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Cyberkinetics Announces Results for Fiscal Year Ended December 31, 2004; Product Development and Clinical Progress Highlight Year.


FOXBOROUGH, Mass. -- Cyberkinetics Neurotechnology Systems, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
: CYKN) today released financial results for the fourth quarter and year ended December 31, 2004, and commented on highlights of the year as well as recent developments.

Financial and Organizational Highlights

--Transformed the company into a publicly traded entity through a merger, effected a private placement financing of $6,000,000, and ended 2004 with $5.2 million in cash and cash equivalents. In the first quarter of 2005, the company secured a $3,000,000 line of credit.

--Increased investments in product development and clinical activities, resulting in a net loss of $7,716,000 in 2004, compared to $4,177,000 in 2003. The increase in net loss also reflects costs associated with the merger and private placement, the cost of operating as a public company and non-cash stock compensation expenses.

--Generated total revenues of $1,537,000 in 2004, compared to $1,284,000 in 2003.

Clinical and Product Development Highlights

--Reported positive initial results from the BrainGate(TM) Neural neural /neu·ral/ (noor´al)
1. pertaining to a nerve or to the nerves.

2. situated in the region of the spinal axis, as the neural arch.


neu·ral
adj.
1.
 Interface System pilot clinical trial, providing proof of concept that the direct brain-computer interface A brain-computer interface (BCI), sometimes called a direct neural interface or a brain-machine interface, is a direct communication pathway between a human or animal brain (or brain cell culture) and an external device.  can be used to control a computer and other devices. In December 2004 Spaulding Rehabilitation Hospital Spaulding Rehabilitation Hospital is a rehabilitation hospital located in Boston, Massachusetts. It is affiliated with the Harvard Medical School. External link
Spaulding Rehabilitation Hospital Network
 (Boston, MA) joined Sargent Rehabilitation rehabilitation: see physical therapy.  Center (Providence Providence, city (1990 pop. 160,728), state capital and seat of Providence co., NE R.I., a port at the head of Providence Bay; founded by Roger Williams 1636, inc. as a city 1832. , RI) as a pilot study site, enhancing Cyberkinetics' clinical and patient recruitment networks. In March 2005, Cyberkinetics announced the addition of a third pilot study site at The Rehabilitation Institute of Chicago The Rehabilitation Institute of Chicago is a rehabilitation hospital located in Chicago, Illinois, United States. It is a part of the McGaw Medical Center of Northwestern University.  (Chicago, IL).

--Submitted 510k premarket notification with the U.S. Food and Drug Administration for the NeuroPort(TM) system, a cortical cor·ti·cal
adj.
1. Of, relating to, derived from, or consisting of cortex.

2. Of, relating to, associated with, or depending on the cerebral cortex.
 monitor intended for temporary recording and monitoring of brain electrical activity.

--Advanced development of a fully implantable cortical sensor A device that measures or detects a real-world condition, such as motion, heat or light and converts the condition into an analog or digital representation. An optical sensor detects the intensity or brightness of light, or the intensity of red, green and blue for color systems.  utilizing short-range wireless telemetry telemetry

Highly automated communications process by which data are collected from instruments located at remote or inaccessible points and transmitted to receiving equipment for measurement, monitoring, display, and recording.
, furthering progress toward Cyberkinetics' goal of eliminating percutaneous percutaneous /per·cu·ta·ne·ous/ (per?ku-ta´ne-us) performed through the skin.

per·cu·ta·ne·ous
adj.
Passed, done, or effected through the unbroken skin.
 (through-the-skin) system elements.

"Cyberkinetics made tremendous progress in delivering on our strategy in 2004," said Chief Executive Officer Timothy R. Surgenor. "Most importantly Adv. 1. most importantly - above and beyond all other consideration; "above all, you must be independent"
above all, most especially
, we generated encouraging preliminary results from our initial patient in the pilot clinical trial of the BrainGate(TM) Neural Interface System. We believe that these results provide proof of concept for our ability to detect, transmit and analyze complex neural signals. In addition, we made exciting progress in product development and we ended the year as a publicly traded company publicly traded company

A company whose shares of common stock are held by the public and are available for purchase by investors. The shares of publicly traded firms are bought and sold on the organized exchanges or in the over-the-counter market.
 with enhanced financial resources, a strong management team and an outstanding board of directors."

"As exciting and productive as the past year was, we are all tremendously energized by the prospects and the challenges of the new year," Surgenor continued. "During 2005, we plan to accomplish the following:

--Accelerate progress in the BrainGate(TM) pilot clinical trial;

--Seek FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 and institutional approvals to investigate the utility of the BrainGate(TM) system in additional clinical indications, such as ALS Als (äls), Ger. Alsen, island, 121 sq mi (313 sq km), Sønderjylland co., S Denmark, in the Lille Bælt, separated from the mainland by the narrow Alensund.  (amyotrophic lateral sclerosis amyotrophic lateral sclerosis (ALS) (ā'mīətrōf`ik, sklĭrō`sĭs) or motor neuron disease, );

--Obtain support from clinical partners and approval from the FDA to implement a second generation software into the BrainGate(TM) clinical trial, providing simpler set-up and system operations as well as an enhanced user interface and additional applications;

--Prepare for a potential limited market release of the NeuroPort(TM) cortical monitor by obtaining 510(k) approval, completing necessary manufacturing improvements and facility inspections, finalizing sales and distribution arrangements, and developing marketing and training programs in support of product launch; and

--Complete bench testing of a fully implantable cortical sensor."

