Page 1

THURSDAY, OCTOBER 10, 201 3

VOL. 17, NO. 196

Washington roundup

PAGE 1 OF 10

The MDD Interview

Medtronic ekes out narrow panel Benatti: ‘People need treatment win for BiV pacing via Block HF every day. We cannot stop.’ By MARK McCARTY Medical Device Daily Washington Editor Medtronic (Minneapolis) said it has scratched out a 4-3 vote at an FDA advisory panel to expand the indications for use for two of its electrophysiology devices, a piece of news that might take the edge off an otherwise difficult week for the firm. The panel’s deliberations were girded by the Block HF trial, which found its way into the literature earlier this year, but the statement indicates only an expanded indication for patients with atrioventricular (AV) block and left ventricular (LV) systolic dysfunction, and does not address other proposed expansions of indications. The company is attempting to find a place on the Supreme Court docket for the preemption case of Stengel v. Medtronic, a suit the firm lost when the Ninth Appeals Court See Washington, Page 6

Endotronix develops implantable sensor for chronic HF patients By OMAR FORD Medical Device Daily Staff Writer One start-up device firm is taking a somewhat unique approach to treating and monitoring patients who suffer from chronic heart failure. Endotronix (Peoria, Illinois) is in the process of developing the Endotronix Care Management Solution to communicate pressures that accurately measure cardiac function. The company said that the device will have a unique capability to accurately capture pulmonary artery pressure data using a convenient, mobile device. The data will be securely transmitted from the remote location to the patient’s Clinical Care Team for review and analysis. Proactive treatment enabled by this solution promises to improve quality of care and patient convenience while See Endotronix, Page 8

2nd of 2 parts By JOHN BROSKY Medical Device Daily European Editor The Managing Director for the Avitum, Italy, operations of B. Braun (Melsungen, Germany), Francesco Benatti, oversees production of two-thirds of the dialysis supply for Italy and a significant share of the European supply. In May, 2012 the facility was shaken to pieces by hundreds of tremors over 10 days and two massive earthquakes. Today B. Braun is back and bigger than ever in Mirandola, Italy. Benatti spoke with Medical Device Daily about the lessons learned from managing in a disaster. MDD: What’s it like to find your factory destroyed? Benatti: You can accept that something can happen once and you get on with things, you manage. When the second See Benatti, Page 7

The Israel Connection

China wades into Israeli innovation through academic collaboration By JONATHAN GOLDSTEIN Medical Device Daily Israel Editor In the previous article (Medical Device Daily, Oct. 9, 2013), we described a number of deals that were announced in the past two months involving Japan and Israel. While these Japanese-Israel awakenings are both welcome and long- overdue, there has been matching news on the China-Israel axis. The Chinese initiatives involve linkage between Chinese universities and top Israeli sites – Tel Aviv University, and the Haifa Technion. In mid September, Tel Aviv University signed an historic agreement with Tsinghua University (Beijing), known as one of China’s elite academies. The activity was as the result of a few years’ efforts, and was based on a Chinese See Israel, Page 9

Don’t miss today’s MDD Extra: Orthopedics

INSIDE:

LABORIE ACQUIRES UROMED’S MUSCLE REHAB BUSINESS . . . . . . . . 2 VERAX BIOMEDICAL COMPLETES $12M FUNDING ROUND . . . . . . . . . 3

To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Copyright © 2013 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.


THURSDAY, OCTOBER 10, 2013

MEDICAL DEVICE DAILY™

Deals roundup

Laborie acquires UroMed’s muscle rehab business A Medical Device Daily Staff Report Laborie Medical Technologies (Toronto), a subsidiary of the Audax Group, has completed the acquisition of UroMed Technology’s (San Ramon, California) pelvic muscle rehabilitation business. UroMed offers biofeedback and electrical stimulation medical equipment and accessories, and consumables for pelvic floor rehabilitation in the treatment of urinary and fecal incontinence. Laborie says the acquisition of UroMed expands its offering in pelvic muscle rehabilitation and in the conservative therapy sector. Laborie is a maker of medical testing equipment and consumables with exceptional brand recognition and industry-leading technologies. Laborie supplies physician offices, hospitals, and mobile providers on six continents. Young Lee, Managing Director of Audax Group, said “Laborie is a market leader in global pelvic health. We will continue to work with Brian Ellacott and the Laborie team to grow the business through organic growth opportunities and strategic add-on acquisitions.” Brian Ellacott, CEO of Laborie, said “The acquisition of UroMed is an exciting development for Laborie. In combining our product lines, we will now be able to deliver better products and services to our customers, while maintaining the standards of support that they have come to expect.” Audax Group is an investor in lower-middle market companies. In other dealmaking news: • MAKO Surgical (Fort Lauderdale, Florida) has completed the acquisition of its four-year partner Pipeline Biomedical Holdings (Cedar Knolls, New Jersey). The transaction is valued at $2.5 million plus 3,953,771 unregistered shares of MAKO stock.

PAGE 2 OF 10

Pipeline is attached with robotic assisted surgery developer MAKO Surgical since 2010. It manufactures orthopedic devices and related instruments for both robotic devices and medical procedures and has been supplying implant technologies for MAKO’s advanced robotic arm Robotic Arm Interactive Orthopedic System, or RIO, which includes Restoris PST Cup and Tapered Stem hip implant system for use with the RIO’s MAKOplasty Total Hip Arthroplasty software. The deal, to some extent, justifies the hefty 85.5% premium paid by Stryker (Kalamazoo, Michigan) for MAKO Surgical (Medical Device Daily, Oct. 3, 2013). • Alphaeon (Newport Beach, California) has acquired an exclusive U.S. license from Visiometrics (Santa Monica, California) to market the HD Analyzer for an undisclosed amount. The HD Analyzer is a device that provides ophthalmologists with an assessment of light scatter inside the eye, which is essential for early detection of the existence of a cataract, commonly referred to as Dysfunctional Lens Syndrome. “This agreement embodies Alphaeon’s commitment to provide specialty physicians with technologies that optimize patient outcomes and experiences,” said Alphaeon CEO Robert Grant. “Light scatter is an early detector of Dysfunctional Lens Syndrome, making the HD Analyzer critical to patients’ understanding of which self-pay vision correction procedure will lead to the best outcomes.” The HD Analyzer is being used by several hundred ophthalmic centers internationally, and clinical validation has been established in more than 20 peer-reviewed publications worldwide. The HD Analyzer’s Optical Scatter Index (OSI) assists in the tracking of cataract progression and is an objective measurement of what a patient actually sees. The patented technology will help ophthalmologists more precisely determine if a 40 to 60 year old patient is better See Deals, Page 5

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. Copyright © 2013. All Rights Reserved. No part of this publication may be reproduced without the written consent of Thomson Reuters. (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. Editorial e-mail: MDD.NewsDesk@medicaldevicedaily.com BUSINESS OFFICE:

Senior Director, Editorial: Donald R. Johnston. Marketing Director: Sarah Cross. E-Marketing Manager: Tessa Turner. Account Representatives: Matt Hertzog, Paul Marino, Greg Rouse, Chris Wiley.

