For personal use only - ASX · Patented platform technology of biodegradable polymers that can be...
Transcript of For personal use only - ASX · Patented platform technology of biodegradable polymers that can be...
PolyNovoMacquarie
Investor Update 5 May 2020
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Disclaimer
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 undertakings in
this presentation.
This presentation is not intended to be relied upon as advice to investors or potential investors and does not take into account the investment
objectives, financial situation or needs of any particular investor. PolyNovo Limited makes no warranty or representation (express or implied) as
to the accuracy, reliability or completeness of the information contained in this presentation. Specifically, several matters referred to in the
presentation remain under investigation and are subject to change or even elimination, depending on further research and investigation. Further,
any opinions (including any forward looking statements) expressed in this presentation are subject to change without notice. PolyNovo and its
directors, officers, employees, advisers and agents shall have no liability (including liability to any person by reason of negligence or negligent
misstatement) for any statements, opinions, information or matters (express or implied) arising out of, or contained in or derived from, or for any
omissions from this presentation, except liability under statute that cannot be excluded.
This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in respect
of shares, or an offer, invitation or recommendation to sell, or a solicitation of any offer to buy, shares in the United States, or in any other
jurisdiction in which, or to any person to whom, such an offer would be illegal.
This presentation may include forward-looking statements. Forward-looking statements are only predictions and are subject to known and
unknown risks, uncertainties and assumptions, many of which are outside the control of PolyNovo. Actual values, results or events may be
materially different to those expressed or implied in this presentation depending on a range of factors. Given these uncertainties, recipients are
cautioned not to place reliance on forward-looking statements. No representation or warranty (express or implied) is made by PolyNovo or any
of its directors, officers, employees, advisers or agents that any forecasts, projections, intentions, expectations or plans set out in this
presentation will be achieved.
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NovoSorb®
• Base polymer developed by the CSIRO (Australian Government Research Organisation)
• PolyNovo developed the polymer further with foaming process and new formulations for medical devices
• Polymer that is programmable for re-absorbsion rate and product attributes.
• Excellent biocompatibility, safety and toxicity profile.
• Biodegrades through hydrolysis and excreted through urine, respiration and macrophage activity.
Patented platform technology of biodegradable polymers that can be utilised as:
o A foam dermal scaffold
o Thermoplastic extrusions
o Filaments for weaving or knitting
o A solution for spray or dip coatings of other devices
o Patents on drug and antimicrobial elution
o 51 patents granted in the family all owned 100% by PolyNovo (4 new patents announced 7 April)
NovoSorb® polymer
A unique platform technology
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Addressable Markets ~$7.5B+ near term
Dermal Scaffold Market
• US market largest, CAGR 10%
• Global market ~$1.5+B, conservative
Hernia Market
• ~$3B
• CAGR 9% with synthetic resorbable 34 %CAGR
Breast Market
• ~$3B
• CAGR 9.3%
Dermal Scaffolds
~$1.5B
Hernia Devices
~$3B
Breast Augmentation/reconstruction
~$3B
Drug Elution/ Chronic disease management
TBD
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Current Products
• A dermal scaffold/matrix allowing for cellular integration, organisation in the repair of dermal loss
• Pure synthetic, has no proteins, antigens or biological elements
• No food for bacteria so does not potentiate infections
• Excellent health economics for total episode treatment cost
• Excellent cosmetic and functional outcomes
• To date BTM healed areas have not required further scar revision which is outstanding
• Key Opinion Leaders have adopted as standard of care
• NovoSorb SynPath® brand registered for future use in US Chronic wound market. Will have a unique reimbursement code and pricing structure for the out-patient market
• Registered brand name for NovoSorb hernia product range
• Made of NovoSorb foam and our own unique NovoSorb film, it is not BTM but a unique product
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Method of closure is the Surgeon’s clinical choiceLarge areas best closed with a split skin graftSmall areas closed under moist dressing
NovoSorb BTM applied to debrided wound bedThe wound is ‘physiologically closed’, limiting contraction and risk of infection.
NovoSorb BTM fully integratedFull thickness tissue deposited within the foam. Once integrated, the seal is ready for removal.
Sealing membrane removed Neo-dermis is ready for final closure
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NovoSorb BTM how it works
Sealing Membrane
Temporary, transparent polyurethane membrane designed to
physiologically close the wound and limit vapor loss.
Bonding Layer
Adhesive layer which bonds the foam and sealing membrane
together.
