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

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

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.

Lateral Lumbar Interbody Fusion Market: Emergence of Advanced Technologies and Future Outlook 2024

Posted On March 10, 2017 By OrthoSpineNews In Spine /

3-10-2017 – Health & Medicine, Press release from: TMR

Lateral lumbar interbody fusion (LLIF) is a minimally invasive technique and is in demand for surgical spinal fusion procedure. LLIF is an effective and safe surgical procedure that makes post-operative recovery quicker and less painful. The incision is made from the side through psoas muscle that allows surgeons to access more surface area with less damage to the tissue and reduced blood loss.

Lateral lumbar interbody fusion is a surgical procedure used to treat specific types of disorders of lumbar spine, such as degenerative disc disease, low grade spondylolisthesis, degenerative scoliosis (asymmetric disc degeneration) and deformity, and some recurrent lumbar herniated disc and lumbar stenosis. Developments in magnification and illumination associated with surgical instrumentation have led to increased applicability of minimally invasive technique for spinal fusion. High device cost and various procedure levels are likely to boost the growth of the market.

Obtain Report Details @www.transparencymarketresearch.com/lateral-lumbar-interbo…

The minimally invasive lateral lumbar interbody fusion has certain advantages such as enhanced spine alignment and easier spine access in several cases such as degenerative diseases and correction in sagittal and coronal deformities. Large number of surgeons prefer this procedure, as it results in less blood loss and lower damage to the tissues around the surgical area. Reduced time for operation and length of hospital stay, greater fusion, and lesser infection rates are the other advantages of this procedure.

Increased incidence of degenerative diseases and rising prevalence of lower back pain in the population above 45 years drive the global lateral lumbar interbody fusion market. Higher visualization resulting in easy and precise operation with less tissue sparing practice are other factors that propel the global lateral lumbar interbody fusion market. However, high cost of operation and risks associated with lateral lumbar interbody fusion such as psoas muscles or neural network injury and bone graft fusion complication restrain the market.

READ THE REST HERE

Stryker’s Spine division to exhibit key technologies at AAOS 2017

Posted On March 10, 2017 By OrthoSpineNews In Spine, Top Stories /

March 09, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that it will demonstrate its Aero-C Cervical Stability System (Aero-C) and Xia 4.5 Cortical Trajectory implants and instruments (Xia CT) at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, March 15–18, 2017, in San Diego (booth No. 3133).

Aero-C, the only straight forward anterior cervical discectomy and fusion (ACDF) device that offers uniform compression across the interbody space, will be displayed at AAOS 2017, highlighting its full commercial launch. Using Aerofoil™ Compression Technology, Aero-C is designed to pull the vertebral bodies toward the implant as it is inserted, creating compressive forces at the implant-to-endplate interface.¹Aerofoil Compression Technology is also available for lateral and anterior lumbar interbody fusion procedures (LLIF and ALIF). Since the initial introduction to the market, over 600 cases have been completed.

Also to be demonstrated at AAOS is Xia CT, which includes implants and instruments used in less invasive LITe LIF posterior lumbar interbody fusion procedures for patients with degenerative disc disease, spondylolisthesis, and trauma. The cortical trajectory procedure facilitates a smaller midline incision to help achieve decompression, fixation, and fusion.² It also is intended to be more muscle sparing than standard open procedures that require lateral dissection, and its reduced incision may allow for more efficient exposure and closure time.² The launch of the Xia CT system occurred in 2016, with 575 cases completed to date.

“Since their introduction last year, Aero-C and Xia CT have been well received by our surgeon customers and have achieved rapid adoption in the marketplace,” said Bradley Paddock, President of Stryker’s Spine division. “These unique products reflect our strong commitment to advancing spine health and helping to enhance outcomes for patients by providing physicians with innovative and differentiated technology.”

