Aroa Biosurgery Ltd · ASX:ARX
Aroa Biosurgery — Investor Presentation (June 2023)
72 slides from Aroa Biosurgery's investor presentation, Jun 1, 2023
Slide 1: Aroa Investor Meeting
For personal use only AROA INVESTOR MEETING 1 JUNE 2023 Unlocking regenerative healing for everybody
Slide 2: Important Notice and Disclaimer
|2 Important Notice and Disclaimer This presentation (Presentation) is dated 1 June 2023 and has been prepared by Aroa Biosurgery Ltd, New Zealand company number 1980577, ARBN 638 867 473 (AROA or the Company). Information in this Presentation For personal use only The information in this Presentati
Slide 3: Important Notice and Disclaimer (cont.)
|3 Important Notice and Disclaimer (cont.) Future performance (cont.) Opinions involve significant elements of subjective judgement and assumptions as to future events which may or may not be correct. Actual results, performance or achievements may differ materially from those expressed or implied i
Slide 4: Agenda
|4 Agenda 1. Introduction Brian Ward 10.00 – 10.10am 10 mins 2. Extracellular Matrix Technology in Wound Care and Dr Samir S. Awad 10.10 – 10.40am For personal use only 30 mins Soft Tissue Reconstruction 3 Sales – Increasing Usage and Leveraging the Brad Adams 10.40 – 11.00am 20 mins Product Portfol
Slide 5: Extracellular Matrix Technology in Wound Care and Soft Tissue Reconstruction
Extracellular For personal use only Matrix Technology in Wound Care and Soft Tissue Reconstruction Samir Awad, M.D., M.P.H., FACS Professor of Surgery; Vice Chair for Surgical Quality and Safety; Baylor College of Medicine
Slide 6: Hernia/Abdominal Wall Reconstruction & Wound Care Experience
Hernia/Abdominal Wall Reconstruction & Wound Care Experience For personal use only 24 years of experience Acute Care/Emergency Surgery and General Surgery Treat many open wounds/Sub-acute surgical wounds Open, Laparoscopic & Robotic o Primary ventral and umbilical hernias o Medium and small incision
Slide 7: Surgical closures can involve many challenges
Surgical closures can involve many challenges which may impact healing and increase the cost of treatment For personal use only Patient factors impact surgical closure • Risk factors for complications include a range of local, systemic and Advanced age extrinsic factors or conditions. Chronic diseas
Slide 8: My motivation to try AROA
My motivation to try AROA For personal use only • Unique ECM derived From Ovine • For Hernia Repair (Sheep) Forestomach • Minimizing the synthetic permanent • Highly Vascular Organ Foreign Body Footprint • Sustains high rate of tissue • Decrease chances of downstream turnover/remodelling complicatio
Slide 9: Optimal wound repair
Optimal wound repair For personal use only • In wound repair, angiogenesis is well recognized as an essential step in healing1 • Vascularity allows tissue to resist or fight infection by delivering essential cells, nutrients and oxygen locally1 • Various materials have been produced whose use in wou
Slide 10: Ovine (sheep) forestomach an ideal source material
Ovine (sheep) forestomach an ideal source material For personal use only Forestomach Gastric Stomach Abundant source – lambs are raised in New Zealand to supply high quality rumen omasum meat products globally abomasum Forestomach is a uniquely vascular tissue, evolved for nutrient absorption1,2 eso
Slide 11: Gentle processing to decellularize while retaining structure and biology
Gentle processing is optimized to effectively decellularize while retaining structure and biology For personal use only Tissue decellularization aims to eliminate Ineffective tissue decellularization can lead to a residual genetic material.1 pro-inflammatory response.2 Layered porcine Layered porcin
Slide 12: AROA ECM gives rise to more blood vessels
AROA ECM™ gives rise to more blood vessels For personal use only In a porcine model of soft tissue repair AROA ECM - treated tissue defects had more blood vessels AROA ECM can lead to improved soft tissue vascularization Source: Irvine, S. M., J. Cayzer, E. M. Todd, S. Lun, E. W. Floden, L. Negron,
Slide 13: AROA ECM facilitates rapid blood vessel formation
AROA ECM facilitates rapid blood vessel formation For personal use only Dye stain shows residual vascular channels are Newly formed tissue demonstrating the establishment retained in AROA ECM of vasculature at the site of AROA ECM application Cells utilize these channels as a template – Builds new b
Slide 14: The Myriad portfolio for soft tissue repair