Foam
Semi-reticulated pen foam that is biocompatible and
biodegradable6
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Regenerative Healing with NovoSorb BTM
BTM membrane closes the woundMinimizes foreign body responseCell migration and neo-angiogenesisBacterial colonization minimized
Minimal granulation tissueFibroblasts synthesize ECMVascularized by ~21 daysDelaminated to receive a skin graft
Regenerated healthy dermisBTM foam thins and breaks downBTM not visible at 12-18 monthsHealthy, uniform dermis remains
1-month6-month
9-month 12-month18-month
Patient biopsies
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Blanching & Delamination, Video
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Allows for Staged Grafting
Pt 5 Day 38 post-NovoSorb BTM
Pt 5 Day 31 post-NovoSorb BTM
Note the maturity of this graft 7 days post- application. The mesh
spaces are closed. A truly outstanding result.
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Necrotising Fasciitis
Three months post grafting
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• CE Burn trial is complete with the results released 7 April 2020
– Excellent take of NovoSorb BTM
– Excellent take of skin grafts
– Excellent cosmetic and functional outcomes
• BARDA funded Feasibility trial publication of results 21 April 2020, sites were – Wake Forest Baptist Health, Winston-Salem,
– University of Tennessee Medical Centre, Memphis
– University of California Davis Medical Centre, Sacramento
– Tampa General Hospital, Tampa
– Arizona Burn Centre, Phoenix
– Lehigh Valley Hospital, Allentown
• Outstanding results with take of NovoSorb BTM, Skin Grafts and outcomes. Clear path for
progress of Pivotal trial
• Granted US FDA “Break through technology” assessment pathway for NovoSorb BTM
which will accelerate US FDA feedback, guidance and support of the trial program
• BARDA funded Pivotal burn trial IDE approval of protocol expected June 2020. The
finalised number of centres, budget and timelines with announcements made in due
course
Clinical Trial update
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Regulatory approvals
ApprovedClass III Medical device
✓US FDA 510(K)
✓CE Certification Europe, UK, Ireland
✓TGA Inclusion
✓NZ MedSafe
✓South Africa
✓India
✓Malaysia
✓Singapore
✓Israel
In Processo South Korea
o Taiwan
o Mexico
o Kuwait
o Sri Lanka
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Current markets
Sweden
Finland
PolyNovo direct market
Distributor markets
USA
⚫ Direct market entry
⚫ Largest global market
⚫ Selling NovoSorb BTM since 2016
⚫ Currently 17 sales people, 3
marketers and 2 sales managers, 1
SVP Sales& Marketing
⚫ Further expansion post-CoVid19
Australia/NZ
⚫ Selling NovoSorb BTM in
Australia and New Zealand
⚫ Direct sales force (3)
⚫ Further expansion post
CoVid19South Africa
⚫ Selling NovoSorb BTM
since 2017
Middle East
⚫ Israel Sept 2018
⚫ Saudi Arabia Sept 2018
⚫ UK direct sales with 3 sales people and 1
dedicated Marketer
⚫ DACH region distribution partner PMI
launch and already placed 3 stock orders
⚫ Other EU markets will be a mix of direct
and distributors
Europe
India and SE Asia
⚫ Myovatec partner in India
⚫ Direct Singapore/ Malaysia 1
salesperson
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H1 Results and current snapshot
Sales Revenue H1
$8.57M
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• Cash on hand per March ASX announcement $7.4M• NAB Finance facility $9.3M, capitalization of hernia factory
and production machines freeing cash for investment in sales growth
• Ascending revenues with US March a record month• Running 2 shifts, 5 days for inventory build in response to
forward demand forecast
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Q3 FY’20 update
• Record sales month in US March 2020
• Australia and New Zealand strong Q3
• DACH region launch was strong with BTM now in 8 Hospitals and further accounts to come on board once virus lock down eases
• Some German and Swiss Surgeons have done many paediatric and adult patients with excellent results
• UK team expanded with 3 sales people and 1 marketer. Evaluations pledged in 12 NHSs and two have started surgeries already with excellent results and other NHSs ready post-CoVid19 restart
• $9.3M bank financing frees cash for further business expansion
• Excellent clinical trial result outcomes, released on ASXFor
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Hernia Factory Development
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• New Factory build– Contractor on schedule
– HVAC ducting, electrical, structural work
advanced
– Completion estimated ~July 2020
• Production equipment delivered
– Custom built production machines have been
delivered
– Machines installed in an off-site facility to
accelerate timeline to market
– Will move machinery into Port Melbourne new
facility ~ June/July 2020
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Global Hernia Market
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Market Drivers
• Resorbable segment growing (34% -3 Year CAGR)
• Steady increase in obesity driving increase in ventral
hernia repairs
• Technological advancements (e.g. materials - less
inflammation, infection & shrinkage)
• Surgical trend towards laparoscopic (~10% CAGR)
• Robot gaining foothold with younger generation
