ORHub, Inc. Expands its Addressable Market with Launch of Transformative Hip and Knee Module

Posted On June 15, 2017 By OrthoSpineNews In Recon, Top Stories /

NEWPORT BEACH, CA–(Marketwired – Jun 14, 2017) – ORHub, Inc. (OTC: ORHB), a cloud-based medical software company established as the Operating Room Hub for data and analytics, today announces that it is launching its new service module for hip and knee surgical procedures, July 2017. With over 100 million surgeries performed in the U.S. every year and growing, this new service line significantly expands the addressable market for the Company’s dynamic analytics capabilities and Surgical Resource Management platform.

“The launch of this new module follows the successful launch of our spine module, which for the past eight months has been in continuous use in two nationally recognized hospitals, achieving overwhelming success. Our hips and knees module is the second of many on our technical road map that will allow us to exponentially grow our addressable market and take advantage of the resulting opportunities,” says ORHub CEO Colt Melby.

According to the Agency for Healthcare Research and Quality, more than 300,000 total hip replacements and 600,000 knee replacements are performed each year in the United States, a figure expected to grow by 13.19 % per year for the next five years. ORHub’s hip and knee service module presents to this growing market unprecedented procedure data and advanced analytics.

ORHub’s Surgical Resource Management software transforms the OR into a highly efficient information center that provides the ability to track and monitor surgical implants, compare material costs, and identify physician and financial impacts in the operating room at the point of surgery. The software also tackles the data chaining needed for cost, usage and eventual outcome correlation in all surgeries without heavy IT investments in infrastructure.

The Company’s spine service line is currently being used for all spine cases in the operating room of two major hospitals in Southern California, where the company recently announced it has successfully collected data from more than 500 surgeries (http://nnw.fm/DTkw3), a number that continues to grow on a daily basis. The data collected provides the hospitals valuable insight that helps identify user needs and make near real-time data driven decisions to improve profitability and the quality of patient care.

“We look forward to updating shareholders on our progress as we continue to build new service modules at a rapid pace conducive to increased corporate value,” says Melby.

ORHub, Transforming the Business of Surgery
The ease of deployment is weeks instead of years, and the power to provide process data for illumination of costs and improvement, gives OR directors and hospital administrators powerful new capabilities to transform the business of surgery. ORHub is capable of agile, low-cost integration with a hospital’s system of choice to complement existing capabilities and provide analytics that are currently not available in the OR suite as a comprehensive view of each episode of care. This puts decision making power at the fingertips of directors and administrators as well as physicians and vendors.

Its case-based subscription model also transforms the business of surgery by moving the infrastructure costs from a CAPEX budget cycle into the operational budget of the OR director. A hospital’s time to insight is transformed from months or weeks to minutes, and the revenue cycle is compressed so time to money is quicker for substantial cash flow improvement.

About ORHub, Inc.
ORHub is a cloud-based software company focused on delivering performance-based medicine at the speed of surgery. The system is in full operation and in daily use at two major hospitals in Southern California.

ORHub enables all parties involved in surgical care to work together to organize, deliver, measure and reimburse in a single uniform process. ORHub’s cloud capabilities also provide a bridge for hospitals in their hybrid cloud strategies, integrating with EHRs and other systems as requested. ORHub is an agile answer for hospitals looking to unlock the power of the OR. Its case-based subscription revenue model also transforms the economics of hospital software from a CAPEX to an OPEX budgeting process.

The need for ORHub is clear. Health care comprises more than 17% of US GDP at over $3 trillion per year. With costs rising every year due to an aging population and more expensive treatments, providers are under severe pressure to become more efficient and reduce costs from payers who are aggressively reducing reimbursements and moving away from fee-for-service and toward performance-based reimbursement. ORHub enables providers to thrive in this new environment by addressing the single largest segment of health care, which is surgical care. ORHub replaces numerous legacy systems with a 360-degree system that is focused on tracking cost from diagnosis to discharge. ORHub has offices in Phoenix, Arizona; Newport Beach, California; and Bellevue, Washington.

Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although the Company believes the expectations reflected in any forward-looking statements are based on reasonable assumptions, it can give no assurances that its expectations will be attained. Such statements are inherently uncertain, and actual results and activities may differ materially from those estimated or projected. Certain factors that can affect the Company’s ability to achieve its anticipated results include, among others, uncertainties inherent in the development of a new software product business.

