Zimmer Biomet completes first TKA with the Rosa Robot

ZIMMER BIOMET: FIRST SURGERY USING ROSA KNEE ROBOT (Orthopedics This Week)

Warsaw, Indiana-based Zimmer Biomet Holdings, Inc. has announced the first surgery using its ROSA Knee Robot for a total knee arthroplasty (TKA). The case was performed by Dr. Dugal James at St. John of God Bendigo Hospital in Bendigo, Australia.

ROSA Knee, which is pending 510(k) review in the U.S., is designed to help surgeons optimize the accuracy and efficiency of TKA surgery.

“This technology enables me to personalize the surgical plan based on each patient’s individual bone and soft tissue anatomy prior to the total knee arthroplasty, which allows for increased efficacy and accuracy during the procedure. During surgery, I am able to adjust that plan based on the knee anatomy and soft tissues in real time,” said Dr. James.

“The ROSA Knee is an exciting and promising component of our growing robotics portfolio, which prioritizes the surgeons’ needs for a technology that complements their expertise and provides accurate, efficient, reproducible and data-driven results,” said Todd Davis, Zimmer Biomet’s Vice President & General Manager, Global Knee Business.

“The successful first case using ROSA Knee demonstrates its ease-of-use and clinical utility, and following its launch, we expect the technology to deliver on its promise to improve operating room efficiency and help surgeons achieve excellent procedural and patient satisfaction outcomes.”

Davis told OTW, “By obtaining our X-rays pre-op we create a 3D model and then plan the case pre-op ensuring that we have no surgical surprises intraoperatively. ROSA measures gaps intraoperatively with a high level of accuracy which will assist the surgeon in implant placement and reduce the need for soft tissue releases.”

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Will the FDA ban reusable orthopedic implants?

UNIVERSITY OF TOLEDO PROFESSOR PETITIONS FDA FOR REPROCESSING BAN (Orthopedics This Week)

University of Toledo professor has petitioned the FDA to ban the reprocessing of pedicle screws and other implantable orthopedic devices.

OTW recently covered the results of multicenter research studies that proposed a superior standard of care and method of delivery that completely eliminated contamination in pedicle screws: Are Your Sterile Implants Really Sterile?

Following the studies, lead researcher Aakash Agarwal, Ph.D., filed a petition with the Food and Drug Administration requesting that the Commissioner of Food and Drugs cease clearing 510(k)s and approving premarket approvals (PMA) for reprocessing of pedicle screws and other implantable orthopedic devices and cease clearing 510(k)s for reusable implantable orthopedic devices.

In the petition, Agarwal highlighted that pedicle screws are being contaminated in two different ways:

First, they undergo repeated bulk-cleaning with dirty instruments from the OR, leading to residue build up at the interfaces and possibly on the surfaces. Due to its concealed nature, this remains unnoticed by the Sterile Processing Department or other hospital staff. Agarwal noted that this type of contamination can be avoided by using a single-use pre-sterilized screws.

The second way that pedicle screws are being contaminated is intraoperatively. Sterile pedicle screw shafts are directly touched by the scrub tech with soiled gloves for loading onto an insertion device. They are then kept exposed on the working table.

A multicenter trial has shown that by the time it is implanted in the patient, it can harbor up to 10e7 bacterial colony forming units. Agarwal noted that use of a functional impermeable sterile-guard around the sterile-implant, which shields the pedicle screws intraoperatively until it is implanted into the patient, resulted in zero contamination. This would be an effective precautionary measure against possible surgical site infection (SSI) or subclinical and chronic sepsis leading to screw loosening and pain.

This could become a major safety initiative undertaken by FDA in upcoming years concerning the handling and delivery of orthopedic implants. It may be prudent for orthopedic device manufacturers to start the remediation process now to avoid delay in future, i.e., by addressing this gap in their quality system, before the FDA gets intimately involved in this initiative.

The FDA Office of the Executive Secretariat acknowledged receipt of the letter and assigned it docket number FDA-2018-P-4143 for future reference.

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Smith & Nephew acquires meniscal repair system for $105M

Smith & Nephew expands opportunity in meniscal repair through acquisition of unique and highly complementary technology (press release)

Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces that it has agreed to acquire Ceterix® Orthopaedics, Inc, the developer of the NovoStitch® Pro Meniscal Repair System.

This unique device addresses complex meniscal tear patterns not adequately served by other repair systems. It is highly complementary to Smith & Nephew’s leading FAST-FIX◊ 360 Meniscal Repair System, which addresses vertical tears, the most commonly repairable meniscal injury today.

