AMxTek LLCAMxTek LLC

Antimicrobial Medical Device:Antimicrobial Medical Device:

Product Development & RegulatoryProduct Development & Regulatory

Consulting ServicesConsulting Services

Presented To: Presented By: Jim Walls

President AMxTek LLC

OverviewOverview

Hospital Acquired Infections [HAIs] & Hospital Acquired Infections [HAIs] & The U.S. Healthcare BurdenThe U.S. Healthcare Burden

AMxTek BackgroundAMxTek Background AMxTek ExperienceAMxTek Experience AMxTek Business ModelAMxTek Business Model AMxTek Corporate Client ActivitiesAMxTek Corporate Client Activities

HAIs & The U.S. Healthcare BurdenHAIs & The U.S. Healthcare Burden

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)

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)

HAIHAI Total Total (1)+(2)(1)+(2) Mortality Mortality Ave. Attributable Ave. Attributable

Cost/PatientCost/Patient

CAUTICAUTI 449,334449,334 0.720.72%(3)%(3) $1,007 $1,007 (6)(6)

CLA-BSICLA-BSI 92,01192,011 25% 25% (5)(5) $29,156 $29,156 (6)(6)

VAPVAP 52,54352,543 46% 46% (4)(4) $28,508 $28,508 (6)(6)

SSISSI 290,485290,485 1.91%1.91%(3)(3) $34,670 $34,670 (6)(6)

OtherOther 386,090386,090 2.48%2.48%(3)(3) $1,617$1,617(3) (3)

TotalTotal 1,737,1251,737,125 2.70%2.70%(3)(3) $2,100$2,100(3)(3)

A Business Case for A Business Case for Antimicrobial [AMx] Medical Devices Antimicrobial [AMx] Medical Devices

AMx medical devices reduce HAIs; resulting in:AMx medical devices reduce HAIs; resulting in:

1.1. Improved patient quality of careImproved patient quality of care Reduced patient morbidity & mortalityReduced patient morbidity & mortality

2.2. HAI cost avoidanceHAI cost avoidance Reduced Antibiotics [ABx] use:Reduced Antibiotics [ABx] use: Reduced preservation stress on microorganisms; Reduced preservation stress on microorganisms;

believed to lead to believed to lead to ‘Multi-Drug Resistant ‘Multi-Drug Resistant Organisms’ Organisms’ [MDROs][MDROs]

3.3. Improved hospital profitability:Improved hospital profitability: Reduced patient-bed days; improved bed Reduced patient-bed days; improved bed

utilizationutilization

A Business Case for A Business Case for Antimicrobial [AMx] Medical Devices Antimicrobial [AMx] Medical Devices

4.4. ReimbursementReimbursement; ; CMS CMS ‘No Pay‘No Pay’ ’ HAIs:HAIs: 2009 – 2009 – NoNo CMS Reimbursement for the Following CMS Reimbursement for the Following

HAIs: HAIs: CAUTICAUTI Pressure UlcersPressure Ulcers Vascular Catheter-Associated InfectionsVascular Catheter-Associated Infections SSIs re MediastinitisSSIs re Mediastinitis

ProposedProposed CMS ‘No Pay’ CMS ‘No Pay’ HAIs:HAIs: VAPVAP Staphylococcus aureus SepticemiaStaphylococcus aureus Septicemia MRSAMRSA Additional Types of SSIsAdditional Types of SSIs

A Business Case for A Business Case for Antimicrobial [AMx] Medical Devices Antimicrobial [AMx] Medical Devices 5.5. Mandatory ReportingMandatory Reporting::

A Business Case for A Business Case for Antimicrobial [AMx] Medical Devices Antimicrobial [AMx] Medical Devices

5.5. Mandatory ReportingMandatory Reporting::

AMxTek AMxTek BACKGROUNDBACKGROUND

AMxTek LLC AMxTek LLC

AMxTek was founded in 2008 by Jim Walls, AMxTek was founded in 2008 by Jim Walls, AMxTek’s President AMxTek’s President

Jim has over 25 years of medical device Jim has over 25 years of medical device product development & regulatory product development & regulatory experience:experience: > 15 years of which is directly related to > 15 years of which is directly related to

‘Combination Medical Products’ ‘Combination Medical Products’ Jim possesses a Jim possesses a Master of EngineeringMaster of Engineering

Science Science degree in degree in Biomedical EngineeringBiomedical Engineering from Rensselaer Polytechnic Institute & a from Rensselaer Polytechnic Institute & a Bachelor of ScienceBachelor of Science degree in degree in Mechanical Mechanical EngineeringEngineering from the University of from the University of ConnecticutConnecticut

