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April 20, 2018 OrthoSpineNews

Shoulder injury? Get “patched up” – literally, says renowned orthopedic surgeon and sports medicine and arthroplasty specialist, Kevin D. Plancher, MD, who is using advanced technology – an all-natural, biologic “patch” about the size of a postage stamp – to repair and heal a certain type of tendon tear in the rotator cuff.

“We find that patients with the patch recover successfully from surgery, and require less time to rehabilitate the injured shoulder, even those patients with diabetes and whom are overweight,” states Dr. Plancher, who founded New York and Connecticut-based Plancher Orthopaedics & Sports Medicine.

This patch helps resolve partial tears of rotator cuff tendons seen in many pro athletes and “weekend warriors”. It can also help large tears caused by injury or by the degeneration of shoulder tissue due to age,” Dr. Plancher says.

Developed by Rotation Medical, Inc., now distributed by Smith & Nephew, it is a “bio-inductive implant.” The patch is composed of collagen fibers from the Achilles tendons of bovine animals, including cows and sheep. Applied to the injured tendon arthroscopically with special instruments, the patch appears to foster new tissue growth that thickens and strengthens the tendon. Eventually, the implant “dissolves” and is absorbed by the body. The federal Food and Drug Administration cleared the way for the implant’s use in 2014.

Researchers are hoping this implant will be the “breakthrough” in rotator cuff repair, Dr. Plancher says. Initial clinical data involving 200 patients and presented at the May 2017 meeting of the Arthroscopy Association of North America indicated that use of the patch resulted in statistically significant improvement in overall shoulder function and pain following surgery. Patch patients generally reported feeling better in the first six months following their procedure than did patients who had undergone more traditional rotator cuff treatments after two years.

“As orthopedic surgeons, we have been searching for a new ‘gold standard’ – that would transform our approach to rotator cuff repair,” Dr. Plancher says. “Most perplexing has been the risk of an injured shoulder tendon re-tearing, actually pulling away from its sutures, in cases of large tears when the tendon has to be affixed to the bone.

Dr. Plancher’s enthusiasm is well founded. Rotator cuff injuries are common with approximately 4 million Americans suffering from a rotator cuff disorder, either due to injury or age, and more than 50 percent of those older than age 60 reportedly have some degree of rotator cuff tear.

The rotator cuff consists of a stabilizing system of four major tendons and muscles that keep the head of the upper arm bone in the shoulder socket, allowing the arm to be raised and rotated. Partial — or complete — tears of these tendons can occur from normal wear over time; repetitive use as occurs in certain sports, such as baseball or tennis, or in occupations like painting or carpentry; and even injury from falls or heavy lifting.

Symptoms of rotator cuff problems include a dull ache in the shoulder, arm weakness, difficulty in lifting or rotating an arm and disturbed sleep. Partial tendon tears, seen in many athletes can affect their careers and can degenerate and often become full thickness tears.

Of course, the best medicine is prevention. To minimize risk of rotator cuff injury, Dr. Plancher advises:

  •     Exercise regularly to keep muscles strong and flexible in and around the shoulder blades and on the backs of shoulders.
  •     Warm up muscles before engaging in sports and other vigorous activities.
  •     Avoid lifting – or trying to catch – large, heavy objects.
  •     Don’t keep arms raised or out from the side for long periods of time. If you must do so, take breaks and put a cold compress on the stressed shoulder several times daily.

Most importantly, if you have any of the above mentioned symptoms for a prolonged period of time make sure you seek medical attention from a fellowship trained shoulder surgeon.

Kevin D. Plancher, MD, MPH, is a board-certified orthopaedic shoulder surgeon, pioneer of shoulder procedures and the founder of Plancher Orthopaedics & Sports Medicine.

Plancher Orthopaedics & Sports Medicine is a comprehensive orthopaedics and sports medicine practice with offices in New York City and Greenwich, CT. http://www.plancherortho.com


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April 6, 2018 OrthoSpineNews

Vail, Colorado, April 06, 2018 (GLOBE NEWSWIRE) — The latest and most up-to-date methods and technologies in shoulder surgery will be the primary topics of discussion at the Vail International Shoulder Summit on April 6th and 7th at the Sonnenalp Hotel in Vail. The Summit is sponsored by Steadman Philippon Research Institute (SPRI), with The Steadman Clinic’s own Peter Millett, MD, MSc serving as the primary host of the event.

