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"Jim is one of those rare individuals with unquestionable moral ethics, character and above all honest.  He is a trustworthy and creative individual who performed a pivotal role in bringing our orthobiologics products to market with unprecedented swiftness.  Unreservedly, I would highly recommend and personally utilize Jim’s expertize to spearhead projects where measurable expectations and extraordinary results are mandated."
~ Jesus Hernandez, CEO
CellRight Technologies

about amxtek llc

AMxTek LLC was founded in 2008 by Jim Walls, MS, BioMed., as a combination product, medical device consulting company, providing ‘front end’ technology due diligence and sourcing, product development and U.S. FDA regulatory services to corporate clients. In 2010, AMxTek began developing Intellectual Property [IP] in the combination product arena, where innovative technologies and novel methods could be brought to bear on unmet clinical needs in the healthcare marketplace, particularly in areas such as Hospital Acquired Infections [HAI], and osteointegration of implants. This IP is made available to interested corporate partners for business development consideration.

management
President - Jim Walls, MS, BioMed.

Jim is a Biomedical Engineer with 30 years of medical device R&D and Product Development experience. For the past 15 years Jim has focused his attention on Hospital Acquired Infections [HAI], and the prevention or reduction of microbial colonization of medical devices. Today such devices are classified as ‘combination products’ by the U.S. FDA since the product provides both device and drug related Modes Of Action [MOA].

Jim possesses a Master of Science degree in Engineering Science/Biomedical Engineering from Rensselaer Polytechnic Institute and a Bachelor of Science degree from The University of Connecticut. He also received Certification in a two year Clinical Engineering Internship program at Hartford Hospital and has taken MBA courses at the University of New Haven.

Jim’s biofilm competency comes from over 15 years of tutelage at the Center of Biofilm Engineering at Montana State University. He was also directly responsible for, and/or contributed significantly to, technology assessment due diligence, product development, in-vitro assay development and the successful commercialization, i.e. regulatory approval, of four distinctly different ‘combination product’ medical devices while a corporate executive; these products include:

Product Description Antimicrobial 510(K) No.
Kerlix™ AMD Antimicrobial Gauze Polyhexamethylene Biguanide [PHMB] K990530
Dover® Silver Antimicrobial Foley Catheter Inorganic Silver Polymer [Ag3PO4] K024010
Agento® I.C. Antimicrobial Endotracheal Tube Colloidal Suspension of Silver Salts K071365
Elutia Antimicrobial Surgical Wound Drain Silver Sulfadiazine/ Polyvinyl Alcohol K063245


Since founding AMxTek LLC, Jim has provided technology and regulatory consulting services to Fortune 100 corporate clients, as well as early-stage entrepreneurial companies having strategic business interests in the ‘combination product’ medical device arena; such companies have included:

Title Company
Vice President of Business Development Bacterin International Holdings, Inc.
Vice President of Research & Development Bard Medical Div., C.R. Bard, Inc.
Vice President of Research & Development Kendall Healthcare Div., Covidien, plc
Director of Business Development Linvatec Corp., Bristol-Myers Squibb Co.


Since founding AMxTek LLC, Jim has been providing consulting services to corporate clients having strategic business interests in the combination product medical device arena; such companies have included:

> Orthopedic Implant Companies
> Hospital & Medical Supply Companies
> Wound Care Product Companies
> Specialty Chemical Companies
> Food Industry Companies

Augmenting AMxTek’s corporate client consulting services, Jim has been active in Intellectual Property [IP] development in the combination product medical device marketplace. Such IP represents business development and/or licensing opportunities for corporate partnering.

scientific advisory board
Joseph Bronzino, Ph.D.

Joe is the Founder and President of the Biomedical Engineering Alliance and Consortium [BEACON], http://www.beaconalliance.org a non-profit organization consisting of academic and medical institutions as well as corporations dedicated to the development of new medical technology. To accomplish this goal, BEACON facilitates collaborative research, industrial partnering and the development of emerging companies.

Dr. Bronzino advises AMxTek on a wide array of technology, biomedical and business development related issues and activities. He also facilitates AMxTek entre to clinicians, research facilities and potential corporate partnering opportunities.

Prior to his retirement, Dr. Bronzino was the Vernon Roosa Professor of Applied Science, an endowed chair at Trinity College, Hartford, CT. Joe is the author of over 200 journal articles and 15 books, including Technology for Patient Care (C.V. Mosby, 1977), Computer Applications for Patient Care (Addison-Wesley, 1982), Biomedical Engineering: Basic Concepts and Instrumentation (PWS Publishing Co., 1986), Expert Systems: Basic Concepts (Research Foundation of State University of New York, 1989), Medical Technology and Society: An Interdisciplinary Perspective (MIT Press and McGraw-Hill, 1990), Management of Medical Technology (Butterworth/Heinemann, 1992), The Biomedical Engineering Handbook (CRC Press, 1st Edition, 1995; 2nd Edition, 2000; 3rd Edition, 2006, 4th edition, 2011), Introduction to Biomedical Engineering (Academic Press, 1st Edition, 1999; 2nd Edition, 2006, 3rd edition 2012), Biomechanics: Principles and Applications (CRC Press, 2002 and 2008), Biomaterials: Principles and Applications (CRC Press, 2002 and 2007), Tissue Engineering (CRC Press, 2002 and 2007), Biomedical Imaging (CRC Press, 2002), Clinical Engineering (CRC Press, 2003), Biotechnology for Biomedical Engineers (CRC Press 2003), Neuroengineering (CRC Press, 2008) and Medical Infrared Imaging (CRC Press 2008).

Dr. Bronzino received the B.S.E.E. degree from Worcester Polytechnic Institute, Worcester, MA, in 1959, the M.S.E.E. degree from the Naval Postgraduate School, Monterey, CA, in 1961, and the Ph.D. degree in electrical engineering from Worcester Polytechnic Institute in 1968.