DJO Global Announces Appointment of Jeffery McCaulley as Global President, DJO Surgical

Posted On May 30, 2017 By OrthoSpineNews In Extremities, Top Stories /

May 30, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc., a leading global provider of medical technologies designed to get and keep people moving, announced the appointment of Jeffery McCaulley as Global President, DJO Surgical, effective immediately. Mr. McCaulley will succeed Brady Shirley, who was appointed DJO’s President and Chief Executive Officer in November, 2016 after successfully doubling revenue and profitability of DJO Surgical since he joined DJO in 2014.

Mr. McCaulley is an experienced senior executive with more than 25 years in the healthcare industry, most recently serving as President and CEO of Smiths Medical, a $1.2B division of Smiths Group, plc. Before joining Smiths Medical, Mr. McCaulley served as President of the Global Reconstructive Division at Zimmer, where he oversaw five global business units and numerous functions. He held previous roles as President and CEO of the Health Division of Wolters Kluwer and Vice President and General Manager of the Global Diabetes Business Unit at Medtronic. Mr. McCaulley began his career at GE Healthcare, where he held progressively more senior roles during his 13 years there, last serving as President and CEO of GE Clinical Services.

Mr. McCaulley received a Bachelor of Science in Aerospace Engineering from the University of Cincinnati and an Executive MBA from the Owen Graduate School of Management at Vanderbilt University.

“Our Surgical business’ best in market performance has and will continue to be the key transformation catalyst in our company. I am excited to combine Jeff’s talent and experience in the space with our exceptional leadership team. Throughout his career, Jeff has a proven track record of accelerating innovation, improving employee and customer engagement, and delivering results. I look forward to this great next chapter for DJO Surgical!” said Mr. Shirley.

“I am very excited to be joining Brady and the team at DJO,” said Mr. McCaulley. “The growth in recent years has been spectacular and I am convinced that we are positioned to continue to make significant market share gains across our portfolio and have the right internal and external teams to improve key areas of patient care and experience.”

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort®, Bell-Horn® and Exos™. For additional information on the Company, please visit www.DJOglobal.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements relate to, among other things, the Company’s expectations for continued market performance, sales growth and growth in market share for DJO’s Surgical Segment. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause actual operating results and market growth to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to the successful execution of the Company’s business transformation plans, including achievement of planned actions to improve liquidity, improvements in operational effectiveness, optimization of the Company’s procurement activities, improvements in manufacturing, distribution, sales and operations planning, and actions to improve the profitability of the mix of our product and customers. Other important factors that could cause actual operating results and market growth for our Surgical Segment to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the continued growth of the surgical implant markets the Company addresses and any impact on these markets from changes in global economic conditions; the impact of potential reductions in reimbursement levels and coverage by Medicare and other governmental and commercial payors; the Company’s highly leveraged financial position; the Company’s ability to successfully develop, license or acquire, and timely introduce and market new products or product enhancements; risks relating to the Company’s international operations; resources needed and risks involved in complying with government regulations and government investigations; the availability and sufficiency of insurance coverage for pending and future product liability claims; and the effects of healthcare reform, Medicare competitive bidding, managed care and buying groups on the prices of the Company’s products. These and other risk factors related to DJO are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 15, 2017. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
David Smith
SVP, Treasurer and Investor Relations
760.734.3075
ir@djoglobal.com

Keck School of Medicine of USC receives $2.2 million NIH grant for bone repair research

Posted On May 26, 2017 By OrthoSpineNews In Financial, Top Stories /

LOS ANGELES – Jay R. Lieberman, MD, chair and professor of orthopedic surgery at the Keck School of Medicine of the University of Southern California has received a five-year, $2.2 million grant from the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases to research gene therapy to enhance repair of extensive bone injuries. Examples of these types of injuries include fractures with extensive bone loss, non-healing fractures, failed spinal fusion and revision of total joint replacement.

Lieberman will genetically manipulate human bone marrow cells to overproduce bone morphogenetic protein (BMP), a protein that spurs progenitor cells to produce bone.

“There are a number of bone injuries that are very difficult to repair and lack satisfactory solutions,” Lieberman says. “My goal with this grant is to determine whether genetically modifying human bone marrow cells to overproduce BMP will help heal large bone defects in an animal model and, ultimately, provide a better alternative for repairs in humans.”