CONTACT INFORMATION

Communications Contact:
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Email Contact

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DJO Global, Inc. Announces Clinical Trial for a New Indication for CMF OL1000™ Bone Growth Stimulators

Posted On June 14, 2017 By OrthoSpineNews In Extremities, Top Stories /

June 13, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO Global” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, announces the onset of a clinical trial for a new indication of the CMF OL1000 Bone Growth Stimulator.

Combined Magnetic Field (CMF) devices have been on the market since the early 1990s, providing medical professionals with a tool for the noninvasive treatment of an established non-union fracture acquired secondary to trauma, excluding all vertebrae and flat bones. Due to the type of signal technology, CMF devices are prescribed for a treatment time of 30-minutes per day. These battery-powered, FDA-approved medical devices can be used in conjunction with non-magnetic internal or external fixation, over a cast or brace.

DJO Global, through its subsidiary, Encore Medical L.P., initiated the application for an Investigational Device Exemption (IDE) Study with the U.S. Food and Drug Administration (FDA) for a new indication of the CMF technology into the fresh fracture market. The prospective, randomized, double-blinded, controlled, multi-center clinical study will evaluate the use of the CMF OL1000 as a noninvasive adjunctive treatment for closed, unstable ankle fractures that require surgical treatment for stabilization. The FDA-approved study initiated enrollment in January of this year.

For more information on this study, please visit: https://www.clinicaltrials.gov/ct2/show/NCT02688855?term=NCT02688855&rank=1.

For more information on the CMF product portfolio, please visit: http://www.djoglobal.com/our-brands/cmf.

About DJO Global

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

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements relate to, among other things, the Company’s expectations regarding the success of the announced clinical trial which are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause the announced clinical trial to not be successful or to differ significantly from the Company’s expectations which are expressed or implied by such forward-looking statements include, but are not limited to the successful execution of the Company’s clinical trial, including complying with regulations applicable to such clinical trials; the failure to receive positive clinical results for this product, and even if we receive positive clinical results, the failure to receive the necessary clearance or approvals from the applicable government regulators to market and sell our products for the desired indications; and the uncertainty of acceptance by healthcare providers of the use of the Company’s product for the requested new indications. These and other risk factors related to DJO Global are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 15, 2017. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.

Contacts

DJO Media Contact:
Brittany Knudson
Marketing Director
760.681.7785
Brittany.Knudson@djoglobal.com
or
DJO Investor Contact:
David Smith
SVP and Treasurer
760.734.3075
ir@djoglobal.com

Zimmer Biomet Holdings Announces Resolution of FDA Warning Letter Related to Its Zhejiang, China Manufacturing Facility

Posted On June 14, 2017 By OrthoSpineNews In Regulatory, Top Stories /

WARSAW, Ind., June 13, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the Warning Letter dated June 3, 2015 relating to its Zhejiang, China manufacturing facility has been closed out.

“The successful clearance of the Warning Letter related to our Zhejiang, China manufacturing facility is a measure of the progress we have made in our ongoing quality and operational excellence journey,” said David Dvorak, Zimmer Biomet’s President and Chief Executive Officer. “Zimmer Biomet takes seriously its responsibility to support surgeons and their patients, and the Company will continue to take the necessary actions to demonstrate our commitment to quality excellence, patient safety and regulatory compliance.”

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see our periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Accordingly, such forward-looking statements speak only as of the date made. Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.

OrthAlign, Inc. Announces First KneeAlign Cases for Total Knee Arthroplasty in Greece

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

ATHENS, GREECE (PRWEB) JUNE 13, 2017

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced today the first set of KneeAlign® cases completed for total knee arthroplasty (TKA) in Greece. These cases were completed by Athens-based orthopaedic surgeon Spyridon Armpis, MD, MSc and continue to reflect the rapid adoption of OrthAlign’s handheld precision alignment and positioning technologies, by surgeons throughout the world.

OrthAlign provides highly accurate, computer-assisted, handheld technologies for surgeons to receive real-time, actionable data for precise alignment and positioning of components in total knee, unicondylar knee, and total hip (both posterior and anterior) arthroplasty surgeries. Over 15 peer-reviewed clinical studies have been published to date, validating OrthAlign’s accuracy, simplicity of use, and benefits in recovery for the patient.

