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REGENERATIVE MEDICAL DEVICES 4 TH JUNE 2015 TISSUE REGENIX GROUP PLC

Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

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Page 1: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

REGENERATIVE MEDICAL DEVICES

4TH JUNE 2015

TISSUE REGENIX GROUP PLC

Page 2: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Disclaimer The information in this Presentation is not intended to form the basis of any contract. By attending the meeting where this Presentation is made or reading the Presentation, you agree to the conditions set out below. The information contained in this document and made verbally to you (together the "Presentation") is confidential. Accordingly, information contained in the Presentation is being supplied to you solely for your information and may not be copied, reproduced or further distributed to any person or published in whole or in part, for any purpose. This Presentation includes certain statements, estimates and projections with respect to the anticipated future performance of Tissue Regenix Group plc (the "Company" and, together with its subsidiary undertakings, the "Group"), its products and the markets in which it operates. Such statements, estimates and projections reflect the various assumptions made by the Group, which assumptions may or may not prove to be correct. The Presentation is provided for general information only and does not purport to contain all the information that may be required to evaluate the Company. No representation or warranty, express or implied, is given as to the accuracy, completeness or fairness of the information or opinions contained in the Presentation and no liability is accepted for any such information or opinions by the Group or any of its respective directors, members, officers, employees, agents or advisers. Save in the case of fraud, no responsibility or liability is accepted by any person for any errors, omissions or inaccuracies in such information or opinions or for any loss, cost or damage suffered or incurred, however arising, directly or indirectly, from any use of, as a result of the reliance on, or otherwise, in connection with, the Presentation. In addition, no duty of care or otherwise is owed by any such person to recipients of the Presentation or any other person in relation to the Presentation. This document (and the information contained herein) does not contain or constitute an offer of securities for sale, or solicitation of an offer to purchase securities, in the United States, Australia, Canada or Japan or any other jurisdiction where such an offer or solicitation would be unlawful. The securities of the Company have not been and will not be registered under the U.S. Securities Act of 1933, as amended ("Securities Act"), and may not be offered or sold in the United States unless the securities are registered under the Securities Act, or an exemption from the registration requirements of the Securities Act is available. No public offering of the securities of the Company will be made in the United States. This document is not for distribution in the United States and is only being supplied to qualified institutional buyers as defined in Rule 144A under the Securities Act ("QIBs"). This Presentation does not constitute a recommendation regarding the securities of the Company, nor shall it (or any part of it), or the fact of its distribution, form the basis of, or be relied on in connection with or act as any inducement to enter into, any contract whatsoever relating to any securities. Neither this presentation nor any copy of it may be, taken or transmitted into or distributed in Canada, Australia, the Republic of Ireland, Japan or the Republic of South Africa or to any resident thereof. Any failure to comply with these restrictions may constitute a violation of the securities laws or the laws of any such jurisdiction. The distribution of this document in other jurisdictions may be restricted by law and the persons into whose possession this document comes should inform themselves about, and observe, any such restrictions. By accepting receipt of, attending any delivery of, or electronically accessing, the Presentation, you agree to be bound by the above limitations and conditions and, in particular, you represent, warrant and undertake to the Group that (i) you are a QIB (as defined above); (ii) you will not forward the Presentation to any other person, or reproduce or publish this document, in whole or in part, for any purpose and (iii) you have read and agree to comply with the contents of this notice.

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Page 3: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Background To Company

• Main offices in York, UK, US office San Antonio, TX • Over 70 employees • Listed on AIM (London Stock Exchange) Ticker: TRX.l • Market cap: $220m

Tissue Regenix Group plc

• University of Leeds, UK (inventors of dCELL® process) • Community Tissue Services Dayton OH • NHSBT, UK • PUCPR, Curitiba, Brazil (heart valves)

Technology partners

• Decellularisation of tissues (animal or human) • Multiple tissue types can be decellularised • Stem cells attracted into matrix (Dardik, Yale)

dCELL® Platform technology

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Page 4: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

dCELL® Process

dCELL® Process

Patent protected

Matrix stored at room

temperature

surgery

Surgeons usual technique

regeneration

Capacity to attract stem cells into matrix

Long term regenerative

repair

Animal or human

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Page 5: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Multiple Applications

Animal or human • Soft tissues

– Wound care – Orthopaedics – Cardiac – Vascular – Urinary

• Future: liver etc.