Lieberman’s study will determine the efficacy and safety of the gene therapy as well as establish a cellular dose of the genetically manipulated cells that can be scaled up for potential use in humans.

An abstract of the grant, 2R01AR057076-06A1, is available on the NIH RePORTER website.

ABOUT THE KECK SCHOOL OF MEDICINE OF USC

Founded in 1885, the Keck School of Medicine of USC is among the nation’s leaders in innovative patient care, scientific discovery, education, and community service. It is part of Keck Medicine of USC, the University of Southern California’s medical enterprise, one of only two university-owned academic medical centers in the Los Angeles area. This includes the Keck Medical Center of USC, composed of the Keck Hospital of USC and the USC Norris Cancer Hospital. The two world-class, USC-owned hospitals are staffed by more than 500 physicians who are faculty at the Keck School. The school today has approximately 1,650 full-time faculty members and voluntary faculty of more than 2,400 physicians. These faculty direct the education of approximately 700 medical students and 1,000 students pursuing graduate and post-graduate degrees. The school trains more than 900 resident physicians in more than 50 specialty or subspecialty programs and is the largest educator of physicians practicing in Southern California. Together, the school’s faculty and residents serve more than 1.5 million patients each year at Keck Hospital of USC and USC Norris Cancer Hospital, as well as USC-affiliated hospitals Children’s Hospital Los Angeles and Los Angeles County + USC Medical Center. Keck School faculty also conduct research and teach at several research centers and institutes, including the USC Norris Comprehensive Cancer Center, the Zilkha Neurogenetic Institute, the Eli and Edythe Broad Center for Stem Cell Research and Regenerative Medicine at USC, the USC Cardiovascular Thoracic Institute, the USC Roski Eye Institute and the USC Institute of Urology.

In 2017, U.S. News & World Report ranked Keck School of Medicine among the Top 40 medical schools in the country. For more information, go to keck.usc.edu.

This press release references support by the National Institutes of Health under award number 2R01AR057076-06A1 ($2,284,028 over five years). One hundred percent of the project’s funding will be federally funded.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

SurGenTec’s GRAFTGUN Receives Key Patent

Posted On May 26, 2017 By OrthoSpineNews In Regulatory, Top Stories / 1

May 25, 2017

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec®, a minimally invasive orthobiologics company, has announced that the United States Patent and Trademark Office has granted a new patent for its bone graft delivery technology.

The proprietary GRAFTGUN® delivery system enables surgeons to deliver the bone graft of their choice (synthetic, allograft, or autograft) in a minimally invasive fashion.

Traditionally, surgeons have used a metal funnel and tamp to place bone graft; these surgeons have sought a solution to overcome the difficulties and dangers with this technique. The GRAFTGUN provides a simple, safe and ergonomic solution to deliver bone graft in hard to reach places.

The GRAFTGUN kit includes a loading device and multiple tube sizes to support a variety of surgical procedures and patient sizes. The tubes have embedded radiopaque markers which enable the surgeon to visualize where their bone graft is being placed on fluoroscopy. The ratcheting technology provides the force necessary to extrude the majority of bone grafts on the market.

SurGenTec develops minimally invasive surgical technologies to help surgeons provide optimal care for their patients. SurGenTec believes the GRAFTGUN will be an asset to surgeons in both spine and orthopedic procedures.

The patent adds to SurGenTec’s portfolio of existing patents and patents pending.

SurGenTec also has several up-and-coming technologies that will be rolled out over the course of this year.

SurGenTec, a privately owned medical device company based out of Boca Raton, FL, plans to release the GRAFTGUN this summer.

Contacts

For SurGenTec
Andrew Shoup, 714-350-2546
Ashoup@SurGenTec.com
www.SurGenTec.com

NovaBone Announces Irrigation Resistant Products with Carriers that have Synergistic Effect in Bone Formation

Posted On May 25, 2017 By OrthoSpineNews In Biologics, Top Stories /

May 24, 2017

JACKSONVILLE, Fla.–(BUSINESS WIRE)–NovaBone Products, a leading biologics medical device company, announces the addition of NovaBone IRM and NovaBone IRM MacroPOR to its portfolio of biologically active bone graft substitutes.

NovaBone IRM, and NovaBone IRM MacroPOR are the most advanced bioactive synthetic bone graft substitutes available to the orthopedic community today. Both formulations optimize osteogenesis, uniquely signal and stimulate osteoblastic activity, and offer angiogenic potential. By design, both formulations are highly irrigation resistant with excellent cohesion and handling properties.

