Medical Device Daily 9Spet2013 DenverProfilePgs1and6

MONDAY, SEPTEMBER 9, 2013 VOL. 17, NO. 173 PAGE 1 OF 10
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INSIDE:
Don’t miss today’s MDD Extra: Neurology
Regional innovation review
A decade of growth in metro
Denver’s medical device sector
By JEFFREY BERG, PhD
Medical Device Daily Contributing Writer
The medical device sector in Metro Denver region
has experienced dramatic growth over the past decade,
including 16% growth during the years of recession, 2001-
2010. This growth followed a report issued in March 2003
by the Governor’s office entitled “Colorado’s Place in the
Sun: A Bioscience Future, An Action plan to Grow Colorado’s
Bioscience Cluster.” Metro Denver currently ranks as the
sixth largest cluster of medical device companies in the U.S.
Over the past five years, the region has seen more growth in
device companies than biotech or pharmaceuticals.
The Fitzsimons Redevelopment Authority (FRA) was
created in 1996 by the University of Colorado (Boulder)
and the city of Aurora. The FRA was given a single mission:
Cook launches LithAssist
to aid in PCNL procedures
By OMAR FORD
Medical Device Daily Staff Writer
Cook Medical (Bloomington, Indiana) reported that
it has developed a new device to simplify percutaneous
nephrolithotomy (PCNL) procedures, during which
physicians break up and remove large kidney stones, or can
use it in the bladder to break up large bladder stones.
The company said that its LithAssist has already
received the nod from the FDA and that last week was the
formal launch of the device.
“We do have an FDA clearance for the device that we
received earlier this year and we have a CE mark as well,”
Rebecca Walendzak, director of global product management
urology for Cook, told Medical Device Daily. “We’ll continue
to work on registrations globally that align with our current
markets that we sell products in. We’re just making this
Report from Europe
Fujifilm SonoSite gets
CE mark for X-Porte kiosk
A Medical Device Daily Staff Report
Fujifilm SonoSite (Bothell, Washington), specialists
in designing ultrasound tools and education for access to
point-of-care visualization, reported CE mark approval of its
newest generation of point-of-care ultrasound, the X-Porte
ultrasound kiosk. Available in a stationary or a detachable
use model, SonoSite said it will begin shipping the X-Porte
kiosk immediately.
The company noted that the X-Porte kiosk was created
toserveabroadspectrumofusers,fromnovicetoadvanced,
and represents an entirely new design and use paradigm
for ultrasound.
“This is a major accomplishment for SonoSite and
a defining moment in the next phase of our innovation
Washington roundup
Medicare panel refutes cost-
to-charge rubric for imaging
By MARK McCARTY
Medical Device Daily Washington Editor
The dust-up over the recent proposal to employ a set
of 15 or more cost-to-charge ratios for Medicare imaging
has resurfaced thanks to a panel that urged a delay in use
of the practice for outpatient imaging pending a review
by the panel. The development would seem to put the
predicament back into play for inpatient imaging as well,
and a trade association has indicated that policymakers on
Capitol Hill are listening. The issue affects payments made
in the calendar year, however, which gives Congress more
time to address the matter than would be the case if the
payment policies were applied to the upcoming fiscal year,
which commences in roughly three weeks.
See Cook, Page 9
See Europe, Page 7 See Washington, Page 8
See Denver, Page 6
PHILIPS TO SUPPLY ULTRASOUND TO MCL’S CARDIO DEPT.. . . . . . . . 2
ENZYMATICS IN ACQUISITION OF ARCHERDX FOR UP TO $50M. . . . . . 3

MONDAY, SEPTEMBER 9, 2013 MEDICAL DEVICE DAILY™
PAGE 2 OF 10
Agreements/contracts
Philips to supply ultrasound
to MCL’s cardio department
See Agreements, Page 4
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Royal Philips (Amsterdam, the Netherlands) and
Medical Center Leeuwarden (MCL; Leeuwarden,
the Netherlands) reported a long-term agreement. The
partnership will give MCL continuous access to Philips’
ultrasoundtechnologythroughoutitscardiologydepartment
for the next ten years. Philips will provide structural
innovation upgrades and consultancy and training services,
maintaining MCL’s access to the latest cardiac ultrasound
technologies for routine and advanced diagnostic purposes
and minimally-invasive interventional procedures.
Philips claims that MCL will be one of the first hospitals
in the Netherlands to enjoy the benefits of Philips’ brand new
EPIQ “anatomical intelligence” ultrasound imaging platform.
This new managed services partnership will support
innovative and affordable care in the Netherlands.
“Ultrasound imaging plays a fundamental and wide-
spread role in cardiology, driven in part by innovations
over the past decade that have dramatically increased its
functionalities,” says Rob Breedveld, MD, cardiologists
at Medical Center Leeuwarden. “It is important for us to
collaborate with a partner that leads the way in technology
innovation. Our close cooperation and long-term
agreements with Philips make sure we have access to the
latest innovations, such as the EPIQ ultrasound system, that
further improve the way our staff can diagnose and treat
patients, while also helping to manage costs.”
The flexibility and cost-effectiveness of ultrasound
imaging means that it is widely used in virtually every phase
of cardiac care, from diagnosis and treatment to patient
monitoring. Because of its 3-D live-imaging capabilities and
inherent safety, it is increasingly being used as an additional
modality for minimally invasive image-guided cardiac
interventions such as heart valve repair/replacements, the
company said.
Philips will install its ultrasound imaging solutions
in many different parts of MCL’s cardiology department,
including in its cardiac emergency department,
catheterization lab, hybrid operating room, pediatric
cardiology unit, coronary care unit and outpatient clinics.
Philips specializes in medical imaging and ultrasound.
In other agreements/contracts:
The U.S. Defense Department (DoD) handed out 3 new
healthcare contracts to Philips Healthcare (Amsterdam,
the Netherlands) and Johnson & Johnson (New Brunswick,
New Jersey), totaling a potential worth of nearly $73 million
for medical equipment, according to massdevice.com.
In a contract report issued August 29, the DoD posted a
$17.1 million contract for Philips’ biomedical equipment and
maintenance for Air Force and Army facilities. Philips won
contract via an online competitive bidding acquisition that
featured only 1 other unnamed rival, according to the DoD
report.
Just a day later, the DoD announced another Philips
contract worth a maximum of $46.3 million over 5 years for
“multi-vendor maintenance services.” That contract, which
is a fixed-price deal with economic price adjustment, was
a competitive acquisition with 5 total offers, the defense
agency said.
