Fossa is Ready to Grab Large Markets

Transcription

1 Gloria Ro Kolb

2 Fossa is Ready to Grab Large Markets 1. Large, profitable Markets Underserved 2. Innovative Products that can Serve Kidney Stone Sweeper is first out of five Capture attention of doctors/leaders 3. Building a Quick and Nimble Company FDA full market approval Issued patents Strong Team Raising $3.5M

3 Current Stone Removal Procedures 5 15 mm Baskets 12% Involved procedure Lengthy & $$ 5-20 mm ESWL-Shock Wave Lithotripsy 82% Doesn t remove In < 7% of hospitals Bleeding

4 Kidney Stones: A Large Opportunity 2M Americans 250,000 Procedures U.S. annual 1% of all Hospital Admissions 6% Growth Rate $2B spent in inefficient process 25% need secondary procedure Target $250M Device Market Source: American Urologic Association, Merrill Lynch, NIH

5 Market Tree 900,000 stone patients who see doctor (50% of all stone sufferers) Not treated (77%) Procedure (23%) Baskets/ Graspers (12%) Lithotripsy (82%) 3-5mm stones (60%) 420,000 procedures New Offering 3-5mm 5-8mm stones (80%) 20,000 proc. Replace Baskets Larger stones (80%) 140,000 proc. Used WITH ESWL 2 nd proc. 40, ,000 primary current procedures 250,000 Replace total current Stents procedures In addition: 200,000 ureteral stents used annually Open/percutaneous (6%) Total 620,000 procedures X $400 = $250M

6 Unmet Needs Smaller hospitals (including global market) Devices to be used with shock waves (75% procedures) Pregnant Women Smaller stones: 3-5mm Market 420,000 patients Currently not treated Cost example: Inpatient Hospital Stay 40% of admitted patients don t receive procedure $1500/night, Average 3 night stay, 150K patients= $675M Source: Medical Devices International

7 First product: Fossa Stone Sweeper 1. Device Expands 2. Passively Dilates Ureter (2-3 Days) 3. Captures & Removes Stone Quicker Definitive Cost Efficient 100% success in Animal Testing

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9 Value for all Customers Doctors 3-4x More $/time Treat New Group of Patients Low risk Commonly-used Technique Patients Definitive removal Less Pain Less Time Less inpatient Stone Sweeper Hospitals/Payers Less time/proc. Less hospital stay Fewer 2 nd Procedures

10 Competition Lacks Full Line % Market- Share Stents Basket Retrieval ESWL FOSSA X X X Boston 52% Scientific BARD 29% Cook 9% Circon, ACMI 5% Source: Medical Data International

11 Common Path: Entry/Sales Strategy Champion surgeons- clinicals, in-house sales Surgeon spreads success with talks and papers (Dr. Long) Market and sell through large partner

12 Intellectual Property Patent # 6,214,037 claims designs for structural integrity expanded position. Patent pending claims cages along the length of the device, expansion, contraction, removal of stone and dilating of duct. Stone removal claim granted Patent pending- spiral, biopsy, cleaning Patent pending- biliary tract International patent filed Provisional Patents- Vein Maturation, No Sheath Device

13 Development Milestones First Clinical Prototypes Existing Reimbursement Codes "approved" 1st Patent Granted Six more Pending Animal Trials Completed FDA Approval Ureteral stent FDA Approval Stone Removal Human Use Nov '01 Dec '01 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov

14 Launched Products FDA Track Record Doctor Sales/Needs Start-Up Experience Run Business Fossa Team Gloria Ro Kolb President & Co-founder Babson MBA,MIT & Stanford Engineer Product Development for J&J, 3yrs Glenn Schneider VP of Sales &Mktg: Over sixteen years in medical sales, marketing, managing, and developing plans Mark Manasas VP of Engineering Led 3 million dollar project at J&J, 6 yrs Over 50 products, Venture-backed startup, Dr. Mike Mitchell Co-founder Surgeon at Brigham & Women s Hospital Harvard Medical School

15 Fossa Team Directors of Quality: Scott Blood Over ten years experience setting up quality systems and as a manufacturing engineer with Medtronic, Percusurge. Board Member: Dr. Jean-luc Boulnois Entrepreneur who started three medical device companies including TechnoMed, ESWL machine mnf. Board Member: Jeffrey Otten President of Brigham & Women s Hospital for last nine years- consistently leading it to top rankings. Advisory Board: Dr. Jeffrey Rovell Over 30 years experience in the Pharmaceutical and Medical Device industries in the fields of product and business development.

16 Net Earnings Target of $10M (000s) Sweepers sold US (US marketshare 0.7% 1.6% 4.0% 9.7% Sweeper sold Int'l Total All Products NET REVENUES $1,080 $4,480 $11,510 $27,080 COGS $320 $1,030 $2,520 $5,580 SALES MKTG $940 $1,340 $1,840 $2,550 R & D $450 $600 $950 $1,110 GEN / ADMIN $320 $620 $900 $1,280 NET EARNINGS ($900) $1,400 $3,200 $10,000

17 Financial Plan Raised $425K Seeking $3.7 Million Profitability in 2004 Exit: Acquired in 3-5 yrs First $2.3 Million Plan (in 000s) (cash flow pos) Product (COGs) $270 Sales and Marketing $940 R & D $450 G & A $340 Contingencies, Future COGs $300 Salaries $490 Promotion $150 Travel $120 Doctor Support $180 Salaries $275 Prototypes/Test $130 Travel $45 Salaries $215

18 Summary 1. Fossa Sweeper can remove stones quickly and more definitively. 2. Markets are large and devices can be very profitable! 3. Fossa is an innovator and executor.

19 You really have something here. Dr. John Long New England Medical Center Thank You!