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Mazor Robotics Receives FDA Clearance for Spinal Deformity Correction Planning Software for the Mazor X Surgical Assurance Platform

Posted On April 12, 2017 By OrthoSpineNews In Regulatory, Robotics /  

April 12, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR)(NASDAQGM: MZOR), a pioneer and leader in the field of surgical guidance systems, has received FDA clearance for its Mazor X Align™ software. Mazor X Align is designed to assist surgeons in planning spinal deformity correction and spinal alignment for procedures performed with the Mazor X Surgical Assurance Platform. The new software will be demonstrated during exhibit hours at the 2017 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Los Angeles, CA, April 22-26.

Mazor X Align leverages Mazor Robotics’ extensive experience in pre-operative planning, image processing, computerized anatomy recognition, and registration of different imaging modalities. It is the latest module to be added to the Mazor X proprietary Pre-operative Analytics software suite, and enables surgeons to create a patient-specific, three-dimensional spinal alignment plan. The 3D plan simulates an entire spine, allowing pre-operative estimation of the impact of a planned surgical correction on the patient’s posture post-operatively, considering segmental range-of-motion and final alignment parameters.

According to Ori Hadomi, CEO of Mazor Robotics, “Mazor X Align is the product of Mazor’s development program and represents our innovative pipeline and visionary team experience. We are dedicated to pushing the envelope bringing to the market advanced products and applications in order to benefit an increasing number of patients suffering from difficult conditions and supporting the medical professionals serving them.”

Mazor X Align will be released to a selection of Mazor X customers in early May. This early release will be followed by a widespread release during the second half of 2017.

During AANS, Mazor Robotics will be hosting the following special presentations at booth #1423:

Presentation: Clinical Experience with Mazor Robotics Guidance Systems
Presenter: Dr. Jae Y. Lim
Date: Monday, April 24
Time: 1:00 – 2:00 pm

Presentation: Initial Case Series with Mazor Robotics’ Next Gen System: Mazor X™
Presenter: Dr. Donald M. Whiting
Date: Monday, April 24
Time: 3:30 – 4:00 pm

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the benefits of the Company’s products, the timing of release of Mazor X Align, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 2, 2016 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

Contacts

EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
Doug Sherk, 646-445-4800
dsherk@evcgroup.com

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OMNIlife science™, Inc. And Global Orthopaedic Technology Enter into Licensing Agreement for APEX™ Knee System

Posted On April 10, 2017 By OrthoSpineNews In Recon, Robotics /  

RAYNHAM, Mass. and SYDNEY, April 7, 2017 /PRNewswire/ — OMNIlife science™, Inc. (“OMNI™”) and Global Orthopaedic Technology Pty Ltd. today announced an exclusive licensing agreement for OMNI’s ‘s APEX™ Knee Implants for Australia, New Zealand and South Africa.

Under the terms of the agreement, Global Orthopaedic Technology will acquire exclusive rights to manufacture, market and distribute the APEX™ Knee Implants in the three countries listed above. Global will continue to market OMNI’s OMNIBotics® robotic-assisted total knee and computer-assisted total hip replacement technology in the agreed markets under a separate distribution agreement. In addition, OMNI will continue to market Global’s Paragon Hip Implants in the United States also under a separate distribution agreement.

“The clinical performance of the APEX™ Knee in Australia, aided by OMNIBotics and other advanced implant delivery systems, continues to drive APEX™ knee growth in Australia,” said Rick Randall, OMNI CEO. “Licensing the knee implants to Global ensures the APEX™ Knee will continue to expand in the evidence-based Australian healthcare market and provide OMNI non-dilutive capital to support the demand for robotic-assisted total joint replacement products in the large U.S. orthopedics market.”

“Following six years of successful distribution of the APEX™ knee in Australia we believe the time is right for Global to secure the license and long term tenure for the product,” commented Andrew Fox-Smith, Global CEO. “The proven clinical success of the APEX™ Knee in conjunction with emerging technologies out of Australia, will provide Global with solid foundations for future development and growth.”

