TecTraum Announces Completion of Multi-Site Clinical Trial Using the pro2cool® Device for the Treatment of Concussions | national company

CLEVELAND–(BUSINESS WIRE)–May 3, 2022–

TecTraum Inc., dedicated to providing the first point-of-care treatment for concussions, announced full enrollment status for a clinical trial that began in fall 2019 using its flagship technology, pro2cool ® .

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The pro2cool ® system is a new non-invasive hypothermic therapy device designed to reduce the severity of concussion symptoms and allow patients to return to their pre-injury baseline more quickly. The device provides localized cooling to the head and neck to lower the temperature of the blood before it enters the brain. In previous clinical trials, researchers have observed significant improvements in clinical outcomes with brain cooling within days of concussion.

Following successful pilot studies, clinical researchers enrolled 174 patients between the ages of 12 and 21 in the largest known concussion therapy trial to validate the system’s efficacy, safety and tolerability. “As the study’s principal investigator, we are grateful for the hard work of the Akron Children’s Hospital research team. We also appreciate the coordination and communication demonstrated in this study by all investigators in this multicenter effort. – Dr. Joseph Congeni, Akron Children’s Hospital

According to the US Centers for Disease Control and Prevention (CDC), up to 3.8 million sports and recreation-related concussions occur each year in the United States alone. In addition, from 2001 to 2012, the rate of emergency room visits doubled for the treatment of children with concussions. With the pro2cool ® system receiving Food and Drug Administration (FDA) designation as a Breakthrough Device, TecTraum is strongly positioned to revolutionize concussion treatment and provide an essential medical device for young athletes.

Clinical and development partners

Four leading pediatric medical centers served as sites of investigation – CS Mott Children’s Hospital at the University of Michigan, Children’s Hospital of Akron, Children’s Hospital of Dayton and the Medical Center of Cincinnati Children’s Hospital, recently named by US News and World Report as the 2021 Best Children’s Hospital in the Midwest and the fourth-largest children’s hospital in the nation.

TecTraum developed pro2cool ® through a partnership with Nottingham-Spirk, a world renowned design company and developer of many successful medical devices.

“We are grateful to our research team at the University of Michigan and to the young athletes and families who were eager to participate in this project,” said Ingrid Ichesco, MD, pediatric sports medicine specialist at Children’s Hospital. CS Mott of the University of Michigan and researcher. at Michigan Medicine.

“Patients and families appreciate exploring non-drug therapy that can be used after a concussion. »

Hypothermic therapy (“cold therapy”) has been shown to be clinically effective in a variety of cardiovascular injuries, including cardiac arrest and myocardial infarction (heart attack). The physiological neuroprotective benefit of cooling the injured region is thought to occur at the cellular level. By interrupting the body’s natural localized inflammatory response with the introduction of cold therapy, the cellular metabolic cascade is attenuated, thereby minimizing the resulting damage caused by the body in response to injury.

“Although pro2cool ® was originally designed for sports-related concussions, TecTraum sees potential applications for its product outside of youth sports. Whether sustaining a concussion on or off the field, TecTraum’s goal is to provide immediate and effective relief that will limit brain damage and improve patient outcomes. – John Zak, CEO of TecTraum

TecTraum expects to submit clinical trial data to the FDA for marketing clearance review later this year 2022, with a commercial launch of the pro2cool® system in Q1 2023.

About TecTraum Inc.

TecTraum Inc. is a team of leading biomedical engineers, successful entrepreneurs, and current and former professional athletes who are passionate about developing breakthrough technologies for the treatment of concussions. At TecTraum, science comes before sales. TecTraum’s pivotal clinical trial aims to benefit the medical field by providing data-driven results and research-based solutions for the treatment of concussions that have been shown to be safe and effective for all users.

For more information about pro2cool ® or a partnership with TecTraum, visit www.pro-2-cool.com.

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SOURCE: TecTraum Inc.

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PUBLISHED: 05/03/2022 08:00 AM/DISC: 05/03/2022 08:02 AM

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