for personal use only - asx2012/05/23 · day 1 post‐recell week 3 post‐recell month 10 14 for...
Post on 06-Jul-2020
1 Views
Preview:
TRANSCRIPT
Australian (ASX: AVH)
U.S. (OTCQX: AVMXY)
May 2012
For
per
sona
l use
onl
y
This presentation may include forward‐looking statements. You can identify these
statements by the fact that they use words such as “anticipate”, “estimate”, “expect”,
“project”, “intend”, “plan”, “believe”, “target”, “may”, “assume” or similar expressions.
These forward looking statements speak only as at the date of this presentation and
are based on management’s expectations and beliefs concerning future events.
Forward‐looking statements are necessarily subject to risks, uncertainties and other
factors, many of which are outside the control of Avita Medical that could cause actual
results to differ materially from such statements. Avita Medical makes no undertaking
to subsequently update or revise the forward‐looking statements made in this release
to reflect events or circumstances after the date of this release. This presentation is
intended to provide background information only and does not constitute or form part
of an offer of securities or a solicitation or invitation to buy or apply for securities, nor
may it or any part of it form the basis of, or be relied on in any connection with any
contract or commitment whatsoever.
2
For
per
sona
l use
onl
y
Avita Medical develops and distributesregenerative, tissue‐engineered products fortreating wounds, burns, scars and skin defects.
Avita's treatment utilizes the patients' own skin toregenerate and expedite wound healing.
• Lead product, ReCell® is on the market & generating revenues.• Regulatory clearance in Europe (CE Marked), Australia (TGA), China (SFDA).
• US FDA trials underway (U.S. Dept. of Defense funded; $3.65M to date); FDA submission expected in 2013
• Australian Exchange (ASX:AVH); U.S. Exchange (OTCQX: AVMHY).• Consolidated Market Valuation $59.5 M (5/15/2012)
• Avg daily volume (3m): 624,658
3
For
per
sona
l use
onl
y
Frontier of medical
technology
Unique product offering
Potential of the technology is
recognized by US DoD
Established track record
4
Novel, patented, platform regenerative medicine technology, with vast market potential for treating unmet therapeutic needs, including burns, reconstructive/ plastic applications, chronic wounds, vitiligo and aesthetics
ReCell® Spray‐on‐Skin® is rapid, low cost, accelerates healing, minimizes scarring, has a low risk of infection, minimizes the donor site, has no lab requirements and can be used in combination with other techniques
No similar harvesting, processing and delivery technology for autologous tissue commercially available
Grants, contract and clinical trial support for the ReCell® technology provided by the US Department of Defense serve to validate ReCell’s potential
Avita’s burns study is the only study conducted by a non‐US company to receive such support from the US Armed Forces (as part of the AFIRM trial)
Over 4,500 patients have been successfully treated with ReCell Spray‐on‐Skin to date
Already commercialized and generating revenues in Europe, Australia and Asia; in late development in the US. (with FDA submission expected in 2013)
ReCell has been embraced by key influential surgeons and Centers of Excellence in the UK, France and Germany
Experienced management team with success in launching new clinical applications
For
per
sona
l use
onl
y
REVENUES5.00
2.50
0.00
$ Millions
2008 2009 2010 2011
LOSS FROM OPERATIONS15.00
7.50
0.00
$ Millions
2008 2009 2010 2011
GROSS PROFIT4.00
2.00
0.00
$ Millions
2008 2009 2010 2011
Revenues of $4.54 million (year ending 30 June 2011)
Gross Profit of $3.5 Million
Overall Gross Margins of 73%
Losses due to Continuing Operations $1.95 Million
Cash on Balance Sheet $9.7 Million (31 March 2012)
No debt
Current U.S. FDA trials funded by US Department of Defense : $3.65 million in total
5
For
per
sona
l use
onl
y
Goal: Regrow, replace, restore function of tissues, organs or limbs damaged, lost or non‐functional (e.g. trauma, disease, senescence)
All tissues and organs – in theory – have capability to regenerate
Fundamental change to practice of medicine
Key Product: ReCell® Spray‐On Skin®
6
For
per
sona
l use
onl
y
Initial product ReCell® Spray‐On Skin®point‐of‐care stem‐cell treatment forwide range of wounds and dermaldefects:
• ChronicWounds• Burns• Plastic and Reconstructive Surgery• Aesthetic/Cosmetic Procedure
Currently on the market & generatingrevenue
• Regulatory clearance in Europe (CEMarked), Australia (TGA), China (SFDA)
• US FDA trials underway (US DoD funded$3.65M )
Regain your normal, healthy and beautiful skin
7
For
per
sona
l use
onl
y
Broad intellectual property portfolio
• 9 patents granted (U.S., PCT, Australia, Japan and EU)
• 7 applications pending
Key technology and associated IP relates to:
• Dissociation of epithelial tissue
• Preparation of stem‐cell‐rich suspension
• Immediate reapplication to patient
Registered trademark ‘Spray‐On Skin’ reinforces the company’s
global branding as ReCell increases its
presence in worldwide markets.