The two-day session begins today, Friday, April 6th with SPRI clinical fellowship and International scholar alumni attending. The Summit continues Saturday the 7th and is open to all orthopaedic surgeons, athletic trainers, physical therapists and professionals in orthopaedics and sports medicine.

Dr. Millett – who is a shoulder, knee and elbow specialist at The Steadman Clinic and has practiced sports medicine there since 2005 – looks forward to the variety of topics that will be discussed at the weekend’s Summit.

“The meeting is truly an international one with surgeons coming from all over the world to speak and present on their areas of expertise,” said Millett. “One of the benefits of the meeting is that, by design, there is ample time for discussion and one-on-one interaction between the presenters and the audience. It’s more like a think tank, incubator type of meeting than a convention, and that’s by intent.”

While Millett and SPRI have played host to numerous national and international conferences over the years that have focused on shoulder surgery and injuries related to the shoulder, this marks just the second time that they have included a day solely for returning alumni.

“Since so many of us know each other so well,” continued Millett, “it creates more openness and frank dialogue. This format allows us to be less reserved, more candid, and therefore more likely to get real advancements. It leads to some great discussion and helps us all learn more about the latest innovations in shoulder care.

“I think the venue in Vail really facilitates a lot of interaction, which no doubt creates a good cross-pollination of ideas,” added Millett. “Hopefully it not only serves as a forum where there is a lot of sharing of knowledge, but also spurs innovation.”

The Shoulder Summit begins Friday with presentations on the AC joint, bicep tendon, shoulder instability and rotator cuff tears. Saturday’s agenda includes segments on shoulder joint preservation and shoulder arthroplasty (total shoulder replacement surgery).

In addition to Millett, Burak Altintas, MD and Robert Boykin, MD will be serving as course directors for this year’s Shoulder Summit. Altintas, a German orthopaedic surgeon—originally from Turkey—is currently serving as an International scholar at SPRI, working closely with Millett and specializing in shoulder injuries and surgery. Boykin, who trained at Harvard, is a former sports medicine fellow at The Steadman Clinic and now practices as an orthopaedic surgeon in Asheville, N.C.

Other key presenters include The Steadman Clinic and SPRI’s own Matthew Provencher, MD and Johnny Huard, PhD. Provencher—a shoulder, knee and sports surgeon at The Steadman Clinic—will concentrate his talks on shoulder instability. Huard—Chief Scientific Officer and Director of the Center for Regenerative Sports Medicine at SPRI and recently named a recipient of the prestigious 2018 ORS (Orthopaedic Research Society) Kappa Delta Award—will talk about the use of biologics in the shoulder during Saturday morning’s discussion on shoulder preservation.

Attachment

Lynda Sampson
The Steadman Clinic 
970-479-1563
lsampson@sprivail.org

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March 23, 2018 OrthoSpineNews

CAMBRIDGE, Mass., March 23, 2018 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, today announced the publication of results from the MACI® (autologous cultured chondrocytes on porcine collagen membrane) Phase 3 SUMMIT  Extension Study in the American Journal of Sports Medicine.  The results demonstrated that the significantly greater improvements in Knee injury and Osteoarthritis Outcome Score (KOOS)1 pain and function scores for MACI versus microfracture shown in the two-year Phase 3 SUMMIT (Superiority of MACI Implant Versus Microfracture Treatment) study were maintained over the additional three-year follow-up in the SUMMIT Extension Study.

MACI is an autologous cellular scaffold product indicated for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  MACI is the first FDA‑approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue.

The FDA approval of MACI was based on the results of the SUMMIT study, a Phase 3, prospective, multicenter, randomized, controlled study that enrolled a total of 144 patients.  The co-primary efficacy endpoint was the change from baseline to two years in the KOOS2 pain and function scores.  The SUMMIT study is the only Phase 3 clinical trial of a cartilage repair product to date to demonstrate statistically significant improvement over microfracture at both one and two years.2

The SUMMIT Extension Study was a three-year follow-up of the SUMMIT clinical trial, entailing up to five years of observation after surgery.  Of the 144 patients randomized in the SUMMIT study, 128 (89%) continued observation out to five years in the SUMMIT Extension Study.  Evaluation of these patients post treatment showed that there was sustained improvement in both KOOS pain and function for the study period.  A post‑hoc evaluation showed that the significantly greater improvement of MACI versus microfracture observed at the two-year endpoint was maintained at the five-year follow-up.  The frequency of adverse events and subsequent surgical procedures were similar in both the MACI and microfracture treatment groups.  The Extension Study is the first study in the field of cartilage repair to provide long-term, five-year follow-up results from a successful multicenter, superiority study in comparison to microfracture.