REPRINTS:

For photocopy rights or reprints, please call Joe Rabus at (770) 810-3121 or e-mail him at joseph.rabus@thomsonreuters.com.

SUBSCRIBER INFORMATION Please call (800) 477-6307 to subscribe or if you have fax transmission problems. Outside U.S. and Canada, call (770) 8103144. Our customer service hours are 8:30 a.m. to 6:00 p.m. EST. EDITORIAL 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 SVP/GROUP PUBLISHER Donald R. Johnston, (770) 810-3118 INTERNET www.medicaldevicedaily.com

To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Copyright © 2013 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.


THURSDAY, OCTOBER 10, 2013

MEDICAL DEVICE DAILY™

Financings roundup

Verax Biomedical completes $12 million funding round A Medical Device Daily Staff Report Signaling its intent to capitalize on the opportunity for its Platelet PGD test for the detection of bacteria in platelets, Verax Biomedical (Marlborough, Massachusetts) reported that it has completed a $12 million financing that Verax says will position the company for aggressive growth in 2014. This financing will also accelerate the completion of clinical studies for an improved version of its bacterial contamination test, the company noted. Both products are designed to address a significant and potentially lethal bacterial contamination risk in transfused platelets. Verax said the additional funding will position the company to meet market demand created by increased focus by regulators, blood bankers and hospitals on the risk of bacterial contamination in platelets, the anticipated release of the company’s second product, an improved version of its Platelet PGD test, and further expansion in overseas markets. The funding round was led by the company’s current venture capital investors. It will also fuel an expansion of the company’s R&D efforts already under way with the recent move of its corporate headquarters and laboratories to a larger facility in Marlborough, Massachusetts. “We are very grateful for the on-going support of our current investors. This additional financing will permit Verax to aggressively capitalize on the opportunity present with our existing product and it sets the stage for the introduction of our improved test that will offer significant advances in performance and ease of use,” said CEO James Lousararian. Verax noted that published studies demonstrate that bacterial contamination in platelets is the greatest infectious threat to transfusion safety and that the Verax test offers a significant advance in patient safety when used to address that risk. Over 100 hospitals in the U.S. and Europe, particularly those that specialize in treating cancer, have already adopted the Verax Platelet PGD test as a safety measure for their platelet inventory, the company said. Blood centers perform culture tests for bacteria in apheresis platelets 24 hours after donation, analyze results and dispose of contaminated units. But platelets have a five-day shelf life and bacteria levels just 24 hours after donation may be too low for detection by culture. Studies show that early culture testing misses an estimated three of every four bacterially contaminated units, which are then released to hospitals for transfusion. The Verax Platelet PGD test is a rapid immunoassay that detects antigens present on the surface of bacteria. It is used at the point of care, usually a hospital transfusion service

PAGE 3 OF 10

laboratory, within 24-hours of transfusion when bacteria, if present, will be at higher levels and easier to detect. The test was cleared by the FDA in 2007 for detecting bacterial contamination in leukoreduced apheresis platelets and in 2009 for use with whole-blood derived platelets. In 2011, the FDA cleared the test as a safety measure for leukoreduced apheresis platelets. All other bacterial contamination tests for platelets currently cleared by the FDA are cleared only as quality control tests, Verax said. In other financing activity: • iScreen Vision (Memphis, Tennessee), a provider of pediatric vision screening equipment and services, said it raised $4 million in a Series B round led by MB Venture Partners. The latest round raised $2.5 million in new money and converted $1 .5 million of debt into Series B shares for a total round of $4 million. Other investors in the round included Innova, which had led the company’s Series A round and was a significant participant in the Series B round; and other new and existing private investors. iScreen Vision reported record sales in the first nine months of 2013 as an increasing number of pediatricians and commercial payers recognized the importance of instrument-based pediatric vision screening in identifying vision abnormalities earlier than traditional screening methods with an eye chart. “Our triple-digit growth rate in sales in 2013 shows that pediatricians are responding very positively to the company’s affordable entry costs, ease of use, electronic records storage, local sales and support, and analysis by trained technicians,” said CEO Buck Brown. “An increasing number of pediatricians recognize the need for earlier detection of childhood vision problems, including the most serious ones that are risk factors for amblyopia, the leading cause of vision loss in children.” Gary Stevenson, co-founder and managing partner of MB Venture Partners, joined iScreen Vision’s board of directors. The firm has been an investor in medical device and other life sciences companies since its founding in 2001. “iScreen Vision is well positioned to capture a significant share of the pediatric vision screening market with its patented cloud-based system,” Stevenson said. “We believe the company has outstanding growth prospects.” The investments from MB Ventures Partners and Innova were both from funds formed under the Tennessee Small Business Company Investment Credit Act (TNInvestco), the company noted. Proceeds from the latest financing will be used primarily to expand iScreen Vision’s sales presence domestically; to launch the company’s international sales efforts; to ramp up production to keep up with rising demand from pediatricians and non-profit vision screening programs; and to increase research and development to continue to enhance the company’s products and services. See Financings, Page 10

To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Copyright © 2013 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.