“NovaBone Products’ base Bioactive Glass technology has proven to out-perform traditional calcium sulfate based synthetic products and demineralized bone matrix products,” said Dennis McBride, Vice President of Sales and Marketing. “We are now advancing our science further by providing formulations with carriers that have a synergistic effect in bone formation and retain molded shapes following implantation and irrigation.”

Novabone offers the broadest portfolio of bioactive synthetic bone graft substitutes in the world, with a robust pipeline of products in development designed to expand the regenerative biologics products the company offers. Presently, products offered include minimally invasive (MIS) delivery devices, strip formulations, putty materials that are hydrated using bone marrow aspirate, and putty formulations that are ready-to-use out of the package.

“We are proud to offer products that allow a surgeon to look to one company when addressing bone grafting needs,” concluded McBride.

NovaBone Products, a privately held company based in Florida, USA since 2002 and a recognized industry leader in bioactive glass design and manufacturing, developed the first bioactive synthetic bone graft offered to the orthopaedic community.

Contacts

NovaBone Products
Arthur Wotiz, President
904-651-0607
awotiz@novabone.com

First Surgery Completed Utilizing the Gramercy Extremity Orthopedic™ Systems

Posted On May 25, 2017 By OrthoSpineNews In Extremities, Top Stories /

DALLAS, TEXAS, USA, May 24, 2017 /EINPresswire.com/ — Gramercy Extremity Orthopedics (GEO) is pleased to announce the first surgery using the GEO™ Bone Screw and GEO CART™ systems. The first surgery was performed by Dr. Peter A. Blume, D.P.M., F.A.C.F.A.S. at Shoreline Surgery Center LLC, Guilford, CT, with outstanding results. As the first offering in the company’s product line, this marks a major milestone for Gramercy Extremity Orthopedics™.

Dr. Blume remarked on the advantages of the GEO™ Bone Screw and GEO CART™ Systems, “I was extremely impressed and pleased with the outcome when utilizing the GEO™ Bone Screw and GEO CART™ systems. The ease in which the system operated was noted by the entire Surgical Center staff and felt that the systems created many efficiencies that are lacking in today’s operating environment. The surgical back table was free of clutter and the implant and instruments were truly best of class. The GEO CART™ finally addresses all the pitfalls when operating with orthopedic hardware, whether it be at the Surgery Center or in the hospital setting.”

The GEO CART™ proprietary point-of-sale system reduces delays in surgery, decreases sterility risks to the patient, eliminates billing mistakes and hand written forms, automatically generates the Implant Usage Form and reduces facility operating expenses.

The GEO CART™ is a computerized mobile implant and instrumentation inventory system based on RFID technology. No bigger than the average medical cart, the GEO CART™ system can hold over 2,000+ items.

The GEO™ Bone Screw System offers a comprehensive array of low profile titanium screw lengths, diameters, thread lengths and fully threaded options. All GEO™ Bone Screws are double sterile packaged, self-drilling, self-tapping, reverse-cutting with variable length short and long threads and a hexalobe head to provide additional stability and torque transfer with less potential for head stripping. All instruments within the GEO™ Bone Screw system are also double sterile packaged in single use kits to ensure a new and sterilized instrument is used every surgery.

“We are all very pleased with the results from today’s surgery. Not only did the implant and instruments all work superbly, the case was performed without issue and in an efficient manner,” says Michael P. Simpson, President and CEO of Gramercy Extremity Orthopedics™. “As for the GEO CART™, in my 16 years in orthopedic medical devices, I have never had the ability to see the transactions remotely from a case within minutes of the surgery happening. This is a significant breakthrough in our industry. I want to thank the GEO™ team for all of their hard work in getting this system to the marketplace”

GEO™ will be exhibiting at the AOFAS Scientific Conference, Seattle, July 12-14, 2017. Booth #610.

About Gramercy Extremity Orthopedics™:

GEO™ was formed from the idea that there could exist a more cost-effective, user-friendly way to supply Orthopedic Medical Implants in today’s healthcare environment. This is accomplished through the use of RFID technology, a groundbreaking Point-of-Sale delivery system, and GEO™ designed best in class sterilized single-use orthopedic implants and instruments. GEO™ is the only solution that provides a significant opportunity to lower real operating costs by creating efficiencies and controls throughout the delivery and consumption of orthopedic implants.

