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Technology BrainGate
The BrainGate Neural Interface System is an investigational device that Cyberkinetics has begun clinically testing. It is not an approved device and it is available only through a clinical study. The System consists of a sensor that is implanted on the motor cortex of the brain and a device that measures and interprets brain signals and translates these signals into useful computer control. It is hoped that the BrainGate System might someday allow people unable to use their arms or hands to control a computer using their thoughts.
Background of the Investigational BrainGate System Individuals with severe paralysis usually have intact brain function but are unable to move due to injury or disease affecting the spinal cord, nerves, or muscles. People who have such severe physical impairments have limited movement ability, and some are unable to use their arms, legs or hands. This is often referred to as quadriplegia. In all primates (including macaque monkeys and humans), the neurons in the motor cortex of the brain normally send their instructions (signals) out to the spinal cord, which in turn drives muscles. Consider the simple voluntary task of moving one finger. This act takes some intention and a simple plan that originates in the cerebral cortex. A few milliseconds before voluntary movement, neural signals, in the form of a stream of impulses, increase in the primary motor cortex. This increase in impulse rate of a large group of neurons carries the commands for movement. When the connection from the brain to the spinal cord has severed, as in severely paralyzed people, the central control for motor behavior in the brain remains healthy, but the command signals are ineffective because they are cut off from the muscles.
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Currently available assistive devices have other significant limitations for both the person in need and the caregiver. The location of these various types of switches must be adjusted frequently as the individual moves in relation to the device. Since many of these people have limited muscle control, adjustment can be a time consuming and constant process for the caregiver, significantly affecting the reliability and accuracy of these devices. In addition, these devices are obtrusive and may prevent the individual from being able to establish eye contact with caregivers. Devices that require the use of the mouth or of the eyes are sometimes considered disfiguring when placed on the individuals head. The level of control that can be achieved with the existing assistive devices is also problematic. The speed of communication for tasks such as typing or changing programs on a personal computer can be very limited. The rate of communication with assistive devices is so limited that they are frequently abandoned by those in need of caregivers. These devices, therefore, have limitations in functionality, ease of use and speed of use and so alternative approaches and devices are needed for many of these people. These types of assistive devices are not neural prosthetics in the sense that they do not directly utilize neural information or signals directly from within the brain. Over the last 30 years the National Institutes of Health (NIH) has actively funded numerous programs to develop neural prosthetics to assist these individuals in regaining their independence. The development of an implantable neural interface that could potentially provide a permanent, reliable and fast output signal to a personal computer would likely be a significant improvement in the quality of communication and computer control available to people with such disabilities. Further developments based on such a system could conceivably allow these people to control devices beyond personal computers such as environmental controls, medical devices designed to power their own limbs, and robotic equipment such as wheelchairs.
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No adverse events Patient able to send movement commands despite not using arm for over three years BrainGate System functions as planned Detects, transmits neural signals -Able to translate movement commands into -cursor control in numerous trials Proof of concept control of useful devices Work now focused on development of next generation software
BrainGate Plan 2005 o Complete Spinal Cord Injury Pilot Trial Accrual -2 leading rehab sites added - Patient screening underway Open ALS Pilot Trial Develop, test next generation operating system -Automate daily set-up -Interface to computer controlled devices Form Partnerships to develop limb movement Obtain grant funding
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Initial Study Participant As of March 2005, one person has been enrolled, implanted and is actively participating in the study at the Sargent Rehabilitation Center study site. Patient 001 is a 25 year-old ventilator-dependent male who is unable to move either upper extremity due to a C4 spinal cord injury suffered in July 2001.
Surgical Implantation In June 2004, after obtaining informed consent, a surgical procedure consisting of an incision and 3 cm diameter craniotomy located above the right primary motor cortex was conducted under general anesthesia. A 4x4 mm, 100 channel sensor was implanted on the surface of the cortex, in the precentral gyrus immediately posterior to the superior frontal sulcus, as identified on presurgical MRI. The surgery lasted approximately 3 hours and was uneventful. The patient was discharged to his primary residence 3 days post-surgery where he recovered for 3 days post-surgery where he recovered for three weeks prior to initiation of device testing.
