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Page 1: connection with, the Presentation. In addition, no duty of ... · USA 2015 CAGR 7% EU 2015 CAGR 5% Autograft 94% Allograft 4% Synthetics 2% ROW 2015 CAGR 6% Procedure Volume ACL*

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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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1. Overview 2. Technology3. Strategy4. Product Portfolio 5. Financial

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•Main offices in Leeds, UK, US office San Antonio, TX

•Over 70 employees

•Listed on AIM, Ticker: TRX.l → Market cap: £130m

Tissue Regenix Group plc

•Removes 99% of cells/DNA creates matrix (animal or human)

•Multiple tissue types can be decellularised

•Stem cells attracted into matrix (Dardik, Yale)

•Regenerates as living tissue → ‘…a living repair’

dCELL® Platform technology

•Regenerative medical devices to address need for long term repairs

•Human dCELL® tissues provide fast route to market launch → early revenue

•Animal dCELL® tissue products follow

•Substantial market opportunity (Wound Care, Orthopaedics, Cardiac & more)

Strategy

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Antony Odell CEO

Tony Hewitt

UK Operations Director

Greg BilaPresident, Tissue

Regenix Wound Care, Inc

Tim Buechner, VP Operations Tissue Regenix Wound Care,

Inc.

Ian Jefferson CFOPeter Hamer

Commercial Director, TRX Orthopaedics Ltd

Drew Distin, VP Tissue Regenix Orthopaedics, Inc

Andrea Rausch Commercial Director,

TRX Cardiac Ltd

Tissue Regenix has a corporate board with a wealth of experience in the commercialization of medical devices, business development and finance.

Tissue Regenix has an executive management team experienced in commercialising products around the world.

John Samuel

Chairman

Antony Odell CEO

Steve CouldwellNED

Alan Miller NEDRandeep Grewal

NEDJon Glenn NED

Ian Jefferson CFO

ShervantiHomer-

Vannianskim

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®

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Human Tissue

• US: Direct ‘hybrid’ marketing model

• ROW: Partner/JV/Licensing

dCELL® evidence base

• Health economics

• Clinical/mechanism of action

Core focus areas

• Wound Care

• Orthopaedics

• Cardiac

Animal Tissue

• EU: CE Mark 3rd party distribution

• US: ‘Hybrid’ model (510k products)

• Partner (PMA products)

• ROW: Regulatory pathway led

dCELL®

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Tissue Regenix entered a Joint Venture in January 2016

Enables deployment of dCELL® human tissue technology in EU

Initial licences for CardioPure™ HAV & HPV (H umanA ortic/P ulmonary V alves) & DermaPure®

Annual technology access fee per application €100k

• Processing fee per tissue (valve/cm2 etc.)

Initial revenues to be derived from cryopreserved-tissues (cornea, heart valves)

• Regulatory approvals H216

Regulatory submissions for dCELL® in progress

• Regulatory approvals expected mid 2017

Donor base expanding to plan

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Trauma426,294

5%

Burn462,352

6%Diabetic

Foot Ulcers1,451,747

18%

Venus Leg Ulcers

959,292 12%

ArterialUlcer

238,3233%

Pressure Ulcer 4,468,052

56%

Wound Prevalence in the US¹

0

10

20

Diabetic LimbComplications

Breast Cancer ColorectalCancer

Lung Cancer ProstateCancer

Leukemia

Annual Direct Healthcare Costs 3

(In Billions of US Dollars)• The CDC estimates that 86M people in the US have pre-diabetes¹

• 29.1 million children and adults have diabetes • 8.9 million are undiagnosed • 4 – 10% have a diabetic foot ulcer

• Highest prevalence of diabetic foot ulcers are found in: • Diabetic population over 65 years of age = 8%²

• Diabetic patients within the VHA = 5.5%¹

• The incidence of diabetic limb amputation is estimated at 15%²

Trauma426,294

18%

Burn41,098

1%

Pressure Ulcer 1,,098,237

34%

Diabetic Foot Ulcer

943,63529%

Venus Leg Ulcer

476,646 15%

ArterialUlcer

238,3233%

Sources: 1. US Wound Biologics Market BioMedGPS, LLC. https://www.smarttrak.net2. “Preventing Foot Ulcers in Patients with Diabetes. JAMA. 2005;293(2):217-228. doi:10.1001/jama.293.2.217; http://jama.jamanetwork.com/article.aspx?articleid=2001193. Diabetic Foot & Ankle 2013. © 2013 Neal R. Barshes et al. Published: 10 October 2013; The system of care for the diabetic foot: objectives, outcomes, and opportunities;

http://diabeticfootandankle.net/index.php/dfa/article/view/21847/html#CIT0005_21847

Surface area reduction less than 50%

in 4 weeks

“Hard to Heal” Wound Prevalence in the US¹

DFU’shighest wound

expenditure

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2014 US Skin Substitutes by Segment¹

Allograft $180.8M

37%

Xenograft $159.3M

29%

Cell-based Bioengineered

$185.9M34%

US Skin Substitutes 5 Forecast by Segment¹

Market size ( millions US Dollars )

