the Company will be able to commence marketing and sales of Cervi-LOK in the US.

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$10.2 billion and is expected to grow at a compound annual growth rate of 3.1 per cent. to 2026. North America is the single largest and most mature market accounting for around 55 per cent. of the total global revenues.

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. The Products still require further independent testing, verification and validation. There is no guarantee that the Products will receive the relevant clearance or approvals, nor that they will work as effectively on live patients as anticipated.

Group Strategy and Business Model

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 Directors believe 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 is planning, subject to regulatory clearance, to commence initial product marketing of Cervi-LOK in 2022. 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.

The Company has a number of key commercial partners to develop, design and manufacture its Products, and assist it through the regulatory process. Emergo Group ("Emergo"), a regulatory consultant in FDA clearance is retained by the Company to provide it with regulatory advice. Lincotek Medical LLC ("Lincotek") is retained by the Company to provide professional product development advisory, regulatory manufacturing and related services. University of Toledo will be performing our independent product testing, and Element Medical will be providing our comparative data.

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 will initially seek 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.

On 17 April 2020 our regulatory consultant Emergo, on behalf of the Company submitted a Pre-Submission to the FDA for Cervi-LOK. The Pre-Submission allows the final application to proceed in a more-timely fashion because it mitigates the scope for FDA inquiries that have the effect of restarting the FDA's 90-day period to comment on the device in question. The FDA provided the Company with written Pre-Submission feedback on its Cervi-LOK Pre-Submission in on 29 July 2020. The feedback was in line with the Directors' expectations and provides the Company with a clear pathway to obtain FDA clearance for Cervi-LOK.

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.

As far as commercialisation strategy is concerned, the Company intends to acquire strategic input from a select group of surgical key opinion leaders ("KOLs") which will help refine the subtleties of the Products and the surgical approach to their implementation. They will also be involved in the necessary studies, white papers, poster presentations and podium appearances which the Directors believe will help to shape the future of the spine market and create better and safer treatment options. Following FDA clearance, a large proportion of the initial revenues will be derived from the surgical KOLs and Primary User Groups Sites. The Company has identified several Primary User Groups Sites, which will be groups of surgeons who are 'early adopters' of the Products, willing to implant them and to collect necessary data demonstrating their clinical relevance and supporting the Company's claims in relation to them.

Promotion of the Company for the benefit of the members as a whole

The Director's believe they have acted in the way most likely to promote the success of the Company for the benefit of its members as a whole, as required by s172 of the Companies Act 2006 as detailed below.

The requirements of s172 are for the Directors to:

-       Consider the likely consequences of any decision in the long term

-       Act fairly between the members of the Company,

-       Maintain a reputation for high standards of business conduct,

-       Consider the interests of the Company's employees,

-       Foster the Company's relationships with suppliers, customers and others, and

-       Consider the impact of the Company's operations on the community and the environment.

Our Board of Directors remain aware of their responsibilities both within and outside of the Group. Within the limitations of a Group with so few employees we endeavour to follow these principles and examples of the application of the s172 are summarised and demonstrated below.

The Company operates as a medical device company developing specific innovative products which is inherently speculative in nature and at times may be dependent upon fund-raising for its continued operation. The nature of the business is well understood by the Company's members, employees and suppliers, and the Directors are transparent about the cash position and funding requirements. 

The Company has invested considerable time in developing and fostering its relationships with its key suppliers.

As a medical device company in the spinal fusion market with operations based in the UK and USA, the Board takes seriously its ethical responsibilities to the communities and environment in which it works.

The interests of employees and consultants are a primary consideration for the Board and are planning to introduce an inclusive share-option programme allowing them to share in the future success of the company. Personal development opportunities are encouraged and supported.

Results for the year

The Group's results for the year are included in the Chief Executive's Statement.