Currently more than 1.2 million1 meniscal tears are treated surgically in the US each year. In only 15-20%1 of the cases is the meniscus repaired, rather than removed.  With products like NovoStitch Pro and FAST-FIX 360 we see the opportunity to double this proportion in the medium term.

Smith & Nephew will pay an initial cash consideration of $50 million and up to a further $55 million over the next five years, contingent on financial performance.

“NovoStitch Pro is an outstanding technology that addresses an unmet clinical need,” said Brad Cannon, President Sports Medicine and ENT, Smith & Nephew. “We are excited by the opportunities to take this new option to our customers. No other company is better positioned to support changing clinical practice as the standard for meniscal treatment pivots from resection to repair.”

The NovoStitch Pro allows surgeons to repair arthroscopically a broader range of meniscal tear types, including horizontal, radial, complex, bucket handle and root tears, as well as vertical tears.

“The new NovoStitch Pro Meniscal Repair System is one of the most innovative technologies developed for arthroscopic knee repair,” said Dr. Peter Kurzweil, president of Memorial Orthopaedic Surgical Group in Long Beach, California. “NovoStitch offers the potential to repair tear types that were previously considered difficult or impossible to sew, with good control and access for the surgeon.”

The NovoStitch Pro will be sold through Smith & Nephew’s extensive sports medicine sales force as well as Ceterix’s existing dedicated sales force. NovoStitch Pro has 510(k) clearance for sale in the US.

“We are proud of the impact our technology has made in developing the meniscal repair market and are excited by the opportunity to reach many more customers and their patients as an integrated part of Smith & Nephew’s extensive Sports Medicine portfolio,” said John McCutcheon, Chief Executive Officer of Ceterix.

The transaction is expected to close in early 2019, subject to the satisfaction of customary conditions. The acquisition will be financed from existing cash and debt facilities.

InvestorsAndrew Swift +44 (0) 20 7960 2285Smith & Nephew

MediaCharles Reynolds +44 (0) 1923 477314Smith & NephewBen Atwell/ Andrew Ward +44 (0) 20 3727 1000FTI Strategic Consulting

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to supporting healthcare professionals in their daily efforts to improve the lives of their patients. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has more than 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 billion. Smith & Nephew is a member of the FTSE 100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

References

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Raising Money for your Orthopedic startup? Use this tool.

Thanks to Joe Hage at MedDevicesGroup.net for sharing Mark Kraus’ investment template.

Mark Kraus was the life sciences chairman for a Seattle-based keiretsu.For investor presentations. He saw a ton of medical device funding pitches.  The questionnaire/template is just the backbone of a pitch.  Mark expects graphs, pictures, timelines, prototype examples, and simple tables to complement the application.”The presentation needs to tell a story that captures the essence of the company and why this is a great investment opportunity,” he said, adding, “If company executives can’t provide the above, they probably aren’t ready.”

Want my money? Then fill this out.

This is my new stock answer whenever a medical device hopeful needs capital.

Fill out this form. If you can’t answer the questions on this form, your prospective investors (“smart money,” if you will) don’t have enough information.  Want my money? Then fill this out.

 

“The presentation needs to tell a story that captures the essence of the company and why this is a great investment opportunity,” he said, adding, “If company executives can’t provide the above, they probably aren’t ready.”

+++

How to Give a Medical Device Pitch

Watch the video below for some sound advice we received a few 10x Medical Device Conferences ago. Full transcript here.

Seasoned VC Jeffrey Kraws summed it up nicely:

“Assume I already know this:

I already know you’re going after a large medical market with unmet medical needs.
I already know you think you have the best medical doctor out there on Planet Earth and he’s the world’s expert in this area.
I also know your management team has gazillions of years of experience and are the best at everything they do and have a proven track record and have done this.
I also know you have strong IP.
I also know you’re going to do this at a cheaper cost than anybody else.
Faster, better, and oh my God, do you know that company A and company B got sold for this much? Their stuff is crap. Our stuff is the real deal. We got all that.”

“I hear that everyday all day long,” Jeff punctuated.

His overarching points: Anticipate his questions. Answer succinctly. Say “I don’t know, I’ll get back to you,” when you don’t know. Then get back to him.

