Spectral Medical, Inc. (OTCMKTS:EDTXF) revealed that its experimental treatment for sepsis failed a late-stage study, delaying the company’s plans to bring the first FDA-approved device to market.
Oct 3 (Reuters) – Spectral Medical Inc said its experimental treatment for sepsis – a common, oft-deadly complication of infection – failed a late-stage study, stymieing the company’s plans to bring to market the first FDA-approved device for the condition.
Sepsis occurs when the immune system goes into overdrive to fight infection or bacterial toxins, triggering a cascade of physiological changes that can lead to multiple organ failure and even death.
Toronto-based Spectral Medical holds North American rights to a system developed by Japan’s Toray Industries Inc, designed to restore blood pressure and correct organ dysfunction by using an antibiotic to detoxify the blood.
Once the patient’s blood has been extracted it is passed through a column to remove a type of toxin, called an endotoxin, which is believed to be a major trigger for sepsis.
The trial did not meet the main goal of absolute reduction in mortality rate at 28 days, Spectral said on Monday.
About Spectral Medical Inc.
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 directed by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX has been approved for therapeutic use in Japan and Europe, and has been used on more than 150,000 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. Over 350,000 patients are diagnosed with septic shock in North America each year, representing a greater than $3 billion market opportunity for Spectral.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT, and on the OTCQX under the symbol EDTXF. For more information, please visit www.spectraldx.com.
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 commercialize its products, 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 mathematical calculation that represents the degree of change over time is known as “percentage change”. In finance, it serves many purposes, and is often used to represent the price change of a commodity.
Percentage change can be applied to any quantity that is measured over time any given time period. Say you are tracking the price of a stock. If the price increased, the formula [(New Price – Old Price)/Old Price] is applied and then take that number and multiply it by 100. If the price of a stock decreased, the formula [(Old Price – New Price)/Old Price] is applied then multiplied by 100.
The formula can be used to track the prices of both individual commodities and large market listings, and also used to compare the values of different currencies. Balance sheets with comparative financial statements often will include prices of specific stocks at different time periods alongside the percentage change over the same periods of time. Over the past three months, Spectral Medical, Inc. (OTCMKTS:EDTXF) has seen 87300 shares trade hands on average.
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Spectral Medical, Inc. (OTCMKTS:EDTXF)’s shares closed the most recent session at $0.22 moving from the previous open or $-1.03. This is compared to the stock’s 52-week high of 1.5 and 52-week low of 0.14.
Companies are ranked according to their market caps, falling into large-cap, mid-cap and small-cap categories.
Large-cap companies have a market cap north of $10 billion. These large companies have usually been in business for a long time, and are major participants in well-established sectors. Investors in large-cap companies don’t necessarily bank large returns in short time periods, though are rewarded with a constant increase in share value over the long run.
Mid-cap companies have a market cap of $2 billion – $10 billion. Mid-cap companies are usually established companies operating in an industry that is expected to experience quick growth. Mid-cap companies are usually in the middle of expansion. They carry higher risk than large-cap companies due to the fact that they are not as established, though their growth potential remains an attraction to investors.
Small-cap companies have a market cap of $300 million – $2 billion. These smaller companies are usually newer or perhaps service a niche market or a new industry. Generally considered to be a higher risk than mid or large-cap in part because of their age, their size and the markets they serve. Small-cap companies usually have fewer resources and are more sensitive to the ebb-and-flow of markets. Spectral Medical, Inc. (OTCMKTS:EDTXF)’s market cap currently sits at $45520000.
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