8
For
per
sona
l use
onl
y
Harnesses body’s intrinsic ability to heal itself and packages it into an easy‐to‐use bedside kit for the clinician
Addresses needs of all stakeholders:
• Patients: Provides improved outcomes
• Surgeon/Clinician: Easy, fast and effective with reduced morbidity; revenue generator
• Healthcare System: Reduced patient care costs
Avita’s regenerative technology
9
For
per
sona
l use
onl
y
Thin, split thickness skin sample (20x20x0.2mm) of similar skin
Tissue sample incubated in proprietary enzyme ‘cocktail’ approx. 20 min
Tissue sample removed from incubator, mechanically agitated to separate cells
Cells rinsed in ‘buffer cocktail’
Suspension filtered
Suspension sprayed on wound, covered with dressing. Remove dressing 5‐7 days post‐op; wound fully re‐epithelialized
10
For
per
sona
l use
onl
y
11
ReCell® suspension sprayed onto wound surface
Disaggregated cells migrate
over wound area
Activated progenitor cells undergo period of high mitotic activity
with rapid proliferation and differentiation
Cell signalling encourages and
directs proliferation,
vascularisation and innervation
Result: ‘normal’, healthy, new skin with full complement of constituent cells types, including melanocytes, keratinocytes, fibroblasts and basal cells in proper
proportionFor
per
sona
l use
onl
y
NORMAL HEALING
Cells gradually detach from the ECM and slowly migrate inward from the
wound edge, limiting cell proliferation and differentiation in order to achieve
initial closure of the wound.
Healing by secondary intentionReCell HEALING
Wound bed ‘seeded’ with activated cells leading to rapid proliferation,
differentiation and radial dissemination outward from islets of regenerative
clusters.
Accelerated regeneration
ReCell counters, cancels and redirects “normal” healing, leading to accelerated regeneration
“Stop” to “Grow”
12
Vs.
For
per
sona
l use
onl
y
13
Applications
Chronic wounds such as diabetic, venous, arterial or pressure ulcers
Burns, scalds and donor sites associated with grafts
Scar revisions to improve colour, texture & function
Pigmentation disorders such as Vitiligo
Epidermal defects such as naevi, acne, discolouration
Prophylactic aesthetic rejuvenation procedures
For
per
sona
l use
onl
y
Prep and debridement
Day 1
post‐ReCell
Week 3
post‐ReCell
Month 10
14
For
per
sona
l use
onl
y
12 months post‐ReCell®Neck pre‐treatment
15
For
per
sona
l use
onl
y
10 month post‐ReCellNeck pre‐treatment
16
For
per
sona
l use
onl
y
2 months post treatmentBefore treatment
17
For
per
sona
l use
onl
y
12 month post‐ReCellPre‐ReCell
18
For
per
sona
l use
onl
y
Lower limb ulcers (venous, pressure and diabetic) are significant health problem and major healthcare burden in OECD countries
Afflicts approximately 1.5% of general population; >3% of population over 70 y.o.
