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Transplant
Continued from page 1
of genomic-based tests. The first test in the company’s pipeline
is a blood test to routinely monitor kidney transplant recipients,
indicating when treatment or biopsy might be required.
“It is a rare opportunity to devote all of your professional
experience and to bring all that to bear on your personal
experiences and your own health as well as thousands of people
in the same position,” Rose told Medical Device Daily.
Currently, organ transplant recipients have to undergo
frequent biopsies as part of the standard protocol to monitor
for problems like graft injury or rejection and doctors don’t
have a good way of differentiating between actionable causes
of rejection so patients are treated with a complex regimen
of immunosuppressive medications that may not be the best
therapy and put them at risk of infection and toxic side effects.
“Almost everything that can go wrong with a graft can be
addressed if you can pick it up soon enough and for me, that’s
what is perhaps most exciting [about this work],” Rose said.
Studies presented this week at the World Transplant
Congress (WTC) in San Francisco support the development of
genomic biomarker-based tests for transplant graft status.
“These studies have demonstrated the feasibility of our
approach to provide rich and objective diagnostic information,”
Rose said. “In the studies, peripheral blood gene expression
profiling demonstrated excellent potential as a non-invasive
monitoring tool that could enable differential diagnosis of graft
status in kidney and liver transplant recipients. The studies also
indicate that molecular profiling of tissue offers the potential to
help clarify ambiguous histological results.”
The company plans to provide diagnostic services through a
CLIA lab, with an initial focus on kidney transplant, and expects
to commercialize its first test early next year, Rose said.
Initially the first test would be used as an adjunct to biopsy,
letting clinicians know when a biopsy is needed to address
potential problems with a transplanted organ.
“It would be nice to have a non-invasive blood test to indicate
when you actually need a biopsy instead of just subjecting
patients to biopsy as part of a protocol,” Rose said.
One of the ongoing challenges in transplant treatment is
subclinical acute kidney rejection (SCAR), defined as histologic
rejection even though the patient’s serum creatinine readings (a
measure of kidney function) are normal. SCAR is associated with
worse long-term graft survival.
John Friedewald presented a study at WTC showing that
peripheral blood gene expression profiling can correctly classify
kidney transplant patients with SCAR, acute rejection, and
transplant excellence.
“Peripheral blood gene expression profiling potentially
provides a viable method for detecting SCAR as part of a
regular surveillance program and for monitoring effectiveness
of treatment,” said Friedewald, an associate professor of
medicine and surgery at Northwestern University’s Feinberg
School of Medicine (Chicago) and a transplant nephrologist
at Northwestern Memorial Hospital and the Kovler Organ
Transplant Center (Chicago).
Friedewald told Medical Device Daily that STAR has been
linked to chronic rejection and is sometimes a milder form of the
rejection process that can fly under the radar, and typically is
undetected by current blood tests. “It’s important to detect this
because it’s treatable,” he said.
Only one in five patients will have STAR, Friedewald said,
but because there is currently no non-invasive monitoring
method, patients are biopsied as part of protocol. That means
about 85% of biopsies are really not necessary, he said.
More research needs to be done, including a larger, multi-
center, ongoing study, funded by the National Institutes of
Health, before this test can move from bench to bedside. But
Friedewald,whoalsoisaclinicaladvisortoTransplantGenomics,
said this is an important first step.
“SCAR is a milder, possibly earlier form of rejection and it’s
very exciting to have discovered signatures based on profiling
blood that are able to diagnose that condition, but our first
test is not a test for SCAR, it’s to differentiate between acute
rejection, acute dysfunction no rejection, and stable graft,” Rose
explained. “And really the idea is that this will be used for routine
screening of all kidney transplant recipients and that any result
other than stable indicates the recipient [needs a biopsy].”
The research that Friedewald is doing with SCAR takes it
a step beyond, Rose said. “In many respects [SCAR detection]
represents the Holy Grail in this field, to detect a problem even
earlier.”
Sunil Kurian, a staff scientist at the Scripps Research
Institute (La Jolla, California) in the Department of Molecular
and Experimental Medicine, and a scientific advisor to
Transplant Genomics, also presented research this week at
WTC. In one study, Kurian and colleagues showed that gene
expression profiling has a predictive accuracy of 90% to 94% for
acute rejection, acute dysfunction no rejection, chronic allograft
nephropathy, and transplant excellence samples, when
compared to histology-documented phenotypes.
He also presented another study that validated biopsy
molecular phenotypes created with a U.S. population in an
independent cohort of significantly different racial/ethnic
backgrounds, using Brazilian kidney transplant patients for
comparison. The researchers concluded that there are strong
unifying immune mechanisms driving transplant disease and
thus international molecular diagnostics are feasible. That
finding wasn’t necessarily surprising, Kurian told MDD, but
genetic ethnic differences in relation to transplant status was
something that hadn’t been explored before.
Transplant Genomics recently obtained an exclusive license
to patent rights co-owned by the Scripps Research Institute
and Northwestern University that provide the foundation for its
clinical tests. //](https://image.slidesharecdn.com/mdd0731141-140805120537-phpapp02/85/Establishment-Labs-innovates-with-Q-Inside-Safety-Technology-insurance-policies-in-implants-5-320.jpg)
![THURSDAY, JULY 31 , 2014 MEDICAL DEVICE DAILY™ PAGE 7 OF 9
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Latin America
Continued from page 1
broke the camel’s back for many consumers. The industry
reached a level of commoditization so high that it became
difficult to guarantee the safety of the procedures. And that
was the extreme case that made clear that the industry needs a
complete disruption to adapt itself to the 21st century needs of
the consumers,” said Juan José Chacón, CEO of Establishment
Labs. “Due to many scandals, the industry entered into a kind of
dormancy in which patients’ expectations were left behind and
that created an opportunity. We are not only talking about safety
issues.”
“Much more important is to fulfill the expectations of the
patients, who are patients but feel like consumers, who are not
sick, and even those who have received a mastectomy due to a
cancer, they will continue to live and for them it is important to
get an aesthetic recovery,” said Chacón.
That’s why the company developed the silicone implants
with an intelligent chip inside. They are branded as Motiva
Implant Matrix.
“This device with the microchip is a joint development with
VeryTeQ (Delray Beach, Florida), which has FDA approval for
human use,” he said.
VeryTeQ obtained approval for the chip in 2004.
The European Union has already granted the CE mark for
the implants with the chip and they are now being delivered
to the UK, Belgium, Germany, Austria, Switzerland, Spain and
Hungary. Beyond Europe, the device is being marketed in some
Asian countries and in September it will be simultaneously
launched in Costa Rica, Panama and Chile.
“One of the most interesting cases is Japan, where breast
augmentations have shrunk 80 percent in the past 10 years. It
is a highly demanding and very meticulous market . . . we saw
that as a potential threat for the traditional industry of breast
implants and as a great opportunity for the creation of a lab
focused on the design, technology and innovation,” said Chacón.
In the U.S., the Costa Rican company is still waiting for a
green light from the FDA, a process that could last as long as
seven years.
The chip, now branded as PositiveID, was approved in 2004
as a class II device with some controls to address risks such as
adverse tissue reaction, compromised information security,
failure of the implanted transponder, failure of the electronic
scanner, electromagnetic interference, electrical hazards and
magnetic resonance imaging incompatibility.
By imbedding the chip into the implants, some of these
risks are dealt with and, at the same time, they allow for greater
safety.
