OrthAlign, Inc. Announces First KneeAlign® Cases Using the All New Rotation and Soft Tissue Balancing System

Posted On October 17, 2018 By OrthoSpineNews In Recon /

Aliso Viejo, CA, Oct. 17, 2018 (GLOBE NEWSWIRE) — OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced the first cases of the KneeAlign® CFS™ system. The CFS system is an accessory that can be used during KneeAlign-assisted total knee arthroplasty (TKA) surgeries, that provides for rotation and soft tissue balancing. The cases were completed by David Mayman, M.D. at Hospital for Special Surgery in New York, NY.

OrthAlign technology provides real-time, actionable data for precise alignment and positioning of implant components. With surgical applications for Total Knee (KneeAlign®), Partial Knee (UniAlign™) and Total Hip arthroplasties (HipAlign®), OrthAlign deploys a platform of solutions directly into the surgeons’ hands via a hand-held device not much bigger than a cellphone. Now, with these new capabilities, the KneeAlign application applies the same levels of accuracy and simplicity to guiding rotation of the femoral component as well as balancing soft tissue in both the extension and flexion gaps during TKA.

“With the addition of rotation and soft tissue balancing, KneeAlign provides me with all of the information I need to achieve an aligned and balanced knee,” said David Mayman, M.D. “This now puts the capabilities of KneeAlign equal to any robotics or navigation system on the market, while at the same time being much faster, simpler, and easier to use.”

“KneeAlign has already powered more than 75,000 cases around the world, providing surgeons with the type of information that delivers confidence to their results on a daily basis,” said Eric Timko, OrthAlign’s CEO and Chairman. “After a diligent research and development process, we’re now bringing that same confidence to rotation and balance during a total knee procedure, which positions KneeAlign among the most complete navigation and robotics solutions available as we power the next 100,000 cases in the coming years.”

OrthAlign will be showcasing its full portfolio of products at this year’s AAHKS meeting in Dallas, TX, November 2-4, 2018 at booth #715.

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit www.orthalign.com or contact Adam Simone (asimone@orthalign.com).

“ORTHALIGN®, KNEEALIGN®, HIPALIGN® and UNIALIGN™ are [registered] trademarks of OrthAlign, Inc.”

Adam Simone
OrthAlign
asimone@orthalign.com

DePuy Synthes Announces Agreement with Ortho Development® Corporation to Promote its KASM® Knee Articulating Spacer Mold

Posted On October 16, 2018 By OrthoSpineNews In Recon /

OCTOBER 16, 2018 Warsaw, IN – Johnson & Johnson Medical Devices Companies* today announced that DePuy Synthes Sales, Inc. has entered into an exclusive agreement with Ortho Development® Corporation to co-promote in the U.S. its KASM® Knee Articulating Spacer Mold. This is a sterile, disposable cement spacer mold for patients who develop an infection after primary knee replacement. This new offering builds upon DePuy Synthes’** commitment to innovative knee solutions focused on helping patients along the care continuum.

Of the five percent of patients who require total knee revision surgery¹, prosthetic joint infections are among the leading cause², with the majority occurring within the first two years after surgery³. Treating this type of infection requires a two-stage process. The primary knee implant is removed and replaced with a temporary antibiotic knee spacer. When the infection has cleared, the patient then undergoes a second surgery to replace the knee, known as a revision procedure.

Knee spacers are typically either static or articulating. Static spacers require patients to keep the infected knee immobilized for up to six months until the infection has cleared. Articulating spacers allow patients to weight bear with the use of crutches or a walker and possibly maintain motion during their recovery. KASM is designed to help preserve range of motion, joint space and soft tissue tension. Additional KASM features include:

Smooth articulating surface for both femur and tibial sides
Open mold design that allows surgeons to customize the fill of each component to accommodate for existing bony defects and other patient-specific conditions
Three sizes to account for a variety of patient anatomies

“KASM provides us with the unique opportunity to help surgeons whose patients have developed an infection to maintain some mobility and freedom they might not otherwise have had throughout the healing process,” said Juan-José Gonzalez, President, DePuy Synthes U.S. “This exclusive agreement with Ortho Development adds to our existing knee portfolio that spans treatment from early intervention to surgical replacement, with the goal of helping people return to living active and fulfilling lives.”