“MACI is the only FDA-approved cartilage repair product that has demonstrated significantly greater improvement versus microfracture in a Phase 3 controlled clinical trial,” said Nick Colangelo, Vericel’s president and chief executive officer. “It is important to both clinicians and patients that MACI, in addition to demonstrating significant improvements compared to microfracture as early as one year, maintains improvements over microfracture out to at least five years.”

The publication is entitled “Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfacture: Five-Year Follow-up of a Prospective Randomized Trial” and the full abstract is available on pubmed: http://journals.sagepub.com/doi/full/10.1177/0363546518756976

About MACI
MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellular scaffold product that is indicated for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  The MACI implant consists of autologous cultured chondrocytes seeded onto a resorbable Type I/III collagen membrane.  Autologous cultured chondrocytes are human-derived cells which are obtained from the patient’s own cartilage for the manufacture of MACI.

Limitations of Use

  • Effectiveness of MACI in joints other than the knee has not been established.
  • Safety and effectiveness of MACI in patients over the age of 55 years have not been established.

Important Safety Information

  • MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin.  MACI is also contraindicated for patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders.  MACI is also not indicated for use in patients who have undergone prior knee surgery in the past six months, excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant.
  • MACI is contraindicated in patients who are unable to follow a physician-prescribed post-surgical rehabilitation program.  The safety of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown.  Expansion of present malignant or dysplastic cells during the culturing process or implantation is possible.
  • Patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases.  A cartilage biopsy and MACI implant may carry the risk of transmitting infectious diseases to healthcare providers handling the tissue.  Universal precautions should be employed when handling the biopsy samples and the MACI product.

About Articular Cartilage Defects of the Knee
Articular cartilage is a highly organized avascular tissue composed of chondrocytes embedded within an extracellular matrix of collagens, proteoglycans and noncollagenous proteins.  Its primary function is to enable the smooth articulation of joint surfaces, and to cushion compressive, tensile and shearing forces.  Articular cartilage damage is caused by both acute and repetitive trauma resulting in knee pain, effusion or mechanical symptoms such as catching and locking, and swelling.  Since articular cartilage is avascular it has little capacity to repair itself or regenerate.  Articular cartilage lesions that are left untreated may progress to debilitating joint pain, dysfunction, and osteoarthritis.3  The prevalence rate for cartilage lesions in the knee has been reported to be 63% in patients undergoing investigational arthroscopies.4

About Vericel Corporation
Vericel is a leader in advanced cell therapies for the sports medicine and severe burn care markets.  The company markets two cell therapy products in the United States.  MACI®(autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  Epicel®(cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area.  For more information, please visit the company’s website at www.vcel.com.

MACI® and Epicel® are registered trademarks of Vericel Corporation. © 2018 Vericel Corporation. All rights reserved.

This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding the commercial potential of our products and growth in revenues, intended product development, clinical activity timing, regulatory progress, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities including maintenance of clinical benefit, regulatory approval requirements, estimating the commercial growth potential of our products and product candidates and growth in revenues and improvement in costs, market demand for our products, and our ability to supply or meet customer demand for our products. These and other significant factors are discussed in greater detail in Vericel’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission (“SEC”) on March 5, 2018, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management’s current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

References

1Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003;1:64.

2Saris D, Price A, Widuchowski W, Bertrand-Marchand M, Caron J, Drogset JO, et al. Matrix-applied characterized autologous cultured chondrocytes versus microfracture: two-year follow-up of a prospective randomized trial. Am J Sports Med. 2014 Jun;42(6):1384-94.

3Bedi A, Feeley BT, Williams RJ. Management of articular cartilage defects of the knee. J Bone Joint Surg Am. 2010;92(4):994‑1009.

4Curl WW, Krome J, Gordon ES, Rushing J, Smith BP, Poehling GG. Cartilage injuries: a review of 31,516 knee arthroscopies. Arthroscopy. 1997;13(4):456-60.

