medical device innovation

157 Pages·2010·0.73 MB·English

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M D D
EDICAL EVICE AILY
MEDICAL DEVICE
INNOVATION
2010
W ’
HAT S NEW AT SELECTED
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DEVELOPMENT STAGE COMPANIES
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MEDICALDEVICEINNOVATION2010
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MEDICALDEVICEINNOVATION2010
Table of Contents
EnteroMedics . . . . . . . . . . . . . . . . . . . . . . . . .52
Company Page Envoy Medical . . . . . . . . . . . . . . . . . . . . . . . .54
Estill Medical Technologies . . . . . . . . . . .56
3T Ophthalmics . . . . . . . . . . . . . . . . . . .7, 146 Exmovere . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Aethlon Medical . . . . . . . . . . . . . . . . . . . . . . .8 GIDynamics . . . . . . . . . . . . . . . . . . . . . .59, 60
AMDL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 GlycoMeds . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
Angel Medical . . . . . . . . . . . . . . . . . . . . . . . . . .11 Harvard University . . . . . . . . . . . . . . . . . . .62
Applied Medical . . . . . . . . . . . . . . . . . . . . . .12 HealthPartners . . . . . . . . . . . . . . . . . . . . . . .63
Aspect Medical . . . . . . . . . . . . . . . . . . . . . . .13 Home Diagnostics . . . . . . . . . . . . . . . . . . . .65
Asthmatx . . . . . . . . . . . . . . . . . . . . . . . . . . .14,16 ImThera Medical . . . . . . . . . . . . . . . . . . . . .66
ATS Medical . . . . . . . . . . . . . . . . . . . . . . . . . .18 InSightec . . . . . . . . . . . . . . . . . . . . . .24, 67, 68
Avantis Medical Systems . . . . . . . . . . . . . .19 Invatec . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Bioheart . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 Kansas State University . . . . . . . . . . . . . . .72
BodyViz . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 Lawrence Livermore National
Brainsgate . . . . . . . . . . . . . . . . . . . . . . . . . . .22 Laboratory . . . . . . . . . . . . . . . . . . . . . . . . .73
Cameron Health . . . . . . . . . . . . . . . . . . . . .23 LenSar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
CapsuTech . . . . . . . . . . . . . . . . . . . . . . . . . . .24 Link-It Medical . . . . . . . . . . . . . . . . . . . . . . .75
Cardiac Dimensions . . . . . . . . . . . . . . . . . .26 Lumalier . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
CardiAQValve Technologies . . . . . . . . .28 Luminex . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78
Cardinal Health . . . . . . . . . . . . . . . . . . . . . . .30 Luminous . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
CardioDX . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31 Mardil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Case Western University . . . . . . . . . . . . . .32 Medical Designs . . . . . . . . . . . . . . . . . . . . . .82
Cepheid . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34 Medical Technologies International . . .83
Chamberlin Group . . . . . . . . . . . . . . . . . . .35 Medical University of South Carolina . .84
Cheetah Medical . . . . . . . . . . . . . . . . . . . . .37 Micrus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
CNSystems Medizintechnik . . . . . . . . . .38 Molecular Detection . . . . . . . . . . . . . . . . . .86
Cochlear . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40 Nanosphere . . . . . . . . . . . . . . . . . . . . . . . . . .87
Coherex Medical . . . . . . . . . . . . . . . . . . . . . .41 Neochord . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Corventis . . . . . . . . . . . . . . . . . . . . . . . . . . . .43 NeuroInterventions . . . . . . . . . . . . . . . . . .90
CVRx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44 New York Presbyterian Hospital . . . . . .92
DiFusion Technology . . . . . . . . . . . . . . . . .46 NIDCR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94
Diopsys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47 NiTi Surgical Solutions . . . . . . . . . . . . . . .95
Draper Laboratories . . . . . . . . . . . . . . . . . .48 NovoCure . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
Drexel University . . . . . . . . . . . . . . . . . . . . .49 NMTMedical . . . . . . . . . . . . . . . . . . . . . . . . .97
Egen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 Nomir Medical . . . . . . . . . . . . . . . . . . . . . .98
Ekos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51 Organ Recovery Systems . . . . . . . . . . . . .99
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MEDICALDEVICEINNOVATION2010
Table of Contents
Company Page superDimension . . . . . . . . . . . . . . . . . . . . .127
SynergEyes . . . . . . . . . . . . . . . . . . . . . . . . . .129
OrthoDynamix . . . . . . . . . . . . . . . . . . . . . . . .101 TBI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .130