Michael Nugent
Gramercy Extremity Orthopedics™
855-436-2278 ext 103
email us here

DERMABOND® PRINEO® Skin Closure System May Improve Outcomes and Lower Hospital Costs

Posted On May 24, 2017 By OrthoSpineNews In Financial, Recon, Top Stories /

SOMERVILLE, N.J., May 24, 2017 /PRNewswire/ — Ethicon^* announced the results of two economic analyses demonstrating that the DERMABOND^®PRINEO^® Skin Closure system, a product that combines a topical skin adhesive with a self-adhering patch, is associated with improved patient outcomes and lower healthcare costs for hospitals. Both studies are being presented at the International Society for Pharmacoeconomics and Outcomes Research’s 22nd Annual International Meeting this week.

The first study, Comparison of Economic and Clinical Outcomes between the DERMABOND® PRINEO® Skin Closure System and Skin Staples in Patients Undergoing Knee Replacement in Real World Clinical Practice,¹ found that the DERMABOND PRINEO System is associated with improved outcomes for patients receiving total knee arthroplasty (TKA) when compared to skin staples. The findings are based on a retrospective analysis of 1,942 TKA procedures using the Premier Perspective^®Hospital Database. Specifically, the DERMABOND PRINEO System was associated with a statistically significant reduction in readmission rates at 30, 60 & 90 days, a reduction in length of hospital stay and a lower probability of being discharged to a skilled nursing facility (SNF). The analysis showed that the 30-day readmission rate for the DERMABOND PRINEO System group was 1.8%, compared to 4.4% for the skin staple group. The costs of 30 day readmissions for TKA have been estimated to be $12,839.² The DERMABOND PRINEO System was also associated with a 12% reduction in length of hospital stay and a 31% reduction in discharge to a SNF or other non-home setting, which could lead to savings in the acute and post-acute setting.

The second study, A U.S. Hospital Budget Impact Analysis of a Skin Closure System Compared with Standard of Care in Hip and Knee Arthroplasty, estimates the 90-day cost impact of the DERMABOND PRINEO System compared to other wound closure methods for hip and knee arthroplasty from a U.S. provider perspective.³ The analysis showed that the use of the DERMABOND PRINEO System DERMABOND PRINEO System in hip and knee arthroplasty may achieve cost savings that could translate into an annual hospital budgetary savings ranging from $28,349 to $39,809 when assuming 500 arthroplasties.³ The predicted cost savings was driven by reductions in dressing materials and post-operative healthcare visits when the DERMABOND PRINEO System is utilized.

“Ethicon is committed to bringing to market innovative products that are designed to provide improved outcomes for patients and enable our customers to provide the best care for their patients,” says Nefertiti Greene, Vice President, Global Wound Closure and Repair Platform Leader at Ethicon. “The DERMABOND PRINEO System has been shown by this research to be an excellent approach to wound closure.”

Reducing the length of a patient’s hospital stay can lead to reduced costs and may also lower the chances of contracting an infection.⁴In addition, reducing readmissions can prevent hospitals from being penalized for readmission rates above the national average for TKA.⁵ The reductions in health care resource utilization demonstrated in these studies are important for hospital systems and health care professionals particularly those who are part of or are considering episode-based payments where both acute and post-acute costs are combined into one payment.

Several benefits associated with the DERMABOND PRINEO System may explain the findings. The product provides significantly greater skin holding strength than skin staples and subcuticular suture,⁶⁺ and acts as a barrier to microbial penetration against organisms commonly associated with surgical site infection.⁷ The DERMABOND PRINEO System requires no postsurgical dressings which may mean easier self-care and greater self-confidence for patients.⁷ Also, if directed by their healthcare professional, patients can shower immediately after surgery⁷ which could lead to a higher level of patient satisfaction.

About Ethicon

From creating the first sutures to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues, and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treating serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.

*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates Ethicon, Inc. is the legal manufacturer of the DERMABOND^®PRINEO^® Skin Closure system. All other trademarks are the property of their respective owners.

+In an ex vivo study, more load in N was required to create a 3-mm gap between skin edges approximated with DERMABOND PRINEO System (22 cm) than with subcuticular 4-0 MONOCRYL® (poliglecaprone 25) Suture or PROXIMATE® Ethicon Endo-Surgery skin staples (P<.001).