(vcel-Corp)

Global Media Contacts:
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Russo Partners LLC
+1 212-845-4271 (office)
+1 858-717-2310 (mobile)
David.schull@russopartnersllc.com

Karen Chase
Russo Partners LLC
+1 646-942-5627 (office)
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Karen.chase@russopartnersllc.com

Investor Contacts:
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The Trout Group
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Lee Stern
The Trout Group
lstern@troutgroup.com
+1 (646) 378-2922


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March 22, 2018 OrthoSpineNews

This month, at the American Academy of Orthopaedic Surgeons meeting, I had the privilege of interviewing Matt Moreau, the Vice President and General Manager of Stryker’s Sports Medicine business. Our topic of conversation was the new technologies that Stryker unveiled at AAOS. Two things were made clear during my discussion with Matt: Stryker’s passion for innovation and an unwavering dedication to patient care. Below are some questions I asked along with his responses.

Q1: What separates the Pivot Guardian Distraction System from what is on the market today? 

The most differentiated advancement designed into the Pivot Guardian Distraction System was eliminating the need for a post to achieve distraction, which helps mitigate complications such as skin tears, nerve damage or total groin numbness that can sometimes last for several weeks or longer for patients.  Since the inception of hip arthroscopy, surgeons have not been given an option from industry to mitigate these significant risks in an elective procedure. Beyond the post-free innovation, the system was really focused on enabling surgeons to see and do more versus current systems on the market.  The innovative boot was designed to better disperse pressure, as well as reduce the risk of heel slip during the procedure, which can save considerable operative and anesthesia time. The boot advancements also give surgeons the option to place the boot on the patient pre-operatively, which allows for patient feedback while they’re awake and potentially reduces OR set-up time.  Lastly, we believe the table design gives surgeons better intraoperative range of motion and more flexibility for c-arm positioning, which is critical to the procedure. 

Q2: What are the advantages of Cobra compared to other suture passers for arthroscopic rotator cuff repair that are currently on the market?

Three things come to mind right away.

  • Cobra’s innovative needle design and stronger material improves clinical performance by addressing misfires and tip breakages associated with the current standard of care.
  • Because the Cobra needle is reusable, it presents an opportunity for us to provide a better business solution to our customers.

3) Utilizing the Cobra technology also cuts down on waste and utilization of customer shelf space. Removing waste is always a goal during development, as well as minimizing or eliminating the need to occupy our customer’s valuable shelf space. 

Q3: When it comes to innovation, is Stryker exclusively focused on acquisitions?

We typically take a hybrid approach of internal development, while also looking at external technologies that would complement our pipeline.  Cobra was an example of purchasing an early stage and innovative technology that we refined over time until we felt it was really positioned to change the standard of care in rotator cuff surgery.


Thank you for taking the time to discuss the new technologies Stryker unveiled at AAOS. We are excited to see what the future holds for you and your team!

 

Related Link Here


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March 19, 2018 OrthoSpineNews

March 19, 2018

SAN DIEGO–(BUSINESS WIRE)–KFx Medical, LLC announced that it has entered into a license agreement with Wright Medical Technology, Inc. (NASDAQ:WMGI) relating to KFx patents used in knotless double row rotator cuff repair.

Under the agreement, Wright and its affiliates will have the right to promote the use of products and techniques for knotless double row rotator cuff repair as claimed in US Patent number 7,585,311 and related patents and applications for the life of those patents. In addition, KFx and Wright agreed to dismiss the related pending litigation between the parties.

Arthrex, Inc. has paid in excess of $35m in damages and interest for its infringement of KFx’s Knotless Double Row Fixation method as described in KFx’s U.S. Patent No. 7,585,311.

Terms of the licensing agreement were not disclosed.

“We are proud to have our innovation recognized by Wright. Previously we announced our licensing agreements with Smith & Nephew, Inc. (NYSE:SNN), Mitek, a Johnson & Johnson Company (NYSE:JNJ), and ConMed (NASDAQ:CNMD) for the same patents. I am pleased with the licensing arrangement with these four world leaders and knowing KFx’s valuable double row knotless rotator cuff technology will reach even more patients,” indicated Tate Scott, President and Chief Executive Officer.

About KFx Medical, LLC

KFx Medical LLC was founded in 2003 to develop products for tissue fixation in a variety of orthopedic surgical procedures performed on the shoulder, knee, foot, and ankle. KFx provides simple systems for orthopedic surgeons focused on sports medicine. The company is privately held. Investors include Alloy VenturesCharter Life SciencesArboretum VenturesMontreux Equity Partners, and MB Venture Partners.

