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CLEVELAND, Aug. 7, 2015 /PRNewswire/ — Synapse Biomedical Inc. (www.synapsebiomedical.com) announced today that the abstract Analysis of Function and Survival in ALS Patients along with Diaphragm Pacing using Virtual Controls by Origent Data Sciences, was accepted for presentation at the 26th Worldwide Symposium ALS/MND this year in Orlando.
Origent Data Sciences, winner of the ALS Prediction Prize4Life Challenge for its health problem progression model in specific patients, has actually deployed their model to Diaphragm Pacing patients. Data collected from the lead-in controlled prospective clinical study in 106 ALS patients at eight centers showed a considerable overall survival benefit for Diaphragm Pacing patients compared to their predicted outcomes. Origent used 4,633 records from the PRO-ACT database, along with internal and external validation for the survival model. Their findings support the hypothesis that DPS improves survival.
Synapse Biomedical began working along with Origent Data Sciences adhering to their well-received presentation at the 2014 MND Symposium in Belgium. “Our interest in working along with Origent has actually been to create a responder model for ALS that can easily recommendations inform clinical decision making,” said Anthony Ignagni, President and Chief Executive Officer. “The patient-doctor interaction is quite essential in assisting specific ALS patients decide on their road of therapies. If we can easily recommendations identify those patients that benefit from Diaphragm Pacing—and we have actually constantly maintained that it is not for everyone—after that patients and the field of ALS clinical research will certainly benefit.”
The controlled methodology Origent used has actually resulted in a robust predictive model for survival in ALS clinical studies. “Using virtual Manage arm techniques might recommendations us steer clear of incorrect conclusions as a result of possibility effects in trials along with small sample sizes,” said Michael Fritz, VP of Clinical and Regulatory Affairs. “Incorporating these techniques in trial design might offer much better tools for patient recruitment, study monitoring, and validation of results.”
(Honest truth sheets, patient testimonial, product video and images: www.synapsebiomedical.com/news/media)
The NeuRx DPS® is available now for ALS (http://www.synapsebiomedical.com/als/neurx-als.shtml) at U.S. and Worldwide sites or much more short article can easily be obtained by contacting Synapse Biomedical, Inc.
About NeuRx DPS® Technology
NeuRx Diaphragm Pacing System® (NeuRx DPS®) is a four-channel, battery-powered neurostimulator along with implanted electrodes. The device provides electrical stimulation to the muscle and nerves of the diaphragm.
The NeuRx DPS® received CE Marking (CE Registration #518356) on November 20, 2007 and is approved for treating patients along with diaphragm dysfunction in the European Union.
The NeuRx DPS® received FDA approval for ventilator dependency from spinal cord injury on June 17, 2008. In Spinal Cord Injury (SCI), the NeuRx DPS® provides ventilator support in patients along with diaphragm dysfunction of neuromuscular origin. Diaphragm dysfunction can easily result in abnormal or absent respiration in patient populations of high-Degree spinal cord injury and various other injuries or diseases affecting the neuromuscular respiratory pathways.
The NeuRx DPS® received FDA approval for treating chronic hypoventilation from ALS on September 28, 2011. The NeuRx DPS® has actually demonstrated that it can easily recommendations individuals along with ALS live longer and sleep much better compared to the latest standard of care, alone.
For much more on current indications for use, visit www.synapsebiomedical.com/products/patientInfo.shtml
About Synapse Biomedical
Founded in 2002, Synapse Biomedical’s mission is to commercialize our life transforming neurostimulation platform used to treat individuals along with respiratory insufficiency. Synapse is based in Oberlin, Ohio, approximately 30 miles west of Cleveland.
About Origent Data Sciences
Founded in 2012, Origent scientists are experts in the development and application of models made to predict the health problem dynamics of specific patients. Origent’s mission is to use predictive health problem models to control and reduce drug and device development risks through improved foresight. Origent is based in the Washington, DC metropolitan area. For much more information, visit: http://www.origent.com/
SOURCE Synapse Biomedical Inc.