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

Posted On June 15, 2017 By OrthoSpineNews In Spine /  

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

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

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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Cretex Companies Acquires Leading Medical Packaging Services Provider

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

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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GE Additive and Stryker Announce Additive Manufacturing Partnership

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

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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SPINEWAY records a new $1M order in the USA

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

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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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

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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

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

Posted On June 14, 2017 By OrthoSpineNews In Extremities /  

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.
Request Sample Copy of the Report @ www.tmrresearch.com/sample/sample?flag=B&rep_id=1175

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.

Request TOC of the Report @ www.tmrresearch.com/sample/sample?flag=T&rep_id=1175

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.

 

READ THE REST HERE

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Spinal Implants Market Is Predicted to Reach USD 14 Billion by 2022

Posted On June 14, 2017 By OrthoSpineNews In Financial /  

Pune, India — (SBWIRE) — 06/14/2017 — Market Highlight

The global spinal implants market has been evaluated to be rapidly growing market and is expected to grow tremendously in the near future. Spinal implants are devices used by surgeons during surgery to treats deformities, stabilize and provide strength to the spine and to expedite the fusion process.

Spinal implants are used to treat spine related disorders including degenerative disc disease, scoliosis, kyphosis, fracture and spondylolisthesis. Global spinal implants market which is currently growing tremendously and is expected to reach USD 14 billion by the end of 2022.

Major Key Players

-Alphatec Spine Inc,
-Amedica Corporation,
-Depuy Synthes Inc. (Johnson & Johnson),
-Exactech Inc.,
-Globus Medical Inc.,
-Integra LifeSciences,
-K2M Inc.,
-LDR Holding Corporation,
-Medtronic plc,
-NuVasive Inc.,
-Orthofix Holdings, Inc.,
-RTI Surgical Inc.,
-Stryker Corporation,
-Quandary Medical LLC,
-Zimmer Biomet

 

READ THE REST HERE

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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.

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