Shared doctor-patient orthopaedic treatment decisions improve outcomes, patient experience

Posted On March 14, 2017 By OrthoSpineNews In Spine /

SAN DIEGO, Calif., March 14, 2017 /PRNewswire-USNewswire/ — Well-informed patients who decide with their orthopaedic surgeon what treatment is best for them have better outcomes and higher patient satisfaction rates, according to new study presented today at the 2017 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).

Shared decision making (SDM), a key component of patient-centered health care, is a process in which doctors and patients work together to make decisions and select tests, treatments and care plans based on clinical evidence (imaging and test results) that balances risks and expected outcomes with patient preferences and values.

Researchers surveyed more than 550 patients with hip or knee osteoarthritis; a slipped or ruptured (herniated) disc in the lower back; or lumbar spinal stenosis, a narrowing of the space around the spinal cord. An initial survey assessed the patient’s knowledge of their condition, preferred treatment (surgical or nonsurgical), baseline quality of life, physical movement capabilities and level of pain. A follow-up survey was administered six months after the initial office visit to patients who had nonsurgical treatment, and six months after surgery for those who had surgery. The follow-up questionnaires focused on treatment, quality of life, regret over their treatment choice and treatment outcomes. Patients with a good understanding of their condition who received their preferred treatment were considered to have made informed patient-centered (IPC) decisions.

The average age of the patients in the study was 63.9. Nearly 53 percent of the patients were female, more than 92 percent were white and 62.6 percent had a college degree. About half of the patients underwent surgery within six months of their initial office visit.

One-third of the patients were deemed “IPC,” and at the follow-up assessment these patients had higher scores related to overall and disease-specific quality of life outcomes. These patients also were more likely to be extremely satisfied with their pain management plan (76.7 percent versus 41.9 percent), very or extremely satisfied with their treatment (70.7 percent versus 34.7 percent), and had less regret with their treatment decision (5.2 percent versus 15 percent).

“This study is unique in its evaluation of the implementation of a shared decision making process as part of a real world orthopaedic elective surgical practice,” said co-study author Thomas Cha, MD, MBA, assistant chief of surgery at the Orthopaedic Spine Center at Massachusetts General Hospital, and an instructor at Harvard Medical School. “Shared decision making did not just result in better patient experience ratings, but also improved patient outcomes.”

“We are committed to improving outcomes after surgical procedures,” said co-author Harry Rubash, MD, emeritus chief of the Department of Orthopaedic Surgery at Massachusetts General Hospital and the Edith M. Ashley professor of orthopaedic surgery at Harvard Medical School. “This study found that surgical patients, who are more informed and have a clear preference for surgery, have better outcomes. It highlights the need to focus further on decision making prior to elective surgeries and other treatments.”

Funding for the study was provided, in part, by a grant from the Gordon and Betty Moore Foundation.

Study abstract

AAOS Information Statement on Surgical Consent

2017 AAOS Annual Meeting Disclosure Statements

The American Academy of Orthopaedic Surgeons
With more than 39,000 members, the American Academy of Orthopaedic Surgeons (AAOS) is the world’s largest association of musculoskeletal specialists. The AAOS provides education programs for orthopaedic surgeons and allied health professionals, champions and advances the highest musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments, and related issues.

Visit AAOS at:
Newsroom.aaos.org for bone and joint health news, stats, facts, images and interview requests.
ANationinMotion.org for inspirational patient stories, and orthopaedic surgeon tips on maintaining bone and joint health, avoiding injuries, treating musculoskeletal conditions and navigating recovery.
Orthoinfo.org for patient information on hundreds of orthopaedic diseases and conditions.
Facebook.com/AAOS1
Twitter.com/AAOS1

CONTACT: Sheryl Cash, 847-384-4032, 847-804-7486, scash@aaos.org | Lauren Pearson Riley, 847-384-4031, 708-227-1773, pearson@aaos.org

This information is being sent to you by:
American Academy of Orthopaedic Surgeons
9400 W. Higgins Road, Rosemont, IL , 60018,
http://www.aaos.org

Even if you live alone, home may be the best place to recover after total joint replacement surgery

Posted On March 14, 2017 By OrthoSpineNews In Recon /

SAN DIEGO, Calif., March 14, 2017 /PRNewswire-USNewswire/ — Despite higher costs, many doctors recommend and some patients prefer, recovery at an in-patient rehabilitation facility following total hip (THR) or total knee replacement (TKR) surgery. And yet a new study to be presented Thursday, March 16, at the 2017 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS), found that even patients who live alone can recover effectively and safely at home.