073076-170517

¹Johnston S, Sutton N. Comparison of Economic and Clinical Outcomes between the Dermabond® Prineo® Skin Closure System and Skin Staples in Patients Undergoing Knee Replacement in Real World Clinical Practice. Poster Presented at: ISPOR 22nd Annual International Meeting; May 20-24, 2017; Boston, MA.
² HCUP Statistical Briefs website. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sbtopic.jsp. Accessed May 17, 2017
³ Sadik, K, Flener J, Gargiulo J, Graves M, Nunley, R Post, Z, Wurzelbacher, Sutton, N, Hogan, Hollman, S, Ferko, N. A U.S. Hospital Budget Impact Analysis of a Skin Closure System Compared with Standard of Care in Hip and Knee Arthroplasty. Poster Presented at: ISPOR 22nd Annual International Meeting; May 20-24, 2017; Boston, MA.
⁴ Hassan M, Tuckman HP, Patrick RH, Kountz DS, Kohn JL. Hospital length of stay and probability of acquiring infection. International Journal of Pharmaceutical and Healthcare Marketing. 2010;4(4):324-338.
⁵ Centers for Medicare & Medicaid Services Readmissions Reduction Program (HRRP) https://www.cms.gov/medicare/medicare-fee-for-service-payment/acuteinpatientpps/readmissions-reduction-program.html. Accessed May 17, 2017.
⁶ Data on file, Ethicon, Inc.: Kumar A. AST-2012- 0290. Completion Report: Study to compare the tissue holding strength of PRINEO Skin Closure System with conventional wound closure techniques. 2012.
⁷ Data on file. Ethicon, Inc. Dermabond Prineo System Master Claims Matrix.

SOURCE Ethicon

MemorialCare Joint Replacement Center At Long Beach Memorial Now Offering Newest Technology In Total Knee Replacement

Posted On May 24, 2017 By OrthoSpineNews In Recon, Robotics, Top Stories /

LONG BEACH, Calif., May 24, 2017 /PRNewswire-USNewswire/ — The MemorialCare Joint Replacement Center at Long Beach Memorial is the first hospital in Long Beach and North Orange County to offer Stryker’s robotic-arm assisted total knee application for use with its Mako System – and now has successfully performed its first total knee replacement case in that region using this new technology. This latest advancement in joint replacement surgery transforms the way total knee replacements are performed.

Total knee replacements in the United States are expected to increase 673 percent by 2030,¹ yet studies have shown that approximately 30 percent of patients are dissatisfied after conventional surgery.² Mako Total Knee combines Stryker’s advanced robotic technology with its clinically proven GetAroundKnee (Triathlon Total Knee System), which enabled surgeons to have a more predictable surgical experience with increased accuracy during laboratory testing.³

“Mako is changing the way joint replacement surgeries are performed by providing each patient with a personalized surgical experience based on their specific diagnosis and anatomy,” said Andrew Wassef, M.D., medical director, MemorialCare Joint Replacement Center, Long Beach Memorial. “Using a virtual 3D model, the Mako System allows surgeons to create each patient’s surgical plan pre-operatively before entering the operating room. During surgery, the surgeon can validate that plan and make any necessary adjustments while guiding the robotic-arm to execute that plan. It’s exciting to be able to offer this transformative technology across the joint replacement service line to perform total knee, total hip and partial knee replacements.”

The Mako Total Knee application is a knee replacement treatment option designed to relieve the pain caused by joint degeneration due to osteoarthritis. Through CT-based 3D modeling of bone anatomy, surgeons can use the Mako System to create a personalized surgical plan and identify the implant size, orientation and alignment based on each patient’s unique anatomy. The Mako System also enables surgeons to virtually modify the surgical plan intra-operatively and assists the surgeon in executing bone resections.

“We are proud to be the first hospital to offer this highly advanced robotic technology in our area,” said Tamra Kaplan, PharmD, chief operating officer, Long Beach Memorial. “This addition to our orthopaedic service line further demonstrates our commitment to provide the community with outstanding healthcare.”

