Rep. Erik Paulsen Co-Sponsor of Bill to Suspend Collecting Medical Device Tax

Posted On December 13, 2017 By OrthoSpineNews In Regulatory /

By Jim Spencer Star Tribune/December 12, 2017

WASHINGTON – Some members of the House Ways and Means Committee, including Minnesota Republican Erik Paulsen, want to suspend collection of a medical device tax for five more years.

Paulsen and Republican colleague Jackie Walorski of Indiana on Tuesday introduced a bill to keep the tax from being collected through 2022. The proposal comes as time runs out on the current two-year moratorium that stopped device companies from having to pay a 2.3 percent sales tax on gross receipts in 2016 and 2017.

“Full repeal is my top priority,” Paulsen said.

But for now, he said, a five-year moratorium seemed like the best available vehicle to keep the tax from coming back Jan. 1. Paulsen believes his proposal can be attached to any of a number of year-end spending measures.

Going forward, Paulsen thinks he makes “a good selling argument” for permanent repeal based on the device companies’ willingness to expand operations by investing tax savings realized during the current moratorium.

The device tax was part of the Affordable Care Act. Collected from 2013 to 2015, it produced more than $5 billion in federal revenue. But it has long been targeted for repeal by the medical device industry, including hundreds of Minnesota medical technology businesses.

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NuVasive To Acquire SafePassage

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

SAN DIEGO, Dec. 12, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, and SafePassage™, a privately-held provider of intraoperative neurophysiological monitoring (IONM) services, announced today that they have entered into a definitive agreement under which NuVasive will acquire SafePassage. Terms of the deal were not disclosed.

With the addition of SafePassage, NuVasive Clinical Services™ (NCS) solidifies its leadership position as the largest provider of outsourced IONM services with more than 550 neurophysiologists and oversight physicians in the U.S., allowing for the delivery of services to over 1,000 customers and 3,000 surgeons. This joining of forces strengthens the Company’s intraoperative neuromonitoring business line, which was formed in July 2016 when the Company acquired Biotronic NeuroNetwork and combined its service offerings with that of the Company’s subsidiary, Impulse Monitoring, Inc. Since then, NCS has further scaled the business, achieving operational efficiencies and driving better clinical outcomes. Following the acquisition of SafePassage, NCS is expected to support greater than 100,000 IONM cases annually in the U.S.

SafePassage is also complementary to the current NCS geographical footprint with limited overlap between existing healthcare accounts. The acquisition helps further accelerate the services business growth and enables deeper reach in key strategic markets while adding significant new coverage, particularly in the densely populated New York region and along the East Coast where NuVasive has traditionally had a strong spine procedural-selling presence.

“The acquisition of SafePassage advances the NuVasive services strategy and expands our ability to transform how spine procedures are approached, measured and valued from a clinical and economic perspective,” said Skip Kiil, executive vice president, Global Commercial of NuVasive. “As the only spine company in the world with dedicated neuromonitoring services operating at this elevated scale, and now with increased case coverage, we are uniquely positioned to deliver greater value across our procedurally-integrated portfolio.

“Just as important, the highly trained and well-respected SafePassage leadership and clinicians have earned the industry reputation of being among the best in the business, and we’re excited to partner with them to provide consistent and quality care to hundreds of surgeons and thousands of patients each year,” continued Kiil.

“For more than a decade, the team at SafePassage has been dedicated to serving patients and surgeons with premium quality intraoperative neurophysiological monitoring services to improve patient outcomes and reduce economic risk for hospitals and surgeons,” said Dan Siegel, chief executive officer of SafePassage. “We are extremely passionate about our vision to eradicate preventable healthcare injury, the third leading cause of death in the United States, and I look forward to joining forces with NuVasive to further our mission worldwide.”

Financial
NuVasive expects the transaction to be accretive to the Company’s non-GAAP earnings per share (EPS) in 2018 and beyond. NuVasive also expects the transaction to support its longer-term targets for revenue growth and expansion of its non-GAAP operating and EBITDA margins. Additionally, the transaction is expected to meet the Company’s goals for return on invested capital for tuck-in acquisitions in three years, consistent with the Company’s previously stated acquisition criteria.

