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The Cooral® System

The Cooral® System – a unique preventive treatment that protects the oral mucosa

The Cooral® System is a novel and unique medical cooling solution for preventive treatment of the painful and debilitating inflammatory condition oral mucositis, a very common adverse effect of chemotherapy and radiation that affects approximately 80 percent of patients. The product has no competitor on the market today. The administration of local, preventive cooling can slow down metabolism and reduce or prevent the development of mucositis. There is an unmet medical need for non-invasive methods that offer more control than the practices currently in use (such as ice-based cryotherapy).

U.S. Food and Drug Administration (FDA) has granted “Breakthrough Device” Designation for the Cooral® System, for prevention of Oral Mucositis.In addition to “Breakthrough Device” Designation, the Cooral® System will benefit significantly from recent Centers for Medicare & Medicaid Services (CMS) reimbursement changes that ensure coverage of medical devices designated as breakthrough by the FDA.

  • Attachable oral device with closed-loop circulatory cooling
  • Maintains temperature at tolerable levels for the full duration of treatment
  • Convenient, easy to use and maintenance free
  • More than pain relief – prevents mucositis from forming

Advantages over ice

  • Controlled temperature
  • Better tolerability
  • Better and more uniform distribution of cooling
  • Makes it possible to target specific and hard-to-reach areas
  • Faster procedure

17 million new cases of cancer worldwide

In 2017 the total incident cases of Oral Mucositis were 1,418,879 in the 7MM

In 2017 the total treated cases of Oral Mucositis were 1,021,399 in the 7MM

The incremental cost of oral mucositis was approximately $3700 per cycle among patients receiving chemotherapy*.

Results from a trial reported grade 0-1 on solid tumors for patient with Cooral® System

The incremental cost of mucositis-related hospitalization among stem cell transplant recipients exceeded $70 000*.

Results from a randomized trial showed severe OM occurred in fewer than 10% of the cases tested with Cooral® System

Results from the randomized trial showed severe OM occurred in fewer than 10% of the cases tested with Cooral® System.

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 ice [Oral Mucositis Assessment Scale (OMAS) mean total 1.77 vs 3.08; p = 0.047].

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 Ice [p = 0.020]

Success stories

What the clients say

Success story

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Success story

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Success story

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Marketing overview

Worldwide target population of 1.75 million patients

The target population for Cooral® is the 1.75 million patients worldwide that receive chemotherapy and thus are at risk of developing OM, which manifests in 80 percent of the cases. Sales will begin with the Cooral® attachments and ECU200 units. The ECU200 water cooling unit will be a one-time purchase plus optional maintenance contracts. As only one patient can be attached per ECU200 unit at a time, clinics should be equipped with enough units to accommodate the number of infusion chairs.

More than 8,000 cooling units needed to supply each infusion chair

There are approximately 2,700 cancer clinics worldwide (900 in Europe, 1,620 in the United States and the Asia-Pacific region). The average clinic houses 3 infusion chairs (based on numbers estimated by KOLs in Sweden and the United States), which extrapolates to 2,700 infusion chairs in Europe and 4,860 in USA+APAC. Based on sales of OM treatment products and the OM prevention drug Palifermin, the 2017-2018 market size for OM management was estimated to be €940M.

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