OMNIlife science™, Inc. Announces 10th Anniversary of APEX Knee™ System

RAYNHAM, Mass., Dec. 12, 2016 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), an established medical technology company targeting the rapidly growing $15 billion global hip and knee replacement medical device sector, today announced the tenth anniversary of the launch of their APEX Knee™ System. Since 2006, the APEX Knee has been used in more than 75,000 total knee replacement procedures worldwide.

Ten years is a significant milestone in the lifetime of orthopedic implants because the results at ten years can generally be used to extrapolate the long term survivorship of the implant. Any device or design-related issues should have become apparent by this time, so device failures would likely be due to wear of the polyethylene components. This is not an issue for the APEX Knee polyethylene because it is EtO sterilized and it has more than 30 years of proven success in other medical devices. According to the latest Australian Registry statistics, the APEX Knee has a survivorship of 99.5%, better than any of its competitors. *

“Our knee implant design philosophy is that the device should allow the patient’s knee kinematics to be dominated by their individual anatomy, not by the implant; that the polyethylene should never see ionizing radiation, and that the instruments should be simple and easy to use,” said George Cipolletti, OMNI co-founder and Chief Technology Officer. “I am really proud that we have accomplished our goal: happy surgeons with happy patients!”

OMNI worked closely with two physicians, Warren Low**, M.D. and Thomas Tkach**, M.D., both at McBride Orthopedic Hospital in Oklahoma City, Oklahoma, to design the APEX Knee. As the first surgeons to implant the knee, they are pleased with its success. “I think the APEX Knee is an excellent implant in terms of sizing, fit, and kinematics as well as in instrumentation,” said Dr. Low. “The APEX Knee has stood the test of time and surgeons are using it in increasing numbers, so they and their patients are demonstrating its efficacy.”

Dr. Tkach commented, “When we started the APEX Knee project with OMNI 10 years ago our goal was simple. To take the experience of the design team accumulated over many years in the OR and in the orthopaedic industry and design a ‘no compromise’ completely new total knee replacement system. I believe we achieved our goal and both my personal clinical experience, as well as that reported from surgeons around the world, indicate that we have created a world class product that remains state of the art in design and performance 10 years after its first implantation. I look forward to seeing what the next 10 years will bring as we continue to improve the implants and instruments that make the APEX Knee System work so well in the hands of so many different surgeons in so many different countries.”

In addition to their hip and knee implants, OMNI has developed OMNIBotics®, an innovative technology platform for robotic-assisted total knee replacement and computer-assisted total hip replacement, enabling a customized procedure for each patient. OMNIBotics is the leading robotic- assisted total knee replacement technology available, with more than 10,000 OMNIBotics procedures performed worldwide.

“The APEX Knee is the foundation of OMNI,” said Rick Randall, CEO. “We have a five year history of combining this outstanding and proven implant with our OMNIBotics technology, resulting in a procedure that goes beyond traditional total knee replacement surgery. It is designed to enable rapid patient recovery through improved implant alignment and kinematic function. We believe it is transformational in its precision and patient benefits.”

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 improve patient care. 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 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

*Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide: AOA; 2016

**Both Warren Low and Thomas Tkach have product development agreements with OMNIlife science, Inc.

SOURCE OMNIlife science, Inc.

SHOULDER INNOVATIONS LAUNCHES SIMPLE, INNOVATIVE TOTAL SHOULDER REPLACEMENT SYSTEM

HOLLAND, Mich., Dec. 12, 2016 (GLOBE NEWSWIRE) — Shoulder Innovations, an emerging developer of shoulder replacement systems, today announced the commercial release of its total shoulder replacement system. The Shoulder Innovations Total Shoulder System includes patented inset glenoid technology, originally innovated by Stephen Gunther, M.D. Since the system’s first availability, it has been implanted in dozens of patients, and is approved in more than ten hospital systems.

In the US alone, more than 100,000 patients receive shoulder replacement surgery each year, and the demand for the procedure is growing nearly 10 percent every year. Despite increasing demand, driven by expansion of the patient population and higher rates of activity, today’s shoulder replacement technologies continue to fall short of surgeon and patient expectations. Some patient populations are experiencing implant loosening rates as high as 20 percent at five years, and revision rates as high as 50 percent at 10 years, which drives patient dissatisfaction and higher health care costs.