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26 OF THE TOP NORTH AMERICAN SPINE SURGEONS

26 OF THE TOP NORTH AMERICAN SPINE SURGEONS (Orthopedics This Week)
When you want to know who the best is, you seek out the best. So we sought out leading spine surgeons and asked them to select their peers who stand out.
Here is that list. It isn’t the be-all and end-all list—but a list of who are arguably some of the finest spine physicians, teachers, investigators or administrators in the country.
This information was obtained via a telephone survey of thought leaders in the field. No one at OTW names surgeons to the list.
The information in quotes is what we heard about these surgeons.
In alphabetical order, then, here are 26 of the finest spine physicians in North America.
Paul A. Anderson, M.D.
Dr. Anderson is an orthopedic surgeon at the University of Wisconsin-Madison and a professor at The University of Wisconsin School of Medicine and Public Health. “He has been and continues to be an academic leader in the spine world. His expertise is based on a valued combination of years of clinical experience, particularly in the areas of trauma and the cervical spine, and a steady stream of continuous research output in biomechanics, outcome studies, and osteoporotic fractures. When Paul Anderson speaks on a subject or relates personal case experience, we as colleagues listen closely.”
Christopher M. Bono, M.D.
Dr. Bono is Chief of Spine Service at Brigham and Women’s Hospital and an associate professor of orthopedic surgery at Harvard Medical School. He is the current president of the North American Spine Society (NASS). “He is a supporter of surgical treatment when appropriate and has taken on the challenging work of trying to convince the NASS that the organization should support surgeons and not be overly focused on nonoperative care. He is a consensus builder who has a lot of energy and enthusiasm for what he does. His modest nature gives him more credibility.”
Darrel S. Brodke, M.D.
Dr. Brodke is the Louis and Janet Peery Presidential Endowed Chair and is professor and Vice Chairman of the Department of Orthopedics at the University of Utah. He is President-Elect of the Cervical Spine Research Society (CSRS). “He has a prominent role as Chair Elect of AOSpine North America. He is responsible for building the orthopedic center at the University of Utah and is one of the most knowledgeable physicians in the spine world on patient reported outcome measures. He is extremely well liked and he does whatever it takes to get things done—even if he won’t get credit for it.”
Jens R. Chapman, M.D.
Dr. Chapman is an orthopedic surgeon at Swedish Medical Center in Seattle, Washington. “He is a recognized leader in spine surgery for his expertise in spine trauma and reconstructive surgery. As a faculty member and past Chair of the University of Washington Department of Orthopedic Surgery, he is widely considered one of the world’s experts on the treatment of spinal trauma. His dedication to education and research are unparalleled, and he has published hundreds of peer-reviewed publications and has led the educational events of numerous national and international meetings. He is involved in the leadership of multiple academic spine societies and authored numerous textbooks on spine surgery and patient outcomes.”
Clinton J. Devin, M.D.
Dr. Devin is an assistant professor of Orthopedics and Rehabilitation at the Vanderbilt University School of Medicine. “He is the Chief of the orthopedic spine service at Vanderbilt, and has presented extensively at national and international meetings on outcome measures and value in spinal surgery. Dr. Devin has been a recognized expert in outcome and quality measurements with patient care and database analysis.”
William F. Donaldson, M.D.
Dr. Donaldson is Chief of Spine and Executive Vice Chair for Clinical Services at the University of Pittsburgh School of Medicine. “His practice revolves around degenerative spinal disorders and adult deformity surgery. He is also Vice Chairman of the Department of Orthopedic Surgery. He is technically gifted as a surgeon.”
Frank J. Eismont, M.D.
Dr. Elsmont is the Leonard M. Miller Professor and Chairman of the Department of Orthopedics at the University of Miami Health System. “He has long been one of the academic leaders in spine surgery, especially in the areas of cervical spine surgery and spinal cord injury. He has had significant contributions to the scientific literature and as an instructor for clinical courses over many years. His experience and clear thought processes make him one of the ‘go to’ surgeons; truly a leader in the field.”
Sanford E. Emery, M.D., M.B.A.
Dr. Emery is a professor and Chairman in the West Virginia University Department of Orthopedics. He is the past president of the CSRS. “He is considered an international thought-leader in the area of cervical spine surgery. He has trained numerous spine fellows and has trained many leaders in spine surgery today. He is also involved in leadership development, and is in the Presidential line of the American Orthopedic Association. He is widely known for his dedication to spine surgery training, but also in the development of leadership skills for surgeons to lead societies, medical centers, departments, and their own clinical practice teams.”