“The accuracy and simplicity of KneeAlign surprised me,” said Dr. Armpis. “The technology not only gives me confidence in my cuts, but allows me to elevate my standard of care for patients. I no longer have to invade the intramedullary canal, I don’t have to make multiple cuts, and it makes me, my OR staff, and the recovery process for my patients more efficient. Going forward, KneeAlign will be a key part of my practice and my patient-tailored recovery program, as I am convinced it will give my patients the best possible outcomes.”

In a published TKA clinical study by Denis Nam, M.D. (Rush University Medical Center, Chicago, IL), significant differences favoring the use of KneeAlign vs. conventional Computer Assisted Surgery were found with regard to the accuracy of femoral component alignment, with 94.9% of patients in the KneeAlign cohort having an alignment within 2° of neutral vs. 92.5% in the CAS cohort. There was also a significant difference in overall mean mechanical alignment of the limb, with 92.5% of patients within 3° of neutral mechanical axis in the KneeAlign cohort vs. 86.3% in the CAS cohort.

In another study by Dr. Nam (conducted as a randomized controlled trial, consisting of five different surgeons), it was found that KneeAlign decreases the incidence of outliers for tibial component alignment in both the coronal and sagittal planes, and improves the surgeon’s ability to achieve a specific, intraoperative goal, compared to conventional, tibial extramedullary (EM) alignment guides in TKA. In the KneeAlign cohort, 95.7% of tibial components were within 2° of perpendicular to the tibial mechanical axis and 95% of tibial components were within 2° of a 3° posterior slope (compared to 68.1% and 72.1% in the EM cohort, respectively).

“OrthAlign is delighted to have successfully completed its first KneeAlign cases in Athens,” said James Young Kim, OrthAlign’s Vice President and General Manager of International. “As Greece comprises of 25,000 TKAs annually, it is seeking a cost-effective solution that helps surgeons achieve quicker, more precise results for their patients. Dr. Armpis approached us with this strong desire and was the first surgeon in Greece to experience the power of KneeAlign. As OrthAlign continues to focus on expanding customer reach and portfolio expansion, we welcome the country of Greece to the OrthAlign family and look forward to further introducing it in the Greek orthopaedic market.”

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

Oska® Wellness Announced as the Presenting Sponsor for the 4th Annual Midwest Pain Treatment Education Expo

Posted On June 13, 2017 By OrthoSpineNews In Extremities, Sports Medicine, Top Stories /

CARLSBAD, Calif., April 18, 2017 /PRNewswire/ — Oska Wellness, a technology company committed to developing cutting-edge consumer health and wellness products, is the presenting sponsor for the 4^th Annual Midwest Pain Treatment Education Expo, August 13, 2017 at the Hilton Hotel, Northbrook, Illinois.

Oska Wellness will have a booth at the Expo with top Oska executives on hand to showcase the benefits of the Oska® Pulse, a revolutionary wearable device to combat pain. The company has donated 10 Oska Pulse devices to be given away as door prizes, along with 20 additional devices to be gifted (to the first 10 people in line at 8 a.m. and again to the first 10 people at 1 p.m.).

The Midwest Pain Treatment Education Expo is produced by Gracie Bagosy-Young, a chronic pain patient advocate and president of the GG Chronic Pain Foundation, whose mission is to raise awareness of chronic pain conditions and educate the chronic pain community on non-drug options and current research.

“This is our biggest outreach event, with outstanding speakers, exhibitors and attendees from all over the country, and will be streamed on Facebook Live and Livestream all over the world,” said Bagosy-Young. “I’m thrilled that Oska Wellness has joined me as presenting sponsor for the Expo and to help spread the message about new non-drug options for managing pain.”

Oska Wellness recently unveiled the new Oska Pulse a small, portable, hands-free device that employs safe Pulsed Electromagnetic Field (PEMF) therapeutic technology, a longtime therapy used by medical practitioners to help people enjoy more active, pain-free and drug-free lives.

“We’re very excited to sponsor the Midwest Pain Treatment Education Expo and share our mission on new ways to provide non-invasive, drug free pain management solutions,” said Greg Houlgate, CEO of Oska Wellness. “Oska Pulse is a smart, safe, easy-to-use, wearable health technology product designed to help reduce muscle stiffness, temporarily relieve minor pain and increase mobility for people who have chronic pain. We will be showcasing Oska Pulse and the benefits of PEMF technology to hundreds of attendees at the Expo.”