Key performance indicators

Key performance indicators for the Group as a measure of financial control are as follows:

Principal risks and uncertainties

The Group is subject to various risks similar to all medical device companies operating in overseas locations relating to political, economic, legal, industry and financial conditions, not all of which are within its control. The Group identifies and monitors the key risks and uncertainties affecting the Group and runs its business in a way that minimises the impact of such risks where possible.

The following risks factors, which are not exhaustive, are particularly relevant to the Group's business activities:

Risk Relating to Obtaining Regulatory Approvals

There can be no assurance that the Company will receive the regulatory approvals required in order to manufacture and sell its Products, including approval by the FDA in the US and the granting of CE mark in Europe. If the Products are not approved and cannot be commercialised, the Company will be unable to generate revenue from them, which would materially adversely affect its business, financial condition and the results of its operations. Moreover, any delay or setback in the regulatory approval process could have a material adverse effect on the Company's business and prospects. To mitigate this the Company employs two key commercial partners, Emergo and Lincotek to develop its Products and ensure that they achieve the regulatory approvals necessary for commercialisation.

Acceptance of the Products in clinical settings

If the Company is unable to convince opinion leaders and health professionals of the benefits of its Products, there could be weak penetration of the market, which might have a material adverse effect on the Company, its business, financial situation, growth and prospects. The slow adoption of new methods and technologies could result in timeframes being longer than anticipated by the Company. However the Company has links with a network of professionals and experts operating in these fields who have advised and given positive feedback as to the suitability and acceptability of the products in development.

No Live Patient Testing

Although Cervi-LOK has undergone significant laboratory-based testing, it has not been tested on live patients and there is no certainty that it will be as effective as envisaged, nor that it will receive regulatory clearance for use in humans. Despite this, the feedback from FDA so far in relation to Cervi-LOK has not highlighted any material issues and the Directors expect that it will successfully achieve regulatory clearance.

Research and development and product obsolescence

Rapidly changing markets, technology, emerging industry standards and frequent introduction of new products will characterise the Company's business. The introduction of new products embodying new technologies, including new manufacturing processes, and the emergence of new industry standards may render the Company's products, less competitive or less marketable.

The process of product development is complex and requires significant continuing costs, development efforts and third-party commitments. The Company's failure to develop new technologies and products and the obsolescence of existing technologies and products could adversely affect the business, financial condition and operating results of the Company.

The Company may be unable to anticipate changes in its potential customer requirements that could make its existing technology obsolete. Its success will depend, in part, on its ability to continue to enhance its existing technologies, develop new technology that addresses the increasing sophistication and varied needs of the market, and respond to technological advances and emerging industry standards and practices on a timely and cost-effective basis. The Company may not be successful in using its new technologies or exploiting its niche markets effectively or adapting its business to evolving customer or medical requirements or preferences or emerging industry standards.

Dependence on key executives, personnel and consultants

The Company's future development and prospects are substantially dependent on the continuing services and performance of the Directors, the Consultants and the Medical Advisory Board. J Lee S Consultants LLC is a particularly important consultant for the Company because it includes the services of Professor Frank Boehm, who is the inventor of the Technologies and has the technical knowledge and expertise to continue to innovate and develop the existing Products and to develop new accompanying, similar or related products. If J Lee S Consultants LLC were to terminate their consultancy agreement with the Company, the Company may be unable to appoint a similarly skilled replacement with the necessary knowledge to innovate and develop the existing Products or to develop new Products. The consultancy agreement with J Lee S Consultants LLC has a termination notice period of one year for each party to mitigate the risk of this agreement being terminated.

The Directors cannot give assurances that they, the Consultants or the Medical Advisory Board will remain with the Company, although the Directors believe that the Company's culture and remuneration packages are attractive. If key members of the Company's management team depart, or are affected by illness, such as COVID-19, and the Company is not be able to find effective replacements in a timely manner or at all, its business may be disrupted or damaged.

