Medicrea Acquires 3 Patents from Dr. Paul McAfee to Enhance Surgical Planning of 3D-Printed Titanium Interbody Devices

Posted On November 28, 2017 By OrthoSpineNews In Spine, Top Stories /

November 28, 2017

NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ Adaptive Spine Intelligence™ (ASI) technology, announced today the Company has acquired three patents from Dr. Paul McAfee, of University of Maryland St. Joseph’s Medical Center. These patents cover the methodology used to measure and plan interbody devices used in spinal surgery.

The three patents acquired from Dr. McAfee protect the associated intellectual property around a novel technique for physiologically selecting interbody device height based on patient anatomy to further enhance Medicrea’s UNiD™ ASI platform.

Dr. McAfee stated, “Medicrea is uniquely positioned to benefit from this intellectual property to enhance their industry-leading surgical planning service. Surgeons understand that the effective use of interbody devices plays an important role in determining outcomes for spinal patients and spend significant time intra-operatively testing for the ‘best-fitting’ interbody device based on a limited range of dimensions provided by legacy manufacturers. However, this current technique often leads to compromise between two available interbody dimensions and lacks scientific rationale. Knowing the level of inventory required to deliver a range meeting patient needs in every case is cost-prohibitive for even the largest legacy manufacturers. There is a clear demand for the reliable planning tools and services available with UNiD™ ASI.”

Medicrea’s systems-based approach to spine with engineering services and in-house 3D-Printing capabilities makes the Company uniquely able to deeply collaborate with surgeons to create interbody device solutions that are adapted to their clinical and mechanical preferences, as demonstrated by the recent FDA clearance of the Company’s IB3D™ offering of 3D-printed Titanium interbody devices with AdapTEK™, surgeon-adaptive technology for unparalleled control of the implant design and dimensions provided.

Denys Sournac, President and Chief Executive Officer, stated, “We are focused on fully integrating the important work done by Dr. McAfee into our proprietary UNiD™ HUB surgical planning software. Combining data-driven planning techniques with the ability to deliver personalized implants will significantly reduce the inventory required for each case while ensuring the optimal implant is provided for the patient at each level operated. Acquiring new planning methodologies, as we have done with Dr. McAfee, will allow Medicrea to further provide healthcare shareholders with scientific evidence supporting the surgical strategy and promoting a cost-effective care continuum in line with our Adaptive Spine Intelligence™ technology.”

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 150,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED
LEI: 969500BR1CPTYMTJBA37

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com

Novastep adds airlockGO® to its cleanSTART® Delivery Platform

Posted On November 28, 2017 By OrthoSpineNews In Extremities, Top Stories /

Orangeburg, NY, Nov. 27, 2017 (GLOBE NEWSWIRE) — Novastep, Inc., and its affiliates (“Novastep” or the “Company”), a global medical technologies company specializing in the foot and ankle, has announced an expansion of their cleanSTART® Delivery Platform with the launch of their airlockGO^® product line.

The airlockGO^®system combines Novastep’s UDI-compliant sterile packed, single-use instruments kits and implants into a ready-to-use holder. Each airlockGO^® box is designed to address a given pathology of the foot and ankle by assembling all-inclusive, self-contained procedure-specific configurations of implants and instruments into a single container. It eliminates the hassle of onsite sterilization. A single airlockGO^®box replaces the need for sterilization trays which undergo costly, timely and sometimes inexact sterilization cycles.

“AirlockGO benefits all parties involved because each unit has everything you need for a given surgery in a single container that is about the size of a shoe box.” said Vadim Gurevich, President and CEO of Novastep Inc., adding that “The entire premise behind AirlockGO is to enhance OR efficiency, reduce costs and improve inventory management.”

Operating room efficiency and cost reduction are prime areas of focus for Novastep. The company works directly with hospitals and surgery centers to reduce healthcare costs and improve process flows. Novastep’s cleanSTART^®deployment technology and airlockGO^® product offerings allow a systematized, logistics platform that substantially reduces inventory and sterile field volumes, while minimizing lost or damaged instrument delays and lifecycle expenses.

Mark Prissel, DPM at Orthopedic Foot & Ankle Center of Columbus, OH, emphasized that “airlockGO is designed to benefit the patient, surgeon, and facility providing a streamlined case-specific approach to high quality single use instruments and implant technology for foot and ankle surgery, while remaining cost conscious.” Prissel further explained that “The result is the same outstanding experience I am accustomed to with the traditional Airlock platform, but with improved efficiency.”