Contacts

KFx Medical, LLC
Tate Scott
President and Chief Executive Officer
619-742-2010
Tate.Scott@kfxmed.com
www.kfxmedical.com


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March 12, 2018 OrthoSpineNews

KIRKLAND, QCMarch 8, 2018 /CNW Telbec/ – Ortho Regenerative Technologies Inc. (CSE: ORTH.CN) (“Ortho RTi” or the “Corporation”), an emerging Orthopaedic and Sports Medicine Technology company, today announced it has received a Notice of Allowance from the European Patent Office for European Patent Application Number 10831000.4 entitled, “Novel Forumulation of Physiological Chitosan-Inorganic Salt Solution/Blood Mixtures for Tissue Repair.”

Once the administrative process is complete, the European Patent that issues from this application will provide intellectual property protection for the composition of matter of Ortho RTi’s ‘Ortho-R’ for the biologic repair of tissue.

“This allowance is from the second series of patent applications we have made to cover our propriety biopolymer platform around the globe,” said Ortho RTi’s Executive Chairman and CEO, Dr. Brent Norton.  “As awareness and acceptance of the promise that Ortho-R holds for improving the repair of three distinct joint tissues – the rotator cuff tendons, the meniscus and articular cartilage – it is important to ensure that the potential market opportunities these represent are well protected.  To that end, our expanding intellectual property estate should ensure that our game-changing technology has long-term market exclusivity.”

About Ortho Regenerative Technologies Inc.

Ortho RTi is an emerging Orthopaedic and Sports Medicine technology company dedicated to the development of novel therapeutic tissue repair devices to dramatically improve the success rate of sports medicine surgeries. Our proprietary biopolymer has been specifically designed to increase the healing rates of sports related injuries to ligaments, tendons and cartilage. The polymer can be directly placed into the site of injury by a surgeon during a routine operative procedure without significantly extending the time of the surgery and without further intervention. Visit us on the internet at www.orthorti.com.

Forward-Looking Statements

This news release may contain certain forward-looking statements regarding the Corporation’s expectations for future events. Such expectations are based on certain assumptions that are founded on currently available information. If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Corporation disclaims any intention or obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.

SOURCE Ortho Regenerative Technologies Inc.

For further information: Stephen Kilmer, Investor & Media Relations, 647.872.4849, kilmer@orthorti.com


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March 7, 2018 OrthoSpineNews

KALAMAZOO, Michigan, USA, March 7, 2018 /PRNewswire/ — Stryker announced today at the American Academy of Orthopaedic Surgeons annual meeting (booth #2451) the launch of its new reusable suture passing technology for use in rotator cuff repair, Cobra.  This first-of-its-kind technology leverages novel needle manufacturing and an innovative jaw design to produce the first reusable needle technology.

Compared to other suture passers on the market, Cobra offers improved needle stiffness to address issues associated with intraoperative misfires and distal tip needle breakages.  In addition, the value-based robust needle technology offers customers a more cost-effective solution. This suture passer utilizes technology that Stryker acquired from Arthrogenx, LLC in 2017.

“We are excited about the launch of the Cobra technology because it provides a unique opportunity for us to significantly increase clinical performance from the current standard of care, while also reducing cost to customers,” said Matt Moreau, Stryker’s Sports Medicine Vice President and General Manager.  “We recognize that our customers will continue to be under tremendous pressure to increase quality while also reducing cost.  Launching the Cobra passer will allow Stryker to better partner with our customers and align with their financial objectives while also improving patient safety.”

Stryker will showcase its latest technologies, including Cobra, at the AAOS meeting from March 7-9, 2018.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Media contact
Heather Morrison
heather@inprela.com
Phone:  612 677 2023

SOURCE Stryker

Related Links

http://www.stryker.com


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March 6, 2018 OrthoSpineNews

LONDON, March 6, 2018 /PRNewswire/ — Smith & Nephew (NYSE: SNN, LSE: SN), the global medical technology business, is pleased to  announce the launch of Q-FIX CURVED, Q-FIX MINI and SUTUREFIX CURVED All-Suture Anchor systems adding to its growing Sports Medicine portfolio. Designed for procedures where space is limited and the anatomy can be difficult to access, the new SUTUREFIX CURVED, Q-FIX CURVED and MINI delivery systems are designed to aid in optimal suture anchor placement during drilling and insertion.

