Conformis Announces the first 3D Total Hip Replacement Surgeries performed at JFK Medical Center in Florida

BILLERICA, Mass., Aug. 01, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that offers patient conforming joint replacement implants, today announced completion of the first two Conformis Hip System implants. The Conformis Hip System is the first ever 3D designed primary total hip replacement system. The first surgeries were performed by Gregory Martin, M.D., Joint Fellowship Trained Orthopedic Surgeon and founder of Personalized Orthopedics of the Palm Beaches, and took place at a leading HCA Facility, JFK Medical Center in Atlantis, Florida on July 31, 2018.

“Partnering with our expert surgeon design team and leveraging our extensive experience in automated 3D printing and additive manufacturing enabled us to bring a revolutionary new hip replacement system to market. Our 3D implant design process provides surgeons with interactive input and improves operational efficiencies compared to 2D templating. The design process produces specific individualized pre-navigated cutting guides and implants. A groundbreaking acetabular reaming system has also been developed,” said Mark Augusti, chief executive officer and president of Conformis. “With this launch, we expect to lead the way in innovative solutions for the $7B hip replacement market by providing surgeons with game-changing operative solutions to better serve them and their patients both in hospitals and ambulatory surgical settings.”

Similar to the design process for the Conformis Knee technologies, the Conformis Hip System uses proprietary advanced imaging and design software, to design, manufacture and deliver the suite of FDA-cleared patient conforming Knee and Hip replacement implants. After each patient’s CT scan is converted into a 3-dimensional computer model, the unique measurements of each patient’s anatomy are transformed into a comprehensive, individualized, pre-operative surgical plan that is delivered to the surgeon well in advance of the operation. Surgeons are able to collaborate with Conformis during the planning process in order to design the optimal Hip System for each patient based on surgeon preferences.

“The Conformis Hip System is designed to address many of the short comings of primary hip replacement today. For the first time, orthopedic surgeons have a fully-guided system designed to address the wide variations in anatomy presented across our cases,” said Dr. Martin M.D*, a member of the surgeon design team. “The Conformis system builds upon traditional methods for hip replacement surgery with proven materials and components which, today, are offered in only limited standard configurations. Due to the accuracy of the personalized pre-operative surgical plan, the 3D printed patient conforming cutting guides and hip implant components, my hope is that with the new Conformis Hip system, surgeons will be able to improve both patient outcomes and operational efficiencies.”

Each component of the Conformis Hip System is pre-navigated to fit the patient, with certain components designed specifically for that patient. The Conformis Hip System is delivered directly to the hospital or surgery center in a single patient-labeled kit, eliminating the need for excess inventory. Patient conforming, single-use, 3D printed cutting guides are also included, limiting the need for the vast amount of reusable instruments required for a standard off-the-shelf total hip replacement.

The first two Conformis Hip System surgeries were conducted as part of a limited launch. Timing for a complete commercial launch is expected to be announced in 2019.

The global hip joint reconstruction market is projected at over $7B, and about 400,000 total hip replacements are performed in the United States each year.

*Gregory Martin, MD is a consultant to Conformis, Inc.

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 designed and manufactured to fit and conform to each patient’s unique anatomy. Conformis offers a broad line of patient conforming total and partial knee systems and a hip system that include sterilized single-use instruments delivered in a single package to the hospital. Conformis owns or exclusively in-licenses over 400 issued patents and pending patent applications that cover patient-specific implants and instrumentation for all major joints. In clinical studies, Conformis iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release about our future expectations, plans and prospects, including statements about the anticipated timing of our product launches, and our financial position and results, total revenue, product revenue, gross margin, operations, 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. You should not place undue reliance on our forward-looking statements. Actual results could differ materially from the expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates and expectations regarding our revenue, gross margin, expenses, revenue growth and other results of operations, 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 our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

Media Contact:

Kelly Wakelee

kwakelee@berrypr.com

(212)-253-8241

Investor Contact:

Oksana Bradley

ir@conformis.com

(781) 374-5598

A photo accompanying this announcement is available at: http://www.globenewswire.com/NewsRoom/AttachmentNg/e52cfbc4-fc9b-4c4d-b337-1990354e34a7

The photo is also available via AP PhotoExpress.

Source: Conformis, Inc.

