Cytyc Corporation Closes
Acquisition of Proxima Therapeutics, Inc.
Cytyc Corp. Press Release
3.07.05
Cytyc Corporation (Nasdaq: CYTC), a leading women's health company,
today announced that it has closed the acquisition of Proxima
Therapeutics, Inc., a privately-held company that develops and markets
innovative radiation delivery systems for the treatment of cancer. The
acquisition closed on March 7, 2005.
Patrick J. Sullivan, Cytyc's chairman, president, and chief executive
officer, said, "The acquisition of Proxima Therapeutics represents
another significant milestone for Cytyc and we are very excited to
further expand our innovative product offerings to include breast cancer
treatment. We believe this is an excellent strategic opportunity for Cytyc
as it allows us to build on our formidable success while advancing our
mission to become the premier provider of best-in-class medical
technologies focused on women's health."
Mr. Sullivan added, "Even though we expect the acquisition to be
slightly dilutive to earnings in the first quarter of 2005, we maintain
our previous earnings guidance for the first quarter of $0.21 to $0.22
per share."
Cytyc Corporation is a leading women's health company that designs,
develops, manufactures, and markets innovative and clinically effective
products. Cytyc products cover a range of women's health applications,
including cervical cancer screening, breast cancer risk assessment, and
treatment of excessive menstrual bleeding. The ThinPrep(R) System is the
most widely used method for cervical cancer screening in the United States.
The ThinPrep System consists of the ThinPrep(R) 2000 Processor,
ThinPrep(R) 3000 Processor, ThinPrep(R) Imaging System, and related
reagents, filters, and other supplies. The ThinPrep System also provides
the platform from which the Company launched its expansion into breast
cancer risk assessment with the FirstCyte(R) Breast Test. Cytyc Surgical
Products, a wholly owned subsidiary of Cytyc Corporation, manufactures
and markets the NovaSure(R) Impedance Controlled Endometrial Ablation
System, or the NovaSure(R) System, an innovative endometrial ablation
device to treat menorrhagia, or excessive menstrual bleeding.
Cytyc is traded on The Nasdaq Stock Market under the symbol CYTC.
Cytyc, ThinPrep, FirstCyte, and NovaSure are registered trademarks of
Cytyc Corporation.
Forward-looking statements in this press release are made pursuant to
the provisions of Section 21E of the Securities Exchange Act of 1934.
Investors are cautioned that statements in this press release which are
not strictly historical statements, including, without limitation,
statements relating to the Company's financial condition, operating
results and future economic performance, and management's expectations
regarding future growth opportunities, product acceptance and business
strategy, constitute forward-looking statements. These statements are
based on current expectations, forecasts and assumptions that are subject
to risks and uncertainties, which could cause actual outcomes and results
to differ materially from those statements. Risks and uncertainties
include, among others, dependence on key personnel and proprietary
technology, uncertainty of product development efforts and product
acceptance, management of growth and product diversification, risks
associated with litigation and arbitration, the effective integration of
acquired businesses and technologies, successful entry into new market
segments, competition and competitive pricing pressures, risks associated
with the FDA regulatory approval processes and any healthcare
reimbursement policies, introduction of technologies that are disruptive
to the Company's business and operations, as well as other risks detailed
in the Company's filings with the Securities and Exchange Commission,
including under the heading "Certain Factors Which May Affect Future
Results" in its 2004 Annual Report on Form 10-K filed with the
Commission. The Company cautions readers not to place undue reliance on
any such forward-looking statements, which speak only as of the date they
were made. The Company disclaims any obligation to publicly update or
revise any such statements to reflect any change in Company expectations
or events, conditions, or circumstances on which any such statements may
be based, or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements.
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Six-Month Results of
Cyberkinetics' BrainGate Neural Interface System Pilot Study Presented at
AAP Meeting
Company Press Release
2.24.05
FOXBOROUGH, Mass.--(BUSINESS WIRE)--Feb. 24, 2005--Interim results of
the clinical study of the BrainGate(TM) Neural Interface System will be
presented today at the annual meeting of the Association of Academic
Physiatrists in Tucson, Arizona. The BrainGate System is being developed
by Cyberkinetics Neurotechnology Systems, Inc. (Cyberkinetics) (OTCBB:
CYKN) and is the subject of an ongoing pilot study under an
Investigational Device Exemption from the U.S. Food and Drug
Administration. The ultimate goal of the BrainGate development program is
to create a safe, effective and unobtrusive universal operating system
which will allow physically disabled people to quickly and reliably
control a wide range of devices using their thoughts, including
computers, assistive technologies and medical devices.
The poster presentation of these interim results from the pilot
(feasibility) study will be made by Jon Mukand, M.D., Ph.D., who is an
investigator for the BrainGate System study at the Sargent
Rehabilitation Center in Providence,
R.I., and a faculty member
of the Brown University School of Medicine. According to Dr. Mukand,
"The first patient in the BrainGate pilot trial has now passed six
months from initial implantation and there have been no adverse events.
The BrainGate System continues to function as planned, allowing the
patient to demonstrate that he can control a computer, external
appliances, and a prosthetic limb. We are extremely encouraged by what
has been achieved to date, and are increasingly convinced that, with
additional development, the BrainGate System may represent a significant
breakthrough in improving functional capability and quality of life for
people with severe neurological disabilities."
"Based on the results we have observed to-date our work with the
first patient and with future patients will be primarily focused on
developments that will allow us to release a next-generation BrainGate
software," said John Donoghue, Ph.D. Chief Scientific Officer of
Cyberkinetics and Chairman of the Department of Neuroscience and Director
of the Brain Science Program at Brown University. "This upgrade is
intended to simplify the trial operations of setting up the BrainGate
interface while at the same time potentially providing a standardized
interface to a personal computer and other communication devices."
Summary of Preliminary Results
The poster, titled "Feasibility Study of the BrainGate(TM) Neural
Interface System for Individuals with Quadriplegia," includes preliminary
data from one patient with a three-year-old spinal cord injury. The
reported results were recorded over a six -month period. The surgery to
implant the BrainGate sensor was performed in June 2004 at Rhode Island Hospital,
Providence, R.I.,
by Gerhard M. Friehs, M.D., Ph.D., director of functional neurosurgery at
Rhode Island Hospital, and associate professor of clinical
neurosciences at Brown
Medical School.
The signal processing function of the BrainGate System was confirmed
by its ability to reliably detect, transmit and analyze brain (neural)
signals from the area of the brain that controls the movement of the hand
and arm. Subsequent to the implant procedure, the patient was immediately
able to send signals from this part of his brain in a controllable and
meaningful fashion in response to directional commands even though he had
not moved his arm in over three years due to a spinal cord injury. This
capability has been maintained over a six-month period, and is
continuing. A system has been developed to generate cursor control from
these neural signals, enabling the patient to perform tasks and operate
basic computer functions in numerous trials. The patient's control of the
cursor was immediate and intuitive, and the patient was able to perform
tasks while speaking and moving his head, without disruption.
These results are preliminary and represent the early outcomes from a
single patient. While the first patient will continue in the study,
Cyberkinetics plans to continue enrollment into the pilot (feasibility)
study. The number of enrollment sites has been increased with the recent
addition of the Spaulding Rehabilitation Center
at the Massachusetts
General Hospital.
