Blackrock Microsystems Obtains Expanded 510(k) to Market NeuroPort System

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Blackrock's NeuroPort Biopotential Neural Signal Processing System enables acute monitoring, signal detection and analysis to facilitate development of new clinical therapies with the potential to improve diagnosis and treatment of a wide range of brain disorders including Epilepsy and Parkinson's disease. The NeuroPort System is uniquely capable of monitoring from as many as 256 channels, with the potential to be scalable to more than a thousand channels (in increments of 256 channels), to improve intracranial high-channel direct recording of brain activity.The enhanced NeuroPort System offers physicians and neuroscience researchers richer data related to spatial and temporal resolution at the level of single neurons.

The NeuroPort System enables us to work directly with leading clinicians to develop applications of our technology to monitor, diagnose and treat a wide range of debilitating diseases and conditions that, today, are poorly managed and diagnosed.

Blackrock Microsystems LLC today announced that it has received a new, expanded 510(k) marketing approval from the U.S. Food and Drug Administration. The new labeling allows the NeuroPort Biopotential Neural Signal Processor (NeuroPort System) to be used with electrodes supplied by users, as well as with the implantable NeuroPort Cortical Microelectrode Array (NeuroPort Array) covered by a previous 510(k). In addition, the new 510(k) for the NeuroPort System has been expanded to include its use in medical applications beyond brain monitoring.

The biopotential signals that the NeuroPort System is designed to detect, record and analyze include electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP).
The NeuroPort System provides neuroscientists, neurologists and neurosurgeons an innovative and unequalled resource to detect, transmit and analyze brain activity in a wide range of intra-operative, outpatient and research settings. Significant advantages of the NeuroPort System include, among others:

  •     Real-time access to data;
  •     Scalable, 256-channel channel recording capability;
  •     Automatic spike sorting with multiple sorting options;
  •     Open data file format that is compatible with third-party applications; and
  •     Synchronous filtering to remove non-biological signals.

"Our 510(k) marketing approval significantly expands the potential medical applications of our NeuroPort Signal Processing platform, which supports our continued drive to develop products to support closed-loop control for therapeutic and prosthetic applications," said Chief Executive Officer Andrew Gotshalk. "The NeuroPort System enables us to work directly with leading clinicians to develop applications of our technology to monitor, diagnose and treat a wide range of debilitating diseases and conditions that, today, are poorly managed and diagnosed."

In March 2009, Blackrock Microsystems acquired worldwide rights to the NeuroPort acute monitoring platform technology from Cyberkinetics Neurotechnology Systems, Inc., formerly of Foxborough, Massachusetts. The NeuroPort System platform is currently used in the BrainGate Neural Interface System (approved under IDE), which is designed for chronic use in people with spinal cord injuries, stroke and neurodegenerative conditions. Cyberkinetics previously obtained 510k clearance to market the NeuroPort System in April 2005, though its use at the time was limited exclusively to acute (< 30 days) intracranial monitoring with a 96-channel microelectrode array (the Utah array).

About Blackrock Microsystems LLC
Blackrock Microsystems, a privately held company, is a leading global marketer in intelligent microsystems that aid neuroscience researchers and physicians in the development of improved medical solutions for the diagnosis and treatment of serious central nervous system diseases and conditions. Blackrock also markets a broad range of neural monitoring equipment to neuroscience researchers worldwide. Additional information is available from the Company's website at http://www.blackrockmicro.com.

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Elizabeth Razee
Razee Corporate Communications
508-252-4143
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Andrew Gotshalk