About the MemorialCare Joint Replacement Center at Long Beach Memorial:

Long Beach Memorial is lauded for superior clinical quality outcomes and has been listed on U.S. News & World Report’s America’s Best Hospitals since the annual rankings began. In this year’s results, Long Beach Memorial received “high performance” rankings in nine clinical specialty areas, including Hip Replacement, Knee Replacement and Orthopedics. It also is among a small percentage of U.S. hospitals consistently recognized for outstanding dedication to patient safety by maintaining a top “A” grade in eight of nine Leapfrog Group Hospital Safety Score evaluations for its ability to prevent errors, injuries, accidents and infections.

JRC specializes in a rapid rehabilitation program – where patients walk the same day of surgery – resulting in a shorter hospital stay – average hospital stay is zero to two days. The JRC features a dedicated unit for joint replacement patients with 15 private rooms, a joint care coordinator to help patients navigate through the program, patient education before and after surgery and “rehab coaches” to provide support as patients take their first steps toward an active lifestyle.

1. Kurtz AAOS. Total knee and hip replacement projections 2030. www.prnewswire.com/news-releases/total-knee and-hip-replacement-surgery projections-show-meteoric-rise-by-2030-55519727.html. Accessed July 4, 2016. 2. Christiaan Keurentjes J, Fiocco M, So-Osman C, et al. Patients with severe radiographic osteoarthritis have better prognosis in physical functioning after hip and knee replacement: a cohort-study. PLOS One. 2013; 8(4): 1-8. 3. Hampp EL, Scholl LY, Prieto M, Chang T, Abbasi AZ, Bhowmik-Stoker M, Otto JK, Jacofsky DJ, Mont MA. “Accuracy Assessment of Robotic and Manual TKA in a Cadaveric Model.” Robotic-arm assisted total knee arthroplasty demonstrated greater accuracy to plan compared to manual technique. ORS 2017 Annual Meeting. San Diego. Poster No.2412.

SOURCE Long Beach Memorial

Boston Scientific is the 2nd biggest dealmaker in medtech since 2012

Posted On May 24, 2017 By OrthoSpineNews In Financial, Top Stories /

Max Stendahl, Biotech Reporter / Boston Business Journal – May 4, 2017

The last five years have seen a flurry of dealmaking in the medical device industry. And according to a new report, Marlborough-based Boston Scientific is responsible for more acquisitions than any other company since 2012 except one.

With 27,000 employees worldwide and around 2,500 here in Massachusetts, Boston Scientific (NYSE: BSX) is the largest medical device firm based in the state by headcount. It’s pulled off eight acquisitions since the beginning of 2012, according to the report by market research firm CB Insights. (The actual number appears to be 10; the report appears to omit one recent deal for an endoscopy firm and another in 2014 for a manufacturer.)

The only medical device company that was more active during this period was Boston Scientific’s rival, Ireland-based Medtronic (NYSE: MDT), which acquired a whopping 15 device firms.

For Boston Scientific, the string of acquisitions has coincided with the tenure of Mike Mahoney, who joined as president in October 2011 and was named CEO a year later. Boston Scientific has seen its stock price increase steadily with the 52-year-old Mahoney at the helm. He remains one of the highest-paid executives among public companies in the state, earning $35.7 million in total compensation plus value realized from past stock awards in 2016.

READ THE REST HERE

Doctor who faced retaliation for raising concerns about double-booked surgeries wins lawsuit

Posted On May 24, 2017 By OrthoSpineNews In Regulatory, Top Stories /

By Jonathan Saltzman – GLOBE STAFF MAY 24, 2017

A prominent Boston neurosurgeon was illegally forced out of his previous job at a New York hospital for strongly objecting to a policy that allowed another surgeon to perform complex spine surgeries on two patients simultaneously, a judge ruled.

Double-booking, as the practice is sometimes called, triggered a fierce dispute among doctors at Massachusetts General Hospital in recent years, leading to the 2015 dismissal of an orthopedic surgeon who opposed it. But Dr. James Holsapple may be the first doctor to win a lawsuit alleging he faced retaliation for challenging the practice.

New York Supreme Court Justice James P. Murphy ruled after a bench trial that University Hospital in Syracuse retaliated against Holsapple after he spoke out about the surgeon running two operating rooms at once.

“Dr. Holsapple vehemently objected and opposed the procedures for valid public health and safety reasons,” Murphy ruled in a 13-page decision received by the neurosurgeon Monday.