“In the past, most surgeons have been reticent to discharge patients directly home after joint replacement surgery if they live by themselves; instead, opting for such patients to enter a rehab facility,” said lead author William J. Hozack, MD, an orthopaedic surgeon at The Rothman Institute and professor of orthopaedic surgery at the Sidney Kimmel Medical College at Thomas Jefferson University. “However, we found that patients living alone were able to safely recover without any increase in the rate of complications. Even more strikingly, patients were generally happy and content being in the comfort of their own home during recovery.”

The study, “Even if You Live Alone, There’s No Place Like Home after Total Joint Arthroplasty,” (LINK) involved 769 patients undergoing primary THR or TKR. Of these, 138 patients lived alone and 631 lived with other people. In both groups, patients age 75 and older were well represented. The patients who lived alone were more likely to stay an additional night in the hospital prior to discharge and utilize more home health services, especially older patients. Limited support without weekly visits was reported by 37.2 percent of patients living alone, although nearly 80 percent had a friend or relative living within 15 miles who could provide help if needed.

Among the results of the study:

There was no increase in complications or unplanned clinical events for patients living alone compared to those living with other people (10.9 percent of patients living alone had complications, compared with 9.5 percent of those recovering at home with support).
There were no significant differences in functional outcomes following surgery, or in reported pain.
Patient satisfaction scores were equivalent in both sets of patients after 90 days.
The cost savings for patients who recovered at home was estimated at $10,776 per patient, or nearly $1.5 million total.

Given the cost savings of in-home recovery, the emotional benefits of patients recovering in familiar surroundings, and no measurable difference in pain, complications or functional outcomes, “we believe home discharge is appropriate for the vast majority of patients undergoing joint replacement, including the nearly 20 percent of patients living on their own,” said Dr. Hozack.

In addition, the July 2016 U.S. Department of Health & Human Services (HHS) Office of Inspector General report, “Adverse Events in Rehabilitation Hospitals: National Incidence Among Medicare Beneficiaries,” highlighted “a surprisingly high rate of adverse events at rehab hospitals across the U.S.,” said Dr. Hozack.

Study abstract

Two additional studies presented at the 2017 AAOS Annual Meeting also found higher rates of complications and morbidity in hip and knee replacements patients who recover at inpatient care facilities:

2017 AAOS Annual Meeting Disclosure Statements

CONTACT: Sheryl Cash, 847-384-4032, 847-804-7486, scash@aaos.org | Lauren Pearson Riley, 847-384-4031, 708-227-1773, pearson@aaos.org

This information is being sent to you by:
American Academy of Orthopaedic Surgeons
9400 W. Higgins Road, Rosemont, IL , 60018,
http://www.aaos.org

BoneSupport TM extends U.S. Distribution agreement for Cerament TM Bone Void Filler

Posted On March 14, 2017 By OrthoSpineNews In Biologics, Top Stories /

Lund, Sweden, 14 March, 2017 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces that it has extended the term of its U.S. distribution agreement with Zimmer Biomet. Under the agreement, Zimmer Biomet will continue to have exclusive rights for BONESUPPORT’s proprietary CERAMENT BONE VOID FILLER product line for Orthopedics, Trauma and Foot and Ankle indications in the United States.

“We are extremely pleased to extend our distribution agreement with Zimmer Biomet,” said Richard Davies, CEO of BONESUPPORT™. “The partnership has been very successful and has resulted in the current rapid growth of our flagship product, CERAMENT in the world’s largest bone graft substitute market. This rapid growth is building an important platform from which we can launch product extensions into the US.”

In addition to commercialization of CERAMENT BONE VOID FILLER in the U.S. market, BONESUPPORT is currently enrolling patients into the FORTIFY Clinical Study, an FDA approved IDE randomized control pivotal study for the Company’s anti-biotic eluting product CERAMENT G. CERAMENT G is currently approved and commercialized in the EU and other markets outside the United States.

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.

