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(AMEX Symbol: XCR) Presentation January 14, 2008.

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Presentation on theme: "(AMEX Symbol: XCR) Presentation January 14, 2008."— Presentation transcript:

1 (AMEX Symbol: XCR) Presentation January 14, 2008

2 Forward-Looking Statements Except for statements of historical fact, the matters discussed in this presentation are forward looking and pursuant to the safe harbor provisions of the private Securities Litigation Reform Act of 1995. These forward-looking statements reflect numerous assumptions and involve a variety of risk and uncertainties, many of which are beyond the company’s control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing, exploiting, and protecting proprietary technologies, the risk that our technology may not be effective, uncertainty as to the outcome of legal proceedings, intense competition, and substantial regulation in the medical device and healthcare industries, as discussed in the Company’s periodic reports filed with the Securities and Exchange Commission, available on its website at http:/www.sec.gov. 2

3 Management Team Terren Peizer Executive Chairman Winson Tang, MD, FACP Chief Operating Officer Victor Gura, MD Chief Medical Officer Robert Weinstein, CPA, MBA Chief Financial Officer CEO, Chairman & Founder Hythiam Amgen, Vertex, Tularik, Isis, Pacific Capital Grp Cedars-Sinai Med. Cntr, Assoc. Clin. Prof., UCLA Citi Private Equity, Able Labs, GE Capital 3

4 Selected Board Members Hans Polaschegg, PhD Dan Goldberger, MSME Kelly McCrann, MBA Fresenius, Chairman - Extracorp Circ & Infusion Tech Committee Sound Surgical, Glucon, OSI Systems, Optiscan, Nellcor DaVita, PacificCare, KPMG, McKinsey 4

5 Xcorporeal Highlights Extra-corporeal medical devices that could replace the function of failing or failed organs Multiple initial products –Portable Hospital Hemodialysis device –Portable Home Hemodialysis device –Wearable Artificial Kidney First U.S. 510(k) filing Q4, 2008 - FDA clearance expected Q1, 2009 Minimal to low risk strategy –Prototype device tested successfully in humans –Well defined and straightforward regulatory strategy –Well delineated reimbursement codes Multi-billion dollar and clearly defined markets 5

6 Xcorporeal Renal Replacement Therapy Devices Portable Hemodialysis Device - Hospital CRRT/Acute Hemodialysis Portable Hemodialysis Device - Home Hemodialysis – ESRD Wearable Artificial Kidney - Home Hemodialysis – ESRD 6

7 Xcorporeal Hospital Portable Renal Replacement Device Truly portable device –Smaller (< two cubic feet) and lighter than competitor devices (30-40 lbs) –Reduced fluid (dialysate) requirement –Easier to operate, reduced training requirement Fully functional –Continuous Renal Replacement Therapy (CRRT) –Intermittent Hemodialysis Product status –Functional prototype undergoing bench testing –FDA 510(k) filing in Q4, 2008 7

8 Xcorporeal Proprietary Disposable Manifold 8 The complexity of setting up a dialysis machine has been reduced to a single step of inserting a proprietary manifold into the machine. This reduces machine size, disposable cost, and simplifies operation.

9 Benefits of Xcorporeal Hospital Portable Renal Replacement Device Decrease workload for hospital ICU staff –No plumbing requirements Use simple tap water versus bagged dialysate –Simple to use operator interface –Snap-in disposable unit –Simple set-up, tear down and clean-up Cost effective –Decrease in medical staff time (nurse, pharmacist) –Decrease in staff training downtime –No need for bagged dialysate ($180/treatment) Flexibility –Truly portable, no utility hookup limitations 9

10 Portable Device Development Timeline Q1 Q2 Q3 Q4 Q1 Q2 2008 2009 Full Product Specification - COMPLETE Functional Prototype - COMPLETE Bench Testing Industrial Design Prototype Pre-Production Prototype Verification & Validation FDA Submission 10

11 Hospital Hemodialysis Device Market US Market Opportunity = $1.4 billion –Growing at 10% per year Aging Population Increasing severity of hospitalized patients Disposable Market –242,000 patient hospitalizations per year estimated 2008 –Average 8 days per hospitalization –$500 revenue per day for fluids and disposables –Disposable Market = 242,000 x 8 x $500 = $968 million Device Market –Market = 62,000 beds x.25/bed x $30k/machine = $465 million 11

