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February 2-4, 2017
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Recon

Powerful Imaging Technology Generates New Evidence on ATTUNE® Knee System

June 16, 2017 OrthoSpineNews

WARSAW, IN – June 15, 2017 – When it comes to evaluating a knee replacement’s long-term performance, registry data is extremely important, but not the only tool. Another well-established, but less universally-known, technique is Radiostereometric Analysis (RSA), an imaging technique that precisely measures implant migration and can help predict implant survivorship.1-3

Given the increasing utilization of, and demand for, RSA evidence in many countries, DePuy Synthes*, part of the Johnson & Johnson Family of Companies, made the decision in 2013 to incorporate RSA into its ATTUNE® Knee Evidence Generation Program strategy, and today announced results of the first and recently-completed two-year investigator-initiated study that evaluated the implant fixation of the ATTUNE Knee tibial base using RSA.4

In this study, conducted by the Canadian RSA Network, tiny beads of less than 1 mm were inserted into the bone surrounding the ATTUNE Knee implant at the time of surgery. These beads, made of tantalum, a metal that is well tolerated by the body, served as markers by which X-rays were used to detect 3D changes in the position of the tibial base relative to the bone over time (implant fixation). This particular study included 30 patients, which is a statistically appropriate sample size in RSA research.

Results of this study, presented at the Canadian Orthopaedic Association Annual Meeting (June 15-18, 2017, Ottawa, CA)4, showed that the ATTUNE Knee tibial base migrated an average of 0.02 mm in the superior-inferior (up and down) direction over 24 months, with an average maximum total point motion of 0.21 mm. Applying published criteria which helps interpret how RSA data can help predict future revision rates1,3, this study’s 2-year RSA results showed that the ATTUNE Knee tibial base achieved stable fixation by demonstrating average micromotion of 0.17 mm between one and two years. This is consistent with implants that have acceptable revision rates due to aseptic loosening.1

“These results are another component of the breadth of data that continue to be generated around the ATTUNE Knee,” said Kim Dwyer, Ph.D., Clinical Research Director, Knees, DePuy Synthes Joint Reconstruction. “The importance of RSA is that it can help predict an implant’s long-term performance while larger and longer survivorship studies are underway.”

Dwyer added that the importance of RSA continues to move from its well-established roots in the Nordic countries of Europe to other parts of the world, including North America. RSA Networks like the Canadian RSA Network can play a pivotal role in enhancing evidence-generation timelines, standardizing methodologies, increasing diversity by including more patients at different sites, and meeting the needs of stakeholders who value fixation evidence.

About DePuy Synthes
DePuy Synthes, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.

©DePuy Synthes 2017. All rights reserved.
DSUS/JRC/0617/2182
June 2017

  1. Ryd L, Albrektsson BE, Carlssson L, Dansgård FHerberts P, Lindstrand A, Dansgård, Regner L, toksvig-Larsen S, Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br 1995;77:377-83.
  2. Kärrholm, J, Gill, RHS, and Valstar, ER, The History and Future of Radiostereometric Analysis. Clin Orthop Rel Res, 2006: 448, 10-21.
  3. Pijls BG, Valstar ER, Nouta KA, Plevier JW, Fiocco M, Middeldorp S, Nelissen RG, Early migration of tibial components is associated with late revision: a systematic review and meta-analysis of 21,000 knee arthroplasties. Acta Orthop 2012;83:614-24.
  4. Richardson, G, Turgeon, T, Gascoyne, T, Laende, E, Bohm, E, Dunbar, M. Stability assessment of a new knee replacement product using radiostereometric analysis. Poster Presentation at the Canadian Orthopaedic Association Meeting, Ottawa, Ontario, 15-18 June 2017.
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ExtremitiesSports Medicine

‘Cool’ New Knee Procedure Eases Arthritis Pain Without Surgery

June 15, 2017 OrthoSpineNews

by LAUREN DUNN and FELIX GUSSONE, MD

A new, non-invasive knee procedure could bring some relief for patients suffering from debilitating chronic pain, for whom surgery is not an option.

The treatment, recently approved by the Food and Drug Administration, is called “cooled radio frequency ablation” and is a less drastic option for people with moderate to severe osteoarthritis pain who are not ready to have knee replacement surgery, or who have health conditions that don’t make them a good candidate for surgery.

