Nearly one-third of osteoarthritis-related costs incurred the year prior to knee replacement surgery are for non-recommended treatments

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

SAN DIEGO, March 14, 2017 /PRNewswire-USNewswire/ — In the year prior to total knee replacement (TKR) surgery, almost one-third of the costs for treatment of arthritis symptoms went toward strategies not recommended by the American Academy of Orthopaedic Surgeons (AAOS), according to new research presented today at the 2017 AAOS Annual Meeting. Costs could decrease by an estimated 30 percent if treatments that are not recommended are no longer utilized.

“As we transition to an era of value based health care, it will be important to consider both the quality of our interventions as well as the cost associated with that care,” said study author Nicholas Bedard, MD, an orthopaedic surgeon at the University of Iowa Hospitals & Clinics.

Researchers reviewed Humana Inc. insurance information (both private and Medicare Advantage plans) from 2007 through 2015 on more than 86,000 patients diagnosed with osteoarthritis of the knee, who went on to have TKR within one year. The costs were specifically related to reimbursement for hyaluronic acid (HA) or corticosteroid (CS) injections, physical therapy (PT), braces and wedge insoles, pain medication and non-steroidal anti-inflammatory drugs (NSAIDs). Only three of these treatments—physical therapy, NSAIDs, and the drug tramadol (short-term for severe pain)—are recommended in the AAOS clinical practice guideline (CPG): “Non-arthroplasty Treatment of Osteoarthritis of the Knee.”

The total costs associated with outpatient knee osteoarthritis was $43,582,648. Among the other findings:

65.8 percent of the patients (56,960) underwent at least one of the analyzed treatments in the year prior to their TKR.
The top three most costly treatments were HA injections, CS injections and PT, accounting for 52.6 percent of expenses (excluding hospital or inpatient), total costs of knee osteoarthritis in the year prior to TKR.
The AAOS recommended treatments—PT, NSAIDs and Tramadol—represented just 11 percent of the total costs; in contrast, 29 percent of the costs were for interventions with strong or moderate recommendations against their use in the AAOS knee CPG.

“We hope that research such as this highlights the high prevalence of low-value interventions in the management of knee osteoarthritis and helps to motivate a transition to higher value care,” said Dr. Bedard.

Study abstract

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; or 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

$Despite the known role of vitamin D in preventing osteoporosis, less than half of elderly hip fracture patients take supplements$

Despite the known role of vitamin D in preventing osteoporosis, less than half of elderly hip fracture patients take supplements

Posted On March 14, 2017 By OrthoSpineNews In Extremities, Spine /

SAN DIEGO, Calif., March 14, 2017 /PRNewswire-USNewswire/ — Despite national recommendations for daily vitamin D intake, a new study presented today at the 2017 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) found that just 45.7 percent of patients reported consistently taking vitamin D supplements following a hip fracture, a known treatment and preventative strategy for osteoporosis.

In the U.S., an estimated 44 million people have osteoporosis and another 10 million are at risk for the disease which causes progressive bone loss and increased fracture risk. One in two women and one in four men older than age 50 years will sustain a bone fracture caused by osteoporosis. These potentially debilitating injuries include fractures of the hip, spine, wrist, arm or leg, often occurring from a fall. A bone fracture is often the first sign of the disease which develops slowly with no other symptoms. Treatments, which include medication, weight-bearing exercise, and/or vitamin D, calcium or estrogen supplements, can prevent subsequent fractures.

The U.S. Food and Nutrition Board (FNB) at the Institute of Medicine of The National Academies recommends 600 International Units (IUs) of vitamin D each day for adults, and 800 IUs for Americans age 71 and older.

In this study, Canadian researchers interviewed 573 hip fracture patients about their vitamin D intake during doctor visits for two years following hip fracture surgery. The mean patient age was 74.1, and the majority of patients (66.3 percent) were women.

Less than 50 percent (47.5 percent) of the patients consistently took vitamin D supplements as recommended, 35.6 percent took supplements inconsistently, and less than 19 percent took no supplements. Despite well-developed guidelines and close follow-up in a clinical trial, a low proportion of elderly hip fracture patients are consistently taking vitamin D. This suggests a need to develop and evaluate additional strategies to promote compliance.

“Vitamin D supplementation following hip fracture surgery is grossly under-prescribed,” said co-study author Mohit Bhandari, MD, an orthopaedic surgeon and research chair in musculoskeletal trauma and surgical outcomes, at McMaster University in Ontario, Canada. “Given its potential to improve patient function independent of other therapies, it seems improved advocacy and education—aimed at doctors and patients—about vitamin D supplementation is both worthwhile and evidence-based.”

Added co-study author Earl Bogoch, MD, an orthopaedic surgeon at the University of Toronto: “The benefits, safety and ease of taking vitamin D appear to be unknown or ignored by this representative cohort group of elderly osteoporotic patients who are identified by numerous guidelines as being most likely to benefit.”

The AAOS position statement, “Orthopaedic Care of Patients with Fragility Fractures,” recommends that U.S. physicians proactively screen, monitor, and, if necessary, assist in getting treatment for elderly and other at-risk patients for osteoporosis following an initial bone fracture to prevent subsequent fractures.