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Page 6: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

dCELL® - why is it different? • Derived from the natural structural tissue to be replaced

– Biomechanical structure and function – short and long term – Appropriate tissue repair environment - attract and support tissue

regeneration, tissue specific micro-scale physical and biochemical architecture.

• Use of low concentration SDS & proteinase inhibitors preserves tissue structure – Others have used high concentrations of reagents that destroy tissue

structure • No use of chemical fixatives

– Others treat acellular biological scaffolds with fixatives which prevents cells migration

• Provides low cost regenerative solution by recruiting and stimulating patients own cells to repair

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Page 7: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Intellectual Property – Underpinning the Development and Commercialisation Strategy

Know

how

Decellularisation of matrices Aus, Can, EU, US

Meniscal Repair [India]

US, China, EU, Japan, Aus

Bladder [EU, Aus] UK, US

Ultrasonic modification

of soft tissues EU, US

Acellular Arteries

[Aus, Br, Can, China, EU, HK, India, Japan,

US]

Granted patents in bold, all others

pending

Trademarks: Tissue Regenix, dCELL, TRx, DermaPure

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Page 8: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Strategy – focussed on core dCELL® technology

US • Human ‘minimally manipulated’

products • Porcine dermis (general surgery) • Pre-IDE preparation

dCELL® evidence base • Health economics • Clinical/mechanism of action

Core focus areas • Wound Care • Orthopaedics • [Cardiac]

EU • CE Mark (porcine products) • Tissue Bank licensing (human tissue)

dCELL®

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Page 9: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Highlights • Launched first product DermaPure™ for chronic wounds (June ‘14)

– Initial revenues – Secured ‘Q’ code – First Medicare coverage secured (Novitas JH/JL & CGS) early ‘15

• Raised £19.2m ($28m) in January – Fund US expansion

• Orthopaedics (Sports Medicine) – Clinical trial for OrthoPure™ XM (meniscus) underway in EU – Clinical trial for OrthoPure™ XT (tendon) clinical trial approved in UK

• recruitment to start H2 ‘15 • Developments

– Human sports medicine process development • Meniscus & tendon

– SurgiPure™ Porcine Dermis – Line extensions

• DermaPure™ - dental/sports medicine • Relocation to new site – expansion of manufacturing

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Page 10: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

BUSINESS REVIEW - WOUND CARE TRX Wound Care Inc.

Page 11: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Remarkable Clinical Results

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Average wound duration (weeks)

Aver

age

wou

nd si

ze (c

m2 )

Note: Wound type & percentage of wounds closed for clinical study in parenthesis beside each product (study end points vary)

Average wound size = 13.1

cm2

Average wound duration = 4.76 years

DFU’s & VLU’s

DermaPure™ – the visible dermal difference

Page 12: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

US Clinical Validation

• DFU (Diabetic Foot Ulcer) Randomised Control Trial (RCT) • 60 patients

– 3 month follow up – Standard of care crossover @ 12 weeks

• 6 centres recruiting

Presentation at SAWC

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• 10 US case series − 12.9cm2 (big) wounds − 100% healing − 6.5 weeks avg time to heal − 1.1 applications (only one

case required two)

Page 13: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

US Rollout Strategy

Phase 1: ACUTE CARE Phase 2: POST-ACUTE CARE

20-30% of chronic wound patients

70-80% of chronic wound patients

Reimbursement not needed Value Analysis Ctte’s [VAC’s]

6-18 months to approve

Reimbursement required under Medicare

First coverage secured in less than 3 months

Chronic wounds associated with other conditions

DFU’s (Diabetic Foot Ulcers) VLU’s (Venous Leg Ulcers)

Hospitals, VA, LTAC’s Wound Care Centers, Outpatient Surgery Centers, Physician Offices

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Page 14: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Reimbursement first steps: Novitas & CGS notices & initial distributor contract

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ABMAC & Private P Tissue Regenix Wound Care Inc. received reimbursement for DermaPure

within the Novitas region effective April 9, 2015 , CGS followed in May ‘15

This allowed Tissue Regenix to execute phase II strategy

Reimbursement scene continues to change potentially favourable to TR as will limit number of applications