About Novastep
Novastep is a global medical device company specializing in the design, development and commercialization of advanced technologies that treat conditions affecting the foot and ankle. The Company is focused on optimizing clinical efficiencies, inventory management and healthcare economics by transforming the way foot and ankle products are deployed and utilized in the surgical environment. Novastep has allied itself with a strategic network of key international opinion leaders to deliver breakthrough technologies, innovative services and compelling medical education programs to the foot and ankle community. Novastep’s portfolio, services and distribution platforms are uniquely positioned to address foot and ankle trauma, deformity corrections and Charcot fracture management.

For further information concerning this announcement and/or Novastep, Inc., send all inquiries to info@novasteportho.com or call 877.287.0795.

Related Links

For general information: novastep-us.com

MEDICA 2017 Proves to Propel TracPatch Wearable Technology into the Global Medical Arena

Posted On November 27, 2017 By OrthoSpineNews In Extremities, Top Stories /

SACRAMENTO, CA (PRWEB) NOVEMBER 22, 2017

El Dorado Hills, CA, November 21st, 2017 Consensus Orthopedics Inc. introduced TracPatch™ at MEDICA 2017 to a phenomenal response. TracPatch asserted itself as the leading wearable device for total joint patient monitoring. Partnering with Wearable Technologies AG at MEDICA in Dusseldorf, Germany, TracPatch™ stole the show as a new revolutionary wearable device empowering at-home patient recovery and remote monitoring for effective managed care.

Dr. John Mariani, a distinguished Orthopedic Surgeon at Reconstructive Orthopedics, says “The international reach of MEDICA and Wearable Technologies AG was extraordinary. Their pavilion at MEDICA provided the ideal platform to showcase TracPatch. Being able to speak closely with health care professionals, leading research centers, and recognized international suppliers reflected the need and desire for TracPatch, a truly innovative product in MedTech.”

Introduced to the international stage at MEDICA, TracPatch passively and continuously tracks a user’s daily activities, including exercise compliance, range of motion, and daily goals, while maintaining the critical connection between the healthcare provider and patient. Through data collection and monitoring, TracPatch™ ensures patients will receive effective care based on their individual needs.

“As a first-time attendee and exhibitor at MEDICA 2017, we were thrilled and humbled by the response TracPatch received. MEDICA provided TracPatch an exceptional introduction to the global healthcare industry. We were able to connect with key decision makers and leaders in the MedTech space and overall I would say MEDICA was a huge hit,” said Michael Droege, Vice President of Global Business Development at Consensus.

The introduction of TracPatch by Consensus Orthopedics at MEDICA in Dusseldorf, Germany is the beginning of an international expansion that will revolutionize the way data is used in orthopedics. Learn more at tracpatch.com

About Consensus® Orthopedics, Inc.
Consensus Orthopedics was founded in 1992 as a medical device consulting company located in California. In 1996, Consensus Orthopedics acquired US Medical Products becoming a global manufacturer of reliable large joint orthopedic devices. Since 1996, Consensus Orthopedics has been providing the orthopedic industry with exceptional hip and knee joint replacement devices. Its signature knee system, the Consensus Knee System, has over 20 years of reliable and reproducible results. With a deep understanding of the orthopedic industry, Consensus launched its innovative TracPatch Technology division focusing on orthopedic wearable technology, which combines Consensus Orthopedics 25 years of orthopedic experience with innovative Big Data capabilities. TracPatch is a revolutionary new device empowering at-home patient recovery and remote monitoring for effective managed care. With a focus on evidence based medicine, Consensus Orthopedics is changing patient care and the future of orthopedics. Learn more at http://www.consensusortho.com.

BONESUPPORT™ Signs Commercialization Agreement for the Italian Market

Posted On November 21, 2017 By OrthoSpineNews In Biologics, Top Stories /

Lund, Sweden, 08.00 CET, 20 November 2017 – BONESUPPORT™, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform today announces it has signed a second distribution agreement for Italy with Citieffe Srl to strengthen its access to trauma and orthopaedic surgeons in this market.Citieffe is a trauma implant manufacturer based in Bologna. It is part of the Medistream Group, owned by ArchiMed an independent French Healthcare Investment Firm. Citieffe, which has a direct sales force in Italy with national coverage, views BONESUPPORT’s CERAMENT® products as a very synergistic addition to its current implant offering to trauma surgeons in particular.

This new commercialization agreement in Italy will improve coverage for BONESUPPORT’s products in a key European market. BONESUPPORT markets its products directly in five European countries: the UK, Germany, Switzerland, Sweden and Denmark. BONESUPPORT has a commercial team of 20 people in Europe focused on driving the sales of its antibiotic-eluting injectable bio-ceramic bone substitute products, CERAMENT® G and CERAMENT® V.