The feds also awarded a medical and surgical products
contract to Johnson & Johnson, giving the deal a 1-year shelf-
life and a maximum value of $9.6 million. J&J’s products will
go to the Army, Navy, Air Force, Marine Corps and federal
civilian agencies, according to the agency.
The Premier (Charlotte, North Carolina) healthcare
alliance has awarded new agreements for hematology

PAGE 3 OF 10
Deals roundup
Enzymatics reports acquisition
of ArcherDx for up to $50M
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Enzymatics (Beverly, Massachusetts) said it has
acquired ArcherDx (Boulder, Colorado), a developer of NGS-
based kits and software solutions for use in investigating
cancer treatment. The deal consists of cash, equity and
potential milestones worth up to $50 million.
Jason Myers, PhD, co-founder and CEO of ArcherDx, has
joined Enzymatics as chief scientific officer. Enzymatics
produces reagents, kits, and assays.
With the acquisition, the company adds genomic
capabilities complementary to its Enzymatics Supply
Chain Solutions and Enzymatics Reagents groups and
greatly expands its new Enzymatics Diagnostics group
with an innovative technology, kits and analytical software
to provide hospitals, research institutions and other
diagnostic providers with a total solution to rapidly and
cost-effectively detect and assess genetic biomarkers.
ArcherDx technology has several advantages in copy
number variation and translocation analyses, and results
are obtained quicker than current methods, offering a more
cost effective approach to healthcare, Enzymatics noted.
“An unprecedented growth in genomics for healthcare is
fueling greater demand for faster, more accurate, and more
costeffectivesequencingapplications.Weareseeingdouble-
digit growth in the placement of new sequencers every year
and broad adoption of genomic technologies across clinical
communities. Enzymatics, which already supplies reagents
and kits to approximately 80% of the NGS industry, together
with ArcherDx, will bring novel sequencing applications
more directly to clinical researchers,” said Jon DiVincenzo,
Enzymatics’ president/CEO. “We are also truly excited to
welcome Jason and his team of scientists and bioinformatics
researchers to our rapidly growing company.”
In other dealmaking activity, Baxter International
(Deerfield,Illinois)reportedthatthecompanyhascompleted
the acquisition of Gambro (Lund, Sweden), a global medical
technology company that makes dialysis products, for
roughly $3.9 billion. The transaction further enhances
Baxter’s global renal leadership and provides the company
with a comprehensive product and therapies portfolio to
meet the needs of patients in the large and growing dialysis
market, the company said.
Baxter said the transaction was financed through a
combination of cash generated from overseas operations
and debt issuances. The impact of the acquisition was
included in the company’s third quarter and full year 2013
guidance.
“The combination of these two respected renal leaders
– Baxter and Gambro – will enable Baxter to better serve
healthcare providers and patients through a collective
offering of innovative renal products and therapies,” said
Robert Parkinson, Jr, chairman/CEO of Baxter. “Together,
we will advance the state of dialysis care for patients with
kidney disease worldwide.”
The acquisition provides a number of long-term growth
opportunities for Baxter around the world, the company
said. With a broad and complementary dialysis product
portfolio and global footprint, Baxter can accelerate
product sales in established markets such as Europe,
where Gambro has an extensive presence. Baxter will also
expand Gambro’s reach in high-growth regions of Latin
America and Asia-Pacific, where Baxter has steadily grown
its peritoneal dialysis (PD) business. In addition, Baxter will
build upon its core portfolio and pipeline of investigational
home hemodialysis and automated PD systems by adding
Gambro’s dialyzers, devices and dialysis solutions, highly
innovative and next-generation monitors, and acute
therapies to treat patients with serious kidney, liver and
lung conditions.
Brik Eyre has been named president of the combined
renal business and has been elected a corporate officer
of Baxter by the company’s boards. Eyre joined Baxter in
2008 and previously served as the general manager of U.S.
Medication Delivery. I

PAGE 4 OF 10
Financings roundup
Advance Medical raises $20M,
acquires Brazilian company
HIT roundup
GLNT expands telemedicine
tech for Parkinson’s Disease
Great Lakes NeuroTechnologies (GLNT; Valley View,
Ohio) said it is launching commercialization and clinical
studies to expand their telemedicine technology, Kinesia
HomeView, for individuals with Parkinson’s disease by
adding real-time video conferencing. The research and
development are being funded in part by a $1.2 million
Phase II Small Business Innovative Research grant from the
National Institutes of Health, National Institute on Minority
Health and Health Disparities. The technology is currently
under development at GLNT with clinical validation studies
planned this fall domestically at The University of Rochester,
The University of Toledo, and internationally at Hospital
Universitario de Burgos in Spain. As part of development,
GLNT is partnering with Vidyo (Hackensack, New Jersey) to
integrate their real-time video conferencing technology into
the Kinesia system.
GLNT currently provides remote monitoring for
Parkinson’s with Kinesia HomeView. The system includes
patient-worn motion sensors and broadband integrated
tablet which patients use to follow video instructions
and complete motor assessments. All data is transmitted
remotely to a HIPAA compliant server and clinicians login
to a website to view symptom reports. Adding video
conferencing will close the loop on clinical workflow by
allowingclinicianstothenremotelydiscusstheresultswith
patients and offer recommendations that can improve their
quality of life. “The clinical market, regulatory environment,
and reimbursement landscape for telemedicine are all
rapidly evolving and Parkinson’s disease is uniquely
positioned to benefit from telemedicine”, said Joseph
Giuffrida, PhD, president and principal investigator on this
program. “Parkinson’s is an incredibly complex disease,
and we are focused on developing remote monitoring
technologies with visualization tools that can scale to
the needs of patient care. Integrating remote monitoring
with real-time video conferencing solves both the
challenges of accurately capturing symptom response to
treatments and accessibility of care, which are critical to
improve quality of life for individuals with Parkinson’s.
Commercially, the technology will position GLNT with a
complete telemedicine solution for both clinical care and
clinical trials markets.” I
Advance Medical (Palo Alto, California), a medical
device, equipment, and diagnostics distribution company
backed by U.S. and Latin American investors, said it
has raised $20 million in an equity financing from new
investors Aberdare Ventures and Arboretum Ventures,
as well as existing investors including Venrock and Jose
Bonchristiano.
The company also reported that it has reached a
definitive agreement to acquire all of the outstanding
shares of Imunotech Sistemas Diagnosticos (Sao Paulo,
Brazil), a company that distributes medical and laboratory
equipment and reagents.
Also, the company says it has added Hector Sobrino,
MD, as general manager for its Mexico operations. Sobrino
was previously at Sanofi where he spent seven years in
commercial roles in Mexico as well as in other countries in
Latin America. The company also added Claudia Goulart,
former CEO of GE Healthcare for Latin America, to its board
of directors.
