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Paris High Court Rules in Favor of CoorsTek in Lawsuit Claiming Trademark Infringement of Ceramic Orthopaedic Hip Componets

Posted On March 12, 2018 By OrthoSpineNews In Regulatory /  

March 07 2018

Paris, France – CoorsTek today announced that the Paris High Court has ruled in its favor in a lawsuit brought by CeramTec GmbH attempting to block the manufacture and sale of CoorsTek’s CeraSurf®-p “pink” ceramic hip components.

In its ruling, the Paris High Court stated that CeramTec sought to “indefinitely perpetuate the technical effect” of its patent covering its Biolox Delta materials—which expired at the same time CeramTec was filing for its “pink” trademarks—in order to prevent its competitors from selling products using the once patented composition. The court found that CeramTec’s actions at the time of filing the trademarks were done in bad faith. The results of this judgement are that CeramTec’s European Union trademark registrations related to the color pink as applied to ceramic implants are invalid and unenforceable throughout the European Union, and that CeramTec’s infringement action against CoorsTek was dismissed.

“CoorsTek is pleased with this decision as it supports CoorsTek’s efforts to be able to provide medical device manufacturers with additional access to high-quality, substantially equivalent implantable ceramic components,” said Jonathan Coors, Co-CEO of CoorsTek. “This ruling is one more step in opening up the implantable device market to further competition, benefitting patients and enabling CoorsTek to achieve its mission of making the world measurably better.”

The inherent pink color of CoorsTek CeraSurf®-p ceramic material is a natural result of the chromium oxide dopant used in the ceramic matrix to provide a combination of hardness and toughness. CeraSurf®-p ceramic hip implant femoral heads (hip balls) and acetabular liners (cups) demonstrate extreme durability and longevity in applications due to a combination of high-performance ceramics, metals and polymers. CeraSurf®-p ceramic femoral heads and acetabular liners have received regulatory approvals and have been distributed for clinical use as bearing surfaces for hip implant systems in South America since 2011 and Europe since 2012, and received FDA 510(k) clearance in the U.S. in 2016.

CeramTec originally brought the suit against CoorsTek in 2013, claiming the development and marketing of the pink CoorsTek acetabular liners and femoral heads was in direct violation of its now invalid European Union trademark registrations.

The Paris High Court decision follows a similar ruling in January 2017, when the U.S. District Court for the District of Colorado ruled in favor of CoorsTek in its lawsuit challenging CeramTec’s claims to the color pink for implantable ceramic components. In that ruling, the U.S. District Court stated that CeramTec does not own any trademark or trade dress rights in the color pink in the U.S. and enjoined CeramTec from interfering with the rights of CoorsTek Medical to market CeraSurf®-p ceramic components in the United States.

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Kuros Biosciences obtains European patent covering osteoinductive materials

Posted On March 12, 2018 By OrthoSpineNews In Regulatory /  

Schlieren (Zurich), Switzerland, March 12, 2018

Kuros announced today that its Dutch subsidiary, Kuros Biosciences BV, has been granted the European patent, EP3021878, entitled “Method for producing an osteoinductive calcium phosphate and products thus obtained” by the European Patent Office (EPO).

The patent covers Kuros’ technology for osteoinductive calcium phosphates and their methods of production. The resulting unique surface topography instructs the body’s own stem cells and osteoprogenitor cells to differentiate into bone forming cells. It forms part of the portfolio of patents and patent applications that Kuros is putting in place to protect its MagnetOs product family.  The MagnetOs family of bone graft substitutes are based on biphasic calcium phosphate materials with a novel submicron surface structure designed to regenerate bone in the implanted site in the body. These highly sophisticated materials have been demonstrated to perform equivalently to autograft in clinically-relevant preclinical models.

“The grant of this patent by the EPO broadens the intellectual property estate around our advanced bone graft substitute materials and reinforces Kuros’ leadership in the field of bone graft substitutes.”, said Joost de Bruijn, CEO of Kuros.