CERAMENT G 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 improve the lives of patients suffering from bone disorders that cause bone voids, lead to injury, breakage, pain, and reduced quality of life. The Company is based in Lund, Sweden. www.bonesupport.com

BONESUPPORT and CERAMENT are registered trademarks.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

bonesupport@citigatedr.co.uk

Implanet Strengthens Its Presence in Australia and New Zealand by Signing an Exclusive Distribution Partnership

Posted On March 14, 2017 By OrthoSpineNews In Spine, Top Stories /

March 14, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, announces the integration of Jazz Claw into the ARTG register. This integration is completing the JAZZ Range for the treatment of Pediatric and Adult Scoliosis. In conjunction, Implanet has signed an exclusive distribution partnership with Device Technologies for Australia and New Zealand. Implanet now markets in 17 countries across the globe, with this partnership significantly enhancing its sales potential in the Asia-Pacific region.

The entire range of Jazz® products will enable Implanet to address a vertebral fusion market estimated to be worth USD 120 million in Australia. Dr. John Choi, from Melbourne’s Spine Ortho Clinic, says: “The clinical benefit Jazz® provides compared with all-screw or screw-and-hook assemblies in the sagittal realignment of patients, as well as in their postoperative recovery, is undeniable. I am delighted to have access to the entire Jazz product range at the Spine Orthopedic Clinic and, more generally, across Australia.”

Implanet has signed an exclusive distribution partnership with Device Technologies, a company with more than 600 employees specializing in medical device distribution. Founded 25 years ago, the company is a pioneer in this sector in Australia, and covers the entire distribution chain from the sale of equipment to associated services. This agreement significantly strengthens Implanet’s geographical coverage through its partners’ various offices and sales agents across Australia and in New Zealand.

Michael Trevaskis, CEO of Device Technologies, concludes: “Jazz® represents truly innovative technology in the field of spine surgery. We are delighted and enthusiastic about the idea of making it available to all hospitals and patients throughout this country, notably for younger and older patients suffering from particularly debilitating deformities. Australian medical facilities are used to being among the world’s best equipped, and we are confident in our ability to provide them with one of the very best spine technologies.”

Ludovic Lastennet, CEO of Implanet, says: “The exclusive partnership with Device Technologies, a major player in Australia and New Zealand, represents a key milestone that opens the way for promising sales prospects for Implanet in the region. This milestone is fully in line with our expansion strategy in partnership with respected commercial partners.”

Next financial press release: 2016 annual results, on March 28, 2017

IMPLANET will participate in the following events:

AAOS (American Academy for Orthopedic Surgeons), San Diego CA, USA, March 15 to 17, 2017
Canaccord Genuity Musculoskeletal Conference, San Diego, CA, USA, March 14, 2017

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Compartment C of the Euronext™ regulated market in Paris.

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net

The Hazards of Travel and How to Minimize Your Risk

Posted On March 13, 2017 By OrthoSpineNews In Spine, Sports Medicine /

Greg Houlgate, Contributor – CEO/President Oska Wellness, Inc.

As a child, I couldn’t wait to go to the airport to watch the enormous planes roll up to the gate and witness the steady stream of people from all walks of life transitioning in the corridors of the terminal. For me, there was a mystique and elegance that was unique on my voyages to the airport.

This mystique is far from relatable these days. In fact, the allure and exotic nature of travel have certainly eroded for many over the past four decades. Like most people I know, we worry about timing to the airport because of traffic on the road, delays at the security checks, lack of adequate places to stage at the gate, and so on. Added to this list include the fear of getting sick from your coughing neighbor, dirty rest areas, filtered air, the constant reminders about access to clean water, and the inevitable struggle that altitude travel can present while attempting to stay healthy on any trip.

The CDC, too, warns us of a list of conditions that could be harmful for humans as we travel. If you read their recommendations, you may never wish to step out of your house at all!

As an active business and leisure traveler for over 40 years, I can certainly share a few horror stories of my own about life on the road. But the reality is, travel is an integral part of the modern world. To avoid travel (specifically air travel) will deny you the opportunities to enjoy potential new adventures and the obvious benefits that leaving the comforts of home can offer.

Each of my less-than-optimal travel experiences has made me somewhat of an expert on how to make travel a healthier and more comfortable experience.

For instance, in advance of any air travel, I am particularly cognizant of my diet, sleep and exercise. Staying hydrated, getting exercise and rest will go a long way to keep you protected when you are in crowded public places. Secondly, I always arm myself with some modern technology to help keep my circulation and health at an optimum level regardless of my ability to move in confined places.

