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  1. 1. THURSDAY, AUGUST 8, 2013 VOL. 17, NO. 152 PAGE 1 OF 10 To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5423. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at INSIDE: Don’t miss today’s MDD Extra: Orthopedics The MDD Interview Change is imminent as FDA, industry forge new relationship 1st of 2 parts By JIM STOMMEN Medical Device Daily Senior Editor Martin Browning is co-founder and president of EduQuest (Hyattstown, Maryland), a regulatory consultancy that was established in 1995 by former FDA investigators. He spent 22 years with the FDA as a local, national, and international expert investigator, and then as a special assistant to the associate commissioner for regulatory affairs. Browning also served as vice chair of the agency’s Electronic Record and Signature Working Group, which drafted the 21 CFR Part 11 regulations, and as chair of the U.S. Government ISO-9000 Committee. MDD:Howwouldyoucharacterizetherelationship between the FDA and the med-tech industry today? Medtronic’s new DBS plus sensing system implanted By AMANDA PEDERSEN Medical Device Daily Senior Staff Writer Medtronic (Minneapolis) stepped into the field of deep brain stimulation (DBS) back in 1987 when it implanted its first DBS system in a patient in France, followed by FDA approval of that system 10 years later to treat essential tremor and tremor associated with Parkinson’s disease. This week the company made another giant leap forward in the DBS space with the first implant of a new DBS plus sensing system that, for the first time, enables the sensing and recording of select brain activity while simultaneously providing targeted DBS therapy. Nowresearcherscanlearnhowthebrainrespondstothe therapy, which in turn could yield unprecedented insights that one day change the way people with neurological and psychological disorders, such as Parkinson’s disease, Report from Europe FFR challenges angiography in coronary lesion diagnosis By JOHN BROSKY Medical Device Daily European Editor PARIS — Coronary lesions may not be as scary as they appear to a cardiologist. The RIPCORD study conducted in the UK showed that after being shown a quantification of the severity of a coronary lesions, cardiologists changed the treatment plan for 26% of patients. “This is a very important study because it pulls the patient back to the diagnostic stage,” said William Wijns, the former president of the European Association for Percutaneous Coronary Interventions (EAPCI; Paris). He noted that in previous studies of fractional flow reserve (FFR), such as the landmark FAME series, patients Washington roundup Guidance for site monitoring eases hand-off to contractors By MARK McCARTY Medical Device Daily Washington Editor FDA has finalized the guidance on clinical trial site monitoring, a document intended to deal with modern capabilities for data transfer as well as the various levels of risk associated with clinical trials. The 2011 draft offered little detail on the responsibilities of the sponsor and a contract research organization when the sponsor hands off site monitoring work to the CRO, but the final document goes into substantially greater detail, including the remark that both parties “should prospectively establish a clear understanding” of their respective responsibilities in such an arrangement. The draft addresses this question by stating little See Medtronic, Page 6 See Europe, Page 8 See Washington, Page 9 See EduQuest, Page 7 CARMENTA RAISES $2M FOR PREECLAMPSIA DEVELOPMENT . . . . . . . .2 DIATHERIX ACQUIRES PATENT TO TEM-PCR FROM QIAGEN. . . . . . . . . 3
  2. 2. THURSDAY, AUGUST 8, 2013 MEDICAL DEVICE DAILY™ PAGE 2 OF 10 Financings roundup Carmenta raises $2 million for preeclampsia development A Medical Device Daily Staff Report MEDICAL DEVICE DAILY™ (ISSN# 1541-0617) is published every business day by AHC Media, 3525 Piedmont Road, Building Six, Suite 400, Atlanta, GA 30305, U.S.A. Opinions expressed are not necessarily those of this publication. Mention of products or services does not constitute endorse- ment. MEDICAL DEVICE DAILY™ is a trademark of AHC Media, a Thompson Media Group, LLC com- pany. Copyright © 2013 AHC Media. All Rights Reserved. No part of this publication may be reproduced without the written consent of AHC Media. (GST Registration Number R128870672) ATLANTA NEWSROOM: Executive Editor: Holland Johnson. Washington Editor: Mark McCarty. Staff Writers: Omar Ford, Amanda Pedersen. Senior Production Editor: Robert Kimball. BUSINESS OFFICE: Senior Director, Editorial: Donald R. Johnston. Marketing Director: Sarah Cross. E-Marketing Coordinator: Tessa Turner. Account Representatives: Matt Hertzog, Paul Marino, Greg Rouse, Chris Wiley. REPRINTS: For photocopy rights or reprints, please call Joe Rabus at (404) 262-5444 or e-mail him at To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5423. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at SUBSCRIBER INFORMATION Please call (800) 477-6307 to subscribe or if you have fax transmission problems. Outside U.S. and Canada, call (404) 262- 5423. Our customer service hours are 8:30 a.m. to 6:00 p.m. EST. EDITORIAL Holland Johnson, (404) 262-5540 Amanda Pedersen, (912) 660-2282 Omar Ford, (404) 262-5546 Mark McCarty, (703) 361-2519 Robert Kimball, (404) 262-5451 Editorial e-mail: SENIOR DIRECTOR, EDITORIAL Donald R. Johnston, (404) 262-5439 INTERNET See Financings, Page 3 Carmenta Bioscience (Palo Alto, California), a privately held medical technology company focused on maternal and fetal health, has secured more than $2 million in seed funding. Proceeds from the financing will support development and commercialization of a new, proprietary testtobetterdiagnoseandpredictpreeclampsiainpregnant women. The test is based on a technology license from Stanford University. Arising in 5-8% of pregnant mothers, preeclampsia is a leading cause of both preterm birth and maternal and fetal death. “We are pleased to count among our financial supporters several influential members of the life science venture community, the entire Carmenta management team, the Life Science Angels, as well as noted scientists and physicians dedicatedtoimprovingthelivesofmothersandtheirbabies. These funds will enable Carmenta to demonstrate clinical validity and enable a soft launch of the test,” said Matthew Cooper, Carmenta’s president/CEO. The technology was discovered by Carmenta’s co-founders, Drs. Atul Butte and Bruce Ling of Stanford University. Their research uncovered a novel combination of clinically relevant, proprietary proteinbiomarkersinserumcapableofidentifyingpregnant mothers with preeclampsia. Carmenta’s test demonstrated extremely high sensitivity and specificity in an initial trial funded by the March of Dimes and the SPARK program at Stanford School of Medicine. Camille Samuels will join the Carmenta board as a result of the financing. “Cami brings a wealth of knowledge and experience to our board. Her background makes her ideally suitedtoguideCarmentaforwardaswedevelopandprepare to commercialize our diagnostic test for preeclampsia,” said Cooper. In other financings news: • PingMD (New York), a mobile communications healthcare solutions company, said Lambda Fund IV is making an investment in PingMD’s $3 million series B-round of funding. PingMD says it is the first ever HIPAA-compliant, completely secure and free-of-charge app-based service designed to restore relationships between patients and their healthcare providers. It is helping to pave the way towards a new era of patient-centric healthcare with improved access and better overall care for patients by providing case collaboration, continuity of care and a permanent record for digital health recordkeeping. Lambda Fund’s Managing Partner Anthony Lamport said: “I am excited about PingMD’s transformational approach to intelligent communications in healthcare.” Given the growing trend of doctors spending less than 10 minutes with each of their patients, founders Gopal Chopra, MD, and Manju Chopra, MD, recognized that technology could improve the escalating healthcare issues including rising costs, slow delivery of care, patient dissatisfaction and physician fatigue. “Mobile technology should improve patient care and make the doctor’s visit more personal, productive and efficient,” said Manju Chopra. “Tech should allow patients and doctors to communicate clearly and effectively, which is why we launched PingMD.” As PingMD continues to secure additional B-round funding, co-founder Gopal Chopra has plans in the works to extend the service in 2013 to all healthcare practitioners, hospitals and healthcare companies. • Medidata Solutions (New York) reported the pricing of an offering of $250 million aggregate principal amount