Impact of COVID-19

The impact of COVID-19 or any other severe communicable disease, if uncontrolled, on the general economic climate could have an adverse effect on the Company. The recent outbreak of COVID-19 may have an adverse effect on the Company's business, financial situation, growth and prospects and has already had a material adverse effect on overall business sentiment and the global economy. There is no assurance there will not be similar outbreaks of other diseases in the future. The impact of the imposition by governments across the world of stringent measures to prevent the spread of COVID-19 or other diseases, and the effect of COVID-19, or any other severe communicable diseases outbreak in the future, on the employees of the Company, could adversely affect the performance of the business activities of the Company and those of the customers, which could lead to a decrease in the demand for their services. It is too early to tell what the long-term impact of COVID-19 will be on the Company's current and future prospects and to what extent it may have a material and adverse effect on the Company's business, results of operations and financial performance.

The Board has confirmed that Emergo and Lincotek, its key suppliers in achieving FDA and regulatory approval, have robust business continuity plans and are able to continue product development during the COVID-19 pandemic and associated travel restrictions. The Board does not expect there to be a material delay to the launch of the Products as a result of COVID-19.

No Current Revenue

The Products remain under development and no revenue has been generated from them as at the date of this Document. The Company's Cervi-LOK Product is expected to launch in 2022 and the other Products are expected to be launched the following year. As such, there is no historical data on which to base the Company's estimated revenue and costs. Therefore, given the high degree of uncertainty in the economy currently and the dependency of the Company on development milestones being met and regulatory approval being obtained there cannot be certainty regarding the size of the market for the Products following their launch or whether the Company has the capacity to generate sufficient revenues to be profitable. To mitigate this the Company has engaged consultants who have extensive experience in the marketing and distribution of products in this sector.

Risk of IP infringement

There is no certainty that the Company can protect its proprietary information or intellectual property which is particularly important considering the Company has developed a number of Products that it regards as unique. There is also a risk that should an employee with knowledge of the Products cease to be employed by the Company they may seek to replicate the Products with a competitor. Although the Company intends to vehemently protect its intellectual property there can be no guarantee that such action will be effective (and will be expensive in any case), there is also a risk that the Company may be pursued by a third party for alleged intellectual property infringement. This risk has been mitigated by the Company engaging specialist patent attorneys to analyse the state of the art and report on the likelihood of the Products infringing the intellectual property subsisting in existing technologies. A Freedom to Operate report produced by Schmeiser, Olsen & Watts has concluded that the likelihood of patent infringement in relation to the Patents is low.

RISKS RELATING TO THE INDUSTRY

Competition in the Market for Spinal Devices

There are a number of companies in the spinal device market offering products that would compete with the Company's Products. These larger, well-funded companies are currently gaining a competitive advantage in the spinal device market by reducing costs through economies of scale. The Company may not currently have the capacity to compete with these existing competitors because the smaller scale of their operation leads to a higher unit cost. Major competitors in the spinal device market include Zimmer Biomet, Medtronic, Johnson & Johnson, NuVasive, Life Spine and Globus Medical. However TruSpine's devices are novel in their design in that they represent a potentially significant development in spinal fixation, by providing stabilisation while not altering the bony spinal anatomy of patients as compared with the use of screws, staples or other devices which currently dominate the spinal market.

RISKS RELATING TO FINANCIAL MATTERS

Currency and Foreign Exchange Risks

The Company's functional and presentational currency is sterling, and this is the currency of the Company's financial statements. However, a significant proportion of the Company's business is conducted in the United States in $USD and therefore certain amounts will need to be translated into sterling. Due to changes in exchange rates between sterling and $USD this could lead to changes in the Company's reported financial results from period to period. Among the factors that may affect currency values are trade balances, levels of short-term interest rates, difference in relative values of similar assets in different currencies, long term opportunities for investments and capital appreciation and political or regulatory developments.