“The idea is to transform these devices into intelligent
devices, to be used to connect the patient with her physician and
with the hospital and to create a link that provides quality of life
for the patient,” said Chacón.
The chip is passive. It does not emit signals or contain a
battery. It is activated though an external radiofrequency reader
adjusted to a specific broadband or through an app in the cloud
that will be available soon for use in smartphones. Patients
can use a login and password to access a database with their
information and data on the device as well as requests from the
medical facility for a follow up.
To further reassure patients, every implant is automatically
covered by a one-year insurance policy with Lloyd’s of London
(London) that covers the quality and replacement of the implant
if it is needed.
“Lloyd’s of London saw in this technology a way of cleaning
the industry and a conflictive background [of the industry] and a
way to regain the trust not only of the medical community, but
more important, of the patients themselves,” Chacón said.
“[In the past] with the disappearance of a company,
guarantees disappeared as well and patients were left alone.
With this insurance we are removing the moral hazard,” said
Chacón who remembers the case of Dow Corning (Midland, MI)
in the nineties and the recent French case. “The majority of the
PIP victims will never receive a compensation.”
At the end of the day, the company is looking to keep doctors
accountable and patients safe.
“In some countries, like in Colombia, it is very common that
patients get surgeries in which they receive different implants
from those that they requested. Sometimes they get a tester,
instead of the real implant, or they receive an implant of one
brand on one side and one of another brand on the other side.
This [new technology] gives the patient the possibility for the
very first time to verify if the doctor implanted the product that
she bought,” said Chacón. “And that empowerment is a great
change. A patient can change her physician and give access to
the new one. She has many more options than the ones that she
has had until now.” //
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- 1. THURSDAY, JULY 31 ,2014 VOLUME 18, NO. 146 To subscribe, please call Medical Device Daily’s Sales Team at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Copyright © 2014 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com MEDICAL DEVICE DAILYTM THE DAILY MEDICAL TECHNOLOGY NEWS SOURCE See Transplant, page 5 See Epic, page 6 See Latin America, page 7 See Beltway, page 8 INSIDE THERMALIN DIABETES RAISES $5.9M TO SUPPORT NEW INSULIN PRODUCTS PAGE 2 INTRINSIC GETS $4.45M FOR HEPCIDIN INDEX STUDY PAGE 3 LATIN AMERICA INSIDE THE BELTWAY WORLD TRANSPLANT CONGRESS Executive Editor Holland Johnson on one of med-tech’s key sectors Read this week’s Thursday Special ORTHOPEDICS EXTRA Epic completes Series C funding to further develop CTC assay By Omar Ford, Staff Writer Epic Sciences (San Diego), a private company that designs diagnostics to personalize and advance the treatment and management of cancer, scored a huge vote of confidence from investors this week, as it is reporting the completion of a $30 million Series C preferred stock financing. The financing included new investors RusnanoMedInvest (RMI) and Arcus Ventures, existing investors Domain Associates, Roche Venture Fund, and Pfizer Venture Investments, as well as undisclosed individual investors. “We’re excited to conclude the Series C for several reasons,” Murali Prahalad, president/CEO of Epic Sciences, told Medical Device Daily. “First, it’s a validation by a very discerning set Costa Rican company innovates with chips, insurance policies in implants By Sergio Held, Staff Writer Costa Rican Establishment Labs (Alajuela, Costa Rica) has developed a breast implant imbedded with a chip that allows patients and physicians to track them and follow up on treatments. Establishment Labs saw an opportunity at a time when the industry hit a global low following the bankruptcy of implant maker, Poly Implant Prothèse (PIP; La Seyne-sur-Mer, France), which faced an avalanche of lawsuits after a series of ruptures in its implants. “What happened with the PIP case was the straw that ACR: reports of anxiety over lung cancer screens overblown By Mark McCarty, Washington Editor The issue of anxiety over false positives in screening procedures for lung cancer resurfaced with a recent statement by the American College of Radiology (Reston, Virginia), citing a new study as evidence that those episodes of anxiety are exaggerated. The release of the study adds fuel to a debate that pulls in the Centers for Medicare & Medicaid Services (CMS), which has to decide whether to deploy a mandate for low-dose CT screening for lung cancer with Congress breathing down the agency’s neck. CMS opened a coverage analysis in February in response New biomarker tests in development to improve transplant recipient care By Amanda Pedersen, Senior Staff Writer Not every CEO can go to work every day knowing they have an opportunity to directly impact their own health as well as thousands of other patients. As a biologist, seasoned biotechnology executive, and 2011 kidney transplant recipient, Stan Rose is in the unique position to do just that. A serial entrepreneur, Rose has spent 25 years working with scientists and clinicians to create commercial value from inventions based on genome technology. Today he is president and CEO of Transplant Genomics (Brookline, Massachusetts), a company working to improve transplant outcomes through the development
- 2. THURSDAY, JULY 31 ,2014 MEDICAL DEVICE DAILY™ PAGE 2 OF 9 MEDICAL DEVICE DAILY Medical Device Daily™ (ISSN# 1541-0617) is published every business day by Thomson Reuters, 115 Perimeter Center Place, Suite 1100, Atlanta, GA 30346 U.S.A. Opinions expressed are not necessarily those of this publication. Mention of products or services does not constitute endorsement. All Rights Reserved. No part of this publication may be reproduced without the written consent of Thomson Reuters (GST Registration Number R128870672). CONTACT US medicaldevicedaily.newsdesk@medicaldevicedaily.com Donald R. Johnston, (770) 810 3118 // Holland Johnson, (770) 810-3122 // Amanda Pedersen, (912) 660-2282 // Omar Ford, (770) 810-3125 // Robert Kimball, (770) 810-3127 // Mark McCarty, (703) 361-2519 // Sarah Cross, (770) 810-3138// Penney Holland (770) 810-3047 // Tracie Webb, (770) 810- 3130 OUR NEWSROOM Holland Johnson (Executive Editor), Robert Kimball (Senior Production Editor), Mark McCarty (Washington Editor), Omar Ford & Amanda Pedersen (Staff Writers) PRACTICAL INFORMATION To subscribe, please contact Tyler Beatty toll free at (855) 260-5607 or outside the U.S. and Canada, call (646) 822-4549 or by email at tyler.beatty@ thomsonreuters.com. For ad rates and information, please contact Tyler Beatty toll free at (855) 260-5607; outside the U.S. and Canada, call (646) 822-4549 or by email at tyler.beatty@thomsonreuters.com. For photocopy rights or reprints, please contact Tyler Beatty toll free at (855) 260-5607; outside the U.S. and Canada, call (646) 822-4549 or by email at tyler.beatty@thomsonreuters.com. Send all press releases and related information to medicaldevicedaily.newsdesk@medicaldevicedaily.com. BUSINESS OFFICE Donald R. Johnston (Senior Director, Editorial), Sarah Cross (Marketing Director), Penney Holland (Web Production Manager), Tracie Webb (Customer Service Manager) DAILY M&A FINANCINGS See M&A, page 6 Thermalin Diabetes raises $5.9M to support new insulin products Staff Report Thermalin Diabetes (Cleveland) has received $5.9 million in fresh capital from private investors in the first tranche of a Series B round. The company says it is developing new types of insulin and the new funds will augment the company’s $1.5 million grant from the National Institutes of Health’s National Institute of Diabetes and Digestive and Kidney Diseases. The company also said it plans to begin studies for a highly- concentrated, rapid-acting insulin for people who need higher insulin doses to control their blood sugar. The product would allow insulin pumps to be much smaller, reducing the insulin reservoir 80%, according to the company. The infusion of cash will also support large animal studies for Thermalin-biphasic, a next-gen replacement for pre-mix insulins which doesn’t require refrigeration. Thermalin Diabetes is also in partnership with the Juvenile Diabetes Research Foundation to find a ultra-fast-acting insulin candidate to be used in an artificial pancreas. In other financing activity: EDG Partners (Atlanta), a private equity firm, reported a growth equity investment in MMIS (Portsmouth, New Hampshire), a technology