Ossur . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102 Texas Heart Institute . . . . . . . . . . . . . . . . .131
Pacific Edge Biotechnology . . . . . . . . . . .103 Thermogenesis . . . . . . . . . . . . . . . . . . . . . .133
Paradigm Spine . . . . . . . . . . . . . . . . . . . . . .104 Transoma Medical . . . . . . . . . . . . . . . . . . .134
PEAK Surgical . . . . . . . . . . . . . . . . . . . . . . . .106 University of Arkansas . . . . . . . . . . .135, 137
PLCMedical . . . . . . . . . . . . . . . . . . . . . . . . .108 University Children’s Hospital . . . . . . . .138
Profound Medical . . . . . . . . . . . . . . . . . . .109 University of Michigan . . . . . . . . . . . . . . .139
ProUroCare Medical . . . . . . . . . . . . . . . . . .111 University of Toronto . . . . . . . . . . . . . . . .140
ReGen Biologics . . . . . . . . . . . . . . . . . . . . . .112 Urovalve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .141
Sanomedics . . . . . . . . . . . . . . . . . . . . . . . . . .113 USEndoscopy . . . . . . . . . . . . . . . . . . . . . . . .143
Sansum Diabetes Research Institute . .114 Ventus Medical . . . . . . . . . . . . . . . . . . . . . .144
Sanuwave . . . . . . . . . . . . . . . . . . . . . . . . . . . .115 Vesticon . . . . . . . . . . . . . . . . . . . . . . . . . . . . .146
Second Sight Medical Products . . . . . . . .116 VisionCare . . . . . . . . . . . . . . . . . . . . . . . . . .148
Sensimed . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117 Vision Center at Children’s Hospital . .149
SeraCare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119 Vital Therapies . . . . . . . . . . . . . . . . . . . . . . .150
SFCFluidics . . . . . . . . . . . . . . . . . . . . . . . . . . .121 VisEn Medical . . . . . . . . . . . . . . . . . . . . . . .151
Shape Medical Systems . . . . . . . . . .122, 123 Wake Forest University . . . . . . . . . . . . . . .152
Stentys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124 Weill Cornell Medical College . . . . . . . . .153
Sunshine Heart . . . . . . . . . . . . . . . . . . . . . .125 Wicab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .154
SuperSonic Imagine . . . . . . . . . . . . . . . . . .126
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MEDICALDEVICEINNOVATION2010
Innovative new companies
provide the lifeblood of med-tec
Of the hundreds of front-page stories published each year in Medical Device Daily, the
largest response often is accorded those in which our writers report on the product-related
activities of development-stage and emerging companies. These stories provide an insight
into the innovative activities occurring at firms that are not yet household names.
While news in this sector often is skewed toward corporate biggies such as Johnson &
Johnson, Medtronic, Boston Scientific, Baxter Healthcare, St. Jude Medical and others – and that
certainly was true during 2009 — we also try to keep a sharp eye out for the activities of so-
called “little guys.” We enjoy being among the first to report on companies being built on ideas
that may turn into the medical technology breakthroughs of tomorrow.
Those ideas, and the future promises they hold, spark the investments that keep this
industry moving. Those investments — coming from financial “angels,” venture capitalists,
corporate collaborators or the public markets that have started to re-open for those firms
deigned to have the right stuff — fuel the climb from concept to commercialization.
The ideas that still are standing after running the harrowing gauntlet of testing, trials, reg-
ulatory scrutiny and increasingly important reimbursement issues may go to market as prod-
ucts in clinicians’ hands. Whether the eventual setting of such products’ use is hospitals,
physicians’ offices or diagnostic labs, the final product marks the end of a long journey of
development and the beginning, it is hoped, of solving a clinical need.
In a time of potential sea changes in the healthcare industry due to new leadership in
Washington, one thing that still has not changed is the value of innovation to the med-tech
field and to humanity as well.
No matter what, an increasingly large aging population in the U.S. and worldwide will con-
tinue to demand the latest and greatest innovations in healthcare. Other long-term trends,
such as large unmet medical needs and increasing prosperity in emerging markets, spell
growing demand for healthcare and med-tech products. Additionally, larger companies that
have recently slashed their R&D budgets may increasingly rely on these innovative small com-
panies for their breakthrough products of the future.
These stories by MDDstaff writers Omar Ford, Rob Kimball, Don Long, Amanda Pedersen,
and Lynn Yoffee offer insight into some of the innovative activities taking place at the young
or modestly sized older companies whose products help fill the pipeline of new technology.