In an effort to impart some of my sagely travel advice to you, the following list includes my personal travel must-haves that I never hit the road without. The best part, they are easily portable and TSA approved to minimize any hassle:

1. Compression socks

Compression socks not only increase circulation, they potentially help stave off DVT or deep vein thrombosis. This condition can be life altering; in some cases, even fatal. Compression socks and other devices can help a person with this condition or prevent it after surgery if they have poor circulation.

2. Neck Pillows

Neck pillows can provide a whole lot of benefit, specifically you have your own clean pillow when you rest on a plane. It’ll help increase your chances of sleep, which (as we all know) can be one of the most challenging aspects of travel, especially internationally.

3. Personal Ear buds and Anti-bacterial Wipes

Personal use ear buds and anti- Bacterial wipes are both recommended as an easy way to take control of your space within an airplane seat, while also keeping sickness at bay.

4. Portable PEMF devices (similar to those that the astronaut’s use)

PEMF is a widely researched therapy that is regularly deployed by our friends at NASA. NASA astronauts have optimized PEMF devices for many years simply due to the clinical efficacy of the many positive effects this technology creates in and around the human body. NASA has determined, through decades of study, that the ravages of air and space travel decrease the body’s ability to maintain proper circulation, bone density and overall wellness. In combating this physical limit, NASA uses PEMF to not only protect but to strength an astronaut during their ventures. One consumer-friendly PEMF device that is FDA-registered and TSA approved is called Oska Pulse (www.oskawellness.com).

Next time you hit the road, arm yourself with these tools and advice to ensure you are maximizing your comfort and health while you travel. Take it from me: it’ll make all the difference.

OMNIlife science™, Inc. Announces First Clinical Use of Novel Robotic Tissue Balancing Device for OMNIBotics® Technology Platform

Posted On March 13, 2017 By OrthoSpineNews In Regulatory, Robotics /

RAYNHAM, Mass., March 13, 2017 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today the first clinical use of a novel robotic tissue balancing device for use with OMNI’s market-leading OMNIBotics® robotic-assisted total knee replacement technology platform. The successful initial procedure took place in Sydney, Australia and was performed by Dr. Brett Fritsch, MD, FRACS, who is also a member of OMNI’s surgeon clinical evaluation and research team. The device has received the CE Mark and a 510(k) has been submitted to FDA for clearance in the United States.

The OMNIBotics system enables optimized knee implant placement using robotics driven by OMNI’s proprietary ART™ software. With more than 13,000 OMNIBotics procedures performed to date worldwide, it provides patient-specific procedures and eliminates the need for preoperative CT scans or x-rays. Intraoperative adjustments are easily made, and the precise alignment of the implant may lead to a more rapid recovery and a more natural feeling total knee replacement.¹ This new robotic tissue balancing device takes patient-specificity one step further and customizes the procedure not only from a skeletal perspective but also from a soft tissue perspective.

“The OMNIBotics tissue balancer provides dynamic real time feedback on the interplay between the soft-tissue envelope and bone cuts in Total Knee Replacement,” said Dr. Brett Fritsch. “Providing a quantitative tool to actively manage soft tissue in combination with the accuracy of a robotic bone cutting guide has the potential to be a significant step forward towards a more natural feeling knee replacement for the patient.”

“The main objective of the OMNI robotics development program is to leverage the capabilities of robotics to assist orthopaedic surgeons in improving patient outcomes at a lower overall cost for the episode of patient care,” said Rick Randall, OMNI CEO. “Our surgeon customers believe a properly aligned and balanced knee throughout the entire range of motion will lead to optimized patient outcomes. The unique capability of robotic-assisted soft tissue balancing, added to the OMNIBotics alignment of the APEX Knee™ is an exciting breakthrough that further advances our value-based outcomes goals.”

ABOUT OMNI

OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

FORWARD LOOKING STATEMENTS

Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms “plans,” “believes” or similar expressions are “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

CONTACT
Cindy Holloway, Director of Marketing Communications Phone: (508) 824-2444
cholloway@omnils.com

¹Ritter, Et al. “The Effect of Alignment and BMI on Failure of Total Knee Replacement”. J Bone Joint Surg, 2011; 93- A:1588-96.

SOURCE OMNIlife science, Inc.