The transaction is expected to close in January 2018, subject to customary closing conditions.

About SafePassage
Founded in 2007 by surgeons, SafePassage’s 135 clinical specialists and support staff service approximately 12,600 cases annually. Privately held and based in New York City, SafePassage provides IONM and EEG services to surgeons and healthcare facilities across the eastern U.S. The Company is Joint Commission accredited since 2014, with recent renewal in 2017.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. Forward-looking statements include, but are not limited to, statements about the timing of the anticipated acquisition, the potential benefits and synergies of the anticipated acquisition, including the expected impact on future financial and operating results, and post-acquisition plans and intentions. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. The following important factors, among others, could cause actual results to differ materially from those set forth in the forward-looking statements: the satisfaction of conditions to closing the agreement, including the risk that any required conditions are not satisfied, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the acquisition; the loss of key employees; the risk that the businesses will not be integrated successfully; unexpected variations in market growth and demand for the combined company’s products and technologies; and the risk that benefits and synergies from the acquisition may not be fully realized or may take longer to realize than expected. Additional risks and uncertainties that may affect future results are described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Episurf Medical reaches milestone of 300 implants

Posted On December 13, 2017 By OrthoSpineNews In Extremities /

Episurf Medical (NASDAQ: EPIS B) today announces that the company has reached another milestone by the planning of its 300th surgery with the Episealer® implant in the coming weeks.

“Strong clinical results, a growing user group among European surgeons, our 300th implant in production, a significant increase in the interest for the Episealer® technology within the orthopaedic industry, and most importantly, a continuous flow of successful patient outcomes. All of this sums it up, Episurf Medical is continuing to establish the Episealer® technology as a treatment alternative for early knee cartilage and bone damages“ says Pål Ryfors, CEO Episurf Medical.

For more information, please contact:

Pål Ryfors, CEO, Episurf Medical

Tel:+46 (0) 709 62 36 69

Email: pal.ryfors@episurf.com

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 09.30 CET on 12 December 2017.

AAOS approves diagnostic and treatment criteria for osteoarthritis of the hip

Posted On December 13, 2017 By OrthoSpineNews In Recon, Top Stories /

ROSEMONT, Ill., Dec. 12, 2017 /PRNewswire-USNewswire/ — The American Academy of Orthopaedic Surgeons (AAOS) Board of Directors approved new Appropriate Use Criteria (AUC) for Management of Osteoarthritis of the Hip.

The AAOS AUCs provide clinicians with algorithms on how to optimally treat an orthopaedic injury or condition, including hypothetical scenarios and possible treatments, ranked for appropriateness based on the latest research and clinical expertise and experience.

The new AUC supports the Clinical Practice Guideline, “Management of Osteoarthritis of the Hip” that strongly recommends:

The use of pre-surgical treatments to ease pain and improve mobility, including corticosteroid injections, physical therapy and non-narcotic medication (specifically acetaminophen, non-steroidal anti-inflammatory drugs or tramadol) for pain.
Both anterior and posterior approaches for total hip replacement (THR) surgery.

In addition, the new criteria highlight when “hip replacement may be appropriate even when patients have modifiable risk factors, such as obesity, mental health disorders, smoking and diabetes,” said Robert H. Quinn, MD, AAOS AUC section leader on the Committee on Evidence-Based Quality and Value.

For example, “some patients, who have worked closely with their medical team to best mitigate these risk factors, might be considered on an individual basis” for surgery, said Dr. Quinn. “In these instances, the doctor and patient must weigh the benefits and risks of surgery. At the end of the day it’s one surgeon and one patient, and hopefully both are considering the optimal treatment, based on the patient’s particular condition and diagnosis.”

The AUC and CPG, “Management of Osteoarthritis of the Hip,” are available through the AAOS OrthoGuidelines website and mobile app.

More Information about the AAOS
With more than 38,000 members, the American Academy of Orthopaedic Surgeons is the world’s largest medical association of musculoskeletal specialists. The AAOS provides educational programs for orthopaedic surgeons and allied health professionals, champions and advances the highest quality musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments and related issues.

