CLEVELAND, Aug. 7, 2015 /PRNewswire/ -- Synapse Biomedical Inc. (www.synapsebiomedical.com) announced today that the abstract Analysis of Function and Survival in ALS Patients with Diaphragm Pacing using Virtual Controls by Origent Data Sciences, was accepted for presentation at the 26th International Symposium ALS/MND this year in Orlando.
Origent Data Sciences, winner of the ALS Prediction Prize4Life Challenge for its disease progression model in individual patients, has 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 significant overall survival benefit for Diaphragm Pacing patients compared to their predicted outcomes. Origent used 4,633 records from the PRO-ACT database, with internal and external validation for the survival model. Their findings support the hypothesis that DPS improves survival.
Synapse Biomedical began working with Origent Data Sciences following their well-received presentation at the 2014 MND Symposium in Belgium. "Our interest in working with Origent has been to develop a responder model for ALS that can help inform clinical decision making," said Anthony Ignagni, President and Chief Executive Officer. "The patient-doctor interaction is very important in helping individual ALS patients decide on their course of therapies. If we can help identify those patients that benefit from Diaphragm Pacing—and we have always maintained that it is not for everyone—then patients and the field of ALS clinical research will benefit."
The controlled methodology Origent used has resulted in a robust predictive model for survival in ALS clinical studies. "Using virtual control arm techniques may help us avoid incorrect conclusions due to chance effects in trials with small sample sizes," said Michael Fritz, VP of Clinical and Regulatory Affairs. "Incorporating these techniques in trial design may provide better tools for patient recruitment, study monitoring, and validation of results."
(Fact 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 International sites or more information can be obtained by contacting Synapse Biomedical, Inc.
About NeuRx DPS® Technology
NeuRx Diaphragm Pacing System® (NeuRx DPS®) is a four-channel, battery-powered neurostimulator 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 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 with diaphragm dysfunction of neuromuscular origin. Diaphragm dysfunction can result in abnormal or absent respiration in patient populations of high-level spinal cord injury and 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 demonstrated that it can help people with ALS live longer and sleep better than the current standard of care, alone.
For 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 people 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 designed to predict the disease dynamics of individual patients. Origent's mission is to use predictive disease models to manage and reduce drug and device development risks through improved foresight. Origent is based in the Washington, DC metropolitan area. For more information, visit: http://www.origent.com/
SOURCE Synapse Biomedical Inc.