Amxtek

AMxTek LLC

Antimicrobial Medical Device: Product Development & Regulatory Consulting Services

Presented To: Presented By: Jim Walls President AMxTek LLC

Overview

Hospital Acquired Infections [HAIs] & The U.S. Healthcare Burden AMxTek Background AMxTek Experience AMxTek Business Model AMxTek Corporate Client Activities

HAIs & The U.S. Healthcare Burden

HAI CAUTI CLACLA-BSI VAP SSI Other Total Total

(1)+(2)

Mortality 0.72%(3) 25% 46%

(5) (4)

Ave. Attributable Cost/Patient $1,007 $29,156 $28,508 $34,670

(6) (6) (6) (6)

449,334 92,011 52,543 290,485 386,090 1,737,125

1.91%(3) 2.48%(3) 2.70%(3)

$1,617(3) $2,100(3)

Other Salient HAI Factoids : • 4.5 HAIs per 100 admissions(1) • 9.3 infections per 1,000 patient-days(1) • 99,00 deaths annually associated with infections(1) •$45 B/yr. in direct medical costs(2)

A Business Case for Antimicrobial [AMx] Medical Devices

AMx medical devices reduce HAIs; resulting in: 1. Improved patient quality of care

Reduced patient morbidity & mortality

2. HAI cost avoidance

Reduced Antibiotics [ABx] use: Reduced preservation stress on microorganisms; believed to lead to ‘Multi-Drug Resistant ‘MultiOrganisms’ [MDROs] 3. Improved hospital profitability: Reduced patient-bed days; improved bed patientutilization

A Business Case for Antimicrobial [AMx] Medical Devices

4.

Reimbursement; Reimbursement; CMS ‘No Pay’ HAIs: Pay’

2009 – No CMS Reimbursement for the Following HAIs: CAUTI Pressure Ulcers Vascular Catheter-Associated Infections CatheterSSIs re Mediastinitis Proposed CMS ‘No Pay’ HAIs: VAP Staphylococcus aureus Septicemia MRSA Additional Types of SSIs

A Business Case for Antimicrobial [AMx] Medical Devices

5. Mandatory Reporting: Reporting:

A Business Case for Antimicrobial [AMx] Medical Devices

5. Mandatory Reporting: Reporting:

AMxTek BACKGROUND

AMxTek LLC

AMxTek was founded in 2008 by Jim Walls, AMxTek’s President Jim has over 25 years of medical device product...