Financing Risks and Requirements for Further Funds

It is likely that the Company will be required to seek further equity financing. The Company's ability to raise further funds will depend on the success of its strategy and operations. The Company may not be successful in procuring the requisite funds on terms that are acceptable to it, or at all. If such funding is unavailable, the Company may be required to reduce the scope of its operations and investments or anticipated expansion, abandon its strategy, incur financial penalties or miss certain opportunities.

The Directors review the Company's funding requirements on a regular basis, and take such action as may be necessary to either curtail expenditures and / or raise additional funds from available sources including the issuance of debt or equity. Management has successfully raised money to date, but there is no guarantee that adequate funds will be available when needed in the future. 

GROUP STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEAR ENDED 29 MARCH 2021

The notes are an integral part of these financial statements 

GROUP STATEMENT OF FINANCIAL POSITION
AS AT 29 MARCH 2021

The Company has elected to take the exemption under section 408 of the Companies Act 2006 not to present the Parent Company Statement of Comprehensive Income.

The loss before tax for the Parent Company for the year was £651,848 (2020: £357,796).

The financial statements were approved by the Board of Directors and authorised for issue on 29 September 2021 and were signed on its behalf by

I A Roberts
Director

The notes are an integral part of these Financial Statements.

GROUP STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 29 MARCH 2021

Year ended 29 March 2021

Retained earnings - The retained earnings reserve includes all current and prior periods retained profits and losses.

Other reserves comprise of 666,667 shares that were acquired from a third party in exchange for monies paid out by the Company on the third party's behalf during the year to 29 March 2019.

Translation reserve - The translation reserves includes foreign exchange movements on translating the overseas subsidiaries records, denominated in USD, to the presentational currency, GBP.

The notes are an integral part of these Financial Statements.

CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEAR ENDED 29 MARCH 2021

The notes are an integral part of these Financial Statements.

COMPANY STATEMENT OF FINANCIAL POSITION
AS AT 29 MARCH 2021

The financial statements were approved by the Board of Directors and authorised for issue on 29 September 2021 and were signed on its behalf by

I A Roberts
Director

The notes are an integral part of these Financial Statements.

COMPANY STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 29 MARCH 2021

The notes are an integral part of these Financial Statements.

COMPANY STATEMENT OF CASH FLOWS
FOR THE YEAR ENDED 29 MARCH 2021

2021

TruSpine Technologies plc, (AQSE: TSP) the medical device company focused on the development of its pioneering "screwless," spinal (vertebral) stabilisation systems, reports its full year results for the year ended 29 March 2021.

The Annual Report and Financial Statements for the year ended 29 March 2021 will shortly be available on the Company's website.  Copies of the Annual Report and Financial Statements will be posted to shareholders shortly.

This announcement contains inside information for the purposes of the UK Market Abuse Regulation and the Directors of the Company are responsible for the release of this announcement.

Enquiries:

CHIEF EXECUTIVE'S STATEMENT

I am pleased to report that in spite of the many challenges presented by Covid-19, TruSpine Technologies plc was able to continue with its IPO plans and was successfully admitted to the Aquis Stock Exchange Growth Market on 20 August 2020 raising gross proceeds of circa £1.4m.

The proceeds are principally being used to progress the development of the Company's pioneering spinal stabilization products, with a specific focus on completing the FDA submission for its first product to market, the Cervi-LOK. TruSpine is excited to announce the decision to commission our regulatory consultant, Emergo, to prepare and file a submission requesting that the FDA examine the CerviLOK to be designated as a "Breakthrough Device."  This category was introduced by the FDA a few years ago and confers on a product recognition that it fulfills a number of exacting criteria.  Our research shows that only a few spinal devices have received this most distinguished designation. 

During the year, product development has progressed well significantly, both with the Cervi-LOK implant and the instrumentation, which will all be sterile packed and single use. Aside from the general strengthening and expansion of the Company's IP, the pre-submission to the FDA for the Cervi-LOK product was also completed. The Company subsequently received written feedback confirming the pathway for additional testing and validation of the product ahead of making the full 510(k) FDA submission for clearance.

