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.


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.

Sara Thatcher
Public Relations

Ryan Weispfenning
Investor Relations

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.

Wexner Medical Center, The Ohio State University
Columbus, Ohio   


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.

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

Charles Reynolds
+44 (0) 1923 477314
Smith & Nephew

Ben Atwell/ Andrew Ward
+44 (0) 20 3727 1000
FTI Strategic Consulting

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to supporting healthcare professionals in their daily efforts to improve the lives of their patients. With leadership positions in Orthopaedic 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.


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.

Is your practice ready for 2019? Here are some Insights from Speakers of the 2019 Newport Beach Ortho Value-Based Care Conference

Lots is happening in the healthcare area and it’s clear that the orthopaedic fee-for-value space will continue to evolve in 2019. Here are some insights from three speakers the 3rd Interdisciplinary Conference on Orthopedic Value based Care taking place on January 18-20, 2018 in beautiful Newport Beach, California.

Alexander R. Vaccaro, MD, PhD, MBA

Richard H. Rothman Professor and Chairman of Orthopedic Surgery

President, Rothman Orthopedic Institute

  • Can you share your best advice for motivating your teams?

Make sure they clearly understand goals and objective of any initiatives and have the opportunity for feedback and buy in. Show that you care about them and their opinions, be humble, celebrate/ recognize/ reward small and large wins, roll up your sleeves.

  • How do you break the silos in your organization?

Communicate , Communicate, Communicate. Reward the Mngt team based on team goals/ targets so that it incentives to work “across lines/ departments”. Have each leader “walk in the other’s shoes” so they get a better understanding of the position, responsibilities, problems / issues, work product. Constantly motivate, meet as a leadership team often, teak the team to dinner/ drinks – get to   know each other personally.

  • OP Surgery is moving to the outpatient area; how do you get ready for it?

Develop OP ASC’s (we now have 8 – and will got up to 12-14 with Northern Jersey and NY). Larger OR’s and PACU bays ; risk assessment all patients for appropriateness of care, visit existing ASC’s that are performing Spine/ Joints on an OP basis. Define specific criteria for cases qualifying for OP ASC. Ensure that the OR’s are big enough.


AnnMargaret McCraw

Chief Executive Officer

Midlands Orthopaedics & Neurosurgery, PA

   What’s the best thing you’ve read lately?

The Ideal Team Player by Patrick Lencioni | What Customers Crave by Nicholas Webb | Start With Why by Simon Sinek (not a recent read, but my “go-to” leadership philosophy)

   How do you promote innovation within your organization? 

Promoting innovation is easier to do when you’re the only private ortho-neuro group left in your MSA of 750,000 people, and you’re surrounded by 45 hospital-employed orthopaedists and 11 hospital-employed neurosurgeons – our survival literally depends on it. We first disrupted our market in 2012 when BCBS SC began to cover outpatient joint replacements in our ASC. Soon after, we began adding spine procedures. The average cost-savings is 15k-$40k per total joint replacement based on the average claims paid by BCBS SC to 3 hospital systems in the area per their own Treatment Cost Estimator. This distinction as the lowest cost surgical provider for complex ortho/spine procedures coupled with excellent outcomes has become our identity. Of course, once you have disrupted a market, you must continue to innovate or be disrupted by the competitors who are always nipping at your heels. To continue thriving, the innovation cycle must become part of the organization’s culture.

   In the past 12 months, how have you adapted to new patient experience expectations in the age of consumerism? 

What Customers Crave by Nicholas Webb is a great resource for this issue. In the previous 12 months, we have focused on reducing the amount of information we’re collecting at the front desk to enhance the intake process; we have initiated an internalPAINLESS (Patients are in Need. Lead Employees Share Solutions.) campaign; and we are in the process of implementing a scheduling platform that will allow patients to self-schedule via an app by Q4 2018.


Scott Sigman, MD

Orthopedic Surgery

National Leader in Opioid Sparing Orthopedic Surgery

Orthopedic Surgical Associates

  How Do You Break Silos In Your Organization?

Specifically, within orthopedics with the use of more expensive non-opioid medications, we found that pharmacy silos give us severe limitation in the ability to use these medications at a number of hospitals across the country.  Our focus has been to try and carve out the use of these medications, so that insurance companies will pay for these medications outside of the typical DRG or payment for an individual surgery.  We did this specifically by lobbying congress as well as CMS, both in person in Washington, D.C. as well as through letter writing campaigns.  We were fortunate to hear that as of January 1st some of these changes will be implemented going forwards through CMS.