About MagnetOs

MagnetOs Granules have CE Mark approval in the EU as a bone void filler for craniomaxillofacial, orthopedic and dental applications with an osteoinductive claim.  MagnetOs Granules and MagnetOs Putty both have US 510k clearance with an osteoconductive claim for use with autograft as a bone graft extender in the posterolateral spine.
For further information, please contact:

Hans Herklots

Lifesci Advisors

hherklots@lifesciadvisors.com

+41 79 598 7149

About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

News release (pdf)

Kuros Biosciences Ltd, Wagistrasse 25, CH-8952 Schlieren

 
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Exactech Receives 510(k) Clearance for Equinoxe® Stemless Shoulder

Posted On March 12, 2018 By OrthoSpineNews In Regulatory /  

March 12, 2018

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a leading developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today it has received clearance from the U.S. Food and Drug Administration to market the Equinoxe® Stemless Shoulder, a bone conserving and canal sparing prosthesis that is compatible with the Equinoxe® Shoulder System. The Stemless Shoulder is the latest addition to the company’s extremities product line.

“Our world-class design team and engineers deserve a lot of praise for this new product, and in particular, for an efficient product development process. Their ingenuity, coupled with their passion for clinical outcomes, allowed them to navigate this product to market very quickly, and is emblematic of our mission to help patients,” said Darin Johnson, Exactech vice president of marketing for extremities.

Designed for anatomic total shoulder arthroplasty, the Stemless Shoulder features a single tray of instruments for operating room efficiency. It uses a three-dimensional porous structure with optimized pore size, count and porosity. In addition, the Stemless Shoulder incorporates a bone cage for bone through-growth to enhance the probability of biologic fixation.

“The Stemless Shoulder’s innovative combination of three-dimensional porous material and bone cage technology help differentiate it from others on the market,” said design team member Buddy Savoie III, MD, of Tulane University. “Exactech’s ability to convert design team concepts and ideas into a reality is quite impressive, and I am certain surgeons will be eager to learn more about this meaningful technology.”

Joining Dr. Savoie on the design team were Pierre-Henri Flurin, MD, of Clinique du Sport in Bordeaux-Mérginac, France; Curtis Noel, MD, of Crystal Clinic Orthopaedic Center in Akron, Ohio; Ryan Simovitch, MD, of Palm Beach Orthopaedic Institute in Palm Beach Gardens, Fla.; Thomas Wright, MD, of the University of Florida; and Joseph Zuckerman, MD, of NYU Langone Orthopaedic Hospital.

Exactech plans to initiate targeted clinical evaluation of the Stemless Shoulder immediately, and will aggressively expand the release throughout the second half of the year.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

Contacts

Exactech
Priscilla Bennett, 352-377-1140
Vice President Corporate & Marketing Communication
media@exac.com

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Ortho RTi Receives Notice of Allowance for European Patent Protecting Ortho-R Technology

Posted On March 12, 2018 By OrthoSpineNews In Sports Medicine /  

KIRKLAND, QC, March 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

Organization Profile

Ortho Regenerative Technologies Inc.

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Solvay’s Zeniva® PEEK enables durable all-polymer knee implant from Okani Medical Technology

