FDA Clears Lensar Laser, InVivo Gains IDE Approval

MONDAY, APRIL 8, 201 3 VOL. 17, NO. 67 PAGE 1 OF 9

Lensar’s laser system cleared InVivo Therapeutics gains IDE
by FDA for arcuate incisions for biopolymer product study
By AMANDA PEDERSEN By OMAR FORD
Medical Device Daily Senior Staff Writer Medical Device Daily Staff Writer
Lensar (Orlando, Florida) reported that the FDA InVivo Therapeutics Holdings (Cambridge,
has cleared its laser system for the execution of arcuate Massachusetts), a developer of groundbreaking
incisions during cataract surgery. Arcuate incisions are technologies for the treatment of spinal cord injuries
precise incisions made on the periphery of the cornea in the (SCI) and other neurotrauma conditions, reported FDA has
context of cataract surgery. approved the company’s Investigational Device Exemption
With this latest regulatory milestone, Lensar says its (IDE) to begin human studies to test its biopolymer scaffold
system is now cleared to perform both corneal and arcuate product, a technology developed to treat patients with
incisions, as well as lens fragmentation and anterior acute, traumatic SCI.
capsulotomy (with or without phacofragmentation), during With this approval, InVivo intends to commence a first-
cataract surgery. The system is already available for sale in-man clinical study in the next few months that will test
to cataract surgeons in the U.S., Europe and several other safety and performance of its biopolymer scaffold in five
countries, the company noted. patients.
Featuring the company’s Augmented Reality technology, “This is going to be an open label study,” Sean Moran
the Lensar laser system is designed to enable cataract Director of Finance for InVivo told Medical Device Daily.

See Lensar, Page 4 See InVivo, Page 5

International report Washington roundup
Hologic gets Health Canada House inks doc fix proposal,
approval for Aptima assays may crowd device tax repeal
A Medical Device Daily Staff Report By MARK McCARTY
Hologic (Bedford, Massachusetts) said that Health Medical Device Daily Washington Editor
Canada has granted medical device licenses for Hologic’s There are a lot of theories about why Congress does
Aptima HPV and Aptima HPV 16 18/45 genotype assays. or does not pass legislation, but two committees of the
Both assays are in vitro nucleic acid amplification tests House of Representatives have published a framework for
(NAATs) that are designed to detect high-risk strains of the repeal of the sustainable growth rate (SGR) contrivance,
the human papillomavirus (HPV) that are associated with a proposal the April 3 statement describes as “fiscally
cervical cancer and precancerous lesions. HPV is among responsible and free of politics.” As one might expect, the
the most common sexually-transmitted infections (STIs) in sticking point is the question of how to pay for the doc fix,
Canada and worldwide. The tests have been approved to and one long-term observer thinks one approach Congress
run on Hologic’s fully automated, high-throughput Tigris could resort to is to throw the device tax repeal under the
instrument system. bus.
The Aptima HPV assay is designed to detect 14 high- The April 3 framework published in a joint statement by
risk HPV types associated with cervical cancer and the House Ways and Means and the Energy and Commerce
See International, Page 6 See Washington, Page 7

Don’t miss today’s MDD Extra: Neurology

INSIDE: CANCER GENETICS LOOKING TO RAISEGROSS PROCEEDS OF $6 MILLION IN IPO ....................... 2
TCS IN MULTI-YEAR DISTRIBUTION DEAL WITH NONIN MEDICAL .......................... 3

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MONDAY, APRIL 8, 2013 MEDICAL DEVICE DAILY™ PAGE 2 OF 9

Financings roundup conversion adjustments and conditions.
The company also reported that in view of the proposed
Cancer Genetics looking to raise financing, the NYSE MKT, which is the company’s current
gross proceeds of $6 million in IPO listing exchange, has granted an additional quarterly
extension of the company’s listing exchange compliance
A Medical Device Daily Staff Report
plan from March 30 to June 30 of this year, although as is
Cancer Genetics (Rutherford, New Jersey), a normal course the company’s exchange compliance would
diagnostics company that develops genomic-based continue to be evaluated on an ongoing basis.
oncology tests and services, reported the pricing of its The initial closing covering the sale of 2,356
initial public offering of 600,000 shares of its common shares of Series A preferred stock, of about $2.35
stock at $10 a share. The gross proceeds are expected to be million in gross proceeds, which is subject to the
$6 million before underwriting discounts and commissions satisfaction of customary closing conditions, is
and other offering expenses. expected to be completed this week. The second
The company has granted the representative of the closing, covering the sale of 1,656 shares of Series A
underwriters a 45-day option to purchase up to 90,000 preferred stock, for an additional amount of roughly
additional shares of common stock to cover over- $1.65 million in gross proceeds, is contingent upon
allotments, if any. The offering is expected to close April 10. stockholder approval.
As of Friday shares of Cancer Genetics’ common stock Cardium said it has also agreed to seek stockholder
were being quoted on the OTCQB Marketplace, operated by approval for the company to effect a reverse stock split of
OTC Markets Group, under the symbol “CGIX”. its issued and outstanding common stock. The Company
Aegis Capital is acting as sole book-running manager plans to submit proposals to approve the sale of the
for the offering. Feltl and Company is acting as co-manager second tranche of 1,656 shares of Series A Preferred Stock
for the offering. and authorization for the proposed reverse stock split of
In other financing activity: its issued and outstanding common stock at Cardium’s
• Cardium Therapeutics (San Diego) said it upcoming annual meeting of stockholders.
has entered into a definitive agreement with a single • PeriGen (Princeton, New Jersey), a provider of real-
institutional healthcare fund managed by Sabby time clinical decision support to perinatal systems, said
Management, the company’s largest shareholder, it received significant industry recognition, raised $6.4
for a financing of up to $4 million in gross proceeds. million in funding, achieved record bookings and expanded
Ladenburg Thalmann & Co., a subsidiary of Ladenburg its senior management team in the first quarter of 2013.
Thalmann Financial Services, served as the exclusive “Our first quarter results illustrate the industry’s
placement agent on the transaction. recognition that PeriGen solutions are best positioned to
Cardium will issue up to 4,012 shares of zero coupon enable superior perinatal care and reduce hospital liability
Series A convertible preferred stock, which are non-voting. risk,” said CEO Matthew Sappern. “Hospitals increasingly
Each share of Series A Preferred Stock has a purchase select us as their preferred perinatal vendor because our
price and liquidation preference of $1,000 a share while solutions provide so much more clinically relevant and
held as preferred stock, or they may be converted into
See Financings, Page 8
10,989 shares of voting common stock, subject to certain

