BrainCool AB, a Swedish medical device company that specializes in medical cooling technology for therapeutic hypothermia (brain cooling) and oncology, has completed patient recruitment in the Scandinavian multi-center pivotal trial of 180 patients to investigate its Cooral® System for prevention of oral mucositis (OM), one of the most debilitating side-effects of both standard and high-dose chemotherapeutic oncology treatments.
The intra-oral cooling device includes a disposable and thermostatically controlled mouthpiece that fills with a hypothermic liquid, which circulates through the system’s channels. As the coolant gradually reaches and maintains a consistently controlled temperature, the system reduces blood flow and exposure of tissue to radiation or chemotherapeutic agents, thus preventing adverse mucosal erythema and ulcerative reactions.
OM significantly affects the quality of life for cancer patients in terms of pain and ability to eat, swallow, and talk. The symptoms are often of such severity that they result in an interruption and curtailment of therapy. OM can also lead to dose reduction of the cancer therapy and treatment delays. In many cases, these patients require hospitalization. OM has a direct and significant effect on the duration of disease remission and cure rates due to its dose-limiting toxicity. In some cases, risk for infection threatens survival, and there is a significant impact on quality of life and cost of care. The presence of OM is a major driver of healthcare cost.
In the United States, BrainCool is conducting a de novo 510(k), with the aim of obtaining product and market clearance in the United States. The de novo process is used for cases in which a device is novel and there is therefore no suitable predicate device to support a standard 510(k) submission. The new device must also present no more than moderate risk.
Clinical Trial and Regulatory Status
The Nordic clinical trial of 180 patients have been recruited over a period of two years across five important medical centers, including the lead site, Karolinska Universitetsjukhuset in Stockholm, Sweden. Clinical data from the Nordic trial will be applicable for FDA submission. BrainCool is currently working on a module-based application wherein the first two modules contain quality routines for product development and manufacturing. The third and final module will contain clinical data from the completed pivotal trial and will be submitted as soon as the results are available. Thereafter, FDA will review the documentation and decide on product and market approval.
BrainCool has been granted FDA Expedited Access Pathway (EAP) status and will be given priority review for the system. EAP projects address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), or are eligible for de novo requests.
“With full patient recruitment for our pivotal trial, we are opening an important new door in cancer care and treatment,” says Martin Waleij, CEO of BrainCool AB. “Conclusive validation that cryotherapeutic intervention with the Cooral System can safely and effectively prevent the excruciating side-effects of oral mucositis is not just a major medical milestone, it’s actually a matter of life and death.”
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