For the fourth quarter of 2004, the net loss applicable to common stockholders was $2,719,000 or $0.19 per share based on 14,162,000 weighted average common shares outstanding, as compared to $1,361,000 or $0.34 per share for the fourth quarter of 2003 based on 4,044,000 weighted average common shares outstanding. For the year ended December 31, 2004, net loss applicable to common stockholders was $7,716,000 or $1.16 per share based on 6,660,000 weighted average common shares outstanding, as compared to $4,177,000 or $1.03 per share based on 4,044,000 weighted average common shares outstanding in 2003. Weighted average common shares outstanding increased primarily due to the conversion of 9,419,000 shares of Series A Redeemable Redeemable

Eligible for redemption under the terms of an indenture.
 Convertible Preferred Stock Convertible Preferred Stock

Preferred stock that includes an option for the holder to convert the preferred shares into a fixed number of common shares, usually anytime after a predetermined date. Also known as "convertible preferred shares".
 in connection with the reverse merger as well as the issuance of 2,000,000 shares of common stock in connection with the subsequent private placement.

Financial results for the quarter and year ended December 31, 2004 are summarized in the table below.

About Cyberkinetics Neurotechnology Systems, Inc.

Cyberkinetics Neurotechnology Systems, a leader in brain-machine interface technology, is developing products to treat nervous system diseases and disorders by bringing together advances in neuroscience neu·ro·sci·ence
n.
Any of the sciences, such as neuroanatomy and neurobiology, that deal with the nervous system.



neuroscience

the embryology, anatomy, physiology, biochemistry and pharmacology of the nervous system.
, computer science and engineering. Cyberkinetics' products are based on over ten years of technology development and cutting-edge neuroscience research at leading academic institutions such as Brown University, the Massachusetts Institute of Technology Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, , Emory University Emory University (ĕm`ərē), near Atlanta, Ga.; coeducational; United Methodist; chartered as Emory College 1836, opened 1837 at Oxford. It became Emory Univ. in 1915 and in 1919 moved to Atlanta. , and the University of Utah The University of Utah (also The U or the U of U or the UU), located in Salt Lake City, is the flagship public research university in the state of Utah, and one of 10 institutions that make up the Utah System of Higher Education. . Cyberkinetics is publicly traded on the Over the Counter Bulletin Board under the ticker symbol Ticker Symbol

An arrangement of characters (usually letters) representing a particular security listed on an exchange or otherwise traded publicly. When a company issues securities to the public marketplace, it selects an available ticker symbol for its securities which investors
 CYKN. The Company is headquartered in Foxborough, Massachusetts Foxborough (or Foxboro) is a town in Norfolk County, Massachusetts, approximately 30 miles (48 km) southwest of Boston and 20 miles (32 km) northeast of Providence, Rhode Island. The population was 16,246 at the 2000 census.  and conducts engineering and research in Salt Lake City, Utah For ships of the United States Navy of the same name, see .
Salt Lake City is the capital and the most populous city of the U.S. state of Utah. The name of the city is often shortened to Salt Lake, or its initials, S.L.C.
. Additional information is available at www.cyberkineticsinc.com.

Cyberkinetics' first product, the BrainGate(TM) Neural Interface System, is designed to give severely paralyzed par·a·lyze  
tr.v. par·a·lyzed, par·a·lyz·ing, par·a·lyz·es
1. To affect with paralysis; cause to be paralytic.

2. To make unable to move or act: paralyzed by fear.
 individuals a long-term, direct brain-computer interface for the purpose of communication and control of a computer and other devices. Patients are currently being enrolled into a pilot clinical trial to test the BrainGate(TM) System's safety and effectiveness. For specific information about the BrainGate(TM) clinical study please send an email to braingateinfo@cktrial.com.

Forward Looking Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 Statement

This announcement contains forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
, including statements about Cyberkinetics' product development plans and progress, anticipated regulatory approvals, corporate financial status and commercial prospects. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995, and can be identified by the use of forward-looking terminology such as "may," "will," "believe," "expect," "anticipate" or other comparable terminology. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected in forward-looking statements and reported results shall not be considered an indication of our future performance. Factors that might cause or contribute to such differences include our limited operating history; our lack of profits from operations; our ability to successfully develop and commercialize our proposed products; a lengthy approval process and the uncertainty of FDA and other governmental regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. ; clinical trials may fail to demonstrate the safety and effectiveness of our products; the degree and nature of our competition; our ability to employ and retain qualified employees; compliance with recent legislation regarding corporate governance Corporate Governance

