ROSEMONT, Ill., Oct. 17, 2017 /PRNewswire-USNewswire/ — The American Academy of Orthopaedic Surgeons (AAOS) today announced plans to create a national family of clinical data registries for a broad range of orthopaedic conditions and procedures. As part of this effort, the American Joint Replacement Registry (AJRR) is integrating into the AAOS effective immediately. The AJRR, a national hip and knee joint replacement registry with 970 participating U.S. hospitals and 40 ambulatory surgery centers, has captured and analyzed data on more than one million procedures since its creation in 2010.
The launch of the new registry program reflects the Academy’s strategic commitment to quality.
“A central group of orthopaedic registries, providing standardized and consistent data, will allow us to optimally measure performance and value, create and recommend informed reimbursement and treatment standards, develop education programs that address practice and treatment deficiencies, and most importantly, continually and collectively improve patient safety, treatment and outcomes,” said AAOS President William J. Maloney, MD.
“We welcome AJRR to our registry family,” added Dr. Maloney. “Their success and standards will serve as the cornerstone of our new program.”
“The Academy and AJRR share a commitment to helping orthopaedic surgeons provide the highest quality musculoskeletal care to patients,” said AJRR Board of Directors Chair Daniel J. Berry, MD. “This new integration will allow us to expand and enhance our data collection capacity. We look forward to a continuing, seamless relationship with our partners and participating facilities as we move forward.”
Nathan Glusenkamp is the new AAOS director of orthopaedic registries. Glusenkamp previously served as president of provider solutions at FIGmd, a rapidly growing health information technology vendor delivering data liquidity interfaces to medical societies and boards. Prior to joining FIGmd, he oversaw the American College of Cardiology’s PINNACLE Registry, the largest observational outpatient cardiovascular registry in the world.
The AJRR will serve as the hip and knee registries for AAOS, continue to operate business as usual without interruption for existing participating sites, and retain the AJRR name. Additional AAOS registries will launch beginning in mid-to-late 2018, and over the next five years, covering a broad range of conditions and procedures and including data from outpatient and in-patient settings.
More Information about the AAOS
With more than 38,000 members, the American Academy of Orthopaedic Surgeons is the world’s largest medical association of musculoskeletal specialists. The AAOS provides educational programs for orthopaedic surgeons and allied health professionals, champions and advances the highest quality musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments and related issues.
Visit AAOS, at: Newsroom.aaos.org for bone and joint health news, stats, facts, images and interview requests. ANationinMotion.org for inspirational patient stories, and orthopaedic surgeon tips on maintaining bone and joint health, avoiding injuries, treating musculoskeletal conditions and navigating recovery. Orthoinfo.org for patient information on hundreds of orthopaedic diseases and conditions.
Facebook.org/AAOS1 Twitter.com/AAOS1
More information about AJRR The American Joint Replacement Registry is a multi-stakeholder, independent organization for data collection and quality improvement initiatives for total hip and knee replacements. AJRR’s goal is to optimize patient outcomes through collection of data on all primary and revision total joint replacement procedures in the U.S. Today, the Registry contains more than 1,000,000 procedures from over 8,000 surgeons. For more information about AJRR, visit www.ajrr.net
Photo: ConforMIS 3D Printing and Additive Manufacturing Facility; Wilmington, MA
BILLERICA, Mass., Oct. 16, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants customized to fit each patient’s unique anatomy, today announced that, while the industry has begun to acknowledge the value of customized knee replacement implant systems compared to traditional off-the-shelf implant systems, it has obtained additional positive clinical data regarding the performance of its customized partial knee replacement implants.