Published results in the Journal of Shoulder and Elbow Surgery show improved implant stability of the Shoulder Innovations inset glenoid, demonstrating an 87 percent reduction in implant micro-motion as compared to conventional glenoid design. Furthermore, the Shoulder Innovations System simplifies shoulder replacement technology in order to improve patient outcomes.

“With the existing shoulder replacement technologies available, deficiency of the bone limits the size and options of replacement devices. This results in unreliable fixation of the glenoid implant, further damaging a patient’s bone structure, which causes glenoid failure and subsequent revision surgery,” said Stephen Gunther, MD, clinical lead of the Shoulder Innovations team.”Our published results show Shoulder Innovations’ new inset glenoid solution provides greater post-surgical implant stability, addressing the leading cause of revision surgery.”

Led by Dr. Gunther, the Shoulder Innovations clinical team designed a revolutionary surgical technique to address these issues. By countersinking the glenoid implant into the scapula, glenoid stability is enhanced providing a solution targeted directly at the leading cause of implant failure. Furthermore, the team has leveraged the elegant simplicity of the technology to create the simplest possible surgical approach, eliminating operative steps, reducing risk, and thereby delivering overall lower cost and operative times.

“We maximized the potential benefits of the inset technology by working with world class surgeons to create a simple, yet robust shoulder replacement system. The inset glenoid surgery requires fewer steps and allows reduced exposure to the glenoid vault,” said Matt Ahearn, president and COO of Shoulder Innovations. “All instrumentation of the Shoulder Innovations’ glenoid and humeral system is delivered in one case, which means less storage, handling, cleaning, and sterilization, resulting in fewer costs, while increasing back table efficiency.”

Additional results published in the Journal of Shoulder and Elbow Surgery show that near-term results of patients treated with severe glenoid bone loss, with minimum of three, and an average of 4.3 year follow-up, have found documented excellent radiographic and functional results using the inset glenoid implant. Separate studies showed a statistically significant increase in range of motion, reduction in pain and high patient satisfaction.

The inset glenoid design offers a number of key advantages to the current on-lay designs. Since loosening of the glenoid component has been a continued reason for shoulder replacement failure, this new inset design offers a strategic advantage over classic glenoid replacement implants. The strong, circumferential, cortical support of the implant around the perimeter shields the implant from rocking horse loosening forces during daily shoulder motion activities. The flat back design, pegs, and cement channels also potentiate the increased fixation strength that decreases the risk of implant loosening.

Additional details on Shoulder Innovations and its Total Shoulder Replacement System are available at shoulderinnovations.com.

About Shoulder Innovations
Shoulder Innovations, LLC is a medical device development company which designs and commercializes innovative products which demonstrate the potential for improved patient care and reduced overall cost to the healthcare system. Leveraging its breakthrough, patented, inset glenoid design, Shoulder Innovations is commercializing a shoulder replacement implant focused on improving outcomes related to the greatest cause of shoulder replacement failure, glenoid loosening. The inset technology reduces micro-motion by up to 87 percent, reducing inflammation and complications. Shoulder Innovations is based in Holland, Mich. Additional information is available at shoulderinnovations.com.

A photo accompanying this release is available at:
http://www.globenewswire.com/newsroom/prs/?pkgid=41982

Brian Burch
(616) 828-9813

KYOCERA Medical Corporation Receives FDA 510(k) Clearance for Initia® Total Hip System, Featuring BIOCERAM AZUL® Ceramic Femoral Head

December 05, 2016

SAN DIEGO–(BUSINESS WIRE)–Kyocera Medical Corporation, a leading manufacturer of implantable systems and advanced ceramic components, today announced it has received the U.S. Food and Drug Administration’s 510(k) clearance for its Initia® Total Hip System.

Developed in collaboration with leading U.S. surgeons, the Initia Total Hip System features Kyocera Medical Corporation’s core technologies — including its own BIOCERAM AZUL® (blue) zirconia-toughened alumina (ZTA) ceramic femoral heads. Initia is also available with cobalt chrome (CoCr) femoral heads, giving surgeons the option of ceramic or metal heads matched to highly cross-linked polyethylene acetabular liners. Designed for a global patient population, the Initia system includes a total of 16 tapered-wedge stem sizes, 12 of which are available in the U.S., with both standard and high femoral offsets.