Ortho Development Corporation designs, develops, manufactures, and markets devices for knee and hip joint reconstruction, spine treatment, and trauma. KASM is one of Ortho Development’s products and received FDA clearance in 2014. This product has also been on the market in Japan for several years.

DePuy Synthes will begin to promote KASM in the latter part of 2018.

About Johnson & Johnson Medical Devices Companies
As the world’s most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopaedics and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. For more information, visit www.jnjmedicaldevices.com.

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

^{*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within the Johnson & Johnson’s Medical Devices segment.

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

1 M. Khan, K. Osman, G. Green, F. S. Haddah (2016). The epidemiology of failure in total knee arthroplasty. The Bone & Joint Journal, 98-B (1 Suppl A), 105-12.

2 Current epidemiology of revision total knee arthroplasty in the United States. Delanois R, Mistry J, Gwam C, Mohamed N, Choksi U, Mont M. J Arthroplasty. 2017 Mar; 32:2663-2668.

3 Prosthetic joint infection. Tande A, Patel R. Clinical Microbiology Reviews. 2014; 27(2)302-345.}

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the agreement with Ortho Development to exclusively promote KASM. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes, any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” in the company’s most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

HSS Receives Landmark $10 Million Grant from Stavros Niarchos Foundation for Complex Joint Reconstruction Center

Posted On October 16, 2018 By OrthoSpineNews In Recon, Top Stories /

NEW YORK, Oct. 16, 2018 /PRNewswire/ — An unprecedented $10 million grant from the Stavros Niarchos Foundation (SNF) has been given to Hospital for Special Surgery (HSS) to name the Complex Joint Reconstruction Center (CJRC). This new commitment will support the endowment of the CJRC for the operation and expansion of its clinical, research and educational programs.

According to the American Joint Replacement Registry, there are over 7 million Americans living with replaced hip and knee joints and, should they fail, treatment is complex and requires specialized management.

“This generous gift will improve the lives of countless patients who suffer from debilitating complications or need revision surgery due to failed implants,” said Thomas P. Sculco, MD, surgeon-in-chief emeritus and director of the CJRC at HSS. “We are deeply honored by the visionary leadership of the SNF in supporting our endeavor to lessen implant failure, restore function, and relieve pain for patients who need specialized joint reconstructions.”

As the first of its kind, the Stavros Niarchos Foundation Complex Joint Reconstruction Center provides the best in diagnosis and treatment for patients with the most challenging conditions in joint reconstructions, regardless of their financial circumstances, and conducts cutting-edge basic and clinical research on the causes and prevention of implant failure.

“Having partnered with HSS for over a decade, the SNF has witnessed first-hand the deep commitment of the people of HSS to excellence and progress in orthopedic care,” said Andreas Dracopoulos, Co-President of the SNF. “We are especially proud to support Dr. Sculco’s vision to improve the lives of patients with the most complex cases of joint reconstruction, and to seek solutions to issues that impact the field at large.”

“HSS is uniquely positioned to develop new techniques and improvements in implant design that will significantly impact global care for these complex problems.” said Dr. Sculco. “People are living longer and leading more active lives thus making the need for progress in our knowledge and treatment of these failed implants more critical than ever.”

Dr. Sculco is internationally recognized as a leader in hip and knee replacement surgery, having pioneered minimally invasive surgical techniques. Now, he is leading efforts to improve the success and longevity of implants to benefit millions of patients worldwide.

Over the past year, the CJRC has expanded its surgical team to 16 experienced orthopedic surgeons and successfully launched a patient registry with over 800 surgical cases already recorded. This registry is the first in the world solely dedicated to capturing vital clinical and outcomes data from patients undergoing joint reconstruction and complex primary joint replacement surgery. This data creates a platform for clinical trials, translational research and innovations in treatment that will lead to improved standards of care. In 2017, the CJRC performed 534 surgeries on patients with complex joint reconstructions.

