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Zimmer Biomet Receives FDA Clearance of ROSA® ONE Spine System for Robotically-Assisted Surgeries

Zimmer Biomet Receives FDA Clearance of ROSA® ONE Spine System for Robotically-Assisted Surgeries

Mar 25, 2019

Zimmer Biomet becomes first company in the world with 510(k) clearance for Brain, Spine and Knee offerings on one robotic platform

WARSAW, Ind., March 25, 2019 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® ONE Spine System for robotically assisted minimally invasive and complex spine surgeries, strengthening the Company’s comprehensive ROSA® ONE Brain and ROSA® Knee portfolio. 

ROSA ONE Spine combines robotics and navigation while delivering a unique real-time patient ‘dynamic tracking’ capability. The platform features 3D intraoperative planning software in addition to a navigation suite of technologies designed to improve implant as well as instrument placement accuracy and predictability.

“ROSA ONE Spine functions as a dual robotics and navigation technology solution for minimally invasive and complex thoracolumbar spine procedures,” said Aure Bruneau, Zimmer Biomet’s Group President, Spine, CMF and Thoracic and Surgery Assisting Technology. “We are extremely excited about the addition of ROSA ONE Spine to our already released ROSA ONE Brain and ROSA Knee Systems.”

About ROSA ONE Spine

ROSA ONE Spine is a robotic and surgical navigation system designed to aid surgeons in performing thoracolumbar minimally invasive and complex spine procedures. ROSA ONE Spine is designed to accommodate each surgeon’s surgical flow. The ROSA ONE Spine System is now available on the same platform as ROSA ONE Brain and ROSA Knee, providing the only robot hardware platform on the market to treat neurosurgical, spinal and knee pathologies. The release of ROSA ONE Spine expands the applications of the ROSA ONE Brain System that received 510(k) clearance earlier this quarter and continues to leverage the robotics platform also utilized for Zimmer Biomet’s flagship orthopedics robot, the ROSA Knee System that received 510(k) clearance and CE Mark approval this quarter. ROSA ONE Spine features a combination of robotic guidance and navigation functionality at the surgeon’s request with a seamless and flexible workflow that ensures surgeons can focus on surgical goals and patient outcomes. The robot introduces ‘dynamic tracking’ functionality that allows the robot to move with the patient, providing accuracy without the need to be attached to the patient or the surgical table. The multi function robot can increase the utilization of the robotic platform within the neurosurgical and orthopedic department, decreasing technology acquisition costs and streamlining service, repair and education.

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, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

ZBH-Corp

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SOURCE Zimmer Biomet Holdings, Inc.

Brainlab Acquires Robotics Platform Company Medineering

Brainlab Acquires Robotics Platform Company Medineering

Brainlab creates first openly scalable medical robotics platform paired with an efficient software ecosystem

MUNICH–(BUSINESS WIRE)–Brainlab, a global pioneer of software-driven medical technology, announced today the acquisition of Medineering, a developer of application-specific robotic technologies. With this move, Brainlab is driving the democratization of digital surgery with scalable solutions that expand clinical frontiers.

This strategic move increases the depth of the Brainlab portfolio in cranial surgery and strengthens its offering in spinal surgery, contributing a powerful digital step in clinical workflows. Brainlab currently markets the Medineering arm under the name Cirq®. Inspired by the form of the human arm, Cirq is an intuitive assistant during surgical procedures. After quick setup, highly adaptable Cirq can be aligned in seven degrees of freedom for maximum positioning flexibility. Once Cirq is locked firmly in place, surgeons are free to focus on subsequent surgical steps with both hands. Navigation integration leverages established workflows, set-up and instrumentation, and extends utilization. The combination of a base arm and attachable “hand” modules makes Cirq scalable and future-proof.

The acquisition adds another platform to the open hardware architecture of the Brainlab digital ecosystem for surgery, enabling other medical technology companies to design their own solutions and applications across many subspecialties. Unlike other closed monolithic industry offerings, this acquisition is expected to offer an open platform for a broad range of clinical opportunities.

