Hogan Lovells advises Tusker Medical on FDA approval of breakthrough therapy for children with chronic ear infections
Washington, D.C., 11 December 2019 – Global law firm Hogan Lovells recently advised Menlo Park, Calif.-based start-up Tusker Medical, Inc. on FDA approval of a medical device-drug combination product, the Tula System.
Every year in the U.S., approximately 700,000 children undergo tympanostomy tube surgery to address recurrent ear infections or persistent fluid in the middle ear. The vast majority of these procedures are conducted under general anesthesia, incurring the costs of the operating-room environment and exposing young children to risks associated with general anesthetic agents.
The Tula System is a suite of pediatric-focused technologies designed to enable placement of tubes in the comfort of an Ear, Nose, and Throat office environment, thus avoiding the operating room.
Our team assisted Tusker Medical with the regulatory strategy, ultimately resulting in approval of this combination product through the medical device PMA pathway. Our work assisted with the overall clinical and regulatory strategy, obtaining breakthrough device designation, and negotiating the approval of the Tula System.
The matter was handled by partners Jonathan Kahan, Randy Prebula, and Jodi Scott, along with senior associate Arthur Kim and associates Wil Henderson and Erkang Ai. Partners Mike Druckman and Craig Smith, and senior associate George O’Brien also provided support.
For further information on FDA’s approval of the Tula System, click here.