EDT Stock

Spectral Medical Inc. Opens the Market (CNW Group/TMX Group Limited) COVID-19 has highlighted the benefits of medical equipment made by Spectral Medical (Spectral Medical Stock Quote, Chart, News TSX:EDT), says Paradigm Capital analyst Corey Hammill, who provided an update to clients on the company on Wednesday in which he reiterated his “Buy” recommendation and $4.00 target price. Toronto-based Spectral Medical is a clinical-stage medical device company creating products for critical care needs in the areas of septic shock and dialysis, including the sepsis diagnostic EAA, the septic shock therapy PMX and the dialysis products SAMI and DIMI. Both EAA and SAMI are approved by the US FDA and Health Canada while PMX is currently in the trial stage. The company released a corporate update on Tuesday, saying its PMX Tigris Trial was experiencing a delay due to COVID-19 taking up resources at some of the clinical sites where it was screening patients for enrolment. At the same time, Spectral said it’s seeing increased interest in using PMX in Canada and the US after recently receiving special authorization to treat COVID-19 patients. Spectral argues there is a strong case for using PMX in COVID-19 patients. “Endotoxin is the primary driver of the cytokine storm and there is reliable evidence that removing endotoxin by the PMX cartridge, reduces circulating levels of cytokines. Increased levels of endotoxin activity as measured by Spectral’s FDA approved Endotoxin Activity Assay (EAA) have been identified in COVID-19 patients in the US, Italy and Asia,” Spectral said in its press release. Spectral’s SAMI dialysis is also seeing increased interest due to the COVID-19 crisis, according to the company, which said there are currently no changes in the regulatory timeline for DIMI, which is up for FDA approval sometime over the next few months. “While COVID-19 has altered some of Spectral’s short-term priorities, our long-term strategy remains unchanged. Regardless of short term data points, our focus has not changed on obtaining the required approvals and commercialization of our products. The significant clinical unmet need that our products address, and the size of those patient populations have not changed. The value of our greatest assets remain unchanged,” said Debra Foster, VP of Clinical Development at Spectral, in the press release. In his report, Hammill highlighted the increased interest in both PMX and SAMI and DIMI, saying that COVID-19 has altered priorities, especially around greater push for home dialysis over dialysis clinics in the US. “While COVID-19 may push out their final Phase 3b trial by a few months, septic shock remains a vital challenge for intensive care units across North America. remains the only company undergoing advanced clinical trials for treating septic shock and have shown previous clinical success in patients targeted with their EAA diagnostic,” Hammill wrote. “The US IDE that is allowing them to use PMX in COVID-19 patients will provide increased visibility for the product to doctors and hospitals, potentially accelerating their rollout once they obtain full FDA approval,” he added. The analyst said Spectral’s distribution partner, Baxter, recently spoke of the opportunity in PMX in its fourth quarter comments, with Hammill calling this a “strong endorsement from a leading critical care company with deep expertise in developing and commercializing new medical devices.” Hammill’s $4.00 price target represented at press time a projected return of 497 per cent.

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