company that makes compliance and collaboration software solutions for pharmaceutical and medical device companies. The investment will be used to help facilitate the continued market growth of MMIS and further enhancement of its current technology leadership position. MMIS offers a cloud-based modular platform that helps its clients to aggregate, manage, and analyze data across an enterprise. The MediSpend Global Compliance Platform, the company’s signature product, was developed by legal experts and IT specialists with healthcare compliance experience. // GTCR acquires Xifin to enhance cloud-based software and technology Staff Report Private equity firm GTCR (Chicago), reported that it has acquired Xifin (San Diego), a provider of cloud-based software and services to diagnostic service providers for an undisclosed sum.Xifin’stechnologyplatformenablesend-to-endconnectivity from patient to payor, linking together the many stakeholders in healthcare delivery and optimizing for the best business and patient outcomes. The company’s customers occupy a diverse set of industry segments, including molecular diagnostics, pain management/ toxicology, anatomic pathology, radiology, hospital outreach, medical device and clinical laboratories. Built on a secure, web services-based technology platform, Xifin’s core product is a cloud-based workflow application
- 3. THURSDAY, JULY 31 ,2014 MEDICAL DEVICE DAILY™ PAGE 3 OF 9 To subscribe, please contact Tyler Beatty toll free at (855) 260-5607; outside the U.S. and Canada at (646) 822-4549 or email at tyler.beatty@thomsonreuters.com. For customer service inquiries call (800) 336-4474; outside the U.S. and Canada call (215) 386-0100 or email medicaldevicedaily.support@thomsonreuters.com. Copyright © 2014 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com GRANTS Intrinsic Lifesciences awarded $4.45M for Hepcidin Index study Staff Report Intrinsic LifeSciences (ILS; La Jolla, California) has been awarded a $4.45 million grant from the National Institutes of Health for its phase II-B Small Business Innovation Research project titled, “Serum Hepcidin Immunoassay: Laboratory to Marketplace.” With the pre-commercialization funding, ILS will establish cGMP/ISO compliant manufacturing of the Intrinsic Hepcidin Index in vitro diagnostic, and perform a prospective clinical study at Boston Children’s Hospital under the direction of Mark Fleming, the pathologist-in-chief. The study aims to clinically validate the Hepcidin Index test for the differential diagnosis of a recently discovered genetic iron disorder, Iron refractory iron deficiency anemia (IRIDA), from other acquired forms of microcytic anemia. “We are extremely pleased that NIH has recognized the potential of the Hepcidin Index test for clinical medicine by deciding to fund our pre-commercialization efforts and clinical study,” said principal investigator Mark Westerman, CEO of ILS. “This study represents a major milestone towards generating pivotal data supporting hepcidin hormone testing in anemic patients and the commercialization of a diagnostic test using our monoclonal antibodies to hepcidin. The Hepcidin Index test is intended to enable the rapid diagnosis of IRIDA without expensive genetic testing or extensive clinical work-ups, and to guide the choice of iron therapies for patients with genetic or acquired anemias.” Hepcidin is the master regulatory hormone that controls dietary iron absorption and circulating plasma iron concentrations essential for normal blood production in the bone marrow. Abnormally low or high blood hepcidin levels are associated with debilitating genetic and chronic human disease that include iron overload diseases or iron- restricted anemias. A low hepcidin is a hallmark of hereditary hemochromatosis, a genetic iron overload disease, and paradoxically, iron deficiency and iron deficiency anemia. Abnormally high hepcidin is the key pathological factor in anemia of inflammation seen in rheumatoid arthritis, chronic infections, cancers, and CKD. High serum hepcidin levels are also implicated in discovered IRIDA. Clinical characteristics of IRIDA patients are similar to anemic pediatric and adolescent patients without the disease, and current tests for these conditions lack sufficient sensitivity for diagnosis and therapeutic choices for treatment of IRIDA. The Hepcidin Index test promises to address this unmet need. IntrinsicLifeSciencesisaprivatelyhelddiagnosticscompany that makes hepcidin diagnostic tests, iron biomarker panels, and algorithms for genetic and acquired iron and inflammatory diseases. In other grant news: • Imbed Biosciences (Madison, Wisconsin), a device company developing materials for wound healing and surgical applications, has been awarded a $1.5 million competitive Small Business Innovation Research (SBIR) phase II grant from the National Institute for Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a division of National Institutes of Health (NIH). Ankit Agarwa, founder/CEO of Imbed and the principal investigator on the grant, said, “this award supports our ongoing investment to develop unique polymeric nanofilm dressings containing silver nanoparticles. The dressing would allow closure of hard-to-heal burns and chronic wounds without infection or silver toxicity.” In phase I, the company validated the feasibility of employing these ultrathin conformal wound dressings in contaminated wounds in mice, which expedited wound closure by reducing bacterial colonization. With this funding, Imbed plans to begin testing the nanofilm dressing in pigs. “Clinical data from porcine wounds will be used to obtain regulatory clearance for human clinical trials,” said co- founder Jonathan McAnulty, who is leading porcine studies as a part of this grant in School of Veterinary Medicine at University of Wisconsin-Madison. • Home genetics startup 23andMe (Mountain View, California) has secured a $1.4 million two-year grant from the National Institutes of Health (NIH) to build survey tools and expand its gene database. With these funds from NIH, the company intends to use its stores of genetic data for various research projects. External researchers will be able to access information on thousands of diseases and traits for more than 400,000 people. The grant “enables researchers from around the world to make genetic discoveries,” Anne Wojcicki, CEO of 23andMe, said in a statement, according to Reuters. Withitsfreshfunding,23andMesaiditplanstodevelopweb- based surveys to explore new genetic associations, enhance its survey tools to collect a broader data-set, utilize whole-genome sequencing data, and provide researchers with de-identified data from its existing genetic database. // Yes, we tweet! Stay Connected. Follow Us on Twitter! www.twitter.com/meddevicesdaily
- 4. THURSDAY, JULY 31 ,2014 MEDICAL DEVICE DAILY™ PAGE 4 OF 9 To subscribe, please contact Tyler Beatty toll free at (855) 260-5607; outside the U.S. and Canada at (646) 822-4549 or email at tyler.beatty@thomsonreuters.com. For customer service inquiries call (800) 336-4474; outside the U.S. and Canada call (215) 386-0100 or email medicaldevicedaily.support@thomsonreuters.com. Copyright © 2014 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com HIT BITS WORLD IN REVIEW Zoll, Asahi gets Japanese approval for R Series device Staff Report Zoll Medical (Chelmsford, Massachusetts), a maker of medical devices and related software solutions, said its Japanese subsidiary, Asahi Kasei Zoll Medical (AZM: Tokyo), has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare to enter the Japanese market with its R Series Monitor/Defibrillator. AZM, a Zoll company established two years ago to pursue the regulatory approval, sale, and marketing of Zoll products in Japan, will begin marketing and selling the R Series in early 2015. The R Series in U.S. hospitals goes beyond defibrillation and uses a complete suite of tools to assist with the delivery of high-quality CPR, now recognized as the single most important factor driving survival from cardiac arrest. The R Series Code-Ready units are designed to assist personnelindelivering“Simple,Smart,andReady”resuscitation to every hospital department. The R Series offers rescuers a CPR Dashboard to monitor depth, rate, release, and perfusion as well as audible prompts for depth and rate. In addition a See- Thru CPR filter removes CPR artifact and enables rescuers to see the underlying rhythm, reducing the duration of pauses. Because less than 25% of in-hospital patients in cardiac arrest have shockable rhythms, the ability to deliver high-quality CPR is critical to survival. The Asahi Kasei Group is a diversified group of companies led by holding company with operations in the chemicals and fibers, homes and construction materials, electronics, and