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Agreements/contracts
Terumo in accord People in the News
with Nonin Medical
• Cognoptix (Acton, Massachusetts), an emerging
Terumo Cardiovascular Systems (Ann Arbor, medical device company, said it has expanded its clinical
Michigan) reported that it has entered into a multi- advisory board, appointing two new members from the
year distribution agreement with Nonin Medical Alzheimer’s Disease-focused clinician community: Carl
(Plymouth, Minnesota), a company that specializes in Sadowsky, MD, director of research at Premiere Research
noninvasive medical monitoring. Institute (West Palm Beach, Florida); and Pierre Tariot, MD,
Beginning May 1, Terumo CVS will distribute Nonin’s director of the Banner Alzheimer’s Institute (Phoenix).
EQUANOX Model 7600 Regional Oximetry System to Cognoptix is developing a method to aid in early-detection
adult and pediatric cardiovascular hospitals in the U.S.; diagnosis of Alzheimer’s to allow treatment before
Nonin’s direct sales force will focus on certain non- signiﬁcant neuronal loss and irreversible brain damage
cardiovascular applications in those hospitals, and occurs.
applications in all other U.S. hospitals. • Hooper Holmes (Basking Ridge, New Jersey)
Terumo CVS manufactures and markets medical devices reported that Gus Halas has been appointed to its board
for the global cardiac surgery market. Nonin Medical and of directors, effective April 2. Halas is currently president/
Terumo CVS will make the announcement at the Society of CEO of the Central Operating Companies at Central Garden
Cardiovascular Anesthesiologists (SCA) Annual Meeting in & Pet Company. Hooper Holmes services include collecting
Miami. personal health data and transforming it into useful
The Nonin EQUANOX Model 7600 Regional Oximetry information.
System is a noninvasive medical monitoring system
that continuously detects oxygen saturation status in
the brain and tissue beneath the sensor during surgical
procedures and in intensive care environments such as
pediatric and neonatal intensive care units.
The system allows anesthesiologists, perfusionists,
cardiovascular surgeons, and other clinicians to
quickly react to reverse tissue ischemia events before
they become critical.
“We are confident that Terumo’s extensive
cardiovascular relationships in heart hospitals,
combined with the clinical benefits and technology
advancements of the EQUANOX System, will drive further
adoption of Nonin’s regional oximetry solution across
the hospital as a cost-effective, standard-of-care tool
that helps prevent brain and organ injury in patients,”
said Chris Holland , VP of business development for
Nonin Medical.

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Lensar from FDA, Lensar is once again reaffirming its commitment
Continued from Page 1 to meeting all of the rapidly evolving needs of the cataract
surgeon community.”
surgeons to execute arcuate incisions with precision and Furthermore, the company noted, the laser system’s
repeatability. Previously, these incisions were made as part sophisticated phacofragmentation techniques provide cataract
of manual, highly variable procedures. With its several FDA surgeons with advantages in more efficient removal of all grades
cleared indications supporting the capabilities of the laser of cataracts and a major reduction or complete elimination
system, the company says it is “providing physicians the of the use of the ultrasound energy required in conventional
most advanced platform for conducting bladeless cataract cataract surgery. The mobile design of the Lensar laser system
surgery and achieving consistent, predictable outcomes.” easily adapts to existing surgical facilities, allowing the system
The company’s next-generation differentiating to be placed in the operating room or in a separate room.
Augmented Reality technology consists of high-resolution For the company’s existing install base, using the Lensar
imaging and measurement technology providing precise laser system for the new indication is simply a matter of a
biometric information and 3-D reconstruction of the anterior software upgrade, Curtis said.
anatomy of the eye. Lensar says its system provides precise “What it really does is opens up an additional market for
capsulotomy incision size, shape, and location, thereby us because there are a lot of doctors that have been looking at
enhancing effective intraocular lens (IOL) lens positioning this technology,” he said. The additional indication for use might
and fitting for each individual patient, leading to optimized help sway doctors who had been sitting on the fence more in
patient outcomes. Lensar’s direction, Curtis added.
“Lensar is deeply committed to providing cataract So far the Lensar system has been “really well received”
surgeons with the most advanced and sophisticated tools in the marketplace and the latest regulatory milestone in
that support their delivery of optimal clinical outcomes to the U.S. is one more validation of the technology, Curtis told
their patients,” said Lensar CEO Nick Curtis. “By adding arcuate MDD. “We’re looking forward to the effect of this on potential
incisions to our growing list of FDA cleared indications for new customers and certainly our existing customer base.”
the Lensar laser system, we have further strengthened our
position as the provider of the industry’s most advanced, Amanda Pedersen, 912-660-2282;
versatile, surgeon- and patient-centric laser cataract system.” amanda.pedersen@achmedia.com
Last year was a memorable one for Lensar as the
company achieved two FDA clearances, raised $24 million
in private financing, installed about 30 of its laser systems
in 11 countries, and was profiled on the popular television
show “The Doctors” (Medical Device Daily, Dec. 11, 2012).
“Milestones of this type underpin the significant traction
that we have experienced in rapidly accelerating the adoption
of the Lensar platform among cataract surgeons around the
world,” Curtis said. “We expect this latest development will only
serve to further increase the growing demand for our system.”
Curtis told Medical Device Daily that the latest FDA
clearance for the Lensar system is significant for the company,
particularly in the U.S. rather than the rest of the world. There
are fewer Toric options on the IOL side in the U.S. compared
to other parts of the world, he explained, which emphasizes
the importance of allowing doctors to use the Lensar system
for making arcuate incisions during cataract surgery.
“The execution of the arcuate incision with Lensar’s
proprietary Augmented Reality imaging system and
advanced laser technology is one of the key recent
advances in the area of cataract surgery. Until recently, these
small and challenging incisions in the cornea were made
manually, leading to variability in predictable outcomes,”
said Louis “Skip” Nichamin, MD, member of Lensar’s medical
advisory board. “Lensar’s advanced technology platform
will help cataract surgeons achieve consistent, predictable
arcuate incision outcomes, regardless of the challenges
and complexity of the procedure. With this latest clearance