  3. 3. THURSDAY, AUGUST 8, 2013 MEDICAL DEVICE DAILY™ PAGE 3 OF 10 To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5423. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at Deals roundup Diatherix acquires patent to Tem-PCR from Qiagen A Medical Device Daily Staff Report Diatherix Laboratories (Huntsville, Alabama) has acquired the patent to Tem-PCR, a diagnostic testing technology that allows for rapid identification of multiple infectious disease organisms. The acquisition from Qiagen (Venlo, the Netherlands), a provider of molecular sample and assay technologies, follows a multi-year agreement through which Diatherix licensed Tem-PCR from Qiagen. Terms of the deal were not disclosed. Diatherix operates as an independent CLIA-certified clinical laboratory providing advanced multiplex molecular diagnostic services to assist healthcare providers in the detection of infectious disease. With the patent acquisition, the company plans to expand its business model to begin manufacturing and distributing diagnostic testing products to healthcare providers for on-site use. The goal is to speed the process of diagnosing and treating infectious diseases, thereby improving outcomes and lowering costs. “We’re extremely pleased to acquire the patent to Tem-PCR,” said Dennis Grimaud, Diatherix Laboratories CEO. “Putting this diagnostic technology in the hands of providers could reduce the time to diagnosis from 24 hours to as few as six to eight hours, speeding the treatment and healing process for patients and generating savings for providers by reducing patient infection rates, decreasing the amount of time patients need to be kept in isolation, and lowering prescription drug costs.” In other dealmaking activity: • Gene by Gene (Houston), a company that makes consumer DNA testing products for ancestry and genealogy applications, said it has acquired Arpeggi (Austin, Texas), a start-up health and GE-backed company that develops solutions for genome sequencing, data management and computational analysis. The combined company will enable the acceleration of a suite of more affordable genetics testing and diagnostic services available to consumers, researchers, and healthcare providers, the company noted. Financial terms of the transaction were not disclosed. • FullCircle Registry (Shelbyville, Kentucky) reported that it is in negotiations and due diligence to buy a medical supply company located in the southern U.S. The name of the company was not disclosed. • BC Technical (West Jordan, Utah), a non-OEM medical imaging solutions provider, said it has acquired C&G Technologies (Jeffersonville, Indiana), a provider of CT solutions. The addition of C&G follows six previous medical imaging acquisitions, BC Technical said.  of its 1.00% convertible senior notes due 2018. Medidata has granted the initial purchasers a 30-day option to purchase up to an additional $37.5 million aggregate principal amount of the Notes on the same terms and conditions to cover over-allotments, if any. The offering is expected to close on August 12. The notes will be senior unsecured obligations of Medidata. Interest on the notes will be paid semi-annually at a rate of 1.00% per year, and the notes will mature on August 1, 2018, unless earlier repurchased or converted. Prior to Feb. 1, 2018, the notes will be convertible at the option of the noteholders only upon the occurrence of specified events; thereafter until maturity the notes will be convertible at the option of the noteholders at any time. Upon conversion, the notes will be settled in cash, shares of Medidata’s common stock or any combination thereof at Medidata’s option. The initial conversion rate per $1,000 principal amount of notes is equivalent to 8.6143 shares of common stock, which is equivalent to a conversion price of approximately $116.09 per share of common stock, subject to adjustment in certain circumstances. This initial conversion price represents a premium of approximately 35% relative to the last reported sale price on August 6, 2013 of Medidata’s common stock of $85.99. Medidata intends to use the net proceeds from the offering for working capital and other general corporate purposes, including to fund possible acquisitions of, or investments in, complementary businesses, products, services, technologies and capital expenditures. • CareInSyncis (Santa Clara, California) reported an investment from Samsung Venture Investment. With this investment, CareInSync says it is enhancing its evidence- based care coordination solution with industry-leading secure mobile communications technology and expanding its mobile offering to the Android platform. CareInSync’s flagship product, Carebook, is an HIPAA-compliant, mobile-care coordination platform connecting physicians, case managers, nurses, and other aftercare professionals in real-time to deliver patient-centered collaborative care. Carebook creates dynamic care teams based on patient needs and tracks changes to the team across patient care transitions. Using Carebook, care team members can securely communicate across the team to collaborate on risk assessments and evidence-based transition plans. Carebook combines HIPAA-compliant secure messaging with patient-centered evidence-based collaboration across a multidisciplinary team. CareInSync offers software solutions that improve communication between disparate healthcare providers via a real-time, mobile, collaboration platform. Samsung Venture Investment manages investment and investment- related activities for Samsung affiliate companies.  Financings Continued from Page 2
  4. 4. THURSDAY, AUGUST 8, 2013 MEDICAL DEVICE DAILY™ PAGE 4 OF 10 To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5423. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at Agreements/contracts Idant to handle blood banking of Stroock firm A Medical Device Daily Staff Report Idant Laboratories, a subsidiary of the medical instrumentation and biotechnology company Daxor, has received a blood banking contract from Stroock & Stroock & Lavan (all New York). The contract provides for eligible employees of Stroock & Stroock & Lavan to store their own (autologous) frozen blood for future use. Stroock & Stroock & Lavan is a national law firm providing transactional and litigation guidance to leading multinational corporations, investment banks and private equity firms in the U.S. and abroad. Stroock’s emphasis on client service and innovation has made it one of the nation’s leading law firms for over 130 years. Frozen blood stored at 150 degrees below freezing can be used for up to 10 years after collection. Blood banks store donor blood in a refrigerated state slightly above freezing. Red blood cells can be used for up to 42 days after collection. However, studies have shown that there is significant decrease of the effectiveness of the blood cells after 2 weeks of refrigerated storage. In contrast, blood frozen at super low temperatures have similar characteristics to freshly donated blood once it is thawed and processed. The freezing of blood requires special techniques to mix the blood with cryopreservatives under sterile conditions to prevent damage to the red cells. The American Medical Association has specifically stated that the safest blood is one’s own. Daxor makes the BVA-100, which is used in conjunction with Volumex, Daxor’s single use diagnostic kit. Stroock is a firm with more than 750 employees, approximately 600 of whom work at their main office at 180 Maiden Lane. In addition to their New York headquarters, Stroock has offices in Los Angeles, Miami and Washington, DC. Charles Moerdler, a senior partner of Stroock, Stroock & Lavan said: “My own experience, and that of my wife, demonstrate how vitally important personal blood storage can be in time of need.” In other agreements/contracts news: • Digital