healthcare business sectors. Masimo releases Radius-7 after European study Masimo (Irvine, California) reported CE mark and limited market release of Radius-7 for the Root patient monitoring and connectivity platform, the first and only wearable, wireless monitor with Masimo’s rainbow SET technology, enabling early identification of clinical deterioration while offering patients continuous monitoring with freedom of movement. With rainbow SET noninvasive measurements, Radius-7 with Root can alert clinicians – at the bedside or remotely, through the Masimo Patient SafetyNet remote monitoring and notification system – of critical changes in a patient’s oxygen saturation, pulse rate, respiration rate, or haemoglobin that may indicate pulmonary, cardiac, or internal bleeding problems. Lightweight at only 155g (0.34 lbs), the Radius-7 attaches to the patient’s arm or can be placed alongside the patient in their bed, allowing untethered monitoring while they are in bed or out. With no need to disconnect and reconnect the cable to get out of bed, the Radius-7 reduces the need for nursing assistance. Studies have shown that patient mobility is a key factor in more rapid patient recovery. “With this new technology we have made another important step to improve patient safety,” said Caroline Stade, chief nursing officer at University Children’s Hospital Basel in Basel, Switzerland. “Children can be cared for and move about as they are able, while remaining under seamless, clinical surveillance. This makes parents, and of course, nurses and clinicians, feel better about the quality of care offered to our pediatric patients.” // ZocDoc brings free online service to Minneapolis Staff Report ZocDoc (New York), a free online service and app used by more than five million patients each month, has arrived in the Minneapolis and Saint Paul areas, delivering what it calls faster access to quality medical care. With ZocDoc, patients can search for nearby, in-network doctors, read verified reviews and health content, see doctors’ availability in real time, and book appointments online. While the average wait to see a physician is over 18 days, the typical ZocDoc patient sees a doctor in under 24 hours, according to the company. ZocDoc says it will help Minnesota patients receive faster care by revealing the hidden supply of doctor appointments (including many last-minute cancellations) and making them instantly available online. To use this free service, patients visit the ZocDoc website (www.zocdoc.com) or the free ZocDoc mobile app for iPhone or Android and enter their location, insurance, and the type of doctor they would like to see. They can also search by additional criteria, such as gender and languages spoken. ZocDoc then shows local physicians’ real-time availability, qualifications, photos, and verified patient reviews to help patients choose the medical provider who best fits their needs. Patients select an available appointment time and click to book that appointment. In other HIT news: McKesson (Atlanta) reported the release of The Library, a single point-of-access for supply chain item information within McKesson Strategic Supply Sourcing. The Library enhances Strategic Supply Sourcing, allowing organizationstoloadproductdataandsharethatcontentamong community members and enterprise colleagues, according to McKesson. The Library aggregates supplier catalog data, enabling customers to search millions of items from multiple sources with a single search. With the Strategic Supply Sourcing Solution, users can find the right item at the lowest price without perusing individual distributor catalogs or web searching. The Library also provides a secure area to house an organization’s personal product and contract information. McKesson is a healthcare services and information technology company. //
- 5. THURSDAY, JULY 31 ,2014 MEDICAL DEVICE DAILY™ PAGE 5 OF 9 To subscribe, please contact Tyler Beatty toll free at (855) 260-5607; outside the U.S. and Canada at (646) 822-4549 or email at tyler.beatty@thomsonreuters.com. For customer service inquiries call (800) 336-4474; outside the U.S. and Canada call (215) 386-0100 or email medicaldevicedaily.support@thomsonreuters.com. Copyright © 2014 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com Transplant Continued from page 1 of genomic-based tests. The first test in the company’s pipeline is a blood test to routinely monitor kidney transplant recipients, indicating when treatment or biopsy might be required. “It is a rare opportunity to devote all of your professional experience and to bring all that to bear on your personal experiences and your own health as well as thousands of people in the same position,” Rose told Medical Device Daily. Currently, organ transplant recipients have to undergo frequent biopsies as part of the standard protocol to monitor for problems like graft injury or rejection and doctors don’t have a good way of differentiating between actionable causes of rejection so patients are treated with a complex regimen of immunosuppressive medications that may not be the best therapy and put them at risk of infection and toxic side effects. “Almost everything that can go wrong with a graft can be addressed if you can pick it up soon enough and for me, that’s what is perhaps most exciting [about this work],” Rose said. Studies presented this week at the World Transplant Congress (WTC) in San Francisco support the development of genomic biomarker-based tests for transplant graft status. “These studies have demonstrated the feasibility of our approach to provide rich and objective diagnostic information,” Rose said. “In the studies, peripheral blood gene expression profiling demonstrated excellent potential as a non-invasive monitoring tool that could enable differential diagnosis of graft status in kidney and liver transplant recipients. The studies also indicate that molecular profiling of tissue offers the potential to help clarify ambiguous histological results.” The company plans to provide diagnostic services through a CLIA lab, with an initial focus on kidney transplant, and expects to commercialize its first test early next year, Rose said. Initially the first test would be used as an adjunct to biopsy, letting clinicians know when a biopsy is needed to address potential problems with a transplanted organ. “It would be nice to have a non-invasive blood test to indicate when you actually need a biopsy instead of just subjecting patients to biopsy as part of a protocol,” Rose said. One of the ongoing challenges in transplant treatment is subclinical acute kidney rejection (SCAR), defined as histologic rejection even though the patient’s serum creatinine readings (a measure of kidney function) are normal. SCAR is associated with worse long-term graft survival. John Friedewald presented a study at WTC showing that peripheral blood gene expression profiling can correctly classify kidney transplant patients with SCAR, acute rejection, and transplant excellence. “Peripheral blood gene expression profiling potentially provides a viable method for detecting SCAR as part of a regular surveillance program and for monitoring effectiveness of treatment,” said Friedewald, an associate professor of medicine and surgery at Northwestern University’s Feinberg School of Medicine (Chicago) and a transplant nephrologist at Northwestern Memorial Hospital and the Kovler Organ Transplant Center (Chicago). Friedewald told Medical Device Daily that STAR has been linked to chronic rejection and is sometimes a milder form of the rejection process that can fly under the radar, and typically is undetected by current blood tests. “It’s important to detect this because it’s treatable,” he said. Only one in five patients will have STAR, Friedewald said, but because there is currently no non-invasive monitoring method, patients are biopsied as part of protocol. That means about 85% of biopsies are really not necessary, he said. More research needs to be done, including a larger, multi- center, ongoing study, funded by the National Institutes of Health, before this test can move from bench to bedside. But Friedewald,whoalsoisaclinicaladvisortoTransplantGenomics, said this is an important first step. “SCAR is a milder, possibly earlier form of rejection and it’s very exciting to have discovered signatures based on profiling blood that are able to diagnose that condition, but our first test is not a test for SCAR, it’s to differentiate between acute rejection, acute dysfunction no rejection, and stable graft,” Rose explained. “And really the idea is that this will be used for routine screening of all kidney transplant recipients and that any result other than stable indicates the recipient [needs a biopsy].” The research that Friedewald