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From Idea to Market – A Successful U.S. Model Ivar Sorensen, Managing Partner, The M&A Group, LLC I n C ollaboration with Venturi Group, LLC. Idea to Market Model. Market Driven Need. Focus on clinical (market) need areas, not tools (technology, software, etc.)

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From Idea to Market – A Successful U.S. Model

Ivar Sorensen, Managing Partner, The M&A Group, LLC

In Collaboration with Venturi Group, LLC

market driven need
Market Driven Need

Focus on clinical (market) need areas, not tools (technology, software, etc.)

  • Focus on the “what”, not the “how”
  • Understand the size of the opportunity
    • Large opportunity = venture backing
    • Smaller opportunity = “angels”, grants, economic development, FFFs
  • Structure effort and focus after these steps, not before
assess prospective solutions
Assess Prospective Solutions
  • Product specification
    • Identify candidate technologies
      • Intellectual property office
      • Literature
    • Patent
    • Scientific/medical
  • “Triage”: Evaluate and test
    • Does it solve the need!
    • Now, after all the above:
      • Start to decide on technology
technology requirements
Technology Requirements
  • Decision points
    • Technologies must meet market need areas (“markets in search of technologies”)
      • Strategic IP protection availability
      • Established proof of capability
      • Development to Proof of Concept (POC) cost target established
  • Multiple technology avenues
    • Confirm the options available
    • Do they “fit”?
the critical experiment
The Critical Experiment
  • Most important final step: “The Critical Experiment”
    • Challenge new paradigm
    • Confirm algorithm
      • Achieve the predicted outcome(s)?
      • Function appropriately in application?
    • Verify technology
      • Perform to specification?
      • Yields a manufacturable and reliable product?
      • Licenses in place or not needed?
  • It is not “nibbling” at the edges!
    • Truly test while you can change direction if needed
    • ~25% rule
an example enteromedics
An Example - EnteroMedics

A Venturi Group Portfolio Company

market driven need assessment
Market Driven Need Assessment

Source: World Health Organization

  • Over 1.4 billion adults are estimated to be overweight, one-third of whom are obese
  • So many at risk, yet the market is underserved
    • Societal burden growing exponentially
    • It is estimated that obesity could affect 42% of Americans by 2030
  • Treatment spectrum limited with significant gaps
    • Diet, exercise and current and new drugs continue to have safety and compliance issues
    • Current surgical options are physical interventions, risky and not lifestyle friendly
    • Nothing in-between for patients
the problem current treatment paradigm
The Problem: Current Treatment Paradigm

Bariatric Surgery


Less Invasive

More Invasive

  • “Barbaric”
  • Bypass & sleeve surgery irreversible and risky
  • Adjustable gastric bands have long-term follow-up burdens (e.g. vomiting, quarterly adjustments) result in major lifestyle changes including side effects, dietary restrictions and food intolerances
  • Serious safety concerns
  • Less effective for morbid obesity
    • Limited weight loss
    • Unsustained effect
  • Adverse side-effects
  • Duration of use restrictions
literature study role of vagus nerve
Literature Study – Role of Vagus Nerve
  • 20% of vagus nerve fibers send instructions from the brain
  • 80% of vagus nerve fibers send messages to the brain
  • Vagusnerve controls:
    • Sensation of hunger
    • Expansion, fullness and emptying of stomach
    • Digestive enzyme secretion
  • Severing the vagus nerve (vagotomy) causes:
    • Reduced appetite
    • Delayed stomach emptying
    • Prevention of weight gain
  • The effects of vagotomy are not sustainable
    • The body accommodates for, or “works around”, the permanent interruption
  • VBLOC® Therapy, a revolutionary solution that fills the significant treatment gap for obesity
  • ReCharge Study:
    • Demonstrated:
      • Clinically meaningful and statistically significant EWL of 25-28% (~10% TBL)
      • Excellent individual weight loss response
    • High patient acceptance — 93% at 12 months
    • Met primary safety endpoint (3.1% SAE rate); Positive CV safety signals
    • High benefit-low risk profile
  • Moving forward with Premarket Approval Application
    • Submission planned for Q2 2013
    • Panel — 4Q13/1Q14
recharge study results weight loss ppg
ReCharge Study Results – Weight Loss PPG

12 Month Data Point –Treatment Group

~26% Excess Weight Loss

~10% Total Body Weight Loss

% Excess Weight Loss

12 Month Data Point –Sham Control Group

contact information
Contact Information

Ivar Sorensen:

p 612.375.1190


3565 IDS Center

80 South Eighth Street

Minneapolis, Minnesota 55402