Preventing lymphedema protecting the quality of life of cancer survivors

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Preventing lymphedemaprotecting the quality of
life of cancer survivors
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ImpediMed

• Lymphedema is a large globally, underserved
  medical condition
• First mover advantage US always the key market
• Decade of clinical validation focus was the US,
  Europe, Australia
• Regulatory reimbursement hurdles cleared for
  breast cancer
• IP protected experienced management team US
  and Europe

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Lymphedema diagnosis

• US - 240,000 new cases/year
• US - 2.3 m breast cancer survivors
• 1 in 4 develop Lymphedema
• Life long management
• Lifelong payment to healthcare
• Impacts quality of life of patient

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ImpediMed solution
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US business model primary focus

• Place L-Dex devices in surgeons office free of
  charge
• Razor blade model - price per test of US25 to
  US45
• Surgeons presently reimbursed US200 by private
  payers
• Targeting average annuity stream per placement
  US20K
• 14K primary targets for breast cancer, 60K for
  pelvic

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• Lymphedema major issue US, Japan, Europe
• Clinical, regulatory, reimbursement focus US
  market
• Limited competition first to market advantage
• Competition hurdles US ideal for IP, Reimb.,
  Reg.
• Proven business model US key beachhead
• Experienced management US/Europe/Japan

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Global Scene point one

• Make it they will come - is not a viable
  strategy
• International outlook needed from day one not
  just for expansion
• Key medical markets are the US, Europe, Japan
• Value proposition starts here focus on
  product/technology benefit
• Focus needs to be from day one in the following
  areas
• clinical benefit positioning for economic and
  clinical outcome
• reimbursement start early, very long process,
  but critical
• regulatory does the indication support the
  value proposition
• distribution/commercialisation consider early

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Global Scene point two

• Challenges of being Australian
• Human resources international experience hard
  to find
• US key market hard to service from Australia
• Clinical data need peer reviewed data for the
  US/Europe
• Investment we need an improved understanding of
  what is needed to develop a global business
  opportunity

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Global value proposition (medical) - built
through 3 key primary components
Regulatory Class and indication
Clinical Trails Marketing Regulatory
Reimbursement Coding, payment, coverage
Distribution/commercialisation final challenge
after primary components in place
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Investment points to consider

• Beware of substantial equivalence
• Can also mean substantial competition 510K
  class 2
• Can also mean substantially equivalent products
  substantially equivalent coding, coverage and
  payment
• Value drivers that should be considered by
  investors
• Intellectual property
• Type of FDA clearance/approval class 2/class3
  major value driver
• Peer reviewed science validating clinical claims
  and benefit!!!
• State of reimbursement
• Technology code - Can also be a hurdle of entry
  for competition
• Code availability or stage of the process
  miscellaneous or cat 3
• Coverage/payment health economics natural
  history studies