The Stavros Niarchos Foundation is one of the world’s leading private international philanthropic organizations, making grants in the areas of health and sports, arts and culture, education, and social welfare. The SNF supports projects that aim to achieve a broad, lasting and positive impact on society.

Spanning over a decade, HSS and SNF’s longstanding relationship has spurred programs such as the Stavros Niarchos Foundation-Thomas P. Sculco, MD International Orthopaedic Fellowship Program, HSS Stavros Niarchos Foundation Orthopaedic Seminar and Academic Visitor Program to educate Greek orthopedic surgeons on ways to improve treatment and outcomes in joint replacement.

Since 2006, HSS has hosted Greek surgeons for the annual HSS Stavros Niarchos Foundation Orthopaedic Seminar Program, which teaches the latest techniques and innovations in complex and primary total hip and knee replacement with the ultimate goal of improving healthcare in Greece.

This year, the seminar will take place on November 27-28, 2018 with two days of didactic sessions, case consultations, roundtable discussions, hands-on workshops and operating room observation at operations at HSS. The following three days will include attendance at the 30^th Annual HSS Holiday Knee & Hip Course, a CME-accredited professional education course.

The program immerses visiting Greek surgeons, typically those early in their careers, in the high-volume joint replacement environment at HSS.

SNF also previously granted HSS $1 million to fund the Thomas P. Sculco, Chair in Orthopedic Surgery, which played an instrumental role in the creation of the CJRC.

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 ninth consecutive year) and No. 3 in rheumatology by U.S.News & World Report (2018-2019). 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. The global standard total knee replacement was developed at HSS in 1969. 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 and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. 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 Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

About the Stavros Niarchos Foundation
The Stavros Niarchos Foundation [(SNF) (www.SNF.org)] is one of the world’s leading private, international philanthropic organizations, making grants in the areas of arts and culture, education, health and sports, and social welfare. Since 1996, the Foundation has committed more than $2.6 billion, through more than 4,000 grants to nonprofit organizations in 124 nations around the world.

The SNF funds organizations and projects, worldwide, that aim to achieve a broad, lasting and positive impact, for society at large, and exhibit strong leadership and sound management. The Foundation also supports projects that facilitate the formation of public-private partnerships as an effective means for serving public welfare.

SOURCE Hospital for Special Surgery

Zimmer Biomet and Apple Collaborate to Launch Major Clinical Study Detailing Patient Experience and Improving Joint Replacement Journey

Posted On October 15, 2018 By OrthoSpineNews In Recon /

WARSAW, Ind., Oct. 15, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc., a global leader in musculoskeletal healthcare, is working with Apple by using Apple Watch and iPhone to change the patient journey for two of the most common surgeries Americans undergo each year – knee and hip replacement. This collaboration has yielded Zimmer Biomet mymobility™, an app that uses Apple Watch to facilitate a new level of connection between patients and their surgical care teams, which can immediately impact the journey patients experience when they undergo these procedures.

In addition to the app, Zimmer Biomet is commencing the mymobility Clinical Study, designed to study the app’s impact on patient outcomes and overall costs for joint replacement patients. During this research study, patients will use Zimmer Biomet mymobility with Apple Watch as they progress through their hip or knee replacement journey. Researchers will combine patient-reported feedback with continuous health and activity data from Apple Watch to provide new insights into the power of the Zimmer Biomet mymobility app to impact the standard of care for these common surgeries. The study is launching today and has the possibility to enroll as many as 10,000 patient participants in the United States.

“We are incredibly excited to work with Apple to transform the knee and hip replacement experience for patients and surgeons,” said Bryan Hanson, President and CEO, Zimmer Biomet. “At Zimmer Biomet, we are committed to improving care decisions through digital health and we are thrilled to launch one of the largest evidence-gathering clinical studies in orthopaedic history.”

“We believe one of the best ways to empower consumers is by giving them the ability to use their health and activity information to improve their own care,” said Jeff Williams, Chief Operating Officer, Apple. “We are proud to enable knee and hip replacement patients to use their own data and share it with their doctors seamlessly, so that they can participate in their care and recovery in a way not previously possible through traditional in-person visits. This solution will connect consumers with their doctors continuously, before and after surgery.”