InVivo study, it is imperative to take the time to get it right, because
Continued from Page 1 any mistakes can lead to years of lost time for the scientists
and patients that follow,” said Frank Reynolds, InVivo CEO.
“The study has a one year-follow-up. Our expectation is that
Reynolds added, “Everyone knows my obsession with
by the end of 2014 we would have data to give to the FDA.”
safe FDA studies. Over the next month or so, we plan to
The company said that there are currently no treatment
finalize the details of our study, and we expect to have all
options approved by the FDA, or in clinical trials, to
data to the FDA by the end of 2014. We will be conducting
intervene directly in the spinal cord following SCI. The trial
an open label study, and so we look forward to keeping
will be conducted at multiple U.S. hospitals, and work to gain
the public aware of its progress. As a historical first-in-
Institutional Review Board (IRB) approval at Massachusetts
man study, this trial marks the next phase in our corporate
General Hospital in Boston is already underway.
growth and begins our mission to maintain a collaborative
“This is a biopolymer scaffolding that’s designed for
relationship with the FDA. We’ve built a framework to
neuro protection. What happens when you have a spinal
optimize speed-to-market for our pipeline of technologies,
chord injury is that you have a penetration within the
and we’ll be working to commercialize over fifteen products
spinal cord and then an internal lesion forms,” Moran said.
in the next five years while remaining focused on mitigating
“You get this scarring process that occurs over 21 days.
patient risk and maximizing patient safety and benefit.”
That scarring process is what puts people in wheelchairs
because the signal from the brain can’t go below the point
Omar Ford, 404-262-5546;
of where the scar is. The biopolymer scaffolding works to
omar.ford@ahcmedia.com
provide structural support and provides what we call pro-
generation and allows for tissue ingrowth. So at the end
of the day you get much better healing and less scarring.
We’ve demonstrated that in primate studies. When we took Patent watch
histological samples we’ve got much better healing and
less scarring.” Antares Pharma gains patent
He added, “so if you have just 10% of a spinal cord left in
a human remarkably through the process of neuroplasticity
for Vibex Quickshot device
signals can be rerouted through the healthy tissue. So what
this product does is it protects the healthy tissue and allows
Antares Pharma (Ewing, New Jersey) reported that
for functional recovery to occur.”
it has received a Notice of Allowance from the U.S. Patent
The company said that although the technology has
Trade Office (USPTO) on a patent application for the VIBEX
yet to gain approval, it has already generated a significant
QuickShot (QS) device, the latest advancement in its
amount of attention from the neurosurgical community.
proprietary line of Vibex auto-injector systems.
“Today there is no treatment for the spinal cord itself,”
Paul Wotton, PhD, president/CEO, said, “The size and
Moran said. “When you come in with a spinal cord injury
scope of our intellectual property portfolio continues to
they decompress the cord, they do a laminectomy to relieve
grow as we develop device technologies that will enhance
pressure and then what will happen is that screws and rods
the product performance of established drugs as well as
will be put in to stabilize the spine, but no neurosurgeon
new drugs in development.”
today actually treats the underlying spinal cord lesion so
Wotton continued, “We believe that many injectable
this product would be the first of its class to do so.”
drugs currently under development will be administered
The company was also recently granted approval from
by self-injection once they reach the market. Our advancing
the FDA on its Humanitarian Use Device (HUD) designation
technology will therefore be important for the growing
request. HUD designation is reserved for devices designed
number of chronic care products that can only be given by
to treat rare diseases or conditions. InVivo has received this
injection.”
designation for the treatment of recent complete spinal cord
The VIBEX QS device offers a dose capacity up to 1
injury (no motor or sensory function) that does not involve
mL and the design can be scaled for larger volumes. The
penetrating injury or complete severing of the spinal cord.
device design emphasizes enhanced performance on the
The HUD designation and clinical trial data are required to
attributes most critical to patient success – speed, comfort
support a Humanitarian Device Exemption application to
and discretion. The new design also accommodates fast
the FDA with the goal of commercializing the scaffold in the
injection of highly-viscous drug products that stall less-
United States sooner than a PMA approval would allow.
powerful conventional auto-injectors. Many self-injectable
“It’s heartbreaking for all of us for it to take even a
biological agents currently marketed and in clinical
minute longer than necessary to begin human studies, and
development are formulated to be administered in a 1 mL
we’ve all heard of, or experienced, treatments that have
dose volume and tend to be of higher viscosity than non-
proven to be unsafe, but when conducting a first-in-man
biologic injectable products.