“We are very fortunate to have top U.S. venture investors
lead our Series B round and to combine with Imunotech, a
companyandteamwithalonganddistinguishedcommercial
track record. Our expanded team, and combined resources
and capabilities, greatly enhance our ability to become the
Latin American commercial partner-of-choice for innovative
companies globally,” said Fred Aslan, MD, the company’s
founder/CEO.
In other financings activity, Tenet Healthcare (Dallas)
is offering to sell $2.8 billion aggregate principal amount
of senior unsecured notes and $1.8 billion aggregate
principal amount of senior secured notes through a
private placement. The secured notes will be guaranteed
by and secured by a pledge of the capital stock and other
ownership interests of certain of Tenet’s subsidiaries. The
proceeds from the offering will be used to finance in part
Tenet’s pending acquisition of Vanguard Health Systems
(Nashville, Tennessee), including the refinancing of certain
of Vanguard’s existing indebtedness.
Tenet is a healthcare services company, and, through its
subsidiaries, operates 49 hospitals, 132 outpatient centers
and Conifer Health Solutions, a leader in business process
solutions for healthcare providers. I
analyzers, automation, reagents, consumables and
service to Abbott Laboratories (Abbott Park, Illinois);
Beckman Coulter (Brea, California); and Sysmex America
(Lincolnshire, Illinois).
The agreements with Abbott Laboratories and Sysmex
America are available to acute care and continuum of care
members of Premier. The agreement with Beckman Coulter
Inc. is available to hospital market facilities.
Premier operates a purchasing network and maintains
clinical, financial and outcomes databases. I
Agreements
Continued from Page 2

PAGE 5 OF 10
(Raleigh, North Carolina) has named
William Cromwell, MD, as chief medical officer. Cromwell
is an internationally recognized expert in the management
of lipid and lipoprotein disorders. He joins LipoScience for
a second time, having previously served as the company’s
chief medical officer from 1999 – 2005. LipoScience is a
diagnostic company specializing in personalized NMR
diagnostics for cardiovascular, metabolic and other
diseases.
(Caesarea, Israel) said Christopher
Prentice has been promoted to senior VP, America & Global
Marketing. Prentice joined Mazor in 2010 and has spent the
past 15 years in healthcare management with a focus on
advancing new technologies in surgery. Mazor Robotics
makes the Renaissance surgical guidance system.
(Auckland, New Zealand) reported three
appointments to its senior management team. Veronique
BouchethasjoinedasVPofbusinessdevelopmentforEurope,
Christopher Stevens has been named as chief operating
officer, and Chris Mander has taken on the role of head of
regulatory and quality. Bouchet has industry experience
and has held a variety of senior international roles across
several therapeutic areas and functions, including strategy,
drug development, business development and M&A, most
recently with AstraZeneca. Stevens previously was chief
technology officer for Orion Health. Mander has more than
20 years of experience from the respiratory medical device
and patient monitoring sectors. Nexus6 is a digital health
company dedicated to improving respiratory care.
(Madison, Wisconsin) has named
Raymond Heller as executive VP of sales and marketing.
Previoulsy, Heller was executive VP of sales at Ohio Medical.
Swallow Solutions’ clinically tested therapy protocol is
designedtostrengthenandimproveswallowingcapabilities
for adults who experience symptoms of dysphagia.
The company makes the Madison Oral Strengthening
Therapeutic device, which is an adjustable mouthpiece
equipped with feedback sensors.
People in the News
Product Briefs
(Greenwich, Connecticut) says
a newly published peer-review study on Stretta therapy is
bringing renewed attention to this non-surgical procedure
that has 10 years of patient data and recently earned The
Society of American Gastrointestinal and Endoscopic
Surgeons (SAGES) highest GRADE recommendation. The
study, published in Gastroenterology Research and Practice,
is titled “Stretta Radiofrequency Treatment for GERD: A
Safe and Effective Modality” and presents facts that dispel
some misconceptions about Stretta. The study concludes
that Stretta is a safe and effective treatment in patients for
whom PPI therapy is undesirable, or the many that prefer
less invasive treatment options. Stretta uses low power and
low temperature radiofrequency (RF) energy to remodel
the lower esophageal sphincter muscle, thus reducing
Gastroesophageal Reflux Disease (GERD) and its symptoms.
Stretta is a minimally invasive treatment for GERD that is
an effective option for patients who do not respond well
to medications. Stretta involves delivery of RF to the LES
and gastric cardia. Studies show Stretta is a safe, effective
and durable therapeutic option. Stretta does not preclude
further steps with more invasive procedures if indicated.
Stretta is currently covered by many insurance plans. Mederi
Therapeutics makes medical devices that deliver RF energy
to treat diseases of the digestive system.
(Columbia, Maryland) said
its multi-center, randomized, controlled clinical trial
evaluating the safety and effectiveness of Grafix for the
treatment of chronic diabetic foot ulcers has been accepted
for podium presentation at the upcoming Symposium on
Advanced Wound Care (SAWC) in Las Vegas. Larry Lavery,
MD, Principal Investigator and Professor of Plastic Surgery
at the University of Texas Southwestern Medical Center,
will discuss the primary and secondary endpoints as well
as additional key safety data from the trial. Grafix is a
human cellular repair matrix containing living stem cells for
acute and chronic wound repair. It is a flexible, conforming
membrane that provides a high quality source of living
mesenchymal stem cells (MSCs) and growth factors directly
to the site of the wound. Grafix is produced by BioSmart
Intelligent Tissue Processing of human placental membrane.
The manufacturing process maintains the integrity of the
extracellular matrix, the viability of the neonatal MSCs,
and the biologically active growth factors. In August,
Osiris reported that the trial had reached the pre-specified
stopping rules for overwhelming efficacy. Additionally, the
trial demonstrated that Grafix closed wounds faster and
required fewer treatments, with fewer adverse events than
standard treatment.
(Frankfurt, Germany) recalled 78,020
microbiology testing panels in the U.S. as they are reporting
false results, U.S. health regulators said. The defect found in
certain MicroScan panels may lead to treatment of patients
with inappropriate antibiotics or to a delay in the therapy
they need, the FDA said on its website. The MicroScan
recall was classified as the most serious type of recall -
one that involves situations in which there is a reasonable
probability that use of these products will cause serious
adverse health consequences or death. Siemens said the
matter impacts only a small number of its customers,
all of whom have been notified and instructed on how to
respond. It said it was taking unspecified corrective action
for the affected panels.