THURSDAY, OCTOBER 10, 2013

MEDICAL DEVICE DAILY™

Agreements/contracts

electroCore expands VNS platform with waveCore A Medical Device Daily Staff Report electroCore (Basking Ridge, New Jersey), said it has expanded its portfolio of vagus nerve stimulation (VNS) delivery technologies by signing a development agreement with waveCore – the maker of externally powered VNS (xVNS) technology. waveCore has agreed to pay electroCore $14 million based on development milestones. waveCore has the rights to a technology capable of transmitting both the signal and power from a transmitter outside the body to a miniature implanted vagus nerve electrode. waveCore, which initially secured the rights to the technology in May 2013, is a company owned by the founding shareholders of electroCore. waveCore, which initially secured the rights to the technology in May 2013, is a company owned by the founding shareholders of electroCore. The first milestone payment of $2 million will be paid immediately to electroCore, to achieve the first in man pilot study. Following this milestone, a second $4 million payment will be made to achieve FDA approval of pivotal study, and the final $8 million will become due when a PMA approval is granted. electroCore, a specialist in the field of electroceuticals, developed what it calls a technological breakthrough in VNS through the production of a non-invasive vagus nerve stimulation (nVNS) device that patients use to self administer their therapy. Vagus nerve stimulation has been proven to release inhibitory neurotransmitters in the nervous system, including norepinephirine, serotonin and GABA, which are believed to play a pivotal role in a wide range of conditions including headache, bronchoconstriction, epilepsy, gastric motility disorders, depression and anxiety. waveCore’s xVNS device comprises an implanted passive cuff electrode, to be placed around the vagus nerve, and a tiny receiver component. The surgical procedure to implant the device is a very simple percutaneous outpatient procedure which can be carried out under local anesthesia. The transmitter (which wirelessly powers the implanted receiver) is typically worn around the neck as a pendant, placed in a pocket, or clipped to clothing. The transmitter is programmed according to each individual patient’s need from delivering 120 seconds of VNS therapy from once a day to every five minutes. By simply removing the transmitter from the proximity of the patient, the stimulation can be immediately terminated. An acute treatment can be triggered on demand by the simple press of a button. In other agreements/contracts news: • NeuroVigil (La Jolla, California), said it will

PAGE 4 OF 10

collaborate with a number of partners in the Silicon Valley where it is opening a satellite research laboratory at NASA Research Park (Mountain View, California), to develop assistive technologies for individuals suffering from ALS and other conditions affecting the central nervous system. “We thank NASA for this wonderful opportunity and are excited to tap into the resonant energy, sense of urgency, innovation and consumer expertise of Silicon Valley and to provide talented individuals with impactful careers which contribute to the public good,” said NeuroVigil’s founder, chairman/CEO Philip Low, PhD. Based on Low’s PhD research in Computational Neuroscience which yielded a mathematical framework to convert single-channel sleep and waking encephalography (EEG) into high-resolution maps of brain activity, NeuroVigil was able to create a wireless neurotechnology platform including an ultra-light device called the iBrain for comfortable at home EEG monitoring, and sophisticated algorithms to analyze the data and extract a bank of drug and pathology biomarkers. NeuroVigil will keep its headquarters in La Jolla and will continue outreach efforts to veterans and Autism and ALS communities in Southern California. • Zimmer Spine (Minneapolis) has signed a distribution agreement for the Lateral Locking Cage (LLC), a minimally invasive lateral interbody cage. Under the terms of this long-term agreement with Frontier Medical Devices (Marquette, Michigan), Zimmer Spine will exclusively market the LLC to healthcare professionals worldwide. Implanted through a minimally invasive lateral approach with dedicated instrumentation, the LLC was designed for the treatment of degenerative disc disease and instability, including grade 1 spondylolisthesis or retrolisthesis. The LLC features a unique locking design that rigidly fastens the cage to the lumbar vertebra, and offers a variety of implant sizes to accommodate a wide range of patient anatomy and pathology. “This distribution agreement for the LLC represents Zimmer Spine’s entry into lateral access surgeries, one of the fastest growing segments of the global spine market,” said Steve Healy, President, Zimmer Spine. “The combination of the LLC and Zimmer Spine’s PathFinder NXT Minimally Invasive Pedicle Screw System provides surgeons with a complete minimally invasive approach, offering potentially faster surgeries and shorter hospital stays. For patients, that can mean less postoperative pain and a faster return to normal function.” Zimmer Spine is a specialist in spine innovation, and provides surgical solutions, training and clinical support that advance and support surgeons. Frontier Medical Devices, a maker of medical implants, specializes in partnering with large-scale medical device companies to commercialize innovative new products. ■

To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Copyright © 2013 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.


THURSDAY, OCTOBER 10, 2013

MEDICAL DEVICE DAILY™

PAGE 5 OF 10

Court report

Product Briefs • Brainlab (Munich, Germany), a software technology company specializing in neuro- and spinal surgery, reported FDA clearance to market Airo Mobile Intraoperative CT in the U.S. The FDA clearance was received by Mobius Imaging, the maker of Airo Mobile Intraoperative CT on Sept. 26. Airo gantry size and overall flexibility allow facilities to now offer high quality imaging for a comprehensive range of clinical procedures while helping overcome conventional intraoperative limitations. Airo offers the imaging quality of a diagnostic CT scanner, full Hounsfield soft tissue imaging, with a scan volume of 51.2cm x 100cm. • Illumina (San Diego) reported an advanced highthroughput screening (HTS) array format that significantly increases the number of samples that can be processed on the Infinium BeadChip family of genotyping arrays. Illumina’s Infinium assay leverages proven chemistries on a new 24-sample HTS BeadChip that supports up to 750,000 markers per sample and increases scanning capacity by up to three-fold. Illumina says its HumanOmniExpress BeadChip will be the first standard array available on the 24-sample HTS BeadChip, part of a portfolio of wholegenome genotyping arrays with new affordable pricing. This powerful array contains approximately 700,000 markers including the latest updates from the 1,000 Genomes Project strategically selected to capture the greatest amount of common SNP variation and drive the discovery of novel associations with traits and disease. It can also include up to 50,000 custom markers, making it ideal for those interested in large genotyping studies such as core labs, genome centers, and biobanks.

People in the News • Instem (Conshohocken, Pennsylvania) has named Edward Lorenti as its VP of Global Sales. Prior to joining Instem, Lorenti was sales director at Accenture (formerly Octagon Research Solutions, which they acquired in 2012) where he was responsible for their enterprise content management and submission software platform serving pharmaceutical and biotechnology organizations worldwide. Instem is a provider of IT solutions to the healthcare market. • Vexim (Toulouse, France) has named Jérôme Marzinski to the position of Deputy CEO. Marzinski will contribute to bringing Vexim into its next phase of development, reporting to the CEO, Vincent Gardès. Marzinski previously was with ev3 as international finance manager and then as Europe GM. Vexim is a medical device company specializing in the minimally-invasive treatment of vertebral fractures.