For more information and ticket options for the Midwest Pain Education Expo, please contact Gracie Bagosy-Young at gracie@ggpainadvocacy.com.

About Oska Wellness
Oska, Inc. is committed to developing health and wellness technology-driven products that assist individuals in living a more active, pain-free lifestyle. Oska Pulse utilizes patented eTec Pulse Technology that specifically optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, similar to the PEMF therapies used in many clinical applications for accelerating the body’s ability to heal itself.

The science and technology behind Oska Pulse was engineered and developed by a team of respected scientists and researchers with over 25 years of experience in engineering health and wellness technologies to treat pain. Oska Wellness, Inc. does not claim the product to diagnose, treat, cure or prevent any medical condition. The company is headquartered in Carlsbad, California and can be found online at www.oksawellness.com.

ADD COUPON CODE “ORTHOSPINECO” FOR $55.00 OFF

Vertera Spine Receives New CMS ICD-10 Code for Radiolucent Porous Interbody Fusion Devices

Posted On June 13, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ATLANTA, June 13, 2017 /PRNewswire/ — Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the U.S. Centers for Medicare & Medicaid Services (CMS) has issued a new ICD-10 code for a radiolucent porous interbody fusion device. The new classification will enable healthcare providers and payers to selectively track the utilization, outcomes and healthcare costs associated with this unique technology class. Vertera Spine’s COHERE Cervical Interbody Fusion Device is the first and only clinically-available porous fusion device manufactured out of the radiolucent plastic polyether ether ketone (PEEK), and is approved for use under the new code. The IDC-10 code is effective October 1, 2017 as an XRG code and listed as “Interbody Fusion Device, Radiolucent Porous.”

Spinal interbody fusion devices have traditionally been classified by the implant material, either synthetic or tissue-derived alternative (e.g. autograft and allograft). However, as more advanced orthopedic biomaterials are developed, the use of a single coding identifier for all synthetic devices may no longer be appropriate for accurately describing fusion procedures. Five years of basic science, preclinical and clinical research^1-3 have shown that porous PEEK possesses several performance characteristics that distinguish it from other fusion devices by combining the osseointegration capabilities of porous metallic devices with the favorable imaging properties of non-porous plastic devices. This valuable combination of device attributes was introduced with FDA clearance of the COHERE device, prompting the issuance of the new ICD-10 code by CMS.

In addition to serving as a tracking method for healthcare payers and providers, the ICD-10 code can also potentially benefit spine surgeons in clearly identifying the best options for patients.

“The issuance of this new code signifies the unique performance of porous PEEK devices compared with other fusion devices and the importance of monitoring how this technology impacts healthcare,” said Richard Guyer, M.D., Texas Back Institute. “As a clinician, I am always looking for innovative technologies, such as Vertera Spine’s porous PEEK COHERE device, that have the potential to improve patient outcomes.”

As stated by Kevin Foley, M.D., Semmes-Murphey Neurologic and Spine Institute:

“The development of porous PEEK has allowed for the combination of radiolucency and porosity in an interbody implant that is completely plastic. In vivo studies have demonstrated that bone will grow into porous implants, improving their osseointegration. Until now, the only porous implants clinically available were made of metal or had a metallic coating, which can limit the surgeon’s ability to assess fusion on imaging. This new code gives us the potential to better correlate bony tissue ingrowth into Vertera Spine’s porous PEEK COHERE device with clinical outcomes.”

Likewise, Erik Westerlund, M.D., St. Francis Spine Center, and an early adopter of Vertera Spine’s COHERE device, shared similar sentiments:

“I began to see my one year follow-up COHERE device patients in May of this year and the results have shown a clear and consistent trend of rapid and readily visible progression to robust osseous union. Not only is there characteristic radiographically visible osseous incorporation at the interconnected porous margin of the COHERE PEEK spacers, there is also a notable continuity of bridging bone across the entire interspace. The grant of a new specific ICD-10 code for porous PEEK will provide myself and other spine surgeons greatly refined capacity to track clinical outcomes and cost savings with this genuinely transformational class of porous PEEK interbody spacers like Vertera Spine’s COHERE.”

