5 Reasons the 3rd Ortho Value-Based Care Conference Will Be the Best Event You Attend in 2019

12-26-2018 / Kain, Zeev

I’m excited to announce the 3rd Interdisciplinary Conference on Orthopedic Value based Care taking place on January 18-20, 2018 in beautiful Newport Beach, California. We’ve planned this conference to be even better than last 2 years highly-rated event!

Here’s five reasons it should be on your to-do list:

  1. One Unique Team Concept

The mission of this conference is to break the silos that exist in a patient’s orthopaedic journey. This is the only conference that brings in speakers that represent players from across the episode: orthopedic surgeons, nurses, physical therapists, healthcare executives, anesthesiologists, patients, digital health experts and futurists. In the same vein, we expect surgical teams to attend and take this opportunity to learn from each other and work toward better patient outcomes together. This worked well at last year’s conference where 40% of the participants were part of a hospital team.

  1. Two Innovative Cadaveric Workshops
    On Friday there are 2 cadaveric workshops that will focus on innovative surgical orthopedic procedures and US based regional anesthesia. Plenty of opportunity to experience new devices and surgical techniques as well the most innovative regional anesthesia techniques.
  2. Three Ambulatory Boot Camps
    Orthopedic spines are heading to the outpatient area and we need to get ready. The first bootcamp will focus on the concept of fee for value in the ambulatory environment and will include practical approaches aught by all the stakeholders. The second bootcamp will focus on the nuts and bolts of building and maintaining an Orthopaedic ambulatory center and the third book camp will focus on building an enhanced recovery model for the patients who are undergoing ambulatory surgery.
  1. Four Complementary Tracks
    To be successful in the world of fee-for-value, one needs to understand all the clinical, financial and operational aspects of this new developing world. This is the ONLY conference that offer three complementary parallel tracks that the various stakeholders can attend! We choose the 4th track, ambulatory, to be held on Friday with no other programing at the same time because of the high interest in this concept.
  2. Five Times the Networking
    Each day offers four opportunities for networking, including breakfast, lunch and two breaks for exchanging best practices and comparing notes. Plus, a free meet and greet wine networking reception on Saturday night will offer a relaxed atmosphere to share insights from day one.

  3. A Six-Star Speaker Lineup
    The agenda has 38 world-class, interdisciplinary speakers. Ortho experts include speakers such as Alexander R. Vaccaro, President and Surgeon-in-Chief at Rothman Institute Orthopedics; Joseph Iannotti, Chair at Cleveland Clinic, Kevin Bozic, Chair at Dell School of Medicine and Tony Romeo from the Rothman Institute of New York. The Executive leaders include individuals such as the CMO of Humana, CMO of Optum, COO of Rothman, Vice Chancellor of UC Davis and others.

Register today!

Published Regenexx Research, Involving Stem Cells And Platelets, Shows Promise For Treating Osteoarthritis Of The Knee

BROOMFIELD, Colo., Dec, 21, 2018 /PRNewswire/ — New research from Regenexx®, which provides advanced interventional orthobiologics, shows greater potential for treating osteoarthritis of the knee with cell-based therapies. The study, published on December 13, 2018, in the Journal of Translational Medicine, was a randomized controlled trial of patients’ own bone marrow concentrate (BMC) and platelet-rich plasma products versus an exercise therapy regimen for patients with moderate knee osteoarthritis, with clinical outcomes documented over a two-year period.

The study included 48 patients, with 22 in the control group (exercise) and 26 receiving the treatment of bone marrow concentrate (which contains mesenchymal stem cells, platelets, and other cells with healing and regeneration potential) and platelet-rich plasma. All patients in the control group crossed over to the BMC treatment group at three months.

Patients who received the BMC treatment improved significantly in activity levels and stability at three months over those who followed the exercise therapy program. Over the two-year period, after receiving the BMC treatment, significant reduction in pain and increased functionality were maintained.

“To the best of our knowledge, this is the first randomized controlled trial comparing patients’ own bone marrow concentrate and therapeutic exercise for knee osteoarthritis,” said Christopher Centeno, M.D., lead researcher on the study. “While exercise therapy alleviated osteoarthritis symptoms and improved function, the specific BMC protocol, while warranting further investigation, had a greater positive impact on the patients.”