Recently, Sam Onukuri, head of Johnson & Johnson’s 3D Printing Center of Excellence, acknowledged the advantages of customized knee implants and instruments that are developed based on a CT or MRI scan of a patient’s anatomy. In an interview generally discussing the advantages of additive manufacturing published in GE Reports by General Electric (GE) and in an “Employee Spotlight” article published by Johnson & Johnson, Onukuri noted the potential advantages of customized knee implants that may reduce both “pain and the recuperation time” compared to traditional off-the-shelf implant systems that come in a limited range of sizes. “Physicians make every effort to find the implant that fits best,” Onukuri says. “But it’s never a perfect match, and the same is true for the tools. As a result, the surgery takes longer — and so can healing and recovery — and the fit may not be perfect.” On the other hand, Onukuri noted that “customized solutions” based on patient CT or MRI scans “can achieve an exact fit for the joint.”
While the orthopedic industry researches potential customized alternatives to traditional off-the-shelf implant technology, ConforMIS continues to develop a growing body of positive clinical data regarding its existing customized knee implants. Most recently, in a study evaluating knee strength and mechanics that compared healthy control patients to those with either a modern off-the-shelf total knee replacement (TKR) or a customized bi-compartmental knee replacement (BKR), the authors concluded that the “study shows that BKR patients exhibit better strength and mechanics while performing activities of daily living.” According to the study results: the TKR group walked significantly slower when compared to both the BKR group and healthy controls (p < 0.05); the TKR knee had less peak extensor moment at stance than both the BKR and healthy control knees (p < 0.05); and both the BKR and healthy control knees displayed larger internal rotation at stance than that of the TKR knee (p < 0.05). The results of the study, for which ConforMIS provided financial support, were published online by International Orthopaedics on September 4, 2017.
“We are very pleased that the industry is now beginning to recognize the advantages and potentially transformative nature of customized knee implant and instrumentation solutions,” said Mark Augusti, Chief Executive Officer and President of ConforMIS. “ConforMIS has been a champion of customized implant technology for over a decade, and the body of clinical data demonstrating both the clinical and the economic advantages of customized total and partial knee implant systems continues to grow.”
About ConforMIS, Inc.
ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 450 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.
Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about the transformative nature of customized implant systems, the economic or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our product development and commercialization efforts, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.
MAHWAH, N.J., Oct. 16, 2017 /PRNewswire/ — Stryker’s Joint Replacement division today announced that its cementless Mako Total Knee with Triathlon Tritanium has received 510(k) market clearance by the U.S. Food and Drug Administration.
Triathlon Tritanium combines the kinematics of Stryker’s market leading Triathlon knee implant with the latest in highly porous biologic fixation technology for a knee system like no other. The innovation of Tritanium’s tibial baseplate and metal-backed patella components are enabled by Stryker’s proprietary AMagine additive manufacturing technology and are SOMA-designed.
With cementless procedures rising in popularity and becoming a fast-growing trend1, Mako Total Knee with Triathlon Tritanium expands the current robotics offering to provide a cementless solution for orthopaedic surgeons seeking a more predictable surgical experience combined with increased operating room efficiency, biologic fixation and an alternative to bone cement.
“With the rise in demand for cementless knee technology, we believe this new offering can have a positive impact on procedural efficiency and patient outcomes,” said Stuart Simpson, President, Stryker’s Joint Replacement division. “We’re excited to continue to lead in robotic technology and combine two of our most advanced and differentiated products to provide surgeons with the ability to transform orthopaedic surgery.”
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.
References:
1.
Table 54: Primary TKA Implant Market. US Markets for Large-Joint Reconstructive Implants 2013. Millennium Research Group. March 2013. Pg. 84
I have seen a lot of tenured ortho sales people leave the comfort of “Big Ortho” and take on the role of Distributor or rep for much smaller start-ups. I want to deconstruct the forces driving this change and the dynamics between all the players. Then, we will explore what drives the variability in results of this new model. Finally, I will leave you with some ideas on how you can become a high caliber distributor prepared to thrive in a new role.
Big Ortho vs The Rep
As pricing pressures continue to push profits down, manufacturers are looking for more ways to improve their bottom line. As referenced in my previous article The Unsung Hero of the Orthopedic Industry – The Rep, the distributors and reps bear the brunt of much of the pricing compression. It seems as though the easy target for the squeezing is the one furthest from the boardroom – the Sales Reps and Distributors.
