The document summarizes an executive summary for UMBRAMED, a medical device startup developing an innovative artificial urinary sphincter. Some key points: - UMBRAMED is developing an electromechanical artificial sphincter to treat severe urinary incontinence, introducing new technologies from aerospace to improve on existing hydraulic devices. - The global market for treating urinary incontinence is over €2.3 billion annually, and UMBRAMED's device could address 20,000 new cases per year in Europe and US worth €60 million. - Clinical trials are underway and the device is being designed and prototyped. Financial projections estimate profitability in 2 years and €20

1. improving your life
A New Artificial Urinary Sphincter
Stefano Rossi
CEO & Founder
Università degli Studi UMBRAGROUP
di Perugia
27 Settembre 2011

2. Contacts
• UMBRAMED
• Stefano Rossi
• Dip. Ingegneria Industriale
Via Duranti 1, 06100 Perugia
• +39 3351321255
• stefanorossi@fulbrightmail.org

3. Executive summary
• UMBRAMED is a medical device company that intends to design, patent
and market medical devices related to the Urology field.
• UMBRAMED has developed in collaboration with top-notch urologists and
Aerospace leader company an innovative electromechanical artificial
sphincter for the treatment of severe urinary incontinence (UI).
• UMBRAMED introduce brand new technologies in the field of Urology
derived from the Aerospace Industry.
• The value of the market of treatment of UI is about € 2.3 B and 20.000
new cases every year represent for UMBRAMED a TAM of € 60 M.
• UMBRAMED will penetrate the market thanks to its collaboration with
key-opinion leaders in the field of Urology.
• UMBRAMED will be profitable in 2 years after CE approval and reaches
20M in revenue by year five in the European and US markets.
• UMBRAMED is looking for a funding of 100.000 Euro in grants to
complete the research program and to start clinical trials for CE approval.

4. The Team
FOUNDERS
• Stefano Rossi Biomedical Engineer (CEO)
Researcher at University of Perugia.
Certificate in Technology Entrepreneurship; FulbrightBEST 2011.
• Katifenia Iannidou MD Ph.D. in Urology (CTO)
Urologist of Urology and Andrology department at University of Perugia.
10 years experience in Urology.
ADVISORY BOARD
•Massimo Porena MD, Ph.D. •Aldo Cocchiglia M.Eng Electronic
Dean of Urology and Andrology department at CEO M31-USA.
University of Perugia. 25 years experience Business Administration
35 years experience in Urology and Andrology. for biomedical start-ups.
•Federico Perni Aerospace Engineer
V.P. Engineer UMBRA GROUP.
25 years experience in Aerospace Industry.

5. Urinary Incontinence (UI)
 An estimated 260 million people worldwide suffer from UI
 E.g., 13 million in the U.S. (Data from Journal of Urology)
 In the U.S. 7% of men over 60 have daily incontinence
 UI is the most common side effect of prostatic cancer therapy
 The financial impact in the U.S. is more than $ 15 billions
(Data from the U.S. Department of Health and Human Services)
 The social and physical impact of UI is significant
 Incontinent patients, psychologically, must deal with embarrassment,
isolation and depression
With the progressive aging of population these figures are
going to rise in the near future

6. Market opportunity
The Potential market of diagnosis and treatment of
UI in the U.S. and EU is estimated in € 2.3 billion.
UMBRAMED focus on the treatment of severe UI
that with 20.000 new cases every year in EU and
in the U.S. represents for the new Artificial Urinary
Sphincter (AUS) a TAM of € 60 million per year at
a CAGR of 5 %

7. Potential Customers and Competitors
 Customers
 Specialists in the medical field of urology
 Patients who suffer from severe UI (20.000 new cases every year)
 Competitors
 “AMS 800” Artificial Urinary Sphincter
 Developed by American Society for Medicine (1983 MI U.S.)
Strengths Weaknesses
•New proprietary technology •Low reputation among
SWOT •Strategic partnerships specialists
•Price
Analysis
Opportunities Threats
•Growing market •Delay in clinical trials
•New competitors in future