Kyocera has manufactured artificial hips, knees and other implantable systems since 1982, and is now one of Japan’s leading suppliers of surgical orthopedic products. Kyocera also manufactures a wide range of implantable ceramic components, including alumina and ZTA ceramic femoral heads, hip liners and shoulder liners, available to original equipment manufacturers (OEMs) in the U.S. and Europe.

In addition to the Initia Total Hip System, Kyocera Medical Corporation’s BIOCERAM AZUL ceramic material is available to medical device OEMs who demand a durable, high-quality, biocompatible solution for implantable components.

The Initia Hip System, along with BIOCERAM AZUL components, will be the highlight of Kyocera Medical Corporation’s technology presentation at the AAOS Annual Meeting, March 15-17, 2017 – booth #4908.

ABOUT KYOCERA

Kyocera International, Inc., headquartered in San Diego, California, serves as the U.S. sales and marketing arm for Kyocera Medical Corporation. Both companies are wholly-owned subsidiaries of Kyoto, Japan-based Kyocera Corporation.

Kyocera Medical Corporation, headquartered in Osaka, Japan, is a producer of ceramic and metal orthopedic systems and components, dental systems and components, and cardiovascular devices.

Kyocera Corporation (NYSE:KYO) (TOKYO: 6971), the parent and global headquarters of the Kyocera Group, was founded in 1959 as a producer of fine ceramics (also known as “advanced ceramics”). Kyocera specializes in combining these engineered materials with other technologies to create medical orthopedic implants and implantable ceramic components, ceramic cutlery and cookware, cutting tools, industrial components, electronic devices, semiconductor packages, solar power generating systems, printers, copiers and mobile phones. During the year ended March 31, 2016, Kyocera Corporation’s consolidated net sales totaled $13.1 billion.

© 2016 KYOCERA Corporation. All rights reserved. Kyocera is a registered trademark of Kyocera Corporation. Initia and BIOCERAM AZUL are registered trademarks of Kyocera Medical Corporation. All other marks are properties of their respective owners.

Photos available by request.

Contacts

Kyocera Medical Corporation
Ken Kaneko, (908) 227-4376
Ken.Kaneko@kyocera.com

Bones from hip replacement transplants give new life

READ THE REST HERE

New Study to Evaluate Virtual Rehabilitation Platform for Physical Therapy after Total Knee Replacement Surgery

November 29, 2016 – SAN DIEGO–(BUSINESS WIRE)–

Reflexion Health, Inc., a digital healthcare company, in conjunction with the Duke Clinical Research Institute (DCRI) announced the enrollment of the first patients in Virtual Exercise Rehabilitation In-home Therapy: A Research Study (VERITAS), which is designed to evaluate the cost and outcomes of using a virtual rehabilitation platform to deliver physical therapy following total knee replacement (TKR) surgery.

According to the Centers for Disease Control and Prevention, 700,000 total knee replacements are performed each year in the United States. TKR is the most frequently performed procedure in the hospital and is more common among women than men.1 The average Medicare expenditure for surgery, hospitalization, and recovery ranges from $16,500 to $33,000 across geographic areas.2 With a significant growth in TKR among younger adults with knee osteoporosis3, an aging population working longer, and a shift to value-based care, the demand for TKR surgery is expected to exceed three million by the year 2030 while at the same time, healthcare systems will continue to optimize costs.

“Physical therapy is often a critical component of care for patients who have TKR surgery. Digital health technology, including virtual and telehealth options, may increase access, improve quality, and lower healthcare costs,” said Janet Prvu Bettger, ScD, associate professor with the Duke Department of Orthopaedic Surgery and principal investigator for the study at the DCRI. “Extending the reach of physical therapists into the home using a digital healthcare platform like VERA can provide remote guidance and supervision for a home-based therapy program; however, implementation in the U.S. has not been widely evaluated until now.”