Michael G. Fehlings, M.D., Ph.D.
Dr. Fehlings is the Krembil Chair in Neural Repair and Regeneration at the University of Toronto. He is also director of that facility’s neuroscience program and co-director of the University of Toronto Spine Program. “He is the top researcher in spinal cord injury in the world. He has one of the most productive researcher ‘machines’ in the world. He conducts both basic science and clinical research and has a very single minded focus that allows him to marshal all the forces needed to get projects done.”
Charles Fisher, M.D.
Dr. Fisher is an orthopedic spine surgeon at the Vancouver Spine Surgery Institute at Vancouver General Hospital. He is also a professor and Director of Clinical Research for the Division of Spine in the Department of Orthopedics at the University of British Columbia. He is the current President of the Canadian Spine Society. “Charles is a leader in evidence-based medicine and a visionary when it comes to clinical outcomes studies of spine surgery. He has systematically and patiently led his group in the development and execution of large, high quality, prospective outcome studies on a variety of important topics.”
John France, M.D.
Dr. France is Chief of the Spine Service and Vice Chairman of Orthopedics at West Virginia University. “A graduate of University of Pittsburgh Medical School and Buffalo Orthopedic residency, he has presented at national and international spine meetings and published extensively concerning traumatic and degenerative aspects of the cervical and lumbar spine. Dr. France is an exceptional spinal and trauma surgeon who chairs many educational course programs.”
Jonathan N. Grauer, M.D.
Dr. Grauer is a professor of Orthopedics and Rehabilitation and associate professor of Pediatrics at the Yale School of Medicine. He is also Co-Director of the Orthopedic Spine Service and Co-Director of the Yale New Haven Hospital Spine Center. “He is such a prolific researcher and has done tons of database analysis. He is an up-and-coming spine surgeon with a system of research at Yale that is second to none.”
James S. Harrop, M.D.
Dr. Harrop is an associate professor of Neurological and Orthopedic Surgery at Thomas Jefferson University in Philadelphia. He is also Co-Director for Adult Reconstructive Spine. “He is an international thought leader and well-respected spine surgeon who has made important contributions in a number of areas including spinal cord injury, spine trauma and degenerative cervical myelopathy. He co-directs the Spinal Cord Injury program at Thomas Jefferson University and holds senior leadership positions in a number of areas of academic neurosurgery and spine surgery.”
Alan S. Hilibrand, M.D.
Dr. Hilibrand is Vice Chairman for Academic Affairs and Faculty Development for the Department of Orthopedic Surgery and the Joseph and Marie Field Professor of Spinal Surgery and professor of Neurological Surgery at the Rothman Institute and the Sidney Kimmel Medical College of Thomas Jefferson University. He is the Co-Director of Spine Surgery and Director of the Spine Fellowship at Rothman Institute. He is a former president of the CSRS. “He has one of the most often-quoted articles in the literature, namely on adjacent segment pathology. He is a terrific leader, and has held various positions of responsibility in different societies. He is an outstanding surgeon, and a kind and caring doctor.”
Langston Holly, M.D.
Dr. Holly is a professor and Co-Vice Chair of Clinical Affairs for the Department of Neurosurgery at the University of Los Angeles California (UCLA) Health. “He is an exceptionally brilliant scientist who has applied his knowledge to clinical practice. He has done groundbreaking work in numerous areas from cerebrospinal fluid pathophysiology in syringomyelia to advanced MRI imaging.”
Wellington K. Hsu, M.D.
Dr. Hsu is the Clifford C. Raisbeck Distinguished Professor of Orthopedic Surgery at Northwestern University School of Medicine. He also heads the Laboratory for Regenerative Technologies in Orthopedic Surgery at UCLA. “He has done pivotal research into spinal fusion biology as well as investigative novel biomaterials for better bone healing. He is an outstanding clinician.”
James D. Kang, M.D.
Dr. Kang is Chairman of the department of orthopedic surgery at Harvard’s Brigham and Women’s Hospital. He is also the current President of The International Society for the Study of the Lumbar Spine (ISSLS). “He was the Vice Chairman of the University of Pittsburgh Medical Center (UPMC) department of orthopedics for many years prior to going to Brigham and Women’s. He is an outstanding surgeon and scientist. He specializes in cases that other surgeons cannot or do not want to tackle. His research efforts have landed him three ISSLS prizes and many other awards.”
Shekar N. Kurpad, M.D., Ph.D.