is doing with SCAR takes it a step beyond, Rose said. “In many respects [SCAR detection] represents the Holy Grail in this field, to detect a problem even earlier.” Sunil Kurian, a staff scientist at the Scripps Research Institute (La Jolla, California) in the Department of Molecular and Experimental Medicine, and a scientific advisor to Transplant Genomics, also presented research this week at WTC. In one study, Kurian and colleagues showed that gene expression profiling has a predictive accuracy of 90% to 94% for acute rejection, acute dysfunction no rejection, chronic allograft nephropathy, and transplant excellence samples, when compared to histology-documented phenotypes. He also presented another study that validated biopsy molecular phenotypes created with a U.S. population in an independent cohort of significantly different racial/ethnic backgrounds, using Brazilian kidney transplant patients for comparison. The researchers concluded that there are strong unifying immune mechanisms driving transplant disease and thus international molecular diagnostics are feasible. That finding wasn’t necessarily surprising, Kurian told MDD, but genetic ethnic differences in relation to transplant status was something that hadn’t been explored before. Transplant Genomics recently obtained an exclusive license to patent rights co-owned by the Scripps Research Institute and Northwestern University that provide the foundation for its clinical tests. //
- 6. THURSDAY, JULY 31 ,2014 MEDICAL DEVICE DAILY™ PAGE 6 OF 9 To subscribe, please contact Tyler Beatty toll free at (855) 260-5607; outside the U.S. and Canada at (646) 822-4549 or email at tyler.beatty@thomsonreuters.com. For customer service inquiries call (800) 336-4474; outside the U.S. and Canada call (215) 386-0100 or email medicaldevicedaily.support@thomsonreuters.com. Copyright © 2014 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com Epic Continued from page 1 M&A Continued from page 2 of investors regarding Epic’s vision of enabling the promise of precision medicine in cancer through the detection and characterization of various cells, particularly CTC’s from a tube of blood. To us it’s an affirmation of their belief in the technology and a vote of confidence in the caliber of the team we’ve been able to assemble to execute on our goals.” Epic is developing a platform that it said will rapidly quantify the proteomic and genomic changes that occur over time during the treatment of a patient’s cancer, from a minimally invasive liquid biopsy. “The clinical utility of being able to detect and characterize circulating tumor cells has been known for more than a decade,” Prahalad said. “There have been multiple companies that have been known to develop solutions to try and do just that. What Epic has found is that just as cancer is extremely heterogeneous, so are CTCs and there are an incredible variety as to surface protein expression and the size of these cells – hence the first two historical approaches basically missed cells they should be seeing.” Prahalad added that, “our no-cell-left-behind-approach looks at all nucleic cells in a sample, and then uses cell shape and stain patterns and software algorithms to identify outliers that are likely to be cancer. We can now do this very robustly and we’re getting a tremendous amount of traction from our key opinion leaders.” EpicprovidesareportthatcanincorporateCTCenumeration, quantitative protein biomarker analysis and single-cell genomic analysis by next generation sequencing (NGS) or fluorescent in situ hybridization (FISH). The information provided by Epic’s report can be used to monitor and personalize cancer treatments at every clinical decision point. With the Series C Financing the company can push forward with the next phase of its plan. “Specifically, the funding enables us to achieve our strategic objectives of transforming the Epic technology platform into 510(k) and PMA solutions that can be readily deployed,” Prahalad told MDD. “It will allow us to conduct clinical trials to also develop some independent diagnostic tests that will aid in therapy selection, staging, and resistance monitoring. It will also help us to build out our lab operations infrastructure to meet growing book of business. Previously the company raised $13.8 million in a Series B funding round. Prahalad spoke as to how the company was able to raise significant funding for the product. “I think we’re able to earn their confidence by doing a couple of things. First, we were very keen to deliver on the milestones promised on our Series B financing. What we did was expand on the capability on our platform to include FISH analysis of CTCs. Second we were able to get tremendous key opinion leader acceptance of our platform. Thirdly we’ve systematically grown our pharma partnerships and we have proceeded to deepen those partnerships those as well,” Prahalad said. Epic’s technology was exclusively licensed from the Kuhn Lab at The Scripps Research Institute (La Jolla, California). “Epic’s technology has achieved an unprecedented level of sensitivity in detecting circulating tumor cells to develop crucial cancer diagnostics for the millions of patients who need better ways to match drugs to their disease subtype and to understand whether their treatment is working,” said Peter Kuhn, professor of biological sciences at the University of Southern California (Los Angeles) and co-founder of Epic. “In the near future, we will be able to answer the questions that doctors and patients have: what is the status of the cancer, what therapy can best treat the cancer and is that therapy working?” // designed to help clients optimize billing and collection practices, automate billing workflow and reduce regulatory compliance risk.Xifin’shealtheconomicsoptimizationplatformalsoincludes additional cloud-based applications, including a laboratory information system, physician and patient portals, enterprise class business intelligence and a physician collaboration network. By bringing together financial and clinical information and combining with advanced business intelligence, As part of the transaction, GTCR will partner with founder and CEO Lâle White and the management team at Xifin as they continue to grow and develop the company’s services and product offering. GTCR’s investment in Xifin was funded from GTCR Fund XI, a private equity fund raised in 2014 with $3.85 billion of limited partner equity capital commitments. GE Capital and CapitalSource provided financing for the transaction. Kirkland & Ellis LLP served as legal counsel to GTCR. // Advertise Here ...and reach high-level med-tech professionals every day! For advertising opportunities in Medical Device Daily, please contact Tyler Beatty at (646) 822-4549 or tyler.beatty@thomsonreuters.com
- 7. THURSDAY, JULY 31 ,2014 MEDICAL DEVICE DAILY™ PAGE 7 OF 9 To subscribe, please contact Tyler Beatty toll free at (855) 260-5607; outside the U.S. and Canada at (646) 822-4549 or email at tyler.beatty@thomsonreuters.com. For customer service inquiries call (800) 336-4474; outside the U.S. and Canada call (215) 386-0100 or email medicaldevicedaily.support@thomsonreuters.com. Copyright © 2014 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com Latin America Continued from page 1 broke the camel’s back for many consumers. The industry reached a level of commoditization so high that it became difficult to guarantee the safety of the procedures. And that was the extreme case that made clear that the industry needs a complete disruption to adapt itself to the 21st century needs of the consumers,” said Juan José Chacón, CEO of Establishment Labs. “Due to many scandals, the industry entered into a kind of dormancy in which patients’ expectations were left behind and that created an opportunity. We are not only talking about safety issues.” “Much more important is to fulfill the expectations of the patients, who are patients but feel like consumers, who are not sick, and even those who have received a mastectomy due to a cancer, they will continue to live and for them it is important to get an aesthetic recovery,” said Chacón. That’s why the company developed the silicone implants with an intelligent chip inside. They are branded as Motiva Implant Matrix. “This device with the microchip is a joint development with VeryTeQ (Delray Beach, Florida), which has FDA approval for human use,” he said. VeryTeQ obtained approval for the chip in 2004. The European Union has already granted the CE mark for the implants with the chip and they are now being delivered to the UK, Belgium, Germany, Austria, Switzerland, Spain and Hungary. Beyond Europe, the device is being marketed in some Asian countries and in September it will be simultaneously launched in Costa