International from Leksell Gamma Knife Perfexion equipped with Extend.
Continued from Page 1 “We are delighted that Extend is now available in Japan,”
precancerous lesions. The Aptima HPV 16 18/45 genotype said Tim Rooney, president and managing director of
assay is approved for genotyping HPV types 16, 18 and/ Elekta K.K. “Clinicians here will now be able to expand the
or 45, which are associated with approximately 80% of versatility of their Leksell Gamma Knife Perfexion system
all invasive cervical cancers worldwide. Detecting the through multi-session radiosurgery. This technology will
specific HPV types 16, 18 and/or 45 provides healthcare enable treatment of lesions immediately adjacent to critical
professionals with additional information regarding a structures, such as the eye, in addition to targets that are
patient’s risk of subsequently developing cervical cancer. simply too large for just one radiosurgery session.”
Both assays can be performed using Hologic’s ThinPrep Since its introduction in Japan in 1991, until the end of 2011,
liquid cytology specimens collected for routine pap tests as Leksell Gamma Knife has been used to treat approximately
well as Hologic’s Aptima cervical specimen collection and 173,000 patients. Through Leksell Gamma Knife Perfexion
transport kit. and its product line, Elekta intends to provide a wide
“Most HPV infections clear up on their own, so it’s range of high-quality treatment options and to continue to
important to identify those persistent, high-risk infections contribute to the field of radiotherapy.
that are most likely to lead to cervical cancer,” said Tom Elekta is a human care company specializing in
Wright, MD, professor of pathology and cell biology at the solutions for treating cancer and brain disorders. The
Columbia University Medical Center. “In numerous clinical company makes tools and treatment planning systems
studies involving approximately 45,000 women, the Aptima for radiation therapy, radiosurgery and brachytherapy, as
HPV assay has consistently shown similar sensitivity and well as workflow enhancing software systems across the
better specificity than the most frequently used DNA-based spectrum of cancer care.
test. This means the Aptima HPV assay is highly accurate
in detecting cervical disease, but is less likely to raise false Aerocrine passes regulatory milestone in Japan
alarms that can result in unnecessary medical procedures.” Aerocrine (Solna, Sweden) said the Japanese authority
The Hologic Aptima HPV assay has been approved for (PMDA) has approved its FeNO (fractional exhaled nitric
two uses: oxide)-measuring device, Niox Mino as a tool for assessing
• To screen patients with atypical squamous cells of patients with airway inflammation such as asthma.
undetermined significance (ASC-US) cervical cytology The Japanese Pharmaceuticals and Medical Devices
results in order to determine the need for referral to Agency (PMDA), decided, after a thorough review, to grant
colposcopy. the 2008 version of the Niox Mino marketing approval in
• To be used adjunctively with cervical cytology to Japan. As Aerocrine introduced a new version in 2010 of
screen women 30 years and older to assess the presence or Niox Mino, the approval will have limited impact on the
absence of high-risk HPV types. company’s sales in Japan in the near future.
The Aptima HPV 16 18/45 genotype assay is intended “We look upon this approval as a positive regulatory
to test specimens from women with Aptima HPV assay milestone. We are very proud of being the first company to
positive results and is approved for two uses: receive approval for the FeNO-method in Japan,” said Tobias
• To be used adjunctively with the Aptima HPV assay Bergenblad, commercial director Aerocrine for Asia.
in women aged 30 years and older in combination with Aerocrine is a medical products company focused
cervical cytology to assess the presence or absence of on improved management and care of patients with
specific highrisk genotypes 16, 18 and/or 45. inflammatory airway diseases such as Asthma.
• To be used adjunctively with the Aptima HPV assay in
women aged 21 years or older with ASCUS cervical cytology Monteris gets Health Canada OK for AutoLITT
results to assess the presence or absence of specific high Monteris Medical (Plymouth, Minnesota) said
risk HPV genotypes 16, 18 and/or 45. The results of this test Health Canada has approved the AutoLITT (now known
are not intended to prevent women from proceeding to as NeuroBlate) system, an MRI-guided ablation therapy for
colposcopy. brain lesions, for commercialization in Canada.
The NeuroBlate System provides focal ablation (lethal
Elekta’s Extend approved in Japan heat therapy) for tumors and has been commercially available
Elekta’s Japanese office, Elekta K.K. (Toyko), said in the U.S. since 2010. “We are excited that the NeuroBlate
that Elekta’s Extend system for multi-session stereotactic System will now be available for neurosurgeons and their
radiosurgery has been approved by the Japanese Health patients in Canada,” said John Schellhorn, president/CEO
Authority. Extend makes it possible to treat indications that of Monteris. “This approval is especially gratifying given
were previously untreatable with Gamma Knife surgery. that the company was founded in Winnipeg, Manitoba and
The ability to treat a broader range of targets and more
challenging cases allows even more patients to benefit See International, Page 8