This article appears in: News Headlines

Referenced Stocks: CFMS

 

OrthoPediatrics Announces Expanded Indication for FIREFLY® Pedicle Screw Navigation Guides

WARSAW, Ind., July 31, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, is pleased to announce that FIREFLY® Pedicle Screw Navigation Guides (“FIREFLY”) received additional FDA 510(k) clearance for an expanded indication to include S2AI [screw] trajectory for sacral-iliac fixation in complex spinal reconstruction surgeries, including scoliosis. When applied to the challenging S2AI trajectory, the precise and personalized mechanical guidance enabled by FIREFLY minimizes complexities associated with crossing the sacral-iliac joint while eliminating the need for excessive radiation/fluoroscopy.

OrthoPediatrics is the exclusive distributor of FIREFLY technology in children’s hospitals in the US. FIREFLY is FDA-cleared for use in adult and pediatric populations and is manufactured by Mighty Oak Medical.

The patient-specific, 3D printed FIREFLY Pedicle Screw Navigation Guides are a novel solution to complex and costly navigation systems. This patented navigation technology is designed to increase OR efficiency and eliminate the need for intraoperative radiation, making it the optimal choice in more complicated spinal construct cases, such as those involving the S2AI trajectory.

David Bailey, Executive Vice President of OrthoPediatrics, commented, “We are pleased our partners at Mighty Oak Medical have received additional FDA clearance for this enhancement of the FIREFLY technology. This signifies another pediatric patient segment that surgeons now can treat efficiently and effectively. Ensuring our customers and their patients have access to this novel technology is one more way we continue leading innovation in pediatric orthopedics.”

About Mighty Oak Medical
Mighty Oak Medical is an independent incubator focused on developing and marketing spinal technologies that improve operating room efficiencies, surgical outcomes, and the overall patient experience, by leveraging the talents of experienced surgeons and biomedical engineers. They are located in Englewood, Colorado. For more information, call 720-398-9703 or send an inquiry to info@mightyoakmedical.com.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

The global bone grafts and substitutes market size is expected to reach USD 3.9 billion by 2025

LONDONJuly 31, 2018 /PRNewswire/ — Bone Grafts and Substitutes Market Size, Share & Trends Analysis Report By Material Type (Natural, Synthetic), By Application Type (Spinal Fusion, Craniomaxillofacial, Long Bone), By Region, And Segment Forecasts, 2018 – 2025.

Download the full report: https://www.reportbuyer.com/product/5479697 

The global bone grafts and substitutes market size is expected to reach USD 3.9 billion by 2025, according to a new report by Grand View Research, Inc. The market is expected to register a healthy CAGR of 5.5% during the forecast period. Demand for bone grafts and substitutes is increasing due to adoption of newer technologies and increasing demand for minimally invasive procedures.

Availability of advanced products in varied shapes and sizes providing high osteoconductive and osteoinductive properties is supporting market growth.Moreover, growing adoption of minimally invasive procedures is spurring demand for bone grafts and substitutes.

In minimally invasive procedures, large incisions and damage to muscles surrounding repair area can be significantly avoided.These techniques also reduce the duration of hospital stay and support rapid wound healing with lesser pain and surgical wounds.

Minimally invasive total joint replacement and spine surgeries are some of the newly adopted procedures. Some of the companies in the bone grafts and substitutes market are DePuy Synthes; Medtronic PLC; Nuvasive, Inc.; Orthofix Holdings, Inc.; Wright Medical Group N.V.; AlloSource, Inc.; and Stryker Corp.

Further key findings from the study suggest:

• Increasing number of orthopedic surgeries and rising demand for minimally invasive surgeries are primary factors driving market growth

• By material type, allografts accounted for the largest market share within the natural segment in 2016, mainly due to properties such as immediate structural support and osteoconductivity. Moreover, allografts do not require another surgery to harvest the bone, which results in reduced surgery time and wound healing, thus, attributing toward segment growth

• North America is the leading regional market, followed by Europe. Rising awareness regarding commercially available products, higher healthcare expenditure, and availability of advanced healthcare infrastructure are prime factors responsible for the region’s expansion

• Key players in the market include DePuy Synthes; Medtronic PLC; Nuvasive, Inc.; Orthofix Holdings, Inc.; Wright Medical Group N.V.; AlloSource, Inc.; and Stryker Corp.