Holsapple, now chief of neurosurgery at Boston Medical Center, was awarded $88,277 in lost wages under the New York State whistle-blower statute. His lawyer estimated that the award could top $150,000 because Holsapple is entitled to interest on lost wages.

Holsapple, who resigned under pressure from University Hospital in 2009 and moved to Boston, said he felt vindicated.

“I did what I thought was right, and I’m grateful that the judge who heard the case saw it the same way,” said Holsapple, who heads the neurosurgery department at the Boston University School of Medicine.

The New York attorney general’s office, which defended University Hospital as part of the State University of New York, referred all questions to the hospital. Darryl Geddes, a hospital spokesman, said he could not comment because the attorney general’s office is considering an appeal.

READ THE REST HERE

BONESUPPORT™ Announces First Patient Enrolled in FORTIFY Trial with CERAMENT®|G

Posted On May 23, 2017 By OrthoSpineNews In Biologics, Top Stories /

Lund, Sweden, 22 May 2017– BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that the first patient has been enrolled by Dr Ravi Karia at the University of Texas Health Science Center at San Antonio into the company’s pivotal Investigational Device Exemption (IDE) trial: A Prospective, Randomized, Multicenter Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures (the FORTIFY trial: ClinicalTrials.gov Identifier: NCT02820363).

CERAMENT G is an injectable antibiotic-eluting bone graft substitute that has proven remodeling capabilities and provides local sustained delivery of gentamicin. The data from the trial will support BONESUPPORT’s PMA (Premarket Approval) filing for CERAMENT G in the US.

In spite of modern day care of open tibial fractures, bone loss coupled with wound contamination and soft tissue damage continue to impair healing and recovery, particularly if infection develops. In addition, open tibial fractures result in a general infirmity, long-term disability and reduction in quality of life for patients, and a significant clinical challenge for orthopedic surgeons.

The FORTIFY trial will assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial will include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union. The trial will also evaluate the safety of CERAMENT G in these patients. The trial will enroll up to 230 patients at up to 30 centers in the US and Europe.

Dr. Douglas Dirschl, the trial’s Principal Investigator, said: “I am excited to take part in the FORTIFY clinical trial. The open tibial fracture remains the most common and one of the most troublesome open fractures managed by orthopedic surgeons. Even with modern treatment protocols, patients suffering this fracture continue to be at substantial risk of infection, fracture non-union, and prolonged disability. A product that could be inserted into the fracture site at the time of definitive treatment that could promote bone formation at the same time as reducing the risk of subsequent infection, would be a major advance in the treatment of these troublesome fractures and would have the potential to provide benefit to thousands of patients each year in the United States.”

Douglas R. Dirschl, MD is the Lowell T. Coggeshall Professor of Orthopedic Surgery and Chairman, Department of Orthopedic Surgery and Rehabilitation Medicine at The University of Chicago Medicine.

“The treatment of the first patient in the FORTIFY trial is another key corporate milestone for BONESUPPORT. This clinical trial in a complex trauma indication is designed to demonstrate proof-of-concept that CERAMENT G can be used to improve and protect the healing process in open bone fractures in combination with standard procedures, minimizing the risk of deep infections which would result in the need for additional remedial procedures,” added Richard Davies, CEO of BONESUPPORT. “We plan to use the clinical data to support our planned PMA filing for CERAMENT G in the US. We also intend to generate additional clinical data with CERAMENT G to gain a broad US label for this novel, injectable antibiotic-eluting bone graft substitute, which is rapidly being adopted in Europe.”

CERAMENT G combines the bone healing and bone remodeling properties of CERAMENT with the antibiotic, gentamicin. CERAMENT G drug-eluting properties enable it to provide an initial high concentration of gentamicin to the environment of the bone fracture and then a longer sustainable dose above the minimum inhibitory concentration of many of the bacteria that could cause a bone infection at the fracture site. This unique antibiotic-eluting profile helps protect the bone healing process and to promote bone remodeling.

CERAMENT G received the European CE Mark in February 2013 and is now marketed in 19 countries outside the US.

Notes to Editor

About BONESUPPORT

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to 12 months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENTG and CERAMENT V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden. www.bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

BONESUPPORT AB

Richard Davies

info@bonesupport.com

+46 (0)46 286 53 24

Citigate Dewe Rogerson

David Dible, Mark Swallow, Marine Perrier

+44 (0)20 7638 9571

bonesupport@citigatedr.co.uk