Cls, Inc 09


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COLUMBIA LIFE SYSTEMS, INC, Philadelphia region, introduces it novel, dynamic and adaptive technology.

Find out why leading neonatalogists are so excited about this new technology, now in clinical trial at Cooper University Hospital.

The SmartBlender, redefining standards in respiratory care management and taking the 'current 1950's medicine into the 21st century'.

The SmartBlender:
Making babies breath at a time.

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Cls, Inc 09

  1. 1. 186 Columbia Life Systems, Inc. SmartBlender™
  2. 2. 187 Columbia Life Systems, Inc. Redefining the standards of respiratory care
  3. 3. 188 Making babies healthier… one breath at a time.
  4. 4. 189 Dr. Jay Greenspan, Chief of Neonatology Thomas Jefferson University Hospital Philadelphia, PA June 2007 “We (currently) have 1950’s medicine in the 21st century” “It’s a little embarrassing that we don’t have a mechanized way”
  5. 5. 190 The SmartBlender™ An adaptive controlled oxygen blender utilizing novel, „smart‟ technology • Delivers continuous supplemental oxygen to newborn babies/patients in respiratory distress  Maintains baby‟s blood-oxygen level, as assessed by a pulse oximeter, at a set range specified by a physician, continuously. Components:  Pulse Oximeter  Oxygen Blender  Computer: Software/Algorithms
  6. 6. 191 SmartBlender™ Technology: Adaptive, Dynamic, Continuous, Accurate NICU PATIENT Newborn baby Blood saturation assessed Proper mix of oxygen by pulse oximetry dispensed by blender Computer Data samples oxygen level interpreted/manipulated every 10 seconds by computer algorithm
  7. 7. 192 SmartBlender™ Value Proposition The SB promotes automatic, adaptive and consistent maintenance of blood saturation which will reduce or eliminate development of acute and chronic health problems due to unregulated oxygen therapy. • Pneumonia, bronchio-pulmonary displasia, retinopathy are just a few of the conditions that can result from inhalation of excessive oxygen amounts. • Clinical study at Pennsylvania Hospital, Philadelphia, PA has indicated: the weaning of patients from oxygen sooner, which may reduce patient length of stay in NICU. • Reduction in patient stay affects hospitals‟ bottom line, therefore reducing costs, increasing profitability • Neonatologists believe: SB promotes better lung health
  8. 8. 193 CLS: The right combination Management believes the four most important advantages of the SmartBlender™: Clinical and therapeutic effectiveness Strong receptivity from physicians Clear path to product reimbursement Reduced cost of treatment
  9. 9. Columbia Life Systems, Inc.: 194 The journey: concept to clinical trial
  10. 10. The process 195 1985 Concept 1999Mallinckrodt/Tyco Phospho-Energetics Ohmeda/Hill-Rom 1987 SmartBlender™ 2000 Hill-Rom/Air-Shields patent Tri-Virix International Otsuka Electronics 2003Draeger Medical 1992 Ventilator patent 2007Respironics 1998 Varian NC Biotechnology SmartBlender™ additional patents Dr. Robert Black 2009Clinical trial at Cooper University Hospital and beyond!
  11. 11. Competitive position: 196 Intellectual Property First patent (#4,886,116) filed 1985 2nd and 3rd patents pending (38 claims)  Solenoid system for oxygen control  Display and User Interface  Methods (CPAP, long-term therapy, Heliox, sleep apnea, weaning, newborn, adult)  Alarm features  Apnea control “Adaptive Controller for Automatic Ventilators” (patent #5,388,575) filed 1992 -SmartTap™
  12. 12. 197 Market: competitive landscape Fixed concentration oxygen blenders, adjusted manually, are the industry standard Four companies control lion‟s share of market No adaptive smart technology blenders are available in the hospital space Bottom line: No competition at this time globally CLS: preparing for market entry
  13. 13. Pediatric and Adult 198 SmartBlender™ Market Applications NICU Post ICU Extubate Pediatric Adult Recovery ER & Transport SICKLE COPD CELL
  14. 14. Pediatric NICU 199 SmartBlender™ Market NICU Post ICU Extubate Pediatric Adult Recovery ER & Transport SICKLE COPD CELL
  15. 15. 200 INFANT Potential: Primary NICU market niche • Price Range/device: $6,000 - $8,000 • Average price/device: $7,000.00 NICU size • Adoption over 7 years: 75 % • # of devices per year: 19,000 beds 2714 US • Annual revenue potential: $ 19M • TOTAL MARKET POTENTIAL: $133M 1 unit/bed
  16. 16. 201 Adult ICU SmartBlender™ Market NICU Post ICU Extubate Pediatric Recovery Adult ER & Transport SICKLE COPD CELL
  17. 17. 202 ADULT Potential: Primary (US) ICU market niche • Price Range/device: $6,000 - $8,000 • Average price/device: ICU $7,000.00 size • Adoption over 7 years: 30% • # of devices per year: 2915 68,000 beds US • Annual revenue potential: $ 20M • TOTAL MARKET POTENTIAL: $143M 1 unit/bed
  18. 18. 203 SmartBlender™ Market Applications ADDITIONAL AREAS NICU Post ICU Extubate Pediatric Recovery Adult ER & Transport SICKLE COPD CELL
  19. 19. SB Market Revenue Projections: 204 Total Market US: $ 276M  NICU & ICU $ 63M Additional market NICU WW: 9000 units @ 75% adoption Additional Market Areas: TBD* ER, Post extubated, Transport, Recovery, COPD, Sickle Cell Total Market Size: $339M ++