Rica, Panama and Chile. “One of the most interesting cases is Japan, where breast augmentations have shrunk 80 percent in the past 10 years. It is a highly demanding and very meticulous market . . . we saw that as a potential threat for the traditional industry of breast implants and as a great opportunity for the creation of a lab focused on the design, technology and innovation,” said Chacón. In the U.S., the Costa Rican company is still waiting for a green light from the FDA, a process that could last as long as seven years. The chip, now branded as PositiveID, was approved in 2004 as a class II device with some controls to address risks such as adverse tissue reaction, compromised information security, failure of the implanted transponder, failure of the electronic scanner, electromagnetic interference, electrical hazards and magnetic resonance imaging incompatibility. By imbedding the chip into the implants, some of these risks are dealt with and, at the same time, they allow for greater safety. “The idea is to transform these devices into intelligent devices, to be used to connect the patient with her physician and with the hospital and to create a link that provides quality of life for the patient,” said Chacón. The chip is passive. It does not emit signals or contain a battery. It is activated though an external radiofrequency reader adjusted to a specific broadband or through an app in the cloud that will be available soon for use in smartphones. Patients can use a login and password to access a database with their information and data on the device as well as requests from the medical facility for a follow up. To further reassure patients, every implant is automatically covered by a one-year insurance policy with Lloyd’s of London (London) that covers the quality and replacement of the implant if it is needed. “Lloyd’s of London saw in this technology a way of cleaning the industry and a conflictive background [of the industry] and a way to regain the trust not only of the medical community, but more important, of the patients themselves,” Chacón said. “[In the past] with the disappearance of a company, guarantees disappeared as well and patients were left alone. With this insurance we are removing the moral hazard,” said Chacón who remembers the case of Dow Corning (Midland, MI) in the nineties and the recent French case. “The majority of the PIP victims will never receive a compensation.” At the end of the day, the company is looking to keep doctors accountable and patients safe. “In some countries, like in Colombia, it is very common that patients get surgeries in which they receive different implants from those that they requested. Sometimes they get a tester, instead of the real implant, or they receive an implant of one brand on one side and one of another brand on the other side. This [new technology] gives the patient the possibility for the very first time to verify if the doctor implanted the product that she bought,” said Chacón. “And that empowerment is a great change. A patient can change her physician and give access to the new one. She has many more options than the ones that she has had until now.” // Is your company featured in this issue? Order a Reprint! Promote it on your website or in your investor kit! For high-quality reprints of articles about your com- pany, please contact Tyler Beatty at (646) 822-4549 or tyler.beatty@thomsonreuters.com
- 8. THURSDAY, JULY 31 ,2014 MEDICAL DEVICE DAILY™ PAGE 8 OF 9 To subscribe, please contact Tyler Beatty toll free at (855) 260-5607; outside the U.S. and Canada at (646) 822-4549 or email at tyler.beatty@thomsonreuters.com. For customer service inquiries call (800) 336-4474; outside the U.S. and Canada call (215) 386-0100 or email medicaldevicedaily.support@thomsonreuters.com. Copyright © 2014 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com Beltway Continued from page 1 to a recommendation by the U.S. Public Services Task Force that LDCT be made available for patients at risk of developing lung cancer, but an advisory hearing conducted for the analysis disclosed some misgivings about the notion, including whether thedosereductionseeninclinicaltrialscouldbereplicatedinreal- world use. Another issue widely cited by critics of the proposal is that a higher rate of screening coupled with the lower rate of specificity seen in LDCT compared to other modalities might spark anxiety in patients returning false negatives on a screening exam, which would not be dispelled until a confirmatory test can be conducted. ACR said in its July 25 statement that anxiety “regarding inconclusive cancer screening test results among some patients is real and is only natural,” but the association pointed to a study by Gareen et al, which appeared in the July 25 issue of Cancer, as evidence that the incidence and effects of anxiety associated with false positive “or other results of computed tomography . . . lung cancer screening exams are far less than claimed by some in the medical community.” Gail Rodriquez, executive director of the Medical Imaging & Technology Alliance (MITA; Arlington, Virginia) expressed similar misgivings over reports of anxiety in an interview in June around the time that members of the Senate and the House of Representatives responded to prodding by public health advocates to force CMS’s hand (Medical Device Daily, June 6, 2014). Ella Kazerooni, chair of the ACR lung screening committee, said in the association’s statement, “unsubstantiated claims of systemic and harmful patient anxiety should now be put to rest and not continue to delay implementation of CT lung cancer screening programs or Medicare coverage for these tests.” ACR said the study by Gareen “found that patients who had an abnormal finding on a lung cancer screening test did not experience more anxiety or reduced quality of life than those who were screened and found to be cancer-free.” ACR added that providers and researchers “continue to work to reduce the number of false-positive exams that patients experience,” and that physicians are striving “to ensure that patients receive results as quickly as possible.” CMS had announced in February it would wrap up the analysis and announce a final decision by February 2015. FDA posts FY ’15 user fee rates FDA posted a schedule for medical device user fees for fiscal 2015 in a July 30 announcement in the Federal Register, mapping out the fee schedule for the second year of the third device user fee agreement. Despite inflation, the line between small businesses and large businesses for the purpose of reduced fees remains at $100 million, while the $30 million threshold for fee waivers likewise holds for fiscal 2015. The full fees for a PMA are at slightly less than $251,000 for the above-$100 million set, while smaller-volume device makers will pay nearly $63,000 for a PMA. Panel-track PMA supplements will cost the applicant $188,000 and $47,043 for large and small businesses, respectively. FDA indicated that 510(k) applications will cost the applicant slightly more than $5,000 ($2,500 for smaller firms), and the agency said that the user fee base revenue amount for fiscal 2015 is projected to be $125.7 million, a sum unadjusted for inflation. The agency reminds the reader that the Medical Device User Fee Agreement III specifies that this sum is “to be further adjusted” for inflation as seen in both payroll and non- payroll costs. The agency indicated it had received full PMA fees for an average of 24 applications between fiscal 2011 and fiscal 2013, whilethesmall-businessPMAfilingsaveragedseveninthatsame time period. The agency took in full 510(k) fees for an average of 2,800 applications between FY 2011 and 2013, although a stead upward trend was in evidence, with 2013 providing the agency with nearly 3,150 full-fee applications. Small-business filings likewise trended up, peaking in 2013 at roughly 1,200 for an average of 1,075. Establishment registrations numbered more than 24,400 in fiscal 2013. CMS extends home health moratorium CMS reported July 29 an extension of its moratorium on enrollment of home health agencies in a number of metropolitan areas, including those for the cities of Chicago, Fort Lauderdale, Florida, Detroit, Dallas, Houston, and Miami. The agency added six months to the moratorium, which originated in July 2013. CMS said the moratorium, provided by the Affordable Care Act, was originally imposed to aid in the agency’s fraud control efforts, but the agency also said it reserves the right to add to the moratorium in six-month increments. Telehealth legislation debuts The U.S. House of Representatives has introduced the Medicare Telehealth Parity Act of 2014, a successor to similar legislation introduced two years ago in an effort to bolster adoption of telehealth. The target areas for this legislation is metropolitan areas of populations less than 50,000, a nod to the need for such services in underserved rural and frontier areas in the U.S. The bill would introduce Medicare coverage over four years, and provides exemptions from site fees for the areas designated by the bill’s language. Services provided by certified diabetes educators would be among the covered services, as would management services for patients with a range of other chronic conditions, including heart failure and chronic obstructive pulmonary disease. The legislation calls on the Centers for Medicare & Medicaid Services to develop a new set of diagnostic codestocovertheseservices,andtheGovernmentAccountability Office would be charged to evaluate the legislation’s effects within two years of implementation. //
