(CAPN) Presents CoSense® Data at the 2014 American Society of Hematology Annual Meeting
REDWOOD CITY, Calif., Dec. 8, 2014 — Capnia, Inc. (NASDAQ: CAPN), focused on the development of medical diagnostics based on its proprietary Sensalyze™ technology for precision metering of gas flow, today announced a poster presentation at the 2014 American Society of Hematology (ASH) Annual Meeting and Exposition, December 6-9, 2014, in San Francisco. The poster describes positive proof-of-concept data for the Company’s CoSense® ETCO Monitor in patients with sickle cell anemia (SCA), a disorder in which patients have chronic hemolysis. CoSense is a portable, non-invasive device that rapidly and accurately measures carbon monoxide in the exhaled breath and therefore measures the rate of hemolysis.
“Sickle cell anemia is the most common inherited lethal disorder and screening for it in resource constrained settings is a significant problem,” said Ashutosh Lal, M.D., Director, Thalassemia Program, The University of California San Francisco, Benioff Children’s Hospital Oakland, and the lead investigator for the study. “Early mortality remains a significant problem in SCA patients in the areas of the world where the disease is most prevalent. These findings provide scientific support for the further development of exhaled carbon monoxide measurement to monitor hemolysis in children with SCA and as a potential point-of-care screening test for SCA.”
“CoSense is currently FDA cleared and CE marked for the detection of hemolysis by measuring end-tidal carbon monoxide, or ETCO,” said Anish Bhatnagar, M.D., Chief Executive Officer of Capnia. “Based on the data from this study, CoSense can be an important tool for non-invasive point of care screening for babies at risk for SCA. We believe CoSense has potential applications in the monitoring of a range of diseases involving hemolysis and altered bilirubin metabolism and we appreciate being able to share these important findings with the hematology community at ASH this year.”
The following is a summary of the data presented at ASH:
Title: Elevated End-Tidal Carbon Monoxide Concentration in Children with Sickle Cell Anemia
Abstract #: 1390
Session: 114
Date and Time: Saturday, December 6, 2014, 5:30 PM-7:30 PM PT
Summary: Carbon monoxide (CO) produced during oxygen-dependent cleavage of porphyrin ring of heme is excreted in exhaled breath. The catabolism of heme is increased when red blood cells are destroyed at an accelerated rate. Thus, quantifying CO in exhaled breath could serve as an indicator of hemolysis. However, the requirement for forced breath sample has precluded measurement of exhaled CO in young children. The goal of this single-center, open-label, non-randomized study was to assess passively-measured end-tidal CO concentration (ETCOc) in children with SCA. In this study, 32 children (16 with SCA and 16 controls) ranging in age from 5-14 years were evaluated.
The study results demonstrated that the mean ETCOc was 5-fold higher in SCA compared with controls, with little overlap seen between the groups. In addition, ETCOc measurements provided both sensitivity and specificity equal to 93.8% for distinguishing SCA from healthy children. These results suggest that ETCOc may be a valuable tool for non-invasive monitoring of the severity of hemolysis in SCA and that ETCOc has potential for use as a point-of-care screening test for SCA.
About Capnia
Capnia, Inc. develops and commercializes diagnostics based on its proprietary Sensalyze™ technology for precision metering of gas flow. Capnia’s lead product is CoSense®, which aids in the diagnosis of hemolysis, a dangerous condition in which red blood cells degrade rapidly. CoSense is a portable, non-invasive device that rapidly and accurately measures carbon monoxide in exhaled breath. CoSense has 510(k) clearance from the FDA and was launched in the U.S. in October 2014. CoSense has also received CE Mark approval for sale in the E.U.
Forward-Looking Statements
This communication 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 and clinical trials; the timing of, and our ability to make, regulatory filings and obtain and maintain regulatory approvals for our product candidates; our intellectual property position; the degree of clinical utility of our products, particularly in specific patient populations; our ability to develop commercial functions; expectations regarding product launch and revenue; our results of operations, cash needs, and spending of the proceeds from this offering; financial condition, liquidity, prospects, growth and strategies; the industry in which we operate; and the trends that may affect the industry or us.
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.
Capnia Contact:
David O’Toole
Chief Financial Officer
Capnia, Inc.
(650) 353-5146
dotoole@capnia.com
Investor Relations Contact:
Matthew Haines
Argot Partners
(646) 681-8192
matthew@argotpartners.com
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