Visit AAOS, at:
Newsroom.aaos.org for bone and joint health news, stats, facts, images and interview requests.
Orthoinfo.org for patient information on hundreds of orthopaedic diseases and conditions. ANationinMotion.org for inspirational patient stories, and orthopaedic surgeon tips on maintaining bone and joint health, avoiding injuries, treating musculoskeletal conditions and navigating recovery.
Facebook.org/AAOS1
Twitter.com/AAOS1
Instagram.com/AAOS_1

SOURCE American Academy of Orthopaedic Surgeons

VEXIM Announces the Results of the Simplified Tender Offer Initiated by Stryker

Posted On December 13, 2017 By OrthoSpineNews In Financial /

December 12, 2017

BALMA, France–(BUSINESS WIRE)–Regulatory News:

VEXIM (Paris:ALVXM), a medical device company specializing in the minimally invasive treatment of vertebral fractures listed on Euronext Growth (FR0011072602 – ALVXM), announces that the simplified public tender offer for the shares and BSAAR warrants of VEXIM (the “offer”), initiated by Stryker France MM Holding SAS (“Stryker”), has closed. The public tender offer was opened from November 16, 2017, to December 6, 2017.

The results were published yesterday by the French financial market authority (Autorité des marchés financiers, the “AMF”). Stryker, which already owned over 50% of the share capital and voting rights of VEXIM at the date of the filing of the public tender offer with the AMF, acquired an additional 4,036,406 shares during the offer period, as well as 226,520 BSAAR warrants that it has exercised for new shares of VEXIM. Stryker now holds 8,416,399 shares of VEXIM representing 92.19 % of its share capital and at least 91.56% of its voting rights.

About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the Masterflow^TM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. VEXIM has been listed on Euronext Growth Paris since May 3^rd 2012. For further information, please visit www.vexim.com

SpineJack®, an innovative implant for treating Vertebral Compression Fractures
The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

Nom : VEXIM
Code ISIN : FR0011072602
Code mnémonique : ALVXM

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
Tél. : +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tél. : +33 1 44 54 36 66 / Tél. : +33 6 48 82 18 94
vexim@alizerp.com

THINK Surgical, Inc. Receives CE Mark Approval for the TSolution One® Surgical System for Total Knee Arthroplasty

Posted On December 13, 2017 By OrthoSpineNews In Recon, Regulatory, Robotics /

FREMONT, Calif., Dec. 11, 2017 /PRNewswire/ — THINK Surgical Inc., a global medical device manufacturer of the only active robotic surgical system for orthopaedic surgery, announces that it has received CE Mark approval for the TSolution One® Surgical System, bringing active robotic precision to Total Knee Arthroplasty (TKA).

The TSolution One Surgical System first entered the European market in 2015 when it received CE Mark approval for Total Hip Arthroplasty (THA). Currently, the system has 510(k) clearance for THA in the United States and four centers are enrolling patients for an IDE clinical study for TKA. Earlier in the year, the TSolution One Surgical System received Korean-FDA clearance for both THA and TKA. It also received approval for sale in Israel by the Ministry of Health for THA.

“We are pleased to offer one of the most advanced technologies in Total Knee Replacement through the TSolution One Surgical System to the European market and other countries that rely on the CE Mark,” said John Hahn, CEO of THINK Surgical, Inc. “Obtaining the CE Mark represents a key milestone towards continuing the global commercialization of our differentiated robotic technology and our commitment to improving patients’ lives and partnering with surgeons to transform orthopedic surgery.”

TSolution One is a robotic system that enables surgeons to create the patient’s personalized pre-surgical joint replacement plan, using CT-based 3D planning and the system’s open implant library to achieve an optimized surgical plan. During surgery, the robot precisely executes the patient’s individual surgical plan by removing diseased bone and preparing the bone cavity and joint surface with sub-millimeter dimensional accuracy.¹THINK’s active robotic technology has been shown to improve joint replacement implant fit and alignment as compared to conventional joint replacement surgery.² Accurate implant fit and alignment may be responsible for reduced postoperative pain, complications, and improved patient function.^3,4

¹Paul HA, Bargar WL, Mittlestadt B, Musits B, Taylor RH, Kazanzides P, et al. Development of a Surgical Robot for Cementless Total Hip Arthroplasty. Clin Orthop Relat Res 1992;285:57–66

²Netravali, Nathan et al., “A Perspective on Robotic Assistance for Knee Arthroplasty” Advances in Orthopedics (2013): DOI http://dx.doi.org/10.1155/2013/970703

³P. F. Choong, M. M. Dowsey, and J. D. Stoney, “Does accurate anatomical alignment result in better function and quality of life? Comparing conventional and computer-assisted total knee arthroplasty,” Journal of Arthroplasty, vol. 24, no. 4, pp. 560–569, 2009.