The SUTUREFIX CURVED and Q-FIX CURVED systems improve access and trajectory when drilling bone tunnels. Both systems optimize the curved geometry of the drill guide while also maximizing drilling accuracy. 1 The incorporation of both visual and tactile cues simplifies drill guide orientation for the surgeon and helps to indicate drilling trajectory.

The Company also introduced its Q-FIX MINI All-Suture Anchor, which reduces the tunnel drill depth and implant length to 17.1mm, making it the shortest all-suture anchor in its class.2

“The new Q-FIX CURVED drilling system and Q-FIX MINI represent another advancement by Smith & Nephew in soft tissue fixation,” said Felix H. “Buddy” Savoie III, MD, Chairman of Orthopaedic Surgery and Chief of Sports Medicine at Tulane University School of Medicine. “The curved drilling system improves access to the inferior glenoid while improving the trajectory of the drill bit, thereby reducing the risk of bicortical perforation. And the MINI anchor’s short drill depth improves patient safety, making it more useful in all applications, especially in small joint soft tissue fixation.”

“The unique tapered distal curve of the SUTUREFIX CURVED Drill Guide allows me to place these anchors anywhere that I would like along the acetabular rim,” said Dr. Marc J. Philippon of the Steadman Philippon Research Institute. “The active deployment of this all-suture anchor system greatly reduces displacement and the new curved guide has a better curvature and drilling trajectory than other curved systems on the market.”

“The Q-FIX MINI, Q-FIX CURVED and SUTUREFIX CURVED enable healthcare professionals to access challenging pathology like they have never been able to do before,” said Scott Schaffner, Senior Vice President Global Marketing, Smith & Nephew. “These new products highly complement our Sports Medicine range and we’re proud to offer them as part of our growing portfolio.”

Unlike other all-suture anchors that require the suture strands to be pulled back against the cortical bone in order to deploy them, Smith & Nephew’s Q-FIX and SUTUREFIX All-Suture Anchor platform uses active deployment3, which eliminates manual tensioning and makes deployment more reliable4, ultimately resulting in improved biomechanical performance among all-suture anchors.5,6,7

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 ReconstructionAdvanced Wound ManagementSports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 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.comfollow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.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.

References:

1.    Data on file. Report P/N 15007031 Rev. A, Q-FIX Family Drill Deviation.
2.    Data on file. Report P/N 15006934 Rev. A, SUTUREFIX And Q-FIX Family Geometric Claims, page 11.
3.    Douglass NP, Behn AW, Safran MR. Cyclic and Load to Failure Properties of All-Suture Anchors in Synthetic Acetabular and Glenoid Cancellous Bone. Arthroscopy. 2017 May;33(5):977-985.e5. doi: 10.1016/j.arthro.2016.11.022. Epub 2017 Jan 26.
4.    Byrd, JWT, Jones, KS, Loring, CL, Sparks, SL. Acetabular All-Suture Anchor for Labral Repair: Incidence of Intraoperative Failure due to Pullout Arthroscopy: The Journal of Arthroscopic & Related Surgery Available online 17 January 2018. doi 10.1016/j.arthro.2017.09.049.
5.    Erickson J, Chiarappa F, Haskel J, Rice J, Hyatt A, Monica J, Dhawan A. Biomechanical Comparison of a First- and a Second-Generation All-Soft Suture Glenoid Anchor. The Orthopaedic Journal of Sports Medicine, 5(7), 2017. doi.org/10.1177/2325967117717010.
6.    Barber AB, Herbert MA. All-Suture Anchors: Biomechanical Analysis of Pullout Strength, Displacement, and Failure Mode. Arthroscopy.2017 Jun;33(6):1113-1121. doi: 10.1016/j.arthro.2016.09.031. Epub 2016 Dec 22.
7.    Nagra NS, Zargar N, Smith RD, Carr AJ. Mechanical Properties of All-suture Anchors for Rotator Cuff Repair.Bone Joint Res. 2017 Feb;6(2):82-89. doi: 10.1302/2046-3758.62.BJR-2016-0225.R1.

