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Spectral Medical receives FDA deficiency letter for Toraymyxin PMA

The FDA sent Spectral Medical a deficiency letter for the PMA application for the sepsis device Toraymyxin, requesting additional information, analyses and testing. After its 100-day review, the agency does not require a new clinical study. Spectral is working on the requested remedial items, does not expect a material delay to the regulatory timeline and is finalizing the work plan. Toraymyxin is approved in Japan and Europe, licensed in Canada and has received Breakthrough Device status in the US. » More on de.investing.com

Historical dividends Dividends

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In 2012, SPECTRAL MEDICAL has already paid €0.0915 in dividends. The last payout was in January 2012.

Financials

In the last quarter, SPECTRAL MEDICAL had revenue of €382.98k and net profit of €204.13k

(EUR)	June 2026	YoY
Revenue	382.98k	24.45%
Gross profit	169.59k	47.90%
Net profit	204.13k	116.94%
EBITDA	1.31m	399.53%

Fundamentals

Metric	Value
Market capitalization	€180.93m
Number of shares	293.55m
52-week high/low	€0.98 - €0.55
Dividends	No
Beta	0.22
P/E ratio	-7.54
PEG ratio	0.08
P/B ratio	-4.06
P/S ratio	110.84

Company profile

Spectral Medical Inc., together with its subsidiaries, focuses on the development and commercialization of products for the treatment of septic shock and renal disease in North America. The company markets Endotoxin Activity Assay, a rapid in vitro diagnostic test for the detection of components of gram negative bacterial cell wall; and Polymyxin B Hemoperfusion, a therapeutic hemoperfusion device that removes endotoxin from the bloodstream. It also develops and manufactures monoclonal and polyclonal antibodies, recombinant cardiac proteins, and calibrators for use in the research and development, as well as products that are manufactured by other diagnostic companies; and develops platform for renal replacement therapy. The company was formerly known as Spectral Diagnostics Inc. and changed its name to Spectral Medical Inc. in December 2014. Spectral Medical Inc. was incorporated in 1991 and is headquartered in Toronto, Canada.