About the BrainGate(TM) Pilot Study
The ongoing pilot (feasibility) study will enroll up to five
quadriplegic individuals between the ages of 18 and 60 who meet the
study's selection criteria. The two primary goals of the pilot clinical
study are to characterize the safety profile of the device and to
evaluate the quality, type, and usefulness of neural output control that
patients can achieve using thoughts. Participants will undergo surgery to
implant the sensor portion of the BrainGate neural interface on the area
of the brain responsible for movement. During the study, they will perform
tasks with the device such as attempting to control the movement of a
cursor on a screen toward a specific target with their thoughts. The
study is expected to last for about 13 months for each patient. At the
end of the study, each participant will undergo another surgery to have
the device removed or may have the option to participate in future
studies.
About the BrainGate(TM) System
Cyberkinetics' BrainGate Neural Interface System is a proprietary,
investigational brain-computer interface device that consists of an
internal neural signal sensor and external processors that convert neural
signals into an output signal under the person's own control. The sensor
consists of a tiny chip about the size of a baby aspirin, with one
hundred electrode sensors each thinner than a hair that detect brain cell
electrical activity. The sensor is implanted on the surface of the area
of the brain responsible for movement, the primary motor cortex. The
sensor is connected by a small wire to a pedestal which is mounted on the
skull, extending through the scalp. The pedestal is in turn connected by
a cable to a cart containing computers, signal processors and monitors
which enable the study operators to determine how well a study
participant can control their neural output.
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,
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, Emory University, and the University of Utah.
Cyberkinetics is publicly traded on the Over the Counter Bulletin Board
under the ticker symbol, CYKN. The Company is headquartered in Foxborough, Massachusetts
and conducts engineering and research in Salt Lake City, Utah.
More information is available at www.cyberkineticsinc.com.
Cyberkinetics' first product, the BrainGate(TM) Neural Interface
System, is designed to give severely paralyzed 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 system's
safety and effectiveness. For specific information about the
BrainGate(TM) clinical trial please send an email to
braingateinfo@cyberkineticsinc.com.
Forward Looking Safe
Harbor Statement:
This press release contains forward-looking statements, including
statements about plans for expansion of the BrainGate initial clinical
trial and ongoing refinements of the BrainGate System. By their nature,
forward-looking statements and forecasts involve risks and uncertainties
because they relate to events and depend on circumstances that will occur
in the near future. There are a number of factors that could cause actual
results and developments to differ materially. For a discussion of those
risks and uncertainties, please see our filings with the Securities and
Exchange Commission.
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Proxima Therapeutics
Enters into an Agreement to be Acquired by Cytyc Corporation
Company Press Release
2.9.05
ALPHARETTA, GA—February 9, 2005 —Proxima Therapeutics,
Inc., a privately-held developer and marketer of internally-delivered, site-specific
cancer treatment systems, today announced that it has entered into a
definitive agreement to be acquired by Cytyc Corporation (Nasdaq: CYTYC),
a leading women’s health company. Under the terms of the agreement,
Proxima will be acquired by Cytyc in an all cash transaction for a
purchase price of $160 million plus a two-year earnout based on
incremental sales growth in 2005 and 2006.
Proxima’s leading product is the MammoSiteŽ Radiation Therapy
System (RTS) for the treatment of breast cancer. MammoSite enables
eligible patients who have undergone a lumpectomy to receive partial
breast irradiation (PBI), the practice of delivering radiation only to
the area where tumors are most likely to recur, while minimizing exposure
to healthy tissue. The MammoSite device is a balloon catheter that
delivers a prescribed dose of radiation from inside the cavity created by
the removal of the breast tumor in just five days.
Since its clearance by the U.S. Food and Drug Administration (FDA) in
2002, MammoSite has been used to treat more than 7,000 breast cancer
patients. In addition to MammoSite, Proxima markets the GliaSite RTS, a
site-specific radiation treatment for brain tumors.
“MammoSite is already a market leader in partial breast
irradiation, and by combining forces with the infrastructure and
resources of Cytyc’s rapidly growing women’s health franchise
we expect that this important therapy will now become even more
accessible to breast cancer patients,” said Timothy Patrick, CEO of
Proxima Therapeutics. “This would not have been possible without
the talents and contributions of the many employees at Proxima
Therapeutics whose efforts have helped bring important new treatment
options to the patients who need them.”
About Proxima Therapeutics, Inc.
Based in Alpharetta
, Ga. , Proxima
Therapeutics, Inc. is a privately held medical device company established
in 1995 to develop site-specific cancer treatment systems for malignant
tumors. Marketed products include MammoSite RTS for breast cancer and
GliaSite RTS for brain cancer . Additional information is available on
the company’s Web site at www.proximatherapeutics.com. Physicians
and patients may call 1-866-PROXIMA (1-866-776-9462) for more
information.
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American Society of Breast
Surgeons Presents First Data from Largest Study of Partial Breast
Irradiation
The American Society of Breast
Surgeons
12.13.04
The American Society of Breast Surgeons today announced that
initial findings from its MammoSite Patient Registry will be presented
today at the 27th Annual San Antonio Breast Cancer Symposium. This data
from the first 793 patients treated with the MammoSite Radiation Therapy
System found good-to-excellent overall cosmetic results that are
comparable to those reported with whole breast radiation therapy and that
the results were reproducible among the multiple institutions
participating in the study. The study reported one local recurrence
(0.1%) which compares favorably to whole breast radiation.
The MammoSite Patient Registry
is a national data collection program designed to analyze the efficacy of
accelerated partial breast irradiation with MammoSite, which was cleared
by the FDA in May 2002. Since then, MammoSite has become the most
widely-used form of partial breast irradiation for the treatment of
breast cancer and has been used to treat more than 7,000 women in
hundreds of treatment centers nationwide. Partial breast irradiation is
the emerging practice of delivering radiation only to the tissue where
cancer is most likely to recur, minimizing exposure to healthy tissue.
The American Society of Breast Surgeons' Patient Registry is the largest
study of partial breast irradiation to date.
"We're pleased that the
data from the American Society of Breast Surgeons' MammoSite Patient
Registry mirrors what we're seeing in clinical practice in terms of good
cosmetic results and reproducibility," said Frank Vicini, M.D.,
radiation oncologist at William Beaumont Hospital
in Royal Oak, Michigan and co-principal investigator
of the MammoSite Patient Registry. "I look forward to continued
evaluation of this promising technology, which has been an appealing
treatment option for both patients and their doctors."
In poster session #4070
entitled, "First Analysis of Patient Demographics and Technical
Reproducibility, Cosmesis and Early Toxicity by the American Society of
Breast Surgeons' MammoSite Breast Brachytherapy Registry Trial in 793
Patients Treated with Accelerated Partial Breast Irradiation," data
from 71 participating institutions shows MammoSite is an acceptable
treatment option. The American Society of Breast Surgeons assumed
responsibility for management of the MammoSite Patient Registry in
November of 2003. Since then, the Society has successfully achieved its
goal of enrolling 1,500 patients in the study.
"The American Society of
Breast Surgeons' Patient Registry will continue to analyze additional
data from the MammoSite Registry in order to provide the medical
community with long-term information for this internal, five-day
radiation therapy," said Peter Beitsch, M.D., director of the Dallas Breast Center
and co-principal investigator of the MammoSite Patient Registry. "As
MammoSite continues to be more widely adopted, data from this patient
registry is assisting physicians to identify the most suitable patients
who will benefit most from MammoSite, so that we can continue to progress
towards less invasive, less time consuming treatments for breast
cancer."