We have seen large companies’ commission rates fall well below 20%. At the same time, ASP’s (Average Selling Prices) continue to fall with corporate negotiated hospital or GPO contracts. The result is an inverse relationship where reps have to do more cases to make the same amount of money as last year. Increasing business 20-30% is a more difficult challenge than ever before due to increased consolidation and competition in the marketplace.
We are left with a dynamic where Small Ortho can capitalize on the inverse relationship Big Ortho reps face. By offering significantly higher commission and the ability to be their own boss, small ortho is attracting experienced representation that can leverage established relationships and navigate familiar approval processes.
“The days of only courting your surgeons and hospitals is passing away along with paper-only records and whiteboard logistics.The Ortho Startup & The Rep”
The orthopedic start up market continues to attract venture and private equity funding as forecasts like, “OrthoBiologics market to reach $6.06B by 2022” present fertile ground. Additionally, as Big Ortho seems more comfortable investing in M&A rather than R&D, start-ups have a clear exit strategy.
As the device market matures and patents expire, new doors open for clever copycats. This phenomenon presents opportunity for smaller, more nimble competitors to gain a strategic advantage and capture business that was once securely owned by Big Ortho. Innovative technology or even just novel improvements to antiquated systems can lead to profitable acquisitions.
This is not to say it is an easy endeavor for start-ups to break into orthopedic implants. R&D, Regulatory affairs, and the rapidly evolving landscapes of hospitals and GPO requirements present evermore complex and time-consuming barriers for small companies. As with any new venture, more time translates into more money and that unknown timeline can be very detrimental to a small company. Finding representatives and distributors capable of steering through this “mine field” is a critical driver of their success.
The Challenge
The challenge for many smaller orthopedic companies is that the caliber of distributor that they are able to attract tend to be limited to a Sales Rep who decided to bail out of a larger company for the reasons described above. They require very little support or training and they can hit the ground running to achieve some success fairly quickly. But, for what these reps bring in strong relationships and technical know-how, they often lack in infrastructure and leadership experience. As a result, what the company ends up with is little more than what we call a “Super Rep” who’s sales plateau sooner than expected.
The reason most plateau quickly is that they don’t have any of the infrastructure that a seasoned distributor typically does. No one can blame them since they are essentially a rep who now enjoys the full distributor commission rather than a split. Rather than owning a business, they effectively only own a job and want to keep overhead low and profits high. This is a short-sighted solution and the distributors who are in this category are quite vulnerable. Without a team and support infrastructure, they are little more than the sum value of the surgeon relationships.
For the manufacturer, this poses a problem of scalability. If these Super Reps don’t begin to take on the responsibilities of a true distributor or agent, they will struggle to capture more geography and build a valuable and sustainable business. While it may satisfy some, manufacturers don’t see these players as long-term partners. The success of Big Ortho came from having strong, long-term partnerships with distributors and agents who invested in their businesses and built sustainable enterprises that were able to scale.
Where many of these new distributors are failing is in building a foundation of scalability and making the necessary investments into their company’s future sustainability. Setting the right foundation for success early in the scaling process is paramount. It’s not necessary to make large capital investments, but setting up the right foundation is paramount to prolonged success.
“As margins continue to tighten, operational efficiencies achieved through smarter distribution and sales will separate winners from losers.”
Data-driven Distribution
Where does one start? First, start with the basics: as a distributor, you need to have a legitimate company website if you want to be seen and prospected by companies looking for new distributors. You and I both know the surgeons and hospitals don’t give much thought to that. But, if you’re successful, M&A will eventually impact the lines you carry. Continually prospecting and being visible to companies with new technologies is a key part of remaining relevant and positioning yourself for success in your local market. Having a website enables you to project the image that you take your business seriously and are taking steps to be professional. Manufacturers want to see that you work ON your business and not merely in it.