PAGE 6 OF 10
Denver
to imagine and govern the evolution of a historic army
medical center into one of the world’s most forward-looking
bioscience districts. The result is the creation of the Anschutz
Medical Campus (Aurora) which includes: Children’s Hospital,
University of Colorado Hospital, the university’s medical,
nursing, dental and pharmacy schools, and the Colorado
Science + Technology Park. A new Veterans Administration
hospital is also under construction at this site. Steve
VanNurden, President and CEO of FRA, assumed this position
in May 2012. He was previously chair of Mayo Clinic
Ventures (Rochester, Minnesota). He defined the aim of the
FRA as providing the infrastructure needed to attract life
science companies to settle in close proximity to academic
sources of technology and to stimulate commercialization.
The Colorado BioScience Association (Denver)
is at the forefront of Colorado’s bioscience growth. It
supports the state-wide bioscience community through
advocacy, resources and advancement of opportunities
for collaboration. April Giles, the association’s President
& CEO, told MDD that it “aims to help companies from
concept to commercialization, to create networks and
resources to help companies in planning their business
and in understanding how federal and state guidelines and
policies have implications in their business.” She referenced
the BioFrontiers Institute at the University of Colorado in
Boulder which conducts research in regenerative medicine
andhasprogramsinareasrelatedtostemcells,biomaterials,
tissue engineering, drug delivery, optical imaging, and
cellular biomechanics. Ms. Giles cited Touch of Life
Technologies (Aurora) as an example of a successful
spinoff from the University of Colorado. It provides human
models that serve as medical simulators for virtual reality-
based training of medical skills through a single hardware
platform.
The Colorado BioScience Association hosts the Rocky
Mountain Life Science Investor & Partnering Conference
which will be held in Denver September 18 and 19 and covers
the fields of biologics, medical devices, drug delivery and
diagnostics. Presentations will be made by companies in
Colorado, Arizona, Utah, New Mexico and Montana. Ms. Giles
said “we think that this region is significantly underserved
as far as investment opportunities are concerned.”
The Colorado Institute for Drug, Device and
Diagnostic Development (CID4 ; Aurora) was formed in
November2009withfundingfrom federalandstatesources
and from the FRA. CID4 is a not-for-profit organization
that receives research proposals which are reviewed by an
advisory committee. A total of 120 technologies have been
screened to date and 8 were selected for investment. The
CID4alsoprovidesmentoringtoanadditional50companies
it which it has not invested. Several of these companies are
housed at The Colorado Science + Technology Park which
serves as an incubator for startups.
Kevin Smith, president/CEO of CID4, noted that “we are
trying to do economic development through innovation
advancement and we’ve had success in commercializing
early stage technologies by company formation. Evidence
of that success is the number of companies that have
been acquired over the past decade. We are looking to find
a way to retain their corporate headquarters after their
acquisition.”
Metro Denver Economic Development
Corporation (Denver) covers 9 counties with a population
of 3 million people. Its mission is to create the environment
and infrastructure that goes with it and to create industry
clusters. According to Tom Clark, CEO, “the achievement
of regional competitiveness comes from not trying to
recruit a few ‘hot’ companies to an area, but by creating a
self-sustaining economic ecosystem that is not primarily
dependent on outside infusions of money and investment.
He citedastudybytheBrookings Institution(Washington,
DC) which found that Metro Denver is the number one region
in the U.S. for people ages 25 to 34 to relocate.
High Country Venture (Boulder) is one of only a few
venture firms in Metro Denver that invests in life science
companies. It was founded in 2004 and invests only in
Colorado-based firms, several of which are spinoffs from
the University of Colorado which has four campuses, with
the largest student body on the Boulder campus. Mark
Lupa, Managing Partner, told MDD that “the area is totally
underserved from a venture capital point of view. There are
many very high quality venture capital opportunities that
can be funded. Our problem is that companies grow up here
then get acquired and move on, but that produces a large
number of people with experience in taking companies
from an early stage to acquisition.”
High Country Venture’s investments are in the range
of $750,000 to $1 million, with a maximum of $4 million
over the life of a company. There are 9 life science
companies in its portfolio including Mosaic Biosciences
(Boulder) which is developing a new class of synthetic
polymer matrices to support native tissue regeneration
with potential applications in the fields of wound healing,
bone regeneration, cartilage repair, stem cell therapy
and cosmetic surgery, and EndoShape (Boulder) which
is developing the Medusa vascular plug made from a
shape memory polymer (SMP) for use in embolization and
occlusion. SMP was licensed from the University of Colorado
and is based on the research of professor Robin Shandas,
PhD, the founder of EndoShape and Chair of the university’s
Department of Bioengineering. I
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PAGE 7 OF 10
Europe
strategy,” said SonoSite President/CEO Kevin Goodwin.
“Once again, our engineering team has achieved the creation
of a remarkable new tool built from the ground up.”
The company said the X-Porte kiosk is an important
milestone in SonoSite’s ongoing effort to improve access
to point-of-care ultrasound visualization. According to
SonoSite, the foundational advancement behind X-Porte is
a new imaging technology never before used in ultrasound
systems: SonoSite’s proprietary Extreme Definition Imaging
(XDI) technology.
XDIwascreatedfollowing35yearsofappliedultrasound
research by the company’s chief technology officer, JJ
Hwang. XDI is designed to significantly reduce visual clutter
from side-lobe artifacts that affect all ultrasound imaging
regardless of system size.
“I believe this reduction in visual clutter sets a new bar
in point-of-care image quality,” said Hwang, who describes
the XDI technology as “an entirely new way to create an
ultrasound image.” He added that it allows the user to realize
much higher resolution.
To maximize the utility of the XDI technology, X-Porte
delivers optimum usability and interoperability through its
groundbreaking visual learning guides. The kiosk integrates
high-resolution ultrasound imaging synchronously with 3-D
animations that enable “any user, any time of day” to make
the most of the operating the technology. These learning
modules can be used simultaneously with live scanning to
optimize in-the-moment performance and user consistency.
“The design genesis is aimed at enabling any and
all members of a healthcare team—nurses, mid-level
providers, and even a physician-hospital administrator—
to be empowered to take advantage of X-Porte’s high-
performance visualization,” Goodwin said.
SonoSite says it partnered with world-leading
product designers and experts in advanced automotive
animation modeling and distance medical learning. To
ensure maximized clinical efficacy, a consortium of expert
physician educators contributed their expertise for each 3-D
application module.
The team also designed a unique, multi-touch, gesture-
driven user interface comparable to those found in the
consumer world. With personalization capability by any
user, controls can be repositioned with the glide of a hand
and without keys or buttons.
The highly cleanable, sealed user interface was designed
with minimal crevices to facilitate optimal infection control.