 

SOURCE Smith & Nephew

Related Links

http://www.smith-nephew.com


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January 24, 2018 OrthoSpineNews

DUBLINJan. 24, 2018 /PRNewswire/ —

The “Sports Medicine Market – Industry Trends, Opportunities and Forecasts to 2023” report has been added to ResearchAndMarkets.com’s offering.

Sports medicine is a branch of medicine that deals with physical fitness and treatment and prevention of injuries related to sports and exercise. Increasing adoption of western sports worldwide has resulted in growing number of sports injuries which is driving the market for sports medicine globally. Rise in the point-of-care testing by various diagnostic products and growing number of sports associations around the world are other factors which further boost the growth of sports medicine market.

Sports complication related to knees, hips, elbows, shoulder, and spine are augmenting the demand for minimally invasive surgical procedures, thereby impacting the overall market growth. Growing popularity of robot-assisted surgeries, development of novel technologies such as 3D MRI, for better and accurate diagnosis, and high investments by the vendors and government for R&D activities will provide a great opportunity for the expansion of global sports medicine market.

By application, shoulder and knee treatment will gain the fastest growth in the sports medicine market. Geographically, Americas holds the largest market share of global sports medicine market owing to widespread acceptance of various sports such as football, basketball, and baseball in which players do get injured. Europe is also witnessing a significant rise in demand for sports medicines in order to provide on the spot treatment for sport-related injuries. APAC region will witness the highest market growth due to favorable government regulations growing sports infrastructure and rising interest of the youth in various western sports such as football and basketball. However, the high cost of sports medicinal instruments and lack of trained professionals will act as a major challenge to the adoption of sports medicine in the developing and underdeveloped countries.

Competitive intelligence section deals with major players in the market, growth strategies, products, financials, and recent investments among others. Key industry players profiled as part of this section are Arthrex, Smith & Nephew, DePuy Synthes, Stryker Corporation, CONMED Corporation, Zimmer Biomet Holdings, Breg, DonJoy, and Mueller Sports Medicine.

Segmentation

By Function

  • Reconstruction
  • Support and Recovery
  • Body Monitoring and Evaluation
  • Others

By Application

  • Knee
  • Shoulder
  • Hip
  • Spine
  • Others

Key Topics Covered:

1. Introduction

2. Research Methodology

3. Executive Summary

4. Market Dynamics

5. Sports Medicine Market Forecast by Function (US$ billion)

6. Sports Medicine Market Forecast by Application (US$ billion)

7. Sports Medicine Market Forecast by Geography (US$ billion)

8. Competitive Intelligence

9. Company Profiles

  • Arthrex
  • Smith & Nephew
  • DePuy Synthes
  • Stryker Corporation
  • CONMED Corporation
  • Zimmer Biomet
  • Breg
  • DonJoy
  • Mueller Sports Medicine

For more information about this report visit https://www.researchandmarkets.com/research/xrgm2q/global_sports?w=5

Media Contact:

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

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December 26, 2017 OrthoSpineNews

WARSAW, Ind.Dec. 22, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the publication of positive results from a pilot study demonstrating the safety and promising efficacy of the nSTRIDE® Autologous Protein Solution (APS) Kit for the treatment of knee osteoarthritis (OA). In the trial, known as PROGRESS II, investigators prepared APS by using Zimmer Biomet’s nSTRIDE APS Kit, which concentrates anti-inflammatory cytokines and growth factors from a sample of the patient’s own blood, for delivery via a single intra-articular injection into the knee joint. The results, which appeared in The American Journal of Sports Medicine1, show significant improvement in the percentage change from baseline in pain scores measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), as well as comparable safety to saline.

OA, the most common type of arthritis, is a progressive disease of the joints. Often referred to as “wear and tear” arthritis, OA occurs when the top layer of cartilage, the slippery tissue that covers the ends of bones in a joint and helps absorb the shock of movement, breaks down and wears away. The bones under the cartilage then rub together, causing pain, swelling and loss of motion in that joint. Eventually, the joint may lose its normal shape and/or develop bone spurs around its edges.

“Inflammation is a critical factor in the pain and cartilage breakdown associated with knee osteoarthritis, and research has established that APS derived from the patient’s whole blood contains a host of powerful anti-inflammatory and anabolic proteins,” said Elizaveta Kon, MD, Associate Professor, Humanitas University, Milan, Italy, and lead investigator of the PROGRESS II trial. “After nearly a decade of preclinical and clinical research into the use of autologous anti-inflammatory cytokines and growth factors to treat osteoarthritis pain, we were pleased to demonstrate that APS, prepared with the nSTRIDE APS Kit, may be a promising, safe and viable new treatment for patients living with osteoarthritis of the knee.”