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Spike Rates Tuned to Direction of Imagined Movement Perievent spike raters and spike rate histograms for Center Out task in a closed loop experiment. (Bottom right)
Performance Results on Closed-Loop Center-Out Task Across Sessions (8/27/049/20/04) In 7/8 sessions, the patients neural cursor selected significantly more intended targets than false positive/unintended targets. Significance calculated using one-sided z-test at alpha 0.01. (Top left)
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Preliminary Observations of Device Safety There were no post-surgical complications, which is supported by the continued ability to record neural activity. No adverse events or other study-related complications have been reported. Safety assessments include daily checks of connector, weekly nurse visits, and monthly physician exams including neurological and mental status exams. Summary of Initial Observations o o Motor cortex neurons of humans remain active years after spinal cord injury. Modulation of neural activity is possible in MI in the absence of limb movement. Using the BrainGate system, the initial participant has immediately gained control of a computer interface, with no special training, and can operate the cursor while performing other voluntary motor tasks. The control signal provided has the potential for 3 dimensions of control from the signals obtained in MI and this signal has been used to control a range of potentially useful devices including computers, robots, and prosthetic limbs.
These observations suggest that the system should be useful in any disabled patient with an intact motor cortex. This initial case report suggests that the BrainGate system, which uses a tested, validated sensor implant which is removable and replaceable, may offer patients with severe disability a universal operating system with which they can control devices in the environment around them.
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Technology (continued)
Future Goals o o Enable individuals with paralysis to use e-mail and telephones to communicate. Provide access to environmental controls, such as bed positioning, television, lights, and thermostats through a desktop application. Improve mobility by interfacing with powered wheelchairs. Provide patients with the ability to adjust their body position to avoid pressure sores. Facilitate control over all of these actions and a range of other software and external device applications through a single, universal integrated interface.
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The BrainGate feasibility trial is being expanded to other clinical sites. Product development is being focused on creation of a streamlined operating system and on the design and testing of a totally implantable sensor system.
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Alta
Alta is a fully implantable high resolution long term sensor that is indicated for chronic real-time monitoring of brain activity. Alta provides long term ability to directly monitor cortical neural activity in specific locations; Alta also allows outpatient monitoring and diagnosis as well as a wide range of potential applications. The current market size for the long term monitoring, diagnosis and treatment of neurological diseases is $1 billion.
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Pre-Clinical Development
Clinical Trials
FDA Review
510(k)
Approval
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Cyberkinetics Neurotechnology Systems, Inc. Technology (continued) In conclusion CYKN develops products designed for use in functional restoration, monitoring, diagnosis and therapy:
BrainGate - Neural Interface System As described, CYKNs lead product is intended to allow a disabled person to control a computer using thought. This system utilizes a long-term implantable sensor, which incorporates a through-the-skin connector. The design is composed of a microarray; connector and electronics package consists of an amplifier, high-bandwidth telemetry and a power source.
NeuroPort - Neural Signal Processor A short-term (0-30 days) intraoperative and post-operative cortical monitor to gain real-time information directly from patients neural signals. Leveraging the BrainGate technology, this product may represent a novel offering in the existing market for cortical monitors by providing a new dimension of information from a dense population of neural cells. The NeuroPort device could represent a breakthrough in the ability to detect and respond to the onset of neurological diseases and disorders, such as epilepsy. A 510(k) application has been submitted to the FDA.
Alta a fully Implantable Sensor was designed to replace the need for a through-the-skin connector in the first-generation BrainGate and NeuroPort systems, Alta will utilize short-range wireless telemetry to enable chronic and long-term monitoring of neural activity in the outpatient setting. The same technology will be used to make the BrainGate safer, more durable, cosmetically more acceptable, and to enhance patient mobility and quality of life. The system, currently under development, is designed to minimize clinical/regulatory hurdles by leveraging the current BrainGate technology whenever possible.
