Con fj dential not for distribution 02 TruSpine Technologies - - PowerPoint PPT Presentation

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The information in this presentation is in summary form and should not be relied upon as a complete and accurate representation of TruSpine Technologies Limited and its various business activities. While management has taken every effort to ensure the accuracy of the material in the presentation, the presentation is provided for information purposes

• nly. No representation or warranty, express or implied, is or will be made by TruSpine

Technologies Limited or its officers, directors, employees or advisers as to the fairness, accuracy, completeness or correctness of the information, opinions and conclusions contained in, or implied by, this presentation, or as to the reasonableness of any assumption, forecasts, prospects or returns contained in, or implied by, this presentation or any part of

• it. The presentation may include information derived from third party sources that has not

been independently verified. This presentation should be read in conjunction with other technical information and reports prepared by independent consultants for TruSpine Technologies Limited. This presentation contains certain forward-looking statements with respect to the financial condition, results of operations and business of TruSpine Technologies Limited and certain plans and objectives of the management of TruSpine Technologies Limited. Forward-looking statements can generally be identified by the use of words such as 'project', 'foresee', 'plan', 'expect', 'aim', 'intend', 'anticipate', 'believe', 'estimate', 'may', 'should', 'will' or similar expressions. Indications of, and guidance on, production targets, targeted output, development or timelines and future financial position and performance are also forward-looking statements. The forward-looking statements included in this presentation involve subjective judgment and analysis and may cause actual results to differ materially from those expressed

• r implied in such statements and are subject to significant business, economic and

competitive uncertainties, risks and contingencies, many of which are outside the control

• f, and are unknown to TruSpine Technologies Limited. These risks include, among others,

changes in the economic climate. If one or more of these risks materialises, or if underlying assumptions prove incorrect, TruSpine Technologies Limited’s actual results may vary materially from those expected, estimated or projected. Given these uncertainties, you are cautioned not to place undue reliance on forward-looking statements. These forward-looking statements are based on information available to us as of the date of this

• presentation. Except as required by law or regulation (including any future stock exchange

listing rules) we undertake no obligation to update these forward-looking statements. This presentation is subject to change without notice. Subject to any obligations under applicable laws, regulations or securities exchange listing rules. TruSpine Technologies Limited disclaims any obligation or undertaking to release any updates or revisions to the presentation to refmect any change in expectations or assumptions. Nothing in the presentation should be interpreted to mean that there has been no change in the afgairs of TruSpine Technologies Limited since the date of the presentation. This presentation does not constitute investment, legal, taxation or other advice and the presentation does not take into account your investment objectives, financial situation nor particular needs. You are responsible for forming your own opinions and conclusions

• n such matters and should make your own independent assessment of the information

contained in, or implied by, this presentation and seek independent professional advice in relation to such information and any action taken on the basis of the information.

TruSpine Technologies Limited

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The Mission

TruSpine will be introducing pioneering products that propose a unique new approach to the greatest challenges facing spinal surgery, a vast and rapidly growing sector of the lucrative MedTech market. – Minimally intrusive devices that achieve spinal stabilisation while avoiding the complications inherent to the current technology. – Technologies that represent the first completely unique approach to spinal stabilisation in a global market marred by limited innovation and outdated legacy technologies. – The first truly new technology to be introduced in over 20 years. – Pipeline of intellectual property that will further expand the product offerings.

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Overview

– Established in 2015. – TruSpine Technologies Limited, acquired IP to support a suite of pioneering products within the spine market. – Established strategic partnership with MIT, CoorsTek, Emergo – Actively developing and commercialising key products: Faci-LOK™ & Cervi-FAS™ System, with others in the pipeline. – Highly experienced management team with proven track record. – IPO on AIM planned for 2019.

RAISING UP TO USD 3 MILLION OF PRE-IPO FUNDING

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Global Market Potential

Th e g l o b a l s p i n a l f u s i o n m a r k e t i s c u r r e n t ly va l u e d at c i r c a $ 7. 1 B n p e r a n n u m , w i t h a n a n t i c i pat e d i n c r e a s e t o g r e at e r t h a n $ 1 0 b n b y 2 0 2 3 D r i v e r s

• E m e r g i n g m a r k e t s – pa r t i c u l a r ly a s i a
• A g e i n g p o p u l at i o n
• P r e va l e n c e o f o b e s i t y
• I n c r e a s i n g awa r e n e s s o f t r e at m e n t o p t i o n s