AMxTek LLCAMxTek LLC

Jim’s Jim’s biofilmbiofilm competency comes from over 15 competency comes from over 15 years of tutelage at the years of tutelage at the Center for Biofilm Center for Biofilm EngineeringEngineering at Montana State University & at Montana State University & being personally responsible for the being personally responsible for the development & commercialization of 4 development & commercialization of 4 generically different AMx medical devices: generically different AMx medical devices: Kendall Healthcare (2)Kendall Healthcare (2), Div. of Covidien, LLC , Div. of Covidien, LLC Bard Medical (1)Bard Medical (1), Div. of C.R. Bard, Inc, Div. of C.R. Bard, Inc.. Bacterin International (1)Bacterin International (1)

Jim possesses Jim possesses Clinical EngineeringClinical Engineering Internship Internship CertificationCertification from Hartford Hospital & has from Hartford Hospital & has taken courses towards his taken courses towards his MBAMBA at the at the University of New HavenUniversity of New Haven

EXPERIENCEEXPERIENCE

Kendall HealthcareKendall Healthcare Div. of Covidien LLCDiv. of Covidien LLC

As As V.P. of R&D,V.P. of R&D, Jim was the strategic architect & Jim was the strategic architect & product champion behind Kendall’s entrance into product champion behind Kendall’s entrance into the infection control [IC] business. During Jim’s 10 the infection control [IC] business. During Jim’s 10 year tenure his strategic and P&L IC contributions year tenure his strategic and P&L IC contributions included:included:Recognition of the enhanced business model & Recognition of the enhanced business model &

P&L opportunity AMx technology provides for P&L opportunity AMx technology provides for quasi-commodity oriented medical devices:quasi-commodity oriented medical devices:

New product life-cycleNew product life-cycle Enhanced ASP & GPEnhanced ASP & GP Cannibalization or market share penetration Cannibalization or market share penetration

significantly improves P&L performancesignificantly improves P&L performanceDevelopment of a suite of in-vitro AMx assays to Development of a suite of in-vitro AMx assays to

enhance internal competency & assessment of enhance internal competency & assessment of efficacy of new AMx technologies & products efficacy of new AMx technologies & products under developmentunder development

Kendall HealthcareKendall Healthcare Div. of Covidien LLCDiv. of Covidien LLC

Development & commercialization of the Development & commercialization of the Kerlix™AMDKerlix™AMD line of Antimicrobial Gauze line of Antimicrobial Gauze Dressings: Dressings: 510(K) # K990530510(K) # K990530Identified & sourced IC technology: Identified & sourced IC technology:

PHMB - Polyhexamethylene Biguanide PHMB - Polyhexamethylene Biguanide Developed manufacturing process methods to bind Developed manufacturing process methods to bind

PHMB to cellulose (i.e. cotton)PHMB to cellulose (i.e. cotton)Developed PHMB formulation to optimize AMx Developed PHMB formulation to optimize AMx

efficacy vs. cytotoxicityefficacy vs. cytotoxicityDeveloped & executed in-vitro, animal & in-vivo Developed & executed in-vitro, animal & in-vivo

product trials in support of FDA 510(K) submission product trials in support of FDA 510(K) submission & new product launch & new product launch

Kendall Healthcare,Kendall Healthcare, Div. of Covidien LLCDiv. of Covidien LLC

Development & commercialization of Development & commercialization of Dover® Dover® SilverSilver, Kendall’s silicone IC Foley catheter; , Kendall’s silicone IC Foley catheter; 510(K) # K024010510(K) # K024010 Identified & sourced IC technology:Identified & sourced IC technology:

AgAg33POPO4 4 inorganic polymerinorganic polymer

Developed & executed in-vitro assay data in support of Developed & executed in-vitro assay data in support of FDA 510(K) submission & new product launchFDA 510(K) submission & new product launch

Poster entitled: Poster entitled: ““Novel Anti-infective Coating Prevents Novel Anti-infective Coating Prevents Biofilm Formation in In-vitro Assay”Biofilm Formation in In-vitro Assay”;; won APIC‘s won APIC‘s ‘Bard ‘Bard UTI Research AwardUTI Research Award’, ’, June 2003June 2003

Chaired Kendall’s ‘Pre-submission’ (a.k.a. Pre-IDE) Chaired Kendall’s ‘Pre-submission’ (a.k.a. Pre-IDE) meeting with FDAmeeting with FDA

Bard Medical Bard Medical C.R. Bard, Inc.C.R. Bard, Inc.

