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Tissue Regenix Group plc
Jefferies Healthcare Conference
London, 19th November 2014
1
DisclaimerThe information contained in this document and made verbally to you (together the "Presentation") is not intended to form the basis of any contract. By attending or reading the Presentation, you agree to the conditions set out below. The Presentation is being supplied only to persons in member states of the European Economic Area who are qualified investors within the meaning of article 2(1)(e) of the Prospectus Directive (Directive 2003/71/EC, as amended) and additionally in the United Kingdom it is only directed at persons with professional experience in matters relating to investments and/or to high net worth companies as described in Article 19(5) and 49(2) respectively of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Financial Promotion Order") or any persons qualifying under another available exemption under the Financial Promotion Order (all such persons being "Relevant Persons"). The Presentation Materials have not been approved by an authorised person as would otherwise be required by section 21 of the Financial Services and Markets Act 2000 (as amended). Recipients of this Presentation should not base any behaviour in relation to the contents of this Presentation, which would amount to market abuse (as defined in Section 118 of the Financial Services and Markets Act 2000).
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. In particular, the distribution of this document in jurisdictions other than the United Kingdom may be restricted by law and persons into whose possession this document comes should inform themselves about, and observe, any such restrictions. Any failure to comply with these restrictions may constitute a violation of laws of any such other jurisdiction. In particular, this document is not for distribution in the United States, Australia, Canada, Japan or the Republic of South Africa.
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 Company and its professional advisers expressly disclaim any obligation or undertaking to disseminate any updates or revisions in relation to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, save as required by FSMA and/or the AIM Rules for Companies and AIM Rules for Nominated Advisers.
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 in it does not constitute a prospectus and does not form any part of an offer of, or invitation to purchase or apply for or enter into any contract or make any other commitment whatsoever in relation to, securities. In particular, details included in this Presentation are subject to updating, revision, further verification and amendment. 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.
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2
Agenda
• Corporate
• Wound Care
• Orthopaedics
• Q&A/Close
3
dCELL® Process
dCELL® Process
Patent protected
Store at room temperature
surge
ry
Surgeons usual technique
regeneration
With patients own cells –natural healing
Long term regenerative
repair
Animal or human
4
Intellectual PropertyK
no
w h
ow
Decellularisation of matrices
Aus, Can, EU, US
Meniscal Repair EU
[Can, India, Japan, US]
Aus, China
Bladder UK
[EU, Aus]
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
5
Strategy
US
• Human ‘1271’products
• Porcine dermis (general surgery)
dCELL® evidence base
• Health economics
• Clinical/mechanism of action
Core focus areas
• Wound Care
• Orthopaedics
EU
• CE Mark (porcine products)
dCELL®
6
Product Pipeline
7
MENISCUSDevelopment
ClinicalHEART VALVE
CommercialDermaPure®
TENDON
PORCINE
HUMAN
MENISCUS
TENDON DERMIS (GEN. SURGERY)
DERMIS (WOUND CARE)
Launch programme
8* Calendar years – indicative timings only dependant on development timings & regulatory considerations
2015 2016
DermaPure®(Dental) (US)
DermaPure®(Ortho) (US)
SurgiPure®(General) (US) dCELL® Meniscus (EU)
dCELL® Tendon (EU)
dCELL® Human Meniscus (US)
dCELL® Human Tendon (US)
SurgiPure®(General) (EU)
PORCINE
HUMAN
Regulatory
• Xenograft (porcine/bovine)
– EU, class III generally
– US, 510k or PMA
– ROW, varies by market
• Human
– EU, no harmonised standard
– US, ‘minimally manipulated’ tissues classed as transplants
– ROW, varies by market
9
11/19/2014 Proprietary and Confidential. © 2014 Tissue Regenix 10
Proprietary and Confidential. © 2014 Tissue
11
THE U.S. WOUND AND TISSUE MARKET WAS VALUED AT OVER $7.8 BILLION IN 2013 1
Acute Wounds:
Trauma Wounds are
responsible for an estimated
2.3M admissions per year 2
Burns represent over
450,000 hospital admits
annually within the US 3
Surgical Wounds related
to surgical site infections are
responsible for an additional
1 million inpatient-days and $1.6
billion in excess costs 4
Chronic Wounds:
1. iData Research Inc., 2013
2. CDC, Trauma Statistics updated February 2014
3.. American Burn Association National Burn Repository (2013 report)
4.. American Journal of Infection Control. 2009 Jun; 37 (5): 389-397
5. Medscape, Diabetic Ulcers, July 9, 2014
Diabetic Ulcers affect 1.5 million patients 5
• 85% of all Lower Extremity Amputations
have DFU origins 6
Venous Leg Ulcers (500K – 2M annually )
• 20% of ulcers not healed within 2 years 8
• 66 % of patients had a history of ulcers lasting
longer than 5 years 8
Arterial Ulcers affect 500,000 people per
year and prevalence increases with age 7
Pressure Ulcers affect an estimated 10%
of all patients within hospitals 9
• The cost of pressure ulcer treatment is
$2.41 billion in excess healthcare 9
6. DESHPANDE AD, HARRIS-HAYES M, SCHOOTMAN M: Epidemiology of diabetes and diabetes-related complications. Phys Ther 88: 1254, 2008.