More than one million knee and hip replacements occur annually in the U.S. This number is expected to grow to 3.5 million by 2035, yet standardization of care and recovery for the procedures is still lacking and costs to the U.S. healthcare system continue to rise. Zimmer Biomet mymobility and Apple Watch will act as a virtual and continuous care team on a patient’s wrist. Patients will be provided with support and guidance as they prepare for and recover from these surgeries, while surgeons will be delivered continuous data to optimize care. The new Zimmer Biomet mymobility app has several features that use both Apple Watch and iPhone through the joint replacement journey, including the ability for surgeons to send education and therapy reminders directly to the patient’s Apple Watch. The app also allows surgeons to monitor patient activity levels throughout the days and weeks while they are preparing for and recovering from surgery.

Facilities participating in the mymobility Clinical Study include:

Academic centers: University of Utah Health; Rush University Medical Center; University of Pennsylvania Health System; Emory University Orthopaedics & Spine Hospital/Emory Healthcare
Hospitals: Hoag Orthopedic Institute in Southern California; Newton-Wellesley Hospital, member of Partners HealthCare founded by Massachusetts General Hospital and Brigham and Women’s Hospital; Centura Health, Porter Hospital – Colorado Joint Replacement (CJR)
Group practices/ambulatory surgery centers: ROC Orthopedics, affiliated with Legacy Meridian Park Medical Center; OrthoBethesda; OrthoArizona; Midwest Center for Joint Replacement; Hartzband Center for Hip & Knee Replacement; New Mexico Orthopaedic Associates; The DeClaire LaMacchia Orthopaedic Institute, affiliated with Michigan Institute for Advanced Surgery; Joint Implant Surgeons; Orthopedic and Fracture Clinic; Panorama Orthopedic and Spine Center

To learn more about the mymobility Clinical Study, visit zbmymobility.com/clinical-study.

Apple, Apple Watch and iPhone are registered trademarks of Apple, Inc.

About the Company
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.

Contacts:

Media
Jon Siegal
781-684-6557
jon.siegal@mslgroup.com

SOURCE Zimmer Biomet Holdings, Inc.

Arthrosurface Launches the Stemless OVOMotion™ Shoulder Arthroplasty System

Posted On October 11, 2018 By OrthoSpineNews In Recon /

FRANKLIN, Mass., Oct. 11, 2018 /PRNewswire/ — Arthrosurface®, Inc. announced today the official launch of its latest product, the stemless OVOMotion™ Shoulder Arthroplasty System with Inlay Glenoid. FDA Cleared in April 2018, this stemless total shoulder system provides the surgeon with an approach that results in increased exposure to the glenoid, minimal bone removal, and is designed for patients with painful and/or severely disabled shoulder joints resulting from arthritis, traumatic events or AVN.

“This truly is a revolutionary stemless total shoulder, which combines the concept of anatomic restoration with an aspherical head design, and also allows improved joint access for ease of preparation of the glenoid,” said Dr. Anthony Miniaci, MD of the Cleveland Clinic. “This combination of an aspherical head and inlay glenoid has shown to be effective in not only active and younger patients but in all of those with glenohumeral arthritis even in the face of posterior subluxation and bone erosion.”

An earlier publication in the Journal of Shoulder and Elbow Surgery demonstrated how the inlay glenoid (socket) design was far superior to the only alternative with respect to the biomechanical stability. Arthrosurface has had long-standing success with the aspherical head design of the existing OVO^® arthroplasty device and the stemless OVOMotion™arthroplasty system expands that technology by maintaining the same external geometry while adding a planar cut for enhanced access to the glenoid. Additionally, the proven fixation method and location are unchanged.

Michael Gombosh, MD from South Florida International Orthopaedics commented, “With the new system, the additional 12.5mm of bone removed from the humeral head has truly improved the technical portion of the procedure. This allows for easier visual and manual access of the glenoid. These steps can be the most challenging portion of the operation, and frequently the most time consuming. With improved visualization, you are able to obtain a more accurate assessment of the morphology and wear pattern within the glenoid, but also establish improved access for glenoid preparation and release of the posterior capsule.”

