Presentation Web Version Public课件.ppt

* * * * * * * * * * APPENDIX * 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 * 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 * 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 * Reimbursement Codes (CMS/Medicare) are Established Procedure Code Amount Comments Ultrafiltration Aquapheresis 36514 $720/tx Code for plasmapheresis Acute / CRRT HD 90935 $406/tx Home HD 90925 90921 $1800/mo Includes all HD supplies Outpatient HD 90925 90921 $96-123/tx Varies depending on region * Regulatory Strategy Device U.S. E.U. Clinical Trials Hospital Hemodialysis 510(k) CE None Home Hemodialysis 510(k) CE 30-40 patients Wearable Artificial Kidney PMA CE Estimate 100-200 patients * Renal Replacement Therapy Market Opportunity - Company estimates $ in millions US Europe Asia Total Hospital Renal Replacement Device: Disposables $968 $660 $484 $2,112 Device $465 $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