Morbidity includes:• Pain & Infection• Impairment of mobility & function• Failure to resolve contributor to loss of limb
Standard of care ineffective• Costly, includes salves and ointments, frequent dressing changes, special compression bandages, medications (includes growth factors), skin grafts (auto or allo)
• Low success rate of treatment; approx. 70% of lower limb ulcers remain unresolved after 20 weeks of treatment
19
For
per
sona
l use
onl
y
Planar Arear: 830 mm2Real Area: 954 mm2Perimeter: 109 mmMissing Volume: 589 mm3
Pre‐op analysis using a Scanner 3D VideoCap®
20
For
per
sona
l use
onl
y
954 mm2 676 mm2 456 mm2 134 mm2
T1 T2 T3 T4 T5
21
For
per
sona
l use
onl
y
T0 T1 @ 7 days
T2 @ 14 days
T3 @ 21 days
T4 @ 28 days
T5 @ 35 days
22
For
per
sona
l use
onl
y
Burns• ReCell® Alone• Combination with other treatments (e.g., mesh grafts, dermal substitutes)
Acute wounds• Surgical• Abrasion• Lacerations
Chronic Wounds• Graft loss• Ulcers (diabetic or venous), alone or in combination with other treatments
Scar remodelling• Burn, graft scars• Surgical scars• Biopsy• Mohs surgery
Reconstructive procedures• Face, nose• In combination with prostheses
Cosmetic relief• Acne scars• Hyper or hypo‐pigmentation
• Liver spots• Sun‐damaged skin• Rejuvenation procedures (wrinkle)
Disease treatment• Vitiligo• Leucoderma
WOUND CARE PLASTICS AESTHETICS
23
For
per
sona
l use
onl
y
Condition Annual number of procedures potentially appropriate for ReCell application
Chronic wounds (lower limb ulcers)
12,000,000Approximately 1.5% of general population (3.2%>70 yo) of OECD countries (1)
Burns650,000 Burns requiring medical intervention (2)
Plastic / Dermatology / Reconstructive
580,000 (US) Treatments sought from plastic surgeons for scar remodeling. (3)
Vitiligo>200,000
Reported cases seeking treatment (prevalence: 2% of population ~ 12 million) (4)
Aesthetics600,000 (US)
Treatment sought from cosmetic surgeons for skin discoloration, acne, skin defects, stretch marks (3)
TOTAL 10 – 12 Million Potential annual procedures
1 Graham et al. Prevalence of lower‐limb ulceration. Adv Skin Wound Care 16(6):305‐16 2003.2 US Center for Disease Control (CDC); AM Burn Assoc National Burn Repository 20053 American Society for Aesthetic Plastic Surgery 20044 Forschner et al. Current state of vitiligo therapy. J Dtsch Dermatol Ges 5(6):467‐75 2007
24
For
per
sona
l use
onl
y
Direct
Distributor
Joint Venture
Regulatory Approval Pending
Avita Medical ItaliaMilan, Italy
Avita Medical EuropeCambridge, UK
Avita Medical AmericasLos Angeles
Avita Medical MENAKuwait
Avita Medical Asia PacificAustralia
25
For
per
sona
l use
onl
y
Randomized, within‐patient, controlled study comparing clinical performance of ReCell® device with STMSG for treatment of deep partial‐thickness burns.
Patients must have injury patterns such that two, 100‐320 cm2 regions (not necessarily contiguous) of 2nd degree depth available for treatment with ReCell and STMSG (control)
Endpoints: 16 weeks post treatment• Superiority: Donor site healing at 2 weeks• Non‐inferiority: Recipient site healing at 4 weeks
106 patients (includes 15% withdrawal rate)
Up to 18 US clinical sites; 8 Subjects per site
Approx. 60% completed with enrollment
26
Study Design
For
per
sona
l use
onl
y
William F. Dolphin, Ph.D., CEO29 years international executive experience; significant M&A experience
Stella Sung, Ph.D., Business Development Officer18 years senior management, business development and venture capital
Andrew Quick, VP Research & Technology20 years medical device experience; expertise in design, development and clinical research
Lorraine Glover, General Manager, Asia Pacific20 years experience in the commercial biotechnology and medical devices industry
William Marshall, VP Operations31 years industry experience; expertise in lean manufacturing, quality and regulatory systems
27
For
per
sona
l use
onl
y
28
Commencement of pilot study of ReCell in scar remodeling Q2 2012
China: Price Code listing; Commercial launch Q4 2012
Feasibility studies of ReCell in chronic wounds H2 2012
IDE for pivotal study of ReCell in scar remodeling Q1 2013
FDA submission for ReCell in burns Mid 2013
For
per
sona
l use
onl
y
Novel, patented, platform regenerative medicine technology—potential to change paradigm of wound healing and treatment of dermal defects
Strong Intellectual Property and first‐mover advantage
Enormous market potential due to applicability in multiple indications
Commercialized and generating revenues internationally
Relatively near term significant value inflection point—FDA submission in 2013
Public Australian company just beginning to gain exposure to US investors
29
For
per
sona
l use
onl
y
COMPANYStella M. Sung, Ph.D., Business Development Officer
9221 Corbin Ave, Suite 220Northridge, CA 91324‐2494
Tel: +1‐818 356 9418Email: SSung@avitamedical.com
www.avitamedical.com
Investor RelationsMark A. McPartland, Senior Vice President
MZ GroupMain: +1‐646‐593‐7140Mobile: +1‐910‐297‐6442markmcp@mzgroup.uswww.mzgroup.com
30
For
per
sona
l use
onl
y
31
For
per
sona
l use
onl
y
32
For
per
sona
l use
onl
y
With ReCell® the regenerative process is regulated and controlled by the presence of “Positively Stressed” keratinocytes (K) yielding enhanced release of key proteins (e.g.,HSP90), platelets (P), releasing PDGF, and Stem Cells (SC) (“intelligent bags of growth factors“ (proliferators, e.g., VEGF), cytokines (immunomodulators) and chemokines (migrators)).
