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     124  0 Kommentare Spectral Medical’s Wholly-Owned Subsidiary Dialco Medical Announces Receipt of Health Canada License for DIMI - Seite 2

    Table 1: DIMI vs. Competitors

    Device Characteristics DIMI Competitors
    (w/Reverse Osmosis (“RO”)
    Portability
    • High
    • Low (RO component adds significant size and weight)
    Multiple Modality
    • Only device capable of performing HD/HDF and PD
    • HD only
    Versatility
    • Pre-packaged dialysate fluid bags make DIMI suitable for any geographic region
    • Open platform compatible with any dialyzer
    • Need for expensive additional water treatment system in geographical areas where water quality is poor
    • Closed platform
    Usability & Training
    • Easy to use – no requirement for patient to undertake maintenance
    • Peace of mind knowing dialysate is pre-mixed to a specific prescription
    • Patients/care givers and providers are required to follow a complex maintenance and verification schedule on a daily and monthly basis.
    Home renovation required
    • No
    • Electric and Plumbing

    Chris Seto, COO and CFO of Spectral, commented, “The Health Canada license for the DIMI RRT system is an important milestone in creating value for our shareholders. We believe DIMI is a disruptive technology that is at the forefront of addressing the most significant barriers to adoption for HHD, and DIMI’s best-in-class differentiating characteristics should be an advantage in penetrating both the Canadian and U.S. markets. We look forward to providing meaningful updates as commercial developments unfold.”

    Dialco recently received its Medical Device Single Audit Program (“MDSAP”) certification, which is the highest quality and regulatory standard in the medical device industry.

    About Spectral

    Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA), the only FDA cleared diagnostic for the risk of developing sepsis.

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    Spectral Medical’s Wholly-Owned Subsidiary Dialco Medical Announces Receipt of Health Canada License for DIMI - Seite 2 Immediately enables DIMI to be used within Canadian hospitals, clinics and in homeTORONTO, March 31, 2021 (GLOBE NEWSWIRE) - Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), today announced that its wholly-owned subsidiary, Dialco …