AventaMed, a commercial stage pediatric ear, nose and throat (ENT) medical device company, has developed the Solo Tympanostomy Tube Device (Solo TTD). This novel device enables ear tube surgery to be performed in the doctor’s office with local anesthesia, rather than the expensive operating room under general anesthesia. The insertion of ear tubes to treat infections and hearing loss, is the number one reason why children undergo surgery. Over 2 million children require this procedure annually, resulting in a significant, $1B market need.
The Solo TTD consolidates the required surgical instruments into one ergonomic, handheld device with a proprietary ear tube pre-loaded at its tip. The device allows an ENT surgeon to rapidly place the ear tube enabling the procedure to be carried out in-office with local anesthesia, eliminating the potential risks of general anesthetic or a costly trip to the hospital operating room.
AventaMed has a highly experienced executive team and Board and has raised $5.5m to complete the development and early clinical studies of the device. The device is CE marked and available in Europe where AventaMed has successfully treated >100 patients. Future funding will support the pivotal clinical study for FDA clearance and commercialization. Reimbursement codes are in place for surgery and large momentum is building for in-office codes in the USA. The Solo TTD device patent is issued, with further IP filed and a Freedom to Operate Analysis complete.
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