Brainlab has been an investor and distribution partner for Medineering for nearly three years. In contrast to robotics concepts that start at over a million dollars, the light weight Medineering arm is available for a fraction of the cost and mounts easily to the siderails of the O.R. table, making the vendor-neutral robotic platform accessible to many of the over 4,000 existing Brainlab customers, and expanding market reach into ambulatory surgery centers. Medineering has demonstrated the feasibility of its mechatronic arm for holding a range of hands, from a straightforward instrument holder to robotic hands for the alignment of biopsy needles, drill guides, and endoscopes. Several applications are already available and in clinical use in Europe, under the name Cirq, with FDA clearance pending in the United States.

“Becoming part of Brainlab means scalability for our technology and improved market access,” comments Stephan Nowatschin, Co-Founder and CEO, Medineering. “Combining our open platform with the software ecosystem from Brainlab will enable more efficient development of very competitive clinical solutions.”

“Medineering introduced a fresh new approach to surgical robotics when we entered into our partnership less than three years ago,” said Stefan Vilsmeier, President and CEO, Brainlab. Today, we are shifting gears and accelerating development with additional resources to address a broader clinical market.”

About Brainlab

Brainlab, headquartered in Munich, develops, manufactures and markets software-driven medical technology, enabling access to advanced, less invasive patient treatments.

Core products center on information-guided surgery, radiosurgery, precision radiation therapy, digital operating room integration, and information and knowledge exchange. Brainlab technology powers treatments in radiosurgery and radiotherapy as well as numerous surgical fields including neurosurgery, orthopedic, ENT, CMF, spine and trauma.

Privately held since its formation in Munich, Germany in 1989, Brainlab has more than 12,850 systems installed in over 100 countries. Brainlab employs almost 1,400 people in 18 offices worldwide, including more than 420 research and development engineers, who form a crucial part of the product development team.

About Medineering

Medineering, headquartered in Munich, develops, manufactures and markets an application-specific and convenient robotic portfolio. The portfolio consists of the Medineering Positioning Arm and compact application-specific robots assisting surgeons in complex anatomical regions. Dr. Maximilian Krinninger and Dr. Stephan Nowatschin founded Medineering in June 2014. The startup has grown rapidly and the young and international team consists of highly specialized robotic engineers, marketing experts and regulatory specialists.

Contacts

Media Contact
Debbra Verard
Brainlab
+1 914-602-4589
Debbra.verard@brainlab.com

SOURCE: BusinessWire March 20, 2019

Centinel Spine Appoints Dirk M. Kuyper and Gregory Rainey to its Board of Directors

Centinel Spine Appoints Dirk M. Kuyper and Gregory Rainey to its Board of Directors

NEW YORK, March 19, 2019 /PRNewswire/ — Centinel Spine®, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced the appointment of Dirk M. Kuyper and Gregory Rainey as members of the Company’s Board of Directors.

“I am thrilled to welcome both Dirk and Gregory to the Centinel board,” says Centinel Spine Chairman & CEO, John Viscogliosi.  “Both individuals bring a wealth of achievement across the industry and decades of proven leadership success that will complement an already experienced board.  I am anticipating that these additions will bring significant value as we push forward in meeting short-term business goals as well as our corporate mission to become the worldwide leading company addressing spinal disease anteriorly.”

Dirk M. Kuyper has had a long and successful career in medical device companies, with his efforts focused on development and implementation of strategy and revenue growth.  Mr. Kuyper is currently the Owner and CEO of Precision Machinists Company, Inc., a manufacturing firm specializing in precision CNC components for the semiconductor, aerospace, and medical device markets. Prior to this, he served as President and CEO of Illuminoss Medical, Inc., a privately-held medical device company specializing in minimally invasive, patient customized orthopedic implants for the treatment of bone fractures. From 2007 to 2012, Mr. Kuyper served as the President & CEO, and as a member of the board of directors, of Alphatec Spine, Inc.  Prior to his work for Alphatec, he served in several executive capacities as President, Executive Vice President, and as Chief Operating Officer for Aesculap, Inc., a division of B. Braun Medical. Since 2013, Mr. Kuyper has served as an independent director, chair of the compensation, and a member of the nominating and governance committees of Conmed Corporation.