The relationship between all the stakeholders in a company. This includes the shareholders, directors, and management of a company, as defined by the corporate charter, bylaws, formal policy, and rule of law.
, including the Sarbanes-Oxley Act See SOX.  of 2002; as well as those risks more fully discussed in our public filings with the Securities and Exchange Commission, all of which are difficult to predict and some of which are beyond our control
Cyberkinetics Neurotechnology Systems, Inc.
                     (A Development-Stage Company)
                 Consolidated Statement of Operations
                              (unaudited)


                          Three months ended          Year ended
                             December 31             December 31
                       ----------------------- -----------------------
                           2004        2003        2004        2003
                       ----------- ----------- ----------- -----------
Revenues:
Product sales         $   227,475 $   190,830 $   652,875 $   509,379
Grant income              224,287     142,518     883,794     774,622
                       ----------- ----------- ----------- -----------
Total revenues            451,762     333,348   1,536,669   1,284,001

Operating expenses:
Cost of product sales      61,684     113,204     262,984     258,801
Research and
 development            2,150,346     760,374   4,308,571   2,600,396
Sales and marketing        72,655      87,373     297,544     263,410
General and
 administrative           882,991     540,117   3,747,127   1,740,565
                       ----------- ----------- ----------- -----------
Total operating
 expenses               3,167,676   1,501,068   8,616,226   4,863,172
                       ----------- ----------- ----------- -----------

Operating loss         (2,715,914) (1,167,720) (7,079,557) (3,579,171)

Other income (expense)
Interest income            12,070      17,478      39,621      66,611
Interest expense          (15,418)     (1,773)    (50,656)     (7,472)
                       ----------- ----------- ----------- -----------
Other income, net          (3,348)     15,705     (11,035)     59,139

Net loss               (2,719,262) (1,152,015) (7,090,592) (3,520,032)

Dividends and accretion
 to redemption value of
 redeemable convertible
 preferred stock                -    (209,099)   (625,149)   (657,196)
                       ----------- ----------- ----------- -----------

Net loss attributable
 to common
 stockholders         $(2,719,262)$(1,361,114)$(7,715,741)$(4,177,228)
                       =========== =========== =========== ===========

Basic and diluted net
 loss attributable to
 common stockholders
 per common share     $     (0.19)$     (0.34)$     (1.16)$     (1.03)
                       =========== =========== =========== ===========

Shares used in
 computing basic and
 diluted net loss
 attributable to
 common stockholders
 per common share      14,161,940   4,044,180   6,660,318   4,044,180
                       =========== =========== =========== ===========


                                          Period from
                                          May 2, 2001
                                         (Inception) to
                                          December 31,
                                              2004
                                        ----------------
Revenues:
Product sales                          $      1,396,503
Grant income                                  1,955,160
                                        ----------------
Total revenues                                3,351,663

Operating expenses:
Cost of product sales                           638,543
Research and development                      7,492,373
Sales and marketing                             584,373
General and administrative                    5,919,643
                                        ----------------
Total operating expenses                     14,634,932
                                        ----------------

Operating loss                              (11,283,269)

Other income (expense)
Interest income                                 138,092
Interest expense                                (63,275)
                                        ----------------
Other income, net                                74,817

Net loss                                    (11,208,452)

Dividends and accretion to
 redemption value of redeemable
 convertible preferred stock                 (1,463,334)
                                        ----------------

Net loss attributable to common
 stockholders                          $    (12,671,786)
                                        ================

Basic and diluted net loss
 attributable to common
 stockholders per common share         $          (3.15)
                                        ================

Shares used in computing basic
 and diluted net loss
 attributable to common
 stockholders per common share                4,018,639
                                        ================



              Cyberkinetics Neurotechnology Systems, Inc.
                     (A Development Stage Company)
                 Condensed Consolidated Balance Sheets
                              (Unaudited)

                                                  December 31,
                                          ---------------------------
                                                 2004         2003
                                          ---------------------------
Assets
Current Assets
     Cash and cash equivalents            $   5,232,641  $  5,067,594
     Other current assets                       726,664       297,189
Net property and equipment                      549,927       399,894
Other Assets                                    246,871       288,889
                                          -------------  -------------
Total Assets                              $   6,756,103  $  6,053,566
                                          =============  =============

Liabilities and stockholders' equity
 (deficit)
Current liabilities                       $   1,308,245  $    758,182
Long-term liabilities                           365,528       131,923

Series A redeemable convertible preferred
 stock                                                -     9,740,302

Stockholders' Equity (Deficit):
     Common stock, $0.01 par value,              16,939         5,344
     Additional paid-in-capital              17,835,622       524,594
     Common stock held in escrow                (13,000)      (13,000)
     Deferred stock-based compensation          (85,445)     (137,734)
     Accumulated deficit                    (12,671,786)  ( 4,956,045)
                                          -------------  -------------
Total stockholders' equity (deficit)          5,082,330    (4,576,841)
                                          -------------  -------------
Total liabilities and stockholders' equity
 (deficit)                                $   6,756,103  $  6,053,566
                                          =============  =============
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Mar 31, 2005
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