As disclosed in the Company's Admission Document, the Company acquired the patents relating to its Technologies from Professor Frank Boehm, (the inventor of the Technologies) pursuant to the IP Sale Agreement. 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$10.2 billion and is expected to grow at a compound annual growth rate of 3.1 per cent. to 2026. North America is the single largest and most mature market accounting for around 55 per cent. of the total global revenues. The largest single sector of the global spinal device market is the spinal stabilisation sector, which is currently estimated to be worth USD$7.1 billion. This sector is estimated to grow at a compound annual growth rate of approximately 3 per cent. per annum, with the minimally invasive spine surgery component of the spinal stabilisation sector estimated to grow at a rate of approximately 6.9 per cent. This is specifically the market sector in which the Company's Products will be positioned. The Company has a phased product development strategy and is planning, subject to regulatory clearance, to commence initial product marketing of Cervi-LOK in the USA. 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.

The Company continues to be in a pre-revenue development phase and remains loss making at this stage of its development. The loss before taxation for the year was £651k (2020: £344k) after administrative expenses of £645k (2020: £341k). The R&D tax credit was £107k (2020: £162k) bringing the loss after tax to £544k (2020: £182k). Development spend for the year was £426k (2020: £225k).

Consolidated net assets at 29 March 2021 amounted to £2.746 million (2020: £1.694 million) including cash and cash equivalents of £543.5k (2020: £135k).

A number of changes to the Management have occurred during the year as TruSpine realigned and strengthened its leadership team for the IPO and next phase of its growth. This included the appointment of an additional non-executive director Nikunj Patel and Anthony Swoboda as Vice President of Sales and Marketing for North America both in June 2021.

On behalf of the Board, I would also like to thank all shareholders for their support, and TruSpine's staff and commercial partners for their hard work during the year.

We are a lean and progressive company with a suite of products and IP that have the potential to provide a potential quantum shift in patient treatment within the Spinal Fixation market, and with our IPO now recently completed we are very well positioned in terms of funding and corporate profile. The board therefore looks to the future with confidence.

Ian Roberts
Chief Executive

STRATEGIC REPORT

The Directors present their Strategic Report on the Group for the year ended 29 March 2021.

Review of the business and future developments

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 Acquis Stock Exchange Growth Market with the issue of 3,700,442 new ordinary shares at the IPO raising gross proceeds of circa £1.4m. In March 2021 the Company raised a further £620,500 through the subscription of 6,205,000 new ordinary shares.

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 Company is seeking to obtain regulatory clearance from the US Food and Drug Administration ("FDA") for its Cervi-LOK product in 2022. Once this has been achieved the Company will concentrate on further development work on its other two products and will subsequently seek clearance for Faci-LOK and GRASP Laminoplasty.

The Company has made a Pre-Submission to the FDA for its Cervi-LOK product and has received written feedback which provides it with a pathway for testing and validation of the product ahead of making the full 510(k) FDA submission for clearance for Cervi-LOK, in-house and independently, and are currently developing all of our regulatory documentation and Quality Management Systems, ready to complete our submission to the FDA for a 510(k) Clearance. 

Once a 510(k) application has been submitted, the FDA's decision to provide clearance normally takes up to 90 days, following which the Company will be able to commence marketing and sales of Cervi-LOK in the US.

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$10.2 billion and is expected to grow at a compound annual growth rate of 3.1 per cent. to 2026. North America is the single largest and most mature market accounting for around 55 per cent. of the total global revenues.

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. The Products still require further independent testing, verification and validation. There is no guarantee that the Products will receive the relevant clearance or approvals, nor that they will work as effectively on live patients as anticipated.

Group Strategy and Business Model

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 Directors believe 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 is planning, subject to regulatory clearance, to commence initial product marketing of Cervi-LOK in 2022. 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.