Spineology® Announces Expanded FDA Clearance of Elite™ Expandable Interbody Fusion System

Posted On March 13, 2017 By OrthoSpineNews In Regulatory /

March 13, 2017

MINNEAPOLIS & ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology, Inc. the innovator in Anatomy-Conserving Surgery™, is excited to announce expanded FDA clearance of the Elite Expandable Interbody Fusion System. Included in the clearance is the addition of a narrower, 10mm, version of the device and an indication to utilize the devices with allograft bone.

“The broader size offering and the allograft bone indication allow the surgeon to pair Elite with Incite™ Cortical Fibers,” said John Booth, CEO of Spineology. “Incite’s excellent handling properties and ability to expand in-situ with the Elite Implant are added benefits not found in competitive systems.”

“The Elite Expandable Interbody device is an ideal choice when treating patients with a minimally invasive approach,” said Dr. Mark Grubb of Cleveland, OH. “The minimal initial starting height and a 10mm wide footprint reduces neural retraction requirements. Additionally, having the Incite bone graft that expands with the implant helps ensure good graft apposition.”

Dr. Dwight Tyndall of Munster, IN, uses Elite with the Spineology ACT MediaLIF™ posterior mid-line approach. “The multiple width, length, and lordosis options make Elite an excellent choice for the mid-line approach and bilateral implant placement,” said Dr. Tyndall.

The Elite Expandable Interbody Fusion implant is inserted into the disc space at a contracted minimum height and is expanded once in position to restore anatomic disc height, provide anterior column support, and potentially facilitate indirect decompression. Elite offers the surgeon the ability to control device expansion and lock the device at any position in the expansion range. The Elite implant is constructed of titanium alloy and has a large graft window to enable bone through-growth, maximizing fusion potential.

Incite Cortical Fibers are fiber-based bone allografts that are naturally osteoconductive and that are carefully processed to maintain their inherent osteoinductive potential. These freeze-dried grafts expand when hydrated in-situ, eliminating concern of graft off-loading following implant expansion.

About Spineology Inc.

Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall Public Relations
Dave Folkens, 651-286-6713
dave@risdall.com

New Presentations and Recent Additions to EOS Product Offering to Be Featured at AAOS Annual Meeting

Posted On March 13, 2017 By OrthoSpineNews In Extremities /

March 13, 2017

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI)(Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, today announced it will exhibit its full EOSapps software suite at the upcoming American Academy of Orthopedic Surgeons (AAOS) Annual Meeting, being held March 14 – 18 in San Diego, California. The AAOS academic program also includes ten oral podium presentations featuring the EOS imaging technology and software solutions.

EOS imaging will particularly showcase hipEOS, a fully integrated pre-op and post-op 3D simulation and planning software which enables enhanced 3D personalized care for patients. hipEOS addresses several key areas of concern for total hip arthroplasty (THA):

Prevention of implant wear, impingement and dislocation risks through personalized implant positioning rather than generic “safe zone” as well as incorporation of functional parameters from standing and seated exams.
Prevention of leg length discrepancy, an important area of concern for patient satisfaction and one of the most common reasons for litigation, through the utilization of weight-bearing 3D data to plan length and position.

Marie Meynadier, CEO of EOS imaging, said: “We are pleased to see increasing acknowledgement in the orthopedic field of the value of EOS 3D imaging and planning, as compared to using higher cost, higher dose, supine CT scanning. The podium presentations highlighting EOS system and applications at this year’s AAOS, along with the significant increase in EOS-related publications in peer-reviewed journals in 2016, which doubled from 2015, support this momentum.”

EOS imaging will be onsite at Booth #4933 (Hall G), where the company will showcase the EOS low dose imaging system and its full suite of FDA cleared surgical planning EOSapps solutions, which includes hipEOS, along with spineEOS and kneeEOS. The EOSapps are online 3D surgical simulation and planning solutions, based on unbiased, weight-bearing EOS images and an accurate 2D/3D patient-specific data set.

In addition to the activities at its booth at AAOS, the Company is scheduled to present at the Canaccord Genuity Musculoskeletal Conference on March 14, 2017 at 10:30 am PST. The conference provides the opportunity for institutional investors to meet with the Company.

