Global Orthopaedic Market Tissue Regenix focused on Meniscal Repair and ACL Reconstruction

26 Pages·2016·2 MB·English

by  Caitlin Pearson

CORPORATE OVERVIEW
1
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TISSUE REGENIX GROUP PLC
Jefferies Healthcare Conference
OVERVIEW
Corporate Structure Background
Tissue Regenix Group plc
•Main offices in Leeds, UK, US office San Antonio, TX
•Over 70 employees
•Listed on AIM, Ticker: TRX.l→ Market cap: £130m
dCELL® Platform technology
•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’
Strategy
•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)
TISSUE REGENIX GROUP PLC
Jefferies Healthcare Conference
Overview
Corporate Board Executive Management
Antony Odell CEO
John Samuel
Greg Bila
Chairman Tony Hewitt President, Tissue Peter Hamer Andrea Rausch
Ian Jefferson CFO Commercial Director, Commercial Director,
UK Operations Director Regenix Wound Care, TRX OrthopaedicsLtd TRX Cardiac Ltd
Inc
Antony Odell Steve Randeep Ian Jefferson
Alan Miller NED Jon Glenn NED
CEO CouldwellNED Grewal NED CFO
Tim Buechner,
Drew Distin,
VP Operations Tissue
VP Tissue Regenix
Regenix Wound Care,
Orthopaedics, Inc
Inc.
Tissue Regenix has a corporate board with a wealth of
Tissue Regenix has an executive management team
experience in the commercialization of medical devices,
experienced in commercialising products around the world.
business development and finance.
TISSUE REGENIX GROUP PLC
Jefferies Healthcare Conference
dCELL® Process
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dCELL® Process
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Product Pipeline and IP
TISSUE REGENIX GROUP PLC
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Our Strategy
dCELL® evidence base
Human Tissue
•Health economics
•US: Direct ‘hybrid’ marketing model
•Clinical/mechanism of action
•ROW: Partner/JV/Licensing
dCELL®
Core focus areas Animal Tissue
•Wound Care •EU: CE Mark 3rd party distribution
•Orthopaedics •US: ‘Hybrid’ model (510k products)
•Cardiac •Partner (PMA products)
•ROW: Regulatory pathway led
TISSUE REGENIX GROUP PLC
Jefferies Healthcare Conference
Operational Overview
Tissue Regenix Wound Care, Inc. OperatingoutoftheUKwithclinicalsites GrantedthefirstdCELL®heart
HeadquarteredinSanAntonio,Texas valve licenceinJanuary2016
acrosstheEU
CommercialisingDermaPure®,a  Completedenrolmentforthe OrthoPure™ XM Supportedby10yearsof
decellurisedhumandermisforthe (porcine meniscus) clinicaltrial clinicaldata fromstudiesin
treatmentofchronicandacutewounds,  Expectedtobegincommercialisation within Brazil
achievingover$1msalesrevenuewithin theEUin2017 Over1,600operations
it’sfirstfullyear successfully completed
Planning entry into the US marketplace, with
FDAmarketclearanceforSurgiPure™XD, human tissue applications through subsidiary EntryintoEUmarketplace in
expected launch H216 Tissue Regenix Orthopedics, Inc in 2017 2017 throughJoint Venture
creatingGBM-VinGermany
TISSUE REGENIX GROUP PLC
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Wound Care Market Overview
Wound Prevalence in the US¹ “Hard to Heal” Wound Prevalence in the US¹
Pre4s,4s5u66r8e%,0 U5l2cer Surface area reduction 2A3Ur8tle,c3rei2ar3 l Pr1e,s,s03u94r8e%, 2U3l7cer 4B11u,0%r9n8
Burn less than 50% 3% Venus Leg
Arterial 462,352 in 4 weeks Ulcer
Ulcer 6% 476,646
238,323 Venus Leg Diabetic 15% Diabetic Foot Trauma
3% Ulcers Foot Ulcers Ulcer 426,294
959,292 1,451,747 943,635 18%
12% 18% Trauma 29%
426,294
5%
Annual Direct Healthcare Costs 3
• The CDC estimates that 86M people in the US have pre-diabetes¹
• 29.1 million children and adults have diabetes (In Billions of US Dollars)
• 8.9 million are undiagnosed
• 4 –10% have a diabetic foot ulcer 20
DFU’s
• Highest prevalence of diabetic foot ulcers are found in: highest wound 10
expenditure
• Diabetic population over 65 years of age = 8%²
• Diabetic patients within the VHA = 5.5%¹ 0
Diabetic LimbBreast Cancer Colorectal Lung Cancer Prostate Leukemia
• The incidence of diabetic limb amputation is estimated at 15% ² Complications Cancer Cancer
Sources:
1. US Wound Biologics Market BioMedGPS, LLC. https://www.smarttrak.net
2. “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=200119
3. Diabetic Foot & Ankle 2013. © 2013 NealR.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
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