Angel, a maker of implantable medical device identification and radiation dose measurement technologies following its recent share exchange with VeriTeQ Acquisition (both Delray Beach, Florida), said Establishment Labs (RL; Alajuela, Costa Rica), d/b/a Motiva (Houston, Texas), is now ready to market the world’s first traceable breast implant with Q Inside, enabling a manufacturer, physician or patient to access a secure online database and retrieve implant-specific data such as serial number, manufacturer name, date of manufacture, lot number, volume, size, and other data. In September 2012, VeriTeQ entered into a development and supply agreement with EL, a global provider of breast implants under the Motiva Implant Matrix brand name, to build next-generation breast implants that contain VeriTeQ’s Unique Device Identifier called Q Inside. “With our FDA cleared Q Inside technology, we believe we offer the only solution of its kind that is currently available to meet the FDA’s Proposed Rule for the unique device identification of implantable medical devices,” said Scott Silverman, chairman/CEO of Digital Angel. “We are very pleased to work with EL, an innovative company with a forward-thinking management team on the cutting edge of healthcare technology.” VeriTeQ’s Q Inside, a passive radio frequency identification (RFID) microchip, enables implantable medical devices to be quickly and safely identified from outside the body. Q Inside is a direct marking technology that provides Automatic Identification and Data Capture technology as required for implantable medical devices under the FDA’s Proposed Rule for UDI. Digital Angel, through its VeriTeQ wholly-owned subsidiary, makes RFID technologies for implantable medical device identification, and dosimeter technologies for use in radiation therapy treatment. Establishment Labs is a privately held, global breast, body and facial aesthetic company. • The Premier (Charlotte, North Carolina) healthcare alliance has awarded new agreements for brachytherapy seeds to Best Medical International (Springfield, Virginia); Bard Medical Division, C. R. Bard (New Providence, New Jersey); and Oncura (Arlington Heights, Illinois). Premier operates a purchasing network and maintains clinical, financial and outcomes databases.  • ERT (Philadelphia) has named James Corrigan as executive VP and chief operating officer. Corrigan joins ERT from General Electric where he spent more than 25 years in senior management roles, most recently as the CEO of its surgery business. ERT is a solution provider for high-quality patient safety and efficacy endpoint data collection. People in the NewsPeople in the News MDD is on Twitter! Stay Connected. Follow Us on Twitter!
  5. 5. THURSDAY, AUGUST 8, 2013 MEDICAL DEVICE DAILY™ PAGE 5 OF 10 To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5423. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at Cook back to shipping Zilver stent after recall A Medical Device Daily Staff Report Cook Medical (Bloomington, Indiana) said it is again shipping its Zilver PTX Drug-Eluting Peripheral Stent to medical centers in the U.S., Japan, Europe and other major markets.Theshipmentsfollowabriefperiodofunavailability due to a voluntary recall by Cook related to an issue with the stent’s delivery catheter that has been resolved. “This is great news for physicians treating peripheral artery disease in the superficial femoral artery because it means the only drug-eluting stent approved to treat this condition is available again in the U.S., Japan, Europe and other key markets,” said Rob Lyles, VP and global leader of Cook’s Peripheral Intervention clinical division. “Clinical trials have shown that compared to bare metal stents, Zilver PTX provides longer-lasting results and cuts the need for repeat procedures in half.” In 2009, Zilver PTX became the first drug-eluting peripheral stent in the world approved for peripheral artery disease (PAD) in the superficial femoral artery (SFA) when it was introduced to European physicians following CE mark approval (Medical Device Daily, Aug. 12, 2009). The device, which received a unanimous recommendation for approval from the circulatory device review panel of the FDA, was approved for U.S. sale in November 2012 (MDD, Nov. 16, 2012). Tens of thousands of PAD patients in Europe, the U.S., Japan and more than 50 other markets around the world have been treated with the Zilver PTX stent. Cook’s device features a self-expanding stent of shape memory nitinol coated with the anti-cell proliferation drug paclitaxel. In more than three years of clinical study compared to bare metal stents, Zilver PTX has been shown to have a proven drug effect, reduced reintervention rates, and longer- lasting vessel patency. The Lancet reported last week that PAD has reached epidemic levels in the developed world, with 38 million new cases reported in the last 10 years. “More than ever, doctors need the best tools possible to treat this disease,” Lyles noted. “As the only company to produce drug eluting stent technology for PAD in the SFA, we’re proud to help address that urgent need.” The device is being shipped, Lyles added, following regulatory approvals of the steps Cook has taken to address the issue of catheter tip separation that prompted Cook’s voluntary recall. Product BriefsProduct Briefs • Affymetrix (Santa Clara, California) reported the launch of the new OncoScan FFPE Assay Kit, a whole- genome copy number assay for highly degraded FFPE solid tumor samples, at the Cancer Cytogenomics Microarray Consortium conference being held in Chicago this week. Despite the growing need of cancer researchers and clinicians, obtaining high-quality, whole-genome copy number data from degraded FFPE-derived tumor DNA has remained extremely challenging due to the limitations of current methods such as FISH, array CGH, and next- generation sequencing technologies. The new OncoScan FFPE Assay Kit, using Affymetrix’ unique Molecular Inversion Probe (MIP) technology, is capable of analyzing small amounts of highly degraded DNA from FFPE samples quickly and affordably, providing a significant step forward in solid tumor cancer analysis. • Royal Philips Electronics (Amsterdam, the Netherlands) reported FDA clearance for its Pinnacle Proton treatment planning system in the U.S. Philips’ Pinnacle is a treatment planning system for external beam radiotherapy, whichprovidesaccuracyandreliabilitytousersindependent of the treatment delivery system. The Proton module is integrated into the Pinnacle planning environment and continues to offer personalized user experience. Designed through extensive clinical collaboration with current proton treatment centers, the Pinnacle proton module addresses some of the major challenges faced within proton planning today. The combination of specially designed tools and the seamless integration within Pinnacle provides an extensive range of functionalities that include composite proton- photon planning, fast commissioning, and automated contouring and re-planning. These features offer clinicians the chance to select the appropriate treatment options for the patient and do the work quickly through improved workflow. • Sonitus Medical (San Mateo, California) A new study in The Laryngoscope shows SoundBite offers advantages over traditional surgically-implanted devices for patients with Single-Sided Deafness. The study, “The SoundBite Hearing System: Patient-Assessed Safety and Benefit Study,” reports the experience of thirty-four patients who wore SoundBite regularly for six months. At the end of the trial period, patients completed a self-assessment and a standardized hearing aid benefit questionnaire. The study concludes that SoundBite offers advantages over many traditional devices in that it does not require surgical placement, and that it provides a high level of patient satisfaction over a six-month period of regular use. SoundBite transmits sound using the principle of bone conduction to restore the sensation of hearing in both ears. Unlike other devices that route sound through skull bones, SoundBite uses the patient’s teeth to transfer sound from the impaired ear to the working ear. This system removes the need for a surgical implant in the skull which eliminates the costs and complications of surgery.