⁴Barrack RL. Dislocation after total hip arthroplasty: Implant design and orientation. J Am Acad Orthop Surg. 2003;11(2):89-99.

About THINK Surgical, Inc.
THINK Surgical, Inc. is committed to the future of orthopaedic surgery and to improving patient care through the development of leading-edge precision technology. THINK Surgical develops, manufactures, and markets the only active robotic surgical system for orthopaedic surgery.

For more information, visit www.THINKSurgical.com.
TSolution One® is a registered trademark of THINK Surgical, Inc.

Contact: Nancy Heinzer
510-249-2318
info@thinksurgical.com

Related Links
THINK Surgical website

SOURCE THINK Surgical, Inc.

DePuy Synthes launches CONCORDE Clear MIS Discectomy Device to simplify spinal fusion surgery

Posted On December 13, 2017 By OrthoSpineNews In Spine /

December 12, 2017

DePuy Synthes today announced the launch of CONCORDE™ Clear MIS Discectomy Device, a surgical solution designed to simplify discectomy in minimally invasive spinal fusion surgery. Now available in Europe, the Middle East and Africa (EMEA), the single-use tool allows surgeons to complete the degenerated disc-removing process (discectomy) more efficiently than using traditional tools, while increasing the amount of disc material removed.

Lumbar disc herniation or prolapse accounts for 5% of all low back pain problems; it is the leading cause of radiating nerve root pain (sciatica) and one of the most common reasons for spinal fusion surgery. It is estimated that 140,000 discectomies for interbody fusion procedures will be performed across EMEA in 2018, of which a growing number will be minimally invasive. According to internal data from DePuy Synthes, minimally invasive surgery (MIS) is the fastest growing category in spinal fusion surgery as it is shown to result in fewer complications compared to open surgery in treating degenerative disc disease. As this procedure becomes more popular, there is a significant need to simplify MIS techniques and develop new instruments that can improve the efficiency of the procedure, while maximizing disc removal.

Discectomy in spinal fusion surgery typically requires the surgeon to work through a small surgical field with limited visibility. Traditionally, it requires several instruments and multiple instrument passes to make sure the disc is cleared and the endplates of the vertebrae are prepped for implants, which increases the risk of injury to the nerve root. The CONCORDE Clear Device is a single-use instrument that removes the degenerated disc and prepares the endplates using readily-available, standard hospital suction. The clear handle also allows surgeons to immediately see the collection of disc material. This simplified approach requires fewer tool passes and instrument exchanges when compared to traditional techniques, and removes a larger disc volume. This allows surgeons to complete the surgery more efficiently, which could lead to improved patient outcomes.

Dr. Gerd Bordon of Hospital de Manises, Valencia, Spain, commented:

CONCORDE Clear is an ideal tool to enhance discectomy procedures. I find it simple to use, it increases the efficiency of my procedures and improves the cleaning of the disc space. I believe it will lead to better patient outcomes in spinal fusion surgery.

The launch of the CONCORDE Clear Device follows DePuy Synthes’ October release of the VIPER PRIME™ System. The VIPER PRIME System is also designed to improve efficiency in spinal surgery. The inserter reduces the number of instruments and the number of instrument passes to place a pedicle screw using a minimally invasive technique.

“The CONCORDE Clear MIS Discectomy Device is a true innovation that embodies our mission to make spinal fusion surgery less invasive for patients and less complicated for surgeons,” said Jordy Winters, Lead, DePuy Synthes Spine EMEA. “Both the CONCORDE Clear Device and the VIPER PRIME System are clear examples of how we continue to innovate in order to meet the increasing demand for MIS in Spine. In swift succession, we have provided two procedural solutions that are intended to make spinal fusion procedures more reproducible for surgeons, and result in better outcomes for patients.”

