About this project
The problem we solve: On any given day, approximately 1 out of every 25 patients in U.S. hospitals has at least one health care-associated infection (HAI). This results in an estimated 722,000 HAIs in U.S. acute care hospitals every year based on a HAI prevalence survey conducted by the CDC. Some of the most common HAI’s are catheter-associated. In fact, as much as 10% of the 215 million annual worldwide urological users and 5% of the 135 million annual venous catheters users have reported a catheter associated urinary tract infection (CAUTI) or blood stream infection (BSI) respectively. These infections are dangerous and result in increased treatment cost and hospital time, as well as patient morbidity and mortality. Current externally applied and/or internally impregnated pharmacologic disinfection methods are inadequate and have been shown to have poor clinical efficacy. Because this problem remains unsolved with current products, infection rates and associated health care costs continue to rise.
About our solution: The Light Line™ Catheter will be the first product to introduce our revolutionary visible light phototherapy (VLP) technology into the catheter market, starting with urinary catheters. Our laboratory efficacy studies utilizing VLP at various dosages and treatment times illustrate advanced bactericidal effects at over a 99.999% reduction against S. aureus, E. coli, P. aeruginosa and other common infectious agents in vitro. Other studies have also illustrated the VLP bactericidal effect on antibiotic resistant bacteria such as MRSA. The local, active, and continuous sterilization could reduce nursing time, unnecessary sterile insertion kit supplies, and infection rates. The VLP system works through activating porphyrins as photosensitizing agents that in turn generate cytotoxic singlet oxygen. The lack of mammalian tissue damage observed is likely due to inherent eukaryotic cell’s antioxidants, which bacteria lack, thus eliminating bacterial growth while minimizing side effects.
Progress to date: To date the team has raised nearly $500,000 including multiple awards and grants. This includes a grant from the National Science Foundation I-CORPS program, NASA, as well as a prize from the United States Patent and Trademark Office. This funding has been used largely for product development, laboratory testing, and intellectual property filing.
The VLP technology has been tested both in-vitro and in-vivo for safety. Positive safety testing results were found in: histology, pathology, microbiology, hemocompatibility, cytotoxicity and sensitivity. A major part of current efforts are directed at the regulatory clearance through the FDA/CE. This will include additional product development, testing, and clinical trials. Clinical trials using the Foley catheter model are set to begin in Q3-2016 in the University of Utah Burn Center and Q1-2017 at the Neuro Intensive Care Unit at Intermountain Medical Center.
About Our Team
Mr. Mitchell Barneck, BS Bioengineering
Emergency Medicine, Medical Student
Location: Portland, Oregon
Medical school: Oregon Health and Science University
Bio: Mitchell Barneck is a 3rd year MD candidate attending OHSU and co-founder of Veritas Medical. He received his Bachelor’s degree in Biomedical Engineering from the University of Utah, graduating Magna Cum Laude. He has authored several publications based on innovative technologies and co-organized a health care innovation course at OHSU. Mr. Barneck is currently a managing partner at Veritas Medical overseeing the mechanical engineering design and development as well as patent strategy.
Title: Light Line Catheter
About Team Members
Nate Rhodes
Chief Executive Officer, MS Bioengineering
Biography: Nate Rhodes holds a Master’s degree in bioengineering from the University of Utah and has worked extensively in medical devices and diagnostics for most of his career. He has an intimate knowledge of the regulatory processes associated with taking a medical device through the FDA. He has nearly a decade of project management experience directly related to medical technology development. He has also authored multiple publications related to entrepreneurship and innovation.
James Allen
VP of Engineering, BS Bioengineering
Biography: James Allen co-founded Veritas Medical and currently serves as the full time Vice President of Engineering. He received a Bachelor’s of Science in Biomedical Engineering from the University of Utah, after which he gained 2 years of industry experience as a project lead Research & Development Engineer at Bard Access Systems, the global leader in vascular catheters. His expertise encompasses catheter specific applicable regulatory standards, testing, and the associated FDA application processes.
John Langell
Chief Medical Officer, MD, PhD, MBA, MPH
Biography: Dr. John Langell is the Chief of General Surgery at the Salt Lake City VA Hospital, Vice Dean for Innovation and the Executive Director of the Center for Medical Innovation at the University of Utah, and Chief Medical Officer at Veritas Medical. He is a leader in medical innovation education and has in-depth expertise in product development and commercialization, business development, and national and global medical technology regulatory compliance and strategy.
Vicki Farrar
Chief Operations Officer, JD
Biography: Ms. Vicki E. Farrar, Esq. is an intellectual property attorney and medical entrepreneur with nearly 40 years of experience. She serves as our Chief Operations Officer. Her previous work includes: Vice President of Regulatory Affairs & Intellectual Property at Q Therapeutics Inc and Cognetix Inc, as well as the President and CEO of Catheter Connections Inc. Ms. Farrar received a Law degree from Wayne State University, and B.A. from American University where each she graduated Summa Cum Laude.
Martin de la Presa
Clinical Supervisor, BA Cognitive and Neuroscience Studies (MD Student)
Biography: Martin de la Presa is a graduating MD candidate at the University of Utah and will begin a General Surgery residency at OHSU this summer. Initially handling much of the financial and business aspects of Veritas Medical, Mr. de la Presa now oversees preparations for clinical trials as the Clinical Supervisor. He has co-authored publications related to cardiac resuscitation and worked as a research associate at the Huntsman Cancer Institute and Utah Department of Emergency Medicine.
Mitchell Barneck, BS Bioengineering