Osteoarthritis, one of the most common causes of chronic joint pain, affects more than 50 million adults in the United States. Annual costs due to medical expenses and lost wages exceed $100 billion. Current treatments include non-steroidal anti-inflammatory drugs, which are not curative and are associated with side effects; corticosteroid injections, which demonstrate only modest clinical benefits; aquatic therapies, which provide short-term benefits; and physical therapy.

While exercise or physical therapy has been shown to improve function and reduce pain, this study showed cell-based therapy to be more effective.

To review the full study and outcomes in the Journal of Translational Medicine, click here.

About Regenexx

Regenexx provides advanced interventional orthobiologics (non-surgical stem cell and blood platelet treatments) for common joint injuries and degenerative joint conditions, such as osteoarthritis and avascular necrosis. These stem cell procedures utilize a patient’s own stem cells or blood platelets to help heal damaged tissues, tendons, ligaments, cartilage, spinal disc, or bone. The company also provides programs for self-funded employers, enabling them to offer their employees an additional choice in care for orthopedic issues. For more information, visit www.regenexx.com or www.regenexxcorporate.com.

Contact:

Amanda Roston

aroston@peppercomm.com

212.931.6139

SOURCE Regenexx

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Early Reviews of Zimmer Biomet/Apple’s Mymobility App

 

December 20, 2018 / Elizabeth Hofheinz, M.P.H., M.Ed.

Approximately two months ago, Zimmer Biomet announced the mymobility app which is meant to walk patients through pre- and post-op large joint arthroplasty care.

Joshua Carothers, M.D., an orthopedic surgeon at New Mexico Orthopaedics in Albuquerque, is one of the first users of this Zimmer Biomet/Apple product. He shared his early experiences with OTW. “While our experience in the study has been limited, with just a few patients enrolled so far, people are definitely excited.”

“mymobility feels cutting-edge. Patients like using the wearable technology to guide their activity pre- and post-surgery. The basic concept of using technology to make the experience better is resonating with patients and I’m excited about using mymobility to improve care for patients with insights on things like patient complications and re-admissions, to name a couple.”

This project is of particular importance to Zimmer Biomet’s CEO Bryan Hanson. “We are incredibly excited to work with Apple to transform the knee and hip replacement experience for patients and surgeons.”

The mymobility app captures data from knee and hip replacement patients and shares it seamlessly with their doctors so that, as Jeff Williams, chief operating officer at Apple explained “They can participate in their care and recovery in a way not previously possible through traditional in-person visits. This solution will connect consumers with their doctors continuously, before and after surgery.”

 

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Conformis readies $21m private placement

 BY 

ConforMIS (NSDQ:CFMS) said this week that it inked a deal with Lincoln Park Capital Fund to sell $21 million of shares of the company’s common stock over the course of a 36-month term.

According to the terms of the deal, ConforMIS also plans to issue an additional 354,430 shares of common stock to Lincoln Park as commitment shares.

In total, the company said it will sell no more than 12,651,640 shares of common stock to Lincoln Park unless it obtains stockholder approval to issue more.

Also this month, ConforMIS announced that it would lay off roughly 10% of its workforce.

 

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FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

December 20, 2018 / FDA News Release

The U.S. Food and Drug Administration has warned Genetech, Inc. of San Diego, California and its president, Edwin N. Pinos for marketing stem cell products without FDA approval and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may have led to microbial contamination, potentially causing serious blood infections in patients. Genetech processed umbilical cord blood into unapproved human cellular products, which was distributed by Liveyon, LLC.

Additionally, as part of the FDA’s overall goal to support the responsible development of safe and effective products for patients, the agency is sending letters to reiterate the FDA’s compliance and enforcement policy to other manufacturers and health care providers who may be offering stem cell treatments.

“The FDA is committed to advancing the field of cell-based regenerative medicine. We’re implementing new policies to make it more efficient to safely develop these promising new technologies. At the same time, we’re also focusing more resources on enforcement when we see companies skirt safety measures and put patients at risk. In this case, the company’s failure to put in place appropriate safeguards may have led to serious blood infections in patients,” said FDA Commissioner Scott Gottlieb, M.D. “We remain committed to supporting the development of safe and effective cell-based regenerative medicine and advancing our comprehensive regenerative medicine policy framework. These efforts include our work to encourage manufacturers to engage with the FDA early so that we can provide guidance about any applicable regulatory requirements. Even though a few sponsors have come to us, we are discouraged by the overall lack of manufacturers wanting to interact with the agency in this enforcement discretion period. The letters we’re issuing today to manufacturers, health care providers and clinics around the country are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients. Time is running out for firms to come into compliance during our period of enforcement discretion. We’ll be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.”