With its first clinical use in Q2 of 2016, COHERE is the first device featuring Vertera Spine’s patented porous PEEK biomaterial technology. Intended for use in anterior cervical fusion surgery, COHERE contains a three-dimensional porous architecture on its bone-contacting sides that is specifically designed and optimized to promote cellular bone formation and effectively form a strong interface with bone. Unlike some porous treatments that are coated onto the device, COHERE’s porous architecture is grown directly from the solid PEEK implant using a proprietary processing method that allows for bone tissue ingrowth on the surface, while retaining strength and durability.

“We are excited that CMS has adopted a new code for radiolucent porous devices and are pleased that COHERE will fall under this designation,” said Chris Lee. Ph.D., founder and CEO of Vertera Spine. “The availability of a radiolucent porous fusion device means that for the first time, bone tissue ingrowth can potentially be assessed into the device. This will allow us to further understand the role of implant integration with clinical outcomes.”

¹Smith KE, et al. Techniques in Orthopaedics, 2017 (accepted in press).
²Torstrick FB, et al. CORR, 2016; 474(11): 2373-2383.
³Evans NT, et al. Acta Biomaterialia, 2015; 13: 159-167.

About Vertera Spine:

Vertera Spine is a privately-held medical device company that develops, markets and sells implants that use or complement its patented porous technology to address critical clinical needs in spine surgery. The company has received funding from the National Science Foundation, Georgia Research Alliance and Duke Angel Network to translate its growing technology portfolio into commercial products. For more information, visit www.verteraspine.com or call 678.705.9039.

COHERE is a registered trademark of Vertera Spine. All other trademarks and trade names are the property of their respective holders.

SOURCE Vertera Spine

SI-BONE, Inc. Announces Blue Cross and Blue Shield of Vermont Establishes Positive Coverage Policy for MIS Sacroiliac Joint Fusion

Posted On June 12, 2017 By OrthoSpineNews In Spine, Top Stories /

SAN JOSE, Calif., June 12, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Blue Cross and Blue Shield of Vermont (BCBSVT), an independent, local, not-for-profit Vermont company, has established a written positive coverage policy for minimally invasive surgical (MIS) SI joint fusion. The policy, available at the link below, will provide coverage for more than 200,000 BCBSVT health plan members and will become effective on July 1, 2017. BCBSVT becomes the fourth BCBS insurer to cover MIS SI joint fusion joining the BCBS insurers HCSC (that includes BCBS of Illinois, Montana, New Mexico, Oklahoma and Texas), BCBS of Michigan and BCBS of Nebraska bringing the total number of people with BCBS insurance who have access to the procedure to over 18 million in eight states.

Craig Bartlett, MD of the University of Vermont Medical Group in Burlington, VT commented: “This is great news and I am delighted for our SI joint patients with Blue Cross Blue Shield of Vermont coverage. I regularly see patients in my practice with chronic sacroiliac joint pain who could benefit from minimally invasive sacroiliac joint fusion with iFuse but I have been unable to perform the procedure due to coverage limitations. Now, with this positive coverage decision, I will be able to provide iFuse as a treatment option to Blue Cross Blue Shield of Vermont patients who are properly diagnosed surgical candidates and meet the treatment criteria.”

“We are very pleased to learn that Blue Cross Blue Shield of Vermont has established a positive coverage policy based on the published peer-reviewed clinical evidence for patients with SI joint related low back or buttock pain who essentially meet the NASS coverage criteria for MIS SI joint fusion,” said Michael Mydra, Vice President, Health Outcomes & Reimbursement at SI-BONE.

http://www.bcbsvt.com/wps/wcm/connect/50f5e2b1-b03e-4192-95e7-efb0f092e319/diagnosis-and-treatment-of-sacroiliac-joint-pain-medical-policy-2017.pdf?MOD=AJPERES

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain^1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.⁵ Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs. Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes. Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Sign, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions. The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution. The iFuse Implant^TMwas designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer reviewed publications including two level 1 randomized controlled trials.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain. Patients with sacroiliac joint dysfunction experience pain that can be debilitating. SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

SOURCE SI-BONE, Inc.

Spring Loaded Technology Officially Launches LevitationTM, the World’s First Compact Bionic Knee Brace, with support from Government of Canada

Posted On June 9, 2017 By OrthoSpineNews In Extremities, Sports Medicine, Top Stories /

HALIFAX, NS – June 9, 2017 – Spring Loaded Technology announces the official launch of its Levitation^TM bionic knee brace for consumer sales across North America, and is now welcoming commercial partnerships with clinics, distributors, and brace retailers across Canada. The product launch takes place as the Government of Canada announces a $2.46-million investment through the Atlantic Canada Opportunities Agency’s Atlantic Innovation Fund (AIF).