8. The state of art:
The hydraulic artificial urinary sphincter “AMS 800”
by American Medical Systems (1983)
VIDEO ANIMATION

9. Problems related to “AMS 800”
 Obsolete hydraulic technology
Last update dates back to 1983
 Technical deficiencies
Hydraulic problems - urethra erosion
 High rate of failure on long term
40% patients re-operated in 5 years (Data from Mayo Clinic)
 Difficult manual activation
 Expensive (about 9.000 euro per unit in Europe)
 Not adjustable in post operative phase
Despite that, 100.000 units have been implanted so far all over
the world because it is the only AUS on the market

10. The Solution
The new electromechanical
Artificial Urinary Sphincter
The main goal of UMBRAMED products is to improve the life quality of
hundreds thousands of people around the world

11. Competitive features
 Innovative and more reliable
 Electromechanical – no more hydraulic problems
 Less invasive and easier to implant
 Only two components already connected
 Suitable for both men and women
 Adjustable in post-operative phase
 Easier to operate
 Advantage for patients with motor disabilities
 Ergonomic enhanced cuff design
 No more urethra erosion
 Economical
 The estimated final price is 7.000 euro;
25% less than the AMS800

12. Development status
 Engineering process  Components design
 Materials and suppliers  Endurance test
Evidence of customers demand :
12 top-notch urologists in Europe interviewed confirmed the value of
the features offered by the UMBRAMED artificial urinary sphincter.
They would spent up to 10.000 Euro for this device.
“It is an innovative device designed to meet the needs of both urologist
and patients”

13. Development status
 A Prototype has been realized
 Two Patents request evaluated
First trials on cadaver will begin at the end of 2011

14. Marketing plan and technological strategies
Strategic Partnerships
UMBRAGroup
Aerospace components leader
900 employees; US, Italy, Germany
Manufacturing facilities and R&D
Urology Department
 Key opinion leaders, MD ENTRY GATE Direct sales
market experts to Urologists
 Advocacy and marketing feedback
Faculty of Engineering
 R&D

15. Business Forecast
Human
First Sales in First Sales in
Clinical
Europe the US
Trials
2012 2013 2014 2015 2016 2017 2018

16. Cash Flow
Cash Flow statement Time period 2012 2013 2014 2015 2016 2017 2018
Beginning CASH Enter 2011 only € - -€ 7.500 -€ 85.000 € 570.000 € 15.000 € 210.000 € 1.495.000
Cash In
Equity Enter >>>>>> € 150.000 € 150.000 € 1.000.000 € - € - € - € -
Loan Enter >>>>>> € - € - € - € - € - € -
Boot strap Enter >>>>>> € - € - € - € - € - € - € -
Friends/family Enter >>>>>> € - € - € - € - € - € - € -
Other Enter >>>>>> € - € - € - € - € - € - € -
Indutrial Partener funds Enter >>>>>> € 50.000 € 50.000 € - € - € - € - € -
AUS sale Enter >>>>>> € - € - € 350.000 € 490.000 € 1.750.000 € 4.900.000 € 8.400.000
Enter >>>>>> € - € - € - € - € - € - € -
Total Cash IN (calculated)
>>> € 200.000 € 200.000 € 1.350.000 € 490.000 € 1.750.000 € 4.900.000 € 8.400.000
Cash out
COGS - Systems Enter >>>>>> € 7.500 € 7.500 € 75.000 € 175.000 € 625.000 € 1.750.000 € 3.000.000
Enter >>>>>> € - € - € - € - € - € - € -
Enter >>>>>> € - € - € - € - € - € - € -
Total COGS (calculated)
>>> € 7.500 € 7.500 € 75.000 € 175.000 € 625.000 € 1.750.000 € 3.000.000
Expense items
Sales Enter >>>>>> € - € - € 150.000 € 150.000 € 200.000 € 250.000 € 350.000
R&D engineers € 50.000 € 50.000 € 50.000 € 100.000 € 150.000 € 150.000 € 150.000
Marketing Enter >>>>>> € - € 50.000 € 150.000 € 150.000 € 200.000 € 250.000 € 250.000
General and adminstrative Enter >>>>>> € 20.000 € 20.000 € 70.000 € 70.000 € 100.000 € 75.000 € 100.000
Silicon Molds Enter >>>>>> € 30.000 € - € - € - € - € - € -
Clinical trials € 100.000 € 150.000 € 200.000 € 300.000
workers in manufturing € 100.000 € 100.000 € 150.000 € 200.000 € 250.000
MD manifacturing facilities € 100.000 € 50.000 € 50.000
Total OPEX (calculated)
>>> € 200.000 € 270.000 € 620.000 € 870.000 € 800.000 € 975.000 € 1.150.000
TAX € - € - € - € - € 130.000 € 890.000 € 1.720.000
Ending CASH (calculated)
>>> -€ 7.500 -€ 85.000 € 570.000 € 15.000 € 210.000 € 1.495.000 € 4.025.000