Aero-C and Xia CT offer advancements that highlight the Spine division’s leadership in pioneering innovative technologies for traditional and minimally invasive surgical techniques. The company offers one of the most comprehensive and diverse product portfolios for the treatment of degenerative and complex spinal disorders. Its suite of leading-edge products includes implants, instruments, and biologics for the cervical, thoracic, and lumbar spine.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

References

PROJ0000050417 Aero-C Anchor Induced Compression Testing Design Iteration Memo
Lee GW, Son JH, Ahn MW, Kim HJ, Yeom JS. (2015) The comparison of pedicle screw and cortical screw in posterior lumbar interbody fusion: a prospective randomized noninferiority trial. The Spine Journal 15, 1519-1526.

Indications for Use

The AERO-C Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. The AERO-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The Xia CT implants and instruments are intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; failed previous fusion.

Content ID: CVAER-PR-2_13458

Contacts

Barbara Sullivan, Sullivan & Associates
bsullivan@sullivanpr.com, 714/374-6174

Study Finds Wide Use of Computed Tomography (CT) for Post-Operative Assessment of Spine Surgery, Despite Radiation Risks for Patients

Posted On March 9, 2017 By OrthoSpineNews In Spine, Top Stories /

March 08, 2017

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical, Inc., maker of the Simplify® cervical artificial disc designed to be clearly viewed on MRI with minimal artifact, announced findings from a new study published in BMC Musculoskeletal Disorders that is the first to estimate the magnitude of computed tomography (CT) imaging for post-operative assessment of spine surgery, which exposes patients to high doses of radiation. The Simplify Disc is considered an investigational device in the U.S.

The study found that CT prevalence following complex spine surgery increased more than two-fold from six months to five years, with patients averaging two scans over that period. Each CT scan has been estimated to deliver the equivalent radiation of 400 to 550 chest X-rays to the patient. The retrospective study utilized data drawn from a Humana database covering eight consecutive years from 2007 through 2014 and comprising adjudicated claims for more than 130,000 complex spine procedures.

While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, surgeons often switch to CT post-operatively because spinal implants usually include metal components. The metal creates artifacts in the MRI image, making the implants difficult to view and affecting visualization of the facets and adjacent levels.

The study authors state, “We detected a high frequency of CT utilization following complex spine surgery. There is emerging evidence of an increased cancer risk due to ionizing radiation exposure with CT. Thus, in the setting of complex spine surgery, actions to mitigate this risk should be considered…(including) adopting non-ferromagnetic implant biomaterials that facilitate MRI post-operatively.”

One device that may minimize the need for post-surgical CT scans is the Simplify Disc, a cervical artificial disc designed to be clearly viewed on MRI without artifact. Composed of PEEK-on-ceramic materials, the Simplify Disc is intended to minimize patient exposure to high-dose ionizing radiation from CT and its associated risks. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. The Simplify Disc is anatomically designed with low height implant options for patients with smaller cervical disc spaces for whom larger implants are not optimal.

The Simplify Disc is currently enrolling patients in a non-randomized pivotal clinical trial in the U.S. – where all patients will receive the device – comparing one-level cervical implantation of the disc between C3 to C7 with cervical fusion surgery from a historical nonconcurrent control group. More information about the clinical trial is available at www.SimplifyTrial.com.

The Simplify Disc has received the CE Mark and has been used to treat 600 patients outside the U.S. over the last three years. Early clinical data has shown substantial improvement in patient pain scores after treatment.

The Simplify Disc is designed to comply with two principles developed by the International Committee on Radiological Protection and endorsed by the U.S. Food and Drug Administration (FDA), which mandate that exams using ionizing radiation – such as CT – be performed only when medically necessary, and that patients should be exposed to the lowest possible radiation.

The BMC Musculoskeletal Disorders article was authored by Vikas Patel, MD, of the University of Colorado Hospital, Denver; Gunnar Andersson, MD, of Rush University Medical Center, Chicago; Steven Garfin, MD, and Donald Resnick, MD, both with the University of California, San Diego; and Jon Block, Ph.D.

ABOUT SIMPLIFY MEDICAL

Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit www.simplifymedical.com.

Caution: The Simplify Disc is an Investigational device in the United States and is limited by law to investigational use.