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS^®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan and the European Union (EC). The Group posted 2016 revenues of €30.8 million and employs 132 people at December 2016, including an R&D team of 43 engineers. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Contacts

EOS imaging
Anne Renevot
CFO
Ph: +33 (0)1 55 25 61 24
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent / Valentine Brouchot
Ph: +33 (0)1 44 71 94 96
eosimaging@newcap.fr
or
The Ruth Group (US)
Press relations / Joanna Zimmerman
Ph: 646-536-7006
jzimmerman@theruthgroup.com

Bioventus Presents Bone Healing, Osteoarthritis Pain and Bone Graft Solutions at AAOS

Posted On March 13, 2017 By OrthoSpineNews In Biologics /

SAN DIEGO – March 14, 2017 – Bioventus, a leader in orthobiologic solutions, today announced its plans for the Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) March 13-18 in the San Diego Convention Center. Among the products clinicians visiting Bioventus in booth #5223 can learn more about is GELSYN-3™ the company’s next generation, three-injection hyaluronic acid (HA).

GELSYN-3 helps relieve pain associated with knee osteoarthritis (OA) and is the company’s latest portfolio addition joining its five-injection knee OA solution called SUPARTZ FX^®, and its single-injection OA product known as DUROLANE^®.Both GELSYN-3 and SUPARTZ FX are available exclusively in the US while DUROLANE is available in OUS markets. Bioventus will also feature the EXOGEN^® Ultrasound Bone Healing System and the associated volume of clinical evidence for efficacy that underscores its position as the #1 prescribed bone healing system in the US.

In addition, Bioventus Surgical will highlight its suite of allograft, cell & marrow and synthetic bone graft solutions including: OSTEOAMP^®, a uniquely processed allograft bone graft substitute; CELLXTRACT^™, a novel cell and bone marrow extraction tool; and SIGNAFUSE^™ a bi-phasic mineral composite combined with a patented bioactive glass and resorbable polymer carrier.

“Since it was established in 2012, Bioventus has expanded its portfolio to include 13 offerings for bone healing, osteoarthritis and bone grafts,” said Tony Bihl, CEO, Bioventus. “Our singular and unique focus is on orthobiologics that provide positive outcomes to benefit patients, surgeons, hospitals and payers. We invite AAOS attendees to visit with us and learn more about our solutions which are not only effective, but are backed by clinical and technical data.”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN Ultrasound Bone Healing System is the #1 prescribed bone healing system in the US and is the only FDA-approved bone healing device that uses safe, effective ultrasound to stimulate the body’s natural healing process. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Media Contact:
Thomas Hill, +1 919-474-6715, thomas.hill@bioventusglobal.com

Bioventus, the Bioventus logo, DUROLANE, OSTEOAMP and EXOGEN are registered trademarks and GELSYN-3, CELLXTRACT and SIGNAFUSE are trademarks of Bioventus LLC of Bioventus LLC. SUPARTZ FX is a registered trademark of Seikagaku Corp.

Summary of Indications for Use

OSTEOAMP may be used in situations where an autograft is appropriate. It should be restricted to homologous use for the repair, replacement or reconstruction of musculoskeletal defects. Please see OSTEOAMP instructions for use for complete list of contraindications, warnings, and precautions. Full prescribing information can be found in product labeling at BioventusSurgical.com or by contacting customer service at 1-800-637-4391. It is available in the US only.

SIGNAFUSE is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SIGNAFUSE is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine fusion procedures). SIGNAFUSE can also be used with autograft as a bone graft extender in the posterolateral spine. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process. Full prescribing information can be found in product labeling at BioventusSurgical.com or by contacting customer service at 1-800-637-4391. It is available in the US only.

CELLXTRACT is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe. Full prescribing information can be found in product labeling at BioventusSurgical.com by contacting customer service at1-800-637-4391.

SUPARTZ FX is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. You should not use SUPARTZ FX if you have infections or skin diseases at the injection site or allergies to avian (bird) products (feathers and eggs). SUPARTZ FX is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site. Full prescribing information can be found at www.SupartzFX.com or by contacting customer service at 1-800-836-4080.

GELSYN-3 is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). GELSYN-3 is not to be administered to patients with known hypersensitivity (allergy) to sodium hyaluronate preparations and should not be injected into the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site. Full prescribing information can be found at www.GelSyn3.com or by contacting customer service at 1-800-836-4080.

EXOGEN

Summary of Indications for Use: In Canada, the EU, Australia and New Zealand

EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) including:

Treatment of delayed union and non-unions†
• Accelerating the time to heal of fresh fractures
• Treatment of stress fractures
• Accelerating repair following osteotomy
• Accelerating repair in bone transport procedures
• Accelerating repair in distraction osteogenesis procedures
• Treatment of joint fusion

† A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.

