TecTraum, Inc.
TecTraum Inc. is pioneering the advancement of concussion therapy with the development of pro2cool®, the world’s first FDA-designated Breakthrough Device for post-concussion cooling therapy. The company’s mission is to provide a safe, effective, and easy-to-use medical device that can be deployed in various settings to reduce the signs and symptoms of concussion, particularly in athletes. TecTraum emphasizes science before sales, conducting extensive clinical trials to validate the safety and efficacy of its technology. Their vision is to revolutionize concussion treatment and improve patient outcomes both on and off the field.
Industries
Nr. of Employees
small (1-50)
Patents
Products
Selective head and neck cooling system (investigational medical device)
A portable, non-invasive device comprising a soft head-and-neck garment and a temperature-control unit designed to deliver localized hypothermic therapy to patients with suspected concussion. Treatment protocol described as two 30-minute sessions delivered within an eight-day window post-injury with a reported treatment setpoint of 6°C; intended for point-of-care use by trained clinicians or certified athletic trainers under prescription.
Selective head and neck cooling system (investigational medical device)
A portable, non-invasive device comprising a soft head-and-neck garment and a temperature-control unit designed to deliver localized hypothermic therapy to patients with suspected concussion. Treatment protocol described as two 30-minute sessions delivered within an eight-day window post-injury with a reported treatment setpoint of 6°C; intended for point-of-care use by trained clinicians or certified athletic trainers under prescription.
Services
Design and conduct of a multi-site clinical trial enrolling adolescent and young adult participants to evaluate safety, tolerability, and efficacy of a localized head/neck cooling treatment for concussion.
Establishing collaborations with pediatric and academic hospitals to act as investigative sites and principal investigators for device evaluation.
Design and conduct of a multi-site clinical trial enrolling adolescent and young adult participants to evaluate safety, tolerability, and efficacy of a localized head/neck cooling treatment for concussion.
Establishing collaborations with pediatric and academic hospitals to act as investigative sites and principal investigators for device evaluation.
Expertise Areas
- Concussion therapy development
- Multi-center clinical trial management
- Pediatric clinical research
- Point-of-care medical device design
Key Technologies
- Selective head and neck hypothermic therapy
- Temperature-controlled medical device software
- Wearable soft-garment cooling interfaces
- Point-of-care portable medical devices
News & Updates
TecTraum Inc. announced that the American Medical Association (AMA) has issued a new Category III CPT code to help clinicians treat sports-related concussion symptoms with pro2cool®. This milestone supports the therapeutic assessment and treatment of concussions and enables important data collection for future FDA approval and reimbursement.
TecTraum completed enrollment for a large, multi-site clinical trial of pro2cool®, enrolling 174 patients aged 12-21. The trial, conducted at leading pediatric hospitals, aims to validate the effectiveness, safety, and tolerability of the device for concussion therapy.
The U.S. Food and Drug Administration (FDA) designated pro2cool® as a Breakthrough Device, recognizing its potential to provide more effective treatment for concussions. This designation positions TecTraum to revolutionize concussion care, especially for young athletes.
An educational article explaining the physiological effects of concussions, symptoms, and the healing process, emphasizing the importance of proper diagnosis and recovery.
This article discusses advancements in helmet technology, including custom-fit helmets and their role in reducing concussion risk, as well as scientific breakthroughs in concussion detection.
Explores the prevalence of concussions in baseball, the evolution of treatment protocols, and the impact of concussions on athletic performance.
TecTraum Inc. announced that the American Medical Association (AMA) has issued a new Category III CPT code to help clinicians treat sports-related concussion symptoms with pro2cool®. This milestone supports the therapeutic assessment and treatment of concussions and enables important data collection for future FDA approval and reimbursement.
TecTraum completed enrollment for a large, multi-site clinical trial of pro2cool®, enrolling 174 patients aged 12-21. The trial, conducted at leading pediatric hospitals, aims to validate the effectiveness, safety, and tolerability of the device for concussion therapy.
The U.S. Food and Drug Administration (FDA) designated pro2cool® as a Breakthrough Device, recognizing its potential to provide more effective treatment for concussions. This designation positions TecTraum to revolutionize concussion care, especially for young athletes.
An educational article explaining the physiological effects of concussions, symptoms, and the healing process, emphasizing the importance of proper diagnosis and recovery.
This article discusses advancements in helmet technology, including custom-fit helmets and their role in reducing concussion risk, as well as scientific breakthroughs in concussion detection.
Explores the prevalence of concussions in baseball, the evolution of treatment protocols, and the impact of concussions on athletic performance.