The Myriad portfolio for soft tissue repair For personal use only Contains 2-, 3- or 5-layers Morcellized AROA ECM of non-crosslinked AROA ECM For soft tissue repair, For management of acute reinforcement or complex and chronic wounds wounds
Slide 15: Myriad products can be used in a contaminated field
Myriad products can be used in a contaminated field For personal use only Wound bed contamination is known to limit the use of certain dermal matrices due to high rates of infection1-3 Myriad products have been shown to be resistant to bacterial contamination4,5 Myriad products may be used in contam
Slide 16: Reduces post-surgical complexity
For personal use only Reduces post-surgical complexity: • Contains anti-inflammatory proteins that help modulate wound proteases • High volume, porous ECM that can fill Redacted – graphic images surgical dead space and help reduce the risk of seroma and hematoma Source: Chaffin A et al. Surgical rec
Slide 17: Facilitates organized functional tissue formation
For personal use only Facilitates organized Pre-operative Week 6 functional tissue formation Redacted – graphic images Source: Dr. Castater, she has a consultancy agreement with AROA.
Slide 18: Pre-operative Week
For personal use only Pre-operative Week 6 Redacted – graphic images
Slide 19: Implanting Myriad Matrix may help reduce surgical closure complications
Implanting Myriad Matrix may help reduce the complications associated with surgical closures For personal use only Surgical closure challenge How Myriad Matrix can help & complication • Contains naturally occurring anti-inflammatory proteins1 Chronically inflamed tissue • Modulates tissue proteases
Slide 20: Surgical Reconstruction of Stage 3 and 4 Pressure Injuries
Surgical Reconstruction of Stage 3 and 4 Pressure Injuries For personal use only A Literature Review and Proposed Algorithm Published in the Advances in Skin and Wound Care -May issue vv https://journals.lww.com/aswcjournal/Fulltext/2023/05000/ Surgical_Reconstruction_of_Stage_3_and_4_Pressure.5.asp
Slide 21: Myriad Ultra/OviTex Reinforced Biologics
Myriad Ultra™/OviTex™ Reinforced Biologics: An evolution in abdominal wall reconstruction AROA ECM Foundation 150+ ECM proteins For personal use only Natural vascular channels known to be important Multiple layers of support angioconduction1 in healing2 AROA ECM are reinforced with interwoven polyme
Slide 22: OviTex was well tolerated in a comparative non-human primate study
OviTex was well tolerated in a comparative non-human primate (NHP) Study1 For personal use only OviTex Resorbable OviTex Permanent Zenapro® Phasix™ Ventralight™ Physiomesh® SurgiMend® Strattice™ • NHP is the leading pre-clinical model for evaluating immune response & tissue remodeling properties1,2,
Slide 23: Pre-operative Week
For personal use only Pre-operative Week 6 Redacted – graphic images Page 23
Slide 24: BRAVO study 2-year results of OviTex 1S
BRAVO1 study - 2-year results of OviTex 1S in ventral hernia repair For personal use only Key study takeaways:2 • OviTex 1S is safe to use in a broad spectrum of ventral hernia repair patients with various techniques v • Low 2.6% Kaplan Meier estimated recurrence rate at 24 months • Ventral hernia r
Slide 25: My OviTex clinical experience to date
How does my OviTex clinical experience to date compare? For personal use only • Total # of OviTex cases to date – 324 Hernia Type # of Cases % of Total Cases • Follow-up range: 3 weeks – 66 months Ventral 169 52% (Mean – 42 Months) Inguinal 61 19% • SSI Rate – 18/214 (5.6%) Hiatal 40 12% • Recurrenc
Slide 26: Summary: versatility and portfolio breadth
Summary – AROA’s versatility & portfolio breadth offers clinicians a unique toolset for soft tissue repair & reconstruction For personal use only AROA’s products provide structure, biology, & undergo constructive remodeling facilitating functional tissue formation ▪ The resistance to bacteria means
Slide 27: Q&A
? For personal use only Q&A Unlocking regenerative healing for everybody
Slide 28: Increasing Usage and Leveraging the Product Portfolio
| 28 Increasing Usage and Leveraging For personal use only the Product Portfolio Brad Adams Photo Vice President, Commercial Operations, North America
Slide 29: Navigating the US Market
| 29 Navigating the US Market • US Wound Market • Huge growth opportunity given US population demographics • Complexity of marketplace provides opportunities for companies offering access across the continuum of care For personal use only • Multiple Business Channels for product distribution AND mul