  6. 6. THURSDAY, AUGUST 8, 2013 MEDICAL DEVICE DAILY™ PAGE 6 OF 10 To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5423. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at Medtronic Continued from Page 1 essential tremor, and treatment-resistant obsessive- compulsive disorder, are treated, Medtronic said. “Devastating conditions like Parkinson’s disease and obsessive-compulsive disorder take a significant toll on countless people, as well as their loved ones,” said Lothar Krinke, PhD, VP and GM of the Deep Brain Stimulation business in Medtronic’s Neuromodulation division. “Medtronic is excited to provide this new system to researchers worldwide, and we expect that their respective studies will lead to accelerated understanding of how neurological and psychological conditions develop and progress. This represents a significant milestone for DBS therapy and the long-term journey toward a closed-loop DBS system, which could personalize therapy by using device data to automatically adjust to the needs of individual patients.” The Activa PC+S DBS system delivers Medtronic DBS therapy while at the same time sensing and recording electrical activity in key areas of the brain using sensing technology and an adjustable algorithm, which enable the system to gather brain signals at various moments as selected by a physician. Initially, this new technology will be made available to a select group of physicians worldwide for use in clinical studies. These physicians will use the system to map the brain’s responses to Medtronic DBS therapy and explore applications for the therapy across a range of neurological and psychological conditions. “This enables researchers in the field to really study what we would call biomarkers, or specific brain signals associated with a disease state of a patient,” Krinke told Medical Device Daily. The Activa PC+S system, which delivers stimulation to targeted areas of the brain like existing Medtronic DBS systems, was implanted for the first time at Ludwig Maximilians University (Munich, Germany) in a person with Parkinson’s disease. This patient will be treated by a team that includes neurologist Kai Bötzel, department of neurology, Ludwig Maximilian University and neurosurgeon Jan Mehrkens, MD, head of functional neurosurgery, Ludwig Maximilian University, who implanted the system. Bötzel will be the first to use data gathered by the Activa PC+S system to gain unprecedented insight into how the brain responds to DBS therapy. “DBS therapy works for people with Parkinson’s disease and other movement disorders, but there is much to learn about how the brain responds to the therapy,” said Bötzel. “This new system will allow us to treat patients with conventional DBS therapy, while at the same time opening the door for research that was not possible until now. We hope these insights will lead to the development of effective new treatments tailored to the needs of individuals.” The Activa PC+S system received CE mark in January but is not yet approved by the FDA, the company noted. Additional implants of the Activa PC+S system, including the first implant in the U.S., is expected to take place in the coming months. DBS therapy uses a surgically implanted device, similar to a pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain. The stimulation can be programmed and adjusted non-invasively by a trained clinician to maximize symptom control and minimize side effects. More than 100,000 patients worldwide have received Medtronic DBS therapy, the company says. The ultimate goal is to be able to offer closed-loop DBS systems, Krinke said. That would make it even more like an implantable cardiac defibrillator which offers stimulation only when the patient needs it. That kind of a system could really transform the DBS field much like the implantable defibrillators transformed the cardiac rhythm management market. But for now, this system is important for research even as an open-loop system into other disease states even beyond the existing applications. “I am convinced that we will find biomarkers that help the physicians identify whether the disease is progressing or whether the patient’s medication needs to be changed,” Krinke said. “It could be a really important diagnostic tool or long-term monitoring tool for the physician, just like today in cardiology.” Medtronic received FDA approval for its first DBS system in 1997 for essential tremor and tremor associated with Parkinson’s disease. Then, in 2002, the company won FDA approval of DBS therapy for the treatment of advanced Parkinson’s, and the following year the system was used to treat patients with symptoms of primary dystonia under a humanitarian device exemption (HDE). In 2009 the device gained approval in Europe and an HDE in the U.S. for treatment-resistant obsessive-compulsive disorder, and in 2010 it was again approved in Europe for the treatment of refractory epilepsy. The same indication was approved in Australia and Canada last year.  Amanda Pedersen, 912-660-2282; Follow MDD on Twitter to keep on top of the latest med-tech updates!