About The American Society of
Breast Surgeons
Founded in 1995, the American
Society of Breast Surgeons represents nearly 1,900 surgeons nationwide
and is one of the fastest growing subspecialty surgical groups in the
country. It was formed to encourage the study of breast surgery, promote
research and development of advanced surgery techniques, improve
standards of practice for breast surgery in the United States and serve as a
forum for the exchange of ideas. For more information, please visit the
American Society of Breast Surgeons' Web site at www.breastsurgeons.org.
About MammoSite
MammoSite is a minimally
invasive balloon catheter that is inserted into the cavity created by a
lumpectomy. During a five-day course of therapy, a tiny radioactive seed
attached to a wire is inserted into the balloon, delivering prescribed levels
of radiation under precise computer control to the targeted tissue
surrounding the cavity.
No source of radiation
remains in the patient's body between treatments or after the final
procedure. Since its clearance by the FDA in May 2002, MammoSite has been
used to treat thousands of early-stage breast cancer patients at more
than 400 U.S.
hospitals and treatment centers. For a list of treatment centers, refer
to www.mammosite.com.
Safety and performance of
MammoSite were evaluated in a multi-center study, which involved women
with early-stage breast cancer. The results of the study were published
in the International Journal of Radiation Oncology-Biology-Physics
(February 2003).
A study published in the American
Journal of Surgery found that, over the course of six years, partial
breast irradiation produces comparable results to whole-breast radiation
therapy in preventing breast cancer recurrence in women with early-stage
breast cancer who are treated with breast-conserving therapy.
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Cyberkinetics Announces $6
Million Private Financing
Company Press Release
11.4.04
Cyberkinetics Neurotechnology
Systems, Inc. (OTCBB:CYKN - News; Cyberkinetics) announced today that it
has entered into definitive purchase agreements for a $6 million private
placement of newly issued shares of common stock and the concurrent
issuance of warrants for the purchase of additional shares of common
stock to institutional and accredited investors. The financing is subject
to closing conditions and is not subject to shareholder approval.
"The proceeds from this financing will be used primarily for the
continued clinical development of our first commercial product candidate,
the
BrainGate(TM) Neural Interface System," said Timothy Surgenor,
President and CEO of Cyberkinetics Neurotechnology Systems, Inc. "In
addition, this capital will enable Cyberkinetics to support earlier-stage
research programs for the development of new neuroscience-based applications
of our core technology."
The Company will issue an aggregate of approximately 2 million shares
of common stock at a price of $3.00 per share, together with a common
stock purchase warrant to purchase up to approximately 660,000 additional
shares of common stock at an exercise price of $6.00 per share. Rodman
& Renshaw served as placement agent for the financing.
The shares of common stock and warrants sold in the private placement
have not been registered under the Securities Act of 1933, as amended, or
state securities laws and may not be offered or sold in the United States
without a registration with the Securities and Exchange Commission (SEC)
or an applicable exemption from the registration requirements. The shares
and warrants were offered and sold only to institutional and accredited
investors. The Company has agreed to file a registration statement with
the SEC covering the resale of the shares of common stock issued in the
private placement and the shares of common stock issued upon exercise of
the warrants.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy any of these securities nor shall there
be any sale of these securities in any state or jurisdiction in which
such offer, solicitation or sale would be unlawful prior to registration
or qualification under the securities laws of any such state or
jurisdiction.
About Cyberkinetics Neurotechnology Systems, Inc.
Cyberkinetics, a leader in neurotechnology, an emerging field driven
by advances in neuroscience, computer science, and engineering, is
focused on treating diseases and disorders of the nervous system.
Cyberkinetics' first product, BrainGate(TM) Neural Interface System, is
designed to give severely paralyzed 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 its safety and effectiveness. Cyberkinetics' intellectual property
features key technologies licensed from Brown
University, the Massachusetts
Institute of Technology, Emory University, and the University of Utah.
Cyberkinetics is headquartered in Foxborough,
Massachusetts and conducts engineering
and research in Salt Lake City,
Utah. More information is
available at www.cyberkineticsinc.com.
Forward Looking Safe
Harbor Statement:
This news release contains "Forward Looking Statements."
These statements are subject to known and unknown risks and uncertainties
that may cause actual future experience and results to differ materially
from the statements made. Forward-looking statements include, but are not
limited to, statements concerning our future expectations, plans,
prospects and future operating results as well as projections of cash and
marketable securities and sufficiency of funding for capital
expenditures. Actual results may differ materially from those indicated
by these forward-looking statements as a result of various factors
including risks related to: our access to additional capital; our ability
to obtain additional funding to support our business activities; our
dependence on third parties for development, manufacture, marketing,
sales and distribution of our products; our development of products; our
ability to obtain and maintain patent protection for our discoveries and
products; and our limited operating history; as well as those risks more
fully discussed in the "Risk Factors" section of the Form 8-K
filed with the Securities and Exchange Commission on October 8, 2004. In
addition, any forward-looking statements represent our views only as of
today and should not be relied upon as representing its views as of any
subsequent date. We do not undertake any obligation to update any
forward-looking statements to reflect events or circumstances after the
date of this release.
Contact:
Media Contact:
MacDougall BioCommunications
Kari Lampka, 508-647-0209
klampka@macbiocom.com
Company Contact:
Cyberkinetics Neurotechnology Systems
Jessica Duda,
508-549-9981, ext 112
IR@cyberkineticsinc.com
Investor Relations
Contact:
Trout Group
Brian Korb, 212-477-9007, ext 23
bkorb@troutgroup.com
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Scientists Gingerly Tap into
Brain's Power
By Kevin Maney, USA
Today
10.11.04
A 25-year-old quadriplegic sits in a wheelchair with wires coming out
of a bottle-cap-size connector stuck in his skull.
The wires run from 100 tiny sensors implanted in his brain and out to
a computer. Using just his thoughts, this former high school football
player is playing the computer game Pong.
It is part of a breakthrough trial, the first of its kind, with
far-reaching implications. Friday, early results were revealed at the American Academy of Physical Medicine and
Rehabilitation annual conference. Cyberkinetics Neurotechnology Systems,
the Foxborough-based company behind the technology, told attendees the
man can use his thoughts to control a computer well enough to operate a
TV, open e-mail and play Pong with 70% accuracy.
"The patient tells me this device has changed his life,"
says Jon Mukand, a physician caring for him at a rehabilitation facility
in Warwick, R.I. The patient, who had the sensors
implanted in June, has not been publicly identified.
The trial is approved by the FDA (news - web sites). Cyberkinetics has
permission to do four more this year.
The significance of the technology, which Cyberkinetics calls
Braingate, goes far beyond the initial effort to help quadriplegics. It
is an early step toward learning to read signals from an array of neurons
and use computers and algorithms to translate the signals into action.
That could lead to artificial limbs that work like the real thing: The
user could think of moving a finger, and the finger would move.
"It's Luke Skywalker," says John Donoghue, the
neuroscientist who led development of the technology at Brown University
and in 2001 founded Cyberkinetics.
The brain in control
Further out, some experts believe, the technology could be built into
a helmet or other device that could read neural signals from outside the
skull, non-invasively. The Defense Advanced Research Projects Agency
(DARPA) is funding research in this field, broadly known as Brain Machine
Interface, or BMI.
DARPA envisions a day when a fighter pilot, for instance, might
operate some controls just by thinking.
BMI is a field about to explode. At Duke University,
a research team has employed different methods to read and interpret
neural signals directly from the human brain. Other research is underway
at universities around the world. Atlanta-based Neural Signals - a
pioneer in BMI for the handicapped – has also been developing a
system for tapping directly into the brain.