- 9. THURSDAY, JULY 31 ,2014 MEDICAL DEVICE DAILY™ PAGE 9 OF 9 To subscribe, please contact Tyler Beatty toll free at (855) 260-5607; outside the U.S. and Canada at (646) 822-4549 or email at tyler.beatty@thomsonreuters.com. For customer service inquiries call (800) 336-4474; outside the U.S. and Canada call (215) 386-0100 or email medicaldevicedaily.support@thomsonreuters.com. Copyright © 2014 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com PEOPLE IN PLACES PRODUCT BRIEFS • The Senate on Tuesday approved President Barack Obama’s nominee to lead the embattled Department of Veterans Affairs. Republicans joined Democrats to approve Robert McDonald as the VA secretary. McDonald didn’t receive a single no vote. After graduating near the top of his class at West Point, McDonald spent five years in the Army, training as an airborne officer and Army Ranger and rising to the rank of captain in the 82nd Airborne Division. He spent 33 years at Procter & Gamble, managing brands like Tide and Cascade, as well as divisions in Asia, before becoming chief executive in 2009. He was deposed in 2013 by investors dissatisfied by the company’s performance. • HealthFleet (Norwalk, Connecticut) named James Boyle as chairman. Boyle was most recently president/CEO of Genworth Financial’s U.S. Life Insurance division and was formerly president/CEO of John Hancock Financial Services. HealthFleet is a platform-as-a-service provider for healthcare. • invendo medical (New York) has named Nachum (Homi) Shamir, a medical device executive, as a new member of its supervisory board. Shamir’s most recent assignment was as president/CEO at Given Imaging. invendo medical makes a single use and computer-assisted robotic colonoscopy system. • Northstar Healthcare (Houston) has named Harry Fleming as its president. Fleming has served as the company’s CFO for the last eighteen months. Northstar owns and manages seven healthcare facilities in Texas and Arizona; four ambulatory surgery centers, two MRI centers and an urgent care center. • Back in the year 2000, many occupational health nurses upgraded their spirometry equipment to hand-held or stand- alone instruments. In 2005, the American Thoracic Society revised their spirometer standards with regard to accuracy and repeatability of tests. The net effect of these developments is that many occupational health nurses are currently seeking to upgrade their now-aging spirometry equipment. Benson Medical Instruments (Minneapolis), initially known for its audiometers for hearing conservation, recently introduced the CCS-200 Spirometer, designed to deliver all of the necessary innovations most occupational health nurses are searching for. One of its features is its ability to share a database with Benson Medical Instruments audiometers and for those nurses who also conduct hearing tests, the CCS-200 Spirometer offers the opportunity to streamline data management at the testing facility. • eZono (Jeno, Germany), a company that makes tablet ultrasound systems, dedicated for procedural ultrasound, reported the release of eZGuide Adaptive Needle Recognition (eZGuide ANR). This new release is a powerful advance in magnetic detection technology. eZGuide ANR automatically calibrates the eZono 4000 systems so clinicians may use their needle of choice with eZGuide Navigation Technology. In addition, automatic on-screen needle information, ensure clinicians are fully aware of the needle trajectory and penetration capabilities, prior to starting an invasive procedure, providing the clinician with the possibility to increase the safety and efficiency for each procedure. eZono says the will upgrade all eZono 4000 users to eZGuide Adaptive Needle Recognition, free of charge, expanding the clinical utility of the eZono 4000 system. • Ion Beam Applications (IBA; Louvain-la-Neuve, Belgium), a maker of proton therapy solutions for the treatment of cancer, has received combined clearances from the FDA that will enable IBA to market-launch the Proton Therapy specific Cone Beam Computed Tomography (CBCT) solution. IBA has received clearance from the FDA for its imaging platform adaPT Insight and for the Compact Gantry Beam Line. Those combined clearances will enable the CBCT solution to be marketed in IBA’s two Proton Therapy solutions Proteus PLUS and Proteus ONE in 2014 and 2015 respectively. As a component of IBA’s Image Guided Proton Therapy solution, CBCT provides 3-D imaging for increased accuracy in patient treatment. It is fully integrated with IBA’s imaging platform adaPT Insight, to offer fast 6-D corrections of patient positioning for IBA’s Proteus PLUS and Proteus ONE proton therapy solutions. IBA’s first CBCT is at the validation phase and the first clinical use is expected for the second half of 2014. • According to Thermo Fisher Scientific (Chicago), clinical laboratories now have access to a new high-performance liquid chromatograph, mass spectrometer and LC-MS software designed and manufactured as FDA Class I devices to be components of laboratory-developed tests for analyzing patient samples. The Thermo Scientific Prelude MD HPLC uses TurboFlow technology to reduce manual sample clean-up steps and variability. The instrument features two parallel channels to enhance sample throughput, and the channels can run identical or different methods simultaneously. The Thermo Scientific Endura MD Mass Spectrometer is designed to combine usability, excellent quantitative performance, sensitivity and robustness for high-confidence LC-MS results. Thermo Scientific ClinQuan MDsoftwareiswrittentostreamlineLC-MSworkflows.Itfeatures three-tiered access to software functions with permission levels for technicians, supervisors, and directors as required by the Clinical Laboratory Improvement Amendments of 1988. MDD is on Twitter! Stay Connected. Follow Us on Twitter! www.twitter.com/meddevicesdaily
- 10. THURSDAY, JULY 31,2014 MEDICAL DEVICE DAILY™ EXTRA PAGE 1 OF 2 Keeping you up to date on recent developments in orthopedics By Holland Johnson, Executive Editor ORTHOPEDICS EXTRA Continues on next page Surgeons create ‘new’ knee cartilage from stem cells in hip Surgeons in Southampton have pioneered a new knee operation that could prevent the development of arthritis – and extend sporting careers. The procedure, which is currently being trialled at Southampton General Hospital (Southhampton, UK), involves coating damaged cartilage with stem cells, taken from a patient’s own hip, and surgical glue. Known as ABICUS – Autologous Bone Marrow Implantation of Cells University Hospital Southampton – the technique, if successful, will regenerate the remaining tissue and create a permanent, “like-for-like” replacement for the first time. Cartilage is a tough, flexible tissue that covers the surface of joints and enables bones to slide over one another while reducing friction and acting as a shock absorber. Damage to the tissue in the knee is common and occurs mainly following sudden twists or direct blows, such as falls or heavy tackles playing sports such as football and rugby, but can also develop over time through gradual wear and tear. Around 10,000 people a year in the UK suffer cartilage damage serious enough to require treatment due to pain, ‘locking’ and reduced flexibility. If left untreated, it can progress to arthritis and severely impair leg movement. Currently, the most commonly used procedure to repair the injury – microfracture – involves trimming any remaining damaged tissue and drilling holes in the bone beneath the defect via keyhole surgery to promote bleeding and scar tissue to work as a substitute. However, the technique has variable results, with studies in the U.S. suggesting the procedure offers only a short term benefit (the first 24 months after surgery), and does not lead to the formation of new cartilage. Patients who undergo the ABICUS operation have the cartilage cut and tidied and undergo microfracture, but their cartilage