• Class action litigation of permanent meshes
• Patient awareness – social and digital media
Global Hernia Market $3.1B
US Ventral Hernia $850M
~400,000 cases
US Hernia Market $1.5B
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Hernia applications
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Targeting 2 major planes of placement
• Intraperitoneal with Syntrel® SS
• Retro-muscular with Syntrel ® DS
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Hernia Development
• Significant engagement with key opinion leaders
• Marketing plan refinement
• Once machinery installed in Port Melbourne commercial validation
processes will run till end of 2020
• Regulatory dossier on track for US FDA filing
• US Market entry ~ July/August 2021
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Other Research & Development
• Breast product– Working with Establishment Labs for first product design
– Regulatory strategy will be US FDA 510(k) with clinicals
• IP- 4 New Patent , total now 51– 2018403989 Oriented biodegradable polyurethanes
• This patent relates to how polyurethanes can be “aligned” within a device to control their properties– 2018390992 Tissue repair laminates
• PolyNovo’s use of this will be in a non-adherent hernia repair device however there are further possible applications of this IP
– 2018390991 Soft tissue implant pocket
• A broad application where you need to cover other devices/ implants to encourage tissue ingrowth and address any potential “dead spaces”
– 2018387125 Tissue repair laminates
• PolyNovo’s first application of this will be in a hernia device where tissue grows into both sides of the device however there are further potential products to be developed around this patent
• BetaCell– The team at BetaCell have repeated pig studies utilizing stem cell derived Islet cells. Good results with some refinment of
the cell transfer in progress. Once the data is complete, they anticipate human trials sometime in 2020
• Drug elution, Organoids and other opportunities utilizing NovoSorb polymer continue to be explored and will get greater resources once hernia transfers to manufacturing
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Offices Refurbishment & Expansion complete
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• Port Melbourne– Combined Unit 1&2 office areas and refurbished
– Allows for future team expansion
– Collaborative areas and meeting rooms
• San Diego– Moved into a larger office space, in the same building, to accommodate expanded team
– Additional resources in Marketing, HR, Clinical Research and Administration
• England/EU– Team currently work from home
– Looking to establish an office 2020/21
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CoVid19 update
• Little impact on PolyNovo supply chain– Adequate raw material supplies
– ~6 months forward inventory holdings and continue to manufacture
• Sales continue with March and April strong performances– Digital campaigns
– Webinars for Peer to Peer clinical results sharing
– Have opened new accounts
– UK and Aust/NZ sales teams cannot enter hospitals but remain in regular contact
– US varies by state as to access but digital meetings are common place
– New sales role recruitment suspended until CoVid lockdown passes
• Factory build on track with builders in team groupings providing safe working environment
• Reduced expenses on travel and conferences…
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The Board PNV
Mr David Williams (B.Ec (Hons), M.Ec, FAICD)
Non-executive Chairman Mr Williams was appointed as a Nonexecutive Director on 28 February 2014 and Chairman on 13 March 2014. Mr Williams is an
experienced Director and investment banker with a proven track record in business development and strategy, as well as in mergers and acquisitions and
capital raising. He possesses 35 years’ experience working with and advising ASX-listed companies in the food, medical device and pharmaceutical sectors.
Mr Williams is currently Chairman of ASX-listed Medical Developments International Ltd (ASX: MVP), Chairman of RMA Global Limited and is Managing
Director of investment bank Kidder Williams Ltd.
Dr David McQuillan (PhD)
Non-executive Director Dr McQuillan was appointed a Director of PolyNovo on 6 August 2012. He has extensive technical, medical, scientific and regulatory
knowledge, as well as merger and acquisition expertise. Previously he was a Fogerty Fellow at the NIH (Bethesda, MD), an NH&MRC Fellow at the University
of Melbourne, and Associate Professor at Texas A&M University (Houston, TX) where he studied Tissue Engineering, Regenerative Medicine, and
Biochemistry of the Extracellular Matrix. Dr McQuillan was with LifeCell Inc/Kinetic Concepts Inc (KCI) for 12 years, holding a number of senior roles, including
Vice President for Research and Development at LifeCell and Senior Vice President of Advanced Research and Technology at KCI. He was Chief Science
Officer for TELA Bio, a VC-funded development- stage biotechnology company from 2013 to 2015. He is currently a Non-Executive Director for Cell Care
Therapeutics Inc (a privately held stem cell company based in Monrovia, CA) and Nonexecutive Director and Co-Founder of ECM Technologies Inc (a privately
held biotechnology company based in Houston, TX).