Marketed as “Coolief”, the procedure uses radio frequency to target and mute the nerves responsible for sending pain signals from the arthritic knee to the brain. Coolief doesn’t repair arthritis in the knee, but eases the pain, helping patients go back to activities without discomfort and fewer medications.

“What we’re changing is the wiring of the knee — so we’re taking away the pain signal and interrupting it,” Dr. Amin Sandeep, a pain specialist at Rush University Medical Center in Chicago who performs the procedure, told NBC News.

One 2016 study compared Coolief to popular cortisone injections, with patients reporting greater, longer-lasting pain relief with the new treatment than injections. Coolief reduces pain for about to 6 to 12 months, depending on how fast the nerves in the knee regenerate.

 

READ THE REST HERE

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Spine

Dr. John Sherman, expert in lumbar disc surgeries, identifies that AnchorKnot® can benefit discectomy patients

June 15, 2017 OrthoSpineNews

EDINA, MN, June 13, 2017 /PRNewswire/ – Twin Cities Orthopedics

Dr. John Sherman has performed the first herniated disc repair at Twin Cities Orthopedics using the AnchorKnot® Tissue Approximation Kit.

As a renowned surgeon, recognized by Becker’s Spine Review for his contributions to the advancement of spine surgery, Dr. Sherman has long identified the need to provide herniated disc repair. “Many studies have shown the size of the disc defect correlates with poor outcomes” as such, “if the AnchorKnot® system can effectively reduce the size of the defect then it may be possible to have better procedural outcomes.”

At Twin Cities Orthopedics, micro discectomy procedures are among the most commonly performed procedures. In the 20+ years that Dr. Sherman has been practicing, a common question arises from his patients: “Patients ask me what will happen to the hole left behind in the disc. It is intuitive to them that something must be done to close the hole, but until now, that hasn’t been possible.” Having used the AnchorKnot® system to effectively repair the disc, Dr. Sherman may now have an answer for them. While the nature of the injury differs from patient to patient, Dr. Sherman adds “I would use the AnchorKnot® system not only for young patients, but for anyone who is diagnosed with a lumbar disc herniation and is deemed a suitable patient for herniated disc repair.”

Neil Godara, General Manager of Anchor Orthopedics, comments that “as we are providing the AnchorKnot® system to more hospitals, we are finding that many surgeons share Dr. Sherman’s assessment on the need for our technology for use in herniated disc repair procedures. We are focused on providing a holistic solution to improve the outcomes of discectomy procedures and to reduce the rate of re-hospitalizations. Ultimately, we are focused on delivering value to patients, physicians and the healthcare system.”

Twin Cities Orthopedics is one of the leading orthopedic practices in the country. As the official sports medicine provider for the Minnesota Vikings, and the naming rights partner for the new home of the Minnesota Vikings in Eagan at the Twin Cities Orthopedics Performance Center and the Twin Cities Orthopedics Stadium, Twin Cities Orthopedics will also be opening a new orthopedic clinic adjacent to these facilities in Spring 2018, demonstrating a strong commitment to providing world class orthopedic and sports medicine care to patients.

About Twin Cities Orthopedics

For more than 75 years, Twin Cities Orthopedics has proudly provided a full spectrum of orthopedic and sports medicine care, devoted to the diagnosis, treatment, rehabilitation and prevention of injuries and conditions that affect the body’s muscles, joints and bones. TCO’s 115 physicians provide superior quality care across 39 state-of-the-art facilities in the Twin Cities and western Wisconsin. Visit TCOmn.com to learn more.

About Anchor Orthopedics

Anchor Orthopedics XT Inc., the developer of the AnchorKnot® Tissue Approximation Kit, aims to provide surgeons with novel solutions that optimize procedures in disc repair in an effort to preserve the biomechanics of the patient and improve surgical outcomes. Our mission is to work closely with surgeons on all aspects of development to create clinical solutions that serve to improve the lives of patients around the world. Anchor Orthopedics XT Inc., located in Mississauga, Canada, is a subsidiary of Baylis Medical Company Inc.