The glass surface has been tested against incidental spills
and allows cleaning with a wide range of disinfectants
without deteriorating the surface over time.
“We combined their many insights with the most
innovative consumer technologies available today, then we
blended in our own inspiration from key engineers at our
company,” Goodwin said.
Apica gets CE mark for ASC
Apica Cardiovascular (Galway, Ireland) said it has
received CE mark approval for its platform Access,
Stabilization, and Closure (ASC) system that allows for the
delivery of aortic and mitral valves through the chest wall
and apex of the beating heart.
According to the company, the ASC system is a platform
technology that can be used by surgeons, in conjunction
with minimally invasive surgical techniques. It delivers
large-bore therapeutic devices into the beating heart of
patients with structural heart disease, via the apex. The ASC
systemisdesignedtobothsealandstabilizethetissueofthe
access site during therapeutic device delivery, minimizing
loss of blood from or induction of air to the beating heart.
On completion of the therapeutic treatment, it is designed
to standardize apical access and closure, leading to safer
heart operations, decreased procedure time and reduced
technical challenges associated with transapical access and
closure.
CE mark approval for the ASC system was based on
meeting all safety and technical performance endpoints
in a multi-center clinical trial conducted in Germany at
the Kerckhoff Klinik (Bad Nauheim), University Heart
Centre (Hamburg), and the Heart Centre (Leipzig). The
ASC system demonstrated an excellent safety profile with
100% technical success, superior ease-of-use for surgeons,
and reductions in both blood loss and operative time, the
company noted. Follow-up assessments of patients showed
that the system provided robust closure, with no post-
operative apical bleeding complications and no degradation
of left ventricular function, Apica added.
“Clinically, the Apica ASC system is easy to use,
standardizing apical access and closure. Its sutureless
access coil minimizes both rib spreading and patient pain,
providing a dry access site with no peri-sheath bleeding
during the TAVI procedure,” said Thomas Walther, MD, the
study’s principal investigator and a pioneering surgeon in
the field of TAVI based at the Kerckhoff Klinik. “Apical closure
was reliable, rapid, and completely dry, demonstrating
a reduction in operative times, blood loss, use of blood
products and apical access site complications.”
The ASC system was initially developed as a result
of collaboration between Apica and a team at Emory
University and the Georgia Institute of Technology
(both Atlanta), led by Drs. Jorge Jimenez, Vinod Thourani
and Ajit Yoganathan. Following initial Series A joint
investment by Triventures, an Israeli-based venture capital
company and Seroba Kernel Life Sciences, a European
venture capital company based in Ireland and the UK, Apica
was established in Galway, Ireland and began developing
the ASC system in early 2011.
Following CE mark approval, the ASC system will
now be selectively launched into specific specialist TAVI
centres across Europe, with the focus on safety, technical
See Europe, Page 9

PAGE 8 OF 10
Washington
The Centers for Medicare & Medicaid Services indicated
in its FY 2014 inpatient prospective payment system (IPPS)
draft that it had enough hospital data to round out a full
set of cost-to-charge ratios (CCRs) for CT and MRI, which
gives the agency a means of recalculating relative weights
for these two modalities (Medical Device Daily, April 30,
2013). The agency subsequently indicated an interest in
employing the same methodology to calculate relative
weights for outpatient imaging as well, which triggered the
evaluation by an advisory panel for outpatient payment.
The hospital outpatient payment panel released a
summary of its recommendations, which include the
suggestion that CMS delay implementation of the CCR
calculations “until data can be reviewed by the panel at its
spring 2014 meeting.” The panel stated that it would address
“interactions between the proposals and their potential
cumulative impact” in that spring meeting.
The Medical Imaging & Technology Alliance (MITA;
Arlington, Virginia) argued in July that the CCR move would
create sufficient reimbursement pressures to blunt patient
access and could produce payment levels for various
modalities that defy the substantial differences in cost
(MDD, July 19, 2013).
Brian Connell, director of government relations at
MITA, told Medical Device Daily that MITA is not ignoring
the inpatient side of the discussion, but he said the focus at
present is “on the finalization of the outpatient payment rule.”
“We are excited to have validation of our concerns
coming from the [hospital outpatient] panel,” Connell said,
adding that other stakeholders who are commenting are
“echoing our concerns. We’re very hopeful CMS will respond
appropriately in the final [outpatient] rule,” he said.
Connell indicated the inpatient situation is a concern,
but said, “right now, the inpatient is a final rule. I think we
have to wait and see after the outpatient final rule before we
see what the next steps are” for the inpatient predicament.
Congress has weighed in on imaging issues frequently
since the Deficit Reduction Act of 2005, and Connell
indicated that the current situation also has the attention of
policymakers on Capitol Hill.
“We’ve already seen that they’re concerned about this
policy,” Connell said. “When you walk them through what
CMS is doing and the practical impact on payment rates,
people are very concerned,” he said.
Connell highlighted one of the more peculiar effects
purported to be associated with the new CCR rubric, stating,
“when you’re paying the same for an X-ray of the head as for
a CT of the head, there’s something obviously wrong with
that equation.” He said some on the Hill are “voicing those
concerns to CMS, asking tough questions,” such as “how
they arrived at that and how they’re going to fix it.”
When asked whether the CCR issue calls for a statutory
fix, Connell said, “we’re hopeful that the draft proposal will
be dropped by CMS in the final rule, which would require
no formal congressional action.” Connell added that any
proposal “that pays the same for services that inherently
cost different amounts and provide different diagnostic
power simply doesn’t make sense. When we look at the end
of the equation” as encoded in the outpatient rule, “you find
payments that lack face validity.”
CMS has been working on the CCR problem for imaging
for several years, which tackles a complicated cost issue for
hospitals in that capital-intensive services lend themselves
less readily to accurate accounting than more discrete
services, such as device implants. Connell acknowledged
that the matter is “a very complex issue,” but said much of
the data available to CMS are “not designed to be used in the
way CMS is attempting to use them.”
FDA; Siemens MicroScan a class I recall
FDA reported that the recall of the Siemens MicroScan
plus and MicroScan rapID/S plus negative panels is a
class I recall due to reports of false susceptible and false
intermediate results for imipenem and meropenem
antimicrobial susceptibility testing. The panels are used in
conjunction with the MicroScan WalkAway system, and the
FDA announcement indicated that the problem “may lead
to treatment with an inappropriate antibiotic or a delay in
initiating appropriate therapy.”