Washington that was assumed in the [budget] baseline” because of the
Continued from Page 1 presumption that armed conflicts would not necessarily
Committees indicates an interest in a “period of stable come to a halt. “It’s as fake as savings come because if we
payments,” to allow providers to brace for long-term changes had a shooting war somewhere, we’d have appropriations”
to the payment system, with the more distant objective being to cover the cost, Antos continued, adding that a budgetary
a series of payment options providers can choose from as clawback of OCO is a case of “projecting peace in the Middle
suits their practice models. The joint statement describes East.”
the SGR hangnail as “a top priority” for the two committees, Still, the OCO is a possible if somewhat unlikely tool
citing the perennial doc fix drama as a source of uncertainty in paying for the doc fix, Antos said. “Two years from now
that makes it difficult “for [physician] practices to plan for if something happens” in terms of military conflict, “we’re
the future.” There is support for an SGR repeal on Capitol Hill going to spend the money.” He said that when it comes to
because the cost of a repeal is nearly at an all-time low, but “solving a political problem like fixing the SGR, remember
policymakers and their advisors believe the price tag will rise that nobody goes back and” inquires where the offset came
again after 2013 (Medical Device Daily, March 18, 2013). from. Should a war break out two years later, members of
Joe Antos, PhD, of the American Enterprise Institute Congress would say “that’s something you couldn’t have
(AEI; Washington) told Medical Device Daily anticipated.”
are a couple of options Congress could avail itself of
in order to eliminate the SGR offset problem, including just FDA seeks feedback on sterilization, export
ignoring the offset altogether. Antos, a healthcare scholar FDA apparently has its eye on two practices important
at AEI, seemed less than dazzled by the latest proposal, to device makers, namely non-sterile conveyance of devices
however. required to be sterile, and certificates of export for devices
The current proposal is “a little more detailed than other not cleared or approved in the U.S.
general statements, but it’s not much more” than prior drafts The agency announced both declarations for collection
addressing this topic, Antos noted, pointing out that the 10-year, of information in the April 5 edition of the Federal Register,
$138 billion cost of an SGR overwrite in the statute will not be but the explanations do little to tip FDA’s hand. The
easy to cover. Still, Antos said, Congress has on one occasion announcement regarding exports is especially terse, stating
dealt with this kind of dilemma without providing a pay-for. little more than that the statute “provides for the exportation
“It hasn’t happened very often, but once in a while of an unapproved device under certain circumstances,”
Congress will direct CBO to not score something” Antos including that the exportation “is not contrary to the public
remarked, stating that the Congressional Budget Office on health and safety and it has the approval of the foreign
one occasion had included a footnote in a legislative report country to which it is intended for export.”
estimating the cost, but that the cost of the offset did not One of the potential corollary issues here is that device
appear anywhere else in the agency’s report. makers sometimes file 510(k) applications with FDA despite
“What this says is Congress can do whatever it wants if having no intent to market the device in the U.S., a move
it has the votes and the gumption,” Antos quipped, adding, often undertaken to deal with nation-of-origin laws.
“I think this is the year that something like that could As for the sterilization issue, the FR notice points out that FDA
happen. They’re having a fire sale on SGR and next year the has allowed device makers to ship products intended to be sterile
prices are going to go back up, so they better take it.” Before for the purpose of sterilization, a practice FDA acknowledges is
legislators get to that point, however, “they’re more likely an economic necessity for many device makers. The rest of the
to look for the offsets, and the offsets are likely to be in the statement consists of federal government boilerplate or facts
Medicare program.” such as are already appreciated by device makers.
“If it looks like there’s an agreement on the Hill . . . to Both announcements set the response deadline at June 4.
repeal the [device] tax, then people would say that leaves us
with another X billion dollars of hole to fill,” Antos pointed Mark McCarty, 703-361-2519
out. “If you were of a suspicious mind, you might say that mark.mccarty@ahcmedia.com
this [device tax repeal] resolution is setting up that scenario,
so that someone thinks they can offer to give up the repeal
of the device tax” in negotiations for the SGR repeal, “and
that will be their contribution to the payment for SGR,” he Sign up for our free, weekly
speculated, although he pointed out that more would have
to be done to completely blank out the cost of the doc fix. e-mail blog, Perspectives, comment-
Antos said the overseas contingency fund (OCO) as ing on today’s med-tech.
an offset could happen in the congressional can-if-they-
want scenario, but he said “the fuzziness of OCO is that Go to www.MedicalDeviceDaily.com and sign up.
it is giving back money from the Department of Defense