Contacts

Chronic Communications
Michelle McAdam, 949-545-6654
michelle@chronic-comm.com

Invibio: FDA reclassified semi-rigid spinal stabilization systems providing new possibilities for treating patients

Posted On March 9, 2017 By OrthoSpineNews In Regulatory, Spine /

THORNTON CLEVELEYS (UK) (PRWEB) MARCH 08, 2017

The US Food and Drug Administration (FDA) has recently reclassified semi-rigid spinal stabilization systems from Class III to Class II (*) offering a regulatory pathway to 510(k) clearance in the United States for innovative devices using PEEK-OPTIMA™ polymer based rods from Invibio Biomaterial Solutions (“Invibio”). When compared to rigid systems, semi-rigid PEEK-OPTIMA rods can deliver similar benefits to titanium and are strong enough to stabilize the spine. The FDA decision supports the safety of semi-rigid systems and provides greater options for surgeons who prefer more flexibility than traditional rigid pedicle screw systems to achieve fusion.

Invibio collaborated closely with medical device manufacturers and the FDA to provide clinical and biomechanical data in support of the use of semi-rigid PEEK-OPTIMA rods for spinal stabilization. The pioneering development and reclassification is expected to assist the medical profession in achieving progress in enhanced spinal fusion systems and procedures.

Clinical evidence: Invibio to support OEMs further with their submissions to the FDA

“The down classification of PEEK-OPTIMA rods as a Class II technology for spinal fusion is a welcome and progressive development for the medical device market. Substantial evidence was presented in reaching this conclusion, including data from over 51,000 PEEK rod implantations. We now have a growing body of clinical evidence that systems based on Invibio´s PEEK-OPTIMA rods have clearly defined advantages over all-metal constructs and have the potential to drive the future of posterior spine stabilization,” commented John Devine, Invibio medical business director.

“Healthcare globally is under pressure to control costs which is why Invibio offers PEEK-OPTIMA spinal rod components to the manufacturer. Compiling evidence that supports the safety and clinical benefits of our materials enables us to also provide an efficient route to market for our customers in terms of manufacturing and regulatory clearance. We look forward to working with our customers to achieve clearance for semi-rigid systems in order to offer improved options for surgeons and ultimately patients,” concluded Devine.

Metal alternative offers distinct advantages

For some time, the medical profession has been aware that spinal-rod components made from PEEK-OPTIMA polymers may be used as an alternative to metal to achieve semi-rigid fixation with posterior pedicle screw systems as an adjunct to fusion. And in fact, they offer distinct advantages over stabilization systems constructed from a metal such as titanium.

“PEEK-polymer solutions are widely recognized for spinal interbody fusion and are frequently used. The versatile PEEK-OPTIMA has a modulus close to that of human bone, and this allows it to be a natural bridge between very rigid metal implants, such as the titanium constructs, and more dynamic approaches. In fact, PEEK-polymer implants offer numerous benefits, including radiolucency, which of course metals don’t allow, while retaining the stability of titanium,” commented Dr. Thierry Desjardins, Neurosurgeon (Cagnes-sur-Mer, France), who has been using PEEK-OPTIMA spinal rods since June 2011 and has always been reluctant to use too rigid a system as this could accelerate degeneration at adjacent spinal segments.

Semi-rigid rods to bridge treatment gap: improved load sharing can encourage fusion

Spinal rods composed of metal are not without challenges, including, but not limited to, rod breakage, the loosening of screws, and accelerated degeneration at adjacent spinal segments. The high stiffness inherent in all-metal constructs is believed to contribute to these clinical challenges and negatively impact patient outcomes.1,2 In addition, a metal such as titanium lacks artifact-free imaging, and inevitably this impacts the ability of surgeons to position stabilization systems accurately.