The Company has a number of key commercial partners to develop, design and manufacture its Products, and assist it through the regulatory process. Emergo Group ("Emergo"), a regulatory consultant in FDA clearance is retained by the Company to provide it with regulatory advice. Lincotek Medical LLC ("Lincotek") is retained by the Company to provide professional product development advisory, regulatory manufacturing and related services. University of Toledo will be performing our independent product testing, and Element Medical will be providing our comparative data.

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 will initially seek 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.

On 17 April 2020 our regulatory consultant Emergo, on behalf of the Company submitted a Pre-Submission to the FDA for Cervi-LOK. The Pre-Submission allows the final application to proceed in a more-timely fashion because it mitigates the scope for FDA inquiries that have the effect of restarting the FDA's 90-day period to comment on the device in question. The FDA provided the Company with written Pre-Submission feedback on its Cervi-LOK Pre-Submission in on 29 July 2020. The feedback was in line with the Directors' expectations and provides the Company with a clear pathway to obtain FDA clearance for Cervi-LOK.

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.

As far as commercialisation strategy is concerned, the Company intends to acquire strategic input from a select group of surgical key opinion leaders ("KOLs") which will help refine the subtleties of the Products and the surgical approach to their implementation. They will also be involved in the necessary studies, white papers, poster presentations and podium appearances which the Directors believe will help to shape the future of the spine market and create better and safer treatment options. Following FDA clearance, a large proportion of the initial revenues will be derived from the surgical KOLs and Primary User Groups Sites. The Company has identified several Primary User Groups Sites, which will be groups of surgeons who are 'early adopters' of the Products, willing to implant them and to collect necessary data demonstrating their clinical relevance and supporting the Company's claims in relation to them.

Promotion of the Company for the benefit of the members as a whole

The Director's believe they have acted in the way most likely to promote the success of the Company for the benefit of its members as a whole, as required by s172 of the Companies Act 2006 as detailed below.

The requirements of s172 are for the Directors to:

-       Consider the likely consequences of any decision in the long term

-       Act fairly between the members of the Company,

-       Maintain a reputation for high standards of business conduct,

-       Consider the interests of the Company's employees,

-       Foster the Company's relationships with suppliers, customers and others, and

-       Consider the impact of the Company's operations on the community and the environment.

Our Board of Directors remain aware of their responsibilities both within and outside of the Group. Within the limitations of a Group with so few employees we endeavour to follow these principles and examples of the application of the s172 are summarised and demonstrated below.

The Company operates as a medical device company developing specific innovative products which is inherently speculative in nature and at times may be dependent upon fund-raising for its continued operation. The nature of the business is well understood by the Company's members, employees and suppliers, and the Directors are transparent about the cash position and funding requirements. 

The Company has invested considerable time in developing and fostering its relationships with its key suppliers.

As a medical device company in the spinal fusion market with operations based in the UK and USA, the Board takes seriously its ethical responsibilities to the communities and environment in which it works.

The interests of employees and consultants are a primary consideration for the Board and are planning to introduce an inclusive share-option programme allowing them to share in the future success of the company. Personal development opportunities are encouraged and supported.

Results for the year

The Group's results for the year are included in the Chief Executive's Statement.

Key performance indicators

Key performance indicators for the Group as a measure of financial control are as follows:

Principal risks and uncertainties

The Group is subject to various risks similar to all medical device companies operating in overseas locations relating to political, economic, legal, industry and financial conditions, not all of which are within its control. The Group identifies and monitors the key risks and uncertainties affecting the Group and runs its business in a way that minimises the impact of such risks where possible.