Court report International
Continued from Page 6
MAKO Surgical wins injunction
a significant portion of our people and operations remain in
against Blue Belt Technologies Canada. We are expanding our sales and marketing efforts
A Medical Device Daily Staff Report to support Canadian neurosurgical centers offering brain
tumor patients new therapies and technologies.”
MAKO Surgical (Fort Lauderdale, Florida) reported that it Monteris Medical is a medical device company
has obtained an order granting permanent injunction enjoining dedicated to the development of innovative MRI-guided,
Blue Belt Technologies (Pittsburgh) from engaging a former laser-based brain lesion therapy.
MAKO employee and requiring the destruction of all proprietary
MAKO business information in Blue Belt’s possession.
MAKO Surgical is a device company that markets its RIO Bioelectronics to distribute in South Korea
Robotic-Arm Interactive Orthopedic system, with specific BioElectronics (Frederick, Maryland) has begun
applications for partial knee resurfacing and total hip product distribution of its ActiPatch Musculoskeletal
replacement, and proprietary Restoris Family of Implants Pain Relief, Allay Menstrual Pain Therapy and
for orthopedic procedures called MAKOplasty. RecoveryRx Chronic and Postoperative wound therapy
On Jan. 30, Blue Belt reported that former MAKO brands with Herapharm (Seoul, South Korea).
sales manager Jeff Gellman had been hired as West Area “South Korea has a population of more than 48 million
Vice President of Sales. MAKO brought an action against with a world leading economy and personal incomes. It is
Blue Belt and Gellman in the U.S. District Court of the an excellent introductory Asian market for BIEL’s award
Southern District of Florida to enforce the non-competition winning products,” said Erin Sanders, BioElectronics Sales
agreement between MAKO and Gellman and to prohibit the Manager.
use or disclosure of MAKO’s proprietary information. BioElectronics is a medical device maker of
By court order dated April 4, Gellman is prohibited from advanced medical devices. Its products are ActiPatch
working for Blue Belt in any capacity until August 2013, and Therapy, for over-the-counter treatment of back pain
may only work in a limited capacity thereafter until 2014. and other musculoskeletal complaints, the Allay
Furthermore, both Blue Belt and Gellman have been ordered menstrual cycle pain therapy, and RecoveryRx for
to certify under penalty of perjury that all MAKO proprietary chronic and post-operative wound care.
information in their possession has been permanently
purged. The U.S. District Court retained jurisdiction of the
matter to ensure compliance with its order.
“MAKO is pleased with the sweeping and substantial
injunctive relief we obtained on an expedited basis,” said
Financings
Continued from Page 2
Maurice Ferre, MD, president/CEO of MAKO. “We will remain
actionable information than other solutions on the market.”
vigilant in protecting the substantial investments made
PeriGen says its suite of fetal surveillance solutions targets
in becoming the leader in the field of robotically assisted
the most common underlying causes of preventable medical
orthopedic surgery.”
errors to help clinicians improve clinical outcomes. Equipped
The injunction was entered contemporaneous to a
with evidence-based methods, these solutions deliver real-
separate settlement agreement among Blue Belt, Gellman
time decision support in a timely and visually intuitive way to
and MAKO, which provided MAKO with the described
nurses and physicians throughout the OB continuum.
stipulated order, along with additional relief and future
In the first quarter of 2013, PeriGen was recognized
protections.
for its innovative contributions to perinatal care when
Blue Belt, which makes the the NavioPFS orthopedic
experts from the National Institutes of Health (NIH)
surgical system with precision robotics for unicondylar
validated the company’s electronic fetal monitoring
knee replacement (UKR), said in a statement sttributed
(EFM) pattern recognition software, PeriCALM Patterns.
to its president/CEO, Eric Timko that it believes “that this
The company also expanded its clinical leadership in
lawsuit was without merit and Mako failed to prove that
Q1 by appointing Thomas Garite, MD, as chief clinical
Blue Belt engaged in any wrongdoing. In fact, Mako failed
officer.
to substantiate many of the allegations it made in its
PeriGen secured $6.4 million from private investors
complaint and we are confident that Blue Belt would have
for further product development and marketing
prevailed had the litigation continued. At the same time,
initiatives. At the same time, PeriGen expanded its
however, Blue Belt determined that it is in our best interest
market reach through a distribution agreement with
to compete with Mako by selling our new robotic technology
leading international system integrator Helix Health
in the marketplace, instead of competing in the courtroom,
Solutions (Dubai).
where no surgeon or patient can benefit.”



Based Proteomic Mass Spectrometry Test on Treatment
Recommendations in Advanced Non Small Cell Lung
Med-Tech Notes Cancer,” shows that VeriStrat significantly influences
therapy recommendations.