33
For
per
sona
l use
onl
y
HSP90 blocks action of TGFb, disinhibiting response to VEGF (vascular endothelial growth factor) and PDGF (platelet‐derived growth factor) by endothelial cells and fibroblasts (Fb) resulting in proliferation and differentiation of key cell types accompanied by rapid development of blood vessels and nerves.
Interplay of inhibition, disinhibition and activation generates a positive feedback cascade resulting in further release of growth factors, cytokines and chemokines.
34
For
per
sona
l use
onl
y
‘Normal’ skin regenerates through maturation and remodeling with appropriate stratification and mix of all cells types (stem cells, keratinocytes, fibroblasts, melanocytes, Langerhans cells, nervous tissue, blood vessels, etc. ) producing texture, pliability, sensitivity , pigmentation and coloration matching the surrounding skin.
35
For
per
sona
l use
onl
y
Procedure Advantages Disadvantages
Skin graft • Standard of care• Specific graft procedure inexpensive• Rapid procedure
• Scarring, cosmetic issues, skin ”quality”• Large, painful donor site• Infection, rejection
• Extended hospitalization• Repeated operations
Cultured epithelia(auto or allo)
• Large coverage• Small donor site• Low infection
• Expensive• 2‐6 weeks to grow• Allograph high rejection rate• Fragile• Cosmetic issues (skin matching, scarring)
• Extended hospitalization with interim wound coverage• Multiple procedures• Require specialised lab facilities• cost of immunosuppressive treatment
Artificial skin • Large coverage• No donor site• Low infection / reject
• Expensive• Fragile• Not skin matched: scarring
• Multiple procedures• “Not‐ready‐for‐prime‐time”
Dermal matrixes • Requires combination of above• Provide rapid coverage• Useful in severe, deep wounds
• Expensive• Extended hospitalization with interim wound coverage
• Multiple procedures• Requires ‘skin’ of some sort
ReCell Spray‐On Skin
• Rapid• Low cost, decrease hospitalization• Minimize donor site• Minimal scar• Low infection / reject• No lab requirements• Can be used in combination with other techniques
• Requires paradigm change
36
For
per
sona
l use
onl
y
Procedure Companies
Skin graft/Wound care:
• 3M Health Care • Baxter• Carrington Laboratories, Inc. • ConvaTec, Ltd. • Covidien, Ltd.• Derma Sciences • GlaxoSmithKline Plc • Healthpoint, Ltd.
• Hill‐Rom Company, Inc. • Johnson & Johnson • Kinetic Concepts, Inc. • Medline Industries • Molnlycke HealthCare • Mylan• Pfizer, Inc. • Smith & Nephew, Plc
Cultured epithelia(autologous, allogeneic or xenogeneic)
• Advanced BioHealing • Ethicon• Fidia Farmaceutici s.p.a.
• Genzyme• Organogenesis Inc.
Dermal matrixes • Integra Inc.
Spray‐on (ReCell) • Avita Medical
37
Range of companies involved with burns/wound care products
For
per
sona
l use
onl
y
top related