From Idea to Market – A Successful U.S. Model Ivar Sorensen, Managing Partner, The M&A Group, LLC...
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Transcript of From Idea to Market – A Successful U.S. Model Ivar Sorensen, Managing Partner, The M&A Group, LLC...
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
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
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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
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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”?
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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
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Market Driven Need Assessment
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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
• Serious safety concerns
• Less effective for morbid obesity
– Limited weight loss
– Unsustained effect
• Adverse side-effects
• Duration of use restrictions
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Pharmaceuticals Bariatric Surgery
• “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
Less Invasive More Invasive
Literature Study – Role of Vagus Nerve
• Vagus nerve 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
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80% of vagus nerve fibers
send messages to the brain
20% of vagus nerve fibers send instructions from
the brain
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
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ReCharge Study Results – Weight Loss PPG
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Base
line
Wee
k 1
Wee
k 3
Wee
k 4
Wee
k 6
Wee
k 8
Wee
k 10
Wee
k 12
4 m
onth
s
5 m
onth
s
6 m
onth
s
8 m
onth
s
10 m
onth
s
11 m
onth
s
12 m
onth
s
0
5
10
15
20
25
30
% E
xces
s W
eigh
t Los
s
12 Month Data Point –Treatment Group~26% Excess Weight Loss~10% Total Body Weight Loss
12 Month Data Point –Sham Control Group
EnteroMedics - Company Information
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Key Balance Sheet Data (March 31, 2013) Diluted Shares Outstanding (March 31, 2013)
Cash & Cash Equivalents $29.6 M Common Shares $55.6 M
Debt $10.0 M Warrants $25.6 M
Total Invested Capital $203.0 M Options $7.6 M
Total $88.8 M
EnteroMedics, Inc. Company Highlights
NASDQ: ETRM Founded: December 2002
Headquarters: Saint Paul, Minnesota Employees: ~ 30
The Venturi Group
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Idea Source
The Venturi Principals
The Facility
The Funding Partners
The Venturi Group
16M&A Group, LLC 3565 IDS Center 80 South Eighth Street Minneapolis, MN 55402 USAm-a-group.com Member FINRA and SIPC
Ivar Sorensen:p [email protected]
Address:3565 IDS Center80 South Eighth StreetMinneapolis, Minnesota 55402www.m-a-group.com
Contact Information