tissue is then coated with a substance made up of bone marrow cells, platelet gel and hyaluronic acid. During the 30-minute procedure, the bone marrow sample is spun in a centrifuge in the operating theater to give a concentrated amount of the patient’s own stem cells. These cells are then mixed with the gel and acid to create a ‘glue’ substance which is placed over the cartilage defect and allowed to set. Gorav Datta, a consultant orthopedic surgeon at Southampton General Hospital and the study’s principal investigator, said, “The development of this technique and the study we are conducting could revolutionise the treatment of common cartilage injury by creating a like-for-like, identical cartilage replacement for the first time. “So far, treatments developed to combat the long-term problems associated with cartilage damage have had varied outcomes, resulting in knee pain for many people in older age and shortened careers for many amateur and professional sports players.” The study at University Hospital Southampton NHS Foundation Trust will compare the results of 40 patients aged between 18 and 65 years, half who will undergo ABICUS and half microfracture alone. Orthopedic outcomes affected by activity level According to a literature review in the July issue of the Journal of the American Academy of Orthopaedic Surgeons (JAAOS), patients’ activity level is a strong predictor for how well they will do with certain treatments and how well they recover from injuries after treatment. Patients are encouraged to ask their orthopaedic surgeon if activity level is an important factor in their treatment decision. For example, more active patients are at a higher risk of re-injury after an anterior cruciate ligament (ACL) reconstruction, and activity level should be considered when deciding which graft to use in the ACL repair. Easily administered, standardized scales for the shoulder, hip, knee and ankle are commonly used in orthopedics to quantify a patient’s activity level. But, the measures of how often, rather than how well, a task is performed do not account for symptoms, functional disabilities, age, weight, overall health and other factors which also may impact prognostic and outcome variables. “In orthopedics, we want to restore function to take away pain and to help patients return to activity,” said orthopaedic surgeon and lead study author Robert Brophy. “We’re still learning about how to best use, quantify and measure activity levels to optimize prognostics and outcomes.” The strongest predictors for failure in rotator cuff tears were patient expectations on the efficacy of physical therapy and baseline activity level. After a rotator cuff tear, patients who were active were less likely to respond to nonsurgical treatment. Preoperative activity levels, age, male gender and lower body mass index (BMI) were predictors of higher activity level at one and five years following total hip replacement surgery. Physical activity – including occupational lifting and standing – may accelerate the development and increased risk of osteoarthritis. Higher baseline activity, lower baseline BMI and higher
- 11. THURSDAY, JULY 31 ,2014 MEDICAL DEVICE DAILY™ EXTRA PAGE 2 OF 2 ORTHOPEDICS EXTRAContinued from previous page level of athletic competition were associated with higher activity levels two years after ACL reconstruction. Female gender, smoking in the 6-month period before surgery, and revision ACL reconstruction were associated with lower activity level. Following ACL reconstruction, patients were significantly less satisfied if they had a lower post-surgical activity level. Increased incidences of knee injury and trauma in the athletic population, rather than participation in physical activity, may cause an increased risk of knee OA. “There’s not just one activity level variable” in these measurements, said Brophy. “It depends on the population, the injury you’re studying, etc. We’re making progress, and the progress varies depending on what you’re looking at.” Genetics involved with menarche may hold keys to preventing diabetes or osteoporosis A novel study shows that the age girls reach puberty is influenced by ‘imprinted genes’ – a subset of genes whose activity differs depending on which parent contributes the gene. This is the first evidence that imprinted genes can control the rate of development after birth and details of this study were published in the journal Nature. Age of the first period, known as menarche, is a marker for the timing of puberty in females. Medical evidence shows that the onset of menses varies between girls, is an inherited trait, and is linked to breast cancer, diabetes and heart disease risks. “This research is the first step in understanding the genetics involved with the onset of puberty in girls,” said Douglas Kiel, director of the musculoskeletal research center at Harvard Medical School-affiliated Hebrew SeniorLife Institute for Aging Research (IFAR; Boston). “By uncovering which genes influence menarche, we can then focus on its link to increased disease risks, such as osteoporosis or diabetes, in later life.” The findings come from an international study of more than 180,000 women involving scientists from 166 institutions around the globe. The researchers identified 123 genetic variations that were associated with the timing of when girls experienced their first menstrual cycle by analyzing the DNA of 182,416 women of European descent from 57 studies. Six of these variants were found to be clustered within imprinted regions of the genome. The activity of imprinted genes differs depending on which parent the gene is inherited from – some genes are only active when inherited from the mother, others are only active when inherited from the father. Both types of imprinted genes were identified as determining puberty timing in girls, indicating a possible biological conflict between the parents over their child’s rate of development. Further evidence for the parental imbalance in inheritance patterns was obtained by analyzing the association between these imprinted genes and timing of puberty in a study of over 35,000 women in Iceland, for whom detailed information on their family trees were available. David Karasik, an associate scientist with Hebrew SeniorLife IFAR who also was involved with the study adds, “The genetics involved in female reproductive maturation is complex. Our findings extend knowledge of genetic influences that could contribute to the development of age-related conditions including menopause and osteoporosis.” Study reveals the atomic structure of key muscle component Actin is the most abundant protein in the body, and when you look more closely at its fundamental role in life, it’s easy to see why. It is the basis of most movement in the body, and all cells and components within them have the capacity to move: muscle contracting, heart beating, blood clotting, and nerve cells communicating, among many other functions. And, movement can turn harmful when cancer cells break away from tumors to set up shop in distant tissues. Adding to the growing fundamental understanding of the machinery of muscle cells, a group of biophysicists from the Perelman School of Medicine at the Univerity of Pennsylvania describe in the journal Science – in minute detail – how actin filaments are stabilized at one of their ends to form a basic muscle structure called the sarcomere. With the help of many other proteins, actin molecules polymerize to form filaments that give rise to structures of many different shapes. The actin filaments have a polarity, with a plus and minus end, reflecting their natural tendency to gain or lose subunits when not stabilized. Actin is one of the two major proteins (together with myosin) that form the sarcomere – the contractile structures of cardiac, skeletal, and smooth muscle cells. In sarcomeres, actin filaments are stabilized at both ends by capping proteins. At the minus end of the filament, the universal capping protein is tropomodulin. “While the existence of this protein has been known for almost 30 years, we still did not know how it actually works,” said senior author Roberto Dominguez, professor of physiology. His lab is dedicated to deciphering the fundamental mechanisms of proteins responsible for movement, and how these components fit together at the atomic level. “We describe how tropomodulin interacts with the slow- growing end of actin filaments,” says coauthor Yadaiah Madasu, a postdoctoral fellow in the Dominquez lab. “From a clinical point of view, we know that mutations in tropomodulin can trigger an accumulation of irregular actin filament bundles, which contribute to nemaline myopathy or other skeletal muscle disorders typified by delayed motor development and muscle weakness.”