Spring Loaded Technology CEO Chris Cowper-Smith describes the announcement as “The next chapter in our journey to change and improve lives in a big way.” COO Dawn Umlah added, “With the support of ACOA, combined with our research and development efforts and leading-edge product development, it’s a game changer. We’re proud to be able to put the world’s first and only compact, bionic knee brace into the hands of consumers on a large scale.”

As the world’s first bionic knee brace, Levitation™ uniquely enhances knee strength, mobility, and endurance by storing energy as the leg bends and then returning that energy as the leg straightens. Current users range from performance athletes, to manual laborers, to people with osteoarthritis. Levitation has proven useful for most knee injuries and conditions.

“The team at Spring Loaded Technology is transforming the versatility of assistive devices,” says

Darren Fisher, Member of Parliament for Dartmouth-Cole Harbour. “They represent a broader

life sciences community working on research that brings solutions to the marketplace. Targeted

investments such as these are helping us grow beyond our borders in line with our Atlantic

Growth Strategy.”

After successfully securing USD $208,000 through an Indiegogo crowdfunding campaign, delivering a $1-million contract for the Canadian forces, and fulfilling hundreds of consumer pre-orders, the Nova Scotia company is entering what they call real-time production. With bolstered manufacturing capacity, product improvements, and increased demand, Spring Loaded Technology is positioned to deliver Levitation across North America, to help people do more of what they love.

To learn more about Levitation™ and Spring Loaded Technology, or to inquire about partnership opportunities, visit www. springloadedtechnology.com.

About Spring Loaded Technology

Spring Loaded Technology is an award-winning company based in Halifax, Nova Scotia, which has designed an entirely new knee bracing technology to enhance the strength and power of the leg muscles. By increasing leg strength, their technology can be used in a wide range of applications including: mobility assistance, fatigue reduction, injury prevention/rehabilitation, and performance enhancement. The company was founded in 2012.

Media Contacts:

Kaleigh DeHart

Uproar PR for Spring Loaded Technology

Office: 321.236.0102

Email: kdehart@uproarpr.com

Alex Smith

Director of Communications and Outreach, Atlantic Canada Opportunities Agency

Cell: (902) 830-3839
Office: (902) 426-9417
E-mail: alex.smith@canada.ca

Camber Spine Technologies Appoints Two New Area Sales Directors

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

WAYNE, Pa., June 9, 2017 /PRNewswire/ — Camber Spine Technologies, a medical device company focused on designing, developing and commercializing innovative and proprietary musculoskeletal implant systems, announced the appointment of two new Area Sales Directors to its sales team, Gant Newsom and Doug Wyciskalla. As part of Camber Spine’s commitment to expanding its sales efforts across the country these new positions have been created for these two very talented spine device sales veterans.

“It is an extreme pleasure to welcome both Gant and Doug to our fast-paced organization,” said Dan Lawson, Camber Spine’s East Coast Area Sales Director. “I have worked with both of them in the past and have witnessed firsthand the level of success, leadership and extreme professionalism that they brought to their organizations.”

Doug Wyciskalla joins Camber Spine as the Midwest Area Sales Director bringing 14 years of sales leadership experience to the Camber Spine organization. Most recently he worked with LDR and Spineart in sales leadership roles. Doug started his career in spine with Kyphon, where his region was always amongst the top in performance. He also spent several years as an area sales director for Paradigm Spine, where he built the sales team across the western U.S. Doug has consistently led teams to exceed sales goals and has been one of the top performers at each of the companies where he has worked.

Gant Newsom, who joins Camber Spine as the Southwest Area Sales Director, has an impressive background with over 10 years of experience in the spine business, having worked with brands such as Globus Medical, Aesculap and most recently LDR and Zimmer Biomet. He, too, was consistently amongst the top performing regions in the U.S. across all product lines and was named MVP of SC Area for 2 years running while working for LDR. Gant lives in Tulsa, Oklahoma with his wife and two daughters and is a graduate of Oklahoma State University.

“With the addition of Gant and Doug along with some newly added sales representatives we are now poised for an extremely aggressive and productive 2017,” said Camber Spine’s Vice President of New Business Development, Seth Anderson. “In addition to having several new exclusive technologies for planned launches over the next two quarters we now have varsity level sales management leading us into new markets across America.”