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.

About Global
Global Orthopaedic Technology Is the largest Australian-owned orthopaedic implant designer and manufacturer.  Through strong engagement with some of Australia’s leading surgeons, universities and researchers, Global endeavours to lead the way in the distribution and development of new and innovative products   to meet the needs of both the surgeons and their patients. Global provides an extensive range of orthopaedic implant solutions from early intervention through to complex end stage surgery for both knee and hip replacement surgery. The hip and knee portfolio is also complimented by a suite of enabling technologies including robotics, patient specific instrumentation and planning tools, designed to improve efficiencies and optimise patient outcomes throughout the continuum of care. For more information about Global, please visit www.globalortho.com.au.

Forward-Looking Statements
Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including 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

SOURCE OMNIlife science, Inc.

Related Links

http://www.omnils.com

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Mazor Robotics Expects to Report Record First Quarter Revenue of Approximately $11.5 Million

Posted On April 5, 2017 By OrthoSpineNews In Financial, Robotics /  

April 05, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical guidance systems, announced today that driven by the strength in Mazor X system sales and increased procedure volume, the Company expects to report record first quarter revenue of approximately $11.5 million. During the first quarter the Company received purchase orders for six Mazor X systems in the U.S., including two trade-in orders from customers who had previously purchased Renaissance systems. In addition, it received a purchase order for a Renaissance brain module upgrade in the international market. In the year-ago first quarter, the Company reported revenue of $6.4 million and received purchase orders for five Renaissance systems.

“The launch of the Mazor X and the rollout of this advanced surgical platform is progressing as planned and to our satisfaction. The first quarter’s results bring the total number of Mazor X systems orders since we began its sale in the second half of 2016 to 40 systems. Additionally, systems have been installed at numerous key sites across the U.S. and have been used clinically in dozens of patient procedures in 2017,” commented Ori Hadomi, Chief Executive Officer. “Our commercial partnership is yielding increased penetration into the U.S. market which leads us to be increasingly optimistic about our growth opportunities in 2017.”

Mazor ended the first quarter with a backlog of 14 Mazor X systems and the Company expects to deliver these systems in 2017. The Company ended 2016 with a total order backlog of 21 Mazor X systems. The Company will report its financial results for the first quarter ended March 31, 2017 in May and will issue a press release with the date, time, dial-in credentials and webcast details.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the Company’s expectations and growth opportunities for 2017, the expected revenue for the first quarter of 2017, the amount of and timing of recording of additional revenue from backlog, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 2, 2016 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

Contacts

U.S. Contacts:
EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
Doug Sherk, 646-445-4800
dsherk@evcgroup.com

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Ottobock Buys Boston-Based “Active” Prosthetic Maker BionX

Posted On April 4, 2017 By OrthoSpineNews In Extremities, Robotics /  

David Holley, March 29, 2017

BionX Medical Technologies, a Boston-area company that makes a prosthetic foot and ankle product that uses robotics technology, has been acquired by Ottobock, a German prosthetics company with North American headquarters in Austin, TX.

The deal was announced earlier this month. Financial terms weren’t disclosed, so it’s hard to tell how good an outcome it is for investors and shareholders. BionX raised more than $60 million in equity and debt funding since its inception, including $17 million in late 2015. The company’s investors include General Catalyst, WFD Ventures, Sigma Partners, Gilde Healthcare, and ZGC Shiner Investment.

BionX was founded as iWalk in 2006 by Hugh Herr, an MIT Media Lab professor who runs the school’s Center for Extreme Bionics and who himself is a double amputee below the knees. The company’s device, called the Empower Ankle, uses robotics to propel an amputee forward while adapting to his or her walking style; the actively driven ankle joint tries to replace the function of muscles and tendons. Ottobock says the device can give the user more energy while walking.