VERITAS is a multi-center, randomized controlled trial and will enroll approximately 300 adult participants scheduled for TKR surgery at six U.S. sites. The treatment group will include 150 adults who will receive Reflexion Health’s proprietary virtual exercise rehabilitation assistant, VERA™, both pre- and post-surgery, compared with a control group of 150 adults who will receive traditional in-home or clinic-based physical therapy at participating sites. Clinical outcomes, health service use, and costs will be examined for three months after surgery.

“With VERITAS, we are eager to confirm what we’ve already demonstrated with hospitals and clinicians in pilot studies — VERA is a cost-effective, scalable, and effective option for improving compliance and recovery in home-based physical therapy following total knee replacement surgery,” said Joseph (Joe) Smith, MD, PhD, President and CEO of Reflexion Health. “VERA embodies our commitment to delivering solutions that improve the patient experience by saving time, travel and costs for both patients and healthcare systems.”

About the Duke Clinical Research Institute

The Duke Clinical Research Institute (DCRI), part of the Duke University School of Medicine, is the largest academic research organization in the world. Its mission is to develop and share knowledge that improves the care of patients through innovative clinical research. The DCRI conducts groundbreaking multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making more than 40 years after its founding.

About Reflexion Health, Inc.

Reflexion Health is a digital healthcare company dedicated to transforming traditional medicine and improving clinical outcomes by using innovative technology solutions to deliver patient-centered care at reduced costs. VERA™, Reflexion Health’s signature solution, is an FDA-cleared Virtual Exercise Rehabilitation Assistant that detects motion and remotely monitors the effectiveness of prescribed physical therapy in real-time. VERA brings the guidance of a physical therapist into the home to coach and motivate patients through recovery from joint replacement surgery or as a preventative therapy to reduce falls. For more information, visit www.reflexionhealth.com and follow us at @ReflexionHealth.

New UK joint registry data confirms positive early results for the DePuy Synthes ATTUNE® Knee System

WARSAW, Ind., Nov. 29, 2016 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Family of Companies, today announced new clinical evidence of the positive performance of the ATTUNE® Knee System. The data shows the importance of evidence generation to monitor both the outcomes and economic benefits of new technology. New research from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR), which tracks and reports on the survivorship of implants, shows results for the performance of the ATTUNE Knee that compare favorably to the class of cemented total knee systems.2 In addition, an analysis of a large U.S. hospital administrative database indicates that ATTUNE Knee patients had 39% lower adjusted odds of discharge to a skilled nursing facility versus patients who received a total knee replacement with a leading competitive knee system.1

Per the 2016 NJR, the ATTUNE Knee estimated cumulative percent revision was 1.39% at 3 years (98.61% survivorship) for 4,463 knees, comparing favorably to the class of Cemented Total Knee Arthroplasty (TKA) that has an estimated cumulative percent revision of 1.50%.

“In addition to survivorship and functional performance, recovery is also being studied. One short term study demonstrated improved patient outcomes as compared to another leading knee system, including less pain, better motion, and increased function.3 Another study showed shorter hospital length of stay, which has important implications for the care trajectory and costs”,1 said Dr. David Fisher**, an orthopaedic surgeon at Ortho Indy in Indianapolis, IN.

The ATTUNE Knee System evidence generation program is the largest in DePuy Synthes’ history with multiple streams of ongoing data collection, both company and investigator initiated.  Studies observe all four constructs in terms of survivorship, patient reported outcomes measures (PROMS), learning curve, and fluoroscopic kinematics studies. Radiostereometric Analysis (RSA) of implant micromotion is also being studied since it has been shown to be predictive of longer term survivorship. Together, these PROMS, kinematics, RSA studies, and survivorship data from national joint registries outside of the US provide a database of clinical performance of the ATTUNE Knee System.

Additional positive, interim results for the ATTUNE Knee were shared in three separate congress presentations at the recent International Society for Technology in Arthroplasty (ISTA) meeting in October 2016.  One reported improved patient reported outcome measures compared to other leading knee systems.4 The second showed reduced incidence of symptomatic patellofemoral crepitus.5The third presentation demonstrated patellofemoral biomechanics that emulated the functionality of a normal knee.

Advancements in TKA surgery systems, such as the ATTUNE Knee, not only benefit patients, but the healthcare system as a whole because patients are able to leave the hospital sooner and return to normal activity.  A 2013 study published in The Journal of Bone and Joint Surgery found that societal savings, such as decreased disability costs, return to independent living, and increased work productivity, far exceeded direct costs [of TKA surgery].