Topical Delivery

/Drug $288M

33%Skin Substitutes

$562M66%

Sources: 1. US Wound Biologics Market BioMedGPS, LLC. https://www.smarttrak.net

Allograft18.1%CAGR

Xenograft 13%

CAGR

Cell-based-13.1%CAGR

• The Wound Biologic Market is projected to be $1.4B by 2019 • The CAGR = 9.8%

• The Skin Substitutes are comprised of three types:¹

• Allografts – Human derived tissue products • Xenograft – animal derived tissue products • Cell-based Bioengineered Tissue – “grown” tissue products

• Cell-based bioengineered tissues continue to decline (-34% in 2014)

• Many new companies have entered the skin substitute market with allograft and xenograft tissue products

$0

$200

$400

$600

$800

$1,000

2014 2015E 2016E 2017E 2018E 2019E

Collagen / Active

Dressings $51.2M

6%

2014 Wound Biologic Market

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Autograft 74%

Allograft 26%

Synthetics 0%

Autograft 96%

Allograft 3%

Synthetic 1%

USA 2015 CAGR 7%

EU 2015 CAGR 5%

Autograft 94%

Allograft 4%

Synthetics 2%

ROW 2015 CAGR 6%

Procedure Volume

ACL* 350,000

Knee Multi-ligament 70,000

Other 90,000

Total 510,000

Procedure Volume

ACL* 210,000

Knee Multi-ligament 42,000

Other 62,000

Total 314,000

Procedure Volume

ACL* 150,000

Knee Multi-ligament 25,000

Other 35,000

Total 210,000

Procedure Volumes of ACL Reconstruction @36 per 100,000. Scandinavian ACL Registry 2004 - 2016

• Total Sales $46.6 Billions at 1.2 % over prior year (CAGR $50 Billions 2020)

• Sports Med/Orthobiologics - Estimated combined revenue of 20% at $9.12 billions (CAGR 6.6% through 2019)

• Demographics continues to serve the segment well age, arthritis, obesity, sports

• Significant need for soft tissue grafts/replacements within ‘Sports Medicine’ arena (Meniscus, Cartilage, Ligaments)

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DermaPure® Redirects Vascular Behavior to Trigger Healing

DermaPure® provides an acellular, intact tissue matrix that signals the body to heal by moving through the normal phases of wound healing (inflammation, proliferation, maturation).

The result is fully revascularized tissue

Commercial traction $1.2m revenue FY16 93% Medicare Coverage Strong clinical support for

product

Treatment of Acute and Chronic Wounds

Chronic wound – A wound that develops over time and does not heal by 50% within 4 weeks of treatment. e.g Diabetic Foot Ulcers

Acute wound – A wound that happens suddenly and is not progressive. Moves through the normal phases of healing. e.g surgical wounds

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Day of Applicationof DermaPure®

Week 1 Week 4 One month post closure

US spends $11bn treating pressure ulcers annually.”National Pressure Ulcer Advisory PanelSept 18th 2015

Pressure Ulcer4 years OldHealed in 4 weeks

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Group Purchasing Organisation

Direct reps

Integrated Delivery Network

Medicare is a federal insurance programme for the

over 65s, which subsidises costs for healthcare treatments through a reimbursement programme.

In order to qualify for this subsidy, the treatment must initially be approved under the relevant Medicare jurisdiction often determined by geographic area.

DermaPure® now has coverage in 7 of the 8 Medicare jurisdictions

National Accounts/

Distributors

- Medicare 'Q' code for reimbursement, came into effect January 1st 2015 - First GPO contract signed in July 2016 which spans across 43 states and is affiliated with 48 IDNs, with a membership comprised of more than 800 acute care hospitals, 186 different Health Systems and more than 1000 long-term care facilities

Jusrisdiction Covered Non-Covered % of Total

Novitas 8,919 24

Noridian 6,460 17

NGS 7,099 19

WPS 4,134 11

First Coast 2,559 7

Palmetto 3,397 9

Cahaba 2,563 7

CGS 1,921 5

Total 34,488 2,563 100%

Tissue Regenix

Coverage

93% 7%

Medicare Coverage 93%

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•First time FDA has reviewed full dCELL® process

•Focus on complex hernias (grade 3-5)

•$300m market opportunity

•Launch H2 2017

•Seeking to appoint a national distributor

•Clarifying reimbursement pathway

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Large addressable market and potential market opportunities

Exceptional product performance

DermaPure® $1.2m in revenue achieved in first full fiscal year

$831K six months to 31 July 2016

Larger and thicker sizes to become available H2 2016

Product extensions into dental, burns and breast augmentation

SurgiPure XD to become available H2 2017

Milestones

Final Medicare jurisdiction

GPO/ IDN Agreements

SurgiPure XD distributor

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Partial Meniscectomy is most common Orthopaedic Procedure at 61 per 100,000 population

Removal of meniscal tissue creates mechanical imbalance – currently limited surgical options available

OrthoPure™ XM first EU Clinical trial enrolment completed

Second clinical trial application to commence H2 2016

Target: Regulatory approval and launch EU 2018

Without Meniscus high peak stress on cartilage

Potential Complications after meniscectomy

The meniscus is a crescent-shaped structure that sits between the femur and tibia (thigh and shin) bones and acts a shock absorber whilst also providing structural integrity to the knee joint.