 

READ THE REST HERE

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Here’s Why the Best Is Yet to Come for Intuitive Surgical, Inc.

Posted On March 31, 2017 By OrthoSpineNews In Financial, Robotics /  

Keith Speights (TMFFishBiz), March 31, 2017

For several years, it looked like Intuitive Surgical (NASDAQ:ISRG) might be past its prime. The robotic surgical system maker’s stock experienced a malaise throughout much of the period between 2012 and late 2015.

Now, however, Intuitive Surgical is on a roll. Its share price is up close to 20% so far in 2017. Could the best be yet to come for Intuitive? I think so.

Trends in its favor

Most people think about the aging of the baby boomer generation as a key demographic trend. And it is. However, millennials (individuals born between 1981 and 1997) have surpassed baby boomers as the largest generation in the U.S. The aging of both groups should benefit Intuitive Surgical.

Hysterectomy ranks as the top surgical procedure performed using Intuitive’s da Vinci robotic surgical system. More than 40% of da Vinci procedures performed in the U.S. last year were hysterectomies. The average age of American women who have hysterectomies is 42. Many in the millennial generation will reach this age in only a few years.

Intuitive Surgical’s second most performed surgical procedure is radical prostatectomy for patients diagnosed with prostate cancer. The average age of American men who are diagnosed with prostate cancer is 66. Some baby boomers have already reached the prime age for developing prostate cancer, but most aren’t quite that old yet.

It’s not just demographic trends that are working in Intuitive Surgical’s favor. The company generated 71% of total revenue in 2016 from recurring sales of instruments, accessories, and services. This percentage has steadily increased in recent years. Intuitive’s huge recurring revenue provides it stability and flexibility that many other companies don’t enjoy.

 

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​Two Cincinnati hospitals among first in nation to perform new kind of robotic surgery

Posted On March 27, 2017 By OrthoSpineNews In Recon, Robotics, Top Stories /  

Mar 23, 2017 – By , Staff reporter Cincinnati Business Courier

Surgeons at Mercy Health-Cincinnati’s Anderson Hospital and St. Elizabeth Healthcare in Edgewood are among the first in the nation to offer a total knee replacement using the Mako Robotic Arm-Assisted Surgery System.

Dr. Suresh Nayak performed Ohio’s first total knee replacement procedure using the robotic-arm-assisted technology together with the Stryker Triathlon Total Knee System at Anderson Hospital on March 7, according to Mercy Health.

Dr. Matthew Hummel of Commonwealth Orthopaedic Centers performed a similar total knee replacement surgery using the new robotic-arm-assisted technology at St. Elizabeth in Northern Kentucky on March 22.

The technology is available at only a handful of medical centers in the nation, a St. Elizabeth spokesman said. The U.S. Food & Drug Administration approved the robotic-arm-assisted technology for total knee replacement in August 2015, but the equipment won’t be available to most health systems until 2018.

The procedure is less invasive than traditional surgery, meaning patients often experience less pain after surgery, less hospitalization and more rapid recovery, according to St. Elizabeth. Patients also often feel better motion and a more natural-feeling knee after the surgery.

READ THE REST HERE

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The robotic have-not: How J&J plans to woo hospitals, knee surgeons

Posted On March 22, 2017 By OrthoSpineNews In Recon, Robotics /  

By ARUNDHATI PARMAR – MedCity News, March 17, 2017

Johnson & Johnson and Verily Life Sciences (formerly Google Life Sciences) have a joint venture to create the next generation of robotic surgery souped up with digital technologies in the future. (Watch out Intuitive Surgical.)

But when it comes to hip and knee replacement today, J&J Depuy Synthes is a robotic have-not.

Competitors have robots or are close to having something robotic in joint replacement.