Having a website also enables you to use an email address with your company’s name on it rather than a gmail, or worse: your AOL address. Nothing says “mom & pop” like a distributor using a internet service provider’s email address. The quality of your website is also important as it projects the image of your company. If it is too “1990’s,” people will draw the conclusion that you are still back in the dark ages and not availing yourself of the latest technologies. This can be an impediment to attracting some of the companies with newer innovations that are seeking representation. A website can be done very inexpensively and deliver the right message and image.
Another inexpensive way to differentiate your distributorship is by leveraging technology to manage your business. Using a whiteboard, Google Calendar and group text messages to manage inventory presents you as a risky proposition when it comes to companies allocating valuable assets to you. As margins continue to tighten, operational efficiencies achieved through smarter distribution and sales will separate winners from losers. Technology should impact your business in several ways: coordinate your team’s schedules, quickly schedule cases, manage day to day sales activities, track your inventory from multiple manufacturers, consolidate your manufacturer’s invoices and open PO’s. In other words, run your business in the 21st century.
While I am biased in believing our platform, Surg.io, is the best solution for reps and distributors, any electronic system is better than none. Keep in mind that manufacturers entrust a great deal of money into your hands by way of implant and instrument inventories. Your existing and future partners want to see that your utilization brings about a healthy return on investment. Nothing is more compelling than efficient infrastructure and solid data to support your request for additional inventory or even, data to support keeping the inventory you currently have. Equally, nothing more undermines your partnership with a manufacturer than inefficient use and tracking of their inventory.
Implementing one of these platforms doesn’t need to be onerous. While there is always a bit of a learning curve when starting up, once you get through the on-boarding process and everyone is using it, it will be a lifesaver. In addition to better organization and inventory utilization, using Surg.io, or a similar platform, helps you create margin in your day for more selling by streamlining all your processes. It enables you to better communicate as well as ensure that everyone is singing from the same sheet of music. If all you’re using is Google Calendar, you’re missing a whole host of features and analytics that can take your business to the next level.
Looking Ahead
As challenges continue to mount and the odds continue to stack against orthopedic distributors, only those who embrace technology and figure out how to leverage it will be able to thrive through the next 10 years of the evolution of the industry. Doing more with less will continue to be the pressure and will require a strategic approach to supply chain management. Projecting a “no tech” business to manufacturers poses a profound risk to distributors and with how easy and inexpensive as it is, seems to be a very risky proposition. The days of only courting your surgeons and hospitals is passing away along with paper-only records and whiteboard logistics.
To learn more about Surg.io and how to leverage it for growth and scalability, visit www.Surg.io and request a demo.
CHICAGO–(BUSINESS WIRE)–Orthopedics leader Medacta International today announced the introduction of the MiniMAX Hip System into its U.S. product portfolio. The MiniMAX is an anatomical cementless stem that is engineered to provide enhanced fit and fill in the metaphyseal femur by following the natural shape of the femoral canal with a unique curved design, ideal for both minimally invasive anterior and posterior hip replacement procedures. The launch follows the successful first stateside surgery utilizing the stem, which was performed by David Scott, M.D., of Spokane, Washington, on September 12.
“The MiniMAX Hip Stem is a very versatile product. It was built as an addition to the product range of stems and instruments dedicated to our AMIS (Anterior Minimally Invasive Surgical) approach to hip replacement, but it also works with posterior techniques, providing surgeons with even more flexibility,” said Francesco Siccardi, Executive Vice President of Medacta International. “Our partners in Europe and Australia have had extremely positive experiences with the implant, and we’re excited to offer it as another option for surgeons in the United States.”
The MiniMAX Hip Stem aims to reduce risk and postoperative pain for patients while making it easier for surgeons to introduce it into the femur. The MiniMAX’s lateral flare design minimizes fracture, and its nine degrees of neck anteversion can provide more joint stability and reduce the risk of dislocation. The short, thin tip with five degrees of curvature lowers the risk of thigh pain caused by distal interference. The implant’s proximal titanium plasma spray and hydroxyapatite coating provide enhanced proximal fixation.