PEEK-OPTIMA polymer based stabilization, on the other hand, effectively functions as a ‘bridge’ approach. Rods made from the material have sufficient strength to reduce the range of motion2,3 in order to stabilize the treated segment4, but possessing a modulus similar to that of cortical bone, they still allow physiological movement on adjacent upper and lower segments.3 As a result, clinical results increasingly suggest that PEEK-OPTIMA spinal rod components preserve or slow down the degeneration of adjacent discs.5 As a consequence, patients may benefit from improved load sharing to encourage fusion,2,6,7 and more physiologic loading at adjacent levels, which may decelerate degeneration.8,9

To learn more, please visit Invibio at the AAOS Annual Meeting – Booth 3545 – March 15-17, 2017

For more information please visit http://bridgethefusiongap

(*) The US Food and Drug Administration (FDA) renamed dynamic stabilization systems as “semi-rigid systems,” and defined them as a sub-type of pedicle screw systems, now referenced as “thoracolumbosacral pedicle screw systems”.
Further information for the final ruling can be found at “Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems.”

REFERENCES
1.Highsmith JM, et al. (2007). Flexible rods and the case for dynamic stabilization. Neurosurgical Focus, 22, 1-5.
2.Gornet MF, et al. (2011). Biomechanical Assessment of a PEEK Rod System for Semi-Rigid Fixation of Lumbar Fusion Constructs. Journal of Biomechanical Engineering, 133, 1-12.
3.Ponnapan RK, et al. (2009). Biomechanical evaluation and comparison of polyetheretherketone rod system to traditional titanium rod fixation. The Spine Journal, 9, 263-267.
4.Turner JL, et al. (2010). The mechanical effect of commercially pure titanium and polyetheretherketone rods on Spinal implants at the operative and adjacent levels. Spine, 35(21), E1076-E1082.
5.Athanasakopoulos M, et al. (2013) Posterior Spinal Fusion Using Pedicle Screws. Orthopedics, 36, e951-e957. doi: 10.3928/01477447-20130624-28
6.Moumene M, et al. (2008). Biomechanical Advantages of Expedium PEEK Rods. DePuy Spine, Inc.
7.Galbusera F, et al. (2010). Rigid and Flexible Spinal Stabilization Devices: A Biomechanical Comparison. Medical Engineering & Physics, 33, 490-496.
8.Ormond DR, et al. Polyetheretherketone (PEEK) rods in lumbar spine degenerative disease: a case series. J Spinal Disord Tec, 12(8), 693-701.
9.De Iure F, et al. (2012). Posterior lumbar fusion by PEEK rods in degenerative spine: preliminary report on 30 cases. Eur Spine J, 21(1), S50-S54.
10.Greene RJ, et al. (2011). Photoelastic Analysis of the Full-field Stress Distribution Induced by a Spinal Implant Construct. Poster #746 presented at the 2011 Orthopaedic Research Society Annual Meeting.

About Invibio Biomaterial Solutions
Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in more than five million implanted devices worldwide.

About Victrex plc
Victrex, headquartered in the UK, is an innovative world leader in high performance polymer solutions focused on the Aerospace, Automotive, Electronics, Energy and Medical markets. Every day, millions of people rely on products or applications which contain our polymers, from smartphones, aeroplanes and cars to oil & gas operations and medical devices. With over 35 years’ experience, we are delivering leading edge solutions to shape future performance for our customers and our markets, and to drive value for our shareholders. Find out more at http://www.victrexplc.com

K2M to Debut Balance ACS™ at Leading Spine Meetings in March 2017

Posted On March 9, 2017 By OrthoSpineNews In Spine /

LEESBURG, Va., March 08, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it will debut the Balance ACS™ (or BACS™) platform at the Annual Meeting of the American Association of Neurological Surgeons/Congress of Neurological Surgeons Section on Disorders of the Spine and Peripheral Nerves (AANS/CNS) and the American Academy of Orthopaedic Surgeons Annual Meeting (AAOS). The Company will also participate in the British Association of Spine Surgeons (BASS) annual meeting, marking the international introduction of the Balance ACS platform.