7. Journal of the American Podiatric Medical Association Vol 101 No 2 March/April 2011
8. AHRQ - Research Protocol – Mar. 5, 2012
9. Ostomy Wound Management 2009;55(11):39–45
11/19/2014 Proprietary and Confidential. © 2014 Tissue Regenix
12
Growth Rate of Wound Care Products in US
2012-2020
Acute / Post Acute Share of HCTPs by Company • Incidence of wounds is growing due to diabetes,
obesity along with lifestyle changes
• Shift from conventional treatment to advanced modalities
to lower overall treatment costs
• Today bioengineered skin & skin substitutes (HCTPs)
represent only 5% of the total wound market
• Despite reductions in reimbursement, skin substitutes
represent one of the highest CAGR segments
Others
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
2013 2014 2015 2016 2017 2018 2019 2020
Pro
ce
du
res
Biologic Skin Substitute Procedures Biosynthetic Skin Substitute Procedures Synthetic Skin Substitute Procedures
Estimated Skin Substitute Procedures
2013 – 2020
2015 - Phase II Sales Strategy & Execution in Outpatient Facilities 2015 - Phase II Strategy 2014 - Phase I Strategy
Sales Targets: • Outpatient Surgery Centers
• Ambulatory Surgery Centers
• Wound Care Centers
• Physician Offices
Critical Success Factors: • Q Code Issuance - Q 4152 issued
• LCD – MAC Coverage
• Private Payer Coverage
• Physician Usage & Adoption
Sales Targets: • Hospitals
• VA Facilities
• LTACs (Long Term Acute Facilities)
Critical Success Factors: • Physician Champion Development
• Trial Usage
• Positive DermaPure Outcomes
• Hospital Approvals - Value Analysis Committees
• Sales Reach & Frequency to Key Accounts
Measure
Outcomes
Clinical Efficacy
Evidence
Clinical
Evaluation
Trial
Physician
Champions
Review
Value Analysis
Committee
Approval
Hospital / IDN
Contract
DemaPure
Demand
Formalized Process w/ Sr. Exec
Leadership & Physician alignment
5-7 months
Standardization Focus
among New Technologies
Up to 6 months
Value Analysis Process
that doesn’t align
physician & hosp. goals
Up to 1 year
No Formal Value Analysis:
Physician Preference
1 – 3 months
Inpatient Facilities Outpatient Facilities
11/19/2014 Proprietary and Confidential. © 2014 Tissue Regenix 14
91 year old male
0
33
55
0
27
46
58
0 1 2 3 4 5
% S
urf
ac
e A
rea
Red
uc
tio
n
Weeks (0 = Application)
Weekly Wound Healing
Patient 1 Patient 2
91 year old male with Charcot foot
• Full thickness wound left foot, plantar
• Wound duration 1 month
• Competitive HCT/P tried and failed prior to DermaPure.
Application Week 2Week 1
Application Week 2Week 1 Week 3
53 year female with Diabetic Foot Ulcer
• Full thickness wound left lateral foot
• Wound duration +6 months
• Competitive HCT/P tried and failed prior to DermaPure.