On Tuesday, Stryker launched its total knee application on the expensive Mako robotduring the annual meeting of the American Academy of Orthopaedic Surgeons in San Diego. That same day at AAOS, Smith & Nephew previewed its hand-held robot-assisted device for total knee replacements in advance of a market release in the second quarter. And Zimmer-Biomet was also proudly displaying its robot on the exhibit floor — the Rosa robot acquired with the purchase of French firm Medtech SA – although the robot won’t be doing total knee replacements until 2018.

There is a general notion that robotics will gain ground in orthopedic surgery though the predictions around adoption pace vary greatly.

One analyst — Brandon Henry from RBC Capital Markets — believes Stryker will be the clear winner with the launch of its total knee on its Mako robotic system and will take market share away from Johnson & Johnson DePuy Synthes and Zimmer-Biomet in the next few years. Another — Richard Newitter from Leerink Partners — believes robotics adoption will be much more gradual and only in complex cases but still having one in the short term is better than not having one.

So in the meantime without a robot, how can J&J DePuy Synthes woo hospitals and knee surgeons, some of whom are part of Medicare’s mandatory 90-day bundled payment program called the Comprehensive Care for Joint Replacement.

Company executives are relying on the wide breadth of J&J’s knee offerings, its services chops and a new company-sponsored whitepaper that touts the economic value of its Attune Knee.

 

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Mazor Robotics and Medtronic Combine Efforts on the Commercialization of Mazor X™: An Innovative Guidance System for Spine Surgery

Posted On March 20, 2017 By OrthoSpineNews In Robotics, Spine /  

ORLANDO, Fla., March 17, 2017 /PRNewswire/ — Mazor Robotics Ltd. is a global leader in the development and distribution of innovative surgical guidance systems for spine and brain surgery. Mazor Robotics Inc., the US subsidiary of Mazor Robotics LTD is recognized as one of largest players in the robotics and simulation industry in the State of Florida, their US headquarters are in downtown Orlando.  In nearby Celebration, The Florida Hospital Nicholson Center serves as the national training center for the new Mazor X™, a transformative platform for spine surgeries, having trained over 100 surgeons from all over the United States in 2016.

“As a pioneer and a leader in the field of surgical guidance systems, Mazor Robotics saw two significant milestones in 2016: the launch of our strategic partnership with Medtronic followed by the commercial release of the new Mazor X™. We are very excited to see what 2017 brings for our company,” says: Christopher Prentice, CEO Mazor Robotics, Inc.

Since signing the agreement in May 2016, Mazor and Medtronic have invested in co-marketing, promotion, and training efforts towards commercialization of Mazor X™, a transformative platform for spine procedures that launched in October at the North American Spine Society (NASS) Annual Meeting. Between the two companies, there are now hundreds of highly experienced capital and clinical specialists responsible for raising the awareness of, selling and supporting Mazor X.

Mazor Robotics (TASE: MZOR; NASDAQ-GM: MZOR) believes in healing through innovation by developing and introducing revolutionary technology and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in a more accurate and secure manner. For more information, please visit www.MazorRobotics.com.

SOURCE Mazor Robotics Ltd.

Related Links

http://www.mazorrobotics.com

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Zimmer Biomet Showcases New Product Innovation, Novel Digital Health Offering and Robotic Technology at AAOS 2017

Posted On March 15, 2017 By OrthoSpineNews In Extremities, Robotics, Spine /  

WARSAW, Ind., March 14, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced plans to highlight its latest commercial offerings and preview its next generation of technological innovations at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting this week in San Diego, CA.  The Company’s state-of-the-art booth (#4333) will feature an immersive and interactive tour of its newly launched digital technology and clinical services offering, Zimmer Biomet Signature Solutions, alongside more than 50 new products from its vast and diversified portfolio.

“We’re proud and excited to showcase our most innovative new commercial offerings to the largest gathering of orthopaedic professionals,” said David Dvorak, President and CEO of Zimmer Biomet. “New this year is a virtual booth experience designed to bring Zimmer Biomet Signature Solutions to life through a guided tour, a sneak preview of our emerging robotics platform and other technologies in our deep pipeline.”