Steve Ek, CEO said, “The OVOMotion™ Shoulder Arthroplasty System builds upon the outstanding clinical results of the OVO System and greatly facilitates surgical access, speed and reproducibility. It also sets the stage for our future modular components.”

The OVOMotion™ Stemless Shoulder Arthroplasty System is now available for use in the United States.

About Arthrosurface
Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. The product offerings include joint preservation implants, instruments and orthobiologics. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 14 years. For more information, please visit our website at www.arthrosurface.com

SOURCE Arthrosurface, Inc.

Medacta International Adds Mpact 3D Metal Implants and Augments to Mpact System for Primary Hip Replacement and Revision Surgeries

Posted On October 11, 2018 By OrthoSpineNews In Recon, Regulatory, Top Stories /

October 11, 2018

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Medacta^® International, the privately owned, global leader in innovative joint replacement and spinal technologies, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the Mpact 3D Metal™ Implants and Augments 3D Metal as enhancements to its Mpact^® System for primary to complex hip revision procedures. The first stateside surgery utilizing the implant and augments was performed this summer by Tyler Goldberg, M.D., of Austin-based Texas Orthopedics, Sports & Rehabilitation Associates.

The new implants, Mpact 3D Metal Acetabular Two-Hole and Multi-Hole Shells, are hemispherical porous shells with multiple highly cross-linked polyethylene liner options. The implants’ ultra-porous material makes them ideal for more demanding primary patient cases or to address difficult revisions with compromised bone. They are complemented by the porous 3D Metal Augments, designed to act as a defect-filling implant in cases of severe bone loss to help increase implant stability. The augments come in a variety of shapes and sizes, giving surgeons intraoperative flexibility to address a wide variety of acetabular defects. Together, these additions strengthen Medacta’s Mpact System and provide surgeons with more options when addressing complex primary hip replacements, as well as revisions.

Dr. Goldberg’s primary case utilized the Mpact Two-Hole Shell. “I was impressed with how firm the Mpact 3D Metal Implant was upon initial impaction. The shell has exceptional grip, making primary fixation easy and solid,” Dr. Goldberg said of his experience. “Knowing the shell is of high porosity and solid nature gave me great confidence for durable bone ingrowth, and my patient is recovering very well.”

The Mpact 3D Metal Implants feature Medacta’s proprietary 3D Metal technology, constructed via additive manufacturing performed by a 3D printer. The result is enhanced initial stability due to a high coefficient of friction at the bone interface and favorable environment for bone without the need for an additional coating. The 3D Metal Shells and Augments have pore sizes of 600-800 micrometers and continuously interconnected open pores with a high-porosity level of 75 percent.

“Medacta continues to expand upon its product portfolios as we seek to help our surgeon partners address more patient cases than ever before, whether it’s a complex primary case or a difficult revision,” said Francesco Siccardi, Executive Vice President of Medacta International. “With the new Mpact 3D Shells and 3D Metal Augments, our Mpact System offers even greater versatility and continues to instill confidence, thanks to both the high-grade materials used and the built-in surgeon education and support system for which Medacta is well known.”

The Mpact 3D Metal Implants and Augments are compatible with several surgical techniques, including Medacta’s Anterior Minimally Invasive Surgery (AMIS^®) approach to hip replacement. The muscle-sparing AMIS approach is supported by the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute, which provides surgeons with educational resources, training and mentorship as well as dedicated tools and instruments as they transition and practice the technique.

For more information, visit Medacta’s Mpact System webpage.

About Medacta International

Medacta^® International is a world leading company, developer and supplier, specializing in joint replacement, spine surgery, and sports medicine solutions. Medacta’s revolutionary approach and responsible innovation, focusing on Minimally Invasive Solutions and Personalized Medicine, have resulted in standard of care breakthroughs in hip replacement with the AMIS^® system and total knee replacement with MyKnee^® patient matched technology. 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, operates in over 30 countries around the globe, and employs more than 930 people. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter and LinkedIn.