As the daily news service of the med-tech industry, Medical Device Dailycomes in contact
with both people and product ideas from companies across the entire spectrum of the sector
– from the smallest start-up to the aforementioned Goliaths. This collection of stories from
recent issues of Medical Device Daily touch on some of the most interesting developments
that have caught our attention during the past year.
— Holland Johnson, Managing Editor
February 2010
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MEDICALDEVICEINNOVATION2010
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MEDICALDEVICEINNOVATION2010
A tiny silicone cup improves the fibrous, protective outer layer of the eye. The cup
administers the drug slowly by passive diffusion through
drug delivery for eye diseases
the sclera, where it reaches the retina and vitreous. The
device is so small the patient’s vision is unlikely to be
By LYNN YOFFEE affected.
Medical Device Daily Staff Writer With preliminary testing complete, Murphree is cur-
Physicians and researchers have, for years, tried to get rently developing a protocol for phase I/II clinical trials in
drugs into the eyes without a great deal of success. Much of humans, focused on retinoblastoma, to take place in 2010.
it washes away and also gets absorbed into the body’s sys- Murphree’s first focus, retinoblastoma, requires rela-
tem. A tiny silicone cup sealed to the outer surface of the tively large doses to achieve a therapeutic concentration in
eye may provide a more effective method for the delivery the retina. A byproduct is that the chemo destroys the bone
of medicines for retinal and vitreous diseases such as can- marrow and depresses the child’s immune system, often
cer, macular degeneration and diabetic retinopathy. leading to secondary infections. All of this delays an effec-
“We can get higher levels of drug in the eye with one- tive administration of the drug and the ability to treat the
one-hundredth of the dose we’d get giving it systemically,” cancer.
A. Linn Murphree, MD, director of the Retinoblastoma “Our preliminary research shows that once the cup is
Program in The Vision Center at Childrens Hospital Los fitted, the child should be able go home for several weeks.
Angeles told Medical Device Daily. “So the patient would Because the drug is being administered directly into the
get much higher levels with lower exposures and virtually eye and not systemically, chemotherapy dosage levels will
none getting into the systemic circulation.” be much lower and the debilitating side effects will be
Murphree’s work centers on treating retinoblastoma, a reduced,” Murphree said.
cancer of the retina that typically afflicts children, which He has tested the device in rabbits and observed they
calls for chemotherapy. Current treatment involves intra- didn’t seem to feel discomfort when the cup was attached,
venous delivery. nor did they experience side effects as they would from
“We wanted any type of system to get chemotherapy systemically administered drugs.
into the eye in a better way,” Murphree said. So he and two The device is 8 mm to 10 mm with a reservoir that is
other colleagues invented silicone cup, which differs from about one-tenth of a millimeter. Liquids, tablets or gels
any sort of implant or insert currently available because it’s could be loaded in the cup.
non-invasive and is attached temporarily with a bioadhe- “We’ve shown that we can get 30 to 40 times more drug
sive glue. this way than if you gave the same amount as an injection,”
“Think about a coffee cup with a flattened rim,” he said. “The difference is that you maintain the concentra-
Murphree said. “When you turn it upside down, it has a wide tion radiant across the eye wall. Theoretically it could deliv-
flange in contact with the eye and a bioadhesive is used on er drugs as large as Avastin and as small as antibiotics or
the lip.” steroids. It can stay on as long or as short a period as you
The device can be reloaded with medication as needed. want.”
Known as the episcleral drug reservoir, it holds the (This story originally appeared in the Aug. 5, 2009, edi-
potential to fundamentally change the delivery of medica- tion of Medical Device Daily)
tions for all eye diseases, according to a report delivered by
Murphree last week at the Association for Research in
Vision and Ophthalmology (ARVO) Summer Eye Research
Conference on Ophthalmic Drug Delivery Systems in
Bethesda, Maryland, where he explained that it works like
an organ-specific transdermal skin patch.
The cup isolates the medication targeted to the eye
from being absorbed into the blood stream. It delivers med-
ications to the interior of the eye over long periods of time
up to months.
Drops, periocular injections and intraocular injections
are currently used to deliver medications to the eye but
generally for short periods of time.
This work is being backed by 3T Ophthalmics(Irvine,
California), which holds the associated intellectual proper-
ty license.
The episcleral drug reservoir is inserted under the thin,
filmy conjunctiva, or covering of the eyeball, to the sclera –
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MEDICALDEVICEINNOVATION2010
Aethlon’s Hemopurifier signs off.