Download the full report: https://www.reportbuyer.com/product/5479697 


About Reportbuyer 

Reportbuyer is a leading industry intelligence solution that provides all market research reports from top publishers 

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Research Advisor at Reportbuyer.com 

Email: sarah@reportbuyer.com 

Tel: +1 (718) 213 4904 

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SOURCE ReportBuyer

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CarboFix’s CarboClear®, Carbon Fiber Pedicle Screw System Has Been Cleared to Be Used in the United States by the FDA

HERZELIYA, IsraelJuly 26, 2018 /PRNewswire/ — CarboFix Orthopedics LTD., is pleased to announce that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for the CarboClear® Carbon Fiber Pedicle Screw System, a novel device to surgically treat oncological patients in the United States. The CarboClear Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced-stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear system provides unique clinical advantages to spine cancer patients and their physicians. Among those advantages are: no backscattering, which allows the use of radiation therapy without harming the healthy surrounding tissue, minimal attenuation of External Beam Radiation (EBRT), allowing radiation to pass through the implant with almost zero reduction in the radiation dose level; and no artifact in CT, for optimal radiation CT planning. CarboClear spinal implants also offers superior fatigue strength, beneficial for a patient population known for extended delays in healing.  Additionally, the CarboClear Pedicle Screw System offers enhanced follow up abilities due to minimal CT/MRI artifact.

Dr. Stefano Boriani, head of oncological spine surgery of GSpine4 at the Galeazzi Institute Milano, said of his clinical experience with the CarboClear® system: “This unique material provide us with additional treatment options that we didn’t have in the past, and in our experience provides better clinical outcomes for the treated patients.”

About CarboFix Orthopedics LTD.

CarboFix Orthopedic Ltd, is recognized as the world’s leading company in developing, manufacturing and marketing innovative carbon fiber orthopedic solutions. CarboFix Orthopedics’ headquarters and manufacturing are located in Herzeliya, Israel, with additional manufacturing for the Asia market in Guangzhou, China. CarboFix is working in the United States through its subsidiary CarboFix Inc. and in the rest of the world through a network of distributors. The company’s products are approved by the FDA, CE and other regulatory bodies.

For more information, please visit www.Carbo-fix.com, or reach out directly to 

Ron Szekely

Int’l V.P., Sales & Marketing

Ron@carbo-fix.com

SOURCE CarboFix Orthopedics LTD.

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NuVasive Unveils Spine’s First Integrated Surgical Automation Platform

SAN DIEGOJuly 27, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Pulse™ surgical automation platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Pulse is the foundation for Surgical Intelligence™, the Company’s ecosystem enabling better surgery. Pulse introduces 2D- and 3D-navigation and smart imaging capabilities while integrating the Company’s leading neuromonitoring, surgical planning, radiation reduction and patient-specific rod bending technologies. This single platform addresses a broad range of clinical challenges, with enhanced utility and intuitive workflow. The fusion of these technologies supports reproducible spine surgery at facilities ranging from major health systems to ambulatory surgery centers.

“Pulse seamlessly integrates multiple intraoperative technologies through an intuitive guided surgical workflow within a single device and footprint in the operating room,” said Dr. Stephen Ryu, neurosurgeon at the Palo Alto Medical Foundation in Palo Alto, Calif. “Unlike other newer surgical technologies, Pulse enhances the surgeon’s ability and can positively affect outcomes by providing a modular platform of useful intraoperative tools that do not disrupt familiar workflow. Additionally, Pulse provides enhanced support throughout each case be it a simple decompression all the way to complex deformity cases.”

Pulse’s FDA clearance marks a major milestone in the Company’s commitment to introduce 2D- and 3D-navigation technology built on a platform of the Company’s NVM5® nerve monitoring systemLessRay®Bendini® and Integrated Global Alignment® (iGA®) systems. The Pulse platform provides an intuitive surgeon experience by anticipating user needs and fusing these technologies to create a seamless, optimized workflow for operating rooms (OR). Through Wi-Fi connectivity and independent device access, case participants can simultaneously view the technologies’ imaging and insights in real time, allowing them to utilize various modules in parallel and further drive OR efficiencies.

“With Pulse, our strategy is to integrate technology to ultimately drive better spinal procedures and meet the unique needs of each OR through customized applications,” said Matt Link, executive vice president of strategy, technology and corporate development at NuVasive. “Through the aggregation of clinical data and intelligent design, Pulse intuitively delivers the necessary technological intervention to drive improvements in procedural workflow and support the clinical needs for each OR, surgeon and case.”

