Con dential – not for distribution€¦ · The information in this presentation is in summary...

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Confidential – not for distribution

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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

only. 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

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

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

of, 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 reflect any change in expectations or assumptions. Nothing in the

presentation should be interpreted to mean that there has been no change in the affairs 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

on 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 p at 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 – p a 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 R A P H I E S 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 T O R

P E T E R H O U G H T O 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 L O T T

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Medical Advisory Board

M A R C R . H A M E T, M D , M B A

R I C H A R D A . B A S 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 CountriesP R O F E S S O R

A B D A L L A H R AW E H

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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 of 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 P E D I C L E S C R E W S

– 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 ™ S y s t e 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 A T H W AY 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

P R OTOT Y P E R E F I N E M E N T

& T ES T I N GA

PR

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5 1 0 K - P R E PA RAT I O N

& F DA S U B M I S S I O N

S P EC I A L I S T P R O D U CT

T ES T I N G

T ES T M A R K E T I N G

M A N U FACT U R I N G

& D I S T R I B U T I O N

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Spinal Portfolio Pipeline

P R O D U C T T I M E

TO M A R K E T

D E S C R I P T I O N

C e r v i - FAS ™ Sys te m

N E A R T E R MThe first 'Minimally Invasive Surgery' posterior cervical fixation system will open

new markets from a diagnostic and therapeutic perspective.

S i n g a p o re L a m i n o p l a s t y ™

T h e re a re a s e r i e s of re l a te d Fra n k B o e h m i nve n t i o n s t h a t t h e c o m p a ny h a s o pt i o n s o n a n d w i l l s e e k to a q u i re a n d d eve l o p i n t i m e a n d t h e a d o pte d s t ra te g y.

M I D -T E R M

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 ForecastI T E M 2 0 1 9

M A R K E T S H A R E S C E N A R I O S

2 0 2 0 2 0 2 1 2 0 2 2

U N I T S

Faci-LOK™ System & Cervi-FAS™ System TruSpine Results 2022

U N I T S U N I T S U N I T SU S D U S D U S D U S D

Faci-LOK™ System

Cervi-FAS™ System

Current F/Cast

Singapore Laminoplasty

TOTA L

G R O S S P R O F I T

E B I T DA

–

–

% 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 FundsFunds raised at this stage will be used to support ongoing product development and overheads in advance of 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 dateSo 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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DAT E TA R G E T C O M PA N Y AC Q U I R O RUSD

TRANSACTION VALUE

TV/LTM SALESB U S I N E S S D E S C R I P T I O N

2 0 1 6 E L L I P S E T EC H N O LO G I ES N uVa s i ve In Progress 4 1 0 M 1 0 XMINIMALLY INVASIVE PAEDIATRIC & ORTHOPAEDIC (MIS) PRODUCTS

2 0 1 6 L D R Z I M M E R B I O M E T 1 . 0 B 1 4 XARTIFICIAL CERVICAL DISC

P R E F DA A P P R OVA L

2 0 1 2 SY N T H ES S P I N E D E P U Y/J & J 2 1 . 3 B 5 XORTHOPAEDIC IMPLANTS & SURGICAL SYSTEMS

2 0 1 5 B I O M E T Z I M M E R 1 3 . 3 B 4 XORTHOPAEDIC RECONSTRUCTIVE PRODUCTS, SPINE TECHNOLOGIES

2 0 0 9 C E RV I T EC H N U VAS I V E 9 0 M N /AARTIFICIAL DISCS - PRE FDA APPROVAL

2 0 1 3 M A KO S U R G I CA L S T RY K E R 1 . 6 5 B 1 6 XORTHOPAEDIC RECONSTRUCTIVE PRODUCTS & SURGICAL SYSTEMS

2 0 0 4 S P I N E CO R E S T RY K E R 1 2 0 M N /AARTIFICIAL DISCS - PRE FDA APPROVAL

2 0 0 8 A B B OT S P I N E Z I M M E R 3 6 0 M 3 XPEDICLE SCREWS MIS SYSTEMS

2 0 0 3 L I N K S P I N E G R O U P D E P U Y S P I N E 3 2 5 M N /AARTIFICIAL DISCS - EXISTING & PRE FDA APPROVAL

2 0 0 8 T H E K E N S P I N E I N T EG RA ( S P I N E ) 2 0 0 M 4 XSPINAL FUSION PRODUCTS

2 0 0 3 S P I N ES O LU T I O N S SY N T H ES S P I N E 3 5 0 M N /AARTIFICIAL DISCS - EXISTING & PRE FDA APPROVAL

2 0 07 P LU S O RT H O PA E D I C S S M I T H & N E P H E W 9 0 0 M 3 XORTHOPAEDIC RECONSTRUCTION PRODUCTS

2 0 07 K Y P H O N M E DT R O N I C 4 . 2 B 6 XMINIMALLY INVASIVE SPINE (MIS) PRODUCTS

2 0 07 S T. F RA N C I S M E D I CA L K Y P H O N 5 2 5 M 1 0 XMINIMALLY INVASIVE SPINE (MIS) PRODUCTS

M E A N 6 . 9 X

2 0 0 6 B L AC K S TO N E O RT H O F I X I N T T L 3 3 3 M 6 XPEDICLE SCREWS AND MIS SYSTEMS

M E D I A N 6 X

2 0 0 3 S P I N A L CO N C E P T S A B B OT T L A B S 2 1 0 M 9 XSPINAL 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 significant benefits 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 flows.

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 S T E P H E N S T: +44 (0)1293 411 740

[email protected]

S A R A H H A S T I LO W T: +44 (0)1293 411 740

[email protected]

M I C H A E L U N W I N T: +44 (0)1293 411 740

[email protected]

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 &

Harefield 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 fulfil

that need.

NORMAN LOTT – CHIEF FINANCIAL OFFICER

Norman Lott is an experienced international CFO with significant Plc experience, having held multiple roles in AIM listed companies

on the London Stock Exchange. He is a member of the Institute of Chartered Accountants in England and Wales having qualified 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 field 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 first introduction to the field 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 figure in the spinal surgery field – 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 fixation

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 U S P I N E T E C H N O LO G I E S L I M I T E D

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

T R U S P I N E T E C H N O LO G I E S

I N T E R N AT I O N A L I N C ( 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 U S P I N E T E C H N O LO G I E S I N T E R N AT I O N A L

L I M I T E D ( U K S U B S I D I A R Y )

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