There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling at www.exogen.com.

Summary of Indications for Use in the US

*Summary of Indications for Use: The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions* excluding skull and vertebra. In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization.

There are no known contraindications for the EXOGEN device. Safety and effectiveness has not been established for individuals lacking skeletal maturity; pregnant or nursing women; patients with cardiac pacemakers; on fractures due to bone cancer; or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling, at www.exogen.com or by contacting customer service at 1-800-836-4080.

*A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

DUROLANE

European Union and Chile:

DUROLANE (3ml): Symptomatic treatment of mild to moderate knee or hip osteoarthritis. In addition, DUROLANE has been approved in the EU for the symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, shoulder, elbow, wrist, fingers, and toes.

DUROLANE SJ (1ml): Symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, elbow, wrist, fingers, and toes.

Both DUROLANE and DUROLANE SJ are also indicated for pain following joint arthroscopy in the presence of osteoarthritis within 3months of the procedure.

Full prescribing information can be found in product labeling, or at www.durolane.com.

Canada:

DUROLANE (3ml): Symptomatic treatment of mild to moderate knee or hip osteoarthritis. In addition, DUROLANE has been licensed for the symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, fingers and toes.

DUROLANE SJ (1ml): Symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, fingers and toes.

Both DUROLANE and DUROLANE SJ are also indicated for pain following joint arthroscopy in the presence of osteoarthritis within 3months of the procedure. There are no known contraindications. You should not use DUROLANE if you have infections or skin disease at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Risks can include transient pain, swelling and/or stiffness at the injection site.

Full prescribing information can be found in product labeling, or at www.durolane.com.

Australia/New Zealand/Mexico:

DUROLANE (3ml): Symptomatic treatment of mild to moderate knee osteoarthritis.

There are no known contraindications. You should not use DUROLANE if you have infections or skin disease at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Risks can include transient pain, swelling and/or stiffness at the injection site. Full prescribing information can be found in product labeling, or at www.durolane.com.

India, Indonesia, U.A.E., Saudi Arabia, Jordan, Hong Kong, Russia:

DUROLANE (3ml): Symptomatic treatment of mild to moderate knee and hip osteoarthritis.

Taiwan:

DUROLANE (3ml): Treatment of pain in OA of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.

DJO Global Announces the Launch of the Altivate™ Anatomic Shoulder System

Posted On March 13, 2017 By OrthoSpineNews In Extremities /

March 13, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced the launch of the AltiVate Anatomic Shoulder System. The system features a short, bone sparing humeral stem anatomically designed through morphologically-based fit analysis to optimize metaphyseal fit and stability. The stem also features P², DJO’s proprietary “porous porous” coating that provides superior bone ingrowth. Coupled with the stem is a glenoid component with patent-pending “Drop and Go™” technology encompassing trilobe features on the peripheral pegs for immediate fixation upon implantation. This data-driven result is a truly anatomic reconstruction with fixation you can feel.

“The AltiVate Anatomic system allows the surgeon to use a short or standard length humeral stem with the same instrument system and introduces a new glenoid component with outstanding initial fixation. The glenoid instrumentation is low profile and user friendly,” states Dr. Gerald Williams of the Rothman Institute and a leading designer of the system. In summary, “this system provides the humeral length you want; the glenoid fixation you need.”

Brady Shirley, President and CEO of DJO Global states, “The release of this new system strengthens our Upper Extremity portfolio, which is already known for its market-leading AltiVate Reverse shoulder system. We believe this will help us sustain our above market growth in this segment. The AltiVate Anatomic is the first of many advancements to come from DJO Global’s developers consisting of world recognized leaders in shoulder arthroplasty.”

This new system will be showcased at this year’s Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS booth #1733) in San Diego, CA.

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 orthopaedic 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 orthopaedic 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® 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 the success of this product family and its Upper Extremity product portfolio. The words “believe,” “will,” “should,” “expect,” ”target,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. 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 the results of the Company’s new product family and Upper Extremity product portfolio to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the complexities and uncertainties associated with the development of new products; the uncertainties associated with acceptance of the new products by surgeons and patients; new product introduction and other business strategies relative to our Surgical Implant segment; the continued growth of the 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, 2015, filed with the Securities and Exchange Commission on March 25, 2016. 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 and Treasurer
760-734-3075
ir@djoglobal.com

Month: March 2017

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