Thermo Fisher gets ISO certification
Thermo Fisher Scientific (San Jose, California) said
its facility in San Jose and its Franklin, Massachusetts site Product Briefs
have achieved ISO 13485 certification, an internationally
recognized standard of quality management for the design
and manufacture of medical devices.
The sites in Franklin and San Jose are the first of Thermo • Promega (Madison, Wisconsin) reported the launch
Fisher’s liquid chromatography and mass spectrometry of GenePrint 10 System for human cell line authentication
sites to achieve ISO 13485 certification. and sample identification. GenePrint 10 includes the eight
Thermo Scientific TLX multiplexed HPLC (high loci recommended by the ANSI Standard (ASN-0002)
performance liquid chromatography) platforms and a Authentication of Human Cell Lines: Standardization of STR
number of Thermo Scientific mass spectrometry systems Profiling, plus Amelogenin for gender identification and
will be designed and manufactured under this standard, the highly polymorphic D21S11 locus for additional power of
paving the way for CE-IVD device registration in Europe discrimination. Short Tandem Repeat (STR) analysis begins
and Class-1 medical device listing in the United States, the with amplification, and the GenePrint 10 System contains all
company said. materials necessary to co-amplify human STR loci, using a
“This is a critical step in our ongoing initiative to develop hot-start thermostable DNA polymerase and a robust buffer
LC-MS (liquid chromatography-mass spectrometry)-based compatible with fast cycling and direct amplification from
devices for the clinical market,” said Dan Shine, president of substrates. Tissue culture cells, important tools in many
Thermo Fisher’s chromatography and mass spectrometry laboratories, are often misidentified or contaminated with
business. “The medical community is expressing great other cells, wasting substantial time, effort and laboratory
interest in utilizing LC-MS technology, and we’re aggressively resources and potentially invalidating published data. To
developing tools to address this growing demand.” remedy this issue, the National Institute of Health and many
journals now recommend or require cell line authentication
Biodesix releases VeriStrat study results before grant approval or acceptance for publication,
Biodesix (Boulder, Colorado), a molecular diagnostic making cell line authentication a very important concern
company dedicated to personalizing medicine, reported the for researchers.
online release of a peer-reviewed study demonstrating that • Syneron Medical (Yokneam, Israel) will begin
physicians are using the company’s VeriStrat test to help the market launch of its Sublative technology for the
guide treatment decisions for patients with advanced non- removal or modification of the appearance of acne scars.
small lung cell cancer (NSCLC). Details of the study and its The acne scar treatment is available on all of the Syneron
results appeared online ahead of print in Current Medical Sublative compatible systems, which includes els Plus,
Research & Opinion. eTwo and eMatrix. Syneron’s Sublative technology is a
“The results of this study show that when physicians bi-polar fractional radiofrequency (RF) energy device
incorporated the VeriStrat test into their clinical practice, proven to effectively treat acne scars. Due to its design,
it had a significant impact on their treatment decisions,” energy can now be delivered beneath the surface of the
said David Brunel, CEO of Biodesix. “This data confirms skin to maximize collagen production while preserving
that VeriStrat provides valuable information to physicians the top layer of the skin intact, the company said. This
as they recommend a therapy for individual patients— means patients benefit from significant results without the
particularly patients with advanced NSCLC who may not down time or potential complications of more aggressive
be receiving personalized therapy due to lack of a genetic treatments.
mutation or squamous histology.”
VeriStrat is a novel, multivariate, serum protein test
designed to provide oncologists with information to Access Medical Device Daily Archives Online!
help them choose between erlotinib and single-agent You have FREE access to articles dating back to 2005
chemotherapy when treating advanced lung cancer — perfect for company research or for finding sup-
patients. The test, which requires only a simple blood draw, porting data for presentations and reports.
provides results in less than 72 hours, allowing physicians
to make quick treatment decisions. Go to www.MedicalDeviceDaily.com for access.
The published study, titled “The Impact of Serum


MDD’s Neurology ExtraADDITIONAL DEVELOPMENTS IN ONE OF MED-TECH’S KEY SECTORS
MONDAY, APRIL 05, 2013 PAGE 1 OF 2

Keeping you up to date on recent developments in neurology
CABG generally not associated with long-term cognitive dysfunction .
. . The cognitive dysfunction observed in patients who undergo coronary artery bypass grafting (CABG) surgery
usually disappears within 8 weeks following surgery, according to a study published in the April 2013 issue of
The Annals of Thoracic Surgery. Previously published estimates of the incidence of post-operative cognitive
dysfunction vary widely, with some studies reporting lasting impairment in as many as 50% of patients. Research-
ers from Monash University and RMIT University (both Victoria, Australia), periodically tested cognitive
function in three sets of patients: 16 patients who underwent elective CABG surgery, 15 patients who underwent
elective chest surgery for lung biopsies or lobectomies, and 15 non-surgical patients. “Our study carefully con-
trolled for a wide range of factors that can influence cognition, such as the residual effect of general anesthesia,
familiarity with testing procedures during retesting (practice effects), general intelligence, age, education levels,
emotional state, and levels of pre-existing impairment,” said Kathryn Bruce, the primary author of the study. The
researchers found that CABG patients performed worse on every subtest prior to surgery, and these disparities
continued following surgery. Anxiety, depression, and stress were associated with impaired cognitive perfor-
mance in patients in the two surgical groups 1 week after surgery. At 1-week post-operation, 44% of CABG patients
and 33% of surgical control patients were significantly impaired; however, by 8-weeks post-operation nearly all
patients had recovered to pre-operation levels with 25% of CABG patients and 13% of surgical control patients
improving beyond their pre-operative performance. The researchers also found that even though the surgical
groups showed impairment, when individual performance within these groups was examined, more than half of
the patients were unaffected by the surgery. The results also showed that the strongest predictor of worse cog-
nitive performance after surgery was the emotional state of the patient, and patients who were anxious or
stressed prior to undergoing surgery generally performed worse afterwards. “Previous research may have over-
estimated the effects of cardiac surgery on cognition. Our data indicate that cardiac bypass surgery has a low
likelihood of causing permanent cognitive deficits,” said senior author Stephen Robinson, PhD. “Cognitive
changes that occur immediately after surgery are likely due to confounding factors and will generally resolve
within a few months.”

Preventing sports-related brain injury in youngsters . . . Ice hockey accounts
for nearly half of all traumatic brain injuries among children and youth participating in organized sports who
required a trip to an emergency department in Canada, according to a new study out of St. Michael’s Hospital
(Toronto). The results are part of a first-of-its-kind study led by Michael Cusimano, MD, that looked at causes of
sports-related brain injuries in Canadian youth and also uncovered some prevention tactics that could be imme-
diately implemented to make sports safer for kids. “Unless we understand how children are getting hurt in sport,
we can’t develop ways to prevent these serious injuries from happening,” said Cusimano, a neurosurgeon and
the lead author of the study. “One would think that we know the reasons why kids are having brain injuries in
sports, but until know, it was based mainly on anecdotes.” The study used data from The Canadian Hospitals
Injury Reporting and Prevention Program to look at the almost 13,000 children and youth aged 5-19 who had a
sports-related brain injury between 1990 and 2009. The results appeared in the journal PLOS ONE. The research-
ers categorized injuries by players’ ages, what sport they occurred in and what mechanisms had caused them –
“struck by player,” “struck by object” (such as net or post), “struck by sport implement” (such as ball or stick),
“struck by playing surface” and “other.” Hockey accounted for 44.3% of all injuries and almost 70% of them
occurred in children over 10 as a result of player-to-player contact or being hit into the boards. Cusimano said
they expected to see high numbers in hockey because it’s Canada’s national sport.

