Capnia awarded NIH grant to develop Sickle Cell Anemia screening in developing countries

Phase 1 SBIR grant is supported by data recently published in the journal Pediatric Blood and Cancer

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REDWOOD CITY, Calif.—Capnia, Inc., which focuses on the development of novel products based on its proprietary technologies for precision metering of gas flow, today announced it has been awarded a Small Business Innovation Research (SBIR) Phase I grant totaling approximately $220,000 by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH). This six month, Phase 1 grant will be used to help fund the development of a modified CoSense® device that is suitable for field use in developing countries with high prevalence of Sickle Cell Disease (SCD), also known as Sickle Cell Anemia (SCA).
The grant is supported by a recently published, peer-reviewed study in Pediatric Blood and Cancer, titled "Point-of-Care End-Tidal Carbon Monoxide [ETCO] Reflects Severity of Hemolysis in Sickle Cell Anemia." Results from the study demonstrate that CoSense accurately distinguishes children with SCA from age-matched healthy controls by measuring ETCO with a simple, rapid, non-invasive breath test. These data suggest that ETCO may be a valuable tool for ongoing non-invasive monitoring of the severity of hemolysis in SCA and that ETCO has potential for use as a point-of-care screening test for SCA.
The Phase 1 project seeks to initiate development of a point-of-care CoSense device that accurately and consistently measures ETCO under the more extreme temperature conditions encountered in developing countries, where 90 percent of the SCA births occur.  "In certain developing territories such as Sub-Saharan Africa and India, 50-90 percent of babies born with SCD do not survive to adulthood," said Anish Bhatnagar, M.D., CEO of Capnia. "Studies have shown that when SCD is diagnosed in the newborn period, early mortality is preventable through prophylactic antibiotics, vaccinations, and health education. Universal newborn screening for SCD has been implemented in the United States with significantly improved morbidity and mortality outcomes, but comparable programs are expensive and difficult to implement in developing countries. While CoSense can be used in health care related environments in these countries, it would be desirable to extend its ability to be used in more remote settings. We are pleased that the NHLBI has recognized the potential of our technology and will be supporting the effort with this grant."
Research and development work supported by the grant will be conducted in collaboration with The University of California San Francisco Benioff Children's Hospital Oakland. Ashutosh Lal, M.D., director, Thalassemia Program, was the principal investigator for the published SCA study and will collaborate with Capnia for this grant. "Our data showed that CoSense can clearly distinguish between SCA and controls using a breath test that is simple and rapid," said Lal. "Our collaboration with Capnia on this Phase I grant will allow us to work on an urgently needed non-invasive point of care solution for lack of screening alternatives for SCA in resource poor countries."
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. 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.

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