100324 jaw a mx tek overview [1.0]
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AMxTek LLC OverviewTRANSCRIPT
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: [email protected] 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
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