Medical Device Company CoolTech Brings Down Fevers
A medical device start-up company in Federal Hill in Baltimore is making progress in receiving approval from the Food and Drug Administration (FDA) in the development of their body temperature-cooling technology.
CoolTech LLC is the company behind the medical device, CoolStat, which works to cool the body through a process known as evaporative cooling. Warm, dry air is pumped through a patient’s nasal passages, in the nose and out of the mouth, while small, controlled spritzes of saline water are delivered through the device into the nose. The warm air passing over the moistened nasal passages works to cool the body as the saline water evaporates, lowering the body temperature and bringing down fever. “The idea is to ‘trick’ the body to cool itself using nothing but warm dry air,” explains CoolTech CEO Brian Lipford.
Development for CoolStat came about in 2012, through Lipford’s work with Key Tech, a medical device development firm in Baltimore, when he met Harikrishna Tandri, M.B.B.S., M.D., co-director of the Arrhythmogenic Right Ventricular Dysplasia (ARVD) Program at Johns Hopkins Hospital. Dr. Tandri, a cardiologist with research interest in cooling patients quickly following cardiac arrest, had developed the idea of using dry air to induce evaporative cooling and was interested in getting his idea from early concept to commercialization. In early 2012, he and Lipford launched CoolTech LLC to make that happen.
A major benefit of the CoolStat device is that it is non-invasive. “The fact that it is non-invasive makes it very easy to apply, and since it acts using your body’s own mechanism to take energy out of your system with a process that uses no chemicals, it means less damage to tissue,” says Dr. Tandri. “There is also a smaller risk of infection for the patient compared to other cooling mechanisms that require more invasive techniques, such as a using a catheter.”
Bringing a fever down can also greatly increase survival outcomes, says Lipford. “The medical community has found that fever is very bad, even relatively low fevers, especially in the intensive care unit,” he explains. “Researchers found that outcomes and overall health of the patients coming through the ICU significantly improves if they actively manage fever.” In addition, if a patient has a cardiac arrest outside of the hospital, their chances of survival are less than 10 percent. But if the patient is cooled immediately after the event, their chances of survival can improve by a factor of two to three.
William DeMore, a mechanical engineer working on the medical device for Key Tech, notes an added benefit to the device in that it is less likely to cause shivering in a patient. “When temperature sensors on the outer surface of your skin get too cold, you start to shiver, which stops us from being able to cool you” says DeMore. “By cooling only on the inside of the body with the dry air flow, we don’t see these skin sensors being triggered, so we can keep the shivering response from happening.”
Dr. Tandri agrees. “It appears that when you use the CoolStat nasal system of cooling, you don’t encounter the undesirable response of shivering,” he explains. “It negates the whole process when you have to use medicines to stop the shivering response in the patient.”
Lipford notes the road hasn’t been easy regarding development of CoolStat, citing initial struggles with obtaining funding. CoolStat applied for and received a little over $4 million from the NIH, Heart Lung and Blood Institute to look at cooling post-cardiac arrest. Once they had early prototypes, they were able to complete pre-clinical testing in pigs, as well as early feasibility testing in humans. “The sum of this work allowed us to go out to a Series A round from angel investors and get additional funding,” notes Lipford.
Between the design tasks, proving safety, building prototypes, formal FDA design controls, and testing in animals and then humans, he stresses that new medical device companies must be in it for the long haul. “People need to realize that introducing a new medical device or tool is a multi-million dollar, multi-year project,” he says. “This is a long, torturous path that is very expensive; if you’re not up for that, don’t even start.”
Lipford notes two programs through the State of Maryland that were helpful for CoolStat to secure additional funding were the Maryland Industrial Partnerships Program (MIPS) and the Maryland Bio Tax Credit Program, formally known as the Maryland Biotechnology Investment Incentive Tax Credit.
The Maryland Industrial Partnerships Program (MIPS) provides funds to encourage partnerships between Maryland companies and research at Maryland universities. MIPS provides matching funds to help Maryland companies, such as CoolTech, pay for university research. The technology for CoolStat is currently licensed out of Johns Hopkins. Lipford says that they applied for and received $90,000 to augment the cost of some human trials, scheduled to start later this year.
Launched in 2007, the Maryland Bio Tax Credit Program, as it is commonly known, provides tax credit to encourage private investment in qualified Maryland biotechnology companies. Funding is distributed in the form of a refundable tax credit equal to 50 percent of an investment to eligible investors. While the recipient companies must be based in Maryland, investors from outside the state and around the world are eligible and encouraged to participate.
“Through an application with the state, I have to first prove that I meet certain criteria to be considered a ‘Qualified Maryland Biotechnology Company.’ Once I am qualified, I can come to you as an investor and say, ‘If you invest $100,000 in my company, you will get $50,000 back from the State of Maryland’ – it’s not a deduction, but a credit on your taxes,” Lipford explains. “Investing in medical devices is risky and investors know that. This tax credit program helps make it easier for investors (to take that risk.)”
CoolStat is one product with multiple indications. Future plans include launching a fever study clinical trial at the University of Maryland, Baltimore and another at Virginia Commonwealth University, which will study the effect of cooling the body on ambulatory patients who have a cardiac arrest outside the hospital. Approvals from the FDA will generate two Investigational Device Exemptions or IDEs, one for each study. An IDE allows an investigational device such as CoolStat to be used in a clinical study in order to collect safety and effectiveness data. In addition, the Department of Defense (DoD) has funded early studies to see if the device can be used in a combat setting for traumatic brain injury, to help soldiers survive these serious events. Lipford explains, “Research shows that if you cool them soon after the trauma, it can improve the likelihood that they will recover and survive.” He adds, “Its ambulatory use would be beneficial since it’s lightweight and easy to install.” Currently, testing is underway at Hopkins in one of their pig labs to test out the device over varying lengths of use and duration.
CoolStat submitted their second-round follow-up application to the FDA in late October, after a lengthy initial review. As the FDA issues a ruling within 30 days of receiving the application, Lipford hopes to obtain an approved IDE soon.
“We’re really looking forward to getting CoolStat into more clinical trials and collecting data,” says Lipford. “We’re excited to see how CoolStat can improve survival outcomes regarding cardiac arrest and fever.” I95
“Researchers found that outcomes and overall health of the patients coming through the ICU significantly improves if they actively manage fever.”