Combined physical and mental activities good for older adults . . . Inac-
tive, older adults, suffering from cognitive complaints, who completed 12 weeks of physical plus mental activity,
experienced significant improvements in their cognitive function, a new study published in JAMA revealed. How-
ever, there was little difference between the control and intervention group. Within the next 40 years, public


MONDAY, APRIL 05, 2013 MDD’S NEUROLOGY EXTRA PAGE 2 OF 2

health authorities expect an explosion of dementia cases as people live longer. Some potential strategies to pre-
vent or delay dementia among asymptomatic individuals include a variety of behavioral interventions. Lifelong
exercise can significantly improve cognitive functioning in later life, a previous study in Psychological Medicine
revealed. However, according to the authors of this latest article, not many studies have observed the effects of
physical and mental activity together. “We found that cognitive scores improved significantly over the course of 12
weeks, but there were no significant differences between the intervention and active control groups. These results
may suggest that in this study population, the amount of activity is more important than the type of activity,
because all groups participated in both mental activity and exercise for [60 minutes/per day, three days/per week]
for 12 weeks. The researchers found that the overall cognitive scores improved greatly but didn’t differ between
the different groups. “The prevalence of cognitive impairment and dementia are projected to rise dramatically dur-
ing the next 40 years, and strategies for maintaining cognitive function with age are critically needed. Physical or
mental activity alone result in small, domain-specific improvements in cognitive function in older adults; combined
interventions may have more global effects,” the authors concluded.

Obama unveils BRAIN Initiative . . . President Obama unveiled a decades-long project last
week designed to map the inner workings of the brain, seeking answers to such challenges as epilepsy, autism and
Alzheimer’s disease. “There’s this enormous mystery, awaiting to be unlocked,” Obama said during remarks at the
White House. The initial cost: $100 million in Obama’s fiscal year 2014 budget to be proposed next week; Congress
must approve the sum. The “BRAIN Initiative” – the acronym stands for “Brain Research through Advancing Innova-
tive Neurotechnologies” – will look into ways people think, learn and remember, Obama said. Its goal is developing
new technologies that can record the activities of individual cells and neurons within the brain. Obama cast the
brain project as an example of how scientific research can generate economic growth, and he took the time to
criticize the sequester – an ongoing series of $85 billion in automatic budget cuts that he said are damaging all
sorts of research efforts. “Ideas are what power our economy,” he said. The brain project is “a bold new research
effort to revolutionize our understanding of the human mind and advance the president’s vision for creating jobs
and building a thriving middle class by investing in research and development,” said a White House statement.
Obama made the brain project a part of his State of the Union Address in February. “Every dollar we invested to
map the human genome returned $140 to our economy — every dollar,” Obama said on Feb. 12. “Today, our scien-
tists are mapping the human brain to unlock the answers to Alzheimer’s.” Scientists will build on the sequencing
of the human genome and other previous discoveries in determining how to address brain disorders. “Significant
breakthroughs in how we treat neurological and psychiatric disease will require a new generation of tools to
enable researchers to record signals from brain cells in much greater numbers and at even faster speeds,” the
White House statement said. It added: “This cannot currently be achieved, but great promise for developing such
technologies lies at the intersections of nanoscience, imaging, engineering, informatics, and other rapidly emerg-
ing fields of science and engineering.”

Resetting the addicted brain with laser light . . . By stimulating one part of the brain with
laser light, researchers at the National Institutes of Health (NIH) and the Ernest Gallo Clinic and Research Center
at UC San Francisco (UCSF) have shown that they can wipe away addictive behavior in rats – or conversely turn
non-addicted rats into compulsive cocaine seekers. “When we turn on a laser light in the prelimbic region of the pre-
frontal cortex, the compulsive cocaine seeking is gone,” said Antonello Bonci, MD, scientific director of the intramural
research program at the NIH’s National Institute of Drug Abuse (NIDA), where the work was done. Bonci is also an
adjunct professor of neurology at UCSF and an adjunct professor at Johns Hopkins University (Baltimore).
Described last week in the journal Nature, the new study demonstrates the central role the prefrontal cortex plays in
compulsive cocaine addiction. It also suggests a new therapy that could be tested immediately in humans, Bonci said.
Any new human therapy would not be based on using lasers, but would most likely rely on electromagnetic stimula-
tion outside the scalp, in particular a technique called transcranial magnetic stimulation (TMS). Clinical trials are now
being designed to test whether this approach works, Bonci added. What makes the new work so promising, said
Bonci, is that Billy Chen of NIDA, the lead author of the study, and his colleagues were working with an animal model
that mimics this sort of compulsive cocaine addiction. The animals, like human addicts, are more likely to make bad
decisions and take cocaine even when they are conditioned to expect self-harm associated with it.

— Compiled by Robert Kimball, MDD Staff Writer
robert.kimball@ahcmedia.com


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