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The ACL is a fibrous band of tissue that runs diagonally across the centre of the knee. Primary function is stability.

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

Approximately 80% of ACL injuries are surgically treated (Autograft, allograft and synthetics)

Autograft requires second surgery site, allograft supply is limited and synthetics lack long term durability

OrthoPure™ XT EU Clinical trial started December 2015.

Target: Regulatory approval EU Q4 2016

US Pilot Clinical Study submission Q4 2016

ASP (£)OrthoPure™

XT

Potential Market

(£)

USA 1,500 765M

EU 1,100 345M

ROW 1,200 252M

Total 1,362B

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Knee RepairACLMeniscus

OrthoPure™XM

Partial Meniscal

Repair

Hip Arthroscopy

Cartilage Repair

OrthoPure™XT

ACL repairPCL, MCL, LCL, MPFL

Foot, Ankle, Shoulder,

Elbow

OrthoPure™XT CE Mark approval

OrthoPure™XM EU clinical trial application

OrthoPure™ XT EU market roll out

OrthoPure™ XM EU clinical trial commence

OrthoPure™ HM Technology transfer (US)

OrthoPure™ HT Technology transfer (US)

OrthoPure™ XM EU Launch

OrthoPure™ XM US clinical study commences

OrthoPure™ XM510k data collection

OrthoPure™ XT US pivotal study commences

OrthoPure™ XT pilot study US

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The data showed:

Freedom from reoperation in this high risk

group was 89% after ten years

Partial cellular repopulation of the valve

CT scans showed absence of

calcification even in the valve root,

essential in this treatment, where, in

younger patients, it is a significant

problem.

Pulmonary: 10 year follow-up

• 155 patients received dCELL® valve

• Mean age of patients 30.8 (+/- 13.1) years

• Aortic: 10 year follow up

• 103 patients received dCELL® valve

• Mean age of patients 46 (+/- 17) years (age range 0.1 to 81 years)

• High risk patient group

• Paediatric follow-up study progressing well in Brazil

• Important data set of over 100 patients below 12 years age range

• Initial results very encouraging

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•Launch of SurgiPure™ XD

•Launch of thicker DermaPure® & additional sizes

• Completion of Medicare reimbursement & private/managed medicare programme

•Federal Supply Schedule (FSS) listing

•Additional stocking distributors signed up

•Commercialisation of alternate applications in US (dental, burns etc.)

•OUS deployment of DermaPure®

•Commence regulatory application for second OrthoPure™ XM trial

•Regulatory approval (CE Mark) in EU for tendon (porcine)

•Commercialisation strategy & partners to be announced

•Regulatory Approvals for cryo- tissues (GBM-V)

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For the 6 months ended 31 July 2016 Tissue

Regenix Group delivered:

Revenue of £631k (2015: £252k)

Operating loss of £5,523k (2015: £4,133k)

Cash balances at the end of the period were

£13,515k (2015: £24,887k) and the Group was

debt free.

The results were in line with our expectations.

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Wound Care Orthopaedics Cardiac Central Total

6m to 31 Jul 16

£’000

6m to 31 Jul 15

£’000

12m to 31 Jan 16

£’000

6m to 31 Jul 16

£’000

6m to 31 Jul 15

£’000

12m to 31 Jan 16

£’000

6m to 31 Jul 16

£’000

6m to 31 Jul 15

£’000

12m to 31 Jan 16

£’000

6m to 31 Jul 16

£’000

6m to 31 Jul 15

£’000

12m to 31 Jan 16

£’000

6m to 31 Jul 16

£’000

6m to 31 Jul 15

£’000

12m to 31 Jan 16

£’000

Revenue 631 244 808 - - - - - - - 8 8 631 252 816

Cost of Sales (119) (62) (154) - - - - - - - - - (119) (62) (154)

Gross Profits 512 182 654 - - - - - - - 8 8 512 190 662

SG&A (3,074) (1,749) (4,938) (1,300) (1,050) (2,382) (255) (107) (352) (1,406) (1,417) (3,232) (6,035) (4,323) (10,904)

Operating Loss (2,562) (1,567) (4,284) (1,300) (1,050) (2,382) (255) (107) (352) (1,406) (1,409) (3,224) (5,523) (4,133) (10,242)

Finance Income - - - - - - - - - 81 116 213 81 116 213

Loss before Taxation (2,562) (1,567) (4,284) (1,300) (1,050) (2,382) (255) (107) (352) (1,325) (1,293) (3,011) (5,442) (4,017) (10,029)

Taxation 50 54 169 200 256 324 30 7 16 - 18 18 280 335 527

Loss for the year (2,512) (1,513) (4,115) (1,100) (794) (2,058) (255) (100) (336) (1,325) (1,275) (2,993) (5,162) (3,682) (9,502)

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