Regional distributor contract Signed after Novitas notice became effective

Experienced surgical & wound care distributor

Covers only 2 of 12 states in Novitas jurisdiction

11% of total Novitas potential population

Minimum $600k commitment over next 12 months

Scope to extend coverage area

Further agreements in pipeline

52m covered lives

Novitas largest of eight national ABMAC’s

Page 15: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Reimbursement → Patient Access & Commercial Opportunity

Patients, Clinicians & Payors • Continue to build awareness of clinical

success • Continue with active engagement with

other ABMAC’s • Leverage Medicare approvals to secure

uptake by: – Commercial payers – Managed Medicare beneficiaries – Paying patients

Hybrid distribution model • Indirect

– Extend in Novitas & CGS states – As other ABMAC’s come on-

stream add to existing or add new partners

• Direct – Focus sales reps in key Novitas &

CGS states – Pipeline visibility – Phased deployment as remaining

ABMAC’s come onstream

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Page 16: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Hybrid Model Gaining Traction

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October 2014

May 2015 NOVITAS

CGS

Page 17: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

US Wound Care

• Commercial traction building – Distribution channels are building

in depth & quality – Novitas decision key as product

now can be used in largest group of chronic wound patients (post-acute)

• Clinical results more than compelling they’re “..visibly different” – Other application areas (burns

etc.)

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Validation

Commercial Delivery

Page 18: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

BUSINESS REVIEW - ORTHOPAEDICS TRX Ortho Ltd

Page 19: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Meniscal Repair Market - responding to clinical needs

Large Global Market Opportunity • Partial Meniscectomy most common Orthopaedic Procedure at 61 per 100,000

population • 2013 – USA 1 Million, Europe 400,000 Meniscal Procedures

Current Therapies/Treatments • For every 100,000 Meniscal injuries approx 20% are repairable • Remaining 80% - Partial Meniscectomy is the treatment of choice and regarded

as sub-optimal • 20-25% of patients remain symptomatic and require ongoing treatments and

surgical interventions • Competitive landscape – Other scaffolds – Orteq, Ivy Sports Medicine, Azellon,

Orthox

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Page 20: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

OrthoPure™ XM (Meniscus) Background

Primary goals with OrthoPure™ XM • In the short term – restore load bearing and shock absorbing functions, contributing to

pain relief and restoring functional mobility • In the long term to lower the risk of Osteoarthritis and the need for further operations.

e.g. Partial Knee Replacement and Total Knee Replacement

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• Meniscus structure is complex and poor to heal beyond the outermost 20%

• Irreparable meniscus tear

• Partial Menisectomy

• dCELL® Meniscus Replacement

Page 21: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

ACL Reconstruction Market - responding to clinical needs

Large Global Market Opportunity

• ACL rupture is the second most common injury of the knee requiring surgical reconstruction

• Approximately 80% of ACL injuries are surgically treated • An estimated 900,000 procedures performed annually growing at 7% CAGR (2012-2020)

Current Therapies/Treatments

• Autograft – 73% • Allograft – 26% • Synthetics – 1% LARS, Neoligaments, Soft Tissue Regeneration • Xenograft Scaffolds – Aperion Biologics

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Page 22: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Sports Medicine – current status

• OrthoPure™ XM & XT [PORCINE] (meniscus & tendon) – CE mark clinical (regulatory) trials – Actively recruiting into meniscus trial – Tendon trial received UK regulatory approval, further approvals pending in Poland &

Spain – Pre-IDE programme underway (tendon & meniscus) – Target: regulatory approval & launch in EU 2016

• Clinical recruitment rate key factor in timeline

• OrthoPure™ HM & HT [HUMAN] (meniscus & tendon) – Processes in development – Room-temperature tendon & partial meniscal repair devices – Target: launch in US 2016

• DermaPure™ (thick) – Process in development – Target: rotator cuff repair

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Page 23: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Launch

Work closely with corporate partner to ensure robust launch package Secure pathway for US pivotal clinical trial (PMA)

Post Launch

Broaden Portfolio through Line Extensions

Build Strong Corporate

Partnership

Pre-Launch

Strategy – Sports Medicine

Select corporate partner with appropriate EU/US sales & marketing infrastructure Target EU markets with clear reimbursement pathways Targeted KOLs (EU/US)

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Page 24: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

BUSINESS REVIEW - CARDIAC TRX Cardiac Ltd

Page 25: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

dCELL® Human Heart Valves

• Brazils first heart valve bank adopted technology early (10 years ago) and has over 1700 patients with implanted valves