Following is a snapshot of the key highlights being featured at the Zimmer Biomet booth (#4333) at AAOS 2017:

  • Zimmer Biomet Signature Solutions
    • Guided tours through the virtual experience every 15 minutes. Members of the press can reserve a spot by contacting Monica Kendrick at monica.kendrick@zimmerbiomet.com.
  • Robotic Technology
    • Catch a glimpse of the future of personalization and intelligent instrument technology through innovative robotics.i
  • Knees
    • Vanguard® Individualized Design (ID), advances soft tissue preservation and balancing through independent medial and lateral articular surface constraint and thickness options.
    • OSSTM Orthopedic Salvage System, a comprehensive modular platform providing surgeons with intraoperative flexibility often required during limb salvage procedures.
    • Persona® Medial Congruent® Bearing, designed to recreate more natural feeling motion of the human knee by maximizing knee joint stability while allowing mobility.
  • Hips
    • Hip Preservation portfolio of options designed to treat conditions leading up to osteoarthritis and potentially preventing the need for total hip replacement.
    • Trabecular MetalTM acetabular cups, which National Joint Registry analysis has recently shown are 21 percent less likely to be re-revised due to infection (statistically significant, p-value=0.036).ii
    • The latest in dual mobility, Microplasty® and revision implant options designed to address the distinct needs of individual patients while simplifying surgical workflow.
  • Personalized Solutions
    • A comprehensive technology-based portfolio of guides, tools and software to support surgical planning, intraoperative guidance and optimal component placement.
  • Bone Cement
    • StageOneTM and StageOne Select Spacer Molds, designed to mold a temporary knee, hip and shoulder spacer for patients undergoing a two stage revision due to an infected total joint.
  • Diagnostics
    • Synovasure® Laboratory Panel for the detection of Periprosthetic Joint Infection (PJI), now includes Microbial ID. These diagnostic tests provide a fast and easy method to diagnose PJI based on the flagship test, which determines the concentration of Alpha Defensin in synovial fluid. Microbial ID detects the presence of microbes in the synovial fluid in a matter of hours.
  • Extremities
    • Vault Reconstruction System (VRS), the first commercially available patient-matched glenoid implant, cleared to specifically treat patients with severe glenoid bone loss and a deficient rotator cuff.
    • L2LTM Radial Head System, a simple, smooth design solution for replacing the proximal radial head in patients with fractures.
  • Foot and Ankle
    • Deformity correcting products available through our partnership with Nextremity Solutions, Inc., including the Nextra®Hammertoe Correction System, the MSP™ Metatarsal Shortening System and the Re+Line® Bunion Correction System.
    • Subchondroplasty® Procedure for foot and ankle surgery, a minimally invasive outpatient intervention that addresses the defects associated with subchondral bone marrow lesions.
  • Trauma
    • A.L.P.S.® Proximal Humerus Plating System, designed to minimize the risk of complications commonly associated with proximal humerus fractures, such as varus collapse, articular screw penetration and subacromial impingement.
    • N-Force Fixation System® with N-Force Blue, an augmented fixation system, integrating fenestrated screws and a Bone Substitute Material into a single construct to provide improved metaphyseal void fill and increase structural support of the implant.
    • RibFix Blu® Thoracic Fixation System, designed and used for the stabilization and rigid fixation of fractures in the chest wall, including sternal reconstructive surgical procedures, trauma or planned osteotomies.
  • Sports Medicine
    • Quattro® Link, a knotless anchor that brings control and efficiency to soft tissue repair.
    • BioWickTM SureLock®, a rotator cuff implant that is an interpositional bioresorbable scaffold wick.
    • SpeedSnareTM Surgical Suture Passer, which allows the ability to pass a suture through single or multiple ports.
    • Gel-One® Cross-Linked Hyaluronate, the first low-volume viscosupplement available in a single-injection formula, for the treatment of pain in osteoarthritis of the knee that does not respond adequately to other conservative treatments.
  • Biologics
    • nSTRIDE® Autologous Protein Solution (ex-US use only), a single-shot autologous anti-inflammatory for treatment of knee osteoarthritis.
    • AmnioFloTM, allograft derived from human amniotic fluid, for joint cushioning and lubrication.
  • Surgical
    • The IntelliCart™ System Duo Fluid Carts, the foundation for infectious waste technology with market-leading 34-liter capacity, extra quiet vacuum pump, clog-free suction manifolds and portable smoke evacuation.
    • Bactisure™ Wound Lavage, clear, low-odor, aqueous solution designed to remove structurally resistant forms of bacteria, including biofilms, on all wound types.
    • The VasoPress® System, reduces the risk of blood clots associated with deep vein thrombosis by propelling the venous blood out of the deep veins while patients are undergoing surgical procedures or immobile for an extended period of time.
  • Spine
    • Mobi-C® Cervical Disc, the first cervical disc replacement device approved for both one and two-level procedures.
    • Vitality® Spinal Fixation System, an adaptable system designed for spinal fixation in complex thoracolumbar procedures.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.

