On September 18, 2020 BrainCool AB, a Swedish medical device innovator, and a world leader in medical cooling technology for therapeutic hypothermia (brain cooling) and oncology, reported late-breaking clinical results of the Cooral System, a novel cooling device for the prevention of Oral Mucositis (OM), at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, BrainCool, SEP 18, 2020, View Source [SID1234565368]).

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Data was collected from a Nordic multi-center pivotal trial led by Karolinska University Hospital, Stockholm, that enrolled 182 patients with multiple myeloma or lymphoma who were scheduled to receive high-dose chemotherapy prior to hematopoietic stem cell transplantation. The abstract was presented at ESMO (Free ESMO Whitepaper) by Java Walladbegi, PhD, Oral Medicine, Department of Oral Medicine & Pathology, Institute of Odontology at The Sahlgrenska Academy, University of Gothenburg, Sweden. Dr. Walladbegi was project manager for the blinded, randomized investigation, which compared the efficacy of ice chips (IC) and an intra-oral cooling device (ICD; Cooral) for cryoprevention of OM.

Results from the randomized trial proved that the Cooral System was as effective as IC in terms of cryoprevention, with severe OM occurring in fewer than 10% of the cases tested. For patients with lymphoma, use of the Cooral System showed vastly improved prevention of OM and was significantly more effective when compared to the conventional method with IC [Oral Mucositis Assessment Scale (OMAS) mean total 1.77 vs 3.08; p = 0.047]. This finding is particularly notable because lymphoma patients are treated with longer courses of chemotherapy, making severe OM a life-threatening inevitability. As for patient-reported tolerability, both diagnostic groups (myeloma and lymphoma), reported a statistically significant higher degree of tolerability when Cooral was used as compared with IC [p = 0.020].

"This is a major breakthrough in patient-centered cancer care and treatment," said Martin Waleij, CEO of BrainCool. "Not only was the Cooral System shown to be safer and more feasible from the standpoint of infection control and comfort, our study shows that its use actually prevents OM occurrence. For patients faced with treatment times of up to six hours or more, that is a truly life-changing difference."

In addition to cancer care improvements, the study indicates potential economic benefits as well. Costs for patients with severe OM in conjunction with stem cell transplantation have been estimated at more than $70,000 per patient. The data presented at ESMO (Free ESMO Whitepaper) are a clear indication that most of these healthcare costs can be prevented with use of the Cooral System.

Presentation of this data at ESMO (Free ESMO Whitepaper) paves the way for market introduction of the Cooral System in the EU, following market clearance in early June 2020 as a class 2 invasive medical device. The device was CE marked for the EU / ESS markets as an invasive medical device this past June, and BrainCool is currently conducting a De Novo 510(k) process to obtain market clearance in the U.S.

The Cooral System features a disposable, thermostatically controlled intra-oral device that comprises closed conduits with continuously circulating water to evenly distribute the hypothermic medium to the oral mucosa. As the hypothermic medium gradually reaches a steady temperature, that temperature is consistently controlled and maintained in the oral mucosa, which in turn leads to reduced blood flow and exposure of tissue to chemotherapeutic agents—thus preventing soreness, erythema and painful ulcerative lesions.

"Oral Mucositis is among the most painful and debilitating adverse effects of both standard and high-dose chemotherapy within the field of oncology," said Dr. Java Walladbegi. "The data speaks for itself, and represents an important milestone in the quest to prevent this potentially lethal side-effect."

"We are opening an important new door in cancer care and treatment," adds Waleij. "Together with an anticipated scientific publication in early 2021, this ESMO (Free ESMO Whitepaper) late-breaking presentation marks the international launch of a groundbreaking improvement in cancer care that significantly improves quality of life for patients, and dramatically reduces the cost to deliver it."

About Oral Mucositis (OM)
OM is a highly significant and sometimes dose-limiting condition that has been reported as the single most-debilitating complication of cancer therapy. OM can be present in combination with a variety of debilitating symptoms that may compromise the ability of patients to maintain oral hygiene practices. For example, intractable oral pain, which may lead to an increased need for analgesics and, on occasions, opioids that are administered intravenously. OM is further associated with undernourishment, weight loss, the use of feeding tubes or total parenteral nutrition, and impaired quality of life, and it can represent a portal of entry for systemic infections that can lead to sepsis and death. Taken together, these symptoms, along with their related sequelae, can result in hospitalization and may incur increased costs for healthcare systems.