Dialco Medical Announces Formation of Medical Advisory Board to Support the Continued Development of DIMI Device
16 März 2022 - 1:00PM
Spectral Medical Inc. (“Spectral” or the “Company”) (TSX:
EDT), today announced that its wholly owned subsidiary,
Dialco Medical Inc. (
“Dialco”), has formed a
Medical Advisory Board to support in guiding the DIMI usability
trial and continued development of the DIMI device.
Medical Advisory Board
members:
- Christopher T.
Chan, MD, serves as Chief of Nephrology at Toronto General
Hospital, as well as Professor of Medicine at the University of
Toronto and R. Fraser Elliott Chair in Home Dialysis at the
University Health Network. Dr. Chan is also Associate Editor for
the Clinical Journal of the American Society of Nephrology.
- Jenny I. Shen, MD,
MS, is an Assistant Professor of Medicine and Physician Specialist
within the Division of Nephrology and Hypertension at Harbor-UCLA
Medical Center. Dr. Shen is an expert in home dialysis and health
disparities.
- Lisa
Koester-Wiedemann, MSN, CS, CNN-NP, is a Renal Nurse Practitioner
in the Division of Nephrology at Washington University and an
expert in home hemodialysis and patient experience.
- Fredric
Finkelstein, MD, is Clinical Professor of Medicine at the Yale
University Medical School, as well as a Nephrology Specialist and
key proponent of patient-centered care. He also served as a
principal investigator for the FREEDOM hemodialysis study.
John Kellum, MD, CMO of Spectral, observed, “We
are extremely pleased to announce our partnership with such a
distinguished group of clinicians and scientists. They not only
represent the top opinion leaders in the home hemodialysis space
but collectively they have expertise in clinical research, patient
care, and patient-centered outcomes related to dialysis in the
home. We could not have a better team advising us.”
Chris Seto, CEO of Spectral, commented, "The
establishment of our Medical Advisory Board is an important
resource as we prepare to commence our upcoming DIMI usability
trial in 2022. This trial is expected to be the final regulatory
step required before seeking FDA clearance for in-home hemodialysis
use. We are thrilled to have attracted some of the world’s leading
experts in home hemodialysis. We believe their clinical expertise
in home hemodialysis will add invaluable feedback to help
accelerate the clinical activities and commercial roll-out of our
DIMI device.”
DIMI is an easy-to-use home hemodialysis
machine, built on the same platform as the Company’s SAMI device.
The Company received FDA 510(k) clearance for DIMI to treat
patients in the hospital or clinical settings and is seeking to
obtain regulatory approval for DIMI in the United States for
in-home use. The Company is planning a usability trial for the DIMI
device, which is designed to evaluate the safety and efficacy of
DIMI in the home setting by analyzing delivered dialysis dose and
potential adverse events during six weeks of use at home compared
to six weeks of use in the hospital setting on the same
patients.
About Spectral
Spectral is a Phase 3 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.
PMX is approved for therapeutic use in Japan and
Europe, and has been used safely and effectively on more than
300,000 patients to date. In March 2009, Spectral obtained the
exclusive development and commercial rights in the U.S. for PMX,
and in November 2010, signed an exclusive distribution agreement
for this product in Canada. Approximately 330,000 patients are
diagnosed with severe sepsis and septic shock in North America each
year.
Spectral, through its wholly owned subsidiary,
Dialco Medical Inc., is also commercializing a new set of
proprietary platforms addressing renal replacement therapy
(RRT) across the dialysis spectrum. SAMI is
targeting the acute RRT market, while DIMI is targeting the chronic
RRT market. Dialco is currently pursuing regulatory approval for
U.S. in-home use of DIMI, which is based on the same RRT platform
as SAMI, but will be intended for home hemodialysis use. DIMI
recently received its FDA 510k clearance for use in hospital and
clinical settings, and obtained its Health Canada license for use
within Canadian hospitals, clinics and in home.
Spectral is listed on the Toronto Stock Exchange
under the symbol EDT. For more information, please
visit www.spectraldx.com.
Forward-looking statement
Information in this news release that is not
current or historical factual information may constitute
forward-looking information within the meaning of securities laws.
Implicit in this information, particularly in respect of the future
outlook of Spectral and anticipated events or results, are
assumptions based on beliefs of Spectral's senior management as
well as information currently available to it. While these
assumptions were considered reasonable by Spectral at the time of
preparation, they may prove to be incorrect. Readers are cautioned
that actual results are subject to a number of risks and
uncertainties, including the availability of funds and resources to
pursue R&D projects, the successful and timely completion of
clinical studies, the ability of Spectral to take advantage of
business opportunities in the biomedical industry, the granting of
necessary approvals by regulatory authorities as well as general
economic, market and business conditions, and could differ
materially from what is currently expected.
The TSX has not reviewed and does not accept responsibility for
the adequacy or accuracy of this statement.
For further information, please contact:
Chris Seto |
Ali Mahdavi |
David Waldman/Natalya Rudman |
CEO |
Capital Markets & Investor
Relations |
US Investor Relations |
Spectral Medical Inc. |
Spinnaker Capital Markets
Inc. |
Crescendo Communications,
LLC |
416-626-3233 ext. 2004 |
416-962-3300 |
212-671-1020 |
cseto@spectraldx.com |
am@spinnakercmi.com |
edt@crescendo-ir.com |
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