TecTraum is committed to developing medical devices that can mitigate the effects of brain trauma.
What is Pro-2-Cool™?
The Pro-2-Cool™ System by TecTraum Inc. is our flagship product. Designed for ease of use and the ability to quickly assembled in the field, this device will potentially bring instantaneous relief to athletes immediately following a concussion. Pro-2-Cool™ is built to provide cooling for the head and neck, lowering blood temperature before it enters the brain. As a low-risk device, safety and effectiveness are dependent on following the instructions for use. Currently, all operations of Pro-2-Cool™ are limited to trained medical personnel only.
Class II Medical Device
A class II medical device is an FDA classification that defines a device as not being a significant risk to patients. We anticipate receiving this designation and will be proven efficacious during the largest clinical trial of its kind. It will be the only FDA cleared apparatus for treating concussions and we are excited for what the future holds.
"Going through the process of designing and developing the Pro-2-Cool™ system and learning more about cooling therapy as a neuro-protectant gives us the confidence to say, not only is it possible hypothermic cooling of the brain works for treating concussions, but it is rather probable."
— Sam Williams and Justin Fargas, former NFL football players.
Built for Functionality
Pro-2-Cool™ is relatively portable and rugged enough to accompany any team’s athletic event, yet small and precise enough for any emergency room or doctor's office. The goal of creating this product was to make a tool that could be used in almost any environment, safely and efficiently.
Concussions are much too frequent among youth athletes, with the most severe damage occurring in the immediate hours following a minor traumatic brain injury. Having a product that can be quickly assembled and applied to a person in the precious minutes immediately following a concussion will prove to be invaluable. TecTraum is optimistic that Pro-2-Cool™ can provide immediate relief that will prevent serious, long-term brain damage.
How Does it Work?
The Pro-2-Cool™ System is a non-invasive hypothermic therapy ("cold therapy") device that provides localized cooling of the head and neck. A liquid coolant is chilled to 6°C (42.8°F) by the device and then circulated through the wearable garment. This creates a conductive heat transfer from the scalp and carotid arteries, to achieve cooling of the brain. Like icing a hurt knee or ankle, colder blood will reduce edema, reduce cellular damage, and help insulate the brain from further damage while it is in a weakened state.
TecTraum Pro-2-Cool™ utilizes cooling therapy – a technology that is already deployed as standard of care for many other health conditions:
• Cardiac arrest (electrical)
• Some forms of Myocardial Infarction or “Heart attack” (circulation)
• Hypoxic Ischemic Encephalopathy or “HIE” (brain injury in newborns)
TecTraum Pro-2-Cool™ cooling therapy improves the outcome in many ways:
• Hyperthermia or increased brain temperature makes the brain more susceptible to damage. Cooling therapy helps to lower intra-brain temperature, rendering it less susceptible to damage.
• An injured brain that is also hot must work harder metabolically, causing increased damage at the cellular level. Cooling therapy slows the metabolic cascade, resulting in less damage.
• The concussed brain is susceptible to edema (swelling) at what is known as the blood-brain-barrier – cooling therapy helps to reduce this effect after impact.
Taking Advantage of the Body's Natural Bottleneck
The brain is the most important organ of the body. Protecting it is the purpose of Pro-2-Cool™ Cooling the blood that enters the brain can reduce additional damage. Luckily, the neck is a natural bottleneck for our body's arteries and blood.
This allows for a relatively simple device to effectively chill the blood.
Our device takes full advantage of human anatomy and maximizes the amount of temperature reduction to blood as it enters the brain. There are no known side effects of mild surface cooling therapy, which allows for extensive field testing of the product.
When designing Pro-2-Cool™ the goal was to create a practical tool that worked. We strived to keep it simple with as few moving parts as possible, yet precise in how cooling is delivered. The device is meant to be assembled in minutes and put to work immediately after a concussion occurs.
How it Works
• Patients are instructed to sit down before the medical device is applied. The total application time during the trial is 30 minutes.
• After the patient is in a comfortable, sitting position, the head and neck garment is affixed. Finding the right balance of comfort when fitting the garment is imperative for treating adolescent subjects.
• A health professional monitors the patient's blood pressure. Vitals are checked, and the entire process is conducted under medical supervision.
Long-Term Concussion Effects
Nearly 4 million sports related concussions are reported each year. Traumatic Brain Injury (mTBI) is more than just a NFL problem. Youth athletes playing contact sports are at risk of receiving head injuries. Every year, awareness grows, and more injuries are reported.
Reporting mTBI is not enough, there needs to be a solution to the injury itself. Currently, the prescribed method of treatment includes resting the brain. While important, we feel this does not go far enough to relieve the risks associated with such a serious injury.
As an example, when a player sprains their ankle, ice is applied to reduce swelling and relieve pain. The same immediate care needs to be given to concussions. It is with the mindset of providing instant relief to concussions that our product, Pro-2-Cool™ was designed and built.
Teen Athletes Concussion Rates
The first demographic Pro-2-Cool™ strives to help are teen athletes. Each year, there are upwards of 500,000 mild traumatic brain injuries, with football being responsible for over 100,000. Being part of a solution for the growing occurrences of concussions is what TecTraum is all about.
Adolescents are at an extreme risk of injury because their bodies and brains are still developing. The frontal lobe, where decision making occurs, does not fully develop until the early 20's. Concussions can be detrimental to childhood development.
Parents understand, anything that can be done to alleviate medical concerns is a process worth undertaking. Pro-2-Cool™ is portable, reliable, and initial studies have shown great promise, especially for teens.
TecTraum believes in science before sales. Concussions are a serious issue and our trials, currently being conducted, are designed to provide accurate results and ultimately help protect teens and families.
Our trial parameters are expanding, and Pro-2-Cool™ is now being tested in schools where thousands of teen athletes can benefit from cooling therapy.
Who we are
Made up of businessmen, doctors, and former NFL players, TecTraum is advancing medical technology. Focused on creating medical devices that are proven to treat trauma induced injuries, our team is made up of experienced professionals.
The founding of TecTraum was in response to the demand for solutions to concussions. As more research becomes available, it is ever more apparent how dangerous brain injuries are.
What We Strive to Achive
Creating a culture of transparency, based around treating concussions is needed in the sporting world. It is the ambition of TecTraum to increase the conversation around concussion relief. Pro-2-Cool™ provides a possible solution to the problem.
While still in the initial testing phases, we are confident that Pro-2-Cool™ will be the first FDA cleared device to reduce the damages from concussions and decrease recovery times.