  20. 20. 205 SmartTap™Ventilator market “Adaptive Controller for Automatic Ventilators” (patent #5,388,575) filed 1992 Integration of SB „smart‟ technology into active, mechanical ventilation (i.e. for intubation)  Worldwide market size is double the combined infant NICU and adult ICU markets: 100,000 + units  Priced similarly to SmartBlender™ SmartTap™Projected revenue: $700M
  21. 21. 206 Moving forward to the Marketplace
  22. 22. Pathways to the Marketplace A. B. Clinical trial concurrent Clinical trial with product re-design concurrent with product re-design Submission of 510(k) Submission of 510(k) FDA clearance FDA clearance Sale of CLS Manufacturing of SB for sales to US luminary hospitals Sale of CLS
  23. 23. 208 Regulatory: 510(k) pathway process to FDA clearance 1. IRB: Investigational Review Board approval 1.9.09 Cooper University Hospital, Camden, NJ Utilization of Predicate device code approved via 510(k): MITI OptiSat 2. Clinical Trial: comprised of 40-60 patients at CUH for 90 days, commencing March 2009 3. 510(k) Application:submission for FDA clearance utilizing trial data 4. FDA clearance time frame: within 60 days of application submission
  24. 24. 209 SmartBlender™ Re-design Objectives 1.Replace computer board 2. Reduce weight and size by 50% 3. Improve industrial design: aesthetic and ergonomic modifications 4.Reduce manufacturing cost from $1,800/unit to $860/unit 5.Submit enhanced design with trial data for FDA clearance
  25. 25. 210 Health and Market Information US infant mortality increasing: ranked 180/222 countries - 42nd in the world with 6.30 deaths/thousand* World infant mortality: 49.4 deaths/thousand* 42.64 deaths/thousand according to CIA World Fact Book Number of premature births continues to rise: IVF procedures and multiple births are on the rise Number of NICU beds continues to grow National healthcare initiative: lower cost of treatment and increase standard of care *according to United Nations
  26. 26. 211 Market Receptivity: What are they saying?*  “concept is superb …great for RNs”  “makes sense … would keep baby‟s SATs in medically desired range”  “may improve outcomes … important to our practice …purchase would be a high priority”  “we are not titrating O2 very well … could shorten hospital stay”  “we‟re currently using 1950s medicine in the 21st century” * excerpts from doctors and clinicians
  27. 27. 212 Market Pricing: What would they pay? Dr. L $7K Dr. LB $6-7K Dr. B No opinion Dr. EB $7-8K Dr. W $5-6K MEAN: $7, 000
  28. 28. 213 Augustine Legido MD, PhD, MBA Chief of Neurology St. Christopher‟s Hospital for Children Philadelphia, PA
  29. 29. Columbia Life Systems: 214 down to business
  30. 30. 215 Who we are Corporate Medical Advisors John Taube Vinod Bhutani, MD President and Founder Professor, Stanford University Brad Coleman Medical Center Software Jay Greenspan, MD Larry Pope Department Chair, Newborn Pediatrics, Thomas Jefferson Engineering University Hospital Lois Smart Pasquale Casale, MD Regulatory Pediatric urology, Children‟s Hospital of Philadelphia (CHOP) Linda D. Rocca Marketing
  31. 31. 216 CLS, Inc. Pre-money valuation • Valuation of $1.5M • Sale of $25K blocks • Liabilities of $320K • $1M investment gains 40% of CLS • Management has made significant cash and human capital investment of $750K in getting the product poised for the final push to market
  32. 32. 217 Use of proceeds Project manager, 18 months $135K Re-design $180K Safety Testing $ 25K Clinical Trial $ 25K Regulatory Consulting $ 45K Legal and Accounting $ 30K Product Launch: device manufacturing $500K Marketing/business development $ 60K TOTAL: $1,000,000
  33. 33. The End Game: Pathway to the 218 marketplace A. B. Clinical trial Clinical trial concurrent concurrent with with product re-design product re-design Submission of 510(k) Submission of 510(k) FDA clearance FDA clearance EXIT: Sale of CLS Manufacturing of SB for sales to US luminary hospitals EXIT:Sale of CLS
  34. 34. 219 The Endgame: Early Exit …Sell to whom?
  35. 35. Why invest in Columbia 220 Life Systems, Inc.? Business • Novel Intellectual property • Cutting edge technology: smart technology does not exist in the marketplace today - NO COMPETITION • Significant market pull from doctors and clinicians • Better medicine: may improve lung health in long run which reduces healthcare costs • Reduces hospital expenditures: pilot studies reveal the weaning of patients off oxygen sooner, saving hospitals hard dollars in NICU costs • Early exit strategy: quick return on investment • Below market valuation • Excellent projected ROI based on expected valuation
  36. 36. 221 Why invest in Columbia Life Systems, Inc.? Medicine • Leads respiratory care management into the 21st century • Significant therapeutic receptivity from doctors and clinicians • May increase respiratory health for patients in NICU/ICU: optimizes manner to dispense oxygen based on patient physiological demand • Better medicine: may improve lung health in long run • Pilot studies show weaning patients off of oxygen sooner; may expedite release from hospital/NICU earlier
  37. 37. 222 Columbia Life Systems SmartBlender™ Making babies healthier one breath at a time.
  38. 38. 223