Dr. Kurpad is Interim Chairman of the department of Neurosurgery at the Medical College of Wisconsin. He is also director of the Spinal Cord Injury Center and Director of the spine surgery fellowship. “He is a clinician scientist with a focused interest in advanced MR imaging approaches to translational models of spinal cord injury and their application into the clinic. He has made important scientific contributions to the application of advanced microstructure imaging of the spinal cord. Dr. Kurpad leads an interdisciplinary translational research team at the Medical College of Wisconsin where he also serves as Interim Chair of the Department of Neurosurgery.”
Brian Kwon, M.D., Ph.D., FRCSC
Dr. Kwon is the Canada Research Chair in Spinal Cord Injury, a professor in the Department of Orthopedics at the University of British Columbia, Associate Director of Clinical Research for the International Collaboration on Repair Discoveries, and Director of the Vancouver Spine Research Program. “He is a unique modern day spine surgeon who also mastered basic science research on SCI. He has made numerous contributions to our understanding and translation of scientific research into the clinical arena.”
Joon Y. Lee, M.D.
Dr. Lee is an associate professor in the department of Orthopedic Surgery at UPMC. “He is the new Fellowship Director for The University of Pittsburgh spine fellowship program. He is Co-Director of the Ferguson Research laboratory at The University of Pittsburgh and is an extensive contributor to national and international spine societies and publications. Dr. Lee has been nationally known for his research and educational endeavors at national meetings.”
Ahmad Nassr, M.D.
Dr. Nassr is an associate professor of Orthopedics at Mayo Clinic in Minnesota. “A graduate of Rush Orthopedic residency program and The University of Pittsburgh Spine fellowship program, Dr. Nassr has presented and published extensively concerning degenerative aspects of the cervical and lumbar spine at national and international spine meetings and publications. Dr. Nassr is a rising star with complex spinal tumor and degenerative spinal reconstruction.”
Laurence D. Rhines, M.D.
Dr. Rhines is a professor in the Department of Neurosurgery at The University of Texas MD Anderson Cancer Center. He is also an adjunct professor in the Department of Neurosurgery at the Baylor College of Medicine. “Dr. Rhines is one of the world leaders in spine oncology surgery. He is not only an outstanding clinician, but an exemplary educator. He has championed evidence based spine oncology principles and helped change the way we manage primary and metastatic spine tumors. Dr. Rhine’s work has helped to save the lives of many patients with primary spine tumors. Beyond lecturing worldwide, Dr. Rhines has helped to develop, initiate and complete numerous research studies allowing us to learn more about how to effectively treat these complex patients.”
Daniel Riew, M.D.
Dr. Riew is a professor of Orthopedic Surgery at the Columbia University Medical Center. He is also Co-Chief of the Spine Division and Director of Cervical Spine Surgery at Columbia. In addition, Dr. Riew is Co-Director of the Adult and Pediatric Comprehensive Spine Fellowship. “He is an accomplished spine surgeon whose talents are unsurpassed. His understanding of the complexities of the cervical spine leads him to be extremely thorough with patients. He is a superb ‘people manager’ who displays a thoughtful manner and great insight when leading others. When leading initiatives at the various spine societies he brings to the table a sound knowledge of what it takes to accomplish things.”
Jeffrey C. Wang, M.D.
Dr. Wang is Chief of the Orthopedic Spine Service at the University of Southern California (USC), Co-Director USC Spine Center, and a professor of Orthopedic Surgery and Neurosurgery at that institution. “He is a leader in multiple spine societies, including AOSpine, NASS, and CSRS. He is an internationally renowned spine surgeon who is great at motivating people. He is an outstanding and innovative researcher and a clinically talented surgeon. He is also a very nice person who gets along with everyone.”
Michael Y. Wang, M.D.
Dr. Wang is a professor of Neurological Surgery & Rehabilitation Medicine and Spine Fellowship Director at the University of Miami Health (UMH) System. He is also the UMH Medical Director, Minimally Invasive Spine UMH, and the UMH Chief of Neurosurgery. “He is a leader and innovator in MIS surgery. He is a pioneer is MIS deformity surgery and has mastered MIS osteotomies and degenerative scoliosis through percutaneous techniques such to minimize blood loss and infections and maintain excellent outcomes.”
Tim Yoon, M.D.
Dr. Yoon is a professor of Orthopedic Surgery at the Emory University School of Medicine. He is also Chief of Orthopedics at the Atlanta Veterans Affairs Hospital. “Tim has established himself as a leading basic science researcher in the spine world. In addition, serving as the current ISSLS secretary, he has established himself as a strong leader on the organizational level. Having sent many residents to train with him at Emory, it is clear that Tim is a superb clinician, surgeon, and teacher.”

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