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Management Team

– B I O G RA P H I ES D E TA I L E D I N A P P E N D I X O N E –

G R O U P C E O

S I M O N S T E P H E N S

G R O U P S A L E S & M A R K E T I N G D I R E C TO R

P E T E R H O U G H TO N

G R O U P C H I E F F I N A N C I A L O F F I C E R

N O R M A N LOT T

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Medical Advisory Board

M A R C R . H A M ET, M D, M BA R I C HA R D A . BAS S I N, M D, F. A .C. S . LEON K LIEM, MD

– Director Interventional Radiology, Stellaris Healthcare. – White Plains Hospital, White Plains, NY. – Assistant Clinical Professor Radiology, Columbia University, NY, NY.

Equity Compensation

– Trained vascular surgeon, Former Director of ER. – Mount Sinai Hospital, New York, NY. – Technical advisor to Goldman Sachs & Smith Barney regarding medical tech investments. – Board Certified Neurosurgeon. – Director of the Hawaiian Neurosurgical Group – Adjuvent professor of Neurosurgery, University of Hawaii

M A R K S M I T H , M D

– Board Certified Neurosurgeon/Spine Surgeon. – Former Associate Professor Neurosurgery- State University of NY- Upstate Medical University. – Cardiovascular Surgeon - London/UK. – Vice Rector Ludes University Lugano - Switzerland – Director of London Core Review Cardiothoracic Surgery Course for the Arab Countries

PR O FES S O R A B DA L L A H RAWEH

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What is Faci-LOK™ System?

The first system specifically designed to stabilise a spinal segment without altering the anatomy in any way. Will be the least invasive and lowest risk of any system on the market, whilst also mitigating potential injury to nerve roots and other complications of screws. The Faci-LOK™ system does not irreversibly destroy the facet joint.

• is fully reversible and can be removed without having altered the anatomy.
• avoids deep bone infections which are associated even the most perfect placement
• f pedicle screws.
• represents a significant cost saving and reduced surgery time.
• will reduce the amount of exposure to radiation for patient, surgeon and staff.
• has considerable diagnostic potential which could truly revolutionise the current

practice of spinal surgery, as well as offering significant therapeutic benefits.

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Global Fusion Market

US$7.1 Bn/yr

VERSUS

PE D IC LE SC REWS

– Screws inserted into vertebrae. – Risk of nerve Injury is a known complication.

• Risk of deep bone infection

– Permanent alteration to anatomy. – Greater Surgical time & Anesthesia. – Unpredictable X-Ray exposure. – Less ability to modify post placement in MIS settings.

Fa c i- LO K™ Sys te m

– No invasion of vertebrae. – No risk of injury to nerve. – Fully Reversible. – Does not alter patient anatomy. – Less Surgical time. – Less Anesthesia. – Significantly less X-Ray exposure. – Faci-LOK System enables surgeon to precisely position vertebrae post placement.

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Current Technology

Pedicle Screws introduced over 30 years ago “Pedicle screws are the most common implant used in spine surgery… unfortunately, unacceptably high rates of misplacements in vertebra persist”1 The real problem… is the use of screws

The REAL solution… avoid screws altogether

1 OrthoSpineNews, 30 March 2016

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Development Timeline

5 1 0 K P AT H WAY C O N F I R M E D B Y F D A F D A C L E A R A N C E M A R K E T R E A D Y

A C T I V I T Y

PROTOTYPE REFINEMENT & TESTING APR' 19 MAY' 19 JUN' 19 JUL' 19 AUG' 19 SEP' 19 OCT' 19 NOV' 19 DEC' 19 JAN' 20 FEB' 20 MAR' 20 APR' 20 MAY 20 JAN' 17 510K - PREPARATION & FDA SUBMISSION SPECIALIST PRODUCT TESTING TEST MARKETING MANUFACTURING & DISTRIBUTION

1 2 1 2

APR' 20 MAY 20 JUN' 20

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Spinal Portfolio Pipeline

PRODUCT TIME TO MARKET DESCRIPTION

Cervi-FAS™ System NEAR TERM The first 'Minimally Invasive Surgery' posterior cervical fixation system will open new markets from a diagnostic and therapeutic perspective. Singapore Laminoplasty™ There are a series of related Frank Boehm inventions that the company has options on and will seek to aquire and develop in time and the adopted strategy. MID-TERM A system that combines the Cervi-Fas anchor with another unique technology to provide laminoplasty, a treatment for cervical stenosis, which is among the most common conditions particularly in populations over the age of 55.