Siemens Healthcare Diagnostics (West Sacramento,
California) initiated the recall Aug. 21, an action that affects
more than 78,000 panels distributed in the U.S. between
July 11, 2011 and Aug. 2, 2013. FDA states that Siemens has
instructed users to “suppress all reporting of sensitive and
intermediate results for imipenem and meropenem,” and
that the firm also recommends customers “consider the
need to review previous test results, conduct patient follow-
up, and/or repeat testing.”
CMS eyes hepatitis C screening
The Centers for Medicare & Medicaid Services announced
Sept. 5 it is considering a request for coverage of screening
for hepatitis C and is accepting comments through Oct. 5.
The agency indicated the request came from within CMS and
said that it expects to render a decision by March 5, 2014.
One commenter pointed to a recent article in the Aug.
28 online edition of the Journal of the American Medical
Association, which reviews a randomized trial for sofosbuvir
and ribavirin for hepatitis C in patients with genotype 1. The
single-center study evaluated the use of these agents in
patients “with unfavorable treatment characteristics,” the
abstract says, using an endpoint of sustained virological
response at 24 weeks. According to the abstract, the trial
returned a 24-week response of 68% for sofosbuvir and 48%
for weight-based or low-dose ribavirin. I
Mark McCarty, 703-361-2519
mark.mccarty@thomsonreuters.com

PAGE 9 OF 10
Cook
Europe
available in the North American market and we’ll continue
to roll out to additional markets throughout the month.”
LithAssist has the potential to impact the nearly 67,000
PCNL procedures are performed each year in the U.S., and
the 466,000 that are performed globally.
“This product addresses a significant need,” Jean-Marc
Creissel, global leader of Cook Medical’s Urology division
told MDD. “It’s the first and only device of its kind that
couples laser fiber access with manual suction control. Up
to now the suction control was managed by a nurse. With
this technology the physician would control everything, the
positioning of the laser fiber as well as the suction.”
He added, “We could compare that to someone being in
a car and one person would have the wheel and one would
have the pedal. With this device, you have one driver.”
Prior to the availability of LithAssist, an assistant
controlled suction by kinking a tube, similar to how one
would stop water flow from a garden hose. LithAssist
allows physicians to control suction more easily during the
procedure. The ergonomic handle allows the physician to
position the laser fiber and suction with one hand. Not only
does this synchronize the procedure by giving the physician
more control, but it also can free an assistant to help with
other aspects of the procedure.
“Our goal for this product is to help physicians use their
lasers for PCNL procedures in a simple way,” said Creissel
in a release. “Streamlined procedures are beneficial for the
physician, the hospital and ultimately the patient. This is just
one more example of our commitment to solving problems
for physicians.”
The company said that the LithAssist works with any
holmium laser, so hospitals can use their current equipment
anddon’thavetopurchaseanyadditionalcapitalequipment.
Cook said that the device is receiving a positive
reception from physicians.
“With a procedure like this, there’s constant irrigation
coming in and constant suction going out and the timing of
that is something the physician wants to have control over,”
Walendzak said. “Giving the physician the ability to have
control over that suction is something they’re very excited
about. It helps them to be able to more effectively treat the
stone with the laser and control where that stone is going.
They have to have irrigation to keep that visual field open
but there’s also a manner in which if suction is too rapid,
you’re going to interfere with the process. So they’re very
excited about the precision and control this device gives
them during the surgery.”
Cook would neither confirm nor completely rule out
the possibility if it would seek approval for the device for
additional indications.
“For us right now, this device is approved for urological
indications, but we have seen the adoption of products and
interest from other specialties and that’s something Cook
would partner with physicians to continue to work on...”
Walendzak told MDD. I
Omar Ford; 770-810-3125
omar.ford@thomsonreuters.com
performance and cost-effectiveness.
In parallel with the limited clinical European launch
of the ASC system, Apica is continuing to develop its
next-generation devices for TAVI, as well as its Universal
Port Access System for minimally invasive delivery
of left ventricular assist devices without the need for
cardiopulmonary bypass in the treatment of congestive
heart failure.
Collaboration accelerates ultrasound
TheFocusedUltrasoundFoundation(Charlottesville,
Virginia) and Royal Philips (Amsterdam, the Netherlands)
have entered into a public-private collaboration with The
Institute of Cancer Research (ICR; London) and The
Royal Marsden NHS Foundation Trust. The partnership
will create a focal point for ultrasound therapy research
at the ICR and The Royal Marsden (London) under the
international Focused Ultrasound Foundation Centers of
Excellence Program.
The new initiative is intended to create a resource
for clinicians and scientists working on high intensity
focused ultrasound therapy, developing clinical evidence
in oncology and establishing best practices, treatment
standards and protocols. Focused ultrasound concentrates
ultrasound energy with high precision on target tissue
in the body to thermally destroy tissue. The technology
is coupled with image guidance to identify, target and
track the treatment in real time. The initiative will launch
this autumn with a clinical trial to evaluate treatment of
bone metastases in cancer patients. A similar center was
established at the University of Virginia (Charlottesville)
in 2009 to advance the use of focused ultrasound, with an
emphasis on brain disorders.
The Focused Ultrasound Foundation is the catalyst for
the collaboration and its leadership will actively engage
with the ICR, The Royal Marsden and Philips to help guide
progress towards standard-setting translational and
clinical research, training and treatment. In establishing
the Focused Ultrasound Centers of Excellence Program,
the Foundation brings together the best people and
resources at luminary research sites throughout the world
in the dynamic multi-disciplinary environment necessary
to foster those activities critical to accelerating progress
towards better patient outcomes.
The center will be led by Gail ter Haar and Nandita
deSouza. Ter Haar heads the ICR’s therapy ultrasound
team. deSouza is the new initiative’s clinical director. I

PAGE 10 OF 10
Med-Tech Notes
Spectrum Plastics is now NPI Medical
The Ansonia, Connecticut, division of Spectrum
Plastics Group (New Haven) has changed its name to NPI
Medical to better reflect its core business.
Under the same ownership, NPI Medical will focus
on providing solutions to its customers’ New Product
Introductions (NPI), especially in the medical device market.
“We have demonstrated our capability in new product
introductions by helping our customers rapidly launch
dozens of new medical device related products in the past
few years. Speed to market is critical to our customers’
success and we have all of the internal capabilities to
meet their needs,” said NPI Medical president Randy Ahlm.
The company is investing in additional cleanrooms, new
machines and additional automation to better serve its
current and prospective customers.
NPI will continue to operate out of its 66,000-square-
foot facility in Ansonia. The company’s senior management
team remains the same and the experienced team of 85
associates will continue in their current roles, meaning
uninterrupted service for current customers. The facility
has multiple production cells arranged to help customers
quickly move from prototype to production, including quick
turn manufacturing for short runs, production injection
molding for high volume programs, a full service tool room
and multiple clean rooms.