Slide 30: Current Market Trends, Behaviours, and Events
| 30 Current Market Trends, Behaviours, and Events • Post Covid – significant cost pressures – threatening margins • Focus on transitioning patients to lowest cost SOCs For personal use only • CMS actively addressing confusion in outpatient cellular and/or tissue-based product ('CTP')1 / 'Skin Subst
Slide 31: SOC – Understanding the Pain Points
| 31 SOC – Understanding the Pain Points Hospitals Nursing Homes/LTACHS Home Care For personal use only Formulary Requirements Insurance Approval/Denial Insurance Approval/Denial Setting Challenges in Application Setting Challenges in Application Pre and Post Care Challenges Product Delivery Extende
Slide 32: Capitalizing on this Environment
| 32 Capitalizing on this Environment • Our Mission • Unlocking regenerative healing for everybody For personal use only Prescribing • Product Opportunity Surgeons • AROA ECM™ technology available as a viable option in Acute most SOCs • Aggressive product line extensions to address specific needs by
Slide 33: Q&A
? For personal use only Q&A Unlocking regenerative healing for everybody
Slide 34: Aligning with GPO & IDN Macro Trends
| 34 Aligning with GPO & IDN Macro Trends For personal use only Wes Snodgrass Photo Director of National Accounts
Slide 35: Key Trends in US Healthcare
| 35 Key Trends in US Healthcare • Workforce shortages, particularly nursing but across the board in key support positions • Financial Pressures • Large number of not-for-profit US Health systems lost staggering amounts of money during and For personal use only post pandemic • Patient volumes and pr
Slide 36: US Contracted Positions – May 2023
| 36 US Contracted Positions – May 2023 Vizient • Vizient is the largest healthcare performance improvement company in the US For personal use only • Over 4000 hospitals, 97% of Academic Medical Centers, 20% of Ambulatory Care Sites • Member owned and based in Dallas TX with members across the count
Slide 37: US Contracted Positions – April 2023
| 37 US Contracted Positions – April 2023 HealthTrust Purchasing Group For personal use only • HealthTrust is the largest “For Profit” Group Purchasing Organization ('GPO') in the US • Owned by Hospital Corporation of America ('HCA'), Tenet Healthcare ('Tenet'), and 6 other healthcare systems • Serv
Slide 38: US Contracted Positions – April 2023
| 38 US Contracted Positions – April 2023 Premier For personal use only • Premier is the second largest healthcare improvement GPO in the US • Over 4000 hospitals are members of Premier as well roughly 250,000 sites of care • Premier has created one of the largest data bases of clinical and care per
Slide 39: US Contracted Positions
| 39 US Contracted Positions Federal Government For personal use only • Currently Full Line Agreement for Endoform and initial Myriad Product on AROA's stand-alone Federal Supply Schedule ('FSS’) • Marathon Medical • Denver based (Service-Disabled Veteran Owned Small Business) distributor covering t
Slide 40: Q&A
? For personal use only Q&A Unlocking regenerative healing for everybody
Slide 41: Session Break
For personal use only 5 Minute Session Break Unlocking regenerative healing for everybody
Slide 42: Myriad and Symphony Market Dynamics
| 42 Myriad and Symphony Market Dynamics For personal use only Brian Ward Photo Chief Executive Officer
Slide 43: Substantial Growth Opportunities > US$3B TAM
| 43 Substantial Growth Opportunities > US$3B1 TAM For personal use only Complex Wounds Soft Tissue Reconstruction Total Addressable Market Total Addressable Market > $1.8B2 USD > $1.3B3 USD e.g. Diabetic Foot Ulcers, e.g. Trauma, tumour removal, e.g. Hernia repair, abdominal Venous Ulcers, Pressure
Slide 44: Myriad: acute surgical soft tissue repair
| 44 Myriad: acute surgical soft tissue repair For personal use only Contains 2-, 3- or 5-layers of Morcellized Myriad AROA ECM For soft tissue repair, For management of acute and reinforcement or complex chronic wounds wounds
Slide 45: Myriad Market Dynamics
Confidential Myriad Market Dynamics | 45 TAM ~US$740M1 For personal use only Market share by company Market share by technology Other Kerecis AROA Synthetic Amnion 2.0% 1.1% 8.5% 7.1% Smith & Nephew Integra 7.2% 25.8% Other Biologic Synthetic Human 41.0% 8.5% Dermal 24.8% MiMedx 11.3% Other Sanara D
Slide 46: Myriad – market potential