Global thought-leader surgeons, engineers, and experts in fields of study such as kinematics, anthropometrics, polyethylene wear and design collaborated to design and test the ATTUNE Knee System. Extensive research and science has gone into the design to help improve functional outcomes for patients, performance for surgeons, and efficiency for providers.

About DePuy Synthes
DePuy Synthes, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, neurological, 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.

*DePuy Synthes represents the products and services of DePuy Orthopaedics, Inc. and its subsidiaries.
**Dr. David Fisher is a paid consultant for DePuy Synthes Companies.

References:
1Etter, K., Lerner, J., de Moor, C, Yoo, A., Kalsekar, I. (2016). PMD10-Comparative Effectiveness of ATTUNE® Versus Triathlon™ Total Knee Systems: Real-World Length of Stay and Discharge Status.” Value in Health 19(3): A298. Premier Perspective™ Database analysis including 38 hospitals, representing 1,178 primary, unilateral TKAs with the ATTUNE Knee and 5,707 primary, unilateral TKAs with Triathlon™. The analysis found that the patients implanted with the ATTUNE Knee had statistically shorter length of stay and were more frequently discharged home vs. a skilled nursing facility compared to the TKAs with Triathlon™.
213th Annual Report 2016: National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, Surgical Data to 31 December 2015, table 3.28.
3Clatworthy, M. (2015). An Early Outcome Study of the ATTUNE Knee System vs. the SIGMA® CR150 Knee System. DePuy Synthes Companies White Paper. DSUS/JRC/0814/0418. In an IRB approved early outcomes study, physiotherapists collected data on 40 patients implanted with ATTUNE Knees and 40 patients with SIGMA CR150 knees. The results demonstrated that patients implanted with the ATTUNE Knee had statistically significant improvements in some early outcomes, other outcomes demonstrated a trend favoring the ATTUNE Knee, and some outcomes were equivalent.
4Hamilton, W., Himden, S., Brenkel, I., Clatworthy, M., Dwyer, K., Lesko, J. and Kantor, S. Early Patient Reported Outcomes With New Primary vs. Contemporary Total Knee Arthroplasty: A Comparison of Two Worldwide, Multi-Center Prospective Studies.  International Society for Technology in Arthroplasty (ISTA):  e-Poster, 5-8 October 2016, Boston, MA. Based on interim data.  The leading knee systems included: 89% PFC SIGMA, 3% Zimmer NexGen, 7% SHO Triathlon, 1% Other.
5Toomey, S., Daccach, J., Shah, J., Himden, S., Lesko, J. and Hamilton, W. Comparing the Incidence of Patellofemoral Complications in a New Total Knee Arthroplasty (TKA) System vs. Currently Available Products in Two, WorldWide, Multi-Center, Prospective Clinical Studies. While not statistically significant, the trend is promising and follow-up is ongoing. Based on interim data.
6Azhar, A. Mannen, E.,Smoger,L., Laz, P, Rulkoetter, P, Shelburne, K.  Evaluation of In Vivo Mechanics for Medialized Dome and Anatomic Patellofemoral Geometries during Knee Extension and Lunge.  Presentation at the International Society for Technology in Arthroplasty, 29th Annual Congress, Boston, MA, 5-8 October 2016.
7Ruiz D, Koenig L, Dall T, et al. The Direct and Indirect Costs to Society of Treatment for End-Stage Knee Osteoarthritis. J Bone Joint Surg Am., 2013; 95: 1473-80.

©DePuy Synthes Companies 2016. All rights reserved.
The third party trademarks used herein are the trademarks of their respective owners.

 

SOURCE DePuy Synthes

Episurf Medical achieves milestone of 150th implant

2016-11-28 – (GLOBE NEWSWIRE) —

Episurf will achieve its 150th implant during the week of 28th November 2016. This milestone of Episealer knee implant surgeries demonstrates the increasing rate of adoption within the orthpaedic community for the Episurf Medical’s patient specific approach for the treatment of focal cartilage lesions.