Researchers involved are expected to publish their
removes H1N1 from blood
results in a peer-reviewed journal in the near future.
What Joyce was able to disclose are some top line data
By LYNN YOFFEE results that show the longer the device is used, the more
Medical Device Daily Staff Writer effective it is at removing a virus from blood. Hemopurifier
Aethlon Medical’s (San Diego) blood filtration device, removed 68% of H1N1 virus from blood plasma in 30 min-
the Hemopurifier, has successfully removed 96% of H1NI in utes, 80% of the virus in two hours, and there was a 96%
blood plasma samples as reported from an emergency reduction of H1N1 observed at six hours.
study authorized by the U.S. Department of Health and Joyce said it’s this feature that will set the Hemopurifier
Human Services (HHS). apart from its closest competitors, whether used against
“At this point we’re in discussions as to what the poten- H1NI or HIV.
tial next steps might be in terms of clinical programs with “There’s a very important mechanism of how our car-
HHS. We’re watching how H1N1 evolves and there are cer- tridge works,” he said. “It’s selective for removing the virus
tainly different opportunities in terms of getting approval and doesn’t indiscriminately remove particles in the blood
via emergency use authorization or humanitarian use. that are needed. The other factor that’s advantageous is
Should H1N1 become virulent, then we think it should be that it removes proteins that shed from virus, so we can
something seriously considered,” Aethlon’s chairman/CEO, preserve immune cells. We see the benefit in use with
Jim Joyce, told Medical Device Daily. antivirals because we think it enhances the ability for
Joyce said the tipping point for an early emergency use antivirals to work, but we also see it as immunotherapeu-
authorization of any type will be if the virus mutates. tic.”
“There are no reports of mutation yet, but you’re seeing Asahi Kasei Medical (Tokyo) has developed a similar
that the hard-hit population has been people under 25, blood filtration device called Planova filters, and the com-
which is concerning because there’s a certain portion of pany has even launched a direct-to-consumer website tout-
that population that should have a robust immune ing its benefits in chronic hepatitis treatment as approved
response. Researchers are now trying to understand how it in Japan. But Joyce points out that this device’s potential
goes from infection to death in a very short time in chil- applications are limited because it strips the blood of too
dren. Given these events, there are some initial indications many components, limiting the amount of time a patient
[that H1N1 could be mutating], but nothing solid yet.” could endure the blood cleansing.
Joyce explained that the Hemopurifier isn’t just a filtra- “But what Asahi has done is to validate the concept of a
tion device; he calls it as an adjunct and treatment enhance- treatment enhancement device and we’re looking to follow
ment device because it can be used in conjunction with along and improve on that,” he said.
common antiviral medication to rid the body of the virus. Hemopurifier employs hollow-fiber dialysis along
“The concept of enhancing the ability of a drug to be with affinity chromatography to selectively bind enve-
effective is no longer theoretical,” Joyce said. “It’s proven. lope viruses. The filtration cartridge is able to capture cir-
There’s a very strong precedent now. Not only can the culating viruses, viral proteins and toxins in an effort to
Hemopurifier enhance outcomes, it can do so dramatically.” reduce viral load so that the patient’s natural immunity
He refers to studies and subsequent data related to the can recover to effectively kill off the infection. But
Hemopurifier’s use to fight hepatitis-C (HCV), the compa- Hemopurifier can also be used in conjunction with drugs
ny’s original indication. Potential applications and related and vaccines.
studies focus on a variety of pathogens that infect the Earlier this year, Aethlon reported results of the first
blood including HIV, hemorrhagic fever and human study of Hemopurifier to treat HIV. Viral load was
cytomegalovirus. reduced by 92% in an HIV-infected individual who received
But heightened concerns over the H1N1 pandemic led to a total of 12 Hemopurifier treatments administered three
the U.S. government’s move to start testing the filter times a week over the span of one month.
against this new influenza. Joyce said Aethlon was asked to But the majority of research has been focused on HCV
ship an undisclosed number of the devices to “a research with results from various studies that demonstrate robust
institute” for testing by third-party researchers. viral load reductions.
Why all the secrecy? In addition to tackling numerous viral indications,
“As this disease has grown, there’s sensitivity to organ- Joyce pointed out that Hemopurifier could aid drug
izations that are housing the virus, especially if they’re in research because the filter isolates live viruses from the
geographically centralized areas,” Joyce said, adding that blood.
further details of the study are confidential until the HHS “Normally researchers are challenged because they
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