Contacts

For Medacta International
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

Catalyst OrthoScience Introduces 3-Peg Glenoid To Its Catalyst CSR™ Total Shoulder System

Posted On October 11, 2018 By OrthoSpineNews In Recon /

October 11, 2018

NAPLES, Fla.–(BUSINESS WIRE)–Catalyst OrthoScience Inc. (Catalyst), a cutting-edge medical device company focused on the upper extremity orthopedics market, today introduced the patent pending 3-Peg Glenoid implant to its innovative Catalyst CSR™ Total Shoulder System. The new implant was unveiled at the American Shoulder and Elbow Surgeons (ASES) 2018 Annual Meeting in Chicago, Ill.

Loosening of the glenoid component is the most common mode of failure in total shoulder arthroplasty^1-3. An inability to achieve long-lasting, secure fixation within the glenoid bone that can withstand the effects of repeated eccentric loading and glenohumeral translation leads to failure⁴.

In order to address this, Catalyst has used a science-based approach to design the 3-Peg Glenoid implant with the specific goal of resolving these challenges. Key features include:

1. Immediate interference fit fixation in the strongest regions of the glenoid vault using a new backside anchoring element design.

2. Tapered walls on the bearing surface to reduce the effects of eccentric loading, which can contribute to implant loosening.

3. Quick, accurate placement of the implant using a streamlined procedure resulting in potential time and cost savings.

“The 3-Peg Glenoid is a great addition to our Catalyst CSR system, and it gives surgeons the option between the existing glenoid with two pegs or the new 3-Peg option,” said Brian Hutchison, executive chairman and CEO of Catalyst. “We have had a number of surgeons use the 3-Peg Glenoid with great results so far.”

Designed by surgeons for surgeons, the Catalyst CSR system represents the next evolution in shoulder surgery. The system includes a multi-planar stemless design which preserves bone and an elliptical humeral component that mimics the natural shoulder anatomy. Additionally, the surgical technique and instrumentation were designed to simplify the glenoid exposure and consistently deliver a precise and accurate shoulder reconstruction.

To learn more about the new 3-Peg Glenoid and the Catalyst CSR system, visit Catalyst at booth J at the ASES meeting, Oct. 11 – 14, 2018.

About Catalyst OrthoScience Inc.

Catalyst OrthoScience develops and markets surgical implants that make orthopedic surgery less invasive and more efficient for both surgeons and patients. Catalyst was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D., who saw the need to make shoulder replacement surgery less invasive and give patients a more natural-feeling shoulder after surgery.

The company’s first offering, the Catalyst CSR Total Shoulder System, represents the next evolution in stemless total shoulder arthroplasty. The Catalyst CSR is a single-tray, bone-preserving total shoulder arthroplasty system containing a precision elliptical humeral head and less invasive glenoid component, using specialized ergonomic instrumentation designed for consistent anatomic joint line restoration and glenoid insertion. The Catalyst CSR system can be used in both inpatient and outpatient settings and was cleared for use by the FDA in 2016.

Catalyst OrthoScience has a growing portfolio of 10 granted U.S. patents with several more pending nationally and internationally. The company is headquartered in Naples, Fla., and its products are available across the U.S. For additional information on the company, please visit www.CatalystOrtho.com.

References

1. Wirth et al. Complications of total shoulder replacement arthroplasty. JBJS 1996: 603-16.

2. Franta et al. The complex characteristics of 282 unsatisfactory shoulder arthroplasties JSES 2007: 555-62.

3. Bohsali et al. Complications of total shoulder arthroplasty JBJS 2006: 2279-92.

4. Matsen et al. Glenoid component failure in total shoulder arthroplasty. JBJS 2008: 885-96.

Contacts

Catalyst OrthoScience Inc.
Brent Narkiewicz
bnarkiewicz@catalystortho.com
or
Surgence Communications Strategies
Wendy Crites Wacker, APR, CPRC, 352-494-2129
wendy@surgencecs.com

EOS imaging Showcases hipEOS at the International Society for Technology in Arthroplasty (ISTA) in London

Posted On October 10, 2018 By OrthoSpineNews In Recon /

October 10, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Euronext, FR0011191766 – EOSI – Eligible PEA – SME), the pioneer of 2D/3D imaging and data solutions for orthopedics, will demonstrate its online hipEOS 3D surgical planning software at its booth during the International Society for Technology in Arthroplasty’s (ISTA) 31^st Annual Congress, being held October 10-13 in London, UK. The ISTA Congress is dedicated to advancing the art and science of technology in joint replacement by connecting leading clinicians, engineers, researchers with industry members from around the globe to address new and foundational topics in arthroplasty.