Source:

http://www.depuysynthes.com/

Camber Spine Announces FDA Clearance Of Spira™-C Open Matrix Cervical Interbody

Posted On December 11, 2017 By OrthoSpineNews In Regulatory, Spine /

WAYNE, Pa., Dec. 7, 2017 /PRNewswire/ — Camber Spine announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SPIRA™-C Open Matrix Cervical Interbody device, an innovative interbody fusion implant, second in the SPIRA™ family to employ a novel arched design as well as Surface by Design™ technology. This clearance marks Camber’s second implant clearance in the SPIRA™ family of implant systems to be released in the U.S. market.

The SPIRA™ family of interbody implants represents the next generation of open architecture; 3-D printed, titanium implants designed to enhance fusion. The combination of smart science and smart surfaces merged with SPIRA™ Arch Technology creates an optimal environment for cell proliferation and bone growth. According to Daniel Pontecorvo, CEO at Camber Spine, “The engineers and designing surgeons leveraged the latest in 3-D printing technology to incorporate the needs at each step of the fusion process with the SPIRA™ family. To enable immediate stability, significant friction was achieved with the unique surface design. For short-term stability, other features were added to the surface design. This includes both a roughened titanium surface designed to promote bone cell proliferation, and a pore size optimized for bone ingrowth. In a way, robust ingrowth achieves a “mechanical fusion”, where we expect patients to feel better quicker. Lastly, long-term stability is achieved with the ultimate endplate-to-endplate fusion. The newly forming bone follows the multiple arches incorporated with the Surface By Design™ to encourage ongrowth and ingrowth throughout the cage. Also, using a key bone-growth principal called “Wolff’s Law”, the arched design structure enables the distribution of load and strain, helping to enhance the fusion. We are very excited about this great implant design.”

The SPIRA™ Open Matrix ALIF implant, the first product released in the SPIRA™ family, also with an open architecture and arched design, was launched only three months ago, and has already been received with great surgeon enthusiasm for the treatment of their patients. Together, with the ENZA™ ALIF implant providing simple and stable, zero-profile integrated fixation, Camber Spine is poised to be a leader in the interbody implant arena.

The Camber Spine SPIRA™-C Open Matrix Cervical Interbody device is indicated for use at one or two contiguous levels in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the degenerative disk disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Camber Spine Technologies SPIRA-C™ Open Matrix Cervical Interbody is intended to be used with additional FDA-cleared supplemental fixation systems.

About Camber Spine

Camber Spine Technologies, LLP, is a fast-growing musculoskeletal implant company founded in 2010 bringing innovative, best-in-class products to the market, providing surgeons and their patients with better treatment options. The company is committed to delivering surgeon inspired new technologies to the spine market. Camber is an ISO 13485 certified medical device company. Camber Spine Technologies, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine. For further information please visit www.cambermedtech.com . For inquiries about SPIRA™-C or distribution opportunities please call 484.427.7060.

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

SOURCE Camber Spine Technologies

Smith & Nephew Announce European Launch of Handheld Imaging Technology a New Era of Evidence-Based Decision Making in Wound Care

Posted On December 11, 2017 By OrthoSpineNews In Extremities /

December 11, 2017

LONDON–(BUSINESS WIRE)–Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, today announces the European launch of MolecuLight i:X^TM, the easy to use, handheld imaging device that instantly measures wound surface area and visualises the presence and distribution of potentially harmful bacteria in wounds.^2,3

Currently wound assessments are made with the naked eye which can lack the accuracy required to most effectively guide clinical decision making.⁴ Using fluorescence, MolecuLight i:X quickly, safely, and easily visualises potentially harmful bacteria^1,2,3in wounds which may otherwise lack signs or symptoms of infection. It enhances a clinician’s ability to choose the right therapy, at the right time for their patient^1,2and can help to guide wound sampling and debridement,^1,5,6 monitor wound progression,^2,3 improve patient engagement^4,5and simplify wound documentation.¹

Clinical data from wound assessments demonstrates that incorporating the MolecuLight i:X into standard care facilitated more objective medical decision making and led to up to 9 times faster wound healing¹ and 54% more accurate swabbing.⁷

“The MolecuLight i:X enables healthcare professionals to see what they have never been able to see before“ said Paolo Di Vincenzo, Smith & Nephew’s Senior Vice President Global Marketing, Wound. “We are proud to partner with MolecuLight Inc. and bring this innovative technology to our customers. It strongly complements our range of advanced wound care products and we believe is set to start a revolution in wound care clinical practice.”

