January 5th, 2015 – Press Release – 140 Patient Clinical Trial with Duette™ Shows no CAUTI

Poiesis Medical was formed to address the challenges all healthcare facilities experience regarding nosocomial infection, specifically catheter-associated urinary tract infection (CAUTI). CAUTI represents the highest hospital-acquired infection and has been targeted by CMS 2015 for a 10% reduction. It is estimated that 17% of patients who develop CAUTI will go on to suffer a sepsis event, with a morality rate of 10%. Thirteen thousand patients die each year due to CAUTIs.

Since inception, Poiesis hypothesized that a healthier intact bladder lining accompanied by better and more consistent drainage would result in reduced CAUTI events. Using the newly designed and patented dual-balloon Duette™ catheter, two clinical trials totaling 140 patients in the acute setting demonstrated no CAUTI events. In addition, other adverse catheter-related events were significantly reduced (blockage, bladder spasms, hematuria, and leakage).*Finally, the wait is over and the DuetteTM technology has been demonstrated.

Acute Trial Highlights:

Facility A: Thought-leading teaching institution (Level One Trauma Center)

  • Experiencing an unacceptable level of CAUTIs
  • Trialed many different catheters before Duette™
  • Identified a trial area for the Duette™ to be piloted
  • Replaced common Foleys with Duette™ catheter
  • Trial was a retrospective comparative
  • Nothing other than the Duette™ changed in patient selection, insertion technique, and removal
  • Poiesis Medical did NOT direct any aspects of the trial—this was nurse driven
  • Pulling together data for publishing, abstract will be released first

Facility B: Part of a nationally-recognized hospital conglomerate (Level One Trauma Center)

This trial mirrored Facility A’s protocols. The results and general experiences were the same. Similarly, pulling together data for publishing, abstract will be released first.

  • No Duette™ complications experienced (product failures, other patient adverse events)
  • Nurse acceptance was high (especially after reviewing Poiesis’ videos)
  • 100% reduction of CAUTIs at both facilities

*References and documentation available upon request.

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