Spectral Medical Announces U.S. FDA Approval of DIMI Trial Protocol Amendment
31 Januar 2022 - 2:00PM
Spectral Medical Inc. (“Spectral” or the “Company”) (TSX:
EDT), today announced that its wholly-owned subsidiary,
Dialco Medical Inc. (“Dialco”) has received approval of a protocol
amendment to its DIMI usability trial from the United States
Federal Food and Drug Agency (“FDA”). This protocol amendment
allows for both improved patient and clinical logistics flow in
conducting the DIMI trial.
The DIMI usability trial 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. The Company is progressing with
contracting clinical trial sites and the trial will include 35
patients in the United States.
Dr. John Kellum, Chief Medical Officer of
Spectral, commented, “This protocol amendment addresses both
patient and clinical logistics flow issues currently experienced
throughout the dialysis clinic industry. We worked closely with our
clinical trial partners and vetted the modifications to our DIMI
protocol with potential clinical trial sites. We now believe we
have an exceptional approved protocol for the DIMI trial and look
forward to onboarding the clinical sites.”
Chris Seto, CEO of Spectral, commented, “We
remain focused on the start of our DIMI usability trial for home
use of this well designed device. We appreciate the support of our
potential clinical site trial partners who have been working hard
to address labor shortages and attrition within dialysis clinics.
They provided us valuable feedback on our amendments to the trial.
Based on the approved protocol amendment, we are now progressing to
the site contracting phase, which we expect will provide greater
visibility on the revised DIMI trial timeline.”
Mr. Seto continued, “We believe this trial will
showcase DIMI as a disruptive technology that is at the forefront
of addressing the most significant barriers to adoption for home
hemodialysis. Specifically, the use of pre-filled dialysate bags
aims to simplify home dialysis for patients and overcome the
challenge of water quality, which is a common issue throughout many
regions across the U.S. We also believe this trial represents an
incredible commercial opportunity to demonstrate positive real
world experience of the versatility of DIMI amongst our clinical
trial partners, who are also our potential customers. Dialco is
committed to bringing this innovative device to empower more
patients and their care partners to transfer from in-center
dialysis to their homes.”
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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