To help surgeons overcome frequent visualization challenges during spine surgery, Pulse integrates multiple high-resolution cameras combined with low-profile, 360-degree arrays to drive uninterrupted line-of-sight and optimized procedural workflow. Additionally, Pulse introduces advanced artificial intelligence (AI) by automating several technologies utilized throughout a procedure.

NuVasive will showcase the Pulse platform at the North American Spine Society 2018 Annual Meeting held September 26-29, 2018 in Los Angeles, Calif.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

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DePuy Synthes Launches CONCORDE LIFT Expandable Interbody Implant as Part of a New Procedural Solution for Minimally Invasive Spine Surgery (MIS)

RAYNHAM, Mass.July 26, 2018 /PRNewswire/ — Johnson & Johnson Medical Devices Companies* today announced that DePuy Synthes** is launching the CONCORDE LIFT Expandable Interbody Device in the U.S. The CONCORDE LIFT Implant is designed to treat patients suffering from degenerative disc disease as part of the new offering called UNLEASH MIS TLIF (Transforaminal Lumbar Interbody Fusion) Procedural Solution. The complete system includes a comprehensive set of solutions to help simplify key stages of this surgery by enhancing surgical efficiency.

During spinal fusion surgery, the degenerated disc is removed and the CONCORDE LIFT Expandable Interbody Device is implanted in its place to help restore the disc height between the two vertebrae in the spine.

“I’ve had the privilege of performing one of the first cases of spinal fusion surgery using the CONCORDE LIFT Implant in the United States and have been very happy with what I have been able to achieve using this device,” said John Hall, M.D., Spine and Orthopaedic Trauma Surgeon***. “I believe that being able to access the disc through a small space and then controllably expanding the cage to fill the disc space allowed me to achieve a reliable fusion.”

By 2020, it is estimated that half of all spinal fusion procedures will be performed using a minimally invasive approach.1While it has a steep learning curve, minimally invasive spine surgery has been associated with reducing complications, blood loss, muscular damage and pain, with a faster recovery for patients compared to conventional open spine surgery.2,3

This MIS TLIF Procedural Solution was developed by DePuy Synthes Spine to simplify key stages of the MIS TLIF surgery and additionally includes the CONCORDE Clear MIS Discectomy Device and the VIPER PRIME System for percutaneous pedicle screw insertion.  Here are the steps involved in the procedure:

  • The single-use CONCORDE Clear MIS Discectomy Device allows the degenerated disc-clearing process to occur with fewer instrument passes while increasing the amount of disc material removed compared to standard discectomy tools.4
  • The CONCORDE LIFT Expandable Interbody Device is inserted once the disc has been cleared. With this implant, the surgeon can expand the cage to specifically fit the cage to an individual patient’s anatomy without being confined to pre-set intervals. The streamlined instrumentation provides tactile feedback during the expansion maneuver and the system offers surgeons the option to back-fill the space with bone graft even after the cage has been fully expanded.
  • The VIPER PRIME System, aimed at efficiency, combines multiple instruments into one screw inserter tool enabling the surgeon to perform percutaneous pedicle screw insertion in a single instrument pass.

This new offering exemplifies the company’s commitment to innovative platforms that are designed to reduce surgical complexity, improve patient outcomes and decrease costs. In an anatomic lab study, this MIS TLIF Solution suggested a potential reduction in instrument passes and showed a reduction in procedure time during disc removal, cage implantation and screw placement compared to a control group of current product offerings****. Based on the early indications of this promising cadaveric study, DePuy Synthes is investing in a health economic study in addition to a clinical study to evaluate the potential benefits of the UNLEASH MIS TLIF Procedural Solution as compared to traditional MIS TLIF procedures.

“This UNLEASH Solution delivers a new offering to help reduce the complexity associated with minimally invasive spine surgery while reducing costs and OR footprint,” said Nadav Tomer, Worldwide President, DePuy Synthes Spine. “DePuy Synthes is committed to innovating the tools and technology required to serve more patients globally in a range of care settings by delivering disruptive procedural solutions that improve outcomes supported by real world clinical and economic evidence.”