  In the past 12 months, how have you adapted to new patient experience expectations in the age of consumerism?

I am a huge believer in social media.  I have postings on Linkedin for my business

friends.  I am also on Facebook for my older population of patients as well as  Instagram for my younger population of patients.  I remain connected with my patients.  With these avenues, we can express the latest state of the art techniques that we are performing and in engaging patients directly, we have found that we have great success.

  Surgeries moving to the outpatient area.  How do you get ready for it?

This has been the natural progression for us in the opioid sparing space. We are now successfully operating on patients near opioid free, which opens up the realm of possibility for outpatient surgery for even more extensive operations such as  total hip and knee replacements as well as outpatient spine surgery.  The patient expectations as well as patient selection I think are paramount to make sure that you have the best chance of success for patient experience.





VGI Medical Surpasses 5,000 SiJoin Implants Used Throughout the United States.

Largo, FL – VGI Medical is dedicated to creating the next generation of spinal implants and procedures to improve the quality of life for its patients. One of the disruptive technologies, SiJoin, that has been developed by VGI Medical has achieved a significant milestone of over 5,000 implants used in more than 1,750 surgical procedures throughout the United States.

The sacroiliac (SI) joint is well documented as a potential source for lower back pain (LBP) and it is estimated that SI joint pain affects 15-25% of patients suffering from LBP. A number of publications have found that SI joint degeneration is present in patients who had previously undergone lumbar fusion surgery and pregnancy related pelvic instability is a common and disabling problem.

SiJoin offers significant clinical advantages to the other technologies currently on the market such as:

  • Tried and True Fusion – The SiJoin procedure utilizes a tried and true method for achieving joint fusion by preparing the joint (decortication), stabilizing the joint via cortical allograft implants, and using bone graft material to enhance  fusion across the joint
  • Less risk – Compared to lateral based SI joint methods, the SiJoin procedure minimizes the risk of the neural complications due to the direct posterior approach
  • Flexibility – The surgeon can choose to use a minimally invasive surgery (MIS), mini-open, or an open approach all while allowing for direct visualization of the SI joint
  • Biomechanics – Biomechanical stabilization of SiJoin is equivalent to lateral rod systems by taking advantage of the “lever arm” concept
  • Revision – Due to its unique design and approach, SiJoin can be used to revise other SI joint fusion procedures
  • Economic advantages – Due to the straight forward and lean business model employed by VGI Medical, SiJoin offers significant advantages to the facility (Acute, Outpatient and ASC) compared to the competition.

VGI Medical was founded in 2007 based on an invention developed by Tov Vestgaarden, PhD. It has become a leader in bringing innovation to the market including VerteLoc, CerLoc, SiJoin and VerteLP. The VerteLoc and CerLoc systems are specifically designed to stabilize and fuse the facet joint by utilizing a unique patented dual geometric design to limit motion of the affected spinal segment. Applying the principles of this success, VGI Medical added SiJoin for Sacroiliac Fusion. VerteLP is one of the latest innovations offering an improved implant for lateral procedures featuring its proprietary Talon Technology.

“ While it is exciting to achieve the 5,000 implant milestone, of greater importance is the number of successful patient outcomes we have seen with SiJoin. It is especially rewarding to see the satisfaction of our surgeon customers and their patients after a successful SiJoin procedure. This milestone demonstrates that SiJoin is the ideal solution for both primary and revision SI cases.” said Tov Vestgaarden, founder and CEO of VGI Medical.


About VGI Medical

VGI Medical is a disruptive force in the spinal implant industry by creating four unique technologies specifically designed to enhance patient outcomes and improve the overall surgeon experience. Our calling is to provide the ideal solution to each clinical challenge faced with the existing technologies on the market today. With over 12,500 implants used since our inception, our implants and instruments have been thoroughly tested with exceptional results.