Seven podium presentations and three posters will highlight the value of EOS as a unique solution along the THA care pathway. This will include clinical results related to the improvement of THA outcomes through a better inclusion of pelvis/spine relations, global body compensation mechanisms, standing and seated functional positions, and image-based quality control tools. In particular, teams from two of the top ten ‘Best Hospitals for Orthopedics”¹, the Hospital of Special Surgery (HSS) and New York University (NYU), from Imperial College, London, and Pitié-Salpêtrière Hospital (Paris) will address how these improvements can be facilitated through EOS full body, weight-bearing and seated exams and of the hipEOS software.

The latest generation of the hipEOS software addresses the risk of implant impingement based on the planed size and position of the components in standing and seated EOS images. The software calculates the theoretical sitting position and offers a range of motion simulation to check for implant impingement based on each patient’s unique anatomy.

Marie Meynadier, Chief Executive Officer of EOS imaging, commented, “Our full body, low dose solution is being recognized across the globe as a superior alternative to traditional imaging. Our EOSapps suite of 3D surgical planning solutions offer an easy way to identify patients at risk, create a personalized plan, and discuss the procedure with patients. We are happy to see our solutions widely represented by worldwide leaders at ISTA and committed to developing innovative solutions that make these growing volume procedures easier and safer for the whole medical community.”

For more information, visit our booth or contact us at: contact@eos-imaging.com

ABOUT EOS IMAGING

EOS imaging is listed on Compartment C of Euronext Paris

ISIN: FR0011191766 – Ticker: EOSI

EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 33 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 280 installed EOS® platforms representing more than one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017. For more information, please visit www.eos-imaging.com.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

¹ https://health.usnews.com/best-hospitals/rankings/orthopedics

Contacts

EOS imaging
Marie Meynadier
CEO
Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
The Ruth Group
Ph: 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com
or
Press Relations (US)
Kirsten Thomas
The Ruth Group Ph: 508-280-6592
kthomas@theruthgroup.com

OrthoSensor Announces Milestone Of 50,000 VERASENSE Sensors Distributed Globally

Posted On October 4, 2018 By OrthoSpineNews In Recon, Top Stories /

DANIA BEACH, Fla., Oct. 4, 2018 /PRNewswire/ — OrthoSensor, Inc., a leader in sensor-assisted technology for total knee replacement (TKR), today announced the milestone achievement of 50,000 VERASENSE sensors distributed worldwide.

VERASENSE provides surgeons with real-time data during surgery that may help patients return to normal activities faster, improve activity level and experience better knee function.^1-3VERASENSE is transforming primary and revision total knee replacement for surgeons and patients across the globe.

“This milestone for OrthoSensor’s leading product—VERASENSE — is an exciting achievement,” said Steve Seger, Sr. Vice President of Sales and Marketing. “We also have excellent growth opportunities with the recent approvals of VERASENSE in Japan and the FDA clearance of VERASENSE for Zimmer Biomet Persona; we’re just getting started. Furthermore, our partnerships with leading joint replacement companies such as Smith & Nephew, Stryker and Zimmer Biomet allow surgeons around the world to easily adopt VERASENSE in primary and revision total knee procedures–taking out the guess work on soft tissue balance and enhancing implant systems they already use.”

OrthoSensor has built strong evidence for positive clinical outcomes with VERASENSE through 40 peer-reviewed manuscripts, 100+ scientific presentations and more than 15 ongoing clinical studies – 4 of which are level one, randomized controlled trials. The most recent publication reports on excellent 3-year patient-reported satisfaction following VERASENSE use during surgery. To learn more visit orthosensor.com

About OrthoSensor, Inc.