“For the first time clinicians can accurately sample a wound in situ to determine if bacteria are present as well as more effectively debride a wound under fluorescence visualisation. These are fundamental areas of everyday wound care that have remained suboptimal for too long, until now,” says Dr. Ralph DaCosta, Founder, Chief Scientific Officer and Director, MolecuLight Inc.

An estimated 2 million people are living with a chronic wound across Europe and an estimated 16% of all chronic wounds remain unresolved after a year or longer.^9,10,11 Ensuring wounds are appropriately diagnosed and treated is a priority for healthcare providers across Europe, reducing cost and improving outcomes for patients.

“Not only has the MolecuLight i:X transformed my department’s clinical decision making in terms of targeting sampling and debridement and improving antimicrobial stewardship, but the benefit to patients has also been exciting to see,” says Rosemary Hill*, Canadian Wound Ostomy Continence Nurse Clinician, Lions Gate Hospital, Vancouver. “By being able to engage patients in their wound healing progress, and by showing them the real-time images, we can reduce anxiety, and provide reassurance regarding the diminishing burden of bacteria.”

The MolecuLight i:X Imaging Device is approved by Health Canada (Medical License #95784) and has CE Marking (Certificate # G1160292355002) for sale in the European Union. The MolecuLight i:X Imaging Device is not available in the US.

Full press pack is available at: http://www.smith-nephew.com/news-and-media/media-releases/news/european-launch-of-handheld-imaging-technology-heralds-new-era-of-evidence-based-decision-making

About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has more than 15,000 employees and a presence in more than 100 countries. Annual sales in 2016 were almost $4.7 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).
For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

To learn more about what we do to help reduce wound infection, please visit www.closertozero.com

Forward-looking Statements
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

^◊ Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.

About MolecuLight Inc.
MolecuLight Inc. is a privately owned, Canadian medical imaging company delivering real-time fluorescence image-guidance solutions that provide clinicians with new information about wound bacterial burden and wound surface area to assist clinicians in making improved diagnostic and treatment decisions.

The MolecuLight i:X is manufactured by MolecuLight® Inc.
MaRS Centre, South Tower 101 College St., Suite 200 Toronto, ON M5G 1L7 Canada
T +1 647.362.4684 F +1 647.362.4730
www.moleculight.com

® Registered trademark acknowledged

[tm] All trademarks acknowledged
MolecuLight i:X and Look to Heal are registered trademarks of MolecuLight Inc in Canada, the US and the UK. MolecuLight DarkDrape is a registered trademark of MolecuLight® Inc in Canada. Other jurisdictions pending

The MolecuLight i:X is distributed by Smith & Nephew
Wound Management
Smith & Nephew Medical Ltd, 101 Hessle Road, Hull HU3 2BN, UK
T +44 (0) 1482 225181 F +44 (0) 1482 328326
www.smith-nephew.com
All Trademarks acknowledged
©October 2017 Smith & Nephew
AWM-AWD-11878

References:

1. DaCosta RS et al. Point-of-care autofluorescence imaging for real-time sampling and treatment guidance of bioburden in chronic wounds: first-in-human results. PLoS One. 2015 Mar 19;10(3).

2. MolecuLight Inc. PN 1189 MolecuLight i:X User Manual. 2016.

3. MolecuLight Inc. Case Study 0051 Track Wound Size and Bacterial Presence with the MolecuLight i:X. 2016.

4. Hoeflok J et al. Pilot clinical evaluation of surgical site infections with a novel handheld fluorescence imaging device. Proceedings of the Annual Military Health System Research Symposium (MHSRS); 2014 Aug 18- 21; Fort Lauderdale, FL.