| 46 Myriad – market potential SAM3 Relevant US SOM4(US$M) Procedure Type TAM2 (US$M) (US$M) Procedures1 @30% For personal use only @50% Trauma 86,783 300 150 45 Lower Limb Ulcers (Inpatient) 179,206 224 112 34 Burns 44,802 113 56 17 Pressure ulcers 14,071 63 32 9 Maxillofacial Reconstruction 25,609
Slide 47: Symphony: chronic complex wounds
Symphony: chronic complex wounds For personal use only Symphony: First Advanced Regenerative ECM combined with Hyaluronic Acid
Slide 48: Symphony Market Dynamics
Confidential | 48 Symphony Market Dynamics TAM ~US$1B1 For personal use only Market share by company Market share by technology Integra Cell Based Kerecis 2.5% 12.1% 5.8% Other 12.1% OrganoGenesis 36.2% Biologic 28.7% Amnion 59.2% Smith & Nephew 21.0% MiMedx 22.4% 1. Management's estimate based on 2
Slide 49: Symphony – market potential
| 49 Symphony – market potential Relevant US SAM3 (US$M) SOM4(US$M) Procedure Type TAM2 (US$M) Procedures1 @50% @30% For personal use only Diabetic Foot Ulcers (Outpatient) 67,863 433 217 65 Venous Leg Ulcers 65,024 415 207 62 Pressure ulcers 7,391 47 24 7 Total 895 448 134 1. Management's estimates
Slide 50: Q&A
? For personal use only Q&A Unlocking regenerative healing for everybody
Slide 51: Symphony: Launching into a Changing Landscape
| 51 Symphony: Launching into a Changing Landscape For personal use only Mike Linnell Photo Global Product Manager
Slide 52: Facilitates regeneration of functional tissue in complex wounds
| 52 Facilitates regeneration of functional 1 tissue in complex wounds For personal use only Advanced combination cellular and tissue product (CTP*), 2 comprising AROA ECM and hyaluronic acid AROA ECM Hyaluronic Acid Symphony Symphony’s key components act synergistically to help drive wound closure3
Slide 53: CTP usage by Wound Type
| 53 CTP usage by Wound Type For personal use only Source: NetHealth (Tissue Analytics) Outpatient data Confidential. Not for distribution.
Slide 54: Significant Shifts in CTP Landscape
Significant Shifts in CTP Landscape For personal use only • Favorable reimbursement may supersede • Currently: clinical outcomes in this space • Further public consultation • Proof of reimbursement is often necessary before clinicians will onboard • LCD overhauls involving multiple Medicare Administ
Slide 55: Amniotic Segment Under Additional Pressures
Amniotic Segment Under Additional Pressures • Regulatory Compliance For personal use only • FDA investigations and warnings letters around “Minimal Manipulation and Homologous Use” • Preserving structure, integrity and biology of the tissue • Product must perform the same basic function/s in the rec
Slide 56: Landscape Changes = New Opportunities
Landscape Changes = New Opportunities For personal use only Opportunities: • Symphony established high-cost bucket (pricing reimbursement) • Early clinical feedback shows effective healing & persistence → conducive for fewer applications • Opportunities for well-priced products (especially with prop
Slide 57: Symphony covered by MACs and contracted with GPOs
Symphony now covered in 6 of 7 MACs, as well as contracted with several major GPO’s and the US DoD For personal use only • Covered (LCD) • First Coast • Novitas • Covered (Medical Necessity) • Noridian • NGS • WPS • Palmetto • Not Covered (we have submitted an application) • CGS Currently testing re
Slide 58: Developing a comprehensive and bespoke support offering
Developing a comprehensive & bespoke support offering - fundamental for customer experience & CTP utilization For personal use only Symphony’s support pathway Coding Set Up Support Concierge Support Claims Support (post claim) • Coding set up in- • Insurance verification service and preauthorization
Slide 59: Symphony Application in Chronic Stage IV Pressure Injury of Heel
For personal use only Symphony Application in Chronic Stage IV Pressure Injury of Heel Alpash K. Patel, DPM Podiatric Surgeon – Oak Bend Medical Center, Richmond, TX Kindred Sugar Land Hospital, Sugar Land, TX For educational purposes only
Slide 60: Symphony Application in Stage IV Chronic Pressure Injury of Heel
60 Symphony Application in Stage IV Chronic Pressure Injury of Heel Alpash K. Patel, DPM. Podiatric Surgery, Kindred Sugar Land Hospital, Sugar Land, TX For personal use only Week 0 Week 4 Week 8 Week 13 Week 17 Redacted – graphic images Dr. Patel has a consultancy agreement with AROA. For education
Slide 61: Q&A
? For personal use only Q&A Unlocking regenerative healing for everybody
Slide 62: Enivo: What's the Opportunity?