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Dr Robyn Elliott (BSc (Hons) Chemistry PhD Inorganic Chemistry)
Dr Elliott is currently Senior Director for Strategic Expansion Projects at CSL Behring, previously she was the Managing Director at IDT Australia and
commenced her career at DBL Faulding. Dr Elliott has a proven track record in product development, clinical trials, regulatory affairs, audits, quality
management and operational strategy. At CSL, her worldwide experience in new plant development and strategy, regulatory affairs and audit will be invaluable to
PolyNovo as the company scales its operations globally.
Mr Philip Powell B.Comm (Hons), ACA, F.Fin, MAICD
Non-executive Director Mr Powell was appointed a Director of PolyNovo on 13 May 2014 and was Acting Managing Director from 15 July 2014 to 13 February
2015. Mr Powell has many years’ experience in investment banking specialising in capital raisings, Initial Public Offerings (IPOs), mergers and acquisitions and
other successful corporate finance assignments across a diverse range of sectors including utilities, IT, pharma, financial services, food and agriculture. He
spent 10 years in senior financial roles at OAMPS Ltd, a former ASX-listed financial services group, and 10 years in audit with Arthur Andersen & Co in
Melbourne, Sydney and Los Angeles. Mr Powell is currently a Non-executive Director of Medical Developments International Ltd (ASX: MVP), RMA Global Ltd
(ASX: RMY) and BARD1 Life Sciences Ltd (ASX:BD1).
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The Board (2)
Mr Leon Hoare (GradDipBus, AssocDipAppSc(Ortho), GAICD)
Non-executive Director Mr Hoare was appointed a Director of PolyNovo on 27 January 2016. He is the Managing Director of Lohmann & Rauscher, Australia &
New Zealand (ANZ), a private EU based medical device company. Previously he was Managing Director of Smith & Nephew ANZ (all divisions) until the end of
2015, one of Smith & Nephew’s largest global subsidiaries outside the USA. He served as President of Smith & Nephew’s Asia-Pacific Advanced Wound
Management (AWM) businesses for 5 years and was a member of the Global Executive Management for the AWM Division. In his 24 years with Smith &
Nephew, he also held roles in marketing, divisional and general management.
His career also included a senior role at Bristol-Myers Squibb in surgical products, and as Vice Chair of Australia’s peak medical device body, Medical
Technology Association of Australia. He is currently a Non-Executive Director of Medical Developments International Ltd (ASX: MVP).
Mr Bruce Rathie (B.Comm, LLB, MBA, FAIM, FAICD, FGIA)
Non-executive Director Mr Rathie is an experienced Company Director with a finance and legal background. He practised as a partner in a large legal firm and
acted as Senior Corporate Counsel to Bell Resources Limited in its early years. He then studied for his MBA in Geneva and embarked on his 15 year
investment banking career. When Head of the Industrial Franchise Group at Salomon Smith Barney he led Salomon’s roles in the Federal Government’s
privatisation of Qantas, Commonwealth Bank (CBA3) and Telstra (T1). He now has over 17 years’ experience as a full time professional Non-executive Director.
He is currently Chairman of Capricorn Mutual Limited and a Non-executive Director of Capricorn Society Limited and Australian Meat Processors Limited. In the
medical device space, he was previously Chairman of ASX listed Anteo Diagnostics Limited and a Director of Compumedics Limited and USCOM Limited. He
has been a Non-executive Director of PolyNovo since February 2010.
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Mr Max Johnston Non-executive Director. Mr Johnston was appointed a Director of PolyNovo on 13 May 2014. Mr Johnston held the position of President
and Chief Executive Officer of Johnson & Johnson Pacific, a division of the world’s largest medical, pharmaceutical and consumer healthcare company for 11
years. Prior to joining Johnson & Johnson, Mr Johnston’s career also included senior roles with Diageo and Unilever in Europe. Mr Johnston has also held
several prominent industry roles as a past President of ACCORD Australasia Limited, a former Vice Chairman of the Australian Food and Grocery Council and a
former member of the board of ASMI. Mr Johnston has had extensive overseas experience during his career in leading businesses in both Western and
Central-Eastern Europe and Africa as well as the Asia-Pacific region. Mr Johnston is currently a Non-executive Director of Medical Developments International
Ltd (ASX: MVP), CannPal Limited (ASX: CP1) ,ProLife Foods NZ , BARD1 Life Sciences Ltd (ASX:BD1) and Non Executive Chairman AusCann (ASX: AC8)
and was a former Non Executive Director of Enero Group Limited (ASX: EGG), and Non-executive Chairman of Probiotec Ltd (ASX: PBP).