About the Johnson & Johnson Medical Devices Companies

As the world’s most comprehensive medical devices business, we are building on a century of experience, leveraging science and technology, to shape the future of healthcare. With unparalleled breadth, depth and reach in surgery, orthopaedics and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. Learn more about our latest innovations by visiting: https://www.jnjmedicaldevices.com.

About DePuy Synthes 

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

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

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

***Consultant to DePuy Synthes Spine

****Comparing CONCORDE Clear MIS Discectomy Tool to traditional discectomy tools, CONCORDE LIFT Expandable Interbody Device to the CONCORDE Bullet Lumbar Interbody System, and VIPER PRIME System to the VIPER 2 MIS Spine System. Results based on non-clinical study (n=3). Cadaveric test results may not necessarily be indicative of clinical performance.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding CONCORDE LIFT Expandable Interbody Implant as part of a new procedural solution for minimally invasive spine surgery that enhances surgical efficiency. 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, Inc., any of the other Johnson & Johnson Medical Devices Companies 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; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes, Inc., any of the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

©DePuy Synthes 2018. All rights reserved. 

095402-180719

1 Huang, Tsung-Jen. The State of the Art in Minimally Invasive Spine Surgery. Biomed Res Int. 2017. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5350391/.

2 Peng, CW et al. Clinical and radiological outcomes of minimally invasive versus open transforaminal lumbar interbody fusion. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1385-9.

3  Phan, K et al. Minimally invasive versus open transforaminal lumbar interbody fusion for treatment of degenerative lumbar disease: systematic review and meta analysis. Eur Spine J 24:1017-1030. 2015.

4 Lavelle, W et al. An In Vitro Study Examining a Novel Suction Curette Device for Lumbar Discectomy Compared with Standard Manual Discectomy. J Neurosurg Spine 26:454-458. 2017.

SOURCE DePuy Synthes

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JOURNEY™ II BCS Knee System demonstrates improved patient outcomes and lower healthcare costs

LONDONJuly 25, 2018 /PRNewswire/ — Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, announced positive clinical results concerning its JOURNEY™ II Bi-Cruciate Stabilized (BCS) knees. These results suggest JOURNEY II BCS is associated with significant healthcare economic benefits in patients implanted with this device compared to other knee systems.

In a retrospective cohort study from the Premier Perspective Database1, JOURNEY II BCS patients exhibited lower mean hospital stays and overall reduced mean costs when compared to other knee patients.  When comparing 1,692 JOURNEY II BCS patients to the same number of other comparable knee patients, data revealed JOURNEY II BCS patients were:

  • 51% less likely to be readmitted to the hospital within 30 days;
  • 35% more likely to be discharged to their home; and
  • 41% less likely to be discharged to a skilled nursing facility for further care.

The results also showed patients with JOURNEY II BCS experienced statistically significantly reduced length of stay and reduced hospital costs, equivalent to approximately 10% in savings to the overall procedure cost ($16,187 vs. $17,877).

Andy Weymann MD, Chief Medical Officer of Smith & Nephew, commented: “To have a knee system that improves patient outcomes while reducing healthcare costs is a tremendous feat for Smith & Nephew.  When we introduced the JOURNEY II Knee System, we wanted to build upon our 150+ years of supporting healthcare professionals and patients in a way that addressed the market where patient outcome measures go beyond implant survivorship.  We know hospitals and healthcare professionals have a wide choice in knee implants and this new retrospective analysis supports our view that JOURNEY II BCS is the leading knee platform available in today’s market.”

The Premier Perspective Database study is not the only recent evidence reporting improved patient outcomes with the JOURNEY II BCS Knee System. In another multi-center study published in Techniques in Orthopaedics, JOURNEY II BCS patients demonstrated a smoother recovery, improved function and increased patient satisfaction.2-6 Specifically, study patients implanted with JOURNEY II BCS had 23 degrees more flexion than patients implanted with another comparable knee system along with significantly improved mean knee society scores (89 vs 81; p<0.001) at 1 year follow-up.2

“Every knee product we manufacture is designed to improve patient outcomes while decreasing hospital costs. It is rewarding to see JOURNEY II BCS patients demonstrating a smoother recovery1-2 and higher patient satisfaction than what we have seen in the past. These outcomes illustrate the value that Smith & Nephew constantly strives to provide to our healthcare system,” Brad Cannon, Chief Marketing Officer.

