REDWOOD CITY, Calif., Sept. 24, 2015 (GLOBE NEWSWIRE) -- Capnia, Inc. (NASDAQ:CAPN), focused on the development of novel products based on its proprietary technologies for precision metering of gas flow, today announced a paper, titled "Measuring End-Tidal Carbon Monoxide of Jaundiced Neonates in the Birth Hospital to Identify Those with Hemolysis," has been published online in Neonatology (2016;109:1-5 [DOI:10.1159/000438482]). This peer-reviewed paper, which is expected to appear in the January 2016 print issue, discusses recent clinical research demonstrating the superiority of CoSense® End-Tidal Carbon Monoxide (ETCO) Monitor at detecting hemolysis in jaundiced newborns.
The results of the study conducted in neonates with bilirubin above the 75th percentile show that CoSense is more effective at identifying hemolysis than traditional measures, such as the Coombs test. Of the 100 high-risk neonates studied at three hospitals in the Intermountain Healthcare System, CoSense showed evidence of hemolysis in 37%, while Coombs testing showed several false negative results. None of the neonates studied with CoSense were readmitted to the hospital. In the same period of time, approximately 3% of the 3,535 neonates on whom CoSense was not used prior to discharge from the hospital, were readmitted for jaundice.
The full publication can be accessed online here.
"Since 2004 the American Academy of Pediatrics (AAP) has recommended the use of ETCO measurement to confirm the presence or absence of hemolysis in neonates and CoSense is the only commercially available device that can accomplish this," said Dr. Robert Christensen, Director of Neonatology Research at Intermountain Healthcare and Chief, Division of Neonatology at the University of Utah School of Medicine. "Jaundice is the number one cause of re-hospitalization during the first weeks after birth. It is an outcome that is highly preventable and innovative technologies, such as CoSense are much needed."
"We are pleased to see this data published in a highly-respected, peer-reviewed medical journal," said Anish Bhatnagar, M.D., Chief Executive Officer of Capnia. "The effective detection of hemolysis in neonates represents a significant unmet medical need, and these data demonstrate that CoSense is a highly effective solution. This data further underscores the significant market for CoSense and we remain focused on our goal of making this important product widely available."
Capnia, Inc. develops and commercializes novel products based on its proprietary technologies for precision metering of gas flow. Capnia's lead product CoSense is based on the Sensalyze™ Technology Platform. It is a portable, non-invasive device that rapidly and accurately measures carbon monoxide (CO) in exhaled breath. CoSense has 510(k) clearance for sale in the U.S. and has received CE Mark certification for sale in the European Union. CoSense is used for the monitoring of CO from internal sources (such as hemolysis, a dangerous condition in which red blood cells degrade rapidly), as well as external sources (such as CO poisoning and smoke inhalation). The initial target market is newborns with jaundice that are at risk for hemolysis, comprising approximately three million births in the U.S. and European Union. The Company's commercial, neonatology-focused product line also includes innovative pulmonary resuscitation solutions, including the NeoPIP™ Infant T-Piece Resuscitator and Universal T-Piece Circuit consumables. Capnia's proprietary therapeutic technology uses nasal, non-inhaled CO2 and is being evaluated to treat the symptoms of allergies, as well as the trigeminally-mediated pain conditions such as cluster headache, trigeminal neuralgia and migraine.
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development, clinical trials, that measuring ETCO may be an effective way to identify pathological hemolytic conditions, and commercialization of CoSense.
We may use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in Capnia's Form 10-Q filed with the Securities and Exchange Commission on August 10, 2015, including under the caption titled "Risk Factors." Capnia expressly disclaims any intent or obligation to update these forward looking statements, except as required by law.