Study abstract

2017 AAOS Annual Meeting Disclosure Statements

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

SpineGuard and Zavation Announce First 20 Cases in USA with Single-Step Insertion of DSG™ “SmartScrew”

Posted On March 14, 2017 By OrthoSpineNews In Spine /

March 14, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced today the first cases in the USA using the one-step-insertion of pedicle “smart screws” guided by DSG™ (Dynamic Surgical Guidance) technology. The surgeries were performed successfully by eminent surgeons throughout the USA.

See 3D animation of the “SmartScrew” here.

Thomas Freeman, Professor of Neurosurgery, Tampa, Fla., said: “I knew immediately where the trajectory of the screw was going, even without fluoroscopy. Rather than use five steps to put a screw into the spine, only one step was needed. I could redirect it easily if needed.”

“The DSG technology will change the way spine surgery is performed. It will allow us to place spinal instrumentation faster, safer and with greater accuracy minimizing the risks to our patients,” said Victor Hayes, MD, Orthopedic Surgeon, Trinity Spine Center, Tampa, Fla.

“Integrating the Dynamic Surgical Guidance technology with pedicle screws will greatly optimize the workflow and accuracy, and reduce radiation exposure for surgeons in both the traditional and MIS surgical settings. Not only will the ‘smart screw’ allow for active real-time guidance and breach-avoidance through the pedicle, but it will also provide unprecedented feedback and confidence in the ultimate fixation of the screw itself,” said Larry Khoo, MD, neurosurgeon at The Spine Clinic, Los Angeles, Calif.

“The procedures that we have performed with the self-guiding ‘Smart Screw’ technology have advanced the safety of spinal surgery exponentially by reducing the probability of nerve and spinal cord injury and reducing radiation exposure to patients and hospital staff,”added Farhan Siddiqi, MD, Assistant Professor, University of South Florida, Trinity Spine Center, Florida Advanced Spine, Sports, and Trauma Centers.

John I. Williams, MD, SpineONE, a division of Ortho NorthEast, Ft. Wayne, Ind., concluded: “One-step technology is something that is being explored by multiple implant manufacturers right now…. this ‘smart screw’ with DSG technology is simply going to remove several steps in the process of applying spinal instrumentation.”

For SpineGuard and Zavation, who announced their co-development partnership in early 2015, these successful first surgeries performed after obtaining 510(k) clearance from the U.S. Food and Drug Administration (FDA) are an essential milestone in preparation for the commercial launch of the Zavation pedicle screw instrumentation that integrates the DSG technology.

Pierre Jérôme, CEO and co-founder of SpineGuard, said: “These surgeries further validate the clinical utility of embedding our DSG technology into the vertebral implant itself, thus enabling its insertion without any preliminary step. We are steadfast in the concept that DSG technology will further secure and simplify the most commonly performed instrumented spine procedure, fusion, while optimizing its cost to the hospital with an ‘integrated guidance’ approach.”

Jeffrey Johnson, CEO and founder of Zavation, added: “Early surgery results with our Z-Direct Screw combined with the DSG technology have been very successful. The single-step technology allows surgeons to use less fluoroscopy and reduce surgery times with excellent screw placement.”

Pedicle screw-based fusion has become the gold standard for treating spine instabilities and deformities. The US spine industry is estimated to have grown 5% between 2015 and 2016 to $7.8 billion in sales to US hospitalsⁱ. This is the highest year-to-year growth in this market since 2010, and reflects the growth in specific sub-segments of the spine market. The US market for spinal implants and devices used in spinal surgery now exceed both the size and growth of the US hip and knee market which was estimated to be $7.5 billion in 2015, up 2.5% from 2014.

More information on the DSG™ technology, its new applications and surgeons’ testimonials here.

More information on the Zavation products that incorporate DSG™ technology click here.

Previous release: SpineGuard extends the utility of its Dynamic Surgical Guidance (DSG ™) technology platform by receiving US patent for “Bone Quality Measurement” application.

Next Press Release: 2016 Full-Year financial results, March 23, 2017

SpineGuard will participate in the ‘Canaccord Genuity Musculoskeletal Conference’ conference on March 14^th, 2017 in San Diego, CA before the American Academy of Orthopedic Surgeons Annual Meeting.

About SpineGuard^®
Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard^®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 50,000 surgical procedures have been performed worldwide with DSG enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

About Zavation
Zavation is an employee-owned medical device company that designs, develops, manufactures and distributes medical device products that provide comprehensive medical solutions to improve and enhance quality of life for patients around the world. Zavation is dedicated to exceeding expectations in product quality, customer service, and product cost. For further information, visit www.zavation.com.

Disclaimer
The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any USA state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

ⁱSource: Orthopedic Network News, 2016 Spinal Surgery Update, Volume 27, Number 4; October 2016.

Contacts

SpineGuard
Pierre Jérôme, +33 (0)1 45 18 45 19
Chief Executive Officer
p.jerome@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Zavation
Jeffrey Johnson, 601-919-1119
Chief Executive Officer
Jeffrey.johnson@zavation.com
or
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent, +33 (0)1 44 71 94 94
spineguard@newcap.fr
or
US
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

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

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

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