“The Episealer concept is gaining traction and less than 6 months after case number 100, we are now reaching 150.  The orthopaedic surgical implant market is decidedly conservative and incrementally, Episurf is moving into the area of evidence-based medicine. The results to date are very encouraging and builds further optimism as they show rapid recovery along with a significant improvement in the quality of life for our patients”, said Dr Leif Ryd, Senior Medical Advisor to Episurf Medical.

“We are pleased to have reached this point so quickly after our 100th surgery”, said Rosemary Cunningham Thomas, CEO of Episurf Medical. “Surgeons are deciding for themselves in increasing numbers that the Episealer procedure provides significant improvements for their patients. The personalised approach, which starts with our Epioscopy® process to fully visualise and assess a patient’s cartilage damage, enables Episurf to tailor every implant to a patient’s specific anatomy and pathology. Our results are being borne out through solid clinical outcomes and a growing forward order book.’’

 

For more information, please contact:

Rosemary Cunningham Thomas, CEO, Episurf Medical

Tel: +46 (0) 70-7655892

Tel: +44 (0) 7803-753603

Email: rosemary@episurf.com

 

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above.

 

Reconstructive Knee Replacement Market to Grow 5.5% Annually Through 2020

CLEVELAND, Nov. 21, 2016 /PRNewswire/ — Demand for reconstructive knee replacements is forecast to increase 5.5 percent annually to $5.0 billion in 2020. The rising incidence of severe osteoarthritis conditions in the aging population will underlie gains. Growth will also benefit from improvements in technology and materials, but will be moderated by limits imposed on health insurance reimbursement rates as well as by the availability of non-surgical alternatives to knee replacement, such as hyaluronic acid injections and reinforced braces. These and other trends are presented in Medical Implants in the US, 6th Edition, a new study from The Freedonia Group, a Cleveland-based industry research firm.

The study is available here
http://www.freedoniagroup.com/industry-study/3465/medical-implants-in-the-us-orthopedic-cardiac-other-6th-edition.htm

Since they were introduced in 1974, knee implants have evolved from simple hinged devices to sophisticated, multiple component configurations that mimic the natural action of the knee.  On average, implants make up about 12 to 15 percent of the cost of knee replacement surgery.  Contract prices of knee replacement systems start at about $3,000 for partial reconstructive models and range up to more than $10,000 for rotating platform models.  Average unit prices are expected to decrease gradually due to healthcare cost containment pressures. The most widely used type of reconstructive knee replacement is the fixed-bearing model.  These models cap the tibia with a flat metal component that holds a plastic spacer securely in place. 

Medical Implants in the US, 6th Edition is a comprehensive look at the medical implants market including orthopedic implants (reconstructive joint replacements, orthobiologicals, spinal implants, trauma implants and dental implants; cardiovascular implants (pacing devices, cardiac stents and structural cardiac implants); and other types. 

Related studies include:                
#3446 World Medical Disposables (August 2016)
http://www.freedoniagroup.com/industry-study/3446/world-medical-disposables.htm 
#3421 In Vitro Diagnostic (IVD) Packaging (June 2016)
http://www.freedoniagroup.com/industry-study/3421/in-vitro-diagnostic-ivd-packaging.htm

About The Freedonia Group – The Freedonia Group, a division of MarketResearch.com, is a leading international industrial research company publishing more than 100 studies annually. Since 1985 we have provided research to customers ranging in size from global conglomerates to one-person consulting firms. More than 90% of the industrial companies in the Fortune 500 use Freedonia Group research to help with their strategic planning. Each study includes product and market analyses and forecasts, in-depth discussions of important industry trends, market share information and profiles of the leading industry players. Reports can be purchased at www.freedoniagroup.com and are also available on www.marketresearch.com and www.profound.com.

Press Contact:
Corinne Gangloff
+1 440.684.9600
cgangloff@freedoniagroup.com

Logo – http://photos.prnewswire.com/prnh/20160805/396004LOGO

SOURCE The Freedonia Group

Related Links

http://www.freedoniagroup.com

Zimmer Biomet Announces Launch of the Comprehensive® Vault Reconstruction System – the First Commercially Available Patient-matched Glenoid Implant

WARSAW, Ind., Nov. 17, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the launch of the Comprehensive® Vault Reconstruction System (VRS), the first patient-matched glenoid implant cleared to specifically treat patients with a severely deficient rotator cuff and extensive bone loss which precludes the use of a standard glenoid baseplate. The VRS uses CT imaging and advanced 3D reconstruction techniques to allow surgeons to personalize each patient’s implant.