Patient 1:
Patient 2:
11/19/2014Proprietary and Confidential. © 2014 Tissue Regenix
16
6 weeks 6 months4 months
HEALEDcompletely
RE-EPITHELIALIZATION
Mean Reductionin Surface Area
Chronic Wound Study Published - Wound Repair & Regeneration
Acute Wound Study Submitted for Publication
Study Results:
• Key differences observed in structural & biomechanical characteristics of skin substitutes:
• These influence distribution and organization of capillary networks within regenerating dermis
• DermaPure™ resulted in increased angiogenesis after wounding compared to controls
• DermaPure™ was the only tissue product observed with elevated mRNA expression of PROK2 and MT6-MMP
• DermaPure™ is a potent angiogenic stimulant & less fibrogenic than alternative substitutes during acute cutaneous wound healing
Study Aim:
• Assess the angiogenic & fibrogenic response to
wounding 50 healthy volunteers
• Compare 4 treatments options:
- Secondary intention healing (control)
- Integra matrix wound dressing (CG)
- Full thickness autograft (Autograft)
- DermaPure™ (DCD)
British Journal
of Surgery
International, Scientific,
Peer Reviewed Online
Journal
11/19/2014
Phase IV Prospective, Multi-Center, Randomized, Single-Blind, Active and Standard
Care-Controlled Study of DermaPure™ in Patients With "Hard to Heal" Chronic,
Neuropathic Diabetic Foot Ulcers With Crossover Design for Standard Care Arm
Robert Kirsner
MD, PhD
University of
Miami
David Armstrong
DPM, MD, PhD
University of Arizona
New England VA
Vickie Driver
MS, DPM
Barbara Aung
DPM
Private Practice
Robert
Frykberg
DPM
Phoenix VA
Howard
Kashefsky
DPMUniversity of North Carolina
Larry Lavery
DPMUniversity of Texas
Southwestern University
Ernest Chiu
MDNew York University
Multicenter clinical investigation; 9 wound care
centers in the US. Enrollment and patient
selection is ongoing. Each site will enroll
approximately 10 patients.
Objectives: Primary: To establish the wound healing
performance and safety of DermaPure™ over a 12 week period, when administered to “hard to heal”
chronic, neuropathic diabetic foot ulcers on up to two
occasions.
Secondary: To investigate the rate of healing,
cellular and biochemical changes compared to
baseline and quality of healing (recurrence) of hard to
heal chronic, neuropathic diabetic foot ulcers after
treatment with DermaPure™.
Crossover of Control patients at 12 weeks
EPA testing at week 0
ORTHOPAEDICS
18
Global 2013 Orthopaedic Market
BMP
Growth Factors
Stem Cells
Synthetic Bone Graft
ScaffoldsAllograft Tissues
• Total Sales $45 Billions at 3.3 % over prior year – CAGR $55 Billions 2018
• $ growth in Hips, Knees and Spine slowed to low to mid single digit range
• Growth in Trauma, Extremities, Sports Med and Biologics robust
• Global Regenerative, Soft Tissue and Cartilage Repair products is expected to grow at 6.6% CAGR through 2019
• Players seek to develop alternatives to Gold Standards of auto grafts (bone and soft tissue)
• Estimated revenue 2012 $4.6 billion
• Demographics continues to serve the segment well age, arthritis, obesity, sports
• Patients will continue to demand alternatives to joint replacement –scaffolds, cell therapies etc – as they seek to extend their physically active lives and putting off major surgery as long as possible
• Significant need for soft tissue grafts/replacements within Sports Medicine arena (Meniscus, Cartilage, Ligaments)
• Orthopaedics remains one of the healthiest segments among medical devices
14%
16%
3%
14%10%
17%
1%
11%
14%
HipsKneesExtremitiesTraumaSoft Tissue/ArthroscopySpineBoneGrowth StimulationBiologicsOther
Report 2014Source: Orthoworld Report 2014, BCC Research
Global Market Drivers
Demographics
By 2050 the number of people over the age of 65 will have tripled to
1.5 billion
EconomicsReimbursement
Funding Structure Healthcare
Systems
Emerging Markets
Technology Innovation
Evidence Platform
LifestylesActivity Levels Quality of Life
DiseaseOsteoarthritis
Obesity Diabetes
Age Group Population(MM) 2005
Population (MM) 2020
Average Annual Growth
<20 2,410 2,513 0.3%
20-39 2,033 2,286 0.8%
40-64 1,536 2,085 2.4%
65+ 473 724 3.5%
Total World Population
6,451 7,608 1.2%
Source: U.S. Bureau of the Census