The PROGRESS II trial was a prospective, randomized, double-blind, saline-controlled pilot study that enrolled 46 patients with unilateral, mild-to-moderate, symptomatic knee OA pain from the four trial sites across Europe. Patients were randomized to receive either a single injection of APS prepared by the nSTRIDE APS Kit (n=31), or a single saline injection (n=15). Patient-reported outcomes and adverse events were assessed at two weeks, and at one, three, six and 12 months post-injection. Clinical effectiveness was measured using the Visual Analog Scale (VAS), the WOMAC, and the Knee Injury and Osteoarthritis Outcome Score (KOOS). X-ray and magnetic resonance imaging (MRI) evaluations were taken at baseline, as well as three and 12 months following treatment.

Top-line results showed that patients treated with APS demonstrated:

  • A 65 percent change in WOMAC pain score from baseline to 12 months compared to a 41 percent change in the saline group (p = 0.02).
  • A 49 percent improvement in VAS pain scores compared to a 13 percent improvement in the saline group (p = 0.06).
  • No procedure- or device-related serious adverse events, and comparable frequency, severity and relatedness of adverse events as compared to the saline group.

The nSTRIDE APS Kit is not commercially available in the United States but is currently marketed in Europe, via CE Mark, and in Japan, where it is marketed as the APS Kit. Results from the PROGRESS II study formed the basis for two additional confirmatory trials: the PROGRESS IV trial (NCT02905240), which received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in July 2016 and is currently enrolling patients, and the PROGRESS V trial (NCT03182374), which is underway in Europe to support global reimbursement efforts.

“As a global leader in musculoskeletal healthcare, Zimmer Biomet is committed to addressing the needs of patients along the entire continuum of care, from the management of symptoms like pain and stiffness with safe, non-invasive intra-articular injections like APS and Gel-One®, to restoring joint function and mobility with our extensive portfolio of implant systems to treat advanced orthopaedic disease,” said David Nolan, Group President, Biologics, Extremities, Sports Medicine, Surgical, Trauma, Foot and Ankle, Office Based Technologies and Zimmer Biomet Signature Solutions. “The positive results of the PROGRESS II trial not only reinforce the safety and clinical value of the autologous anti-inflammatory protein solution prepared with the nSTRIDE APS Kit, but also lay the groundwork to advance our regulatory efforts in the United States and accelerate our commercial adoption and expansion in Europe and Asia-Pacific.”

About nSTRIDE APS
The nSTRIDE APS Kit is currently under clinical evaluation in the United States. It holds a CE Mark in Europe and is approved in Japan as the APS Kit. The device produces an anti-inflammatory-rich cellular solution from a patient’s own blood. The output of the nSTRIDE APS Kit contains white blood cells and their corresponding anti-inflammatory cytokines in concentrations much higher than that of whole blood, in addition to anabolic cytokines that may promote cartilage health.2 These anti-inflammatory cytokines target and inhibit the pro-inflammatory and catabolic cytokines Interleukin-1 (IL-1) and Tumor Necrosis Factor Alpha (TNFα). Zimmer Biomet currently licenses the nSTRIDE APS technology to Owl Manor Veterinary, a privately held medical device company dedicated to joint preservation, tendon and ligament treatment, and advanced wound care treatment of equine and canine companion animals, under the brand name Pro-Stride Injection™.  For more information, please visit http://www.omveterinary.com/.

References:

  1. Kon E, Engebretsen L, Verdonk P, Nehrer S, Filardo G Clinical outcomes of an autologous protein solution injection for knee osteoarthritis: a 1-year pilot double-blinded randomized controlled trial. Published in The American Journal of Sports Medicine, October 2017 [Epub ahead of print].
  2. O’Shaughnessey K, Matuska A, Hoeppner J, et al. Autologous protein solution prepared from the blood of osteoarthritic patients contains an enhanced profile of anti-inflammatory cytokines and anabolic growth factors. J Orthop Res 2014;32(10):1349-55.

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 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, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s 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.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this release are cautioned not to rely on these forward-looking statements, since 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 release.

ZBH-Corp

 

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmer.com