As highlighted last year with the release of the FDA’s comprehensive regenerative medicine policy framework, including the FDA’s final guidance (Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use), the FDA intends to apply a risk-based approach to enforcement of cell-based regenerative medicine products, taking into account how products are being administered as well as the diseases and conditions for which they are intended to be used. However, the FDA does not intend to exercise such enforcement discretion for those products that pose a potential significant safety concern to patients.

Under this policy, the agency noted that it intends to exercise enforcement discretion for certain products until November 2020 with respect to the FDA’s investigational new drug application and premarket approval requirements when the use of the product does not raise reported safety concerns or potential significant safety concerns. Although the FDA has not evaluated the application of the compliance and enforcement policy to the specific manufacturers and health care providers who received the letters, or evaluated their products, the letters are intended to serve as a reminder of the enforcement discretion period and to encourage all affected manufacturers and health care providers to engage with the agency in advance of that date to determine if their products are subject to the agency’s premarket approval requirements.

The FDA offers opportunities for this type of engagement between potential manufacturers and the agency, such as through the INTERACT program, to facilitate product development. It also encourages the use of its expedited programs whenever applicable, in addition to the collaborative development of products as the FDA Commissioner and Center for Biologics Evaluation and Research director discussed in a New England Journal of Medicinedisclaimer icon perspective.

In the case of Genetech, the FDA inspected the company’s facility this past June and found the company was processing cellular products from human umbilical cord blood for administration by intra-articular (joint) injection, intravenous injection or application directly to the affected tissue to treat a variety of orthopedic conditions. These products were distributed by Liveyon in Yorba Linda, California as ReGen5, ReGen10 and ReGen30. The Genetech products are not intended for homologous use (products that are intended for the same function in the recipient as the donor), and while the products have a systemic effect, they are not intended for allogeneic (genetically similar) use in a first or second-degree blood relative. As such, the products are regulated as both drug and biological products. To lawfully market these products, an approved biologics license application is needed. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or INDs exist for the Genetech-processed, Liveyon-distributed products.

During the inspection, the FDA documented evidence of significant deviations from CGTP and CGMP requirements in the manufacture of the umbilical cord blood-derived products, including: deficient donor eligibility practices; unvalidated manufacturing processes; uncontrolled environment; lack of control over the components used in production and a lack of defined areas or a control system to prevent contamination and mix-ups. These deviations pose a significant risk that the products may be contaminated with microorganisms or have other serious product quality defects.

The FDA and the Centers for Disease Control and Prevention have received numerous reports of safety issues including those involving microbial contamination and are aware of 12 patients who received Genetech products from Liveyon and subsequently became ill due to blood and other infections caused by a number of bacteria, including Escherichia coli (E. coli), as described in a forthcoming Morbidity and Mortality Weekly Report (MMWR), titled “Notes from the Field: Bloodstream and Joint Infections in Patients After Receiving Bacterially Contaminated Umbilical Cord Blood-derived Stem Cell Products for Non-hematopoietic Conditions — United States, 2018.”

In September, Liveyon suspended shipment of all product pending an inquiry by the FDA into the source of the adverse reactions. Liveyon also voluntarily recalled all Genetech products it may have distributed.

“The FDA remains committed to taking action against products being unlawfully marketed and which pose a potential significant risk to patient safety at this time. However, the agency is also committed to ensuring that patients have access to safe and effective regenerative medicine products as efficiently as possible,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

The FDA requested a response from Genetech, within 15 working days of the letter’s issuance, that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by companies and owners could lead to enforcement action such as seizure, injunction or prosecution.