Posted On March 12, 2018 By OrthoSpineNews In Recon, Top Stories /  
Alpharetta, Ga., March 5, 2018 — Solvay, a leading global supplier of specialty polymers, announced that Okani Medical Technology, a China-based pioneer in artificial joint applications, has developed an all-polymer knee implant based on Solvay’s Zeniva® polyetheretherketone (PEEK). Okani’s novel ORGKnee™ implant offers a longer service life at a lower cost than traditional metallic implant systems. Solvay’s booth at AAOS 2018 will feature the ORGknee™ implant in multiple sizes.
Okani evaluated Zeniva® PEEK’s suitability for the femoral and tibial tray components of its knee implant according to ISO 14243-1:2009, which simulates normal walking behavior over 10 years. The findings, which Okani will present at the Orthopaedic Research Society (ORS) 2018 Annual Meeting next week, indicate that the ORGKnee™ implant made of Zeniva® PEEK exhibited 50 percent less wear versus a metal implant as measured by material loss over 3 million cycles.
Okani selected Zeniva® PEEK for its ORGKnee™ implant due, in part, to the material’s success in spinal implant applications. Unlike implants made of cobalt chrome or titanium alloys, those molded from Zeniva® PEEK exhibit a modulus similar to cortical bone, which can improve patient comfort, provide a more stable fixation over time and extend implant lifetime due to significantly reduced wear of the total knee-joint prosthesis.
“PEEK’s injection molding capability makes large-scale production of ORGKnee™ implants possible in a fraction of the time and cost it takes to make metal implants, which can take up to three months to manufacture, machine and polish using methods that can pose risks both to workers and the environment,” said Zhonglin Zhu, chief technology officer for Okani.
Another motivation that prompted Okani’s decision to work with Solvay was the polymer supplier’s reputation for partnering with highly innovative medical device companies.
“Okani’s implant is not only a perfect showcase for the unique properties of Zeniva® PEEK, but also for Solvay’s open innovation business model, which takes a collaborative approach to helping medical device customers foster innovation and optimize their technology,” said Jeff Hrivnak, global business manager for Healthcare at Solvay’s Specialty Polymers Business Unit.
Okani’s ORGKnee™ implant enters pre-clinical trials this April before undergoing standard clinical trials by China’s Food and Drug Administration (CFDA) in September, 2018. The company plans to commercially launch its ORGKnee™ solution in 2020 after CFDA approvals are complete.
For more information about this application and related news about specialty polymers for healthcare, please go to solvayhealthcarenews.com.
® Zeniva is a registered trademark of Solvay
™ ORGKnee is a trademark of Okani Medical Technology

Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, ultra-high performance aromatic polymers, and high barrier polymers – for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil & Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries. Learn more at www.solvayspecialtypolymers.com.

Solvay is an advanced materials and specialty chemicals company, committed to developing chemistry that address key societal challenges. Solvay innovates and partners with customers worldwide in many diverse end markets. Its products are used in planes, cars, batteries, smart and medical devices, as well as in mineral and oil and gas extraction, enhancing efficiency and sustainability. Its light-weighting materials promote cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 24,500 employees in 61 countries. Net sales were €10.1 billion in 2017, with 90% from activities where Solvay ranks among the world’s top 3 leaders, resulting in an EBITDA margin of 22%. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris (Bloomberg: SOLB.BB – Reuters: SOLB.BR) and in the United States its shares (SOLVY) are traded through a level-1 ADR program.

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Geisinger Announces It Will Stand Behind Cost of Hip Surgery for a Lifetime

Posted On March 10, 2018 By OrthoSpineNews In Recon /  

March 08, 2018

DANVILLE, Pa. & CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Once again, Geisinger is pioneering a ground-breaking new model for care in which the innovative health system has announced it will expand its ProvenCare Total Hip program even further by standing behind the costs associated with orthopaedic surgeries for a lifetime.

Geisinger collaborated with Medacta International, a global leader in orthopaedic medical devices, on a first-of-its-kind pilot program to provide a Geisinger Health Plan member who was receiving hip-replacement surgery an unlimited time frame for future surgical care and cost that may be needed. These costs will be proportionally shared between Geisinger and Medacta, including the device itself and all hospital costs, while the patient remains with Geisinger Health Plan and is treated by Geisinger providers.

“Surgeon education and mentorship is a core pillar of Medacta’s mission, with hundreds of surgeons from around the world receiving training each year through our renowned M.O.R.E. Institute and AMIS Education Program,” said Francesco Siccardi, Executive Vice President of Medacta International. “This value-based care partnership with Geisinger, our first, further underscores Medacta’s commitment to improving the patient experience while redefining the orthopaedic ‘product’ to encompass not only the implant, but also accompanying surgical technique, education and instrumentation. We are proud to go beyond implant replacement and share in the risk and overall cost of patient care, which we believe to be an unprecedented step for an orthopaedic manufacturer.”

