{"id":468455,"date":"2021-03-31T08:03:28","date_gmt":"2021-03-31T12:03:28","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=468455"},"modified":"2021-03-31T08:03:28","modified_gmt":"2021-03-31T12:03:28","slug":"spectral-medicals-wholly-owned-subsidiary-dialco-medical-announces-receipt-of-health-canada-license-for-dimi","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/spectral-medicals-wholly-owned-subsidiary-dialco-medical-announces-receipt-of-health-canada-license-for-dimi\/","title":{"rendered":"Spectral Medical\u2019s Wholly-Owned Subsidiary Dialco Medical Announces Receipt of Health Canada License for DIMI"},"content":{"rendered":"

\nImmediately enables DIMI to be used within Canadian hospitals, clinics and in home
\n<\/h2>\n
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TORONTO, March 31, 2021 (GLOBE NEWSWIRE) — Spectral Medical Inc.<\/strong> (\u201cSpectral\u201d or the \u201cCompany\u201d) (TSX: EDT)<\/strong>, today announced that its wholly-owned subsidiary, Dialco Medical Inc. (\u201cDialco\u201d<\/strong>) has obtained its Health Canada license for the DIMI RRT system.<\/p>\n

As per the Health Canada license, DIMI is a prescription only medical device, indicated for hemodialysis (\u201cHD\u201d<\/strong>), hemodiafiltration (\u201cHDF\u201d<\/strong>) and ultrafiltration (\u201cUF\u201d<\/strong>) for patients weighing 20 kgs or more, and can be used in hospitals, clinics and at home (by a trained and qualified individual considered to be competent in the use of this device).<\/p>\n

\u201cWith DIMI licensed in Canada, Dialco can continue to move down its commercialization pathways,\u201d said Dr. Gualtiero Guadagni, President of Dialco Medical. \u201cDIMI\u2019s versatility addresses many of the barriers to adoption for home hemodialysis, and positions DIMI as the ideal device for multiple segments of chronic dialysis patients across Canada. DIMI provides patients and their care partners with the option and flexibility to dialyze conveniently at home, while reducing lengthy and time exhaustive travel to in-centre hemodialysis. For nursing homes this provides the opportunity to care for their patients safely on site. Additionally, DIMI\u2019s use of pre-packaged dialysate fluid bags addresses water quality issues as barriers to hemodialysis in rural and indigenous communities. Ultimately, we believe DIMI can assist healthcare networks across Canada to meet the needs of chronic dialysis patients while improving health outcomes and reducing costs.\u201d<\/p>\n

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\n Remaining Health Canada Approval:<\/em>
\n <\/strong>\n <\/p>\n

There remains one final Health Canada license for DIMI to unlock the full dialysis modality of the device. Management expects to make its submission to Health Canada for peritoneal dialysis (\u201cPD\u201d<\/strong>) in Q3 2021. Currently, there are no competing chronic dialysis devices with multiple modality. DIMI is the only device capable of performing both HD and PD, which helps late-stage PD patients transition to HD seamlessly.<\/p>\n

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\n DIMI Value Proposition: Addressing Barriers to Adoption for Home HD<\/em>
\n <\/strong>\n <\/p>\n

The DIMI renal replacement system is based on a fully integrated cassette technology, which simplifies set-up, operation, and management of a dialysis session when compared to other instruments currently available on the market. The DIMI system comes fully assembled and uses pre-packaged dialysis fluid bags providing greater portability and versatility.<\/p>\n

\n Table 1: DIMI vs. Competitors <\/strong>\n <\/p>\n\n\n\n\n\n\n\n
\n Device Characteristics<\/strong>\n <\/td>\n\n DIMI<\/strong>\n <\/td>\n\n Competitors <\/strong>
\n
\n (w\/Reverse Osmosis (\u201cRO\u201d)<\/strong>\n <\/td>\n<\/tr>\n
Portability<\/td>\n\n
    \n
  • High<\/li>\n<\/ul>\n<\/td>\n
\n
    \n
  • Low (RO component adds significant size and weight)<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Multiple Modality<\/td>\n\n
    \n
  • Only device capable of performing HD\/HDF and PD<\/li>\n<\/ul>\n<\/td>\n
\n
    \n
  • HD only<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Versatility<\/td>\n\n
    \n
  • Pre-packaged dialysate fluid bags make DIMI suitable for any geographic region<\/li>\n
  • Open platform compatible with any dialyzer<\/li>\n<\/ul>\n<\/td>\n
\n
    \n
  • Need for expensive additional water treatment system in geographical areas where water quality is poor<\/li>\n
  • Closed platform<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Usability & Training<\/td>\n\n
    \n
  • Easy to use \u2013 no requirement for patient to undertake maintenance<\/li>\n
  • Peace of mind knowing dialysate is pre-mixed to a specific prescription<\/li>\n<\/ul>\n<\/td>\n
\n
    \n
  • Patients\/care givers and providers are required to follow a complex maintenance and verification schedule on a daily and monthly basis.<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Home renovation required<\/td>\n\n
    \n
  • No<\/li>\n<\/ul>\n<\/td>\n
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