Media Contact Person:
Ester Kwok
Global Product Manager
Anchor Orthopedics XT Inc.
Tel: 647-484-0662 ext 388
ekwok@anchorortho.com
http://www.anchorortho.com

PRM-00214 EN J-1 V-1 © Anchor Orthopedics XT Inc., 2017. Anchor Orthopedics XT and AnchorKnot® are trademarks and/or registered trademarks of Anchor Orthopedics XT Inc. in the USA and/or other countries. All other trademarks are the property of their respective owners. CAUTION: Federal Law (USA) restricts the use of these devices to or by the order of a physician. Before use, consult product labels and Instructions for Use for Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Directions for Use. The AnchorKnot® Suture Passer (2-0) is an accessory of the Anchor System. The Anchor System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the Anchor Endoscope and accessories are intended to aid the surgeon’s visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants. Other examples of generic surgical use of the Anchor System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ). Patents pending and/or issued.

SOURCE Anchor Orthopedics

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BiologicsTop Stories

SANUWAVE Appoints Interventional Concepts as Territory Sales Manager and Partner to Access Clinical Trial Participation in Colombia; Revenue Expected Before Year End

June 15, 2017 OrthoSpineNews

SUWANEE, GA–(Marketwired – Jun 14, 2017) –  SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company has appointed Interventional Concepts, Inc. to act as Territory Sales Manager for sourcing and screening of potential distributors and access to clinical trials participation for SANUWAVE’s products in Colombia.

André Mouton, V.P. International Sales and Relations of SANUWAVE, stated, “This decision to engage Interventional Concepts was made to increase our focus and visibility within South America. It is of the utmost importance that we partner with distributors that have influence and a good track record within the Colombian market. We also need speedy access to potential clinical trials to ensure we add value with our product offering as well as clinically proven outcome. These factors will lead to faster market entry and closer ties with identified Key Opinion Leaders (KOL’s),” concluded André Mouton.

Julio G. Martinez-Clark, Interventional Concepts’ CEO, stated, “Interventional Concepts is an ideal partner for SANUWAVE by providing regulatory and commercial support when introducing and expanding the company’s medical device portfolio in Colombia.”

“By partnering with Interventional Concepts, SANUWAVE will have access to a multidisciplinary team of life science professionals in Colombia that will facilitate SANUWAVE’s local market access efforts,” continued Mr. Martinez-Clark. “Our expertise in medical device clinical trials and commercialization, knowledge of the local market, and wide network of local contacts enable us to offer a wide range of services to forward-thinking companies like SANUWAVE. This partnership will allow SANUWAVE to successfully enter the market and achieve long-term growth and success in Colombia.”

SANUWAVE is using this occasion to further educate on our lead wound care product dermaPACE®. This Extracorporeal Shockwave Technology (ESWT) device, based upon electrohydraulic principles, is CE Marked and has enjoyed success in certain markets within the European Union treating a wide variety of skin conditions such as pressure ulcers, burns, post-operative wounds, and scar reduction. dermaPACE has been proven, in two US based clinical trials enrolling 336 subjects, to be safe and effective in the treatment of Diabetic Foot Ulcers. Within a few weeks of initial treatment, wounds treated with dermaPACE reduce in area at superior rates compared to control subjects. dermaPACE exhibits superiority in wound area reduction within 12 weeks of initial treatment and exhibits superiority in wound closure within 20 weeks of initial treatment. The use of dermaPACE allows the clinician to more easily, and more cost-effectively, manage wounds. More importantly, the patient’s quality of life improves significantly.

For more information on SANUWAVE’s technology, please read our blog, “Shock This”, on our website at www.sanuwave.com.

About Interventional Concepts, Inc.
Interventional Concepts is based in Miami, FL and was founded in 2010 by Dr. Pedro Martinez-Clark — an interventional cardiologist, an innovator, founder and advisor to MedTech companies — to help medical device companies conduct early-stage clinical trials and have access to the Colombian market. The company offers a wide range of market access services including market research and testing, product and trademark registration, regulatory legal representation, distributor search and selection, new entity set-up, and operations services for life science companies looking to enter and achieve long-term growth in Latin America — with a special focus on Colombia. Interventional Concepts has helped companies like Avinger, Mitralign, MitraSpan conduct clinical trials in Colombia; and companies like ClarVista Medical, CeloNova BioSciences, Abiomed, Volcano, and Mount Sinai’s Center For Personalized Cancer Therapeutics register their products and formulate a market access strategy in Colombia.