17. Profit & Loss
Income statement 2012 2013 2014 2015 2016 2017 2018
Revenue
Gross revenue € - € - € 350.000,00 € 490.000,00 € 1.750.000,00 € 4.900.000,00 € 8.400.000,00
Cost of goods sold € 7.500,00 € 7.500,00 € 75.000,00 € 175.000,00 € 625.000,00 € 1.750.000,00 € 3.000.000,00
Gross margin -€ 7.500,00 -€ 7.500,00 € 275.000,00 € 315.000,00 € 1.125.000,00 € 3.150.000,00 € 5.400.000,00
GM% #DIV/0! #DIV/0! 78,57% 64,29% 64,29% 64,29% 64,29%
Operating expenses
Sales € - € - € 150.000,00 € 150.000,00 € 200.000,00 € 250.000,00 € 350.000,00
R&D engineers € 50.000,00 € 50.000,00 € 50.000,00 € 100.000,00 € 150.000,00 € 150.000,00 € 150.000,00
Marketing € - € 50.000,00 € 150.000,00 € 150.000,00 € 200.000,00 € 250.000,00 € 250.000,00
General and adminstrative € 20.000,00 € 20.000,00 € 70.000,00 € 70.000,00 € 100.000,00 € 75.000,00 € 100.000,00
Silicon Molds € 30.000,00 € - € - € - € - € - € -
Clinical trials € 100.000,00 € 150.000,00 € 200.000,00 € 300.000,00 € - € - € -
workers in manufturing € - € - € 100.000,00 € 100.000,00 € 150.000,00 € 200.000,00 € 250.000,00
Operating income -€ 207.500,00 -€ 277.500,00 -€ 445.000,00 -€ 555.000,00 € 325.000,00 € 2.225.000,00 € 4.300.000,00
Operating Margin #DIV/0! #DIV/0! -127,14% -113,27% 18,57% 45,41% 51,19%
Interest expense on long-term debt € - € - € - € - € - € - € 1,00
Operating income before other items -€ 207.500,00 -€ 277.500,00 -€ 445.000,00 -€ 555.000,00 € 325.000,00 € 2.225.000,00 € 4.299.999,00
Loss (gain) on sale of assets € - € - € - € - € - € - € -
Other unusual expenses (income) € - € - € - € - € - € - € -
Earnings before taxes -€ 207.500,00 -€ 277.500,00 -€ 445.000,00 -€ 555.000,00 € 325.000,00 € 2.225.000,00 € 4.299.999,00
Taxes on income (assume rate = x%) 40% € - € - € - € - € 130.000,00 € 890.000,00 € 1.719.999,60
Net income (loss) -€ 207.500,00 -€ 277.500,00 -€ 445.000,00 -€ 555.000,00 € 195.000,00 € 1.335.000,00 € 2.579.999,40

18. improving your life
The gold standard in the treatment
of severe UI
Università degli Studi UMBRAGROUP
di Perugia