Tusker Medical, Inc.’s Medical Device-Drug Combination Product FDA Approval


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.

Tusker Medical develops a suite of pediatric-focused technologies designed to enable placement of tubes in the comfort of an office environment, thus avoiding general anesthetics.

The matter was handled by partners Jonathan Kahan (Picture), 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.

Involved fees earner: Erkang Ai – Hogan Lovells; Michael Druckman – Hogan Lovells; Wil Henderson – Hogan Lovells; Jonathan Kahan – Hogan Lovells; Arthur Kim – Hogan Lovells; George O’Brien – Hogan Lovells; Randy Prebula – Hogan Lovells; Jodi Scott – Hogan Lovells; Craig Smith – Hogan Lovells;

Law Firms: Hogan Lovells;

Clients: Tusker Medical, Inc.;

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Author: Ambrogio Visconti