BioReliance opens new facility in Rockville
Sigma-Aldrich’s (St. Louis) BioReliance, the biologics and
early-development services business under SAFC, has opened
a new clearance services facility in Rockville, Maryland. This
facility, commissioned on Aug. 1, allows BioReliance to offer
increased capacity and flexible scheduling while maintaining
its core focus on providing industry-leading quality, expertise
and value. The new U.S. facility more than doubles the
amount of space available to clients to conduct their critical
downstream bioprocessing studies.
Designed with input from clients and built to
complement BioReliance’s global viral clearance services
capabilities, the Rockville facility features four large
clearance suites with modular layouts that allow for
customized laboratory setups. All studies performed at the
facility are completely secure and supported by dedicated
scientists and state-of-the-art chromatography equipment,
such as GE Healthcare’s AKTA avant.
“Combiningourdeepknowledgeandprovenexperience
with a global investment in modern facilities and equipment
enables BioReliance to offer robust validation packages and
proprietary CompleteClearance services to our clients. It’s
all about simplifying the viral clearance process through
an unrivaled combination of scientific expertise, client-
focused service and decades of experience,” said Archie
Cullen, president of BioReliance. “Any time a client comes to
work with us, they are assured that their study is expertly
designedandperformedbypersonnelthathaveparticipated
in thousands of successful studies in support of clinical and
commercial biopharmaceutical products.”
Sigma-Aldrich acquired BioReliance in January 2012.
Casa Grande deploys Radar management
Radar Medical Systems (Chagrin Falls, Ohio), a
division of RadNet (New York), said that Casa Grande
Regional Medical Center (Casa Grande, Arizona) has
implemented Radar for Critical Test Results Management.
Prior to deploying Radar, which provides automated,
secure delivery, receipt and confirmation of any type of
healthcare communication, Casa Grande used a manual
system to contact referring physicians and to track results
of those communications.
Toan Bui, RIS/PACS Administrator at Casa Grande, notes
that a more secure process is a strong advantage on the
compliance front. “We have proof that we have contacted our
referring doctors, and we can run HIPAA-compliant reports
in seconds,” Bui said. “Not only can we track communication
activity in RADAR, as opposed to a spreadsheet, we can also
measure the productivity gains we’re making.”
BP monitors set for stable market growth
The world market for blood pressure monitors will
enjoy steady growth in the years ahead as aging populations
climb in number and diseases exacting their toll require
observation and supervision, according to a new report
from IHS (Austin, Texas).
Global revenue for blood pressure monitors is set to
reach $854.9 million by year-end, up a modest 2 percent from
$838.8millionin2012.Revenueexpansionwillholdfirmatthe
2% to 3% range for the next three years, before bounding to a
5% increase by 2017. By then, industry takings will amount to
$963.2 million, as shown in the attached figure. The majority
of revenue will stem from automatic upper-arm monitors,
which is the preferred type of blood pressure monitor.
“One important reason for the consistent rise in revenue
over the years is that the worldwide population of those
aged 65 and above will continue to grow over time, making
up an increasingly larger percentage,” said Roeen Roashan,
analyst for consumer medical devices and digital health. “As
a result, health monitoring will increase, which will drive
market growth for blood pressure monitors. While evident
in all regions, the phenomenon will be particularly apparent
in Europe and Asia.”
Overall, blood pressure monitors will be part of an
$8.2 billion market this year for consumer medical devices
including blood glucose meters, activity and heart-rate
monitors, and hearing aids. By 2017, total revenue for
consumer medical devices will equate to a staggering $10.6
billion.

Keeping you up to date on recent developments in neurology
New laser-based tool could dramatically improve the accuracy of brain tumor
surgery . . . A new laser-based technology may make brain tumor surgery much more accurate, allowing surgeons
to tell cancer tissue from normal brain at the microscopic level while they are operating, and avoid leaving behind cells that
could spawn a new tumor. In a new paper, featured on the cover of the journal Science Translational Medicine, a team of
University of Michigan Medical School (Ann Arbor) and Harvard University (Cambridge, Massachusetts) research-
ers describes how the technique allows them to “see” the tiniest areas of tumor cells in brain tissue. They used this tech-
nique to distinguish tumor from healthy tissue in the brains of living mice – and then showed that the same was possible
in tissue removed from a patient with glioblastoma multiforme, one of the most deadly brain tumors. Now, the team is
working to develop the approach, called SRS microscopy, for use during an operation to guide them in removing tissue, and
test it in a clinical trial at U-M. On average, patients diagnosed with glioblastoma multiforme live only 18 months after diag-
nosis. Surgery is one of the most effective treatments for such tumors, but less than a quarter of patients’ operations
achieve the best possible results, according to a study published last fall in the Journal of Neurosurgery. “Though brain
tumor surgery has advanced in many ways, survival for many patients is still poor, in part because surgeons can’t be sure
that they’ve removed all tumor tissue before the operation is over,” says co-lead author Daniel Orringer, MD, a lecturer in
the U-M Department of Neurosurgery who has worked with the Harvard team since a chance meeting with a team member
during his U-M residency.“We need better tools for visualizing tumor during surgery, and SRS microscopy is highly promis-
ing,” he continues. “With SRS we can see something that’s invisible through conventional surgical microscopy.” The SRS in
the technique’s name stands for stimulated Raman scattering. Named for C.V. Raman, one of the Indian scientists who co-
discovered the effect and shared a 1930 Nobel Prize in physics for it, Raman scattering involves allows researchers to
measure the unique chemical signature of materials. In the SRS technique, they can detect a weak light signal that comes
out of a material after it’s hit with light from a non-invasive laser. By carefully analyzing the spectrum of colors in the light
signal, the researchers can tell a lot about the chemical makeup of the sample. Over the past 15 years, Sunney Xie, PhD, of
the Department of Chemistry and Chemical Biology at Harvard University – the senior author of the new paper – has
advanced the technique for high-speed chemical imaging. By amplifying the weak Raman signal by more than 10,000 times,
it is now possible to make multicolor SRS images of living tissue or other materials. The team can even make 30 new
images every second – the rate needed to create videos of the tissue in real time. A multidisciplinary team of chemists,
neurosurgeons, pathologists and others worked to develop and test the tool.