The first patient enrolled in the pilot – an active, 53-year-old woman – underwent successful total hip replacement surgery on Monday, February 26, 2018, with plans underway to expand the program. This is the first time ever that a patient will be afforded the full range of care – both hospital care and device replacement – for future revisions at no charge when all services are delivered to Geisinger Health Plan members by Geisinger providers.

Under the country’s current reimbursement system, hospitals are often paid more when something goes wrong during surgery. Geisinger has long served as the national model for reversing this trend and a champion of delivering high quality care at lower costs to the more than 3 million patients seeking treatment every year.

“Rather than follow the prevalent fee-for-service model, Geisinger rewards value,” said Michael Suk, MD, JD, MPH, MBA chair of the Geisinger Musculoskeletal Institute and the Department of Orthopaedic Surgery. “When it comes to the hip replacement pilot program, what we’re saying to our patients is that the level of service we’ll provide will be so exemplary that if there’s a problem tomorrow or 20, 30, or 40 years from now, we’ll take care of it. Geisinger continues to drive the national dialogue on value-based orthopaedic surgery through this groundbreaking expansion of our ProvenCare model.”

In 2006, Geisinger transformed the health care industry by introducing its renowned ProvenCare program. This multifaceted program includes the reengineering of care using evidence-based “bundles” and adoption of a fixed per-case rate that covers preadmission, inpatient, and follow up care, including any and all complications 90 days post–procedure.

In 2014, Geisinger launched ProvenCare Hip Fracture, Total Hip, Total Knee and Lumbar Spine in yet another chapter of the health system’s transformative care.

“Since introducing the ProvenCare orthopaedic protocols, we’ve witnessed a decrease in readmissions and a reduction in length-of-stay figures when it comes to total hip replacements,” said Dr. Suk. “By affixing evidenced-based protocols to all hip and knee surgeries, we are able to ensure the same high-quality care is delivered to every patient, every time. In 2018, we’re expanding our ProvenCare commitment even further.”

About Medacta International

Medacta® International is a world leading manufacturer of orthopaedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

About Geisinger

Geisinger is an integrated health services organization widely recognized for its early adoptions of the electronic health record and the development of innovative care delivery models such as ProvenHealth Navigator®, ProvenCare® and ProvenExperience®. As one of the nation’s largest health service organizations, Geisinger serves more than 3 million residents throughout 45 counties in central, south-central and northeast Pennsylvania, and in southern New Jersey at AtlantiCare, a Malcolm Baldrige National Quality Award recipient. In 2017, the Geisinger Commonwealth School of Medicine and Geisinger Jersey Shore Hospital became the newest members of Geisinger. The physician-led system is comprised of approximately 30,000 employees, including nearly 1,600 employed physicians, 13 hospital campuses, two research centers, and a 583,000-member health plan, all of which leverage an estimated $12.7 billion positive impact on the Pennsylvania and New Jersey economies. Geisinger has repeatedly garnered national accolades for integration, quality and service. In addition to fulfilling its patient care mission, Geisinger has a long-standing commitment to medical education, research and community service. For more information, visit www.geisinger.org, or connect with us on Facebook, Instagram, LinkedIn and Twitter.

Contacts

CONTACT for Geisinger:
Wendy Wilson, 570-840-0878
WKWilson@geisinger.edu
or
CONTACT for Medacta International:
Jill Bongiorni, 516-729-2250
jill@torchcomllc.com

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DeGen Medical Receives E3 MIS™ System FDA Clearance

Posted On March 9, 2018 By OrthoSpineNews In Regulatory /  

Florence, S.C., March 09, 2018 (GLOBE NEWSWIRE) — DeGen Medical announced the FDA clearance of E3 MIS™ Modular Pedicle Screw System for thoraco-lumbar spine. E3 MIS™system addresses a wide range of surgical options, pre-assembled or modular screws, straight or curved rods, and titanium or cobalt-chrome rods. It allows the surgeon intra-operative flexibility for bone grafting and screw placement. The screw thread is specifically engineered to combine the option for standard or cortical screw placement.