| 62 Enivo: What’s the Opportunity ? For personal use only Isaac Mason Photo Vice President Product Development
Slide 63: The Problem - High Cost of Surgical Complications
| 63 The Problem - High Cost of Surgical Complications Site Specific Surgical Sites Complications Challenge For personal use only Non-infectious wound complication ('NIWC') rate of 13.4% - 15.2% in flap and implant reconstructions1, with 10.3%1 High level of wound Mastectomy incidence of surgical si
Slide 64: Enivo
| 64 Enivo1 For personal use only 1 1. New product platform, not yet cleared for sale.
Slide 65: How Does it Work? Pulsed Air Closure Technology (PACT)
| 65 How Does it Work? – Pulsed Air Closure Technology (PACT™) No Vacuum – Vacuum Applied – Preclinical Snapshot1 No Apposition Tissue Apposition • Use of Enivo resulted in near For personal use only complete dead space closure at the conclusion of treatment (14 days), with a median seroma area of 2
Slide 66: Significant Market Opportunity
| 66 Significant Market Opportunity Addressable Clinical Speciality US TAM (USD)1 Primary Use Cases Procedures (PA)1 For personal use only Open Colorectal General $245m ~215,000 Mastectomy Reconstruction / Plastics & Trauma >US $285m ~190,000 Reconstructive Panniculectomy $1.0B TAM1 Spinal Decompres
Slide 67: Competitor Landscape – Key Product Characteristics
| 67 Competitor Landscape1 – Key Product Characteristics Tissue Apposition For personal use only Adhesives / Fixation Enivo Surgical Drains Incisional NPWT Treatment Duration Fluid Management 1. This slide represents Management’s proposed strategy and opinion.
Slide 68: Step change in soft tissue reconstruction
| 68 Step change in soft tissue reconstruction1 & For personal use only Expected to improve healing rates & quality with fewer complications Soft Tissue Soft Tissue Soft Tissue Reconstruction Reconstruction Reconstruction >US$1.7B TAM2 >US$1.0B TAM3 >US$2.7B TAM4 Plastics, General, Plastics, General
Slide 69: Next steps
| 69 Next steps Received Enivo pilot mastectomy trial – 10 patients over a Initial US NZ Pilot 12-month period. For personal use only FDA 510k Clinical Study Clearance1 Further US US FDA engagement ongoing. Further update FDA Submission targeted in Q4 FY24. 1. US regulatory clearance received to dat
Slide 70: Q&A
? For personal use only Q&A Unlocking regenerative healing for everybody
Slide 71: Open Q&A
? For personal use only Open Q&A Unlocking regenerative healing for everybody
Slide 72: Contacts
CONTACTS For personal use only Simon Hinsley Matt Wright Sarah Tora Investor Relations Media Corporate Communications Manager m +61 401 809 653 m +61 451 896 420 m +64 21 531 043 shinsley@aroabio.com matt@nwrcommunications.com.au sarah.tora@aroabio.com Visit our website www.aroabio.com and find us o