Jury awards KFx $29M in patent infringement against Arthrex A Medical Device Daily Staff Report KFx Medical (Carlsbad, California) said that a jury in the United States District Court for the Southern District of California awarded it $29 million in its patent infringement case against Arthrex (Naples, Florida). The jury found that Arthrex willfully infringed the KFx patents by promoting its SutureBridge and SpeedBridge rotator-cuff repair procedures. The jury also upheld the validity of KFx’s patents. KFx filed a complaint against Arthrex on August 1, 2011, alleging claims of induced and contributory infringement of United States Patent Number 7,585,311 (“the ‘311 Patent”), and later amended the complaint to add related patents (Medical Device Daily, Aug. 3, 2011). On August 13, KFx said that it had entered into an agreement licensing the ‘311 and related patents, which are used in knotless double row rotator cuff repair. Hundreds of thousands of arthroscopic rotator cuff repairs in the United States utilize the technique to achieve an anatomic reattachment of tendon to bone. ■

Deals

Continued from Page 2 suited for laser vision correction or lens replacement surgery. • QuadMed (Sussex, Wisconsin) and Novia CareClinics (Indianapolis) – two providers of employer-sponsored healthcare management solutions and on-site primary care – have entered into a definitive agreement whereby QuadMed will acquire all of Novia CareClinics operations and merge their executive management and operations teams accordingly. The transaction will strengthen both companies’ leadership positions in the healthcare markets they serve, enabling them to offer the best of their respective models to a wider range of employers who are seeking to improve access to quality healthcare while also reducing costs. “This acquisition is a cultural and strategic fit that supports both companies’ vision for growth,” said Tim Dickman, president of QuadMed, a subsidiary of global printer and media channel integrator Quad/Graphics. “Novia’s leadership in developing and managing onsite and shared primary care clinics for small to mid-size companies and the public sector complements QuadMed’s successful model of ground-breaking healthcare management solutions for larger companies with a national presence.” Together, QuadMed and Novia CareClinics will operate more than 90 clinic locations across 18 U.S. states and serve the needs of more than 150,000 patients. The combined company will maintain existing administrative support offices in Wisconsin as well as Indianapolis where Novia CareClinics is headquartered. ■

To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Copyright © 2013 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.


THURSDAY, OCTOBER 10, 2013

Washington

MEDICAL DEVICE DAILY™

Continued from Page 1 ruled against the firm in an en banc hearing last year. The Supreme Court declined to hear an appeal of Medtronic’s patent lawsuit with Edwards Lifesciences (Irvine, California) over their respective catheter-based aortic valve entries, although the latest court decision does not enjoin Medtronic from selling the CoreValve TAVR device (MDD, Oct. 8). The injunction question will be revisited in a lower court, however. Medtronic unveiled data from the Block HF trial at the Heart Rhythm Society (Washington) annual meeting earlier this year (Medical Device Daily, May 14, 2013), and the FDA executive summary indicated the firm was intent on expanding indications for both cardiac resynchronization therapy with pacing (CRT-P) and with defibrillation (CRT-D). Medtronic sought to expand indications for CRT-P to patients with symptomatic class III and IV heart failure refractory to medical management with a left ventricular ejection fraction of 35% or less and prolonged QRS intervals. The company also sought to expand indications for class I-III patients with atrioventricular block and an ejection fraction of no more than 50%. For CRT-D, Medtronic had filed for three expanded indications, including class III and IV patients with LVEF of 35% or less and prolonged QRS intervals, along with an indication for CRT-D in patients with left bundle branch block, a QRS duration of at least 130 milliseconds, and LVEF of no more than 30% for patients in functional class I heart failure. The Medtronic statement notes that the advisory panel had voted 4-3 that the benefits outweigh the risks when expanding the indications for both devices as a means of biventricular (BiV) pacing for patients with AV block and LV systolic dysfunction. According to Medtronic, Block HF had demonstrated a 27% relative risk reduction in a composite endpoint of “death, healthcare utilization visits requiring IV heart failure therapy, and significant increase in left ventricular end systolic volume index.” Block HF is also said to have disclosed “improvements in both cardiac function and quality of life.” One of the more interesting points in the Medtronic statement was that the panel had voted 6-1 that the data demonstrated a reasonable assurance of safety, and 7-0 that the data indicated efficacy. The statement does not explain the discrepancy between these two landslide votes and the narrow 4-3 final vote that the data gave reasonable assurance that the benefits outweigh the risks. One explanation might be that panelists were concerned about the potential for offlabel use in the post-market setting, although an expansion into class I heart failure patients might also have driven some of the reticence on the panel’s part. Medtronic noted that more than a million Americans suffer from AV block, but does not break those numbers down by heart failure class. The statement makes reference to data indicating that heart failure “will cost the United

PAGE 6 OF 10

States an estimated $32 billion in 2013, with projections showing a 120% increase in cost by 2030 for a total of $70 billion.” David Steinhaus, MD, medical director for the cardiac rhythm disease management unit at Medtronic, said, “as the longest running trial of its kind, BLOCK HF has shown superior long-term outcomes of BiV pacing for these patients.” Steinhaus also said, “as the regulatory process continues, we look forward to working with the FDA to expand the use of our CRT devices to treat this specific patient population.”

Article urges expanded bundled payments Bundled payments for heart disease are a fact of life, so the issues often revolve around the question of how to bundle payments rather than whether. According to an article appearing Sept. 23 online edition of JAMA Internal Medicine, an increase in spending after 30 days have passed since an infarct suggests a need to bundle payments beyond 30 days in an effort to stanch increases in spending on these patients. The study, authored in part by Donald Likosky, PhD, of the Dartmouth Institute (Lebanon, New Hampshire), evaluated data from patients hospitalized with acute myocardial infarcts (AMI) between 1998 and 1999, and matched those data from a similar patient population admitted in 2008. The article states that patients from the latter cohort “were older and had more comorbidities but slightly less ischemic heart disease and cerebrovascular disease.” The article points to a 19% decline in the rate of hospitalizations for AMI in 2008, but claims that expenditures per patient “increased by 16.5%” for an absolute difference of roughly $6,100. Of greater interest in the context of bundled payments, however, is the statement that nearly 26% of the riskadjusted increase in spending took place within 30 days of admission, while the balance occurred after 30 days. The authors state that the findings suggest that current bundled payment constructs “do not contain spending beyond 30 days, which accounted for most of the expenditure growth for such patients from 1998 through 1999 and 2008.” The article suggests that the data hint at a need to “extend bundled or episode-based reimbursements to periods beyond 30 days.” ■ Mark McCarty, 703-361-2519 mark.mccarty@thomsonreuters.com Access Medical Device Daily Archives Online! You have FREE access to articles dating back to 2005 — perfect for company research or for finding supporting data for presentations and reports. Go to www.MedicalDeviceDaily.com for access.

