Preceptis Medical Receives FDA Clearance for Expanded Labeling for Hummingbird System
Innovative office procedure is general anesthesia and OR-free
MAPLE GROVE, Minn.--(BUSINESS WIRE)-- Preceptis Medical, Inc., an innovative surgical technology company dedicated to providing less invasive options for pediatric patients, today announced U.S. FDA clearance for expanded indications for use for the Hummingbird® Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. Previously cleared in children 6-24 months, this new labeling allows in-office procedures in all children six months and older.
The Hummingbird TTS uniquely combines the separate tools and steps performed in standard ear tube procedures into one comprehensive device. With the Hummingbird, otolaryngologists or ear, nose and throat specialists (ENTs) can now make an incision and deliver an ear tube using a single pass in the office environment. The device eliminates the need for fasting, general anesthesia, and an operating room – all with 98% success in the office setting.1 The procedure requires only a topical anesthetic, and parents can be present with their child to provide further comfort.
“This device has been a gamechanger for patients and families. Having their child’s ear tubes placed in a quick office visit is comforting to parents, and they have been happy with the results. We look forward to offering this procedure to even more eligible patients,” said Dr. Nathan Page, pediatric otolaryngologist at Phoenix Children’s, one of the nation’s largest pediatric health care systems.
“When I first began working with the Preceptis team on the clinical study, my hope was that one day the Hummingbird would be available for all of my pediatric patients,” said Dr. Shelagh Cofer, Division Chair of Pediatric Otolaryngology at the Mayo Clinic. “I am proud to have been a part of the study and excited to see the culmination of years of work in this fully expanded label.”
Approximately one million children undergo ear tube procedures annually in an operating room in the United States alone.2 In-office ear tube placement using the Hummingbird can save thousands of dollars per patient by shifting the procedure from the operating room to the office setting.
“Our goal when we started Preceptis was to provide a safe, simple, and less expensive ear tube procedure option to all families. This final label expansion represents the work of many ENTs, clinical study coordinators, and team members, and I appreciate the trust parents put into Preceptis and our ENTs while participating in the study,” said Steve Anderson, Chief Executive Officer, Preceptis Medical.
“Parent and ENT feedback has been extremely positive, and we have seen ever increasing demand for the in-office ear tube procedure option as more parents, pediatricians, and ENTs become aware of the product,” shared Greg Mielke, Chief Commercial Officer for Preceptis. “We have also received strong support from the insurance community both locally and nationally, and this expanded label will increase patient access and improved health equity in our communities.”
Preceptis Medical has successfully completed its initial launch and plans to build on strong momentum and demand from parents and providers through a larger commercial launch to expand access to this option in the future.
About Preceptis Medical
Preceptis Medical was founded by parents, including a pediatric anesthesiologist, who wanted to design products focused on improving the lives of children. The Hummingbird device was developed in partnership with leading pediatric ENTs to simplify ear tube procedures while reducing the risks associated with the use of general anesthesia in children. The company’s goal is to broaden the options available to ENTs and parents, focusing on the safety and comfort of the child, while reducing healthcare costs. The Hummingbird® Tympanostomy Tube System (TTS) is FDA 510(k) cleared for use in children 6 months and older. For more information, visit www.hummingbirdeartubes.com.
1 FDA 510(k) files K200952 and K221254
2 IBM Marketscan® Commercial Claims and Medicaid Database.
Source: Preceptis Medical, Inc.