  7. 7. THURSDAY, AUGUST 8, 2013 MEDICAL DEVICE DAILY™ PAGE 7 OF 10 To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5423. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at EduQuest Continued from Page 1 MARTIN BROWNING Heads Regulatory Consultancy Has it changed over the past couple of years? Browning: The change is somewhat noticeable. The FDA went from having what they would describe as a “collegial” atmosphere and encouraging that while also recognizing that they are a law enforcement agency with obligations relative to such enforcement. The agency has always been on a kind of seesaw, but right now you see the agency wanting to cooperate more with the industry, wanting to get more things done. They have to cooperate, because there is congressional pressure on the agency to work more with industry to get things done. You see that kind of tendency throughout government these days, so that’s reflected in FDA’s present attitude. MDD: It seems like much more attention is being focused today on meeting QSR requirements. What are the implications of that for both industry and the agency? Browning: One of the key things that has happened relative to the QSR requirements is that they are pretty much in line with the international ISO standards. As FDA has published more guidance and has internally changed its enforcement approaches, that’s where some of the more obvious changes have occurred. You see FDA putting more emphasis on the European style of encouraging industry to cooperate and comply, so there’s more emphasis on voluntary compliance. At the same time industry, because of the pressure being put on it internationally, is becoming more compliant with what essentially is a single set of standards. QSR isn’t quite the same as the rest of the world, but it is a similar set of standards. Because of that, the pressure is on industry, and they’re finally deciding that they don’t need to fight all these things; that they need to go ahead and comply as best they can. So there is renewed interest by industry in meeting the QSR. We’ve also seen quite a few changes by FDA in recent years to certain aspects that were contentious before – what is validation and that kind of thing. FDA actually has tempered some of its views relative to that. It has been a decade-long drift for FDA, but especially in the past couple of years they have been trying to get a better handle on recalls and encouraging industry to do things to prevent recalls. Most of those are QSR-related recalls, so FDA is looking for more cooperative mechanisms to get compliance. That fosters a better attitude on the part of industry too. If they know the agency is going to work with them a bit, industry tends to try to comply a little more. MDD: You referenced guidances, and I think that’s one thing that has stood out recently. It seems like FDA is doing a much better job of offering guidances in areas that impact that relationship. Browning:Ithinkthat’strue,butunfortunatelyalotofthe guidance they’re offering right now is more informal, where they’re simply recognizing someinternationallypublished standards or referencing people to those standards. That’s an important thing, but the problem with guidance over the past decade or so is that they said they were going to follow what is called Good Guidance Practices, but that made it almost as difficult for the agency to generate guidance documents as to generate regulations. For a few presidential administrations, they published very little in the way of meaningful guidance, but now that’s sort of breaking loose. Even though it’s not being published as formal guidance,there’salotmorerecognitionofinformalguidance and a lot more reference to existing international standards. That certainly is an obvious change. FDA is participating more broadly in standards work internationally and in harmonization activities in general. MDD: While not a “change” per se, the agency’s much broader involvement in seeing that all elements of the supply chain adhere to FDA rules and regulations is something that has brought significant change to the way OEMs and their suppliers work with one another. What does that mean in terms of staffing, training, etc.? Browning: This is an evolving activity with most of our clients, as it is with industry as a whole. What’s happening is that FDA, recognizing that there are many significant weaknesses in control of the supply chain and products coming through the supply chain, also recognizes that it doesn’t have the resources to deal with those things themselves. So they have been putting pressure on industry to deal with their own supply chain issues – to make industry perform as the enforcement tool of regulatory system compliance relative to suppliers, especially since the supply chain now goes much farther away from the OEM than it ever did before. The agency is grappling with how to deal with that; they’re so overwhelmed just with facilities that make finished devices and pharmaceuticals that they can’t deal with all those supply chain issues. So they’ve put pressure on industry to focus more on the supply chain internally. I think industry has responded fairly well, but they’re grappling with a lot of difficulties. In essence, ISO:9000, when it originally came out, and most of the other international standards as well, were designed to be supply chain standards. Problems with the supply chain were what prompted those standards to be a See EduQuest, Page 10
  8. 8. THURSDAY, AUGUST 8, 2013 MEDICAL DEVICE DAILY™ PAGE 8 OF 10 To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5423. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at Europe Continued from Page 1 were already committed to revascularization in a cath lab for the treatment of at least one coronary artery with a stent. “Here with stable patients, other forms of therapy can be considered by the cardiologist,” said Wijns. The RIPCORD study asked whether routine assessment for the diagnosis of chest pain using an FFR pressure wire would influence the management strategy for coronary artery disease (CAD) compared to the current routine assessment based on angiography alone. Where angiography provides a qualitative visual assessment, FFR provides a quantifiable measure of the pressure drop across a lesion using a sensor at the tip of a catheter. Presented by lead author Nick Curzen, MD, from the University Hospital Southampton (Southampton, UK), the RIPCORD study recruited 200 patients at 10 sites in the UK. Each patient underwent diagnostic coronary angiography carried out by one cardiologist who used the results to develop a treatment plan that considered medical treatment, PCI, and coronary artery bypass grafting (CABG), as well as a recommendation for further information. This cardiologist then left the room and each patient in the study then underwent FFR performed by a second cardiologist. The FFR results were then shown to the first cardiologist, who used them to develop a second treatment plan for the patient. The primary endpoint of the study was the difference between the two plans from the same cardiologists. Curzen reported FFR assessment led to a significant change in management 26% of patients and that in a total of 64 cases, or 32% or patients, FFR leads to a change in the judgment as to whether a coronary artery has a “significant” lesion compared to angiogram alone. “These results have potentially important implications forclinicalpractice,”heconcluded.