Gregory Rainey is currently principal of CCI Performance Group, a consulting firm that he founded in 2004 to take advantage of his extensive knowledge and experience in the healthcare industry.  He utilizes comprehensive insight and versatility within the healthcare industry to deliver sustainable business solutions for leading Fortune 500 client companies, as well as start-up ventures.  Previously, Mr. Rainey spent more than a decade with Stryker Corporation, as Vice President of Sales for the Orthopedic Division.  He led the national sales organization to overall sales growth of $425 million in four years, and his leadership was integral toward catapulting the organization from the fourth to the first-rated, fastest-growing company in the industry.  Mr. Rainey’s earlier career successes span tenures with multiple companies, including Joint Medical Corporation and U.S. Surgical Corporation.  He currently sits on the public board of CAS Medical (CASM), where he serves as Chairman of the Governance Committee, and also serves on the Board of Directors for Catalyst Orthoscience.  Mr. Rainey previously sat on the public board of RTI Surgical (RTIX).

“The combined experience of Dirk and Gregory brings an additional level of diversity to the board, which is extremely valuable to our team,” says Viscogliosi. “I welcome both of these high caliber leaders and look forward to working with them.”

About Centinel Spine, LLC

Centinel Spine®, LLC is the largest privately-held spine company focused on anterior column reconstruction. The company offers a continuum of trusted, brand-name motion-preserving and fusion solutions backed by over 30 years of clinical success — providing the most robust and clinically-proven Total Disc Replacement and Integrated Interbody™ portfolios in the world.

The company began operations in 2008 through the merger-acquisition of two pioneering medical device companies—Raymedica, LLC and Surgicraft, LTD. UK-based Surgicraft launched the first Stand-Alone/No Profile® anterior lumbar interbody fusion device in the world in 1988, which was the basis for future generations of the market-leading Integrated Interbody™ technology platform known today as STALIF®. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission to become the worldwide leading company addressing spinal disease anteriorly with the widest breadth & depth of technology platforms.

The company recently acquired the prodisc® Total Disc Replacement Technology Platform—the most extensive cervical and lumbar motion-preserving reconstruction portfolio available today.   With the addition of prodisc, Centinel Spine stands alone as the only company with comprehensive motion-preserving and fusion solutions for both cervical and lumbar anterior column reconstruction.

Centinel Spine derived its name from the “Sentinel Sign”, the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please visit the company’s website at www.CentinelSpine.com or contact:

Varun Gandhi
SVP, Corporate Finance & Strategic Planning 
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: v.gandhi@centinelspine.com

SOURCE Centinel Spine, LLC

RTI Surgical® Completes Acquisition of Paradigm Spine

RTI Surgical® Completes Acquisition of Paradigm Spine

Company Integrates coflex® Interlaminar Stabilization® Device into Growing Spine Portfolio

Further Advances RTI’s Strategic Transformation Focused on Spine and OEM

DEERFIELD, Ill., March 08, 2019 (GLOBE NEWSWIRE) — RTI Surgical Holdings, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced it has completed the acquisition of Paradigm Spine, LLC, a leader in motion preservation and non-fusion spinal implant technology. Paradigm Spine’s primary product is the coflex® Interlaminar Stabilization® device.

“The acquisition of Paradigm aligns with RTI’s growth strategy focused on investing in differentiated products and building scale within our spine business,” said Camille Farhat, President and CEO, RTI Surgical. “It marks the second completed acquisition for RTI’s spine portfolio since the second half of 2017 when we initiated a strategic transformation to reduce complexity, drive operational excellence and accelerate growth for RTI.”

Coflex is a differentiated, minimally invasive motion preserving stabilization implant that is FDA PMA-approved for the treatment of moderate to severe lumbar spinal stenosis (LSS) in conjunction with decompression. LSS is a debilitating and degenerative disease that impacts approximately 1.6 million patients annually in the United States. Coflex is a significant addition to RTI’s existing spine portfolio, which consists of high-quality hardware, interbody, and biologic options.

Mr. Farhat added: “The addition of coflex allows RTI to provide surgeons who treat patients with moderate to severe LSS a PMA-approved device supported by more than 12 years of clinical data and with expanding coverage from payors. With RTI’s demand generation expertise, scale and infrastructure and the experience of key members of the legacy Paradigm Spine team joining RTI, we are well-positioned to grow coflex as the treatment of choice and standard of care for appropriate LSS patients.”

Piper Jaffray & Co. served as financial advisors to RTI, and Sidley Austin LLP and Holland & Knight LLP served as legal counsel on the transaction and financing, respectively. Dorsey & Whitney LLP served as legal counsel to Paradigm Spine.