“I was impressed with how well the MiniMAX Hip Stem replicates the natural anatomy of the human hip, rather than having the patient’s anatomy conform to the shape of the implant, like many other popular models,” said Dr. Scott. “Pairing the MiniMAX with a minimally invasive approach made for an efficient, effective procedure and my patient is recovering well.”
First introduced in Europe in 2007, the MiniMAX Hip Stem is associated with proven clinical results, obtaining a survival rate at 5 years of 97.5 percent considering revision for any reason and 100 percent considering aseptic loosening as endpoint, according to internal Medacta research.
John Masonis, M.D., of Charlotte, North Carolina, will perform a live surgery using Medacta’s AMIS platform to implant the MiniMAX Hip Stem at the 6th Annual ICJR Anterior Approach Hip Course on Thursday, Oct. 19 at noon Central.
“Surgeons attending the live surgery will receive education on the surgical and patient processes associated with the anterior approach to hip replacement and while doing so, will be able to see the MiniMAX stem and AMIS platform in clinical practice for themselves,” said Dr. Masonis.
Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS®system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.
Contacts
For Medacta International, Inc.
Jill Bongiorni, 516-729-2250 Jill@torchcomllc.com
WEST CHESTER, Pa., Oct. 12, 2017 /PRNewswire/ — Today DePuy Synthes* announced the U.S. launch of the new TFNA Augmentation System, the first and only polymethylmethacrylate (PMMA) cement with specific trauma device indications, offered exclusively for use with the TFNA System. The TFNA Augmentation System is used to address the needs of patients with hip fractures and who have poor bone quality.
The TFNA Augmentation System can be used to provide enhanced implant fixation in cases where the potential risk of cut-out is significant. Cut-out is a loss of implant anchorage or stability in the bone, frequently occurring in those with poor bone quality. It causes the femoral neck-shaft angle to collapse, and is a leading clinical complication during hip fracture surgery. Cut-out can also lead to reoperation, which increases risks to the patient and increases costs to the healthcare system. Each year, more than 300,000 hip fractures occur in the U.S.1 These fractures are common in the elderly, especially those with osteoporotic bone. Fractures are expected to increase as the population ages.2 When used together with the TFNA System, the TFNA Augmentation System is designed to help reduce the risk of cut-out and provide enhanced implant fixation.3,4
“The TFNA Augmentation System addresses an important clinical need for patients who undergo hip fracture surgery, especially those who suffer from poor bone quality,” said Charisse Y. Sparks, MD, Franchise Medical Leader Trauma, DePuy Synthes Trauma. “This new system complements the TFNA System and has the potential to improve patient outcomes, reduce costs, and increase patient satisfaction.”
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.
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 effectiveness and value of the TFNA Augmentation System. 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 and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; 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 January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and 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 DePuy Synthes nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.
1 Agency for Healthcare Research and Quality. National and regional estimates on hospital use for all patients from the HCUP Nationwide Inpatient Sample (NIS). 2013.http://www.ahrq.gov/research/index.html. Accessed 12 October 2015.
2 Cummings SR. Rubin SM, Black D. The future of hip fractures in the United States. Numbers, costs and potential effect of postmenopausal estrogen. Clin Orthop Relat Res. 1990;252:163-166
3 DePuy Synthes test data on file, Windchill 0000268245.
4 Hofmann L, Zderic I, Hagen J, Agarwal Y, Scherrer S, Weber A, Altmann M, Windolf M, Gueorguiev B. Biomechanical effect of bone cement augmentation on the fixation strength of TFNA blades and screws. Presented at 22nd Congress of the European Society of Biomechanics. 10-13 July 106. Lyon, France.
Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, announces today that Olivier Bohuon, 58, has notified the Board of his intention to retire by the end of 2018, after seven years as Chief Executive Officer. The Board is commencing a search for a successor. In the meantime, Olivier will continue to lead Smith & Nephew and drive the Company’s growth initiatives and operating plans.