The JOURNEY II BCS is a member of the JOURNEY II Total Knee Arthroplasty (TKA) system, which also includes JOURNEY II Cruciate Retaining (CR) and the recently launched bi-cruciate retaining JOURNEY II XR.

About Smith & Nephew 

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic ReconstructionAdvanced Wound ManagementSports Medicine and Trauma & Extremities, Smith & Nephew has around 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 FTSE100 (LSE:SN, NYSE:SNN).

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

Forward-looking Statements 

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.

™Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.

  1. Mayman DJ, Patel AR, Carroll KM. Hospital Related Clinical and Economic Outcomes of a Bicruciate Knee System in Total Knee Arthroplasty Patients.Poster presented at: ISPOR Symposium; May 19-23, 2018Baltimore, Maryland, USA.
  2. Nodzo, SR; Carroll KM, Mayman DJ. The Bicruciate Substituting Knee Design and Initial Experience. Tech Orthop. 2018;33:37-41.
  3. Scott CE, Howie CR, MacDonald D, Biant LC; Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9)
  4. J Orthop. 2017 Jan 7;14(1):201-206. doi: 10.1016/j.jor.2016.12.005. eCollection 2017. Bi-cruciate substituting total knee arthroplasty improved medio-lateral instability in mid-flexion range
  5. In Vivo Kinematic Comparison of a Bicruciate Stabilized Total Knee Arthroplasty and the Normal Knee Using Fluoroscopy Trevor F. Grieco, MS a, *, Adrija Sharma, PhD a, Garett M. Dessinger, BS a, Harold E. Cates, MD b, Richard D. Komistek, PhD. The Journal of Arthroplasty, September 2017
  6. A comparison of Rolback Ratio between Bicruciate Substituting Total Knee Arthroplasty and Oxford Unicompartmental Knee Arthroplasty. DOI: 10.1055/s-0037-1604445. ISSN 1538-8506. The Journal of Knee Surgery. Takanori Iriuchishima, Keinosuke Ryu

SOURCE Smith & Nephew

Related Links

http://www.smith-nephew.com

Bioventus Enters Into Definitive Agreement to Divest BMP Development Program to Viscogliosi Brothers, LLC

July 23, 2018

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, has entered into a definitive agreement to divest its next generation bone morphogenetic protein (BMP) development program to a new company formed by Viscogliosi Brothers, LLC (VB), a private equity investment firm focused on developing innovative neuromusculoskeletal technologies.

Bioventus acquired the exclusive, worldwide license to the BMP portfolio of development programs and associated intellectual property from Pfizer, Inc., in 2013. The portfolio, which will now be sold to VB, includes the next-generation BMP in development, as well as a BMP program for soft tissue indications.

The transaction is expected to close in late Q3 and is conditional on VB having raised the requisite funds to complete the sale. When completed, Bioventus will receive an equity stake in the new company formed by Viscogliosi Brothers that will work on the BMP program. In addition, Bioventus will have an observational board seat to follow the progress being made as the work continues. The parties have agreed not to disclose the sale price.

“Divesting the BMP program gives us the opportunity to increase the R&D investment in other areas of our portfolio to support additional short and mid-term programs, while maintaining a stake in its development,” said Tony Bihl, CEO of Bioventus. “We now expect to leverage resources to make additional investments that will expand and grow our portfolio in osteoarthritis, surgical and non-surgical bone healing.”

“Stimulating the body to heal itself is the future of healthcare.” said Anthony G. Viscogliosi, Principal of Viscogliosi Brothers, LLC. “Viscogliosi Brothers has formed a new company to actualize this future by acquiring the next generation BMP development program of Bioventus. Through this acquisition, we are fortunate for Bioventus’ effort to enable us to take the next steps of initiating a clinical program to further evaluate the BMP technology to do safer, faster, and better healing for spine fusion.”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus and the Bioventus logo, are registered trademarks of Bioventus LLC

About Viscogliosi Brothers, LLC

Established by Marc R. Viscogliosi, John J. Viscogliosi and Anthony G. Viscogliosi in New York City, in 1999, Viscogliosi Brothers, LLC (VB), is a family office holding company specializing in venture capital, private equity and merchant banking in the neuro-musculoskeletal/orthopedic industry.

VB’s vision is dedicated to improving healthcare and the quality of life for humanity by finding innovative orthopedic concepts and supporting them to become sustainable technologies that can be commercialized globally to lead the evolution in orthopedic standards of care.