“The treatment options for extensive glenoid deficiencies were limited to bone grafting or hemi-arthroplasties, both of which were unreliable and had marginal success,” said Dr. David Dines, Orthopedic Surgeon at the Hospital for Special Surgery in New York and Professor of Orthopedic Surgery at Weill Cornell Medical College.  “The Comprehensive Vault Reconstruction System represents an important advance in shoulder reconstruction by streamlining and personalizing the implant procedure in hope of more predictable outcomes and results that extend beyond pain relief, to restoring function and improving overall quality of life.”

The first implantation of the VRS took place on September 21, 2016, at the University of Virginia Hospital in Charlottesville, Va. and was successfully performed by Dr. Stephen Brockmeier.

“The Comprehensive Vault Reconstruction System is another example of our commitment to addressing the clinical and unmet needs of shoulder specialists,” said Orsa Britton, Vice President and General Manager of Zimmer Biomet’s global Extremities business. “This innovative, patient-specific implant, coupled with extensive pre-operative planning software, will expand viable treatment options for patients with severe glenoid deformities.”

About Zimmer Biomet

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

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

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

Cautionary Statement Regarding Forward-Looking Statements

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

Logo – http://photos.prnewswire.com/prnh/20150624/225371LOGO

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com

First-ever functional, patient-specific hip replacement procedures performed in the USA

14 November 2016

Corin is excited to announce that during the week of November 7, the first-ever functional, patient specific hip replacement procedures were performed using its Optimized Positioning System (OPS™).  Corin’s OPS™ is the first FDA-cleared technology to help surgeons achieve functional, patient-specific component alignment in total hip replacement.

“Corin’s OPS™ technology optimizes the orientation of each individual patient’s acetabular component by incorporating functional assessments into the planning phase. The system allows surgeons to understand the biomechanics of each patient’s pelvis during daily activities, creating the critical inputs required to optimize surgical outcomes and streamline procedural workflows,” said Jim Pierrepont, PhD, Corin’s Head of Technology.

During the course of the week over 25 OPS™ surgeries were performed at ten centers by Dr Steven Barnett of Orthopaedic Specialty Institute in Orange County, CA; Dr Michael Bradley of South County Orthopaedics in Wakefield, RI; Dr H. John Cooper of New York Orthopaedics in New York, NY; Dr Todd Kelley of University of Cincinnati in Cincinnati, OH; Dr Stefan Kreuzer of Inov8 Orthopaedics in Houston, TX; Dr Michael Miranda and Dr David Watson of Florida Orthopaedic Institute in Temple Terrace, FL; Dr Stephen Raterman of Florida Medical Clinic in Tampa, FL, Dr Herrick Siegel of University of Alabama in Birmingham, AL; Dr Michael Swank of Reconstructive Orthopaedics and Sports Medicine in Cincinnati, OH; and Dr Jonathan Vigdorchik of NYU Hospital for Joint Disease in New York, NY.

“OPS™ and functional component positioning represent a necessary paradigm shift in orthopaedics.  While we have made great progress making surgery less invasive, we have been on a quest for a better way to place components based on individual patients’ needs. Until now, we have based our knowledge of implant position on a 30-year-old publication, which has recently been challenged with data from institutions such as The Mayo Clinic in Rochester, MN and The Hospital for Special Surgery (HSS) in New York,” explained Dr Stefan Kreuzer.

Dr Michael Miranda added, “OPS™ is the first available system that takes us forward in understanding and addressing functional implant positioning. I am very excited to have access to this innovation to help me individualize every patient’s surgery by optimizing implant positioning to improve clinical outcomes.”

“Combined with Corin’s leading portfolio of hip, knee, and extremities prostheses and rapidly expanding global footprint, OPS™ provides a strong foundation for future growth. OPS™ represents Corin’s ongoing commitment to deliver solutions that matter to our surgeon customers and their patients,” said Paul Berman, Corin’s US President.