E3 MIS™ System allows surgeons three different MIS towers to choose from inter-operatively in a two-tray configuration.

The E3 MIS™ System features:

  • Modular tulip heads and screws compatible with the current F1 MPS™ system and 5.5mm rod offerings.
  • Several titanium alloy and cobalt-chrome modular screw head options, including MIS and Spondy.
  • A complement of surgical instruments to facilitate MIS and Open approaches.
  • Screw sizes starting at 4.0mm diameter (solid) and 4.5mm diameter (cannulated) through 10mm diameter.
  • Cortical-cancellous thread design or F1 MPS™ thread design.
  • Four different options for percutaneous rod insertion.
  • MIS towers range from 11mm to 16mm in diameter.

DeGen Medical would like to thank the following doctors for their contributions to this innovative and versatile system: Dr. Rakesh Chokshi, Dr. P. Douglas deHoll, Dr. Gene Massey, and Dr. Daniel Williams.

About DeGen Medical, Inc.

DeGen Medical, Inc. is a medical-device development company dedicated to providing surgeons with innovative products engineered to improve quality of life for patients with complex spinal disorders. World-class implants, coupled with intuitively-designed instrumentation, provide a complete package to promote superior surgical outcomes. Our passion to advance spine-care solutions is driven by clinical insights, sound research, and science-based design. DeGen Medical maintains the highest quality standards to provide reliable products and safeguard patient health.

For more information, please contact:

Jessica McCracken
DeGen Medical, Inc.
843-407-0538
jessica@degenmedical.com

Attachment:

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/2ed524a9-c64f-4c18-9ba2-985de87ecff0




	

		

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AmnioFix® Injectable Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the FDA for the Treatment of Osteoarthritis of the Knee

			


	Posted On March 9, 2018

	By OrthoSpineNews

	In Regulatory

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MARIETTA, Ga., March 9, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that the U.S. Food and Drug Administration (FDA) has granted MiMedx’s micronized amniotic tissue, AmnioFix® Injectable, the Regenerative Medicine Advanced Therapy (RMAT) designation for use in the treatment of Osteoarthritis (OA) of the knee.










In its letter to the Company, the FDA confirmed its determination that MiMedx Allogeneic Micronized Dehydrated Human Amnion/Chorion Membrane (micronized dHACM) for the treatment of OA of the knee meets the criteria for RMAT designation. The FDA further stated that MiMedx has provided clinical information to demonstrate preliminary clinical evidence to indicate that the drug has the potential to address unmet medical needs for this condition.


In granting the RMAT designation to MiMedx AmnioFix Injectable for use in the treatment of OA of the knee, the FDA committed to a multidisciplinary comprehensive discussion with MiMedx regarding the Company’s development program, including planned clinical trials and plans for expediting the manufacturing development strategy.


“The FDA’s RMAT designation for AmnioFix Injectable is an important milestone for MiMedx and highlights the importance of introducing promising therapies in areas of considerable unmet medical need. We are especially pleased that the FDA will meet to discuss expediting our development and manufacturing of this product to serve the needs of patients suffering from OA of the knee. We look forward to discussions with the FDA,” said Parker H. “Pete” Petit, Chairman and Chief Executive Officer.


“AmnioFix Injectable has been shown to have the potential to reduce pain and improve function in patients with OA of the knee. Given the lack of treatment options for patients with this condition, and the high risks associated with using opioids to manage pain, AmnioFix Injectable has the opportunity to address a significant unmet clinical need by providing physicians and their patients with a new front-line therapy,” added Bill Taylor, President and COO. “In addition, we believe AmnioFix Injectable has the potential to become a blockbuster therapeutic biologic, with long-term peak revenue potentially exceeding $4 billion for musculoskeletal pain management within the more than $12 billionaddressable U.S. joint pain injection market.”


An investigational regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious condition, and if preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such condition.


“Our clinical, scientific and regulatory team has done a superb job in the development of this product, and we are very fortunate to have such a talented and dedicated team in our organization,” noted Taylor.