i Concept device – not for sale in the US

ii 1. According to NJR data from 2003 to 2015 where 9,573 Trabecular Metal and 30,452 non-Trabecular Metal cups were used in revision THA and based on hazard ratios adjusted by patient gender, age group, and indications (OA/non-OA).

2. NJR data shows a higher percentage of TM cups were used with antibiotic bone cement compared to all other non-TM cementless cups.

SOURCE Zimmer Biomet Holdings, Inc.

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Stryker launches expensive Mako robot for knee replacement in cost-conscious era

Posted On March 15, 2017 By OrthoSpineNews In Recon, Robotics, Top Stories /  

By ARUNDHATI PARMAR – MedCity News

As value-based care and bundled payments begin to take hold in the orthopedics industry and healthcare overall, Kalamazoo, Michigan-based Stryker is doing something counterintuitive.

It is launching an expensive piece of equipment. Coinciding with the first day of the annual meeting of the American Academy of Orthopaedics Surgeons (AAOS) in San Diego, the orthopedics company announced Tuesday that the MAKO robot is now officially launched in the U.S. to perform total knee replacements. (MAKO has been available to perform total hip knee replacements and partial knees in the U.S. up until now.)

Why introduce a reportedly million-dollar piece of new technology at a time when hospitals and orthopedics practices are racing to reduce the cost of hip and knee replacements?

In a phone interview, Stuart Simpson, vice president and general manager, Stryker, shared his confidence that the Mako robot with the total knee application would have both clinical and economic benefits that hospitals would find compelling.

To step back a bit, Stryker made a bold acquisition of Mako for nearly $1.65 billion in 2013. Bold because none of the larger ortho players had envisioned joint replacement procedures to be done by a robot. The company has also bucked the consolidation trend in the marketplace – think Zimmer buying Biomet; Wright Medical buying Tornier – although there leaked reports showed that it was exploring a merger with Smith & Nephew. The bet was new, innovative technology backed by proper clinical and economic validation would win the future.

Mako’s total knee application — where the Mako robot would implant Stryker’s Triathlon knee — won FDA approval back in August 2015. But Kevin Lobo, the company’s CEO made the rather atypical decision to delay a wide sales roll out nationwide until 2017. [ I reported on that decision for a different publication last year].

In that two years, Mako’s total knee application has been used on a limited basis in 65 hospitals in the U.S., U.K., Japan and Germany, Simpson said and more than 1,400 cases have been performed.

Now it’s ready for full launch and the hope is that the clinical benefits noticed in the partial knee application by using the Mako robot will extend to the total knee as well.

 

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