• Compelling clinical data continues to emerge from Brazil – Presentations at recent Heart Valve Society meeting in Monaco – 10 year 160 patient follow up for dCELL® Human Pulmonary Heart Valves –

demonstrably more effective than standard cryopreserved – Unique 10 year follow up for dCELL® Human Aortic valves in 100 patients

• High risk group of younger patients • Partial repopulation of grafts

• Retrospective data collection from 50 paediatric patients underway – Initial findings encouraging – Unique data set in complex patient type

• Licensing discussions with selected partners now entering an advanced stage

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Page 26: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

FINANCIAL

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Page 27: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Income Statement

12 months to 31-Jan-15

£'000

12 months to 31-Jan-14

£'000 Comments

Operating Income 100 6

Administrative expenses (8,469) (6,583)

Increase in line with expectations as we invest in development and in infrastructure to market our products

Operating loss (8,369) (6,577)

Finance income 168 274

Loss before tax (8,201) (6,303)

Taxation 620 710 Continued R&D tax credit refund

Loss after tax attributable to equity holders of the parent (7,581) (5,593)

Loss per share, basic and diluted (1.19p) (0.88p)

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Page 28: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

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Balance Sheet

31 Jan 2015 £'000

31 Jan 2014 £'000

Comments

Non-current assets Property, plant and equipment 435 472 Total non-current assets 435 472 Current assets Inventory 34 - Trade and other receivables 1,947 1,127 Cash and cash equivalent 10,257 18,483 Additional £19m raised post year-end

Total current assets 12,238 19,610 Total assets 12,673 20,082 Current liabilities Trade and other payables (1,095) (1,104) Total liabilities (1,095) (1,104) Net assets 11,578 18,978 Equity Share capital 3,271 3,267 Share premium 31,972 31,971 Merger Reserve 10,884 10,884 Reverse acquisition reserve (7,148) (7,148) Reserve for own shares (831) (831) Share based payment reserve 810 630 Retained earning deficit (27,380) (19,795) Total equity 11,578 18,978

Page 29: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Share Register

Invesco Perpetual 27.8% IP Group plc 16.8% Woodford Investment Management 14.5% • Strong blue chip fund investor base • January fund raise oversubscribed

Page 30: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

PRODUCT PORTFOLIO

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Page 31: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Product line extensions

DermaPure™ Chronic Wounds Acute Wounds Dental Burns Rotator Cuff

Repair

OrthoPure™ XM

Partial Meniscal

Repair

Hip Arthroscopy

Cartilage Repair

OrthoPure™ XT ACL repair PCL, MCL, LCL,

MPFL

Foot, Ankle, Shoulder,

Elbow

SurgiPure™ General Surgery

Breast Reconstruction

Page 32: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Product Pipeline – Through Development To Commercially Available Products

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2015* 2016*

DermaPure®(Dental) (US)

DermaPure®(Ortho) (US)

SurgiPure™ XD G. Surgery (US)

OrthoPure™ XM (EU)

OrthoPure™ XT (EU)

OrthoPure™ XM (US)

OrthoPure™ XT (US)

PORCINE

HUMAN

SurgiPure™ XD G. Surgery (EU)

dCELL® Heart Valve

*Calendar years – indicative timings only dependant on development timings & regulatory considerations

Page 33: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

Conclusion & Outlook • DermaPure® clinical

performance outstanding – Medicare coverage increasing

• Clinical trials for porcine sports medicine products underway in EU

• Multiple product launches (US & EU) planned in next 18 months

• Pre-IDE programme underway for porcine sports medicine products in US

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FIRST PRODUCT LAUNCHED ON TIME INTO WORLDS LARGEST

HEALTHCARE MARKET

MULTIPLE CLINICAL TRIALS IN PROGRESS US, EU & BRAZIL

EARLY REIMBURSEMENT FOR DERMAPURE™

SOLID WOUND CARE COMMERCIALISATION

PLATFORM BUILT FOR FUTURE GROWTH

VALIDATION OF TECHNOLOGY IN MULTIPLE APPLICATION AREAS &

COMMERCIAL DELIVERY

Page 34: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

APPENDIX Tissue Regenix Group plc – Preliminary Results

Page 35: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

DermaPure™ - the visible dermal difference

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Page 36: Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 • Developments – Human sports medicine process development ... 2015 , CGS followed

SAWC Poster – May ‘15

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