To be certain, the technology today is experimental and crude, perhaps
at a stage similar to the first pacemaker in 1950, which was the size of
a boombox and delivered jolts through wires implanted in the heart.
The Cyberkinetics trial "is great," says Jeff Hawkins,
author of On Intelligence, a book about the brain out this month. But
measuring enough neurons to do complex tasks like grasp a cup or speak
words isn't close to feasible today. "Hooking your brain up to a
machine in a way that the two could communicate rapidly and accurately is
still science fiction," Hawkins says.
Layered on all of the BMI research are ethical and societal issues
about messing with the brain to improve people. But those, too, are a
long way from the research happening now.
Monkeys chasing dots
The Cyberkinetics technology grew out of experiments with monkeys at
Brown. Donoghue and his research team implanted sensors in the brains of
monkeys, and got them to play a simple computer game - chasing dots
around a screen with a cursor using a mouse - to get a food reward. As
the monkeys played, computers read signals from the sensors and looked
for patterns. From the patterns, the team developed mathematical models
to determine which signals meant to move left, right, up, down and so on.
After a while, the team disconnected the mouse and ran the cursor off the
monkeys' thoughts. It worked: The monkeys could chase the dots by
thinking of what they'd normally do with their hands.
A driving concept is to make the computer control natural, so a
patient doesn't have to learn new skills.
The reason it works has to do with a discovery made by neuroscientists
in the 1990s. The billions of neurons in each region of the brain work on
physical tasks like an orchestra, and each neuron is one instrument.
With an orchestra, if you listen to only a few of the instruments, you
could probably pick up what song is being played, but you wouldn't get
all its richness and subtlety. Similarly, scientists found that if you
can listen to any random group of neurons in a region, you can decipher
generally what the region is trying to do - but you wouldn't get the
richness and subtlety that might let a person do complex tasks.
The more neurons you can listen to, the more precisely you can pick
out the song.
Cyberkinetics' big breakthrough is listening to up to 100 neurons at
once and applying the computing power to make sense of that data almost
instantly. The 100 sensors stick out from a chip the size of a contact
lens. Through a hole in the skull, the chip is pressed into the cortex
surface "like a thumbtack," Donoghue says.
Most of the sensors get near enough to a neuron to read its pattern of
electrical pulses as they turn on and off, much like the 1s and 0s that
are the basis for computing. Wires carry the signals out through a
connector in the skull, and the computer does the rest.
Patient gaining accuracy
Cyberkinetics technicians work with the former football player three
times a week, trying to fine-tune the system so he can do more tasks. He
can move a cursor around a screen. If he leaves the cursor on a spot and
dwells on it, that works like a mouse click.
Once he can control a computer, the possibilities get interesting. A
computer could drive a motorized wheelchair, allowing him to go where he
thinks about going. It could control his environment - lights, heat,
locking or unlocking doors. And he could tap out e-mails, albeit slowly.
At this point, though, the equipment is unwieldy. The computer, two
screens and other parts of the system are stacked on a tall cart. The
processor and software can't do all the computations quite fast enough to
move the cursor in real time - not instantly, the way your hand moves
when you tell it to move. And because the sensors tap no more than 100
neurons, the cursor doesn't always move precisely. That's why a one-time
athlete can play Pong at only 70% accuracy.
Though implanting a chip in the brain might seem alarming, devices are
already regularly implanted in brains to help people who have severe
epilepsy, Parkinson's disease (news - web sites) or other neurological
disorders. "We put drugs in our brains to improve them, even
caffeine," says Arthur Caplan, head of the Center for Bioethics at
the University
of Pennsylvania.
"I don't think the brain is some sacrosanct organ you can't
touch."
Not everyone is a fan of Cyberkinetics' human trials. "I am very
skeptical," says Miguel Nicolelis, co-director of the Duke center
doing similar research. "They seem to want to simply push their
views and make a buck without much consideration of what is appropriate
and safe to suggest to different patients.
"At the moment, though, "The patient is very, very
happy," says Mukand, who is also functioning as the FDA's
investigator on the case.
Help with prosthetic limbs?
One way or another, neuroscience and technology are crashing together.
The Duke team has not implanted a permanent device in a human, but it
has implanted sensors in monkeys who then move a robot arm by thought.
Duke's results, published in July in the journal Neuroscience, show that
the idea of using neurons to guide a prosthetic device can work.
To really be useful, the technology will have to get smaller, cheaper
and wireless - perhaps a computer worn behind the ear. Down the road, it
will have to tap many more neurons, and then the challenge will be
building software to analyze more complicated patterns from so many more
neurons.
"Brains are incredibly complex organs," author Hawkins says.
"There are 100,000 neurons in a square millimeter of cortex. There
are very precise codes in the neurons. The details matter."
A yet bigger challenge - the one DARPA faces - will be reading neural
signals without drilling holes in people's skulls. Over the past decade,
researchers have used the electroencephalogram (EEG) to pick up brain
waves through electrodes attached to the head. After months of training,
users can learn to play simple video games - such as making a wheel turn
faster - with their thoughts. But EEG readings are too broad and weak to
drive more specific tasks.
In June, researchers at Washington
University, St. Louis, reported using a different
external device - an electrocorticographic (ECoG) - to get more precise
readings from outside the head. With a few hours of training, users could
track targets on a screen.
But researchers at Duke, Brown and Cyberkinetics believe that the only
way to get signals that can operate a robot arm, do e-mail or move a
wheelchair is to touch the brain directly.
As with most technological developments, the devices will get smaller
and better and the software will be made smarter, until some of what now
seems bizarre becomes real. Society will be forced to debate the
questions the technology raises.
"There are those who say this is slippery slope stuff - that this
technology is opening the door to dangerous technologies that could
enhance, improve and optimize someone," says bioethicist Caplan.
"But I'm unwilling to hold hostage this kind of exciting medical
research for those kinds of fears."
Back to Top
Proxima Therapeutics Receives FDA
Clearance for Next Generation Mammosite Device
Company Press Release
09.22.04
Proxima Therapeutics, Inc. today announced that it has received
marketing clearance from the United States Food and Drug Administration
(FDA) for the next generation of its MammoSite balloon catheter device.
The latest version of the MammoSite device incorporates a number of
enhanced design features. These include a thinner catheter shaft and a
smaller balloon profile that will provide an even less-invasive means of
delivering partial breast irradiation to women with early stage breast
cancer.
Partial breast irradiation is the practice of delivering radiation
only to the tissue immediately surrounding the removed tumor, where cancer
is most likely to recur, thereby limiting radiation exposure to healthy
tissue. MammoSite, the most widely practiced form of partial breast
irradiation in the world, enables physicians to deliver radiation therapy
from inside the breast over a five-day period. Since its original FDA
clearance in 2002, MammoSite has helped make breast conservation therapy
an option for thousands of women with breast cancer, many of whom are
unable to endure the demands of a conventional six-week course of
external beam radiation therapy.
“With this new generation of MammoSite we are able to ensure
that our patients receive the prescribed radiation therapy, but in a more
comfortable manner,” said Timothy Patrick, president and chief
executive officer of Proxima Therapeutics, Inc. “Proxima is
committed to providing patients with a less-invasive, five-day radiation
treatment while they are combating their disease.”
The next generation MammoSite will be available in the fourth quarter
of 2004.