To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Copyright © 2013 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.


THURSDAY, OCTOBER 10, 2013

MEDICAL DEVICE DAILY™

Benatti

Continued from Page 1 earthquake came we were already operating, even if it was only in part of the building. There were 130 of us inside and everyone was running out. Luckily no one was injured. I sat in the parking area wondering what I should be doing next. What I could expect? Maybe in Japan or where earthquakes are more frequent, a managing director has some procedural instructions. I’m wondering if there is going to be another earthquake. The building seemed too damaged to consider working there the next day or anytime soon. We do not produce cars or washing machines. We are in the dialysis business and there are people who need a treatment every two days, three times a week, 156 times a year. We can not suddenly stop. MDD: What was the priority? Benatti: I decided we needed tents, big tents, and began making phone calls asking people to bring us something to store our products. We rented containers to be set up as offices and a base for operations. Then I started contacting suppliers outside the area struck by the earthquake to see if it was possible to relocate production temporarily. Then we had to organize the logistics, including a bus to shuttle our people there every day and bring them home in the afternoon. The main company in Germany, fortunately, was able to ship fresh product, so we had to coordinate these shipments for re-distribution to customers. After that we could assess the damage, determining what needed to be done to put things back in good working order. MDD: Why didn’t you just leave the region? Benatti: You have to think within the context of the facility. There are not wheels under the factory that we can move it from one site to another. The facility is here and you need to live with it, work with it. The idea of moving was never seriously discussed. The company, the president of the Board of B. Braun, confirmed from the first day a decision to stay and rebuild the facility as soon as possible. Engineers and architects determined 70% of facility was damaged but could be restored while 30% was destroyed, to be demolished and replaced. By July, we were already starting this reconstruction work and actually increased capacity to meet a greater demand. By September 2012 we were able to meet a goal for increased production. We finished the reconstruction with a celebration in March, 2013. The decision was actually to improve the facility itself, to do everything possible with new technologies, new methods to build a state of the art facility that can resist, anticipate events. Before May 2012 it seemed enough to have a building with a roof. Now all of us want a building designed to withstand any possibility, even flooding. To be prepared. Our mentality has changed a lot. MDD: Subcontractors are critical to your production. Have they bounced back as well? Benatti: The Italian subcontracting model was an

PAGE 7 OF 10

advantage as some of our suppliers were not located within the affected region. They helped us to keep production going. There were some located in the affected area, and they suffered from the impact. They have since organized themselves to continue production. They shifted to Francesco Benatti other areas temporarily. It taught Managing in a crisis us that the relations between a big company and smaller suppliers can help significantly. Fair and good cooperation, that’s the basis for everything. MDD: Have you reconsidered your approach to operations as well? Benatti: Considering what happened last year, we’ve learned you should never say ‘Never!’ We have now carefully evaluated all the risks for the company and operations. For example, just-in-time inventory poses a problem. The lean warehouse management can be a disadvantage for our model of business. As it happened, we had stock we were able to send on for final production at another facility. Without this safety stock we would have shut down until our production space was ready. Things need to be managed correctly, of course. We can not keep a huge stock, but we see now we need to keep a safety stock. MDD: What other lessons have you learned? Benatti: What I would underline is a personal experience when such a crisis happens of getting through the first moment, the first hour. You open your eyes and say ‘My God, what are we going to do?’ But leading a company, you have to lead. What I learned was how all the employees, all the people in the company were so willing to work together. We came through something together, and we know the importance of staying together. Indeed, we created a motto “All Together Now” It means when we are all together we can do anything. This was the most important thing I learned. ■

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 company, please contact Joe Rabus at (770) 810-3121, or joseph.rabus@thomsonreuters.com

To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Copyright © 2013 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.


THURSDAY, OCTOBER 10, 2013

Endotronix

MEDICAL DEVICE DAILY™

Continued from Page 1 lowering the overall cost of chronic heart failure (CHF) care. Representatives from the firm spoke with Medical Device Daily this week about the development of the technology and the next steps that the firm would embark upon. Endotronix was founded in June 2007 by a cardiothoracic surgeon, Anthony Nunez, MD, and a mechanical engineer, Harry Rowland, PhD, who serves as the firms president/CEO. “The two of us linked up,” Rowland, told Medical Device Daily. “I had the technology background and he knew all about the critical applications. So we really decided to launch this company. Both of us had family members who were impacted by heart failure. We’ve not only seen what heart failure does to individuals, but also to patients at family level. This drove the two to look at developing a more humane and effective way to care for and improve the quality of life for CHF patients. Following this invention, the co-founders were introduced to Luxemburg Capital’s James Hummer, a successful healthcare entrepreneur who shared Endotronix’s vision to deliver improved clinical outcomes while reducing the cost of care. With Luxemburg Capital’s leadership and investment, Endotronix expanded its development efforts in pursuit of commercializing the technology. “We’ve been really been active in moving the technology forward . . . but we’ve been a little bit under the radar,” Rowland told MDD. “But now as we see the market factors kind of opening up and we see people really looking for technology that can provide real meaningful clinical data . . . the whole digital health [market] is mature enough for us to bring this technology to market.” The tiny pressure sensor, under development, is implanted in the patient’s pulmonary artery during a short, routinely performed, low-cost catheterization procedure. Once the sensor is in place, the portable reader (about the size of a cell phone or small tablet device) can be easily carried by the patient or simply kept in a convenient location at the patient’s home. To obtain an instantaneous measurement of PA pressure, the reader is turned on and held against the patient’s chest for 20 to 30 seconds. The reader will be designed to transmit power wirelessly to the sensor, allowing the sensor to accurately measure and transmit the PA pressure to the reader. The reader sends the pressure data securely to the patient’s healthcare provider via a wireless, secure link to the Endotronix clinical care management software. The patient’s data is immediately analyzed by the system, and monitored by the Clinical Care Team (either the payer/provider team or a team sourced through Endotronix). If the pressure levels warrant urgent attention or further analysis, an alert is raised so that the patient’s care can be proactively managed. Endotronix said the Clinical Care Team then acts to deliver timely and personalized clinical interventions.

