Dignitana, a world leader in medical scalp-cooling technology, has entered an exclusive partnership with Boa Technology, creator of the award-winning, patented Boa system, to produce an adaptive, precision fit cap for use with the DigniCap scalp cooling system.
DigniCap was cleared by the U.S. Food and Drug Administration in December 2015, and is the first medical scalp cooling device to receive FDA clearance.
The DigniCap scalp cooling system features a patented tight-fitting silicone cooling cap that is placed directly on the head, and an outer neoprene cap that insulates and secures the silicone cap. A liquid coolant circulates throughout the silicone cap, delivering consistent and controlled cooling to all areas of the scalp.
The cap is fitted to the head, and the temperature of the scalp is lowered, resulting in vasoconstriction with reduced delivery of chemotherapy to the scalp, as well as reduced cellular uptake of drugs due to decreased intra follicular metabolic rate. These factors together reduce the risk of chemotherapy-induced hair loss.
The Boa system will be incorporated into the outer neoprene cap, where it provides micro-adjustability and an enhanced level of fit, function and comfort customized for each individual patient.
During scalp cooling therapy, which is administered as patients undergo chemotherapy infusion, the Boa system will help to ensure complete coverage to assure consistent cooling to all areas of the scalp.
Boa's single-handed adjustment makes it easy for clinicians and cappers to fine-tune the fit of the cap at any time throughout the infusion process.
"Proper fit is critical to scalp cooling success," said William Cronin, CEO of Dignitana, Inc.
"Boa is the uncontested leader in precision fit technology for wearable medical devices, and we are especially excited to announce this exclusive partnership on the eve of the one-year anniversary of our FDA clearance.
“Together, we are committed to giving breast cancer patients the best possible option for avoiding chemotherapy related hair loss."
The Boa system originated in 1998 in the snowboard industry to provide customized comfort and smooth, even closures in boots without pressure points. Designed to address deficiencies found in traditional snowboard boot closures, Boa innovations opened the door to improved fit and performance in multiple sport categories.
Today, Boa Technology provides fit solutions across many industries, including a host of prescription orthotics and prosthetics and over-the-counter support braces. Boa's partnership with Dignitana brings it solidly into a new sector of the wearable precision medical solutions.
"We are delighted to partner with Dignitana and applaud the innovation and clinical rigor that makes them a world leader in scalp cooling therapeutics," said Bret Bostock, Global Manager for Boa Technology's Medical division.
"We recognize the critical impact that this device brings to cancer patients across the country, and we are enormously pleased that our technology is being used to enhance quality of life for so many in this meaningful way."
In its first year of production, the DigniCap® system has signed contracts with 53 medical centers across 17 U.S. states. Enhanced outer caps featuring the Boa system will be available in 2017.