About MammoSite
MammoSite delivers a prescribed dose of radiation only to the area
directly surrounding the tumor site, where recurrence is most likely. The
MammoSite device is a minimally invasive balloon catheter that is
inserted into the cavity created by a lumpectomy. During a five-day
course of therapy, a tiny radioactive seed attached to a wire is inserted
into the balloon, delivering prescribed levels of radiation under precise
computer control to the targeted tissue surrounding the cavity. No source
of radiation remains in the patient’s body between treatments or
after the final procedure. Safety and performance of MammoSite for
delivery of internal radiation were evaluated in a multi-center study,
which involved women with early-stage breast cancer. The results of the
study were published in the International Journal of Radiation
Oncology*Biology*Physics (February 2003). For a list of treatment
centers, refer to www.mammosite.com .
A study published in the Journal of the National Cancer Institute
(August 2003) demonstrated that after five years, the local recurrence
rate in certain selected patients treated with partial breast irradiation
was similar to that seen in a group of patients treated with traditional
whole breast radiation therapy.
The American Society of Breast Surgeons is currently managing a
MammoSite Patient Registry that now includes more than 1,500 patients.
The national prospective data collection program is designed to report on
the results achieved in the clinical setting in order to monitor the
long-term outcomes of patients treated with MammoSite.
About Proxima Therapeutics
Based in Alpharetta,
Ga., Proxima Therapeutics,
Inc. is a privately held medical device company established in 1995 to
develop site-specific cancer treatment systems for malignant tumors.
Marketed products include GliaSite RTS for brain cancer and MammoSite RTS
for breast cancer. Additional information is available on the
company’s Web site at www.mammosite.com. Physicians and patients
may call 1-86-MAMMOSITE (1-866-266-6748) for more information.
Back to Top
FDA Clears First Device for
Removing Blood Clots in Stroke Patients
Company
Press Release
08.16.04
Concentric
Medical, a privately held medical device company, announced today it has
received clearance from the US Food and Drug Administration (FDA) to
market the Merci(R) Retriever. This is the first medical device cleared
by the FDA to remove blood clots from the brain in patients experiencing
an ischemic stroke.
An
ischemic stroke occurs when a blood vessel in the brain is blocked by a
blood clot which can impair brain function and cause severe disability or
death. Of the 700,000 annual strokes in the US, approximately 83 percent
(or 581,000) are ischemic. The Merci Retriever is a novel therapy that
removes clots, restores blood flow and offers hope for ischemic stroke
patients with no other options.
The
FDA granted clearance after a thorough review of patient data obtained in
a clinical study at 25 medical centers in the United States. The MERCI
(Mechanical Embolus Removal in Cerebral Ischemia) Trial evaluated the
device in 141 patients who were ineligible for a "clot-busting"
drug that can only be used within three hours of stroke onset.
Physicians
participating in the study navigated the Merci Retriever into the brain
using standard catheterization techniques. A small puncture in the groin
was used to introduce the Merci Retriever into an artery leading to the
brain. Upon reaching the targeted area, the Merci Retriever is designed
to restore blood flow by engaging, capturing and removing the blood clot.
"FDA
clearance of the Merci Retriever heralds a new era in stroke
management," said Wade Smith, MD, PhD, National Principal
Investigator for the MERCI Study and Associate Professor of Neurology,
University of California, San Francisco. "This is a very exciting
result for all of our patients and for stroke research. We experienced
some remarkable outcomes during the trial and look forward to having this
available for patients experiencing devastating strokes."
"Our
goal has been to develop a straightforward technology that will change
how stroke is treated around the world," said Gary Curtis, President
and CEO of Concentric Medical. "In the US
alone, stroke rates are increasing as our population ages, and costing the
US
economy an estimated $53 billion annually. By working with stroke centers
to increase public awareness of the Merci Retriever and stroke symptoms,
we expect to greatly improve stroke management."
According
to the American Heart Association, stroke killed 163,538 people in 2001
and is the leading cause of serious, long-term disability in the US.
It is also the third largest cause of death, ranking behind heart disease
and all forms of cancer. Research indicates approximately 500,000
Americans suffer a new stroke each year and 200,000 have a recurrent
stroke. By 2050, an estimated one million will have strokes annually.
About
Concentric Medical
Located
in Mountain View, California, and founded in 1999, Concentric
Medical has gathered together a dynamic team of medical professionals,
engineers and employees to open the pathway to new stroke treatments.
More information about Concentric Medical and its products can be found
at http://www.concentric-medical.com/.
Back
to Top
Cyberkinetics Named Among
Top 15 Emerging Life Sciences Companies of 2004
Company
Press Release
July 28, 2004
Cyberkinetics,
Inc. this morning announced that it has been selected as a member of
FierceBiotech’s annual “The Fierce 15,” a list of the
top emerging biotech and life sciences companies of 2004.
FierceBiotech
Editor-in-chief John D. Carroll said that he chose Cyberkinetics for the
potential he sees in its BrainGate™ product: “We believe that
Cyberkinetics’ technology, which is designed to allow quadriplegic
people to control computers and computer controlled devices using their
thoughts, is based on solid science and backed up by a great management
team. If it works, we believe that Cyberkinetics will have achieved an
incredible feat.”
"FierceBiotech
is recognized for its savvy coverage of trends and businesses in the
biotech and life sciences industries," said Tim Surgenor, President
and CEO of Cyberkinetics. "Being selected as a member of The Fierce
15 is an honor that recognizes Cyberkinetics’ potential to become a
leader for the development of brain–computer interface
devices."
Cyberkinetics’
BrainGate™ development program is an effort to develop an
implantable system which can be used to provide an important advance in
the level of independence for severely disabled people. The implant is
designed to allow brain signals from the motor cortex to be collected,
processed and analyzed, eventually producing an interface with a personal
computer. In this way, the BrainGate™ System has the potential to
afford people the opportunity to use the computer as a gateway to
communicate and control assistive devices in their environment.
Cyberkinetics is currently conducting a pilot clinical trial of the
BrainGate ™ Neural Interface System that can enroll up to five
severely disabled people unable to use their arms and legs.
The
Fierce 15 celebrates the spirit of being “fierce” –
daring to be innovative and aggressive, even in an industry with a long
time-to-market. The list of Fierce 15 companies is available in
today’s issue of FierceBiotech and on the FierceBiotech web site at
http://www.fiercebiotech.com.
FierceBiotech
publishes a daily email briefing read by more than 31,000 executives in
over 100 countries. Since its launch in March 2000, FierceBiotech has
been recognized as a must-read source of news and intelligence for the
biotech industry.
About
Cyberkinetics, Inc.
Cyberkinetics
is a leader in neurotechnology, an emerging field driven by advances in
neuroscience, computer science, and engineering that address the medical
treatment of nervous system dysfunction. Cyberkinetics’ first
product, the BrainGate™ Neural Interface System, is designed to provide
severely paralyzed patients with a long-term, direct brain-computer
interface for the purpose of communication and control of a computer.
Cyberkinetics’ intellectual property features key technologies
licensed from Brown University, the Massachusetts Institute of
Technology, Emory University, and the University of Utah.
Cyberkinetics is headquartered in Foxborough,
Massachusetts and conducts engineering
and research in Salt Lake City,
Utah.
More
information is available at www.cyberkineticsinc.com.
About
FierceBiotech
FierceBiotech
is an internationally recognized email newsletter for the biotech
industry. Every business day, more than 31,000 executives in over 100
countries rely on FierceBiotech for a quick, authoritative briefing on
the day’s top stories. It is published by FierceMarkets, Inc., a
business publishing company based in Washington, DC.
