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ViOptix Announces FDA Clearance of Intra.Ox System for Assessment of Tissue Perfusion

Newark, CA, August X, 2021, ViOptix Inc. announces its Intra.Ox System receives FDA clearance.


The Intra.Ox™ Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. It is indicated for use in assessing perfusion such as in creating an anastomosis during colorectal surgery


There are 400,000 colorectal surgeries performed per year with an anastomotic leak rate from 5-15%. Anastomotic leaks can result in unintended morbidities and mortalities. The Intra.Ox system provides a direct measurement of saturated oxygen (StO2) in the tissue and good oxygenation has been shown to reduce the incidence of leaks and improve outcomes. The unique technology, offered only by ViOptix, has been proven in 1000s of cases and documented in numerous peer-reviewed clinical articles.


The Intra.Ox system is convenient, easy to use and requires no special training or capital equipment. It only requires a reusable handpiece, which can be used multiple times, and a disposable sterile sheath that costs a few hundred dollars. Intra.Ox does not require dyes, and can be used to take unlimited number of readings during a case. Additionally, since no capital equipment is required there is no set up time or delay between readings. Preliminary results from a multi-center prospective study comparing Intra.Ox to traditional imaging for use in colorectal surgery shows strong correlation with the current standard of care.


“We are excited to offer surgeons a better alternative for assessing tissue perfusion during an extracorporeal anastomosis” stated Scott Coleridge, CEO of ViOptix. “This proprietary technology is also used in our T.Ox system, which is the standard of care in reconstructive surgery and has been clinically validated in multiple peer-reviewed studies and used in over 100,000 flap cases.” Continued Mr. Coleridge. “Now this proven technology is available for bowel and renal surgery.”


About ViOptix, Inc.


ViOptix™ is the recognized leader in real-time measurement of tissue oxygen saturation, an indicator of tissue heal and viability. Founded in 1999, ViOptix is dedicated to providing world-class technology that measures tissue health to help improve patient surgical outcomes by detecting problems before
symptoms are visible. Beginning with breast reconstruction surgery, the company is steadily expanding the types of surgical procedures that can utilize the ViOptix platform. ViOptix is developing and marketing clinically validated, FDA- cleared products that are being adopted as the standard of care at many of America’s leading hospitals including:

  • T.Ox™: Measures tissue oxygen saturation post-operatively in real time
  • T.Ox Remote™: Gives the clinician “anytime, anywhere” access to patient – critical data on tissue oxygenation
  • Intra.Ox™: Measures tissue oxygenation in real time

In 2013, ViOptix received the prestigious Frost & Sullivan Best Practices Award recognizing superior leadership, technological innovation, customer service, and strategic product development. The company is headquartered in Newark, California.


Contact: info@ViOptix.com


References

  1. Wallace B, Schuepbach F, Gaukel S, Marwan AI, Staerkle RF, Vuille-dit-Bille RN. Evidence according to Cochrane Systematic Reviews on Alterable Risk Factors for Anastomotic Leakage in Colorectal Surgery. Gastroenterol Res Pract. 2020;2020:9057963.

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