As Bard’s As Bard’s V.P. of R&DV.P. of R&D, Jim’s strategic IC , Jim’s strategic IC contributions included: contributions included:

Vetting 2Vetting 2ndnd generation ‘home grown’ IC technology generation ‘home grown’ IC technologyColloidal Silver Salts; R. Terry, Pat. #s 6,716,895 & Colloidal Silver Salts; R. Terry, Pat. #s 6,716,895 &

6,949,5986,949,598 Advancement of Bard’s technical competency & self-Advancement of Bard’s technical competency & self-

sufficiency re. AMx in-vitro assay testingsufficiency re. AMx in-vitro assay testing Management of Bard’s Management of Bard’s Agento® IC Agento® IC Silver-Coated Silver-Coated

Endotracheal Tube Endotracheal Tube clinical trial: clinical trial: 510(K) # : K071365; 510(K) # : K071365; The The ‘NASCENT’‘NASCENT’ Clinical Trial included: 54 sites & 2,003 patients; Clinical Trial included: 54 sites & 2,003 patients;

outcome results indicated outcome results indicated Agento®:Agento®:Reduced the incidence of VAP by 36% Reduced the incidence of VAP by 36% Reduced the incidence of VAP by 48% for patients intubated Reduced the incidence of VAP by 48% for patients intubated

≤ 10 days≤ 10 daysDelayed the onset of VAPDelayed the onset of VAP

Bacterin International, Inc.Bacterin International, Inc.

As As V.P. of Business DevelopmentV.P. of Business Development, Jim’s , Jim’s responsibilities included directing AMx medical responsibilities included directing AMx medical device product development for both device product development for both BacterinBacterin & & ‘Corporate Alliance Partners’ [CAP]‘Corporate Alliance Partners’ [CAP]. Jim’s . Jim’s medical device IC contributions included:medical device IC contributions included:

Development & FDA approval of Development & FDA approval of ElutiaElutia, the first , the first antimicrobial surgical wound drain; antimicrobial surgical wound drain; 510(K) #: K063245510(K) #: K063245 IC Technology – PVA/SSD; Pat. Applic. # 20080063693IC Technology – PVA/SSD; Pat. Applic. # 20080063693Negotiated with FDA re ‘Product Classification’; in-Negotiated with FDA re ‘Product Classification’; in-

vitro test methods; & Claims/Indication for Usevitro test methods; & Claims/Indication for Use Managed Managed CAP CAP AMx product development programs; AMx product development programs;

including:including:FDA Pre-IDE Meeting re AMx Vascular Access Device FDA Pre-IDE Meeting re AMx Vascular Access Device

QuoNova, LLCQuoNova, LLC

As As V.P. of Product Development V.P. of Product Development for this early stage for this early stage ‘Quorum Sensing Blocking’ [QSB]‘Quorum Sensing Blocking’ [QSB] technology technology [AI-1 pathway], Jim was responsible for [AI-1 pathway], Jim was responsible for increasing asset value by converting IC ‘science’ increasing asset value by converting IC ‘science’ into commercial, value-added IC products. into commercial, value-added IC products.

Transitioned Transitioned QSBQSB lab ‘science’ into IC Wound Care lab ‘science’ into IC Wound Care DressingsDressingsManaged ‘partial-thickness’ wound healing animal trial Managed ‘partial-thickness’ wound healing animal trial

at U.S. medical research universityat U.S. medical research university Regulatory – Drafted Regulatory – Drafted Request For Designation [RFD]Request For Designation [RFD] re. re.

FDA submissionFDA submission

AMxTek LLC AMxTek LLC CONSULTING SERVICESCONSULTING SERVICES

PRODUCT DEVELOPMENTPRODUCT DEVELOPMENT REGULATORYREGULATORY

AMxTek Consulting ServicesAMxTek Consulting Services

AMxTek consulting servicesAMxTek consulting services::1.1. Manage/oversee ‘in-house’ AMx Product Manage/oversee ‘in-house’ AMx Product

Development programsDevelopment programs Benefit:Benefit: Partner builds core technical Partner builds core technical

competence in AMx product development & competence in AMx product development & technology assessmenttechnology assessment

Benefit:Benefit: Partner gains objective vetting of in- Partner gains objective vetting of in-house AMx technologies &/or programshouse AMx technologies &/or programs

2.2. Sources AMx technology/IPSources AMx technology/IP Benefit:Benefit: Partner maintains anonymity Partner maintains anonymity Benefit:Benefit: Partner benefits from AMxTek’s Partner benefits from AMxTek’s

objectivity, experience & technology resource objectivity, experience & technology resource networknetwork

AMxTek Consulting ServicesAMxTek Consulting Services3.3. Partner out-sources AMx Product Partner out-sources AMx Product

Development program directly to AMxTekDevelopment program directly to AMxTek Benefit:Benefit: A ‘Phase-Gate’ Product Development A ‘Phase-Gate’ Product Development

approach ensures Partner’s oversight & control over approach ensures Partner’s oversight & control over project management & expensesproject management & expenses