The FDA will also provide MiMedx with intensive guidance on efficient drug development, as well as an organizational commitment to involve senior management in facilitating the product’s development program. The RMAT designation includes all of the benefits of the Fast Track and Breakthrough Therapy designation programs, including early interaction with sponsors, which may be used to discuss potential surrogate or intermediate endpoints to support accelerated approval.


About Osteoarthritis of the Knee


Osteoarthritis of the knee is an irreversible and persistent condition, prevalent in adult populations and even more so in older populations, associated with pain, restricted mobility, swelling and ultimately joint instability that can significantly limit day-to-day functioning. Osteoarthritis affects an estimated 31 million Americans and is the leading cause of disability in American adults. Prevalence increases with age ranging from about 2% among persons under age 45 and more than 80% among those over 75. Symptomatic OA of the knee presents in 14 million Americans including 2 million under the age of 45, and more than 6 million between the ages of 45 and 64.


The disorder occurs when the joint surface cartilage (also called hyaline cartilage or articular cartilage) becomes worn away leaving the raw bone beneath exposed. The cartilage normally serves as a “pad” or a bearing in the joint. When the bearing wears away, the result is a roughed joint surface that causes the pain and stiffness associated with osteoarthritis.


Knee osteoarthritis is the leading cause of limitations in activities of daily living such as walking and climbing stairs. Knee osteoarthritis symptoms often develop slowly and may become markedly worse over time or with specific activities. Characteristic signs and symptoms of osteoarthritis include stiffness, pain, soreness, inflexibility, swelling, grating/creaking, bone spurs and deformity. While knee osteoarthritis is often a progressive and irreversible degenerative process, functional improvement and pain control are the most common treatments used to treat this condition.


About MiMedx


MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to give physicians products and tissues to help the body heal itself.  The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.


Safe Harbor Statement


This press release includes forward-looking statements that may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.  Actual results may differ from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company’s most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.


SOURCE MiMedx Group, Inc.


Related Links


http://www.mimedx.com






	

		

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Paragon 28® launches the industry’s most robust screw and instrumentation system for addressing Charcot arthropathy – Joust™ Beaming Screw System

			


	Posted On March 9, 2018

	By OrthoSpineNews

	In Extremities, Top Stories

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ENGLEWOOD, Colo., March 9, 2018 /PRNewswire/ — Since its inception, Paragon 28® has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28® has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach and facilitate reproducible results benefitting both the surgeon and patient.


The Joust™ Beaming Screw System offers surgeons 220 unique beam options to address Charcot foot deformity.


The system is made up of 5.0, 5.5, and 7.2 mm, solid and cannulated beams. The beams are Type II Anodized Ti-64AI-4V for improved fatigue strength. All beams have a sharp tip for ease of insertion and are offered headless to minimize prominence. The 7.2 mm beams are available in 65-185 mm in length to address varying patient anatomy and to aid in allowing surgeons to place a medial column beam into the posterior aspect of the talus. The 5.0 and 5.5 mm beams are offered in 50-120 mm lengths to accommodate varying patient anatomies and to allow for increased bone capture. The system offers partially threaded and fully threaded options to allow for compression or increased thread purchase depending on the surgical requirements and anatomy.


The system includes instrumentation designed to facilitate placement of a K-wire down the center of the intramedullary canal of the medial column. The patent pending PRECISION® Guide aids in positioning of the K-wire simplifying placement which may reduce intraoperative fluoroscopy time. All instrumentation is designed to assist in the surgeons preferred approach, cannulated or solid.


Finally, the system allows surgeons to buttress the medial column beam with a 2.0 mm thick Gorilla® Straddle Plate to further reinforce the construct.  Surgeons may utilize the PRECISION® Guide in conjunction with the Straddle Plate and medial column beam to avoid interference between the plate screws and the beam.


