Tusker Medical Announces First Patient Enrollment in Pivotal Clinical Trial Assessing In-Office Pediatric Tympanostomy Tube Placement
MENLO PARK, Calif., Feb. 15, 2018 /PRNewswire/ -- Tusker Medical, Inc. today announced the enrollment of the first in-office patients in the OTTER Study, the pivotal clinical study for Tusker's TULA (Tubes Under Local Anesthesia) System. Via an approved Investigational Device Exemption (IDE), the OTTER Study will evaluate the in-office placement of tympanostomy tubes in approximately 300 children ages 6 months through 12 years old enrolled at up to 25 investigational sites in the United States and Canada.
Tympanostomy tube insertion is the most common ambulatory pediatric surgery in the United States,1 performed to treat recurrent ear infections or persistent fluid in the middle ear. "Tubes are very effective for pediatric patients, but must be inserted in the operating room under general anesthesia. This is often quite concerning for parents of small children, can be stressful for the child, requires pre-procedure fasting, and time off after the procedure" said Larry Lustig, MD, principal investigator and Chair of the Department of Otolaryngology-Head & Neck Surgery at the Columbia University Medical Center in New York City. "While general anesthesia for tube procedures is considered quite safe, there is an emerging body of research suggesting that there may be longer-term neurodevelopmental risks associated with pediatric general anesthesia. The OTTER Study will investigate a new device/drug combination product designed to enable in-office tube procedures in pediatric patients, avoiding the risks of general anesthesia."
The TULA technology consists of an Iontophoresis System, a local anesthetic, and a Tube Delivery System. In combination with the local anesthetic, the Iontophoresis System is designed to provide safe, reliable, and child-friendly bilateral local anesthesia of the tympanic membrane, enabling a viable alternative to general anesthesia. "The Tusker Iontophoresis System uses a small amount of electrical current to accelerate the uptake of the local anesthetic into the tympanic membrane," said Amir Abolfathi, President and CEO of Tusker Medical. "This provides an alternative to phenol (a denaturing acid), ear canal injections, or other local anesthesia methods, none of which have FDA approval for pediatric tympanic membrane anesthesia and are often painful or take an unacceptably long time to achieve anesthesia."
Once the tympanic membrane is numb, the Tube Delivery System is used to insert the tympanostomy tube. With a single button push, the Tube Delivery System automatically creates the myringotomy and inserts the tube in less than 500 milliseconds. The myringotomy cutter is exposed only for the very brief moment when the myringotomy is created, and is otherwise recessed within the device, an important safety feature when performing procedures in an awake child. Parents are present during the TULA office-based procedure, and younger children may sit on their parent's lap, if desired.
Sedatives or anxiolytics such as midazolam or nitrous oxide are not permitted in the OTTER study. "Most ENT surgeons are unfamiliar with or uncomfortable administering respiratory depressants in their office setting," said Sujana Chandrasekhar, MD, past President of the American Academy of Otolaryngology-Head and Neck Surgery and Tusker Medical Scientific Advisor. "The goal of the TULA technology is to provide an option for in-office pediatric tube placement that is acceptable and accessible to the broad otolaryngology community and their patients." Ototoxicity, pharmacokinetic, and adult clinical study results for the Tusker technology were submitted to FDA to assess the TULA System prior to initiation of the OTTER Study.
About Tusker Medical
Tusker Medical, Inc. (www.TuskerMed.com), headquartered in Menlo Park, CA, is a privately-held company focused on innovative technology for ENT surgeons and their patients. The TULA System for in-office pediatric tube placement is not approved for sale in the United States, and is available for Investigational Use Only. The www.goTULA.com website provides additional information regarding the OTTER study.
Use of Forward-Looking Statements
Certain statements in the press release are forward-looking statements, based on Tusker's current expectations and assumptions and that involve risks and uncertainties. Any statements contained in the press release that are not statements of historical fact should be construed as forward-looking statements. Actual results could differ materially and adversely from those projected or anticipated in the forward-looking statements as a result of a number of risks and uncertainties pertaining to Tusker's business. Furthermore, Tusker undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
1 Rosenfeld RM, Schwartz SR, Pynnonen MA, Tunkel DE, et al. Clinical practice guideline: Tympanostomy tubes in children. Otolaryngol Head Neck Surg 149(1S); S1-S35, 2013.
SOURCE Tusker Medical