Rossi stefano umbramed startcup

A New Artificial Urinary Sphincter

Stefano RossiCEO & Founder

Università degli Studi di Perugia

UMBRAGROUP

improving your life

27 27 SettembreSettembre 20112011

Contacts

• UMBRAMED• Stefano Rossi• Dip. Ingegneria Industriale

Via Duranti 1, 06100 Perugia• +39 3351321255• [email protected]

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.

The Team• 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.Dean of Urology and Andrology department at University of Perugia.35 years experience in Urology and Andrology.

•Federico Perni Aerospace EngineerV.P. Engineer UMBRA GROUP.25 years experience in Aerospace Industry.

FOUNDERS

•Aldo Cocchiglia M.Eng ElectronicCEO M31-USA.25 years experience Business Administration for biomedical start-ups.

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

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 %

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.)

TThreats•Delay in clinical trials•New competitors in future

OOpportunities•Growing market

WWeaknesses•Low reputation among specialists

SStrengths•New proprietary technology•Strategic partnerships•Price

SWOTSWOTAnalysisAnalysis

The state of art:The hydraulic artificial urinary sphincter “AMS 800”

by American Medical Systems (1983)

VIDEO ANIMATIONVIDEO ANIMATION

Obsolete hydraulic technologyLast update dates back to 1983

Technical deficienciesHydraulic problems - urethra erosion

High rate of failure on long term40% 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

Problems related to “AMS 800”

Despite that, 100.000 units have been implanted so far all over the world because it is the only AUS on the market

The new electromechanical The new electromechanical Artificial Urinary Sphincter Artificial Urinary Sphincter

The Solution

The main goal of UMBRAMED products is to improve the life qualitThe main goal of UMBRAMED products is to improve the life quality of y of hundreds thousands of people around the worldhundreds thousands of people around the world

Competitive features Innovative and more reliable

Electromechanical – no more hydraulic problems

Less invasive and easier to implantOnly 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

Development status Engineering processMaterials and suppliers

“It is an innovative device designed to meet the needs of both urologist and patients”

Components design 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.

Development status

A Prototype has been realized Two Patents request evaluated

First trials on cadaver will begin at the end of 2011

Marketing plan and technological strategies

Faculty of Engineering R&D

UMBRAGroupAerospace components leader900 employees; US, Italy, GermanyManufacturing facilities and R&D

Urology DepartmentKey opinion leaders, MD

market experts Advocacy and marketing feedback

Strategic Partnerships

ENTRY GATE Direct salesto Urologists

First Sales in Europe

First Sales in the US

Human Clinical Trials

Business Forecast

2012 2013 20162015 20172014 2018

Cash FlowCash Flow statement Time period 2012 2013 2014 2015 2016 2017 2018Beginning 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 outCOGS - 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 itemsSales 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€

Profit & LossIncome statement 2012 2013 2014 2015 2016 2017 2018Revenue

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 expensesSales -€ -€ 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€

The gold standard in the treatment of severe UI

improving your life

Università degli Studi di Perugia

UMBRAGROUP