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Light Line Catheter

by Mitchell Barneck, BS Bioengineering

The Light Line catheter employs a novel visible light phototherapy technology to actively disinfect the device while residing within a patient’s body.

Salt Lake City, UT Medical Device

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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.

About Our Company


Veritas Medical LLC
Location: Salt Lake City, Utah
Website: http://www.LightLineMedical.com
Twitter: @VeritasMed
Facebook: http://www.facebook.com/VeritasMedicalLLC/
Product stage: ready
Sales: Working on it
Employees: 5-10

How We Help Patients

There are an estimated 722,000 healthcare-associated infections (HAIs) in U.S. acute care hospitals every year based on a HAI prevalence survey conducted by the CDC. This resulted in almost 100,000 deaths in the United States alone each year. In addition to the lives lost, the CDC estimates that between $30-$45 billion is spent preventing and treating HAIs. Most of us know someone who contracted an infection while being treated at the hospital, and the bacteria causing them are becoming increasingly resistant to antibiotics. We are working to end preventable deaths and costs caused by device-related infections by providing clinicians with more advanced technologies in the fight against antibiotic-resistant bacteria. Please join with us and vote for the Light Line™ Catheter, supporting our mission to end catheter-associated HAIs.

How We Help Physicians

As most clinicians know, almost every patient arriving at the hospital will require some form of medical tubing to access various compartments of the body, including vascular and urinary catheters, endotracheal tubes, drainage tubes and ports. While their utilization differs, they all share the same risks of infections and the associated morbidity and mortality risk. Antibiotic utilization is continually leading to more resistant bacterial strains. This is not only dangerous for the patient, but costly to the healthcare system now that the Center for Medicaid and Medicare in 2008 released a statement indicating they would not pay for Hospital Acquired Infections. This places significant burden on the healthcare system and patients alike. We need to investigate and implement non-antibiotic based novel technologies in order to more adequately address these growing issues. The Light Line™ Catheter with its Visible Light Phototherapy technology has the potential to address these concerns.

Challenge Mission

Mission: Our team is committed to not only develop this technology, but also support and teach others through our co-organized innovation seminars and integration with the Utah Center for Medical Innovation.
Use of funds: All funds won will be further directed toward the commercialization of the Light Line™ Catheter. Current efforts are focused on the regulatory testing needed to gain FDA clearance.
Intellectual Property Status: 4 patents have been filed encompassing the utilization, methods, and apparatus associated with this visible light phototherapy technology. An independent patent attorney analysis indicates we have both patentability and freedom to operate.
Patent Link: https://www.google.com/patents/US20130267888
FDA Status: The Light Line™ system falls under a 510(k) de-novo pathway, which has been confirmed by an independent regulatory consulting firm. This is due to the similar use indications of antimicrobial catheters, but utilizing a technology similar to that used in the topical phototherapy of acne. We have identified all of the applicable testing standards required for an FDA clearance submission and are currently raising funds to finalize laboratory and clinical testing for the urinary catheter version.
Personal Message: “I will prevent disease whenever I can, for prevention is preferable to cure.” This is one of the many things we swear to fulfil upon entering a career in medicine. Most of us, healthcare worker or not, have seen the negative effects of hospital-acquired infections. These infections can be prevented with investigation and implementation of new technologies like ours. Please join with us and vote for the Light Line™ Catheter, supporting our mission to end catheter-associated HAIs.

Supporters

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    07/11/2016 Alex Fair - Investor

    Interested in trying the project.

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    07/11/2016 Alex Fair - Investor

    Followed the project.

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    07/11/2016 Alex Fair - Investor

    Liked the project.

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    06/01/2016 Ravi Shah - Physician

    Liked the project.

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    06/01/2016 Ravi Shah - Physician

    Interested in trying the project.

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    06/01/2016 Ravi Shah - Physician

    Followed the project.

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    06/01/2016 Ravi Shah - Physician

    Interested in piloting the project.

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    05/26/2016 Peter Barnes - Medical Student

    Followed the project.

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    05/26/2016 Nathaniel Rhodes - Engineer

    Liked the project.

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    05/26/2016 Peter Barnes - Medical Student

    Liked the project.

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    05/26/2016 Peter Barnes - Medical Student

    Interested in trying the project.

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    05/16/2016 Dr. John Dayton - Physician

    Interested in trying the project.

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    05/16/2016 Dr. John Dayton - Physician

    Followed the project.

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    05/16/2016 Dr. John Dayton - Physician

    Liked the project.

5

likes

4

Follows

1

Pilots

0

Partners

68

Interest
Score

7

Adoption
Score


Mitchell Barneck, BS Bioengineering
Medical Student
Light Line Catheter
Oregon Health and Science University

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