Polynovo Limited · ASX:PNV
Polynovo — Investor Presentation (September 2017)
27 slides from Polynovo's investor presentation, Sep 25, 2017
Slide 1: PolyNovo Investor Presentation
For personal use only PolyNovo Investor Presentation 25 September 2017 ASX: PNV
Slide 2: Disclaimer
Disclaimer For personal use only This presentation has been prepared by PolyNovo Limited and is provided for general information purposes only. No party other than PolyNovo has authorised or caused the issue of this document, or takes responsibility for, or makes any statements, representations or u
Slide 3: PolyNovo Board
For personal use only PolyNovo Board Page 3
Slide 4: PolyNovo Management
PolyNovo Management For personal use only Page 4
Slide 5: Corporate Overview: Key Milestones
Corporate Overview For personal use only Key Milestones 2004 PolyNovo incorporated ex-CSIRO 2006 NovoSkin feasibility study 2008 Port Melbourne facility established 2010 NovoSkin is incorporated Bio-Innovation SA grant ($217K) 2011 Feasibility study on NovoPore NPWT Share price 5 year graph 2013 Fir
Slide 6: Share Placement
Share Placement For personal use only • PolyNovo has completed a $7M Date Item 22/9/17 Record date for SPP offer capital raising via private 25/9/17 Recommencement of trading placement at $0.27 2/10/17 Settlement of placement • Further capital raising will now 2/10/17 SPP offer booklet despatched an
Slide 7: Capital Raising – use of new funds
Capital Raising – use of new funds For personal use only • Expanding sales and support infrastructure to accelerate sales, focused on the US market – Sales staff, Clinical support role and marketing promotion • Accelerating R&D program to support breast & hernia applications • Supporting the R&D eff
Slide 8: NovoSorb Polymer, a platform technology
NovoSorb™ Polymer , a platform technology For personal use only NovoSorb • Developed by the CSIRO and spun out as PolyNovo. Listed on the ASX 2004 • Unique attribute is that the Polyurethane is made with no aromatic isocyanates or solvents • Excellent biocompatibility, safety and toxicity profile •
Slide 9: NovoSorb BTM product description
NovoSorb BTM product description For personal use only BTM is a fully synthetic, biodegradable dermal matrix with 3 layers: • Sealing membrane A temporary, transparent, polyurethane sealing membrane designed to physiologically ‘close’ the wound limiting water loss/evaporation • Bonding layer A tempo
Slide 10: PolyNovo Resources
PolyNovo Resources For personal use only • Melbourne team currently 22 FTE: – Currently recruiting additional 2 Research & Development Scientists to increase our new product development speed to market. Areas of focus being Breast, Hernia and Drug Elution portfolios. • US Team 8 FTE – Sales team of
Slide 11: Expanded cleanroom production facility - New
Expanded cleanroom production facility- New For personal use only Page 11
Slide 12: BTM Sales in US
BTM Sales in US For personal use only • First NovoSorb BTM commercial sales • Progressing through the hospital procurement committees/process in many major US hospitals with further account conversions anticipated in the coming months • Surgeon experience positive with the NovoSorb BTM showing robus
Slide 13: BTM on Sale - Australia & New Zealand
BTM on Sale - Australia & New Zealand For personal use only • Device Technologies (DT) exclusive distribution agreement, sales achieved • NZ registration with MedSafe • Australia sales through the TGA exemption scheme • Sales to date for necrotizing fasciitis, free flaps and burns • Clinician focuse
Slide 14: BTM on Sale – Rest of World
BTM on Sale – Rest of World For personal use only South Africa and other African Countries • Ascendis Medical subsidiary, Surgical Innovations, is our exclusive distributor • 5 dedicated BTM sales representatives, experienced in the plastic/burn surgery segment • Initial sales focus is the private m
Slide 15: CE Mark Trial Update
CE Mark Trial Update For personal use only A CE Mark is a regulatory standard/requirement for many countries eg: Europe, Australia, SE-Asia. Clinical trails are required as part of a Class III certification • PolyNovo require 30 burn patients enrolled in the trial • Outcomes: – BTM take, skin graft
Slide 16: BARDA PMA Trial Programs
BARDA PMA Trial Programs For personal use only BARDA is a US Federal agency within the Department of Human & Health Services. They are charged with preparing for mass disaster management. BARDA awarded PolyNovo a contract which funds our US based clinical trials program. Success in these trials will
Slide 17: New Business opportunities
New Business opportunities For personal use only NovoSorb platform technology • Currently exploring options with a breast prosthesis manufacturer to partner in the development of PolyNovo NovoSorb based breast products. These include – a reinforcement “breast sling” used in cosmetic and reconstructi
Slide 18: New Product Pipeline
New Product Pipeline For personal use only Product BTM Breast Sling Hernia Breast form Skin Depots Wounds & Burns * Dates are best estimates Regulatory FDA 510(k) cleared – on sale US FDA PMA clinical trials US FDA 510(k) US FDA510(k) PNV Polymer & BTM based on current awareness predicates supplier.
Slide 19: NovoSorb BTM: Biodegradable Temporising Matrix
For personal use only NovoSorb™ BTM Biodegradable Temporising Matrix A Synthetic Dermal Matrix Some graphic images in the next section Improving Outcomes, Changing Lives
Slide 20: BTM Application and Integration
BTM Application and Integration How BTM works For personal use only BTM only applied to a surgically debrided wound bed The wound is ‘physiologically closed’, limiting contraction and risk of infection. 1 BTM fully integrated 2 The dermis is regenerated within the scaffold/foam. Once fully integrate
Slide 21: BTM - Necrotizing Fasciitis
BTM - Necrotizing Fasciitis For personal use only Loss of arm, shoulder and skin on right flank through necrotising fasciitis. NovoSorb BTM applied directly over the exposed ribs, new dermis BTM applied formed and area successfully closed with minimal scar/ contraction. Post these pictures fat conti
Slide 22: Necrotizing Fasciitis - Neck
Necrotizing Fasciitis- Neck For personal use only Full thickness loss of dermis, through surgical removal. NovoSorb BTM applied , integrated and closed with a split skin graft. The neck is known as a difficult area for grafting and post-graft contraction. Note the low scar outcome and full range of
Slide 23: BTM Over Bone
BTM Over Bone For personal use only Full thickness burn through to a burnt skull as a result of a bush fire. The bone was burred back until micro-bleeding was achieved. NovoSorb BTM applied, a new dermis generated into the BTM. Delaminated and closed with a split skin graft. Outstanding result that
Slide 24: Allows for Staged Grafting
Allows for Staged Grafting For personal use only In large (% of body surface area) full thickness burns Note the maturity of this the matrix needs to stay in place until the patient is graft 7 days post- stabilised and surgery can be scheduled to apply skin application. The mesh spaces are closed. g
Slide 25: Outcomes of the first five burn patients
Outcomes of the first five burn patients For personal use only Pt 1 Day 536 Pt 2 Day 368 Pt 3 Day 312 Pt 4 Day 171 Pt 5 Day 194 Page 25
Slide 26: Free Flap application
Free Flap application For personal use only Free flaps are full thickness muscle grafts taken from the forearm for head and neck surgical repair. The NovoSorb BTM repairs the defect in the forearm and allows full dermal regeneration over the exposed tendons. This restores full function, reduces scar
Slide 27: PolyNovo - The Australian Team
PolyNovo - The Australian Team For personal use only Page 27 24/09/2017