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  • 1. improving your life A New Artificial Urinary Sphincter Stefano Rossi CEO & FounderUniversità 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 TeamFOUNDERS • 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 ElectronicDean of Urology and Andrology department at CEO M31-USA.University of Perugia. 25 years experience Business Administration35 years experience in Urology and Andrology. for biomedical start-ups.•Federico Perni Aerospace EngineerV.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 urologistand 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 strategiesStrategic 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 ForecastHuman First Sales in First Sales inClinical Europe the US Trials 2012 2013 2014 2015 2016 2017 2018
  • 16. 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 € 1.495.000Cash 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 € 8.400.000Cash 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 € 1.150.000TAX € - € - € - € - € 130.000 € 890.000 € 1.720.000Ending CASH (calculated) >>> -€ 7.500 -€ 85.000 € 570.000 € 15.000 € 210.000 € 1.495.000 € 4.025.000
  • 17. 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 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 € 250.000,00Operating 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 € - € - € - € - € - € - € 1,00Operating 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 € 4.299.999,00Taxes on income (assume rate = x%) 40% € - € - € - € - € 130.000,00 € 890.000,00 € 1.719.999,60Net 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 UIUniversità degli Studi UMBRAGROUP di Perugia