12 Xcorporeal Home Portable Renal Replacement Device 12 Truly portable device –Smaller (< two cubic feet) and lighter than competitor devices (30-40 lbs) –Reduced fluid requirement –Easier to operate, reduced training requirement –No special plumbing nor electrical requirements Fully functional –Wide range of flow rates – treat larger patients Product status –Working prototype –FDA 510(k) filing in Q2 2009

13 Benefits of Xcorporeal Home Portable Renal Replacement Device Truly portable –Substantially smaller and lighter than any existing device –No utility requirements, tap water and 110VAC only Ease of Use –No fluid handling device –Fully disposable fluid circuit, no cleaning or sterilization –50 – 600 ml / minute range of flow rates Ease of Treatment –One step, one-handed set up –Graphical user interface 13

14 Home Use Development Timeline Q1 Q2 Q3 Q4 Q1 Q2 2008 2009 Full Product Specification - COMPLETE Functional Prototype - COMPLETE Bench Testing Industrial Design Prototype Pre-Production Prototype Verification & Validation FDA Submission Clinical Trial 14

15 Chronic Hemodialysis Market U.S. Market Opportunity = $6.7 billion –357,000 chronic dialysis patients –3 treatments per week –$120 Medicare reimbursement / treatment –Market = 357,000 x 3 x $120 x 52 weeks = $6.7 billion Home hemodialysis penetration is less than 1% today but will grow because –Appropriate equipment becomes available (Xcorporeal, NxStage, Fresenius off label) –Longer, more frequent therapy is better medicine (4+ treatments per week versus 3) –Home hemodialysis reduces capital and skilled labor requirements 15

16 Home Hemodialysis is a significant Growth Opportunity in ESRD Patient Benefits –Increased time on hemodialysis with improved outcomes –Potential for daily dialysis –Improved quality of life: diet, sleep, time Provider Benefits –Decreased need for nurses/techs –Increase in revenues without need for additional infrastructure –More frequent treatments decreases need for expensive medications 16

17 Home Hemodialysis Device Comparison 17 Xcorporeal Renal Solutions (*)NxStage Fresenius 2008K Blood Flow Rates 50 – 600 150 - 40050 - 60020 - 600 Dialysate Flow Rates 50 – 500 200 - 40050 - 200100 - 800 Dialysate/4-hr (liters) 6 620 - 30120 Dialysate Regeneration Yes No Dry Weight (pounds) < 40 19580160 Size (cubic feet) < 2.0 165 Portable Yes NoPartialNo Drainage Required No Yes Installation Cost Low Medium High * Not marketed.

18 Xcorporeal Wearable Artificial Kidney “Disruptive” technology Wearable, battery operated light-weight device Fully automated, simple to use Prototype tested successfully Successful human trials published in The Lancet & Kidney International December 2007 24 hrs/7 days therapy with potential to revolutionize care of ESRD patients 18

19 Wearable Artificial Kidney Feasibility Prototype 19

20 Waste Infusate Heparin Bi- Carbonate Sorbent 3 Sorbent 2 Sorbent 1 Bi Phase Pump Dialyzer Bubble Sensor Blood Sensor Metering Pump Metering Pump Metering Pump Metering Pump Patient Blood Loop Sterile Change weekly in clinic Dialysate Loop Change daily at home Drain Valve Wearable Artificial Kidney 20

21 Clinical Trial Results Initial clinical study conducted with a prototype device at The Royal Free Hospital, London –8 ESRD subjects dialyzed for mean of 6.4 hrs –Clearances of creatinine, urea, and beta-2- microglobulin achieved (chart follows) –No adverse events reported –Subjects were able to walk unhindered during dialysis treatment –Presented at ASN November 5, 2007 21

22 Clinical Trial Results Sustained reductions in key blood chemistries Clearance of both small and middle molecules Clearance meets or exceeds daily toxin production 22

23 WAK Development Timeline Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2008 2009 2010 Feasibility Prototype - COMPLETE Feasibility Studies - COMPLETE Second Generation Prototype Longer Duration Feasibility Studies Pre-Production Prototype Clinical Trial 23

24 Intellectual Property Portable Artificial Kidney –18 patents pending or in process Wearable Artificial Kidney –Exclusive in-licensed patents Wearable ultra-filtration device –Wearable, self-contained, device for continuous excess fluid management Wearable continuous renal replacement therapy device –Expands on patent above to include renal replacement patients and battery-operated power source 24