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Proxima Therapeutics Receives US
Patent for Device to Deliver Internal Radiation Therapy for Spinal
Metastases
Company
Press Release
July 26, 2004
Proxima
Therapeutics, Inc. today announced that the company has expanded its
strong intellectual property portfolio with a recently issued second
patent (US
Patent # 6,749,555 B1) for delivery of brachytherapy for spinal
metastases. The device design incorporates Proxima’s proprietary
inflatable balloon catheter technology currently in commercial use to
deliver internal radiation therapy for breast and brain cancer. The
spinal column is the most frequent site of bone metastasis in the body,
and it is estimated that spinal metastases affect more than 100,000
individuals annually.
Brachytherapy
refers to the practice of delivering radiation internally.
Proxima’s devices deliver a site-specific, prescribed dose of
radiation from within the cavity of a resected tumor to maximize the dose
of radiation to the tissue most likely for recurrence, while minimizing
radiation exposure to healthy tissue. The spinal cord has a low threshold
for radiation and thus focusing the radiation dose increases the
likelihood of tumor control and significantly reduces the risk for spinal
cord injury. Like Proxima’s other brachytherapy treatments,
radiation therapy will be delivered in considerably less time than other
currently available treatments, an additional benefit for patients.
“Proxima
is always looking to build on the success of our current products,
MammoSite and GliaSite. Our efforts in research and development have
resulted in an extremely strong intellectual property position, as we now
have more than 20 issued patents,” said Timothy J. Patrick,
president and CEO of Proxima Therapeutics. “Expanding into the
spinal market makes sense, as there is an unmet need for a targeted
treatment that protects the spinal cord while delivering the necessary
radiation to control tumor growth. We believe this will be an attractive
treatment option for patients confronting spinal metastatic
cancer.”
About
Proxima Therapeutics, Inc.
Based
in Alpharetta, Ga., Proxima Therapeutics, Inc. is a
privately held medical device company established in 1995 to develop
site-specific cancer treatment systems for malignant tumors. Marketed
products include MammoSite RTS for breast cancer and GliaSite RTS for
brain cancer. Additional information is available on the company’s
Web site at www.proximatherapeutics.com. Physicians and patients may call
1-866-PROXIMA (1-866-776-9462) for more information.
Back
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Study Indicates That
MammoSite Offers Significant Advantages Over Conventional Boost Therapy for
Breast Cancer
Company
Press Release
05.17.04
Study
results presented at the Annual Meeting of the American Brachytherapy
Society in Barcelona
, Spain ,
show that the MammoSite Radiation Therapy System (RTS) is potentially a
more efficient way to deliver a boost of radiation to a breast tumor site
following whole breast external beam radiation. In the study, researchers
compared MammoSite to electron radiotherapy, currently the method most
often used to deliver a boost of radiation. According to the results of a
2001 study published in the New England Journal of Medicine, an electron
boost dose of radiation following a lumpectomy and whole breast external
beam radiation is particularly important for high risk breast cancer
patients, reducing local recurrence rates by 48% in women younger than
40.
In
this clinical analysis, the median amount of targeted tissue that
received the prescribed radiation dose was 37.6 percent for patients who
received electron boost radiotherapy. With MammoSite, that coverage was
improved to 100 percent, nearly a three-fold improvement. Patients who
were treated with MammoSite also had a significantly smaller amount of
healthy tissue exposed unnecessarily to radiation than patients who were
treated with electron radiotherapy.
Developed
by Proxima Therapeutics, Inc., MammoSite is the most widely used partial
breast irradiation treatment in the world, and has been used as a primary
therapy for thousands of women since its FDA clearance in May 2002.
Partial breast irradiation is the emerging practice of delivering
radiation only to the tissue where cancer is most likely to recur,
minimizing exposure to healthy tissue. Doctors at hundreds of hospitals
and radiation treatment facilities offer MammoSite to appropriate,
early-stage patients, allowing them to benefit from a site-specific
treatment delivered in only five days.
“The
advantage of administering a boost of radiation therapy is that higher
doses of radiation can safely be delivered to the tissue surrounding the
tumor site following a course of whole-breast external beam
radiation,” said Bradley Prestige, MD, radiation oncologist at Cancer Therapy
Research Center
in San Antonio.
“The study results indicate that the targeted manner in which
MammoSite delivers radiation to the tumor site makes it an optimal choice
for delivering a boost of radiation to breast cancer patients.
Additionally, the boost therapy can be completed in 1 day vs. 5 days for
electron radiotherapy.”
“These
study results demonstrate the high degree of precision and accuracy that
MammoSite provides as a boost treatment compared to electron
radiotherapy,” said Tim Patrick, president and chief executive
officer of Proxima Therapeutics, Inc. “When physicians believe that
a boost of radiation is indicated for breast cancer patients following
external beam radiation, we hope that this compelling data will encourage
them to use MammoSite. This should expand the adoption of MammoSite
beyond its already broadly accepted application as primary therapy for
appropriate patients.”
About
MammoSite RTS
MammoSite
RTS is a minimally invasive balloon catheter that is inserted into the
cavity created by a lumpectomy. During a five-day course of therapy, a
tiny radioactive seed attached to a wire is inserted into the balloon,
delivering prescribed levels of radiation under precise computer control
to the targeted tissue surrounding the cavity. No source of radiation
remains in the patient’s body between treatments or after the final
procedure. The American Society of Breast Surgeons is currently managing
a MammoSite Patient Registry that now includes more than 1,000 patients.
Safety and performance of MammoSite for delivery of internal radiation
were evaluated in a multi-center study, which involved women with
early-stage breast cancer. The results of the study were published in the
International Journal of Radiation Oncology*Biology*Physics (February
2003). For a list of current treatment centers, refer to www.mammosite.com.
About
Proxima Therapeutics
Based
in Alpharetta , Ga. , Proxima Therapeutics, Inc. is a
privately held medical device company established in 1995 to develop
site-specific cancer treatment systems for breast and brain tumors.
Products include GliaSite RTS for brain cancer and MammoSite RTS for
breast cancer. Additional information is available on the company’s
Web site at www.mammosite.com. Physicians and patients may call
1-86-MAMMOSITE (1-866-266-6748) for more information.
Back
to Top
Saegis Pharmaceuticals
Begins Phase II Clinical Trial of SGS742 for Alzheimer’s Disease
Company
Press Release
04.20.04
Saegis
Pharmaceuticals, Inc., a privately-held biopharmaceutical company focused
on developing medicines that protect and enhance the function of the
human mind, announced today that patient enrollment has begun in a Phase
II trial of its lead product candidate, SGS742 for Alzheimer’s
disease. SGS742 is a selective, orally active GABAB receptor antagonist.
The multicenter, double blind, Phase II trial will evaluate the safety
and efficacy of SGS742 in patients with mild to moderate
Alzheimer’s disease. Patients will be enrolled in various sites in
the United States.
“There
is a clear need for drugs with improved therapeutic profiles to treat
this devastating disease,” said Rodney Pearlman, Ph.D., President
and CEO of Saegis. “SGS742 has already demonstrated an ability to
improve learning and memory in preclinical and clinical studies. We are
very excited to advance this product further into clinical development
for Alzheimer’s disease.”
“SGS742
has already demonstrated encouraging results to show improvement in
attention and memory in earlier clinical trials,” stated Annette
Madrid, Vice President, Clinical Development. “We believe SGS742
may provide a new standard of care for Alzheimer’s patients.”