“Managementofpatients with stable angina alone is flawed and would be improved by routine use of FFR at the diagnostic stage.” He suggested that RIPCORD provides proof of principle and that a large-scale randomized trial comparing angiography with FFR for patients with stable angina is warranted. In 2010 FFR received the highest recommendation from the European Society of Cardiology in its guidelines for treatment of myocardial infarction with a Class I recommendation supported by Level A evidence. Despite this encouragement, most patients with chest pain are assessed by angiogram alone, Curzen noted. “Angiographic assessment of chest pain is flawed because it doesn’t assess the functional significance of coronary artery disease,” he said. Cardium to distribute Excellagen in Germany Cardium Therapeutics (San Diego) has entered into a distribution agreement with Kasiak Holdings (Maharashtra,India)forthemarketingandsaleofExcellagen advanced wound care product in Germany and Switzerland. Kasiak Holdings is focused on developing stem cell-based therapeutics for the treatment of diabetic foot ulcers. Kasiak Holdings is affiliated with Kasiak Research, which is an operating unit of India-based Bharat Serums and Vaccines, that develops and manufactures specialized biological, pharmaceutical and biotechnology products. Cardium’s Excellagen is an aseptically-manufactured, quaternary fibrillar Type I bovine collagen homogenate that is configured into a staggered array of three-dimensional, triple helical, telopeptide-deleted, tropocollagen molecules. This linear array forms a flowable, biocompatible and bioactive structural matrix that can promote chemotaxis, cellular adhesion, migration and proliferation to stimulate tissue formation. The Excellagen homogenate represents a new product delivery platform that allows for the potential development of a portfolio of advanced tissue regeneration therapeutic opportunities that could include anti-infectives, antibiotics, peptides, proteins, small molecules, DNA, stem cells, differentiated cells and conditioned cell media. Excellagen is a syringe-based, professional-use, pharmaceutically-formulated 2.6% fibrillar Type I bovine collagen homogenate that functions as an acellular biological modulator to activate the wound healing process and significantly accelerate the growth of granulation tissue. Cardium says there have been important, positive findings reported by physicians using Excellagen as part of Cardium’s physician sampling, patient outreach and market “seeding” programs. In several case studies, physicians reported a rapid onset of the growth of granulation tissue in a wide array of wounds, including non-healing diabetic foot ulcers (consistent with the results of Cardium’s Matrix clinical study), as well as pressure ulcers, venous ulcers and Mohs surgical wounds. Kasiak Holding, initiated as an Indo-German Joint Venture, is developing novel biologics for regenerative medicine including stem cell based therapies for diabetic foot ulcers.  ADVERTISE HERE ...and reach high-level med-tech professionals every day! For advertising opportunities in Medical Device Daily, please contact Joe Rabus at (404) 262-5444 or
  9. 9. THURSDAY, AUGUST 8, 2013 MEDICAL DEVICE DAILY™ PAGE 9 OF 10 To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5423. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at Washington Continued from Page 1 more than that the sponsor would “retain responsibility for oversight of the work completed by the CRO(s)” that take on the task, but the Advanced Medical Technology Association (AdvaMed; Washington) asserted in a Nov. 28, 2011 comment for the docket that the association’s members “would like to strongly encourage” the agency to fill out some details. Among AdvaMed’s comments in this regard was that giving CROs a shared responsibility for the conduct of device trials would give CROs “a strong rationale to comply” with the relevant regulations. Precisely how much pressure the final guidance puts on CROs is difficult to forecast, however. FDA indicated that the onus for site compliance lies, in the final analysis, with the sponsor via the observation that sponsors “retain responsibility for oversight of the work completed by the CRO(s) that assume this responsibility.” The draft had made note of the agency’s withdrawal of a 1988 guidance on the subject (Medical Device Daily, Aug. 30, 2011), which had emphasized personal contact between the sponsor (or CRO) and site study personnel. However, FDA evinced in the 2011 draft some empathy with the notion that data are the essential thing, stating that a risk-based monitoring approach focused on “the most critical data elements” might be more appropriate in some instances than an emphasis on “routine visits to all clinical sites.” However, a data-intensive paradigm might be presumed to create a greater liability where data analysis is concerned. Statutory authority questioned for data sharing FDA’s recent proposal to disclose data from failed clinical trials, first proposed by commissioner Margaret Hamburg in a public forum in 2011, is now a formal policy proposal, but at least one life science company sees a legal question in the mix. FDA unveiled a formal proposal to this end in early June (Medical Device Daily, June 10), at which time the agency explained that such data could be made available via a Freedom of Information Act request. The proposal triggered heated dissent, including from the Washington Legal Foundation (WLF; Washington). Richard Samp, WLF’s chief counsel, told MDD at the time of the formal proposal that disclosures that allow a firm to leverage information in such a way as to reduce barriers to market entry would be tantamount to disclosure of trade secrets and hence would be illegal. Mark Duval, President of Duval & Associates (Minneapolis) had broached the question of the legality of the move as well, a point raised by the Aug. 5 letter to the docket from Novartis Pharmaceuticals (Rockville, Maryland). Gretchen Trout, chief of North American policy at Novartis, told FDA that disclosure of what has up to now been seen as confidential information “was not the genesis for section 1124” of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), the user fee legislation that also contained provisions addressing the agency’s task of fostering innovation. FDA commissioner Margaret Hamburg, MD, floated a trial balloon of sorts on the subject at the annual meeting of the Food and Drug Law Institute (FDLI; Washington) in 2011, at which time she declined to address a query from Medical Device Daily as to whether FDA was considering a policy that would allow the agency to make such disclosures without the consent of the sponsor (MDD, April 6, 2011). Trout stated that nothing in section 1124 “explicitly addresses the subject of releasing clinical and pre-clinical data from marketing applications,” saying that the agency should seek “specific legislation to authorize the release of this information” to anyone outside the agency. Trout remarks further that the Food and Drug Administration Modernization Act of 1997 permits FDA to use data from marketing applications in its review of subsequent regulatory filings, but that FDAMA applies a six-year moratorium to such uses after the date of the filing of the earlier product. The only language in FDASIA that seems to address the data disclosure proposal is found in section 1124 (a)(3), which states that FDA is tasked with identifying “regulatory and scientific gaps that impede the timely regulatory review of . . . medical products,” including “companion products.” Trout closed the Novartis letter by remarking that FDA’s pursuit of such disclosures in the interest of public health has in the past been addressed by requests to sponsors for voluntary disclosure, and that any policy of unilateral disclosure minus explicit statutory authorization would amount to the exercise of a “nebulous authority.” FDA updates device interop standards Device interoperability continues to be an imperative at FDA, which released a list of 25 standards that are new to the agency’s list of recognized standards. The formal additions should at least clarify which standards developers can refer to in device filings and cut down somewhat on queries to FDA’s Office of Device Evaluation. FDA noted in the Aug. 6 Federal Register that it has adoptedtwostandardstodealwithrolesandresponsibilities for risk management for IT networks incorporating medical devices, namely a 2010 edition of IEC 80001-1 and a similar document by ANSI/AAMI/IEC. The agency has added several standards to address the category of personal health device communication, including the first edition of ISO/IEEE 11073- 10417 for glucose monitors. The FR notice states that FDA is open to comment on the inclusion of these standards, but notes that their inclusion to the FDA roster of standards is effective upon the date of the announcement.  Mark McCarty, 703-365-2519