About Camber Spine Technologies

Camber Spine Technologies, LLP, is a medical device company focused on the design, development and commercialization of innovative and proprietary musculoskeletal implant systems. The company is committed to delivering surgeon inspired new technologies to the spine market. Camber Spine Technologies, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine.

All of Camber Spine Technologies’ products are proudly MADE IN THE USA.

If you would like more information about this topic, please contact Mindy Elgart, Marketing Director at 484.420.4671 or email at melgart@cambermedtech.com

SOURCE Camber Spine Technologies

joimax® Elevates Its Presence across Europe and Asia

Posted On June 8, 2017 By OrthoSpineNews In Spine, Top Stories /

June 08, 2017

IRVINE, Calif.–(BUSINESS WIRE)–Over the last few weeks, joimax^® participated in numerous scientific meetings, held across Europe and Asia. During these meetings, the German-based company reiterated its position as market leader for endoscopic minimally invasive spine surgery.

Starting in early May, joimax^® exhibited at this year’s Global Spine Congress (GSC, http://www.gsc2017.org) in Milan, Italy, including a Meet-the-Expert Session at its booth and at the Intermediate Meeting of the World Congress of Minimally Invasive Spine Surgery and Techniques (WCMISST) in Paris, France. Numerous joimax^® faculty members presented the latest results in endoscopic spine surgery.

From May 11 to 14, joimax^® participated in the 10^th Conference of the Chinese Association of Orthopedic Surgeons, held in cooperation with the North American Spine Society (CAOS/NASS) in Guangzhou, China. The conference was combined with a highly attended workshop on principles and techniques of complex spine surgery. This session was video transmitted to 20,000 hubs.

During the annual meeting of the German Society of Neurosurgery (DGNC) in Magdeburg, Germany, from May 14 to 17, joimax^®exhibited its complete product range. The lunch symposium, covering the treatment options in endoscopic decompression and pain therapy, was presented by the well-recognized joimax^® faculty members Drs. Erik Traupe, Guntram Krzok and Ralf Wagner.

From May 18 to 20, joimax^® participated in the first International Spine Conference at the KCM clinic in Jelenia Gora, Poland, highlighting the achievements of modern endoscopic minimally invasive spine surgery. In live surgeries various endoscopic techniques in cervical and lumbar cases were performed. The session was coupled with a simultaneous discussion between surgeons and participants.

“The International Spine Conference in Poland marks the successful kick-off for the cooperation with our new partner to start extensive market activities in this country,” says Wolfgang Ries, Founder and CEO of joimax^®. “Both, training and education, which also started in Poland, now are the key to success to further deepen the endoscopic knowledge of spine surgeons.”

In early June, the annual meeting of the International Society for the Study of the Lumbar Spine (ISSLS) took place in Athens, Greece, followed by the annual congress of the French Society of Spinal Surgery (Societé Francaise de Chirurgie Rachidienne, SFCR) in Lille, France. Both meetings attracted many spine specialists and generated good traffic at the joimax^® booths.

Since its inception, joimax^® participates in the European Course for Minimally Invasive Spinal Surgery (EUCMISS, http://www.eucmiss.com). This year’s 5^th Course in Madrid, Spain, was held on June 1 and 2. It was a special course of globally leading experts in minimally invasive spine, exchanging the practical and scientific experience in presentation and multidisciplinary cadaver courses.

joimax^® will continue its activities by exhibiting at the NSpine Main Conference in London, UK, from June 12 to 15 and then they head back to Asia to attend the 6^th Asian Conference of Minimally Invasive Spine Surgery Techniques (ACMISST) in Bangkok, Thailand between June 29 and July 2 with a faculty presentation and a booth presence.

About joimax^®

Founded in Karlsruhe, Germany, in 2001, joimax^® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS^® (transforaminal), iLESSYS^® (interlaminar) and CESSYS^® (cervical) for decompression procedures, MultiZYTE^® RT (e.g. for rhizotomy) and with MultiZYTE^® SI for SI-Joint therapy or with EndoLIF^® and Percusys^® for endoscopic minimally invasive assisted stabilizations, proven endoscopic systems are provided that, together, cover a whole variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax^® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

joimax^® Inc.
Melissa Brumley
001 949 859 3472
Melissa.brumley@joimaxusa.com