Alzheimer’s
disease is the most common form of dementia affecting over 4.5 million
people in the U.S.
in 2002 alone. Therapeutics to treat Alzheimer’s disease are now
the fastest growing segment of the CNS market with 2002 worldwide sales
of $1.5 billion.
Saegis
has completed a Phase II clinical trial of SGS742 in Mild Cognitive
Impairment and demonstrated that patients treated with SGS742 exhibited
improvements in multiple cognition domains, including psychomotor speed,
attention and memory. SGS742 was found to be safe and very well
tolerated. Results from this study were presented at the 56th Annual
Meeting of the American Academy of Neurology in San Francisco on April 27th, 2004.
A significant
amount of preclinical and clinical evidence has been collected
demonstrating that SGS742 has the ability to enhance learning in mice,
rats, primates and most recently in humans. SGS742 also appears to have
an improved safety and side-effect profile over currently marketed drugs
to treat Alzheimer’s disease. Saegis has an exclusive license to
SGS742 from Novartis Pharma AG.
About
Saegis Pharmaceuticals
Founded
in 1999, Saegis Pharmaceuticals is a pioneer in the development of
medicines that protect and enhance the function of the human mind.
Through licensing activity, development partnerships and internal
discovery programs, Saegis Pharmaceuticals is building a portfolio of
compounds with activity against a range of disorders of the brain and central
nervous system, including Alzheimer’s disease, mild cognitive
impairment, and cognitive impairment associated with schizophrenia.
Currently the Company has three orally available small molecule compounds
in clinical development, two of which have already demonstrated efficacy
and safety in humans. These development activities are also supported by
investments in Saegis Pharmaceuticals by Versant Ventures, Technology
Partners, Sofinnova Ventures (U.S.), Sofinnova Partners (Paris), Polaris
Venture Partners, NeuroVentures, the Stanley Medical Research Institute
and Novartis AG. For more information, visit www.saegispharma.com.
Back
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Cyberkinetics Initiates
Pilot Study of BrianGateTM Neural Interface System
Company
Press Release
04.20.04
Cyberkinetics,
Inc. today announced that it has initiated a pilot study of the
investigational BrainGate™ Neural Interface System. Cyberkinetics
received regulatory clearance to conduct the study under an
Investigational Device Exemption (IDE) from the U.S. Food and Drug
Administration (FDA) and the study protocol has received Institutional
Review Board (IRB) approval. The goal of the pilot study is to evaluate
the safety of the BrainGate System in humans and to demonstrate initial
proof of principle of the ability of quadriplegic patients to control a
computer cursor with their thoughts.
“The
ultimate goal of the BrainGate development program is to develop a safe,
effective and unobtrusive neural interface which will allow quadriplegic
people to control computers and computer controlled devices using their
thoughts. The pilot study that we have started today is a first important
step toward that objective,” said Tim Surgenor, President and CEO
of Cyberkinetics. “The BrainGate neural interface is a
groundbreaking effort to develop an implantable system which can be
routinely used to provide an important advance in the level of
independence for quadriplegics.”
“Although
medical science has given quadriplegic patients longer and healthier
lives, there are significant limitations to our ability to provide these
patients with the independence that they are seeking,” said Jon
Mukand, M.D., Ph.D., an investigator for the study with Sargent Rehabilitation
Center and Medical Director of
Southern New England Rehabilitation Center at Saint Joseph Hospital.
“If this study is successful, the BrainGate System could
potentially enable paralyzed patients to gain an unprecedented level of
independence with everyday activities such as typing, maneuvering
wheelchairs and operating other computerized systems such as
environmental controls, robotics, and the internet.”
About
the BrainGate™ Pilot Study
The
pilot (feasibility) study will enroll a maximum of five quadriplegic
(unable to use the arms and legs) patients between the ages of 18 and 60
who meet the study’s rigorous selection criteria, which include
that the patient be able to verbally communicate. Each patient will
undergo surgery in which the sensor portion of the BrainGate neural
interface will be implanted on the surface of the primary motor cortex,
the portion of the brain responsible for movement. There are two primary
goals of the pilot clinical study: the first is to characterize the
safety profile of the device and the second is to evaluate the quality,
type, and usefulness of neural output control that patients can achieve.
The study is expected to last for about 13 months for each patient,
during which time they will perform tasks with the device such as
attempting to control the movement of a cursor on a screen by imagining
movement of their arm to move the cursor toward a specific target. At the end of the study, each patient
will undergo another surgery to have the device removed or have the
option to participate in future studies.
Cyberkinetics anticipates reporting initial study results in late
2004.
The
first clinical site to be initiated by Cyberkinetics is the Sargent Rehabilitation
Center in Warwick, Rhode Island. Dr. Jon Mukand, who is on the faculty
of Brown University, is the Principal
Investigator. The surgery to
implant the sensor and pedestal portions of the BrainGate device will be
conducted at Rhode Island Hospital in Providence
by Gerhard M. Friehs, M.D., Ph.D., director of functional neurosurgery
and associate professor of clinical neurosciences at Brown Medical
School.
About
the BrainGate™ System:
Cyberkinetics’
BrainGate Neural Interface System is a proprietary, investigational
brain-computer interface device that consists of an internal neural
signal sensor and external processors that convert neural signals into an
output signal under the person’s own control. The sensor consists of a tiny chip
about the size of a baby aspirin, with one hundred electrode sensors each
thinner than a hair that detect brain cell electrical activity. The sensor will be implanted on the
surface of the area of the brain responsible for movement, the primary
motor cortex. The sensor will be
connected by a small wire to a pedestal which will be mounted on the
skull, extending through the scalp.
The pedestal will be connected by a cable to a cart containing
several computers and monitor which will enable the study operators to
determine how well a patient can control their neural output.
Previous
research conducted in non-human primates using an early version of
Cyberkinetics’ technology was published by researchers led by
Professor John Donoghue, Ph.D., Chairman of the Department of
Neuroscience and Director of the Brain Science Program at Brown
University, and Cyberkinetics’ founder and Chief Scientific Officer
(Serruya et al., 2002 Nature 416:141). The study demonstrated that neural
output signals from fewer than 30 motor cortex neurons (an area of the
brain responsible for movement) could be decoded in real-time into
signals that provided animals the ability to neurally control cursor
movements via a computer interface.
About
Cyberkinetics, Inc.
Cyberkinetics
is a leader in neurotechnology, an emerging field driven by advances in
neuroscience, computer science, and engineering that promises to
revolutionize the medical treatment of nervous system dysfunction. Cyberkinetics’ first product,
BrainGate™, is designed to give severely paralyzed patients a
long-term, direct brain-computer interface for the purpose of
communication and control of a computer.
Cyberkinetics’ intellectual property features key
technologies licensed from Brown
University, the Massachusetts
Institute of Technology, Emory University, and the University of Utah. Cyberkinetics is headquartered in Foxborough, Massachusetts
and conducts engineering and research in Salt Lake City, Utah. More information is available at
www.cyberkineticsinc.com.
Pilot
Study Information:
If you
are interested in receiving information about the BrainGate pilot study
please contact: Jon Mukand, M.D.,
Ph.D. (401) 886-6600
Back
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Proxima Therapeutics
Receives FDA Clearance for Next Generation Mammosite Device
Company
Press Release
04.01.04
Proxima
Therapeutics, Inc. today announced that it has received marketing
clearance from the United States Food and Drug Administration (FDA) for
elliptical-shaped MammoSite balloon catheters. The new elliptical balloon
catheters will enable more women to now be eligible for partial breast
irradiation following lumpectomy. The spherical MammoSite balloon
catheters, which have been used to treat thousands of patients, will
still be available.
