AMxTek LLC Overview

1. AMxTek LLC
Antimicrobial Medical Device:
Product Development & Regulatory
Consulting Services
Presented To:
Presented By: Jim Walls
President
AMxTek LLC

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

3. HAIs & The U.S. Healthcare Burden
HAI Total (1)+(2) Mortality Ave. Attributable
Cost/Patient
CAUTI 449,334 0.72%(3) $1,007 (6)
CLA-BSI 92,011 25% (5) $29,156 (6)
VAP 52,543 46% (4) $28,508 (6)
SSI 290,485 1.91%(3) $34,670 (6)
Other 386,090 2.48%(3) $1,617(3)
Total 1,737,125 2.70%(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)

4. 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
Organisms’ [MDROs]
3. Improved hospital profitability:
 Reduced patient-bed days; improved bed
utilization

5. A Business Case for
Antimicrobial [AMx] Medical Devices
4. Reimbursement; CMS „No Pay‟ HAIs:
 2009 – No CMS Reimbursement for the Following
HAIs:
 CAUTI
 Pressure Ulcers
 Vascular Catheter-Associated Infections
 SSIs re Mediastinitis
 Proposed CMS „No Pay‟ HAIs:
 VAP
 Staphylococcus aureus Septicemia
 MRSA
 Additional Types of SSIs

6. A Business Case for
Antimicrobial [AMx] Medical Devices
 5. Mandatory Reporting:

7. A Business Case for
Antimicrobial [AMx] Medical Devices
5. Mandatory Reporting:

8. AMxTek
BACKGROUND

9. AMxTek LLC
AMxTek was founded in 2008 by Jim
Walls, AMxTek‟s President
 Jim has over 25 years of medical device
product development & regulatory
experience:
 > 15 years of which is directly related to
„Combination Medical Products‟
 Jim possesses a Master of Engineering
Science degree in Biomedical Engineering
from Rensselaer Polytechnic Institute & a
Bachelor of Science degree in Mechanical
Engineering from the University of
Connecticut

10. AMxTek LLC
 Jim‟s biofilm competency comes from over 15
years of tutelage at the Center for Biofilm
Engineering at Montana State University &
being personally responsible for the
development & commercialization of 4
generically different AMx medical devices:
 Kendall Healthcare (2), Div. of Covidien, LLC
 Bard Medical (1), Div. of C.R. Bard, Inc.
 Bacterin International (1)
 Jim possesses Clinical Engineering Internship
Certification from Hartford Hospital & has
taken courses towards his MBA at the
University of New Haven

11. EXPERIENCE

12. Kendall Healthcare
Div. of Covidien LLC
As V.P. of R&D, Jim was the strategic architect &
product champion behind Kendall‟s entrance into
the infection control [IC] business. During Jim‟s 10
year tenure his strategic and P&L IC contributions
included:
Recognition of the enhanced business model &
P&L opportunity AMx technology provides for
quasi-commodity oriented medical devices:
 New product life-cycle
 Enhanced ASP & GP
 Cannibalization or market share penetration
significantly improves P&L performance
Development of a suite of in-vitro AMx assays to
enhance internal competency & assessment of
efficacy of new AMx technologies & products
under development

13. Kendall Healthcare
Div. of Covidien LLC
 Development & commercialization of the
Kerlix™AMD line of Antimicrobial Gauze
Dressings: 510(K) # K990530
Identified & sourced IC technology:
 PHMB - Polyhexamethylene Biguanide
Developed manufacturing process methods to bind
PHMB to cellulose (i.e. cotton)
Developed PHMB formulation to optimize AMx
efficacy vs. cytotoxicity
Developed & executed in-vitro, animal & in-vivo
product trials in support of FDA 510(K) submission
& new product launch

14. Kendall Healthcare,
Div. of Covidien LLC
 Development & commercialization of Dover®
Silver, Kendall‟s silicone IC Foley catheter;
510(K) # K024010
 Identified & sourced IC technology:
 Ag3PO4 inorganic polymer
 Developed & executed in-vitro assay data in support of
FDA 510(K) submission & new product launch
 Poster entitled: “Novel Anti-infective Coating
Prevents Biofilm Formation in In-vitro Assay”; won
APIC„s ‘Bard UTI Research Award’, June 2003
 Chaired Kendall‟s „Pre-submission‟ (a.k.a. Pre-IDE)
meeting with FDA

15. Bard Medical
C.R. Bard, Inc.
As Bard‟s V.P. of R&D, Jim‟s strategic IC
contributions included:
 Vetting 2nd generation „home grown‟ IC technology
 Colloidal Silver Salts; R. Terry, Pat. #s 6,716,895 &
6,949,598
 Advancement of Bard‟s technical competency & self-
sufficiency re. AMx in-vitro assay testing
 Management of Bard‟s Agento® IC Silver-Coated
Endotracheal Tube clinical trial: 510(K) # : K071365;
 The „NASCENT‟ Clinical Trial included: 54 sites & 2,003 patients;
outcome results indicated Agento®:
 Reduced the incidence of VAP by 36%
 Reduced the incidence of VAP by 48% for patients intubated
≤ 10 days
 Delayed the onset of VAP