Product Page:

http://www. paragon28.com/products/joust-beaming-screw-system/


Contact:

Jim Edson, 1-971-400-7193, jedson@paragon28.com


 


SOURCE Paragon 28


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HSS Study Finds Consensus Needed for Joint Replacement Performance Measurement

			


	Posted On March 9, 2018

	By OrthoSpineNews

	In Recon

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NEW ORLEANS, March 9, 2018 /PRNewswire-USNewswire/ — Researchers from Hospital for Special Surgery (HSS), a world leader in musculoskeletal research and care, are calling for greater consensus in the orthopedic community around standardizing methods used to calculate patient-reported outcome measures (PROMs) for hip and knee replacements. Their research shows that current performance measures varied significantly depending on which method was applied when assessing outcomes from these procedures. These results were presented today at the 2018 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting.










“While significant progress has been made collecting PROMs data for joint replacements, no guidelines exist on the most accurate way to analyze these data to objectively measure and improve performance,” said lead author Stephen Lyman, PhD, associate scientist at HSS. “Before policies are enacted, clinicians and payers must reach a consensus about which measures reflects the meaningful improvement in joint-related health.”


PROMs are considered the gold standard for evaluating the effectiveness of hip or knee replacement procedures. Two of the most commonly utilized PROMs for the hip and knee are the Hip Disability and Osteoarthritis Outcomes Survey (HOOS), the Knee Injury and Osteoarthritis Outcomes Survey (KOOS), respectively, and their short form versions HOOS, JR. and KOOS, JR., respectively. The Centers for Medicare and Medicaid Services (CMS) have adopted these surveys in their Comprehensive Care for Joint Replacement (CJR) Model, which is a bundled payment plan for all primary elective total joint replacements performed in eligible Medicare patients.


This study, performed at HSS, included 2,323 people who underwent a total hip replacement procedure, and 2,630 people who underwent a total knee replacement procedure. Meaningful change of PROMs can be assessed using three measures: Minimal Detectable Change (MDC), Minimal Clinically Important Change, and Substantial Clinical Benefit. Answers from the HOOS and KOOS (original or JR.) are used to score these measures and currently several different methods can be applied to calculate the total score.


The results showed that there is wide variability in benchmarks when these methods are used to calculate them:


    

  • Distribution-based approach, which relies on distribution of the data and assumes a normal distribution of responses and does not include patient input.
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  • Anchor-based approach, a patient-centric approach where an anchor question on the HOOS/KOOS regarding patient perception of a change in health is used to assess the change in PROMs scores.
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  • Anchor-based ROC approach, which uses the area under the ROC curve to determine the optimal delta score that best predicts those who experienced a minimal improvement and those who did not and does not include patient input.
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“We believe meaningful use of PROMs to assess care delivery and quality requires an understanding of how much change over time should be expected and how much change matters to patients,” Alexander McLawhorn, MD, MBA, an orthopedic surgeon at HSS. “The anchor-based assessment is the only method that accounts for the patients’ perspective.”


“We hope this analysis sparks important discussions about how quality and appropriateness are measured,” said senior author Catherine H. MacLean, MD, PhD, chief value medical officer at HSS. “The orthopedic community must be careful before we start using PROMs scores for performance evaluations, and as a next step HSS researchers plan to explore in depth the care experience and broad outcomes of patients in relation to changes in their patient reported outcome scores.”


About HSS | Hospital for Special Surgery

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the eighth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2017-2018). Founded in 1863, the Hospital has one of the lowest infection rates in the country, and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients from 80 countries, and performed more than 32,000 surgical procedures. In addition to Patient Care, HSS leads the field in research, innovation, and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair, and tissue regeneration. The HSS Innovation Institute was formed in 2015 to realize the potential of new drugs, therapeutics and devices; the global standard total knee replacement was developed at HSS in 1969, and in 2017 HSS made 130 invention submissions (more than 2x the submissions in 2015). The HSS Education Institute provides continuing medical curriculum to more than 15,000 subscribing musculoskeletal healthcare professionals in 110 countries. Through HSS Global, the institution is collaborating with medical centers worldwide to advance the quality and value of care, and to make world-class HSS care more accessible to more people.


SOURCE Hospital for Special Surgery


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