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Management
Mr Jan-Marcel Gielen (CA, Bachelor Bus (Acc))
Chief Financial Officer and Company Secretary
Mr Gielen joined PolyNovo on 13 December 2018. Mr Gielen holds a Bachelor of Business (Accounting) degree from Monash University, is a member of the
Institute of Chartered Accountants and commenced his career with Pitcher Partners. Since then Mr Gielen has held senior finance roles for various businesses
across a range of industries such as retail, ICT, logistics (3PL) & medical, both locally and internationally. Mr Gielen has extensive experience in CFO and
Finance Director roles for fast growing PE and VC backed businesses and played an important part in expanding these businesses globally, both from a
financial and operational perspective. Mr Gielen had a long involvement from inception with ICIX, a leading SaaS platform supporting global retailers and
manufacturers where he served as Finance Director in Silicon Valley. Mr Gielen’s most recent role was CFO of CardioScan for 6 years, Australia’s largest
cardiac reporting provider, which during his tenure the business expanded to HK, Singapore & North America.
Mr Paul Brennan (MBA, BSc (Nursing) RN RM)
Managing Director
Mr Brennan was appointed Chief Executive Officer (CEO) of PolyNovo Ltd on 13 February 2015. Appointed MD 23 April 2020. Mr Brennan has extensive
knowledge, exposure and understanding of the health system through his clinical background and commercial exposure with various multinational companies.
He has coordinated the marketing, global strategy development, new product development and regulatory processes for the Asia-Pacific region for industry-
leading organisations in relation to medical products and devices.
Mr Brennan has an intimate knowledge of the manufacturing and production processes. Previously he was Marketing Director Austral ia and New Zealand and
Sales Director New Zealand for Smith & Nephew Healthcare from 2008 to his commencement with PolyNovo in February 2015. Mr Brennan holds a MBA from
Swinburne University, a Bachelor of Science (Nursing) from the University of New England in NSW, Certificate in Midwifery Central Coast Area Health Service
NSW, and General Nursing certificate from St Vincent’s Hospital Darlinghurst NSW.
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Management (2)
Mr Gordon Fleming (BSc (Hon) Industrial Chemistry, MBA)
Director of Operations
Gordon’s career spans three decades in Australia, Asia, and Europe including more than 20 years best -in-class manufacturing experience in the Chemical, FMCG, Food and Packaging sectors. After completing his degree in Industrial Chemistry at the University of NSW, Gordon began a 15- year stint in food sciences, during which time he held a range of operational leadership positions with Australian and Asian food manufacturers including Meadow Lea and Don Smallgoods.
Aside from a two year stint in the commercial packaging industry, Gordon’s career has been with BASF, the German chemical giant. Following four years as BASF–Australia’s Manufacturing and Operations Manager, Gordon was made the global Head of Intelligence and Synergies, based in Ludwigshafen, Germany and in which capacity he introduced best practice manufacturing processes at 25 major sites across the world. He returned to Melbourne in 2013 as Head of Technology and Operational
Dr. Tim Moore Principle Scientist
completed a Bachelor of Applied Science (Chemistry) degree at Swinburne University of Technology, followed by an honours degree and PhD degree. Dr.
Moore’s PhD dissertation was in the field of biodegradable polyurethanes; the title was ‘Design and Synthesis of Biodegradable Thermoplastic Polyurethanes
for Tissue Engineering’. Dr. Moore has been involved with PolyNovo since its inception and is a co-inventor of some of the variants of NovoSorb™. He has been
working on the development of biodegradable polymers for medical devices for over ten years. His main area of expertise is in polyurethanes and the
development of biomaterials for use in medical devices. He developed a novel range of biodegradable chain extenders which is included in several of
PolyNovo’s patent applications. Dr. Moore is involved in project management and product development in PolyNovo’s leading applications. Dr. Moore is also
responsible for the maintenance of PolyNovo’s extensive Intellectual Property Portfolio. He is co-author on a number of peer-reviewed papers and patent
applications. He was a co-recipient of the CSIRO Molecular Science Divisional Strategic Action Plan Award for Innovation (2004) and of the CSIRO medal in
Research Achievement category (2005).
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NovoSorb BTM over tendon
Degloving injury with tendons missing the paratenon.
NovoSorb BTM was left on for 9 weeks before grafting.
Day 316
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