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

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

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  1. From Idea to Market – A Successful U.S. Model Ivar Sorensen, Managing Partner, The M&A Group, LLC In Collaboration with Venturi Group, LLC

  2. Idea to Market Model

  3. 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

  4. 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

  5. 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”?

  6. 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

  7. An Example - EnteroMedics A Venturi Group Portfolio Company

  8. 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

  9. The Problem: Current Treatment Paradigm Bariatric Surgery Pharmaceuticals 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

  10. 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

  11. Critical Experiment

  12. EnteroMedics • 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

  13. 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

  14. EnteroMedics - Company Information

  15. The Venturi Group

  16. Contact Information Ivar Sorensen: p 612.375.1190 ivar@m-a-group.com Address: 3565 IDS Center 80 South Eighth Street Minneapolis, Minnesota 55402 www.m-a-group.com

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