CLEVELAND--(BUSINESS WIRE)--TecTraum Inc., dedicated to providing the world’s first point-of-care treatment for concussions known as pro2cool®, announces today that the American Medical Association (AMA) has issued a new Category III Current Procedural Terminology (CPT®) code to help clinicians treat sports-related concussion symptoms with its flagship technology, pro2cool®. The AMA recognizes that healthcare technology evolves rapidly and developed Category III codes to recognize emerging technologies as a means of treating patients with noninvasive measures. CPT® is a registered trademark of the American Medical Association.
The pro2cool® system is a novel, noninvasive hypothermic therapy device designed to reduce the severity of concussion symptoms and allow patients to return to their pre-injury baseline sooner. The device provides localized cooling for the head and neck to lower blood temperature before it enters the brain. In previous clinical trials, researchers observed significant improvements in clinical outcomes through the cooling of the brain within days of the concussion.
According to the U.S. Centers for Disease Control and Prevention (CDC), as many as 3.8 million sports and recreation-related concussions occur each year in the United States alone. Additionally, from 2001 to 2012, the rate of emergency room visits doubled for treating children with concussions. The AMA’s website publishes updates of the CPT® Editorial Panel of the Category III codes in July and January, and they provide important clinical information. CPT® codes are used by Government payers and commercial health plans for reimbursement, but they also are intended to be used for data collection to validate more widespread usage or to provide documentation for the Food and Drug Administration (FDA) approval process.
“This new recognition by the American Medical Association represents a major milestone for pro2cool® and captures the importance of the advancement and evolution of new technologies in the healthcare environment,” said John Zak, MD, TecTraum’s CEO. “TecTraum is strongly positioned for revolutionizing the treatment of concussions and providing an essential medical device for young athletes. The Category III CPT® issuing brings us one step closer to delivering noninvasive concussion therapy to patients and will allow for important data collection needed to expand our usage beyond sports-related injuries.”
The new Category III CPT® code for pro2cool® was awarded on July 1, 2022, however, is not able to be used in medical billing until TecTraum receives market authorization from the FDA. The new code that was awarded to the company (CPT 0776T) is defined as the following:
- Therapeutic induction of intra-brain hypothermia, including placement of a mechanical temperature-controlled cooling device to the neck over carotids and head, including monitoring (e.g., vital signs and sport concussion assessment tool 5 [SCAT5]), 30 minutes of treatment.
The pro2cool® device is not currently cleared for use by the FDA. TecTraum anticipates submission of clinical trial data to the FDA for consideration of market authorization later this year 2022, with a commercial launch of the pro2cool® system early next year 2023.
About TecTraum Inc.
TecTraum Inc. is a team of leading biomedical engineers, physicians, entrepreneurs, and current and former professional athletes who are passionate about developing breakthrough technology for the treatment of concussions. At TecTraum, science comes before sales. TecTraum’s pivotal clinical trial is aimed at benefitting patients and the medical field by providing data-driven results and research-based solutions for the treatment of concussions that are proven safe and effective for all users.
For more information about pro2cool® or partnering with TecTraum, visit www.pro-2-cool.com.