The following risks factors, which are not exhaustive, are particularly relevant to the Group's business activities:

Risk Relating to Obtaining Regulatory Approvals

There can be no assurance that the Company will receive the regulatory approvals required in order to manufacture and sell its Products, including approval by the FDA in the US and the granting of CE mark in Europe. If the Products are not approved and cannot be commercialised, the Company will be unable to generate revenue from them, which would materially adversely affect its business, financial condition and the results of its operations. Moreover, any delay or setback in the regulatory approval process could have a material adverse effect on the Company's business and prospects. To mitigate this the Company employs two key commercial partners, Emergo and Lincotek to develop its Products and ensure that they achieve the regulatory approvals necessary for commercialisation.

Acceptance of the Products in clinical settings

If the Company is unable to convince opinion leaders and health professionals of the benefits of its Products, there could be weak penetration of the market, which might have a material adverse effect on the Company, its business, financial situation, growth and prospects. The slow adoption of new methods and technologies could result in timeframes being longer than anticipated by the Company. However the Company has links with a network of professionals and experts operating in these fields who have advised and given positive feedback as to the suitability and acceptability of the products in development.

No Live Patient Testing

Although Cervi-LOK has undergone significant laboratory-based testing, it has not been tested on live patients and there is no certainty that it will be as effective as envisaged, nor that it will receive regulatory clearance for use in humans. Despite this, the feedback from FDA so far in relation to Cervi-LOK has not highlighted any material issues and the Directors expect that it will successfully achieve regulatory clearance.

Research and development and product obsolescence

Rapidly changing markets, technology, emerging industry standards and frequent introduction of new products will characterise the Company's business. The introduction of new products embodying new technologies, including new manufacturing processes, and the emergence of new industry standards may render the Company's products, less competitive or less marketable.

The process of product development is complex and requires significant continuing costs, development efforts and third-party commitments. The Company's failure to develop new technologies and products and the obsolescence of existing technologies and products could adversely affect the business, financial condition and operating results of the Company.

The Company may be unable to anticipate changes in its potential customer requirements that could make its existing technology obsolete. Its success will depend, in part, on its ability to continue to enhance its existing technologies, develop new technology that addresses the increasing sophistication and varied needs of the market, and respond to technological advances and emerging industry standards and practices on a timely and cost-effective basis. The Company may not be successful in using its new technologies or exploiting its niche markets effectively or adapting its business to evolving customer or medical requirements or preferences or emerging industry standards.

Dependence on key executives, personnel and consultants

The Company's future development and prospects are substantially dependent on the continuing services and performance of the Directors, the Consultants and the Medical Advisory Board. J Lee S Consultants LLC is a particularly important consultant for the Company because it includes the services of Professor Frank Boehm, who is the inventor of the Technologies and has the technical knowledge and expertise to continue to innovate and develop the existing Products and to develop new accompanying, similar or related products. If J Lee S Consultants LLC were to terminate their consultancy agreement with the Company, the Company may be unable to appoint a similarly skilled replacement with the necessary knowledge to innovate and develop the existing Products or to develop new Products. The consultancy agreement with J Lee S Consultants LLC has a termination notice period of one year for each party to mitigate the risk of this agreement being terminated.

The Directors cannot give assurances that they, the Consultants or the Medical Advisory Board will remain with the Company, although the Directors believe that the Company's culture and remuneration packages are attractive. If key members of the Company's management team depart, or are affected by illness, such as COVID-19, and the Company is not be able to find effective replacements in a timely manner or at all, its business may be disrupted or damaged.

Impact of COVID-19

The impact of COVID-19 or any other severe communicable disease, if uncontrolled, on the general economic climate could have an adverse effect on the Company. The recent outbreak of COVID-19 may have an adverse effect on the Company's business, financial situation, growth and prospects and has already had a material adverse effect on overall business sentiment and the global economy. There is no assurance there will not be similar outbreaks of other diseases in the future. The impact of the imposition by governments across the world of stringent measures to prevent the spread of COVID-19 or other diseases, and the effect of COVID-19, or any other severe communicable diseases outbreak in the future, on the employees of the Company, could adversely affect the performance of the business activities of the Company and those of the customers, which could lead to a decrease in the demand for their services. It is too early to tell what the long-term impact of COVID-19 will be on the Company's current and future prospects and to what extent it may have a material and adverse effect on the Company's business, results of operations and financial performance.