Partial
breast irradiation is the emerging practice of delivering radiation only
to the tissue immediately surrounding the removed tumor, where cancer is
most likely to recur, thereby limiting radiation exposure to healthy
tissue. MammoSite, the most widely practiced form of partial breast
irradiation in the world, enables physicians to deliver radiation therapy
from inside the breast over a five-day period. Since its original FDA
clearance in 2002, MammoSite has helped make breast conservation therapy
an option for more women with breast cancer, many of whom are unable to
endure the demands of a conventional six-week course of external beam
radiation therapy.
“It
is clear from the large number of women who have opted for MammoSite that
the treatment is attractive to patients. Now that the catheter will be
offered in a different shape, MammoSite will be available to an even
greater number of women, giving them a broader range of options as they
make informed decisions about their treatment,” said Timothy
Patrick, president and chief executive officer of Proxima Therapeutics,
Inc. “The team at Proxima Therapeutics is committed to providing
breast cancer patients with simple, safe and effective treatments that
allow for a quick return to their normal routines.”
About
MammoSite
MammoSite
delivers a prescribed dose of radiation only to the area directly
surrounding the tumor site, where recurrence is most likely. The
MammoSite device is a minimally invasive balloon catheter that is
inserted into the cavity created by a lumpectomy. During a five-day
course of therapy, a tiny radioactive seed attached to a wire is inserted
into the balloon, delivering prescribed levels of radiation under precise
computer control to the targeted tissue surrounding the cavity. No source
of radiation remains in the patient’s body between treatments or
after the final procedure. Safety and performance of MammoSite for
delivery of internal radiation were evaluated in a multi-center study,
which involved women with early-stage breast cancer. The results of the
study were published in the International Journal of Radiation
Oncology*Biology*Physics (February 2003). For a list of treatment
centers, refer to www.mammosite.com .
A
recent study published in the Journal of the National Cancer Institute
(August 2003) demonstrated that after five years, the local recurrence
rate in patients treated with partial breast irradiation was similar to
that seen in a group of patients treated with traditional external beam
radiation.
The
American Society of Breast Surgeons is currently managing a MammoSite
Patient Registry that now includes more than 1,000 patients. The national
prospective data collection program is designed to report on the results
achieved in the clinical setting in order to monitor the long-term
outcomes of patients treated with MammoSite.
About
Proxima Therapeutics
Based
in Alpharetta , Ga. , Proxima Therapeutics, Inc. is a
privately held medical device company established in 1995 to develop
site-specific cancer treatment systems for breast and brain tumors.
Products include GliaSite RTS for brain cancer and MammoSite RTS for
breast cancer. Additional information is available on the company’s
Web site at www.mammosite.com. Physicians and patients may call
1-86-MAMMOSITE (1-866-266-6748) for more information.
Back
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Spine Wave's $22.25M led
Q4 2003 Venture Capital
Dan Strempel, Fairfield
County Business Journal
February 16, 2004
A Shelton company that
is developing an injection to rejuvenate degenerating discs in the spine turned
out to the biggest local winner in what was a hot quarter for venture
capital investments.
Spine
Wave Inc. closed on the $22.25 million investment in October.
"We'll
be using the monies to further our development efforts and hopefully to
initiate clinical trials on a few of our technologies this year,"
said Spine Wave president Mark LoGuidice.
The
funding, he said, would help with the expensive proposition of clinical
testing, with the goal of regulatory approval both in the United States
and abroad.
LoGuidice
said the key to landing the investment was "a combination of
technologies that are addressing very large markets and are well
protected with intellectual property, and an experienced management
team."
Spine
Wave's investors included Morgenthaler Ventures, New Enterprise
Associates, Canaan Partners, Thoma Cressey Equity Partners, Collinson
Howe & Lennox, California Technology Ventures, New Venture Partners,
NeuroVentures Capital and Spring Ridge Ventures.
Spine
Wave employs 19 people in Shelton.
Investments
double over Q3
According
to the PricewaterhouseCoopers/Thomson Venture Economics/National Venture
Capital Association MoneyTree Survey, 10 Connecticut companies received $66.7
million in venture capital funds during the fourth quarter of 2003
&151; more than double the $33.1 million invested in six companies in
the third quarter of 2003.
The
$66.7 million represents a 10 percent drop from $73.9 million invested
during the fourth quarter 2002, but for full year 2003, venture investing
in Connecticut
totaled $253.2 million, a 17 percent increase over 2002's $217.2 million.
Other
local companies that received fourth-quarter investments include:
AimNet
Solutions Inc. of Norwalk,
a network infrastructure provider, that received $2.5 million in its
fourth round of financing;
MCubed
Technologies Inc. of Monroe,
a manufacturer of components for semiconductors, received $2.4 million in
its seventh round of financing.
"The
two sectors in Connecticut that showed the most strength in Q4 2003 were
biotechnology and medical devices and equipment, demonstrating venture
capitalists' continued support for development of emerging life sciences
companies in Connecticut," said Owen Davis, co-chair of
PricewaterhouseCoopers' venture capital/private equity practice in
Connecticut and Westchester County, N.Y.
In Connecticut,
biotechnology companies obtained the largest share of venture capital
funds for the fourth quarter &151; a total investment of $30.1
million in two companies. The medical devices and equipment industry
ranked second, with $22.3 million invested in one company. Information
technology services ranked third, with one company receiving a total $5.0
million. Telecommunications followed with $3.6 million invested in three
companies.
Two
spinal technologies
LoGuidice
and John Pafford, former executives at Medtronic Sofamor Danek, founded
Spine Wave back in 2000.
In
April 2002, Spine Wave received a $5.5 million investment from New
Enterprise Associates and simultaneously acquired a company called VERTx
Inc. As part of the deal, Spine Wave acquired VERTx's technology for a
device to repair and treat vertebral compression fractions associated
with osteoporosis.
The
company's other major product platform is being developed in conjunction
with a company called Protein Polymer Technologies Inc. (PPTI).
The
spine supports about one-half of the body's weight and is a highly
flexible structure. The spinal disc is like a jelly-filled tire between
the bony vertebrae, a key component providing for flexibility and acting
as a shock absorber.
The
jellylike nucleus can be damaged from extreme lifting or twisting. It
also can degenerate over time resulting in persistent pain.
Spine
Wave and PPTI are initially developing an injectable protein-based
formulation for the repair of damaged or deteriorated spinal discs. Based
on PPTI's proprietary tissue adhesive technology, the product under
development has the potential to be an effective outpatient surgical
treatment for chronic low-back pain.
If
approved, LoGuidice said the product and technology would be sold to
hospitals as individual doctors request it for patients.
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Kadmus Pharmaceuticals
Inc. Receives $15.3 Million in Series A Financing Round
Company
Press Release
February 9, 2004
Kadmus
Pharmaceuticals Inc., a private biopharmaceutical company developing
therapeutics for the treatment of pain, obesity, and other unmet medical
needs, today announced that it has received $15.3 million in its Series A
financing round, led by Vengrowth Advanced Life Sciences Fund.
Joining
VenGrowth in the round as a new investor is Softbank Life Science
Ventures. Sanderling Ventures, NeuroVentures, CDP Capital, Gray Ghost LLC
and Bio*One Capital, t | 
