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"I would rank AMxTek LLC as one of
the most insightful and focused
teams with whom I've partnered.
"

~ Ross Ian Garrett, Ph.D.
Sr. Director of Research
Zimmer Biologics

services
consulting services
AMxTek LLC Consulting Services provide corporate clients with technology, product development and regulatory affairs expertise gained from over 15 successful years of commercializing combination product medical devices. AMxTek’s principal has had direct responsibility and accountability for:
  • Technology Due Dilligence
  • Sourcing of Technology
  • Product Development of Combination Products
  • In-vitro Assay Development and Effectiveness Testing
  • In-situ, Animal and Clinical Trials of Combination Medical Devices
  • FDA Regulatory Pathway Assessment, Agency Pre-submission Meetings and Pre-market Notification [510(k)] Submissions

  • Pertinent details regarding the aforementioned Commercialized Combination Products can be found here.

     



    intellectual property [ip] development

    See AMxTek Management for a detailed background of AMxTek’s principal – Jim Walls, MS BioMed

    When AMxTek is not providing Combination Product Medical Device Consulting Services to Corporate Clients, AMxTek undertakes concept and IP development within this hybrid product niche, when various technologies and novel methods can be brought to bear upon unmet clinical needs in the healthcare arena.

    In particular, Hospital Acquired Infections [HAI] are attributed to over 99,000 deaths per year in the U.S.1, with an incidence rate of approximately 4.5 HAIs per 100-hospital admissions1 Direct hospital cost associated with treating HAIs is estimated to range from $35.7 - $45.0B per year2, with attributable per patient cost of $25,903 per HAI2. The Centers for Medicare & Medicaid Services [CMS] no longer reimburse hospitals for certain types of HAIs; consequently hospitals must now absorb such incremental costs. When HAI-related hospitalization costs exceed CMS procedure reimbursement fees, the healthcare institution incurs a financial loss. Consequently, Combination Product Medical Devices, capable of preventing or lowering the incidence of HAIs provide a significant value proposition to all concerned parties:

    • Patients – Receive better quality healthcare by reducing the risk of infection, with its associated morbidity, mortality and/or reduced quality of life related sequelae
    • Hospitals – Provide better quality healthcare and patient outcomes, while improving bed utilization rate [bed-turnover], revenue contribution and profitability
    • CMS/3rd Party Payers - Reduces unnecessary hospital payments attributable to ‘Hospital Acquired Conditions’, enabling the payer to control its costs and improve profitability

    For the past 15 years, AMxTek’s principal has identified such HAI-related product and business opportunities, and has successfully commercialized clinical solutions ahead of the marketplace. This competency and entrepreneurial spirit continues under the AMxTek business model.




    1 Klevens, RM et al. Estimating Health Care-Associated Infections and Deaths in U. S. Hospitals, 2002. Public Health Report 2007; 122:160-166
    2 Scott II, RD. The Direct Medical Costs Of Healthcare-Associated Infections in U. S. Hospitals and the Benefit of Prevention. Centers for Disease Control and Prevention March 2009

    The table below identifies IP developed by AMxTek’s principal and provides a brief description of current AMxTek LLC medical device IP available for business development and/or license opportunities. Queries regarding business development interest can be made via AMxTek’s Contact Us webpage.

     

    Patent # Patent Title Inventor Status
    US 4,169,465 Method and Apparatus For Obtaining Non-Invasive
    Cardio-Pulmonary Measurements
    Walls et al. Expired, Public Domain
    US 6,053,905 Self Contained Urethral Catheter Assembly With
    Lubricating Chamber
    Daignault, Jr. et al. Assigned
    US 6,619,837 B2 Probe Cover With Lubrication Well Walls et al. Assigned
    US 7,655,000 B2 Urology Catheter Walls et al. Assigned
    USPTO: US2011/0196502
    PCT: WO2011/097506A2 & A3
    EPO: EP2531225
    Methods Of Using Water-Soluble Inorganic Compounds For Implants Walls Available For Business Development and/or License



    USPTO, PCT and EPO Patent Publications entitled Methods Of Using Water-Soluble Inorganic Compounds For Implants pertain to employing the antimicrobial and osteogenic ionic dissolution attributes of inorganic compounds, and particularly water-soluble bioactive glass particles, in various implant embodiments; clinical applications include:

    Porous-Coated Orthopedic and Spinal Implants

    Orthopedic Reconstruction
    Orthopedic Revision Surgery
    Primary Joint Infection [PJI]
    Orthopedic Trauma
    Orthobiologics
    Bone Cement
    Dental

    Status of pending Patent Applications:

    USPTO: AMxTek LLC has recently received USPTO Notification of Allowance regarding certain Method Claims associated with the seeding and fixating of water-soluble inorganic particles, particularly bioactive glass particles, within the interstices of porous coated implants, which upon particle dissolution provide for antimicrobial implant prophylaxis and/or osteostimulative bone matrix deposition within the porous coating, enhancing implant fixation. Further details can be gleaned from the AMxTek BLOG, or by contacting the company directly via the Contact Us webpage.

    PCT: A Written Opinion by the PCT International Searching Authority found certain Patent Publication claims to possess: i) Novelty and an Inventive Step; and ii) Industrial Applicability; Oct. 28, 2011