Health care professionals and consumers should report any adverse events related to treatments with the Liveyon products, Genetech products or other stem cell treatments to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed formcan be submitted online or via fax to 1-800-FDA-0178. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Ex-Cleveland Clinic Innovations head sentenced to 30 months in prison for role in $2.7M fraud case

 Paige Minemyer

The former head of Cleveland Clinic Innovations, who pleaded guilty to defrauding the health system out of nearly $3 million, was sentenced to 30 months in prison.

Gary Fingerhut, 58, was also ordered to pay the more than $2.7 million that was diverted from the Cleveland Clinic as part of the scheme in restitution, the Department of Justice announcedFingerhut pleaded guilty to one count of wire services fraud and one count of making false statements for his role in October 2017.

Fingerhut was expected to be sentenced in January, and attorneys anticipated that he could face between 41 and 51 months in jail.

Fingerhut was the executive director of Cleveland Clinic Innovations for two years before the FBI uncovered the fraud scheme in 2015. Fingerhut conspired with Wisam Rizk, chief technology officer of Interactive Visual Health Records, a spinoff of Innovations that was formed to build a digital charting tool for the clinic’s doctors.

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Photo: (Getty Images/alfexe)

 

Implantable Medical Devices Market to Reach US$49.8 Billion by 2024 End, Manufacturers Focus on Improving Biomaterial Design and Functionality, Says TMR

ALBANY, New YorkDecember 19, 2018 /PRNewswire/ —

The global implantable medical devices market stood at US$32.3 billion in 2015. Expanding at a CAGR of 4.9% during 2016-2024, the global market will reach a worth of US$49.8 billion by the end of this period.

Among the various types of biomaterials used, titanium presently hold the dominating share in the implantable medical devices market. However, in the near future, it is expected to be superseded by the zirconium. The rising popularity of zirconium in various types of implants can be attributed to its better mechanical attributes and its design flexibility.

Geographically, North America presently dominates the global implantable medical devices market by contributing a share of 42% in 2015, with the U.S. expected to be the cynosure of attention for manufacturers. The growth is driven by the robust demand for modern healthcare facilities by large population base.

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Rapid Advances in Dental Cosmetics impart Considerable Growth Impetus to Market

Implantable medical devices has been occupying increasingly significant position in healthcare, world over, rising on the back of constant advances in biomaterial design and functionality. The biomaterials in these devices have been extensively used in the diagnosis, prognosis, and treatment of a range of diseases, primarily musculoskeletal disorders. This is a key aspect underpinning the rapid evolution of the implantable medical devices market.

The surging demand for various biomaterials for dental implants is accentuating revenues of the market. Moreover, rapid advances being made in dental cosmetics, especially supported by substantial demand for dental prosthetic surgeries, in developing and developed countries are imparting constant impetus to the global implantable medical devices market’s growth. Furthermore, the demand for implantable medical devices is increasingly bolstered by the rising role of biomaterials in cosmetic procedures in various parts of the world. This is catalyzed by the growing number of cosmetic procedures in the fashion and entertainment industry.

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Search for Novel Biomaterials to unlock Lucrative Prospects

The implantable medical devices market is, however, beset by the lack of availability of biomaterials with better safety profile and significant biocompatibility, sensitivity, and longevity. For instance, the extensive use of nickel in the device is considered to up the risk of cancer in the users.

Nevertheless, several manufacturers of implantable medical devices and researchers are engaged in developing better devices, dovetailed by advanced nanofabrication technologies. The search for novel biomaterial will pave way to substantial revenue streams for players in the implantable medical devices market in the coming year. Relentless focus of prominent players on technological upgrades will further support the rapid expansion of the implantable medical devices market.

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The competitive dynamics of the global implantable medical devices market is expected to be influenced by various strategies adopted by large as well as small players. Transparency Market Research (TMR), however, notes that on account of robust technical competence and financial clout big players have will make the entry of small and average-sized players increasingly difficult in the implantable medical devices market. Prudent manufacturers of implantable medical devices are aiming at bringing advancement or improvements in the design parameter, powering approaches, and the functionality of their devices. The focus will enable them to gain a better hold over the market. Large players are expected to commit massive funds on research and development activities to get a stronghold over the global implantable medical devices market, observes TMR. Moreover, they are engaging in geographic expansion strategies to consolidate their footprints in the coming years.