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Development Partners

– Leading global manufacturer of medical devices. – Engaged to develop and manufacture spinal devices. – Leading global manufacturer of medical devices. – Development & manufacture of VOSC™ catheter. – Global medical device regulatory/registration partner. – FDA & CE approval processes for all TruSpine products.

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Financial Forecast

ITEM 2019 MARKET SHARE SCENARIOS 2020 2021 2022 UNITS Faci-LOK™ System & Cervi-FAS™ System TruSpine Results 2022 UNITS UNITS UNITS USD USD USD USD Faci-LOK™ System Cervi-FAS™ System Current F/Cast Singapore Laminoplasty TOTAL GROSS PROFIT EBITDA – – % OF GLOBAL MKT REVENUE 2022 EBITDA 2022 % OF MIS MKT EBITDA % 505 4,900 4,703 29,204 14,400 53,900 – 2.8% 182.4M 81.0M – 1.20M 5.6% 44% 12.25M 11.17M 73.01M 34.20M 134.75M – – 3,500 8,400 – 5.6% 351.3M 140.5M – 11.3% 40% 5.60M 13.44M – 5,405 37,407 76,700 – 14.1% 858.2M 343.3M – 6.72M 44.89M 91.20M (2.91M) (6.32M) 34.65M 81.01M 13.45M 28.2% 40% 89.78M 182.39M

Use Of Funds Funds raised at this stage will be used to support ongoing product development and overheads in advance

• f the forthcoming IPO. During this phase, overheads will continue to be kept to a minimum in order to

ensure that the majority of funds are used for developing the company’s products and IP. Investment to date So far the company has raised $3.5m from both private and pension scheme investors. Development costs have been expensed not capitalised.

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DATE TARGET COMPANY ACQUIROR

USD TRANSACTION VALUE TV/LTM SALES

BUSINESS DESCRIPTION

2016 ELLIPSE TECHNOLOGIES NuVasive In Progress 410M 10 X

MINIMALLY INVASIVE PAEDIATRIC & ORTHOPAEDIC (MIS) PRODUCTS

2016 LDR ZIMMER BIOMET 1.0B 14 X

ARTIFICIAL CERVICAL DISC

PRE FDA APPROVAL

2012 SYNTHES SPINE DEPUY/J&J 21.3B 5 X

ORTHOPAEDIC IMPLANTS & SURGICAL SYSTEMS

2015 BIOMET ZIMMER 13.3B 4 X

ORTHOPAEDIC RECONSTRUCTIVE PRODUCTS, SPINE TECHNOLOGIES

2009 CERVITECH NUVASIVE 90M N/A

ARTIFICIAL DISCS - PRE FDA APPROVAL

2013 MAKO SURGICAL STRYKER 1.65B 16 X

ORTHOPAEDIC RECONSTRUCTIVE PRODUCTS & SURGICAL SYSTEMS

2004 SPINE CORE STRYKER 120M N/A

ARTIFICIAL DISCS - PRE FDA APPROVAL

2008 ABBOT SPINE ZIMMER 360M 3 X

PEDICLE SCREWS MIS SYSTEMS

2003 LINK SPINE GROUP DEPUY SPINE 325M N/A

ARTIFICIAL DISCS - EXISTING & PRE FDA APPROVAL

2008 THEKEN SPINE INTEGRA (SPINE) 200M 4 X

SPINAL FUSION PRODUCTS

2003 SPINESOLUTIONS SYNTHES SPINE 350M N/A

ARTIFICIAL DISCS - EXISTING & PRE FDA APPROVAL

2007 PLUS ORTHOPAEDICS SMITH & NEPHEW 900M 3 X

ORTHOPAEDIC RECONSTRUCTION PRODUCTS

2007 KYPHON MEDTRONIC 4.2B 6 X

MINIMALLY INVASIVE SPINE (MIS) PRODUCTS

2007

• ST. FRANCIS MEDICAL

KYPHON 525M 10 X

MINIMALLY INVASIVE SPINE (MIS) PRODUCTS

MEAN 6.9 X 2006 BLACKSTONE ORTHOFIX INTTL 333M 6 X

PEDICLE SCREWS AND MIS SYSTEMS

MEDIAN 6 X 2003 SPINAL CONCEPTS ABBOTT LABS 210M 9 X

SPINAL FUSION PRODUCTS

Historical Acquisitions: Spinal

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Why TruSpine Technologies Limited?