The Board has confirmed that Emergo and Lincotek, its key suppliers in achieving FDA and regulatory approval, have robust business continuity plans and are able to continue product development during the COVID-19 pandemic and associated travel restrictions. The Board does not expect there to be a material delay to the launch of the Products as a result of COVID-19.

No Current Revenue

The Products remain under development and no revenue has been generated from them as at the date of this Document. The Company's Cervi-LOK Product is expected to launch in 2022 and the other Products are expected to be launched the following year. As such, there is no historical data on which to base the Company's estimated revenue and costs. Therefore, given the high degree of uncertainty in the economy currently and the dependency of the Company on development milestones being met and regulatory approval being obtained there cannot be certainty regarding the size of the market for the Products following their launch or whether the Company has the capacity to generate sufficient revenues to be profitable. To mitigate this the Company has engaged consultants who have extensive experience in the marketing and distribution of products in this sector.

Risk of IP infringement

There is no certainty that the Company can protect its proprietary information or intellectual property which is particularly important considering the Company has developed a number of Products that it regards as unique. There is also a risk that should an employee with knowledge of the Products cease to be employed by the Company they may seek to replicate the Products with a competitor. Although the Company intends to vehemently protect its intellectual property there can be no guarantee that such action will be effective (and will be expensive in any case), there is also a risk that the Company may be pursued by a third party for alleged intellectual property infringement. This risk has been mitigated by the Company engaging specialist patent attorneys to analyse the state of the art and report on the likelihood of the Products infringing the intellectual property subsisting in existing technologies. A Freedom to Operate report produced by Schmeiser, Olsen & Watts has concluded that the likelihood of patent infringement in relation to the Patents is low.

RISKS RELATING TO THE INDUSTRY

Competition in the Market for Spinal Devices

There are a number of companies in the spinal device market offering products that would compete with the Company's Products. These larger, well-funded companies are currently gaining a competitive advantage in the spinal device market by reducing costs through economies of scale. The Company may not currently have the capacity to compete with these existing competitors because the smaller scale of their operation leads to a higher unit cost. Major competitors in the spinal device market include Zimmer Biomet, Medtronic, Johnson & Johnson, NuVasive, Life Spine and Globus Medical. However TruSpine's devices are novel in their design in that they represent a potentially significant development in spinal fixation, by providing stabilisation while not altering the bony spinal anatomy of patients as compared with the use of screws, staples or other devices which currently dominate the spinal market.

RISKS RELATING TO FINANCIAL MATTERS

Currency and Foreign Exchange Risks

The Company's functional and presentational currency is sterling, and this is the currency of the Company's financial statements. However, a significant proportion of the Company's business is conducted in the United States in $USD and therefore certain amounts will need to be translated into sterling. Due to changes in exchange rates between sterling and $USD this could lead to changes in the Company's reported financial results from period to period. Among the factors that may affect currency values are trade balances, levels of short-term interest rates, difference in relative values of similar assets in different currencies, long term opportunities for investments and capital appreciation and political or regulatory developments.

Financing Risks and Requirements for Further Funds

It is likely that the Company will be required to seek further equity financing. The Company's ability to raise further funds will depend on the success of its strategy and operations. The Company may not be successful in procuring the requisite funds on terms that are acceptable to it, or at all. If such funding is unavailable, the Company may be required to reduce the scope of its operations and investments or anticipated expansion, abandon its strategy, incur financial penalties or miss certain opportunities.

The Directors review the Company's funding requirements on a regular basis, and take such action as may be necessary to either curtail expenditures and / or raise additional funds from available sources including the issuance of debt or equity. Management has successfully raised money to date, but there is no guarantee that adequate funds will be available when needed in the future. 

GROUP STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEAR ENDED 29 MARCH 2021