About RTI Surgical Holdings, Inc.
RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic and trauma procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com. Connect with us on LinkedIn and Twitter.

Forward-Looking Statements
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements, gaining market share and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

MEDIA AND INVESTOR CONTACT:
Molly Poarch
mpoarch@rtix.com
+1 224 287 2661

International Women’s Day

International Women’s Day

It’s International Women’s Day today, 8th March 2019, and it seemed like a good opportunity to talk to the women at Ortho Consulting Group (OCG) about their roles in the business, what inspires them in the workplace and their proudest achievements. We also discussed who they consider to be inspirational women and how they see the future of women in business. 

Polly White
Business Manager

I work on the operational side at OCG making sure the business runs smoothly behind the scenes. I work part time, flexible hours to fit my job in with my family, which works well for me. It means time management and planning is essential though and learning to say no!

A business which embraces flexible working can reap the rewards of attracting talent who might not have otherwise been able to apply for the job.

I’ve been inspired by loads of people (men & women!) in teams and businesses I’ve worked in. Female senior leaders are especially impressive as they are still breaking through a traditionally male-dominated ceiling. There is still a perception that women must behave like the candidates on ‘The Apprentice’ to cut through and be impressive.  

“The most successful women in business I have worked with are just themselves. They believe in themselves. They believe that they are equal. They believe that they can make a difference. And they believe that they can contribute positively to success”.  

I’m not one to reflect – it’s something I should do a lot more of. We all should. When I think back on my proudest achievements, I have had many more than I first thought. Having the opportunity to be part of the awesome communications team at O2, launching the iPhone and The O2 venue was a highlight. And winning a company-wide award for creativity and innovation at AXA. But above those, carving myself a work-life balance that works for me, my children and the business is one of my proudest working achievements. It’s really hard to do as you can feel torn in every direction, and you have to make some tough decisions to break from the norm, but it CAN be done. Especially when you find a company like OCG who makes flexible working a success. Everybody wins.

Lynsey Rowland
Research Manager

My interest in Orthopaedics started with myself becoming an amputee. The role as a researcher in this field was a fantastic opportunity for me. My main responsibility at OCG is to find distributors within the Orthopaedic market. I have also just recently got involved with the executive search side of the business, researching applicants’ CV’s. 

I am able to do the majority of my work from home, which means being very disciplined with my time.

The flexibility of being able to fit work around family life is great. Hopefully more companies will follow suit and introduce flexible working hours where possible.

“I really enjoy my job and I feel like a valued member of the team. We all support one another in and outside of work. Most importantly we understand what is required of us all, making our working environment an exciting, fun place to be”. 

Inspirational people for me are those that I have personally come into contact with through various walks of life or who I have worked with throughout my career. My life experiences have shown me to be honest, believe in myself and going with what is true to me. I have had to learn to deal with life changing experiences, which have been difficult at times but overall it has made me a stronger person. 

I’m hopeful that both my son and daughter will have the same equal opportunities in the workplace in whatever they decide to do in the future.

Fiona Walters
Executive Recruiter

Executive search is my predominant focus at Ortho Consulting Group, but I am also involved with other projects and help manage the finance function in the business. What really inspired me when I joined in 2010, and still motivates me now, was Matt’s flexible approach to women in the workplace.

I’ve been lucky to work the hours that suit me and as a result have a genuine work-life balance.

From a commercial perspective, this means I can give 100% to my job and consistently go above and beyond for my team. My proudest achievement at OCG is making the highest value executive search placement in the history of the company. I’m also proud of my achievements and work experience prior to joining the OCG team. My nursing career and International Product Management experience helps drive successes in my work today.  

In Orthopaedics, I’ve been lucky enough to work with some exceptional female leaders who exhibit great talent in what is traditionally a male-dominated environment.    

For the future, I hope that more employers embrace the concept of flexible working. It’s well-documented that these arrangements can help to increase productivity and enhance employee engagement and loyalty. I’d like to think that by the time my children are in employment there will be a further move to gender balance at work. 

Matt Woods, Founder of Ortho Consulting Group commented; “I’m proud to have built a balanced team who can all play to their strengths and deliver best-in-class results irrespective of their gender or hours worked. I’m committed to a culture of equality in the workplace and have direct experience of how this approach is practical and has a positive business impact” 

About International Women’s Day 

International Women’s Day 2019 (IWD 2019) is a worldwide event that celebrates women’s achievements – from the political to the social – while calling for gender equality. 