Rapidly growing medical market with global value expected to top $10 billion by 2022. Innovative & disruptive spinal products with supporting IP and the potential to revolutionise the industry. The TruSpine products provide signifjcant benefjts to Patients, hospitals, surgical teams and insurance companies alike, and therefore represent something of a panacea. Cornerstone products Faci-LOK™ System, Cervi-FAS™ System forecast to generate early stage cash fmows. Highly experienced Board and management team to drive rapid growth and success. Near term liquidity event for investors with target AIM listing in H1-2019.

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Contact

For more information, please contact: S I M O N ST E P H E N S T: +44 (0)1293 411 740 simon.stephens@truspine.org SA RA H HASTI LOW T: +44 (0)1293 411 740 sarah.hastilow@copiancapital.com M I C H A E L U N WI N T: +44 (0)1293 411 740 mike.unwin@copiancapital.com TruSpine Technologies Limited Spectrum House, Beehive Ring Road, Gatwick Airport, West Sussex, RH6 0LG www.truspine.org

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Appendix 1: Management Team

SIMON STEPHENS - GROUP CEO Simon is a Senior Executive with nearly 20 years of board level experience in technology development and clinical engineering, with roles ranging from CTO to CEO. Most recently Simon has held the position of Research Director for London Valve therapies where he was responsible for the provision of a new service for the analysis of CT/Echocardiography scans for bleeding edge transcathether cardiac interventions mainly for Mitral Valve/Left Ventricular procedures. He is also a Research Fellow at the Royal Brompton & Harefjeld NHS Foundation Trust. Simon has a passion and track record for the development and commercialisation of disruptive medical technologies and software systems, including intelligent software solutions for the rapidly evolving CIS (Clinical Information Systems) sector. In a previous role as CTO for Hometrack, he was responsible for developing software technologies that resulted in the company being sold in 2017 for £120m. His core strengths lie in his ability to identify and assess the need for new technology, resulting in the creation stakeholder value through the successful realisation of commercially viable solutions and products that fulfjl that need. NORMAN LOTT – CHIEF FINANCIAL OFFICER Norman Lott is an experienced international CFO with signifjcant Plc experience, having held multiple roles in AIM listed companies

• n the London Stock Exchange. He is a member of the Institute of Chartered Accountants in England and Wales having qualifjed in

1980, and aside from his experience as a CFO, he has also held positions in business management including that of CEO. He has also been involved in several international M&A transactions, and also has direct experience in this sector.

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PETER HOUGHTON – GROUP SALES & MARKETING DIRECTOR Peter has over 22 years of experience in the medical device fjeld holding an array of sales and sales leadership positions within the vascular, neuroscience, orthopedic and biologic markets. He began his career with a small Midwest medical distributor before joining Arrow International ultimately accepting a promotion and relocating to the Boston area. Joining the sales leadership team at Codman (a Johnson and Johnson Company) was his fjrst introduction to the fjeld of neurosciences and his exposure to the spine market. For the past 12 years, he has been working directly in the spinal implant market leading successful sales teams with industry leaders Medtronic Spine & Biologics, innovators K2M, Inc. and most recently as principal of a medical distributorship. Mr. Houghton received his BA from Northern Illinois University.

Appendix 1: Management Team

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• F. HARRISON BOEHM, MD – INVENTOR & TECHNICAL CONSULTANT

Pre-eminent fjgure in the spinal surgery fjeld – a medical doctor who has performed more than 2,000 neurosurgical procedures and published numerous articles and original research papers on spinal surgery. Chief designer of the Faci-LOK™ series of facet fjxation devices and has licensed or sold spine IP to major spinal instrumentation companies. Awarded 12 patents and 40+ more are currently being examined. Previous invention won the coveted Frost & Sullivan award, considered the highest award in Spinal Technology, for the best new spine technology introduced in 2006. Visiting Research Scientist at MIT 2016.

Appendix 2: Inventor

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Appendix 3: Corporate Structure

T R US P I NE T ECH NOLOG I ES LI MI T ED

( U K H O L D I N G C O M P A N Y )

T R US P I NE T ECH NOLOG I ES IN T E RN ATIO NAL INC

( U S S U B S I D I A R Y )

Corporate structure is based on UK Holding company with US and UK subsidiaries focusing on each product range, and that deal with FDA & US sales and marketing, and CE and European sales and marketing respectively. Group IP is protected in the non-trading holding company.

T R US P I NE T ECHNOLOG I ES I N TERN ATI ON A L LI MI TED

( U K S U B S I D I A R Y )