Spectral Medical’s Wholly-Owned Subsidiary Dialco Medical Announces DIMI Usability Trial Posted on the ClinicalTrials.gov Website
TORONTO, May 05, 2021 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), today announced that the DIMI usability trial, run by its wholly-owned subsidiary, Dialco Medical Inc. (“Dialco''), is registered and posted on the ClinicalTrials.gov website under the identifier of NCT04868643.
DIMI is an innovative renal replacement system 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. DIMI was recently cleared by the FDA to treat patients with acute and/or chronic renal failure with or without fluid overload using hemodialysis, hemodiafiltration, hemofiltration and/or ultrafiltration in hospital or other in-center settings.
DIMI Usability Trial Summary
The prospective multicenter, open label, non-randomized and cross-over study 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 trial will include 35 patients in the United States and is expected to enroll the first patient by the end of the third quarter of 2021. Additional details of the study can be found on https://clinicaltrials.gov.
“The design of the DIMI usability trial is very similar to the recent Outset Medical trial and the previous NxStage trial. The key measure of success will be demonstrating that DIMI can deliver the prescribed dialysis needs per session, both in-center and in the home environment, while maintaining safeguards for the mitigation of safety risks,” said Dr. John Kellum, Chief Medical Officer of Dialco Medical Inc. “We are in the final stages of engaging a CRO and onboarding trial sites that are able to enroll suitable patients on an expeditious basis to ensure we are in a position to enroll the first patient by late summer. Prior to patient enrollment, Dialco will work closely with our clinical partners to deliver DIMI device training to their staff. We are committed to providing full support to physicians, nurses, patients and their care partners throughout the trial and beyond, and look forward to the successful completion of the trial.”
Table 1: Anticipated Trial Milestones
|Key Usability Trial Milestones:||Anticipated Timing|
|Engage CRO to run usability trial||May 2021|
|Contract clinical sites||June 2021|
|Site activation - including study training and device training||August 2021|
|First patient enrolment||September 2021|
|Primary completion||May 2022|
|Study completion||September 2022|
“We look forward to engaging our usability trial partners shortly, and working with the clinical sites to demonstrate the ease-of-use and safety of DIMI to home patients and their care partners,” said Dr. Gualtiero Guadagni, President of Dialco Medical Inc. “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. The use of pre-filled dialysate bags aims to simplify dialysis for home 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 and the versatility of DIMI amongst our clinical trial partners, who are also our potential customers. Dialco is committed to bringing this disruptive innovation to empower more patients and their care partners transfer in-center dialysis to their homes.”
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.
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.