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Devices FDA

 News Release - June 23, 2020

Preceptis Medical announces the Hummingbird(R) device has received FDA 510(k) clearance for ear tube placement in young children in the ENT's office without general anesthesia

Preceptis Medical has received FDA 510(k) clearance for Hummingbird in-office use in young children following a Pivotal Clinic Study that treated over 200 children1, 2

99% of children successfully received ear tubes in the ENT surgeon's office with only a topical anesthetic. The median bi-lateral procedure time was 5 minutes1

Annually, close to 1 million children receive ear tubes in the operating room under general anesthesia in the United States, making it one of the most common pediatric surgeries3, 4


MAPLE GROVE, Minn., June 23, 2020 -- (Healthcare Sales & Marketing Network) -- Preceptis Medical is pleased to announce that the Hummingbird® Tympanostomy Tube System (the Hummingbird) has received US Food and Drug Administration (FDA) 510(k) clearance for use in children in the ENT surgeon's office. The Hummingbird is an innovative tool that significantly reduces trauma and procedure time for ear tube placement, enabling ENT surgeons to perform ear tube procedures (tympanostomy) in young children without general anesthesia.

Ear tube procedures are one of the most common pediatric surgeries performed under general anesthesia for young children in the United States3, 4. Preceptis Medical's innovative technology allows ENTs to offer parents and their young children a safe, convenient and less expensive option for pediatric ear tube procedures by eliminating the need for general anesthesia and an operating room.

"Feedback from ENTs, parents, and pediatricians has been extremely positive, and we are proud of what our team and investigators have accomplished, especially during this challenging time with COVID-19. This is an important milestone enabled by our partner ENTs and healthcare organizations, as well as our investors that have shared in our vision from the beginning," stated Steve Anderson, CEO of Preceptis Medical.

Using the Hummingbird, ENT surgeons performed the entire bi-lateral ear tube procedure in 5 minutes (median time) with 99% of procedures completed in the office1. Parents were able to stay with their child the entire time, the child was not required to fast prior to the procedure, and the child could immediately return to normal activities. Parental survey feedback was overwhelmingly positive on recommending the procedure to other parents as well as wanting an alternative to general anesthesia.1, 2

Dr. Shelagh Cofer MD, Otolaryngologist at the Mayo Clinic and Principle Investigator for the Hummingbird said, "The availability of a device that makes it possible to offer ear tube placement for young children in the office in a safe and effective way is a major advancement. The benefits of the option of office ear tubes are huge in terms of convenience for patients and caregivers, reduction of risk and exposure to general anesthetic, and potential cost savings as well."

Joe Delgado, CFO, mentioned, "This is personal for me. My daughter Vivian needed two sets of ear tubes. The first set was done the traditional way with an operating room and general anesthesia. The second set was done with the Hummingbird and was vastly less stressful. My wife and I experienced firsthand the positive impact of the Hummingbird on our daughter and the parent experience, and the Hummingbird has the potential to save thousands of dollars per procedure as well."

Preceptis recently closed its Series B funding and intends a pilot commercial launch in select markets in the second half of 2020.

For more information on Preceptis Medical and the Hummingbird TTS, visit www.HummingbirdEarTubes.com

Sources:
  1. K200952 510k Summary
  2. Preceptis Pivotal Clinic Study, Data on File
  3. IBM Marketscan® Commercial Claims and Medicaid Database
  4. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009:11:16


Source: Preceptis Medical

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