TecTraum Inc. develops pro2cool®, an investigational medical device that delivers localized cooling to the head and neck as a potential treatment for concussion. Founded when professional athletes joined engineers to address the lack of concussion therapies, the company has studied the system through a multi-center clinical trial involving pediatric hospitals and high school athletes in Ohio and Michigan. The device received FDA Breakthrough Device designation in June 2021 but has not received FDA market authorization.
FDA Breakthrough Device Designation
compliance_program
Hybernia Medical, INCFounded and managed since 2006 by physicians and inventors, Hybernia Medical develops endovascular medical technology for selectively cooling the brain during acute ischemic stroke treatment. The Mineola company’s patented Delta-H Cooling Technology is designed to deliver rapid, controlled hypothermic protection through the same arterial access used for endovascular stroke care. Originally spun off from Columbia University, Hybernia is a clinical-development-stage company whose technology has advanced from bench engineering to preclinical testing and a first-in-human study.UNIONDALE, NY
BrainCoolBrainCool provides the IQool System, an advanced, non-invasive, non-adhesive temperature management system consisting of soft silicone pads and a control unit. The company also provides clinical training, customer service, and assistance with hospital acquisition of the system.ANNAPOLIS, MD
Cryothermic SystemsFounded in 2008 in Cleveland, Ohio, Cryothermic Systems develops medical devices that cool the body rapidly and noninvasively, led by its Cryo Cooling System for targeted temperature management. Its activated cooling packs reach -5°C in seconds and are designed to start cooling in the field before patients reach emergency, cardiac, or intensive care. The company was founded by Harvard-trained cardiothoracic surgeon Aqeel Sandhu and was formerly known as Life Core Technologies.CLEVELAND, OH
Innovative Medical Equipment, LLCInnovative Medical Equipment, LLC manufactures ThermaZone thermoelectric thermal therapy devices that provide controlled heat and cold therapy without ice. Its product range includes reusable and single-patient-use therapy pads, dual-modality braces, and related accessories for clinical, in-home, orthopedic, pain-management, rehabilitation, and Veterans Affairs use.BEACHWOOD, OH