Benefit:Benefit: Partner off-loads constrained or Partner off-loads constrained or inexperienced technical resources onto AMxTekinexperienced technical resources onto AMxTek

Benefit:Benefit: AMxTek’s AMx medical device product AMxTek’s AMx medical device product development experience reduces Partner’s TTM/FDA development experience reduces Partner’s TTM/FDA submissionsubmission

4.4. AMxTek consults with Partner re. FDA AMxTek consults with Partner re. FDA Regulatory submission; filing strategy; & Regulatory submission; filing strategy; & IFU/Claims developmentIFU/Claims development

Benefit:Benefit: Partner gains AMxTek’s ‘Combination Partner gains AMxTek’s ‘Combination Medical Product’ experience with FDA. Medical Product’ experience with FDA.

RFDsRFDs Pre-IDE MeetingsPre-IDE Meetings 510(k) submissions510(k) submissions IFU/Claims-supported product testing IFU/Claims-supported product testing

AMXTEK AMXTEK CORPORATE CLIENT ACTIVITIESCORPORATE CLIENT ACTIVITIES

Major Medical Supply CompaniesMajor Medical Supply Companies:: Technology ‘due diligence’; In-vitro test methods & in-situ Technology ‘due diligence’; In-vitro test methods & in-situ

protocol development & data review; 510(k) submission review; protocol development & data review; 510(k) submission review; FDA Pre-IDE Meeting response strategy; Regulatory pathway FDA Pre-IDE Meeting response strategy; Regulatory pathway assessmentassessment

Small Medical Supply CompanySmall Medical Supply Company:: Product development – AMx wound care dressing Product development – AMx wound care dressing

Orthopedic Implant CompaniesOrthopedic Implant Companies:: Technology ‘due diligence’; Regulatory pathway assessment; Technology ‘due diligence’; Regulatory pathway assessment;

FDA Pre-IDE Meetings;FDA Pre-IDE Meetings;

Food IndustryFood Industry:: Technology ‘due diligence’; Assessment of FCS regulatory Technology ‘due diligence’; Assessment of FCS regulatory

pathway; COGS analysispathway; COGS analysis

How To Reach How To Reach AMxTek LLCAMxTek LLC

Jim WallsJim WallsPresidentPresident49 Farm View Rd.49 Farm View Rd.Bethany, CT 06524Bethany, CT 06524Email: Email: amxtek@comcast.net Office: (203) 393-1387Office: (203) 393-1387Mobile: (203) 859-2997Mobile: (203) 859-2997

ReferencesReferences

1.1. Klevens, Edwards, Richards, et al. Klevens, Edwards, Richards, et al. Pub Health ReportPub Health Report 2007; 122:160 – 6 2007; 122:160 – 6

2.2. Weber, DJ et al. Comparison of Hospital-wide Surveillance and Weber, DJ et al. Comparison of Hospital-wide Surveillance and Targeted ICU Surveillance of HAIs. Targeted ICU Surveillance of HAIs. Infect Control & Hospital Infect Control & Hospital Epidemiology 2007;28:1361-1366Epidemiology 2007;28:1361-1366

3.3. Martone, WJ, et al. Incidence and Nature of Endemic and Epidemic Martone, WJ, et al. Incidence and Nature of Endemic and Epidemic Nosocomial InfectionsNosocomial Infections. II Endemic and Epidemic Hospital Infections; . II Endemic and Epidemic Hospital Infections; Table 27- 4 p593Table 27- 4 p593

4.4. Ibrahim, EH, et al. The Occurrence of VAP in a Community Hospital: Ibrahim, EH, et al. The Occurrence of VAP in a Community Hospital: Risk factors and Clinical Outcomes. Risk factors and Clinical Outcomes. Chest 2001 Aug; 120(2):555-561Chest 2001 Aug; 120(2):555-561

5.5. O’Grady, NP, et al. “Guidelines for the Prevention of Intravascular O’Grady, NP, et al. “Guidelines for the Prevention of Intravascular Catheter-related Bloodstream Infections”. Catheter-related Bloodstream Infections”. CDC, Aug. 9, 2002, Vol. 51, CDC, Aug. 9, 2002, Vol. 51, No. RR10, pp1 – 26No. RR10, pp1 – 26

6.6. Scott II, R.D. The Direct Medical Costs of HAIs in U.S. Hospitals and the Scott II, R.D. The Direct Medical Costs of HAIs in U.S. Hospitals and the Benefit of Prevention. Benefit of Prevention. CDC; March 2009CDC; March 2009

THANK YOU THANK YOU FOR YOUR ATTENTIONFOR YOUR ATTENTION