  10. 10. THURSDAY, AUGUST 8, 2013 MEDICAL DEVICE DAILY™ PAGE 10 OF 10 To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5423. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at mechanism for controlling suppliers. But it hasn’t helped tremendously, mainly because of the explosion of the supplychainfromarelativelysmall,controlledenvironment to one that’s totally global now. With that pressure, industry is having a few struggles. We’re finding there’s more and more contract law, more rigid agreements, and more understandings that have to be entered into. There’s also the recognition that industry is required to “trust and verify” their suppliers, where it used to be that FDA had that responsibility. So that is keeping the pressure on the industry to regulate itself, in essence. This actually is the ideal time for FDA to come out with some supplier guidance and give uniform guidance to enable suppliers to more thoroughly comply. That’s the kind of guidance they could jointly develop with industry to make it meaningful and helpful to both parties – giving FDA the assurance they need while putting more pressure on industry to clean up the supply chain themselves. (In Part 2 of this MDD Interview next week, Martin Browning discusses the problem with regulating electronic interfaces among devices, the outlook for dealing with healthcare IT, changes in regulating diagnostic tests, what’s happening in the harmonization arena, and issues pertaining to international markets.)  EduQuest Continued from Page 7 HIT roundup St. Louis Children’s selects iMDsoft’s MetaVision system A Medical Device Daily Staff Report iMDsoft (Needham, Massachusetts), a provider of anesthesia information management systems, reported that St. Louis Children’s Hospital has implemented MetaVision in 114 beds across its perioperative environment. St. Louis Children’s is a 258 bed hospital that provides a full range of pediatric services to the St. Louis metropolitan area and a primary service region covering six states. The MetaVision Anesthesia Information Management Systemsupportstheworkflowanddocumentationprocesses throughout the entire anesthesia process and beyond, from pre-op, through intra-op and into recovery. It has powerful clinical decision support tools that improve patient care and adherence to internal protocols and regulatory guidelines. The system generates an accurate, billable anesthesia record including accurate tracking of events, medications and procedures. Billable events are captured, which helps maximize accuracy of both professional and facility charges. “It is always gratifying when existing clients choose MetaVision for additional sites, testifying to their satisfaction,” said David Sides, CEO of iMDsoft. “We feel confident that St. Louis Children’s Hospital will realize positive clinical outcomes, as well as financial gains in the areas of pay-per-performance initiatives, billing, and operations.” In other HIT activity, GenomeDx Biosciences (Pleasanton, California), a genomic testing company, said it replaced its document management system with Veeva Systems’ (San Francisco) Vault QualityDocs, a cloud-based content solution developed specifically for life sciences organizations. GenomeDx said that one of the key reasons it chose Vault QualityDocs is for its ability to track and review a document through all stages of its lifecycle – with notes, edits, annotations, and more – from anywhere without downloading it.  Grants roundup NIH gives start-up Aradigm boost for GERD research A Medical Device Daily Staff Report The National Heart, Lung, and Blood Institute, National Institutes of Health (NIH), awarded Aradigm (Hayward, California) a Small Business Initiative Research (SBIR) grant to investigate the development and validation of tests for gastro-esophageal reflux with aspirations into the respiratory tract. The principal investigators and co- inventors of the new diagnostic tests are Homer Boushey, University of California, San Francisco (UCSF) and Igor Gonda, Aradigm. The grant of around $260,000 is funding laboratory work and a human clinical trial to be conducted at UCSF. Aspiration of gastric contents into the respiratory tract causes significant morbidity and mortality and is accepted as the key initiating event for aspiration pneumonitis – a form of acutelunginjurycausedbytheacidityofthegastriccontents, and aspiration pneumonia – the consequence of the growth ofpathogenicbacteriacontainedintheoropharynxaspirated into the tracheobronchial tree. When subclinical events of gastric aspiration occur, it is described as “silent aspiration” or “microaspiration.” Chronic, recurrent microaspirations have been implicated in the pathogenesis and worsening of many severe chronic pulmonary diseases of unknown origin, such idiopathic pulmonary fibrosis, bronchiolitis obliterans after lung transplantation, pulmonary disease in conditions associated with esophageal dysfunction and delayed gastric emptying such as cystic fibrosis and scleroderma, and the very common conditions of community acquired pneumonia in the elderly, asthma and COPD. Aradigm is an emerging company focused on the development and commercialization of a portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases. 
  11. 11. Keeping you up to date on recent developments in orthopedics Pain of artificial legs could be eased by real-time monitoring . . . When Ron Bailey lost his right leg below the knee 10 years ago after a head-on collision, he was fitted with a prosthetic leg and began learn- ing to use it in his daily life as a real estate agent in Federal Way, Washington. For a couple of years after the amputation, Bailey, 66, said the remaining part of his leg shrank, which is common after the surgery. This caused him discomfort in the socket, the connection point of his limb to the prosthesis. To make it comfortable enough to wear, Bailey swapped out sockets of different sizes and used fabric pieces called socks to cushion the impact and adjust the fit. “In the end, the socket is the most important part,” Bailey said. “You can have a great prosthetic foot, but if the socket isn’t comfortable, you’re not going to wear it.” Many people who use prostheses experience pain on a daily basis where their skin meets the socket, particularly those who have diabetes or other diseases that affect their physiology. University of Washington (Seattle) engineers aim to ease this discomfort with research that could help build better sockets. They have developed a device that tracks how much a person’s limb swells and shrinks when inside a prosthetic socket. The data could help doctors and patients predict how and when their limbs will swell, which could be used to build smarter sockets.“This provides us a window into what’s happening,” said principal investigator Joan Sanders, a UW professor of bioengineering. “I’m really encouraged by what we have so far.” This is the portable device that tracks fluid volume changes. The electrodes, at right, are fastened to a patient’s leg and transmit data to the device Credit: Joan Sanders, U of Wash. Soft tissues in a prosthesis socket swell and shrink often during the day. This is a natural fluctuation that happens when we increase physical activity, sit or stand and even eat salty foods. But in a fixed socket, these fluid volume changes can be particularly painful, forcing people to seek relief by removing their artificial limb or adjusting the snugness of the fit by adding or removing fabric socks. If physicians can track when an individual typically experiences volume changes in his or her prosthesis socket, they can better fit patients with artificial limbs and reduce the amount of pain, said Kate Allyn, the team’s lead research prosthe- tist who has worked for years making and fitting artificial limbs to patients.The device measures the percent increase or decrease of fluid volume in a patient’s limb by receiving data from small electrodes placed in different spots on the leg. Instrument electronics can be worn in a fanny pack and include a circuit board that calculates the fluid volume change in the leg tissues, transmitting the data wirelessly to a computer or storing it on the device. Over the past two years, engi- neers tested a larger prototype on about 60 patients in their Seattle lab. Now they have a checkbook-sized portable version that they have brought to clinics in Seattle and San