Balance ACS is a comprehensive platform applying three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes in spine patients. BACS provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

During the meetings, K2M will demo the BACS System, which provides the necessary services to facilitate quality surgical outcomes and support the intraoperative process. The Company will also unveil a BACS app, which serves as a convenient portal for surgeons to access the BACS System, including:

BACS Preauthorization: An easy-to-follow insurance documentation tool that displays payer- and patient-specific requirements.
BACS Surgical Planner: A surgical image measuring technology to assist in planning and preoperative implant selection.
BACS Anatomical Modeling: 3D-printed anatomical models to aid in visualization of patient anatomy for surgical planning and intraoperative use.
BACS Data Management: A data collection and operative reporting system to track patient quality metrics achieved with spinal balance.

“K2M is excited to introduce the Balance ACS platform of three-dimensional solutions and host educational workshops at leading spine conferences in the United States and internationally,” said K2M President and CEO Eric Major. “Our experience developing complex spine innovations and advancements in 3D solutions has led us to a comprehensive, next-generation BACS platform to help surgeons achieve quality outcomes and Total Body Balance for their patients.”

K2M Meeting Participation Details

K2M will showcase the Balance ACS platform and demo the BACS System and the BACS app. The Company will also host physician workshops featuring prominent spine surgeons presenting on the latest research and clinical applications of the platform.

Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves: March 8–10, Las Vegas, NV
- BACS Platform Exhibition and BACS App Demo: Booth #901
- Workshop: Techniques to Optimize Spinal Balance
  - Friday, March 10, 2017; Noon–1 p.m. (PST); Marquis 6
  - Faculty: Andrew Dailey, MD
American Academy of Orthopaedic Surgeons Annual Meeting: March 14–18, San Diego, CA
- BACS Platform Exhibition and BACS App Demo: Booth #425
British Association of Spine Surgeons: March 15–17, Manchester, UK
- BACS Platform Exhibition and BACS App Demo: Compass Room, Stand #C9
- Workshop: Techniques to Optimize Spinal Balance
  - Wednesday, March 15, 2017; 12:30–13:15; Aldridge Studio
  - Faculty: Robert Lee, BSc, MBBS, FRCS

For more information about Balance ACS and K2M, visit www.BACS.com and www.K2M.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects, including with respect to our international distribution partners in Australia and Japan. In some cases, you can identify these forward-looking statements by the use of words such as ““outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; in adequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due to sales of additional shares by our pre-IPO owners or otherwise; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com 

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

Bio2 Technologies, Inc. to Present Results from Ovine Spinal Fusion Study

Posted On March 9, 2017 By OrthoSpineNews In Biologics, Spine, Top Stories /

WOBURN, Mass., March 8, 2017 /PRNewswire/ — Bio2 Technologies will present a poster at the Annual Meeting of the Orthopaedic Research Society (http://www.ors.org) in San Diego, CA on March 22, 2017 reporting the results from an ovine interbody fusion study conducted at Colorado State University comparing Bio2’s Vitrium device to an implant of similar design constructed from PEEK polymer. Autograft bone was placed in the central lumen of both devices.

Vitrium is an advanced orthobiomaterial with structural properties similar to cortical bone. It is composed of bioactive glass, a material with well-established osteostimulative properties. Bio2 has developed a proprietary manufacturing process to produce a strong, three-dimensional structure featuring interconnected pores facilitating the propagation of new bone.

The biomechanical tests (performed by mdevdev, San Francisco, CA) evaluated Vitrium’s ability to exhibit the ideal characteristics of a spinal fusion product, prospectively defined as: a) an effective, safe resorption/bone formation profile, b) stimulation of new bone formation to increase fusion rates, and c) sufficient strength to bear/share physiologic loads. Janet Krevolin, Ph.D., Bio2’s Chief Technical Officer and co-author of the poster, stated “the test results clearly demonstrated that Vitrium achieved these objectives. All subjects demonstrated a reduction in motion at 26 weeks indicating a fusion taking place for both the Vitrium and PEEK implants. Of note, in axial compressive load to failure testing the Vitrium fusion exhibited strength in excess of the adjoining vertebral bodies, whereas the PEEK fusion failed at the fusion site. The test data show the Vitrium devices exhibited the ideal characteristics of an interbody fusion product.”

Additional information on Vitrium and the ovine spinal fusion study may be found at: http://www.bio2tech.com

SOURCE Bio2 Technologies, Inc.