To accomplish this vision, VB discovers technologies, creates products and develops, builds, operates and finances companies founded on innovative and “life changing” technologies. VB principals have participated in more than 300 transactions, have invested in more than 20 companies and have formed more than ten funds.

Companies and funds that VB participated in have generated more than $1.5 billion in exit proceeds for investors through 14 exits in the last 18 years. Through its portfolio companies VB has defined 7 new orthopedic industry categories and its investments have helped commercialize more than 75 medtech devices, including eleven number one orthopedic technologies in seven market leading businesses.

VB orthopedic portfolio companies’ products have been implanted in nearly 300,000 people in more than 70 countries globally.

For additional information, please contact:

Anthony G. Viscogliosi, Principal
Email: aviscogliosi@vbllc.com
Website: www.vbllc.com

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities. The securities have not been registered under the Securities Act of 1933 (the “Act”) and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. This press release is being issued pursuant to and in accordance with Rule 135c under the Act.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

Nuvasive Launches MAGEC X For Early Onset Scoliosis Treatment

SAN DIEGOJuly 19, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the U.S. launch of MAGEC X, a new procedural solution within the MAGEC product family that addresses Early Onset Scoliosis (EOS).

MAGEC X features updates across all rod diameters in the portfolio, including 5.0mm diameter rods for patients, delivering a 68 percent performance increase over the previous generation in titanium rod fatigue testing. When paired with the NuVasive Reline® Small Stature system, the first pediatric deformity fixation solution to integrate both 4.5mm and 5.0mm rods in a low-profile tulip, MAGEC X provides increased construct strength without sacrificing the optimal profile for EOS patients.

“NuVasive’s MAGEC X 5.0mm solution is unique because it allows you to upsize your rod with low-profile screws, giving you the flexibility at the time of surgery to use a larger rod without having to change your screws – that’s really key,” said Dr. Peter Sturm, Alvin H. Crawford Chair of Spine Surgery, Cincinnati Children’s Hospital Medical Center. “Further, the upgrade of the internal components in MAGEC X rods gives me even more confidence in the performance of a system that has radically changed how we treat this challenging patient population.”

The development of MAGEC X is also distinguished by a number of internal rod mechanism advancements, most notably a reinforced locking pin and a robust actuator seal designed to further contain and reduce the release of titanium wear debris. Additionally, it includes an anti-jam feature to simplify intraoperative and postoperative rod lengthening. Key aesthetic improvements, such as laser-marked sagittal bending lines, help to enhance surgeon workflow efficiency and ease of use.

“More than 100,000 children are diagnosed with scoliosis each year in the United States; the launch of MAGEC X exemplifies our continued dedication to the advancement of EOS treatment and support of the pediatric surgeon community,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “MAGEC X represents the culmination of over a decade of clinical experience and innovation, resulting in a stronger and smarter MAGEC implant design.”

This full commercial launch of MAGEC X follows the Company’s preview announcement, which occurred at the POSNA Annual Meeting in May in Austin, Texas.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

Zavation Announces 510(k) Clearance of the Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage)

FLOWOOD, Miss.July 17, 2018 /PRNewswire/ — Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, announced today that it has received 510(k) clearance from the FDA to market Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage).

For More Information on Zavation’s Complete Product Portfolio, Visit: http://zavation.com/.

The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy.  The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients.  The device can be adjusted to the required height after implantation. The device is mechanically locked at the required height by means of a locking screw. Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.

The Normandy VBR System is indicated for use in the cervical spine (C2-C7) and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Normandy VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.

The Normandy VBR System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation.

Jeffrey Johnson (Zavation CEO) stated, “Our research and development team has hit a home run with this new expandable corpectomy device.  Not only is it one of the first expandable corpectomy devices cleared for cervical use; but the ease of insertion, ease of expansion, and large graft area sets a new industry standard!”

Zavation will showcase the Normandy VBR Corpectomy Cage System at the North American Spine Society (NASS) in Los Angeles, CA September 26-29, 2018.

About Zavation Medical Products, LLC– Based in Flowood, MS, Zavation designs, engineers, and manufactures a portfolio of spinal hardware covering key areas including thoracolumbar, cervical, interbody fusion, and minimally invasive surgery.

SOURCE Zavation

Related Links

http://zavation.com