PAGE 8 OF 10

Rowland said what made this device possible was the convergence of mobile platforms and healthcare. “The revolution in digital communications and mobile technologies really powers individuals and in our case, patients, into having access to information that matters to them any time and anywhere,” he said. “As consumers we all benefit from that by pulling up our i-Phones and Android devices all the time. But for patients, it’s also an opportunity for them to know that anytime and anywhere, however they’re feeling, they have access expert advice and expert information. This whole mobile computing basically brings in a new platform for healthcare providers such as ourselves to leverage those tools to impact the patient.” Rowland added, “For us we see that the patient has these tools and has this disease and that they’re going to be using the tools to learn about the disease every day . . . if we can augment that information that they have by providing intercardiac pressures, so they can measure their internal heart pressures anytime; anywhere in the world and have access to that information, we believe that’s how we’re going to impact heart failure care globally.” To help with its mission the company licensed two patents from NASA for ultra miniature wireless sensor designs, which led to the patenting a new type of wireless sensor reader. In addition, the firm attracted more than $10 million private angel funding. Rowland added that the company was in the process of working on a significant funding round. But one of the key strengths of the company is its team which boasts members from different backgrounds and different disciplines. The company says this is a plus. One member of the team is Nicolas Chronos MD, who serves as the firm’s Chief Medical Officer. He was brought on by the firm in July. “The application of advanced sensor technology to medicine attracted me to the company and this company specifically has unique approaches to development and interrogation that will allow us to better manage patients in the outpatient setting,” Chronos said. Currently the company is vying for FDA approval of the device. But a key element in the firm understanding the proper pathway to take revolves around an FDA review panel for CardioMems (Atlanta) which took place on Wednesday. CardioMems has developed a heart failure monitoring device. As of press times results of the panel were not available. MDD spoke with members of Endologix’ management team who attended the meeting about the importance of the panel for the space. “It’s going to be key for us to really understand what the pathway is,” Kevin MacDonald Vice President, Regulatory told MDD, during a break in the Wednesday panel. “With this being the first technology to go down this pathway, it really sets a stage and a precedence that we’ll be held to and a See Endotronix, Page 10

To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Copyright © 2013 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.


THURSDAY, OCTOBER 10, 2013

Israel

MEDICAL DEVICE DAILY™

Continued from Page 1 long-term vision of high-quality international academic excellence, together with the need to enhance the Chinese Mainland’s innovation-capacity. China sees that if money can buy large corporations abroad, it should be able to purchase academic excellence to complement its local expertise, and to improve its economy in longer-term. The XIN Center (‘New’ in Chinese) will include international interdisciplinary research buildings in Beijing and Tel Aviv, will allow for teaching and research in a number of scientific fields – starting from nanotechnology and the life sciences. The Chinese authorities believed that to achieve innovation success in today’s environment, they must provide a novel approach to academic study: import the best academic ‘brands’ to China, but also ensure a highly industry-oriented perspective to the research institution. “With input from commercial groups from the outset of the research program, our collaboration will focus on research that will be able to be applied to industry, and hence will earn a spot within this XIN center environment,” explained Professor Yael Hanein, the Director TelAviv’s Nanotechnology Center, who is coordinating the interaction with Tsinghua. “It’s a new type of industryguided applied science research – even for Israel – which will leverage both universities’ ability to harness projects and personnel, and linking that skill, from the outset, with commercially-directed (or socially important) goals. It will also ensure industry-quality project design and management skills.” Nanomedicine and nanomechanics are the planned areas on which research will focus initially, Hanein told Medical Device Daily, as these were the areas of interest which overlapped at both facilities, and offer major industrial potential. An independent innovation expert explained: “It’s basically an experiment of taking Government sponsorships of startups one stage earlier – to invest in areas of applied research which match a longer term strategic/commercial purpose. Applying commercial project-management approaches might well lead to improved efficiency at the research level.” A spokesman for Tel Aviv University told MDD that given the strategic importance and potential of this collaboration, “the Presidents of Tsinghua and Tel Aviv University are starting a fund-raising campaign for XIN, targeted at providing physical facilities and resources that will enable exchange and cooperation between the institutions.” Beyond (likely philanthropic) fundraising for the academic partnership, private funds will also be at hand, to assist startups to emerge from these technologies. To this end, Infinity Group (Beijing), an Israel-China investment house was introduced into the consortium. Infinity’s close connections with both the Chinese and Israeli Governments has helped add a commercial dimension, and will play a role in ensuring that applied research is chosen with welltuned commercial perspectives in mind. “The combination

PAGE 9 OF 10

of talent from both universities plus Infinity Group’s commercialization value can generate high value,” explained Amir Gal-Or, Founder and Managing Director of Infinity Group. As part of the process, Infinity plans to raise a seed fund, primarily from Chinese sources including the Government and Tsinghua’s Alumni, to support bridging the academic/ commercial divide for such translational projects. The first investment in XIN-derived projects would be expected within 12 months, Gal-Or predicted, and would lead to investment in approximately three such translational projects per year.

$130 million investment in Israeli academia Barely two weeks following the TAU-Tsinghua cooperation in mid September, and Haifa’s Technion Institute of Technology announced a similar deal. A major collaboration agreement was signed between the Technion and a burgeoning Shantou University (STU; Guangdong, China) in Guangdong, China’s hi-tech province in the Southern tip of the State. The prestige of the world-renowned Technion had been enhanced with the development of the Technion-Cornell Innovation Institute (TCII) campus to be built on Roosevelt Island in New York, and it might have partially been this factor that encouraged an academic partnership, allied to a $130 million donation by a private party associated with STU. Technion has embarked on a large-scale cooperation with in the epicenter of Chinese hi-tech. STU is supported by Li Ka Shing, Asia’s wealthiest man, who sees education as key to the growth of China’s next generation. The partnership, to be known as Technion Guangdong Institute of Technology (TGIT), is planned to be set up at STU; it will involve the Chinese authorities setting aside approximately $147 million to fund construction and initial operations, as well as 330,000 square meters close to the STU campus. The support by the Li Ka Shing Foundation of this project is also associated with a $130 million donation to Technion. This funding will be spread out over 10 years, and is earmarked to improve Technion’s infrastructure, Israel’s Haaretz daily reported. Some of this funding, it is understood, has come from profits that Horizons Ventures (one of the tycoon’s investment arms) had made from the $1 billion sale of Israeli portfolio company, Waze (Raanana) to Google (Mountain View, California). a few months ago. Describing the potential of TGIT collaboration, Hong Kong’s South China Morning Post reported Li Ka Shing as stating that the collaboration “combined the start-up nation with the nation of endless opportunities.” As of academic year 2014, TGIT will begin offering undergraduate programs – awarded by the Technion, and conducted in English. In parallel with supporting undergraduate studies, this partnership will incentivize collaborative research, especially in areas of life sciences research based on Big Data. Commenting on this initiative, Professor Gu Peihua, See Israel, Page 10

To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Copyright © 2013 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.