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Timothy R. Surgenor 24 President, Chief Executive Officer and Director John P. Donoghue, Ph.D. 25 Founder, Chief Scientific Officer and Director Christopher Flaherty Executive Vice President, Technology and Intellectual Property Burke T. Barrett 19 Vice President, Clinical Operations Kimi E. Iguchi Vice President, Finance Jon P. Joseph, Ph.D. 17 Vice President, R&D and Applications Development Nandini Murthy Vice President, Regulatory Affairs and Quality Systems 14 2 2 10 1 2 20 2 4 2
Brown University.
Cardiofocus, Cyberonics
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Philip W. Morgan
Consultant Mr. Morgan has been a Director of Cyberkinetics since August 2003. Mr. Morgan is currently a consultant to Global Life Science Ventures, which is located in Zug, Switzerland, Munich, Germany and London, England. Previously, Mr. Morgan was Healthcare and Biotechnology Investment Specialist with UK-based 3i plc where he worked on both European and American investments. Mr. Morgan has also held management roles with Rhne Poulenc (now Aventis (NYSE:AVE)), Johnson & Johnson (NYSE:JNJ) and C.R. Bard Inc. (NYSE:BCR). Mr. Morgan is a Director of the Global Life Science Ventures (GP) Ltd., the GLSV Special Partner Ltd. and Munich Biotech AG. He received his B.Sc. in Chemistry and Physics at the University of London in 1968 and his M.A. in Marketing at the University of Lancaster in 1971.
Theo Melas-Kyriazi
Self-employed Mr. Melas-Kyriazi has been a director of our company since November 2004 and is currently self-employed. Mr. Melas-Kyriazi was affiliated with Thermo Electron Corporation (NYSE:TMO) from 1986 to October 2004. He served as Chief Financial Officer of TMO from 1999 until October 2004, and from 1994 to 1997, he served as Chief Executive Officer and President of Thermo Spectra Corporation, a publicly traded subsidiary of TMO. Mr. Melas-Kyriazi received his Bachelor of Arts Degree in Economics from Harvard College in 1981 and his MBA from The Harvard Business School in 1983.
Daniel E. Geffken
Senior Vice President and Chief Financial Officer, Omnisonics Medical Technologies, Inc. Mr. Geffken has been a director of Cyberkinetics since January 2005 and is currently the Senior Vice President and Chief Financial Officer of Omnisonics Medical Technologies, Inc. Mr. Geffken joined Omnisonics Medical Technologies, Inc. in December of 2003. Previously, Mr. Geffken was Senior Vice President of Finance and Chief Financial Officer at Transkaryotic Therapies, Inc. from February 1997 to April 2003. Prior to Transkaryotic Therapies, Inc., Mr. Geffken held a variety of senior financial roles at Cytotherapeutics, Inc, Anderson Group (now Moscow CableCom Corp.) and Medchem Products (now C. R. Bard Inc.). Mr. Geffken also spent several years at KPMG. Mr. Geffken received his Bachelor of Science Degree in Economics from The Wharton School at the University of Pennsylvania in 1979 and his MBA from The Harvard Business School in 1987.
Timothy R. Surgenor
President and Chief Executive Officer Mr. Surgenor joined Cyberkinetics in 2003 from Haemonetics Corporation (NYSE:HAE), a medical device company located in Braintree, MA where he was Executive Vice President with responsibility for business development, global marketing, quality assurance and regulatory affairs from 1999- 2003. While at Haemonetics, Mr. Surgenor was an active member of the investor relations effort. From 1994 -1999, Mr. Surgenor was President of Genzyme Tissue Repair, the cell therapy division of Genzyme Corporation (NASDAQ:GENZ) located in Cambridge, MA. While at Genzyme Tissue Repair, Mr. Surgenor led successful public offerings which raised approximately $100 million. Previously, Mr. Surgenor was Executive Vice President and Chief Financial Officer of BioSurface Technology, Inc. and also held various positions in operations at Integrated Genetics. Mr. Surgenor received a B.A. in Biochemistry from Williams College in 1981 and an M.B.A. from Harvard Business School in 1987.
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