Orthopaedic strategy
Porcine DevelopmentsFocus on CE Marks and EMEA CommercialisationMeniscus and ACL Scaffold
Clinical and ‘Economic’ Proof KOL’s, Clinical Studies, Agencies, Consultancies
Human Tissue DevelopmentsFocus on USA market model and CommercialisationMeniscus and ACL Scaffold
Innovation that is commercially viable
and aligned to market requirements
addressing clinical need
Orthopaedic -go to market strategyEU• Launch criteria
– Third Party Distribution model– Focused country launch– Select markets with clear
reimbursement pathways– Targeted KOL’s
• Post Market Support– Post Market Surveillance– Registries– High end case studies at
recognised centres
• Product development– Broaden portfolio through line
extensions
US• Launch criteria
1) human dCELL® tendon 2) human dCELL® meniscus
– Hybrid (direct/distributor) model
– Reimbursement strategy– Targeted KOL’s
• Sports medicine
• Post Market Support– Case studies at key centres
• Product development– Increase donor supply
22
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
Primary goal with dCELL® Meniscus• 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 OA and the need for further operations. e.g. PKR
and TKR
dCELL® Meniscus Background
• Meniscus structure is complex and poor to heal beyond the outermost 20%
• Irreparable meniscus tear
• Partial Menisectomy
• dCELL® Meniscus Replacement
dCELL® Meniscus Milestones
• Preclinical safety study completed (2013)
• VOC feedback (2013)
• Cadaver development workshops with 3 leading UK KOL surgeons (2013 and 2014)
• Clinical Trial Centres approved – Ethics Committees, Competent Authorities, SIVs (2014)
• Investigator Surgeon Training (2014)
• Clinical trial start targeted for Q4 2014
dCELL® Porcine Meniscus Clinical Trial
Design: Prospective, open label, single-arm multi-center study
Primary Objective:To assess the safety and performance of dCELL® Meniscus in improving pain
Secondary Objective:To assess subject’s knee functional improvement following implantation
Indications:
Treatment of chronic pain following failed previous meniscus repair or partial Meniscectomy
60 patients to be implanted with dCELL® Meniscus
Expected enrollment period 6 months
24 months Follow-up:7-14 days1 month3 months6 months12 months24 months
Primary efficacy variable:
Pain relief as assessed by change in VAS pain score from baseline
Secondary efficacy variables:
Integration success over time IKDC score change over time Lysholm score change over time KOOS score change over time Ease of use
26
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
Primary goal with dCELL® ACL Scaffold
• Restore ‘normal joint’ mechanics
• Functions as a dynamic implant for host cell repopulation and ultimate ligamentization
dCELL® ACL Scaffold -Updates
• Preclinical safety study initiated January 2014
• VOC feedback positive on key product features
• Final Report on Pre-Clinical due Dec 2014
• Clinical Trial Centres identified
• Clinical submission Q1 2015
• Clinical trial start targeted for Q3 2015
Financials
• Cash at 31/7/14– £14.5m
• Operating loss (6m to 31/7/14)– £3.8m
• Expenditure on US subsidiary costs in line with expectations
• Two porcine product development programmes entering clinical phase (meniscus/tendon)
• Capex remains low– Leeds site upgrade costs
• Current funding raised in 2012 for porcine developments– CE mark not PMA
30
Newsflow
2015
• Commercial*
– DermaPure™ line extensions
– SurgiPure™ (general surgery, wound care)
• Development– Clinical
• DermaPure™, meniscus (porcine), tendon (porcine), human heart valve
• Operations– Leeds relocation
2016
• Commercial *
– CE mark: meniscus (porcine), tendon (porcine)
– US human ortho (meniscus, tendon)
31* indicative timings only dependant on development progress, clinical trial recruitment rate & regulatory considerations
Outlook
• Strong pipeline
• Company focus shifting to commercial & manufacturing activity
• Further product development opportunities– Line extensions
• Strengthening operational management team in EU
• Depth & breadth– Geographically (USA & EU)
– Market focus (orthopaedics & wound care)
32
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