Browse Press Release – https://www.transparencymarketresearch.com/pressrelease/global-implantable-medical-devices-market.htm

Some of the key players in the global implantable medical devices market are Zimmer Biomet, Smith & Nephew plc, Johnson & Johnson, Stryker Corporation, and Abbott Laboratories.

The study presented here is based on a report by Transparency Market Research (TMR) titled “Implantable Medical Devices Market (Product – Reconstructive Joint Replacement (Shoulder Implants, Ankle Implants, Elbow Implants, Hip Implants, and Knee Implants), Spinal Implants (Thoracolumbar Implants, Intervertebral Spacers, and Non-bone Implants), Dental Implants, and Cardiovascular Implants; Material – Titanium, Stainless Steel, Titanium Alloy, CoCr Alloy, and Zirconium. End User  Hospitals (More than 500 Beds, 200 – 499 Beds, and Less than 200 Beds), Ambulatory Surgery Centers (ASCs), and Clinics) – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2016-2024″.

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Transparency Market Research (TMR) is a global market intelligence company providing business information reports and services. The company’s exclusive blend of quantitative forecasting and trend analysis provides forward-looking insight for thousands of decision makers. TMR’s experienced team of analysts, researchers, and consultants use proprietary data sources and various tools and techniques to gather and analyze information.

TMR’s data repository is continuously updated and revised by a team of research experts so that it always reflects the latest trends and information. With extensive research and analysis capabilities, Transparency Market Research employs rigorous primary and secondary research techniques to develop distinctive data sets and research material for business reports.

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SOURCE Transparency Market Research

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Medtronic Completes Acquisition of Mazor Robotics

DUBLIN – December 19, 2018 – Medtronic plc (NYSE:MDT) today announced it has completed the acquisition of Israel-based Mazor Robotics (NASDAQ:MZOR, TASE:MZOR.TZ). Under the terms of the acquisition agreement announced on September 20, 2018, Mazor shareholders will receive $58.50 per American Depository Share, or $29.25 per ordinary share, in cash. The total value of the transaction is reported at $1.7 billion, or $1.3 billion net of Medtronic’s existing stake in Mazor and cash acquired. Medtronic’s acquisition of Mazor ranks among the largest orthopedic deals completed in 2018.

This acquisition strengthens Medtronic’s position as a global innovator in enabling technologies for spine surgery. By combining Medtronic’s market-leading spine implants, navigation, and 3D imaging technology with Mazor’s robotic-assisted surgery systems, Medtronic offers a fully-integrated procedural solution for surgical planning, workflow, execution and confirmation.

“With today’s announcement, in bringing the two companies together Medtronic aims to accelerate the advancement and adoption of robotic-assisted surgery in spine for the benefit of patients, providers, and the healthcare system more broadly,” said Geoff Martha, executive vice president and president of the Restorative Therapies Group at Medtronic. “This is the latest example of our Surgical Synergy strategy, which we believe will transform spine care through procedural solutions that integrate implants, biologics and enabling technologies like navigation, 3D imaging, robotics and powered surgical tools.”

Medtronic believes robotic-assisted surgery can play a transformative role in refining procedures, reducing variability and impacting procedural outcomes in spine surgery. The Mazor X(TM) Stealth Edition – a co-development effort between Mazor and Medtronic – was recently cleared by the FDA. This new system seamlessly incorporates StealthStation(TM) software into the Mazor(TM) X robotic-assisted surgery platform – leveraging the power of two industry-leading technologies to deliver procedural predictability and flexibility through real-time image guidance, visualization and navigation informed by interactive 3D planning and information systems.

“Everything that happens in the operating room depends on the trained medical professionals who are there, and that will never change. However, the Mazor X Stealth Edition gives us a very powerful tool to plan our desired surgical procedure and help make sure the surgery takes place exactly as planned with a high degree of accuracy,” commented Christopher R. Good, M.D. F.A.C.S., spine surgeon, director of Scoliosis & Spinal Deformity and president of Virginia Spine Institute. “Incorporating multiple modalities together, including computerized surgical planning, three-dimensional assessment of spinal anatomy, robotic guidance and live navigation feedback all in one platform leads to a synergy that makes my operating room much smarter.”

Mazor Robotics joins Medtronic’s Neurosurgery business, which is part of the Restorative Therapies Group’s Brain Therapies division.