OrthoSensor, Inc., a leader in Sensor-Assisted Total Knee Arthroplasty, develops and commercializes intelligent orthopedic devices and data services that provide quantitative feedback to surgeons and hospitals. The sensor utilizes advanced proprietary sensor and communications technologies, coupled with the company’s innovative software products, to facilitate evidence-based decisions in orthopaedic surgery – with the goal of improving patient outcomes and potentially reducing the cost of treating musculoskeletal disease.

OrthoSensor^® VERASENSE^™, and OrthoLogIQ^® are trademarks of OrthoSensor, Inc.

References:

1.      Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR. Primary TKA Patients with Quantifiably Balanced Soft-Tissue Achieve Significant Clinical Gains Sooner than Unbalanced Patients. Advances in Orthopedics, vol. 2014, Article ID 628695, 6 pages, 2014.
2.      Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR. A new method for defining balance: promising short-term clinical outcomes of sensor-guided TKA. J Arthroplasty 2014; 29:955–960.
3.      2-Year Clinical Outcomes. OrthoSensor Multicenter Evaluation. Pending publication. Data on file at OrthoSensor, Inc.
4.      Gustke, K., Golladay, G., Roche, M., Elson, L., Jerry, G., Anderson, C. The satisfied total knee replacement patient: 3-year multicenter study. EC Orthopedics 9.3 (2018): 122-127.

Contact:
Yvette Cuello
954-666-0282
ycuello@orthosensor.com

SOURCE OrthoSensor, Inc.

OMNIlife science™, Inc. Achieves Milestone with OMNIBotics® Active Spacer

Posted On October 3, 2018 By OrthoSpineNews In Recon, Robotics /

RAYNHAM, Mass., Oct. 3, 2018 /PRNewswire/ — OMNIlife science, Inc. (“OMNI”), a privately-held, medical technology company targeting the $15 billion global hip and knee replacement device market, reported today that the positive clinical benefits of the OMNIBotics® Robotic Active Spacer continue to be reinforced by more than 1,000 successful procedures performed to date. Orthopaedic surgeons have been evaluating this revolutionary system that utilizes a miniature robot to ensure the ligaments will be “balanced” after the knee replacement.

A basic tenet of knee replacement is to balance the tension of the ligaments to ensure smoother knee function and better alignment. However, balancing frequently involves making small incisions in tighter ligaments to create equal ligament tension. The Active Spacer helps the surgeon position implants in anatomic alignment while maintaining ligament balance without having to incise ligaments. Early data on the use of the Active Spacer is showing a much higher rate of patient satisfaction at both three and six months’ post-surgery than what has been typically reported in the literature.

“We are pleased the benefits of OMNIBotics Active Spacer technology continue to be validated by multiple surgeons,” said Rick Epstein, CEO of OMNI. “Our OMNIBotics robotic-assisted technology guides the surgeon to the optimal implant position to achieve both mechanical alignment and balance, and each of the cuts are made with robotic precision. We believe a properly aligned and carefully balanced knee will result in optimized patient outcomes and it is exciting to be working with surgeons to advance the field of knee replacement with robotics.”

OMNIBotics with Active Spacer is the first and only robotic system to integrate ligament tension with bone alignment.

“I’ve been doing knee surgery for 25 years,” stated Jeffrey H. DeClaire, M.D. (DeClaire LaMacchia Orthopedic Institute, Rochester Hills, MI), “and I’ve always been very focused on balancing the knee, but there’s never been any way to measure and validate ligament balance and ligament tension in knee arthroplasty until the OMNIBotics Active Spacer. This is a real breakthrough because now I know that each total knee arthroplasty I perform is precisely balanced with consistency and reproducibility that significantly improves the accuracy of the procedure, in addition to facilitating improved patient outcomes and patient satisfaction.”

ABOUT OMNI

OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

FORWARD LOOKING STATEMENTS

Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms “plans,” “believes” or similar expressions are “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

CONTACT

Cindy Holloway, Director of Marketing Communications Phone: (508) 824-2444
cholloway@omnils.com

SOURCE OMNIlife science, Inc.

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