5. Raizman R. Point-of-care fluorescence imaging device guides care and patient education in obese patients with surgical site infections. Presented at: CAWC 2016. Proceedings of the Annual Canadian Association of Wound Care Conference (CAWC); 2016 Nov 3-6, Niagara Falls, ON.

6. Raizman R. Fluorescence imaging positively predicts bacterial presence and guides wound cleaning and patient education in a series of pilonidal sinus patients. Proceedings of the Annual Wounds UK Conference; 2016 Nov 14-16; Harrogate, UK.

7. Ottolino-Perry K et al. Improved detection of wound bacteria using fluorescence image guided wound sampling in diabetic foot ulcers. Int Wound J. 2017 Feb 28. doi: 10.1111/iwj.12717.

8. Posnett J et al. J. Wound Care (April 2009), The Resource Impact of Wounds on Health-care Providers in Europe, vol.18 (4).

9. Lindholm C and Searle R. Wound management for the 21st century: combining effectiveness and efficiency. Int Wound J. 2016 Jul;13 Suppl 2:5-15.

10. Siddiqui AR and Bernstein JM. Chronic wound infection: facts and controversies. Clin Dermatol. 2010;28:519–26.

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* Rosemary Hill is a paid consultant of Smith & Nephew or MolecuLight Inc.

Contacts

Media Enquiries
Rachel Cunningham
Rachel@roadcommunications.co.uk
+4420 8995 5832
or
Fabienne Merlet
Fabienne@roadcommunications.co.uk
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or
Dave Snyder
Smith & Nephew
+1 (978) 749-1440

Sports Medicine Market by Product, Application & Region – Global Forecast to 2022

Posted On December 11, 2017 By OrthoSpineNews In Sports Medicine /

DUBLIN, Dec. 11, 2017 /PRNewswire/ —

The “Sports Medicine Market – Global Forecast to 2022” report has been added to Research and Markets’ offering.

The global sports medicine market is projected to reach USD 8.24 Billion by 2022 from USD 5.78 Billion in 2017, at a CAGR of 7.4% during the forecast period. The increasing incidence of sports injuries, continuous influx of new products and treatment modalities, and developments in the field of regenerative medicine are some of the major factors driving the growth of the global sports medicine market.

The sports medicine market is segmented on the basis of product, application, and region. On the basis of product, the global market is segmented into body reconstruction products, body support & recovery products, and accessories. The body reconstruction products segment is further categorized into implants, fracture & ligament repair devices, arthroscopy devices, prosthetics, and orthobiologics. The orthobiologics segment is expected to grow at the highest CAGR during the forecast period. The high growth in this segment can be attributed to the recent developments in regenerative medicine, allografts, and stem cell therapy.

The body support & recovery products segment is further divided into braces and supports, compression clothing, and physiotherapy equipment. The physiotherapy equipment segment is further categorized into thermal therapy, electrostimulation, and other therapies.

Based on application, the market is segmented into shoulder, foot and ankle, elbow & wrist, back & spine, hip & groin, knee, and other injuries (head, face, and finger injuries). In 2017, the knee injuries segment is estimated to command the largest share of the sports medicine market. Growth in the knee injuries segment can be attributed to the increasing participation in sports like football and basketball at a younger age, resulting in high prevalence of knee injuries.

The elbow and wrist injuries segment is estimated to register the highest CAGR during to forecast period. This can be attributed to the increasing number of injuries in sports, like rowing, racquet sports, and golf, where there is a repetitive overuse of elbow and wrists.

Companies Mentioned

Arthrex
Breg
Conmed
Depuy Synthes Companies
Djo Global
Medtronic
Mueller Sports Medicine
Performance Health International Limited
Rti Surgical
Smith & Nephew
Stryker
Wright Medical Group
Zimmer Biomet

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights

5 Market Overview

6 Sports Medicine Market, By Product

7 Sports Medicine Market, By Application

8 Sports Medicine Market, By Region

9 Competitive Landscape

10 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/research/4f5vzv/sports_medicine

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

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SOURCE Research and Markets

Author: OrthoSpineNews

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