16. Bacterin International, Inc.
As V.P. of Business Development, Jim‟s
responsibilities included directing AMx medical
device product development for both Bacterin &
„Corporate Alliance Partners‟ [CAP]. Jim‟s
medical device IC contributions included:
 Development & FDA approval of Elutia, the first
antimicrobial surgical wound drain; 510(K) #: K063245
 IC Technology – PVA/SSD; Pat. Applic. # 20080063693
 Negotiated with FDA re „Product Classification‟; in-
vitro test methods; & Claims/Indication for Use
 Managed CAP AMx product development programs;
including:
 FDA Pre-IDE Meeting re AMx Vascular Access Device

17. QuoNova, LLC
As V.P. of Product Development for this early stage
„Quorum Sensing Blocking‟ [QSB] technology
[AI-1 pathway], Jim was responsible for
increasing asset value by converting IC „science‟
into commercial, value-added IC products.
 Transitioned QSB lab „science‟ into IC Wound Care
Dressings
 Managed „partial-thickness‟ wound healing animal trial
at U.S. medical research university
 Regulatory – Drafted Request For Designation [RFD] re.
FDA submission

18. AMxTek LLC
CONSULTING SERVICES
 PRODUCT DEVELOPMENT
 REGULATORY

19. AMxTek Consulting Services
AMxTek consulting services:
1. Manage/oversee „in-house‟ AMx Product
Development programs
 Benefit: Partner builds core technical
competence in AMx product development &
technology assessment
 Benefit: Partner gains objective vetting of in-
house AMx technologies &/or programs
2. Sources AMx technology/IP
 Benefit: Partner maintains anonymity
 Benefit: Partner benefits from AMxTek‟s
objectivity, experience & technology resource
network

20. AMxTek Consulting Services
3. Partner out-sources AMx Product
Development program directly to AMxTek
 Benefit: A „Phase-Gate‟ Product Development
approach ensures Partner‟s oversight & control over
project management & expenses
 Benefit: Partner off-loads constrained or
inexperienced technical resources onto AMxTek
 Benefit: AMxTek‟s AMx medical device product
development experience reduces Partner‟s TTM/FDA
submission
4. AMxTek consults with Partner re. FDA
Regulatory submission; filing strategy; &
IFU/Claims development
 Benefit: Partner gains AMxTek‟s „Combination
Medical Product‟ experience with FDA.
 RFDs
 Pre-IDE Meetings
 510(k) submissions
 IFU/Claims-supported product testing

21. AMXTEK
CORPORATE CLIENT ACTIVITIES
 Major Medical Supply Companies:
 Technology ‘due diligence’; In-vitro test methods & in-situ
protocol development & data review; 510(k) submission review;
FDA Pre-IDE Meeting response strategy; Regulatory pathway
assessment
 Small Medical Supply Company:
 Product development – AMx wound care dressing
 Orthopedic Implant Companies:
 Technology ‘due diligence’; Regulatory pathway assessment;
FDA Pre-IDE Meetings;
 Food Industry:
 Technology ‘due diligence’; Assessment of FCS regulatory
pathway; COGS analysis

22. How To Reach
AMxTek LLC
Jim Walls
President
49 Farm View Rd.
Bethany, CT 06524
Email: amxtek@comcast.net
Office: (203) 393-1387
Mobile: (203) 859-2997

23. References
1. Klevens, Edwards, Richards, et al. Pub Health Report 2007; 122:160 – 6
2. Weber, DJ et al. Comparison of Hospital-wide Surveillance and
Targeted ICU Surveillance of HAIs. Infect Control & Hospital
Epidemiology 2007;28:1361-1366
3. Martone, WJ, et al. Incidence and Nature of Endemic and Epidemic
Nosocomial Infections. II Endemic and Epidemic Hospital Infections;
Table 27- 4 p593
4. Ibrahim, EH, et al. The Occurrence of VAP in a Community Hospital:
Risk factors and Clinical Outcomes. Chest 2001 Aug; 120(2):555-561
5. O‟Grady, NP, et al. “Guidelines for the Prevention of Intravascular
Catheter-related Bloodstream Infections”. CDC, Aug. 9, 2002, Vol. 51,
No. RR10, pp1 – 26
6. Scott II, R.D. The Direct Medical Costs of HAIs in U.S. Hospitals and the
Benefit of Prevention. CDC; March 2009

24. THANK YOU
FOR YOUR ATTENTION