About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB: SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

CONTACT INFORMATION

 

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FinancialTop Stories

Cretex Companies Acquires Leading Medical Packaging Services Provider

June 15, 2017 OrthoSpineNews

ELK RIVER, MN, June 13, 2017— Cretex Companies (www.cretex.com) today announced it has acquired Quality Tech Services (QTS), a supplier of outsourced packaging services to the medical device industry.

We are extremely pleased to have QTS join our Cretex Medical group of companies,” said Lynn Schuler, Chief Executive Officer of Cretex Companies, Inc. “QTS is widely recognized as a leading provider of validated assembly, kitting, and packaging solutions. Their experienced team, including packaging engineers and microbiologists, are experts in the end‐of‐line, critical processes that most companies don’t understand or do well. By adding QTS’s capabilities, we’ve made Cretex Medical an even better outsource partner for medical device companies.”

Located in Bloomington, MN, QTS specializes in cleanroom assembly, packaging and labeling, sterilization management, process development and validations, and material sourcing and supply chain management. They serve a broad set of Original Equipment Manufacturers (OEMs) in the orthopedic, neurology, pulmonary, dental, and other medical device markets.

Doug Wilder, President of QTS, said, “We’re very excited to become part of the Cretex Medical group. Medical device OEMs are increasingly looking for providers who bring end‐to‐end solutions. They are actively pruning their supplier base and rewarding those who can do more. Combining Cretex and QTS creates significant upside for our customers. Equally important, the combination will be great for our employees. The cultures of the two companies are very similar. Customer service, quality, and providing a positive work environment are values that we share. We’re anxious to get started.”

Terms of the acquisition were not disclosed.

About Cretex Companies, Inc.

Cretex, established in 1917, is a privately held, diversified manufacturing company headquartered in Elk River, Minnesota serving four major markets: medical, aerospace & defense, industrial, and infrastructure. Under the Cretex Medical brand, the company’s subsidiaries rms, rms Surgical, Meier, Spectralytics, JunoPacific, and QTS provide contract manufacturing and outsourcing services to medical device manufacturers (OEMs). Cretex Medical provides a full suite of capabilities, including precision machining, metal stamping and fabrication, laser processing, plastic injection molding, medical device assembly and cleanroom packaging. Cretex Companies employs about 2,000 people in 14 locations in Minnesota, California, Tennessee, and Wisconsin.

Contact Info

Katie Welch Len

612‐720‐9374

Email: katiep@newsworthycommunications.com

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SpineTop Stories

GE Additive and Stryker Announce Additive Manufacturing Partnership

June 15, 2017 OrthoSpineNews

June 14, 2017

BERLIN–(BUSINESS WIRE)–GE Additive (NYSE: GE) and Stryker have entered a partnership agreement to support Stryker’s growth in additive manufacturing. The agreement covers new additive machines, materials and services for Stryker’s global supply chain operations. The announcement was made at GE’s Minds + Machines event, GE’s premier industrial internet event dedicated to software, innovation and the sharing of the most powerful digital industrial outcomes.

“GE and Stryker share a similar vision and both of us understand the transformative power of additive design and manufacturing,” said Vice President and General Manager of GE Additive, Mohammad Ehteshami. “We regard Stryker as one of the most experienced practitioners of metal additive, with a range of commercialised medical products. We will continue to innovate with new additive products, materials, and technologies, which will support their growth.”

Stryker has already invested in Concept Laser and Arcam machines. The company’s investment in additive manufacturing began in 2001 and, since then, Stryker has collaborated with leading universities in Ireland and the UK to industrialize 3D printing for the healthcare industry. Stryker recently opened a global technology development center with an additive technology manufacturing hub in Carrigtohill, County Cork, Ireland. Additive manufacturing allows Stryker to address design complexity and achieve previously unmanufacturable geometries.

“Working with GE Additive and leveraging their expertise is a very compelling proposition for Stryker,” said John Haller, Vice President of Global Supply at Stryker. “We believe this collaboration will accelerate our additive manufacturing journey and support our mission to make healthcare better.”

For many years, GE has been a leading end user and innovator in the additive manufacturing space. In addition to the $1.4 billion investment in Concept Laser and Arcam, GE has also invested approximately $1.5 billion in manufacturing and additive technologies over the past 10 years, developed additive applications across six GE businesses, created new services applications across the company, and earned 346 patents in powder metals used in the additive process. In 2016, the company established GE Additive to become a leading supplier of additive technology, materials and services for industries and businesses worldwide.