Francisco. Researchers are testing the device by asking patients to go through a routine that includes sitting, standing and walking as the device records fluid changes. In the UW lab, Bailey does a series of 90-second exercises while wearing the portable device. Data is transmitted wirelessly to a tablet that displays the changes in his limb size about 15 times a second. Longer term, researchers want to build a smaller device that patients could wear for a couple of weeks or longer to monitor changes in their limb size as they go about their daily routines. The hope is that prosthetic limb sockets will become more robust and flexible, accommodating natural changes in swelling without causing discomfort or inconvenience. Fracture risk predicted by quality of bone as well as bone density . . . In a study carried out at the University of Eastern Finland, bone histomorphometry and infrared spectroscopy revealed abnormal bone properties in children with vertebral fractures and in children after solid organ transplantation. Bone compositional changes in children with vertebral fractures and after different types of organ transplantation have not been reported previously. Bone samples were investigated using bone histomorphometry, a microscopic method that provides informa- tion about bone metabolism and remodelling. In children with vertebral fractures, there were changes in bone composi- tion, such as lower carbonate-to-phosphate-ratio and increased collagen maturity, which could explain the increased fracture risk. The results also suggest that in children who have undergone kidney, liver or heart transplantation, the vari- ous changes related to bone microarchitecture and turnover may be more important predictors of fracture risk than low- ered bone mineral density alone. Early detection of such changes in bone quality could help prevent fractures. Osteoporo- sis is the most common metabolic bone disease characterized by abnormal bone formation and resorption which lead to increased risk of bone fractures. However, the present diagnostics based on the measurement of bone mineral density predict fractures only moderately. In addition to decreased bone mineral density, changes in bone quality could explain increased fragility related to osteoporosis. The present study confirmed that bone histomorphometry is needed in clinical MDD’s Ortho Extra THURSDAY, AUGUST 8, 2013 PAGE 1 OF 2 AD D I T I O N A L DE V E L O P M E N T S I N ON E O F ME D -T E C H ’ S K E Y SE C T O R S To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5423. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  12. 12. THURSDAY, AUGUST 8, 2013 MDD’S ORTHO EXTRA PAGE 2 OF 2 To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5423. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at practice to study remodelling balance in bone in certain patient groups. “Especially in clinically challenging scenarios where different treatment options are being considered, bone histomorphometry provides valuable information. An accu- rate diagnosis and choice of medication are especially important when treating paediatric patients,” says Inari Tamminen, MD, whose doctoral thesis on the topic was published in June. The findings were originally published in the Journal of Bone and Mineral Research and the Journal of Bone and Mineral Metabolism. The histomorphometry laboratory at the University of Eastern Finland in Kuopio is one of the few in the world analyzing clinical bone biopsies. More than 70 patient samples are analyzed annually. Over 30 years of expertise in quantitative histomorphometry have formed a solid basis for high quality research. Recent projects focus on paediatric patients with osteoporosis, genetic disorders and insufficiency frac- tures. McMaster researchers find home of best stem cells for bone marrow trans- plants . . . McMaster University (Hamilton, Ontario) researchers have revealed the location of human blood stem cells that may improve bone marrow transplants. The best stem cells are at the ends of the bone. It is hoped this discovery will lead to lowering the amount of bone marrow needed for a donation while increasing regeneration and lessening rejec- tion in the recipient patients, says principal investigator Mick Bhatia, professor and scientific director of the McMaster Stem Cell and Cancer Research Institute. In a paper published online by the journal Cell Stem Cell, his team reports that human stem cells (HSC) residing in the end (trabecular region) of the bones display the highest regenerative ability of the blood and immune system. “Like the best professional hockey players, our findings indicate blood stem cells are not all equal,” said Bhatia. “We now reveal the reason why – it’s not the players themselves, but the effect the arena has on them that makes them the highest scorers.” Bone marrow transplants have been done for more than 50 years and are routine in most hospitals, providing a life saving treatment for cancer and other diseases including leukemia, anemia, and immune disor- ders. Study links vitamin D deficiency to accelerated aging of bones . . . Everyone knows that as we grow older our bones become more fragile. Now a team of U.S. and German scientists led by researchers with the U.S. Department of Energy (DOE)’s Lawrence Berkeley National Laboratory (Berkeley Lab) and the University of California Berkeley has shown that this bone-aging process can be significantly accelerated through deficiency of vita- min D – the sunshine vitamin. Vitamin D deficiency is a widespread medical condition that has been linked to the health and fracture risk of human bone on the basis of low calcium intake and reduced bone density. However, working at Berke- ley Lab’s Advanced Light ALS), a DOE national user facility, the international team demonstrated that vitamin D deficiency also reduces bone quality. “The assumption has been that the main problem with vitamin D deficiency is reduced mineral- ization for the creation of new bone mass, but we’ve shown that low levels of vitamin D also induces premature aging of existing bone,” says Robert Ritchie, who led the U.S. portion of this collaboration. Ritchie holds joint appointments with Berkeley Lab’s Materials Sciences Division and the University of California (UC) Berkeley’s Materials Science and Engineer- ing Department. “Unraveling the complexity of human bone structure may provide some insight into more effective ways to prevent or treat fractures in patients with vitamin D deficiency,” says Björn Busse, of the Department of Osteology and Biomechanics at the University Medical Center in Hamburg, Germany, who led the German portion of the team. Ritchie and Busse have reported their findings in the journal Science Translational Medicine. The paper is titled “We hypothesized that restoring the normal level of vitamin D not only corrects the imbalance of mineralized and non-mineralized bone quantities, but also initiates simultaneous multiscale alterations in bone structure that affects both the intrinsic and extrin- sic fracture mechanisms,” Ritchie says. To test this hypothesis, Busse and his German team collected samples of iliac crest bone cores from 30 participants, half of whom were deficient in vitamin D and showed early signs of osteomalacia. For this study, a normal vitamin D level was defined as a serum concentration of 20 micrograms per liter or higher. For the vitamin D deficiency group the mean serum concentration was 10 micrograms per liter. The bone samples were sent to Ritchie and his team for analysis at the ALS using Fourier Transform Infrared (FTIR) spectroscopy and X-ray computed microtomogra- phy. The FTIR spectroscopy capabilities of ALS beamlines 1.4.3 and 5.4.1 provide molecular-level chemical information, and ALS Beamline 8.3.2 provides non-destructive 3-D imaging at a resolution of approximately one micron. Ritchie and his team found that while vitamin D-deficient subjects had less overall mineralization due to a reduction of mineralized bone, underneath the new non-mineralized surfaces, the existing bone was actually more heavily mineralized, and displayed the structural characteristics – mature collagen molecules and mineral crystals – of older and more brittle bone. — Compiled by Holland Johnson, MDD Executive Editor