Navigation Links
CoAxia Announces Completion of Enrollment in Ischemic Stroke Trial
Date:2/12/2010

MINNEAPOLIS, Feb. 12 /PRNewswire/ -- CoAxia™, Inc. of Maple Grove, MN, announced today the completion of enrollment in its SENTIS randomized, controlled, pivotal trial of NeuroFlo™ Perfusion Augmentation Therapy as an acute interventional treatment for ischemic stroke.  The Company plans to complete data collection and analysis of results in Q3 of 2010 and, if warranted, submit a PMA to the US FDA.

Ischemic stroke is one of the largest causes of death and disability in the western world, affecting over 650,000 patients annually in the United States alone, and responsible for $70B in annual costs for the long term care of stroke-disabled patients.  Whereas in the US approximately 5% of ischemic stroke patients are treated acutely, CoAxia believes that if the NeuroFlo treatment proves safe and effective, as many as 50% of stroke patients may become eligible for treatment – a significant potential benefit to stroke patients and the healthcare system.

The SENTIS trial is being performed in the US and Europe under an FDA IDE, and includes ischemic stroke patients treated within 14 hours of the onset of symptoms.  By comparison, the only other approved stroke therapy in the US is the intravenous delivery of the thrombolytic drug tPA, which is approved for a three hour time window.  SENTIS is a 1:1 randomized, controlled study with a neurological improvement endpoint measured at 90 days after symptom onset.  The outcome measure is the Stroke Global Score as defined by the National Institute of Neurological Disease and Stroke (NINDS). With 515 patients enrolled at over 50 stroke centers in 10 countries, CoAxia believes that it will have sufficient patients and site diversity to accurately measure safety and efficacy of the NeuroFlo technology in a broad segment of ischemic stroke patients.

Professor Ashfaq Shuaib, Director of Stroke Services at the University of Alberta Medical Center, and Principal Investigator of the SENTIS trial commented; "The SENTIS trial will provide the safety and efficacy data which stroke neurologists demand for adoption of a new stroke therapy: randomized, controlled data with a 90 day neurological endpoint.  CoAxia has conducted this study at the highest level, and I am confident that the quality of the data, if the trial proves positive, will allow clinical adoption of this exciting new technology."

Lorinda Austin, Vice President of Clinical Affairs commented, "The SENTIS trial is a collaboration between CoAxia and stroke researchers from the US, Canada, Europe and Israel.  Completion of enrollment of 515 patients is a key milestone for the trial.  It indicates the worldwide clinical interest in the technology, and it signals our new focus: to complete patient data collection and determine our safety and efficacy profile."

Andrew M. Weiss, President and CEO commented, "CoAxia has invested more than 4 years and over $40M in the SENTIS trial, and we are excited about the ability to determine the safety and efficacy outcomes of the SENTIS trial later this year.  If positive, we will have plans in place to submit our PMA to the FDA as well as initiate commercialization in Europe and around the world."

CoAxia, Inc. is a venture-backed, privately held, clinical-stage company focused on providing perfusion augmentation therapies that improve outcomes for patients with cerebral ischemia resulting from stroke, vasospasm and other conditions.

SOURCE CoAxia, Inc.

RELATED LINKS
http://www.coaxia.com

'/>"/>

SOURCE CoAxia, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. 3SBio Inc. Announces Unaudited Fourth Quarter and Full Year 2009 Results
2. Kendle Announces Details Regarding Fourth Quarter and Full-Year 2009 Earnings Conference Call and Webcast
3. Moleac Announces Breakthrough Results on Neuroprotective and Neurogenerative Properties of NeuroAiD
4. Intellect Neurosciences, Inc. Announces Preliminary Agreement with Significant Shareholders to Provide Interim Funding and Assist the Company in Efforts to Secure Additional Financing
5. Kinexus Announces the Launch of a New Protein Kinase Microarray
6. Ardea Biosciences Announces Appointment of Felix J. Baker, Ph.D. to Board of Directors
7. Tianyin Pharmaceutical Co., Inc. Announces Record Second Quarter 2010 Financial Results
8. Silicon Kinetics Announces New Biosensor Chips With Wide Palette of Surface Chemistries
9. Neurocrine Biosciences Announces the Appointment of William H. Rastetter to Its Board of Directors
10. Healthcare Data Solutions Announces Expansion of its Healthcare Customer Solutions Team With Two Key Additions
11. Angiotech Pharmaceuticals Announces Conference Call and Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... , Dec. 2, 2016 More than $4.3 ... 11th Double Helix Medals dinner ( DHMD ). The gala was held ... New York City and honored Alan ... contributions, respectively, to health and medicine and the public understanding ... in 2006, the event has raised $40 million for ...
(Date:12/2/2016)... , Dec. 2, 2016 CytRx Corporation ... development company specializing in oncology, today announced the appointment ... sarcoma surgeon, industry consultant, and private healthcare investor, to ... a healthcare leader with clinical and strategic experience at ... CytRx,s Chairman and CEO. "As one of the world,s ...
(Date:12/2/2016)... ... December 01, 2016 , ... ... the value of DNA microarray comparative genomic hybridization (array CGH) for HER2 ... Cancer Symposium. Using molecular test results from tumors with previously documented positive, ...
(Date:12/2/2016)... ... December 01, 2016 , ... The Conference Forum has announced that the ... will take place on February 1-3, 2017 at the Roosevelt Hotel in New York ... program provides a unique 360-degree approach, which addresses the most up-to-date information regarding business ...
Breaking Biology Technology:
(Date:11/29/2016)... Nov. 29, 2016   Neurotechnology , ... object recognition technologies, today released FingerCell 3.0, ... recognition solutions that run on low-power, low-memory ... using less than 128KB of memory, enabling ... that have limited on-board resources, such as: ...
(Date:11/22/2016)... Nov. 22, 2016   MedNet Solutions , an ... spectrum of clinical research, is pleased to announce that ... Healthcare and Life Sciences Awards as "Most Outstanding ... an unprecedented year of recognition and growth for MedNet, ... 15 years. iMedNet ™ , ...
(Date:11/16/2016)... Calif. , Nov. 16, 2016 ... user experience and security for consumer electronics, and ... the financial and retail industry, today announced a ... and convenient way to authenticate users of mobile ... Sensory,s TrulySecure™ software which requires no ...
Breaking Biology News(10 mins):