GE Additive is part of GE (NYSE: GE) – the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. GE Additive includes additive machine providers Concept Laser and ArcamEBM; along with additive material provider AP&C and additive service provider to the medical industry, DTI. As a notable user of additive technologies GE recognize the value and potential it brings to modern design and manufacturing. GE is organized around a global exchange of knowledge, the “GE Store,” through which each business shares and accesses the same technology, resources and intellect. GE delivers better outcomes for customers by speaking the language of industry. www.geadditive.com

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. More information is available at www.stryker.com.

Contacts

GE Additive
Rick Kennedy, +1 513.607.0609
rick.l.kennedy@ge.com

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SpineTop Stories

SPINEWAY records a new $1M order in the USA

June 15, 2017 OrthoSpineNews

Press Release – Ecully, 14 June 2017

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), has obtained a new order via its California partner amounting to $1M.

This order, recorded by the Group’s US subsidiary, Spineway USA Inc., will be fulfilled in the next few weeks. It concerns the Mont-Blanc, Twin Peaks, Blue Mountain and Ayers Rocks product lines and shows US surgeons’ increasing interest in Spineway’s products.

With $3M in orders received in eight months, Spineway confirms the rise of its US subsidiary and reconfirms its ambition to generate a significant portion of its revenue from the US market.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLAN FOR SMES)
Find out all about Spineway at www.spineway.com

Next communication:
2017 First Semester Sales – 18 July 2017, after market closes

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), received the OSEO Excellence award as well as the Deloitte Fast 50 award in 2011. Rhône Alpes INPI Patent Innovation Award (2013) – Talent INPI award (2015).
ISIN code: FR0011398874 – ALSPW     

Investor Relations
David Siegrist – Finance Director
Tel: +33 (0)4 72 77 01 52
finance.dsg@spineway.com		 Financial Communication
Jérôme Gacoin / Solène Kennis
Tel: +33 (0)1 75 77 54 68
skennis@aelium.fr

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/8e361d3c-34b3-4ec1-9234-125a04d93c00

 

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ReconTop Stories

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

June 15, 2017 OrthoSpineNews

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

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ExtremitiesTop Stories

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

June 14, 2017 OrthoSpineNews

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

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Extremities

Extremity Reconstruction Market : By Product Type, Market, Players and Regions-Forecast to 2025

June 14, 2017 OrthoSpineNews

Press release from: TMR Research – 06-14-2017

The global market for extremity reconstruction is expected to witness a high level of growth in the next few years. The rising number of cases of abnormalities and injuries in the lower and upper extremity of the human body is one of the vital factors estimated to encourage the growth of the global market in the coming years. In addition, several advancements in the healthcare infrastructure are anticipated to accelerate the development of the market in the near future. The implant devices for different parts of the human body comprises the extremity reconstruction market in the coming years.

A tremendous rise in the geriatric population and the rising incidences of obesity and diabetes are some of the major factors that are estimated to fuel the development of the global extremity reconstruction market in the near future. Moreover, the increasing cases of osteoarthritis and rheumatoid are likely to accelerate the growth of the market in the coming years. The rising awareness regarding the benefits of small joint reconstruction implants among patients is predicted to encourage the growth of the global extremity reconstruction market in the next few years.
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Technological advancements and the availability of required infrastructure are projected to augment extremity reconstruction market in North America market in the next few years. The leading players operating in the extremity reconstruction market across the globe are emphasizing on introducing innovative implants in order to attract a large number of consumers and attain a leading position in the market. Additionally, the rising level of competition is predicted to expand the product portfolio and benefit the patients in the coming years.

Global Extremity Reconstruction Market: Overview

The increasing incidence of injuries, abnormalities, and congenital defects in the upper or lower extremity of human body has fueled the demand for reconstructive surgical procedures. Implant devices for the shoulder, wrist, ankle joints, digits, elbow, and foot are part of the extremity reconstruction market.

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The primary driver of the global extremity reconstruction market is the large pool of geriatric population. According to the Centers of Disease Control and Prevention, with a rise in the geriatric population in the U.S., by the year 2040, the number of patients affected by arthritis is expected to increase to 78 million. Since aged people are more prone to injuries, growth in geriatric population is expected to fuel the demand for reconstructive surgical procedures.

 

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