The theme for IWD 2019 is #BalanceForBetterrecognising the growing global push for professional and social equality. The aim of the theme is to encourage gender balance in boardrooms, in the media and in wealth as a way for economies to thrive.  

www.internationalwomensday.com 

#IWD2019 #BalanceforBetter 

About Ortho Consulting Group 

Our business is focused on providing Orthopaedic and Spine manufacturers with a consultancy service to grow their OUS business. We can source and manage your sales channels and help you build your executive team. The key to our success is that we don’t only sit behind a desk, instead we spend time in the OUS markets, co-travelling with manufacturers and distributors to understand what is needed to be successful and then providing a clear route to market.   

Intellijoint Surgical appoints top innovative orthopaedic surgeon, Jonathan Vigdorchik, MD, to Scientific Advisory Board

Intellijoint Surgical appoints top innovative orthopaedic surgeon, Jonathan Vigdorchik, MD, to Scientific Advisory Board

WATERLOO, ON, March 5, 2019 /PRNewswire/ – Intellijoint Surgical, a Canadian-held company developing and commercializing smart navigation for total joint replacements, is pleased to announce the appointment of Jonathan M. Vigdorchik, MD, to its Scientific Advisory Board (SAB). Dr. Vigdorchik is an Orthopedic Surgeon at the Hospital for Special Surgery.

Intellijoint Surgical’s flagship technology – Intellijoint HIP – is disrupting traditional navigation within total hip replacement surgery by being smarter, faster, and more affordable. The appointment of Dr. Vigdorchik to its SAB brings together innovators who are focused on advancing orthopedic surgery through surgeon education and the development of new technology to improve patient outcomes.

“Through research and diverse surgical experiences, I have seen how navigation can be used to improve patients’ outcomes following total joint replacement,” explained Dr. Vigdorchik. “Intellijoint’s core technology has enabled a new era of surgical navigation by providing highly accurate and cost-effective measurements for implant positioning and limb length, maintaining efficiency of my workflow, respecting my implant preferences, all without the need for radiation from a CT scan or an increase in operative time.”  

Dr. Vigdorchik has years of surgical experience with navigation and robotics, and adopted Intellijoint HIP over three years ago for most of his surgical cases. Dr. Vigdorchik is fellowship trained in Adult Reconstruction and Joint Replacement at Hospital for Special Surgery, and an assistant professor of orthopedic surgery at Weill Cornell Medical College. He specializes in all types of hip surgery from hip preservation to hip resurfacing, hip replacement, and revision.

“The need for the next generation of surgical navigation is evident through the exceptional growth and global adoption we are experiencing,” said Armen Bakirtzian, CEO and co-founder of Intellijoint Surgical. “We are excited to partner with Dr. Vigdorchik to develop new technologies and educate orthopedic surgeons on how to effectively integrate them into their practices.”

Dr. Vigdorchik joins an esteemed group of orthopaedic surgeons on Intellijoint Surgical’s SAB: Chairman, Dr. Allan Gross at Mount Sinai Hospital (Toronto, Ont.), and members: Dr. Wayne Paprosky at Rush University Medical Center (Chicago, Ill.); Dr. Michael Bradley at South County Hospital (South Kingstown, R.I.); Dr. Ran Schwarzkopf at NYU Langone Orthopedic Hospital (New York, N.Y.); and Dr. Michael Alexiades at Hospital for Special Surgery (New York, NY).

About Intellijoint Surgical:

Intellijoint Surgical® develops and commercializes surgical navigation solutions. Intellijoint’s flagship product, Intellijoint HIP® provides surgeons with real-time, intraoperative measurements to ensure proper size selection and positioning of orthopaedic implants during total hip replacements. Intellijoint is committed to improving patients’ lives by providing every surgeon with effective, easy-to-use technology.

Intellijoint Surgical is the recipient of the North American Frost & Sullivan Enabling Technology Leadership Award, the Futurpreneur Shopify True Grit Award and the Growing Strong Futurpreneur Award.

SOURCE Intellijoint Surgical Inc., PRNewswire March 5, 2019

Related Links

https://www.intellijointsurgical.com/