THURSDAY, OCTOBER 10, 2013

MEDICAL DEVICE DAILY™

Financings

Continued from Page 3 • Francisco Partners (San Francisco), a technologyfocused private equity firm, reported a strategic investment in NexTech (Tampa, Florida), a provider of fully integrated electronic medical records, practice management, and marketing software solutions for specialty physician practices. Closing is subject to customary conditions, including Hart-Scott-Rodino clearance. “NexTech is highly respected in the healthcare industry for its fully integrated offering, specialty focus, and leadingedge technology combined with 17 years of experience and strong customer service,” said Ezra Perlman, a partner at Francisco Partners. “NexTech’s products are among the most trusted within its specialty focus areas, and we look forward to supporting the company in its continued growth.” NexTech was founded to develop a completely integrated EMR, practice management and marketing software offering for specialty physicians. According to Francisco Partners, the company’s unique focus on developing and supporting specialty-specific products fueled significant growth in these markets. This new partnership between NexTech and Francisco Partners is designed to enhance and support NexTech’s infrastructure and growth in medical specialties, including: bariatric surgery, dermatology, gastroenterology, ophthalmology, orthopedic surgery, otolaryngology, plastic surgery, general surgery centers and urology. “We founded the company to offer physicians the highest standard of excellence for their practice management and EMR needs,” said Kamal Majeed, PhD, founder/CEO at NexTech. “Our focus and culture from day one has been the customer. If you develop feature-rich products centered on your customers’ needs and provide best-in-class support and training for those products, then you’ve delivered value and earned customer loyalty. Francisco Partners’ deep technology expertise, impressive track record in healthcare technology, and long tradition of successfully partnering with founders will enable us to accelerate our growth, innovate and ultimately better realize our mission to support physicians.” NexTech was advised by Raymond James and Holland & Knight. Shearman & Sterling acted as legal advisor to Francisco Partners. Financial terms of the transaction were not disclosed. • CytRx (Los Angeles), a biopharmaceutical R&D company specializing in oncology, reported the pricing of its underwritten public offering. CytRx is offering 10 million shares of common stock at a public offering price of $2.25 a share for gross proceeds of $22.5 million, prior to deducting the underwriting discount and estimated offering expenses payable by the company.

PAGE 10 OF 10

CytRx said it intends to use the net proceeds of the offering to fund its clinical trials of its drug candidate aldoxorubicin and for general corporate purposes, which may include working capital, capital expenditures, R&D and other commercial expenditures. CytRx has granted the underwriters a 30-day option to purchase up to an aggregate of 1 .5 million additional shares of common stock to cover over-allotments, if any. The offering is expected to close on or about Oct. 14, subject to satisfaction of customary closing conditions, the firm noted. Aegis Capital is acting as the sole book-running manager for the offering. H.C. Wainwright & Co. is acting as a co-lead manager for the offering. ■

Israel

Continued from Page 9 Provost at STU, explained the rationale of TGIT at the signing ceremony: “What Technion has done to advance the Israeli economy through student and staff research and innovation is an example for Chinese universities to follow. If many universities in Guangdong and China do the same as Technion has been doing in Israel, an innovation-based economy will emerge.” From his perspective, Professor Peretz Lavie, president of Technion, described the partnership as “a major breakthrough and an opportunity to strengthen ties between Israel and China.” One theme that seems to consistent across crossnational cooperations, but much more so across the EastWest Divide is a need for constant discussion, validation of goals, and mutual trust. While its technology prowess and engineering capabilities need no introduction, Israel’s business approach is maturing and leading to valuable, and creative Far Eastern partnerships. These approaches – whether at a corporate level with a Japanese player, at an investment level with a large pharmaceutical, or with Chinese giants in infrastructure deals for bi-national innovation centers are evidence of a prevailing mutual respect and an understanding of cultural similarities and differences. As long as there is clarity regarding what each team should bring to the party, all parties have much to benefit from successful outcomes. ■

Endotronix

Continued from Page 8 standard that we’ll be held to.” “This is really an important panel for the field of implantable sensors because it will give us guidance as to the clinical path . . . that our regulatory experts will define for us,” said Chronos, the former president of Saint Joseph’s Translational Research Institute (Atlanta). “We’re going to learn a great deal about the regulatory approach . . . and then be able to understand what is the pathway that we’re going to need to apply in discussion with the FDA.” ■ Omar Ford;770-810-3125

To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Copyright © 2013 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.


MDD’s Ortho Extra ADDITIONAL DEVELOPMENTS

THURSDAY, OCTOBER 10, 2013

IN

ONE

OF

M E D -T E C H ’ S K E Y S E C T O R S

PAGE 1 OF 2

Keeping you up to date on recent developments in orthopedics Lower cost treatment regimen for bone metastases not widely used . . . Justin Bekelman, MD, of the University of Pennsylvania Perelman School of Medicine, Philadelphia, and colleagues conducted a study to examine whethersingle-fraction radiation treatment, shown to be as effective as multiple-fraction treatment with less potential for harm, has been incorporated into routine clinical practice for Medicare beneficiaries with prostate cancer and at what cost savings. Single-fraction radiotherapy is where a large dose of radiation is given in one session; with multiple-fraction radiotherapy, radiation is delivered in smaller doses over a longer period of time. “Palliative radiotherapy, comprising l or more fractions (i.e., treatments) of daily radiation, is the mainstay of treatment for painful bone metastases. In 2005, a U.S.-based randomized trial demonstrated no difference in pain relief between single- and multiple-fraction radiotherapy for uncomplicated bone metastases, confirming results from international trials,” according to background information in the article appearing in the October 9 issue of JAMA. As reported in the Research Letter, the authors selected patients age 65 years or older with prostate cancer and bone metastases and subsequent courses of radiotherapy from January 2006 through December 2009 from the Surveillance, Epidemiology and End Results (SEER)-Medicare database. For each patient, the researchers identified the initial outpatient course of radiotherapy following the first diagnosis of bone metastasis (index course) and determined the dates and number of radiotherapy fractions based on Medicare claims for radiation delivery (Medicare reimburses each radiotherapy fraction individually). Of 3,050 patients included in the study, 3.3% had single-fraction radiotherapy and 50.3% received more than 10 fractions. Average 45-day radiotherapy-related expenditures were a relative 62% lower for patients treated with single relative to multiple fractions ($1,873 for single vs. $4,967 for multiple fractions). “Despite evidence demonstrating comparable pain relief for single-fraction treatment, only 3.3% of Medicare beneficiaries with bone metastases from prostate cancer received single-fraction treatment. Patients who received single-fraction radiotherapy had poorer prognoses, perhaps reflecting the perception that single-fraction treatment should be reserved for patients with limited life expectancy or poor performance status. However, single-fraction treatment has substantial benefits for patient-centric palliative care, including greater quality of life and convenience, reduced travel time, and lower treatment costs,” the authors conclude.