25 Selected Financial Information September 30, 2007 Cash and Marketable Securities - $20.3 million Shares Outstanding - 14.4 million Market Capitalization - $72 million at 12/31/07 $1.2 million monthly cash burn rate 25

26 Company Near-Term Milestones Hospital Portable Hemodialysis Device –Functional Prototype (completed)Q4, 2007 –Pre-Production PrototypeQ3, 2008 –FDA 510(k) submissionQ4, 2008 –Commercialization targetQ2, 2009 Home Portable Hemodialysis Device –Functional Prototype (completed)Q4, 2007 –Pre-Production PrototypeQ3, 2008 –Clinical trialQ2, 2009 –FDA 510(k) submissionQ3, 2009 –Commercialization targetQ4, 2009 26

27 Comparable – NxStage Medical (NXTM) Emerging growth hemodialysis company “System One” device –Home hemodialysis: > 2,000 patients; <0.5% market –Hospital CRRT for acute renal failure Financial Metrics –$560M market capitalization – 12/31/07 14x trailing twelve months revenues 9x annualized Q3, 2007 revenues –Quarter ended September 30, 2007 financial highlights $33M in cash $13M operating expenses $16.1M operating loss 27

28 Comparable Acquisition Fresenius purchase of Renal Solutions $190 million purchase price –$100 million at closing –$60 million in one year, $30 million contingency Sorbent technology Allient device –Cleared by FDA over two years ago –Not brought to market Why significant for Xcorporeal –Suggests sorbent technology valuable –High acquisition price for “scarce” assets 28

29 Xcorporeal Highlights Extra-corporeal medical devices that could replace the function of failing or failed organs Multiple initial products –Portable Hospital Hemodialysis device –Portable Home Hemodialysis device –Wearable Artificial Kidney First U.S. 510(k) filing Q4, 2008 - FDA clearance expected Q1, 2009 Minimal to low risk strategy –Prototype device tested successfully in humans –Well defined and straightforward regulatory strategy –Well delineated reimbursement codes Multi-billion dollar and clearly defined markets 29

30 APPENDIX 30

31 Management Team Nina Peled, PhD, MBA SVP - Quality & Regulatory James Braig, MSME SVP - Product Dev. Barry Fulkerson VP - Hardware Systems Russ Joseph, MS VP - Disposable Engineer Hansen, Cygnus, Amira, Lumenis, i-STAT, BM Optiscan, Square One Tech, Ohio Medical NxStage, COBE (Prisma, CS3), Gambro Gish Biomedical, Sorin, Baxter Healthcare 31

32 Product Development Team Internal team of engineers with expertise in dialysis equipment and disposables who previously worked at Cobe, Gambro, Aksys, NxStage and Baxter Contract Product Development Group in Southern California to leverage the expertise of an additional 10-15 engineers Manufacturing to be outsourced 32

33 Renal Disease Overview Acute Renal Failure –Hospital-based, majority in Intensive Care Unit –200,000 acute renal failure patients – 50% mortality rate End Stage Renal Failure –Approximately 2 million “known” ESRD patients worldwide –65% of patients expire within 5 years –Patient’s poor quality of life Care provided primarily outside the home Non-ambulatory Intermittent care – Significant peaks and valleys –Constantly ill –Majority disabled 33

34 Reimbursement Codes (CMS/Medicare) are Established ProcedureCodeAmount Comments Ultrafiltration Aquapheresis 36514$720/txCode for plasmapheresis Acute / CRRT HD90935$406/tx Home HD90925 90921 $1800/moIncludes all HD supplies Outpatient HD90925 90921 $96-123/txVaries depending on region 34

35 Regulatory Strategy Device U.S.E.U.Clinical Trials Hospital Hemodialysis 510(k) CE None Home Hemodialysis510(k) CE 30-40 patients Wearable Artificial Kidney PMA CE Estimate 100- 200 patients 35

36 Renal Replacement Therapy Market Opportunity - Company estimates $ in millions USEuropeAsiaTotal Hospital Renal Replacement Device: Disposables$968$660$484$2,112 Device$465 $232$1,162 Total Hospital RR Device$1,433$1,125$716$3,274 ESRD-Home Renal Replacement Device and Wearable Artificial Kidney: Total Home RRD and WAK$6,704$7,146$3,537$17,387 Total All Devices$8,137$8,271$4,253$20,661 36


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