TruSpine Technologies Limited Investor update January 2018
Fundraising After a slow start, due in part to market conditions, Brexit concerns, and changes in legislation for pension related investments, the company saw a welcome increase in equity investment from several funding sources. The most significant of which came from AIM listed investing company Primorus Investments Plc, who invested £500K in a placing late last summer. This year the company has already secured further funding through a placing that closed at the end of January, from which the funds are imminently expected to arrive. This clearly illustrates a continued high degree of confidence in the company and its products. The company intends to secure up to a further $1.5m USD in order to fully fund it to its first FDA clearance, and subsequent planned IPO.
Product Development & IP There have been additional Intellectual Property filings/publications, including regular updates to incorporate all additional design modifications and nuances, and as a result the company’s IP position is considered by the patent attorneys to be extremely robust. Once again this process continues to illustrate the validity of the unique and disruptive attributes of the company’s products. Significant recent filings/publications include; 1. Provisional Application for CerviFAS dated Nov 30th 2017 2. Notice of publication for FaciLOK dated Nov 9th 2017 Final development and testing of the FaciLOK (Lumbar spine fixation system) and its implantation instrumentation, is expected to complete and reach “design freeze” in the near future. The development team and the inventor have been applied in ensuring that the FaciLOK can be successfully and safely implanted into patients with a minimum level of surgical skill, thereby broadening the scope for market adoption.
TruSpine Technologies Limited 101 Finsbury Pavement, Moorgate, London, EC2A 1RS Tel: +44 (0)20 3638 5025 Company Number 09345973
The belief now is that we have the strong potential for adoption by organisations such as ambulatory centres and pain management specialist, in addition to traditional hospitals. The CerviFAS (Cervical spine fixation system) and its implementation are also very close to design freeze, which means one can follow very close behind the other in the FDA approval process. Assuming the availability of sufficient funding, then it would also be possible to run the two in parallel.
HealthTech Summit Update Last summer TruSpine were independently cited as one of the 20 most promising Med Tech companies in Europe, and consequently were asked to present at the Healthtech Summit in Lausanne. From this experience it became further evident that TruSpine appear to be the only company applying any level of true innovation to the spine market at this point, this was further confirmed by other major med tech company representatives in attendance during the summit. In addition, it became apparent that TruSpine is certainly on the radar of the major players in the spine market, who appear to be keeping a watching brief to see how things develop. As previously stated, the market is characterised by the acquisition of emerging companies by the major players at an appropriate time in their development, particularly when there is disruptive technology involved such as is the case with TruSpine. The selection for this event certainly assisted in building TruSpine’s profile, as well as underpinning the belief that the company’s strategy and products do have the scope and potential we all believe they do.
New additions Simon Stephens – Group CEO The company is very pleased to confirm the recent appointment of Mr Simon Stephens as the company’s Group CEO. Simon brings with him a wealth of experience in leveraging value from tech businesses in general, as well as specialist expertise in Med Tech development, most recently in the transcatheter mitral valve sector. Simon also has a strong base in the City. TruSpine Technologies Limited 101 Finsbury Pavement, Moorgate, London, EC2A 1RS Tel: +44 (0)20 3638 5025 Company Number 09345973
We believe that Simon is properly qualified and experienced to provide the cohesive strategy and leadership, necessary not only to take the company through the final phase of completion and FDA clearance of its products, but also to navigate a clear course through the forthcoming planned IPO. Professor Abdallah Raweh – Medical Advisory Board Professor Raweh is an internationally acclaimed Cardiac surgeon who operates out of London, New York, Milan, Dubai and Abu Dhabi. Professor Raweh has received many accolades and enjoyed numerous high profile positions during his career, including his current position as Vice Rector and Full Professor of Cardiac Surgery, L.U. de S University, Lugano, Switzerland. Professor Raweh brings with him a wealth of knowledge and medical expertise, particularly in the areas of Cardio Thoracic and vascular surgery. He is also very well placed to assist in promoting adoption of the company’s products in some key geographical areas.
IPO Plans for Truspine to IPO in the coming months with Cenkos Securities of London and the rest of the IPO team remain on track, and at a meeting last week it was agreed that the listing should be secured as soon as possible this year. This is planned to be concurrent with FDA clearance for the first product, which will cement a far more substantial pre-money valuation. As previously stated an IPO will not only provide the company with enhanced corporate credibility, but will also facilitate an opportunity to raise the next level of funding required for the wider commercialisation of the company’s products. Assuming the company is not pursued for acquisition in a trade sale first, which as has been stated before is characteristic of the spine market.
R&D Tax Credit claim The company is progressing well with a multi hundred thousand GBP claim in association with KPMG, who have now completed their initial DD and validity checks. This included a meeting with the inventor in the last week of January, as well as several meetings with the company and their financial advisers. It will take a further 2 weeks to confirm the exact quantum of the claim, at which point KPMG will commence work on the submission itself. KPMG expect that the process will take circa 2 months in total to complete. A bridge funding option has already been arranged to enable the company to access part of the claim in advance to the FDA application process.
TruSpine Technologies Limited 101 Finsbury Pavement, Moorgate, London, EC2A 1RS Tel: +44 (0)20 3638 5025 Company Number 09345973
This R&D Tax Credit claim will provide the company with a large part of the remaining vital funding requirement to compete the first FDA clearance, following which the company will clearly be in a very strong position.
Summary We hope that the information above provides you with a more incisive view of the company’s progress and current position. Should you wish to us to discuss any of the matters raised, or to discuss investment opportunities into TruSpine in general, please the persons listed below in the first instance.
information The Enduro Partnership
[email protected] Tel: +44 (0)1293 804780
or
[email protected]
TruSpine Technologies Limited 101 Finsbury Pavement, Moorgate, London, EC2A 1RS Tel: +44 (0)20 3638 5025 Company Number 09345973