Brain clues reveal risk of psychotic illness . . . New research has shown that people with psy-
chotic illness show similar brain changes to immediate family members who present no signs of illness. In a study detailed
in the journal JAMA Psychiatry, researchers at Monash University (Victoria, Australia), in collaboration with The Univer-
sity of Melbourne in Australia and the University of Cambridge in the UK, found that these brain changes represent
a marker of genetic risk of developing psychotic illnesses, such as schizophrenia. Lead researcher, Alex Fornito, Deputy
Director of Monash Clinical and Imaging Neuroscience in the School of Psychology and Psychiatry, said these genetic mark-
ers could be targeted in the development of new treatments that may help to reduce the risk of developing psychotic ill-
ness. “First-degree relatives of people with psychosis are at increased genetic risk of developing a psychotic illness,” For-
nito said. “We have found that people with psychosis and their unaffected first-degree relatives, who otherwise present no
signs of illness, show similar brain changes when compared to healthy people.” Fornito said even at the earliest signs of
illness, patients showed altered activity (when compared to healthy people) in a specific brain circuit that links a region
deep in the brain called the striatum with the prefrontal cortex. This circuit plays an important role in attention, learning
and memory. “The fact that we see the same brain changes in this group, in the absence of any overt signs of illness, points
to a neural biomarker of risk for psychosis.” The study examined 19 young people experiencing their first episode of psy-
chotic illness and 25 of their unaffected parents or siblings. A group of 26 healthy unrelated participants was also recruited
to draw comparison. The researchers used magnetic resonance imaging, or MRI, to map the activity of different brain sys-
tems. The study also found a change in brain activity that was specific to patients but not their relatives. Associate Profes-
sor Fornito said this change may reflect a ‘switch’ that determines whether a person transitions from an at-risk state to
full-blown illness. “We know that activity in brain circuits linking the striatum and prefrontal cortex are heavily influenced
MDD’s Neurology Extra
MONDAY, SEPTEMBER 9, 2013 PAGE 1 OF 2
AD D I T I O N A L DE V E L O P M E N T S I N ON E O F ME D -T E C H ’ S K E Y SE C T O R S

MONDAY, SEPTEMBER 9, 2013 MDD’S NEUROLOGY EXTRA PAGE 2 OF 2
by the neurotransmitter dopamine, which is a major target for all medications currently used to treat psychosis,” Fornito
said. “The difficulty is that these drugs have rather diffuse effects on the brain, affecting many different systems. They also
often have unpleasant side effects. Our findings point to a more specific treatment target. We are currently investigating
whether we can selectively improve activity patterns in the affected brain circuits using non-invasive magnetic stimulation
techniques. If successful, using these techniques in at-risk populations may help delay, minimise or prevent the impact of
psychosis onset.”
Faulty recycling by brain’s trash collectors may contribute to Alzheimer’s . .
. A defective trash-disposal system in the brain’s resident immune cells may be a major contributor to neurodegenerative
disease, a scientific team from the Stanford University School of Medicine (Palo Alto, California) has found. Prelimi-
nary observations show that this defect appears in the brains of patients who died of Alzheimer’s disease, so correcting it
may someday prove to be an effective way of preventing or slowing the course of the disease. “We were fortunate in being
able to compare microglia – the brain’s own immune cells – from five patients who died of Alzheimer’s disease with five
who died of other causes,” said Tony Wyss-Coray, PhD, professor of neurology and neurological sciences at the medical
school and senior research career scientist at the Veterans Affairs Palo Alto Health Care System. “And we discovered that
in Alzheimer’s disease, the microglia are defective. One of these cells’ main functions, removing garbage, is impaired.”
Wyss-Coray is the senior author of the study, which will be published Sept. 4 in Neuron. The lead author was postdoctoral
scholar Kurt Lucin, PhD. Microglia, one of several important cell types in the brain, serve as both cops and trash collectors.
These immune cells continuously police the brain, making sure everything is running smoothly. When they sense a patho-
gen, they pull out the molecular equivalent of a pistol. If they spot a dead cell or a clump of protein detritus, they don a pair
of overalls and hasten to remove it. They do this by engulfing and ingesting the target in a process called phagocytosis.
Many cells can do this, but microglia are the pros – and they’d better be, said Wyss-Coray. “If they don’t clear up all the
detritus in the brain efficiently, debris left lying around can trigger inflammation and consequent injury to neurons.” Pro-
teins called phagocytic receptors on the surface of microglia look out for characteristic earmarks of detritus, dead cells and
potentially toxic substances such as A-beta, a protein widely implicated in Alzheimer’s disease. A-beta is prone to clump
into plaques that abound in the brains of people with Alzheimer’s and, to a lesser extent, in the rest of us as we grow older.
When a targeted protein or piece of cellular debris is bound by a phagocytic receptor, part of the microglial cell’s outer
membrane forms a bubble that encloses the target, migrates inward and fuses with the cell’s high-powered digestive
machinery, which breaks down the ingested contents.
Discovery helps to unlock brain’s speech-learning mechanism . . . University of
Southern California (Los Angeles) scientists have discovered a population of neurons in the brains of juvenile songbirds
that are necessary for allowing the birds to recognize the vocal sounds they are learning to imitate. These neurons encode
a memory of learned vocal sounds and form a crucial (and hitherto only theorized) part of the neural system that allows
songbirds to hear, imitate, and learn its species’ songs – just as human infants acquire speech sounds. This discovery will
allow scientists to uncover the exact neural mechanisms that allow songbirds to hear their own self-produced songs, com-
pare them to the memory of the song that they are trying to imitate, and then adjust their vocalizations accordingly. This
brain-behavior system is thought to be a model for how human infants learn to speak, so understanding it could prove
crucial to future understanding and treatment of language disorders in children. In both songbirds and humans, feedback
of self-produced vocalizations is compared to memorized vocal sounds and progressively refined to achieve a correct
imitation. “Every neurodevelopmental disorder you can think of – including Tourette syndrome, autism, and Rett syndrome
– entails in some way a breakdown in auditory processing and vocal communication. Understanding mechanisms of vocal
learning at a cellular level is a huge step toward being able to someday address the biological issues behind the behavioral
issues,” said Sarah Bottjer, senior author of an article on the research that appears in the Sept. 4 issue of the Journal of
Neuroscience. Bottjer collaborated with lead author Jennifer Achiro, a graduate student at USC, to examine the activity of
neurons in songbirds brains using electrodes to record the activity of individual neurons. In the basal ganglia – a complex
system of neurons in the brain responsible for, among other things, procedural learning – Bottjer and Achiro were able to
isolate two different types of neurons in young songbirds: ones that were activated only when the birds heard themselves
singing, and others that were activated only when the birds heard the songs of adult birds that they were trying to imitate.
The two sets of neurons allow the songbirds to recognize both their current behavior and a goal behavior that they would
like to achieve.
— Compiled by Robert Kimball, MDD Staff Writer
robert.kimball@thomsonreuters.com

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