Bone Therapeutics’ allogeneic osteoblastic product to enter clinic for the treatment of delayed union fractures . . . Bone Therepeutics (Gosselies, Belgium), the leading biopharmaceutical company focused on innovative cell therapy products for the treatment of bone diseases, announces today that it has received clearance from the Competent Authorities in Belgium and the UK for a phase I/IIa trial with its allogeneic cell therapy product ALLOB for the treatment of delayed union fractures. ALLOB is an allogeneic, osteoblastic (i.e. bone-forming) cell therapy product. ALLOB has already shown safety and efficacy in preclinical studies and has the potential to become a first-line treatment for impaired fracture healing, thanks to its minimally invasive percutaneous administration, avoiding the need for surgery. This first-in-human, proof-of-concept, phase I/IIa study is a 6 months open-label trial to evaluate the safety and efficacy of ALLOB in the treatment of delayed union fractures of long bones. Thirty-two patients will be enrolled in 10 centers. They will receive a single percutaneous administration of ALLOB directly into the fracture site. ALLOB-treated patients will be assessed in comparison to baseline at 2 weeks, 1, 3 and 6 months using clinical (e.g., pain, weight-bearing) and radiological evaluation. Bone Therapeutics has already secured both ‘Tissue Establishment’ and ‘GMP’ Accreditation for the in-house manufacturing of ALLOB. This not only allows Bone Therapeutics to have enhanced control over ALLOB’s production, but secures the manufacturing runway for scale up of production to support ALLOB’s further development. Enrico Bastianelli, CEO of Bone Therapeutics commented, “This new clinical trial clearance from the Competent Authorities in Belgium and the UK is an important milestone in the development of ALLOB and further validates Bone Therapeutics’ clinical, regulatory and manufacturing To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Copyright © 2013 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.


THURSDAY, OCTOBER 10, 2013

MDD’S ORTHO EXTRA

PAGE 2 OF 2

capabilities. The only way to address delayed union fractures currently is invasive surgery which could have severe complications and a long hospital stay. With ALLOB’s bone regenerative mode of action and minimally invasive administration, Bone Therapeutics’ allogeneic product could become a first-line treatment.”

New study reveals cost savings for those who need surgery . . . In late summer and early fall when youth and college sports begin, it’s a similar refrain: a star on the varsity basketball team tore her anterior cruciate ligament (ACL) and is out for the season after surgery. A college football game stopped as a defensive safety hobbles off the field with an ACL injury. Annually in the U.S., more than 200,000 ACL injuries are reported, often by active young adult and adolescent athletes, though they can occur at any age. Depending on the severity of the injury, treatment may include rehabilitation or surgery and rehabilitation, and many patients and their families struggle with treatment decisions. To aid in the decision making process, a study published today in the Journal of Bone and Joint Surgery (JBJS) offers new information for those considering or needing surgery. For the first time, researchers assessed the economic and societal impact of ACL surgery in relation to the cost of the procedure and confirmed a significant cost savings to society over time. The study, “Societal and Economic Impact of Anterior Cruciate Ligament Tears,” found the average lifetime societal benefit of reconstruction surgery is $50,000 per patient, with the majority of the societal savings coming from the patient’s ability to return to a more functional and pain-free lifestyle and by minimizing any further damage to the knee that can lead to the development knee osteoarthritis in the future. In fact, the authors estimate lifetime societal savings in the U.S. of about $10.1 billion for the ACL surgeries annually. “We know ACL patients who need it benefit from surgery, but until now, the true value of ACL reconstruction surgery has been hard to quantify,” said John ongue, MD, American Academy of Orthopaedic Surgeons (AAOS; Rosemont, Illinois) past-president. “Considering many ACL patients are young and eager to get back to their active lives, this study provides a key perspective they can look to when evaluating surgery versus rehabilitation.” An ACL injury can severely limit a person’s level of activity and result in long-term repercussions such as an increasedrisk of knee osteoarthritis, which can lead to debilitating pain and make walking and standing difficult. Each ACL injury is different and can range from a stretched ligament to a partial tear to a complete rupture. Equally so, each type of treatment is different, from structured rehabilitation to surgical reconstruction followed by rehabilitation. Patients or their family members should have complete ample information about costs, potential limitations and benefits of each type of treatment before making their decision. In situations where a patient is active, such as a high school or college athlete, and would like to return to that active lifestyle after treatment, surgery to repair a partial or complete tear is often the best option, with a long-term success rate of 82% to 95%. Rehabilitation can also be successful for patients depending upon their activity level, age and the severity of their injury. Through this study, patients now have the opportunity to compare direct and indirect costs of surgical reconstruction or rehabilitation and better understand the overall benefits of each treatment relative to the societal and economic savings. “In younger patients, surgery for an ACL tear is usually the best option for getting them back on their feet and reducing the likelihood of arthritis down the road,” said Mininder Kocher, MD, study author. “Patients and their families are often worried about their ability to return to sports, their mobility in the future and the cost of the surgery. This study sheds light on all three of these important factors.” To conduct the study, researchers reviewed data from the randomized controlled trial known as the KANON study, and the Multicenter Orthopaedic Outcomes Network (MOON) ACL reconstruction prospective cohort as well as literature. The data were applied to a Markov decision model from which they estimated the total societal savings associated with ACL reconstruction surgery by comparing costs for direct medical care and indirect costs, including lost wages from work and disability payments for both surgical and non-surgical treatments. “This is the first study to demonstrate the importance of a societal perspective when considering the costs and benefits of ACL repair and policies that will affect access to this procedure,” said study author and health care economist Lane Koenig, Ph.D. — Compiled by Holland Johnson, MDD Executive Editor holland.johnson@thomsonreuters.com

To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Copyright © 2013 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.

East Meets West II  

We mention a few pieces of news associated with increasing links between the Israeli and Chinese scientific research communities

Advertisement