Spine Surgeon Becomes First In Western Pennsylvania To Reintroduce Lumbar Artificial Disc

PITTSBURGH, PA, December 5, 2018 // — Dr. Jocelyn Idema, Orthopaedic Spine Surgeon at The Center for Disc Replacement Surgery at Advanced Orthopaedics and Rehabilitation (AOR), recently implanted Centinel Spine’s newest generation of the prodisc L lumbar artificial disc replacement.  The prodisc L® is a Total Disc Replacement (TDR) technology platform that offers a surgical alternative to spinal fusions. Patients usually suffer from a single level degenerated disc in the lower (lumbar) spine and this technology works to relieve pain while allowing the potential for motion at the diseased spinal segment. 

As lower spine treatments continue to make advancements through innovative technologies and motion preserving techniques, patients are seeking out alternatives to lumbar fusions.  The goal at The Center for Disc Replacement Surgery at AOR is to improve the motion and function of the spine while maintaining the highest quality and highest standards of care related to both surgical and non-surgical spine interventions through evidence based medicine practices.  “By using newer motion preserving techniques, spinal discs can help retain the forward-to-back, bending side-to-side, and turning left-to-right spinal motion you were intended to have.” says Dr. Idema.  “This in turn helps to reduce the wear and tear associated with your spine above and below the damaged area.”  “I can’t begin to describe how this newest generation of lumbar artificial discs will continue to be a game-changer for patients.” reports Dr. Idema after the procedure.  She further  continues  “I have been doing cervical (neck) artificial disc replacement for years with really high success rates but the lumbar artificial discs only recently are making a resurgence because of various limitations including insurance companies authorizing the procedures.”

Centinel Spine is currently the only company in the United States to offer both upper and lower spine Total Disc Replacement devices.  The prodisc I implant, the predecessor of the prodisc L implant, was first implanted in 1990. The prodisc L implant that is used today was introduced outside the United States in 1999. It was approved by the Food and Drug Administration (FDA) for use in the United States in August 2006.   A prodisc L IDE clinical study evaluated the prodisc L Total Disc Replacement surgery compared to spinal fusion surgery*. The study demonstrated that prodisc L surgery is a safe and effective alternative to fusion surgery* for qualified patients.

About Centinal Spine
From the foundation of knowledge gained from the long-term clinical success of its lumbar products, Centinel launched its cervical product in 2008. Today, Centinel Spine still embraces the pioneering culture from 1924.  In 2006, the FDA Approved the prodisc L—the 2nd U.S. Lumbar Total Disc Replacement device and in 2007, the  FDA approved the  prodisc C—the 1st Complete U.S. Cervical and Lumbar offering.

For more information, please visit www.centinelspine.com and connect on Twitter and Facebook.

Johnson & Johnson Announces $5 Billion Share Repurchase Program

NEW BRUNSWICK, N.J.Dec. 17, 2018 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) today announced that the Board of Directors has authorized the repurchase of up to $5 billion of the company’s common stock.

“Based on our continued strong performance and, more importantly, the confidence we have in our business going forward, the Board of Directors and management team believe that the company’s shares are an attractive investment opportunity,” said Alex Gorsky, Chairman and Chief Executive Officer.  “Our strong cash flow enables us to simultaneously return value to shareholders through our regular quarterly dividend and share repurchases, while at the same time continuing to deploy capital that will further strengthen our robust enterprise pipeline and drive long-term growth.”

Repurchases may be made at management’s discretion from time to time on the open market or through privately negotiated transactions. The repurchase program has no time limit and may be suspended for periods or discontinued at any time.  Any shares acquired will be available for general corporate purposes. The company had approximately 2,683.2 million shares of common stock outstanding as of September 30, 2018.  The company does not expect to incur debt to fund the share repurchase program.

Johnson & Johnson reaffirms its full-year 2018 sales and adjusted earnings per share guidance of $81.0 to $81.4 billion and $8.13 to $8.18 per share, respectively.

About Johnson & Johnson

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to the company’s plans with respect to share repurchases, involving, among other things, uncertainties inherent in business and financial planning. 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 Johnson & Johnson. Risks and uncertainties include, but are not limited to, market conditions; the possibility that the repurchase program may be suspended or discontinued; economic factors, such as interest rate and currency exchange rate fluctuations; uncertainty of commercial success for new and existing products; the ability of the company to successfully execute strategic plans; the impact of acquisitions and divestitures; significant adverse litigation or government action, including related to product liability claims; challenges and uncertainties inherent in new product development; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; changes to governmental laws and regulations and domestic and foreign health care reforms. 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. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

SOURCE Johnson & Johnson

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