Olivier Bohuon, Chief Executive Officer, said:
“Since I joined the Company in 2011, we have transformed Smith & Nephew into a more focused, efficient and innovative business and I am proud of the value we have created for all of our stakeholders. Looking ahead to the next long-term phase of growth, I have decided to announce my retirement plans now, providing ample time to identify a successor and ensure a smooth transition. I am committed to leading the Company in the meantime, as we remain resolutely focused on delivering a solid performance in 2017, while positioning the Company for further success in the future.”
Roberto Quarta, Chairman said:
“On behalf of the Board, I want to thank Olivier for his professional and personal commitment and dedication to Smith & Nephew during his tenure as our CEO. Under Olivier’s leadership Smith & Nephew has undergone important and necessary change and is now a stronger Company. As Smith & Nephew enters its next chapter, the Board is determined to build on this to deliver accelerating growth, improved efficiency and further value for shareholders.”
Enquiries
Investors
Ingeborg Øie
+44 (0) 20 7960 2285
Smith & Nephew
Media
Charles Reynolds
+44 (0) 1923 477314
Smith & Nephew
Ben Atwell / Debbie Scott
+44 (0) 20 3727 1000
FTI Consulting
Forward calendar
The Q3 Trading Report will be released on 3 November 2017.
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.
Lund, Sweden, 08:00 CEST 9 October 2017 – BONESUPPORT™ an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform announces that the first patient has been recruited in a study evaluating CERAMENT® G and CERAMENT® V in patients undergoing hip and knee arthroplasty revisions. Professor Carlo Romanò is the Principal Investigator for the study, which will take place at 6 different clinical centers in Italy and is expected to recruit approximately 135 patients.
The investigator-led study is an open-label, prospective cohort, observational clinical trial designed to evaluate the effectiveness and safety of CERAMENT G or CERAMENT V when used to fill bone defects in the tibia and/or femur shaft and/or acetabulum in patients scheduled for two-stage hip or knee prosthesis re-implantation for periprosthetic joint infections (PJIs).
The results from the study will be compared to a cohort of patients, at the same clinical centers, who were treated using current standard, of care.
The aim of the study is to show an improved clinical outcome and a lower infection rate for the CERAMENT G or CERAMENT V group compared to the retrospective control cohort where neither CERAMENT G or CERAMENT V were used.
One endpoint of the study will be the rate of PJIs according to the Musculoskeletal Infection Society (MSIS) criteria during the one year follow-up.
Professor Carlo Romanò, the study’s Principal Investigator, said: “PJIs remain one of the most feared complications after orthopedic surgery. The ability of microorganisms to adhere to the surface of an implant and to immediately produce a protective biofilm is currently considered as the main challenge in the treatment of implant-related infections. At present, there is no accepted approach for preventing recurring PJIs in patients undergoing revision arthroplasty. We have already conducted a pilot study that showed a beneficial outcome from using CERAMENT G and CERAMENT V in a small series of patients undergoing two-stage knee and hip arthroplasty revisions. The aim of the larger study which we are now conducting is to confirm these promising initial results in a larger cohort of patients and compare the results to a retrospective control.”
Richard Davies, CEO of BONESUPPORT, commented: “The start of this study is a key step in our strategy to build a compelling data set to support the prophylactic use of both CERAMENT G and CERAMENT V in patients undergoing hip and knee arthroplasty revisions. We are confident that CERAMENT G and CERAMENT V’s ability to elute the antibiotics gentamicin and vancomycin respectively, while at the same time, remodeling to bone, will allow them to deliver a reduction in the rate of PJIs in this study.”
BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT®BONE VOID FILLER (BVF), CERAMENT®G and CERAMENT®V are all based on the Company’s novel and proprietary CERAMENT technology platform.
The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.
BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.
The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.
BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com
*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States.
BONESUPPORT™ and CERAMENT® are registered trademarks.
RAYNHAM, Mass., Oct. 5, 2017 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), an established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today that surgeons have completed more than 17,000 total knee replacements worldwide using the OMNIBotics robotic-assisted total knee replacement technology platform. The OMNIBotics system enables optimized implant placement using robotics driven by OMNI’s proprietary ART™ software. Surgeons can efficiently plan a procedure that is specific to each patient using a patented intra-operative 3-D modeling technique that eliminates the need for preoperative CT scans or x-rays. This results in a more precise alignment of the knee implant that many surgeons believe can lead to more rapid recovery and a more natural feeling knee replacement.