Financial Highlights
The transaction is expected to be modestly dilutive to Medtronic’s fiscal 2019 adjusted earnings per share, but given the current strength of Medtronic’s business, the company expects to absorb the dilution. Consistent with its long-term financial objectives, Medtronic projects the acquisition to generate a double-digit return on invested capital (ROIC) by year four, with an increasing contribution thereafter.

Medtronic’s financial advisors for the transaction are Perella Weinberg Partners LP and Goldman Sachs & Co. LLC, with Meitar Liquornik Geva Leshem Tal and Ropes & Gray LLP acting as legal advisors. Mazor’s financial advisors are J.P. Morgan Securities LLC and Duff & Phelps LLC, with Kirkland & Ellis LLP and Luchtenstein Levy Wiseman Law office acting as legal advisors.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:
Sara Thatcher
Public Relations
+1-901-399-2098

Ryan Weispfenning
Investor Relations
+1-763-505-4626

CartiHeal Performs First Agili-C™ Implant Case at The Ohio State University

KFAR SABA, Israel and COLUMBUS, OhioDec. 19, 2018 /PRNewswire/ — CartiHeal, developer of Agili-C, a proprietary implant for the treatment of joint surface lesions, announced today the successful enrollment of the first patient in the Agili-C Investigational Device Exemption (IDE) pivotal study at The Ohio State University Wexner Medical Center.

The surgery was performed by site Investigators Dr. Christopher Kaeding and Dr. David Flanigan at The Ohio State University Wexner Medical Center in Columbus, Ohio. The Ohio State University Wexner Medical Center is one of 30 U.S. and O.U.S sites in the new Food and Drug Administration (FDA) IDE trial aiming to show the superiority of the Agili-C implant over the current standard of care in the treatment of cartilage defects in arthritic and non-arthritic knees.

The first patient enrolled at The Ohio State University Wexner Medical Center had mild osteoarthritis and two cartilage lesions on both of the femoral condyles. “We are very happy that our first patient in the study was randomized to the Agili-C arm. The patient was treated with two implants, one each condyle,” said Dr. Kaeding. “Dr. Flanigan and I look forward to expanding upon our initial successful clinical procedure.”

“We are excited with the first enrollment at The Ohio State University Wexner Medical Center,” said CartiHeal’s Founder and CEO, Nir Altschuler. “The site is of great importance due to its strong professional reputation and strategic location, and we look forward to a fruitful collaboration with Dr. Kaeding and Dr. Flanigan.” The pivotal study aims to show the superiority of the Agili-C implant over the current standard of care in the treatment of cartilage defects in arthritic and non-arthritic knees.

About the Agili-C™ Implant

Agili-C™ is a cell-free, off-the-shelf implant for use in cartilage and osteochondral defects in traumatic and osteoarthritic joints. The implant is a porous, biocompatible, and resorbable bi-phasic scaffold, consisting of interconnected natural inorganic calcium carbonate (aragonite).

The Agili-C™ implant is CE marked for use in cartilage and osteochondral defects. Agili-C™ has been implanted in over 400 patients with cartilage lesions in the knee, ankle and great toe in a series of trials conducted in leading centers in Europe and Israel. In these trials, the implant was used to treat a broad spectrum of cartilage lesions, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.

Agili-C™ IDE Clinical Study

The clinical study is a prospective, multi-center, open-label, randomized, and controlled trial aims to show the superiority of the Agili-C™ implant over the current surgical standard of care, micro-fracture or debridement, for the treatment of variety of cartilage lesions of the knee.

For more information please refer to https://www.cartiheal.com/

About CartiHeal

With offices in Closter, New Jersey, and Kfar Saba, Israel, CartiHeal, a privately-held medical device company develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

In the United States, the Agili-C implant is not available for sale – it is an investigational device limited for use in the IDE study.

Contact
Wexner Medical Center, The Ohio State University
Columbus, Ohio   
Courtney.Wright@osumc.edu

CartiHeal
info@cartiheal.com   
www.cartiheal.com

SOURCE CartiHeal

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

18 December 2018

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

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

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

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

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

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

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

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

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

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

Investors
Andrew Swift
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Smith & Nephew

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Smith & Nephew

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About Smith & Nephew

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

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

References

1. 2018 SmartTRAK US Meniscal Repair Fixation market report

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.