In addition to the clinical benefits, the OMNIBotics system provides proven savings per episode of care through a reduced learning curve for the surgeon and O.R. staff as well as a fast case-to-case turnaround and a compact physical footprint which improves efficiency. There is no capital investment cost for the hospital and no annual maintenance or software upgrade fees. This makes the OMNIBotics system a more cost-effective way for healthcare providers to offer robotic-assisted total knee replacement surgery to their patients.
“As one of the first surgeons to adopt OMNIBotics and having performed more than 1500 procedures, this significant milestone validates my experience with the technology,” said Ronald LaButti, DO, FAOAO, orthopedic surgeon with Advanced Orthopedics of Oklahoma and Oklahoma Surgical Hospital in Tulsa, OK. “I am committed to providing orthopedic care that is second to none and find that the precision of the OMNIBotics patient-specific procedure enables my patients to recover more quickly and results in excellent clinical outcomes as well as very satisfied patients.”
Market research estimates that in the next 5 years, more than 20% of total knee replacement procedures will be performed using robotic-assistance. OMNI has anticipated this demand and is focused on designing breakthrough complementary technologies like their recently FDA cleared Active Spacer which, for the first time, provides the surgeon with a quantitative tool to actively manage the tension on ligaments and pressures in the knee joint itself with dynamic real-time feedback.
“OMNI has been at the forefront of robotic-assisted total knee replacement technology since the initial introduction of our first robotic total knee systems in 2010 and passing this 17,000 robotic- assisted TKA procedure milestone shows that we are still going strong,” stated Carl Knobloch, OMNI’s Vice President of Marketing. “We continue to see increased interest in our latest OMNIBotics technology from surgeons, patients and hospitals. With the pending addition to the OMNIBotics platform of our recently FDA cleared Active Spacer robotic soft tissue balancing technology, we expect the rate of adoption and case volumes to increase significantly in the coming year.
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
WATERLOO, ON, Oct. 4, 2017 /PRNewswire/ – Intellijoint Surgical®, a medical technology company, is pleased to announce that it has received the approval of the CE Mark (Conformité Européenne) for its intellijoint HIP® System in Europe. A 3D Mini-Optical Navigation System, intellijoint HIP® provides surgeons with precise measurements for cup position, leg length and offset for Total Hip Arthroplasty (THA). Requiring no pre-operative or intra-operative imaging, the system can be used with any implant manufacturer.
intellijoint HIP, the flagship product by Intellijoint Surgical is available for both an anterior approach as well as lateral and posterior approaches, regardless of incision size. The 3D Mini-Optical tracking by Intellijoint is the only one of its kind and serves as the core technology for THA’s and other orthopedic surgical applications in development.
“The CE mark supports our mission of making the intellijoint HIP technology accessible to every surgeon and every patient,” explained Intellijoint CEO Armen Bakirtzian. “Intellijoint Surgical has developed a global strategy for its product portfolio and our rapid expansion in the US market paired with our versatile business model has prepared us for global scale.”
Intellijoint Surgical plans to enter the European market in 2018 and expects approval for intellijoint HIP from the Australian Therapeutic Goods Administration (TGA) by November 2017. Intellijoint Surgical will be demonstrating the capabilities of the intellijoint HIP System at several orthopedic conferences this year including the American Association of Hip and Knee Surgeons (AAHKS) annual meeting in Dallas, Texas this fall.
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 positioning of orthopaedic implants during Total Hip Arthroplasty. Intellijoint is committed to driving clinical results through the development of solutions that are accessible, fast, and easy-to-use. Intellijoint is setting the new standard in miniature 3D surgical navigation.
Intellijoint Surgical is the recipient of the 2015 North American Frost & Sullivan Enabling Technology Leadership Award and the Futurpreneur Shopify True Grit Award 2016.