Richard Davies, CEO of BONESUPPORT, commented: “I am pleased that we have signed this agreement with Citieffe, a commercial partner that will give us access to a portfolio of new trauma customers in the Italian market. We see Italy as a particularly important sales opportunity for CERAMENT® G and CERAMENT® V given the size of the market and the clear clinical and economic benefits that our antibiotic-eluting products deliver. I look forward to a mutually beneficial relationship with Citieffe.”

For more information contact:

Richard Davies, CEO

+46 (0) 46 286 53 71

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

Citigate Dewe Rogerson

Pip Batty, David Dible, Marine Perrier

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

About BONESUPPORT™

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

About Us

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bioceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.BONESUPPORT’s marketed synthetic bone graft substitutes CERAMENT™ BONE VOID FILLER (BVF), CERAMENT™ G* and CERAMENT™ V* are all based on the Company’s novel and proprietary CERAMENT technology platform.The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot. The Company’s research and development is focused on the continuing development and refinement of its existing technology to extend its use into additional indications by the elution of other drugs and therapeutic agents.BONESUPPORT’s products are based on an innovative technology backed by an intellectual property portfolio of approximately 100 registered and/or pending patents. BONESUPPORT has a nine year track record of safety and efficacy in treating patients with an estimated number of 30,000 procedures performed to date with its products worldwide based on sales data.BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent.The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies.BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152).Further information is available at ww.bonesupport.com*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United StatesBONESUPPORT™ is a registered trademark.

Paradigm Spine, LLC Announces-Highmark, Inc. Is 1st Private Payor To Issue Exclusive Positive Coverage Policy For coflex® Interlaminar Stabilization®

Posted On November 20, 2017 By OrthoSpineNews In Spine, Top Stories /

NEW YORK, Nov. 20, 2017 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis announces issuance of a Highmark, Inc. Medical Policy, entitled “Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)” dated November 6, 2017. The coverage policy may be found here https://www.highmarkbcbswv.com/west-virginia-commercial-medical-policy/S-191-016.html

Importantly, the Medical Policy specifically excludes any other interspinous distraction or interlaminar stabilization devices, other than the coflex^® device, from coverage. Highmark, Inc. is the first commercial insurance carrier to provide exclusive coverage for the coflex^® device, due to the more than 85 peer-reviewed published articles supporting the safety and effectiveness of the coflex^® technology.

Lumbar spinal stenosis (“LSS”), affecting 1.6 million patients annually, is a debilitating and degenerative disease in older patients (>50 yrs) often associated with significant leg and back pain, leg numbness and weakness, causing a significant reduction in an active lifestyle. Traditional surgical treatment options for LSS includes a decompression that removes bone and soft tissue and may also require a fusion to stabilize the spine. The coflex^® device is a non-fusion, motion preserving stabilization implant, that is FDA PMA approved for the treatment of Lumbar Spinal Stenosis, and can be used in conjunction with a decompression or used in lieu of a spinal fusion.

To learn more about coflex^® Interlaminar Stabilization^®, please visit www.coflexsolution.com.

J. Rush Fisher, MD, Chief of Spine Section, Christiana Care Health Services – “Over the last four years, I’ve treated 67 patients with coflex^® and have been very satisfied with the outcomes. Coflex^® offers stability to the spine while maintaining physiologic function to the motion segment. The coflex^® procedure is often an outpatient, non-fusion procedure that allows for fast recovery, and a high quality functionally active lifestyle for my patients. I’m understandably pleased that insurance coverage will now be available to more of my patients.”

Marc Viscogliosi, Chairman & CEO – “With over 85 peer-review published articles, including landmark 5 year follow-up studies, medical society guidelines, and now with commercial insurance coverage, it is wonderful to be able to expand patient access to the coflex^® technology. We are particularly gratified by the recognition of Highmark to exclusively cover coflex^® as the only interlaminar/interspinous device treatment option for LSS.”

About Paradigm Spine, LLC

Paradigm Spine, LLC was founded in 2004 and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company’s signature product is the coflex^® Interlaminar Stabilization^®device, which has more than 20 years of clinical history and patients treated in more than 40 countries worldwide.

SOURCE Paradigm Spine, LLC

Invibio Investing to Accelerate Innovation for Medical Device Companies

Posted On November 17, 2017 By OrthoSpineNews In Biologics, Top Stories /

THORNTON CLEVELEYS, UNITED KINGDOM (PRWEB) NOVEMBER 16, 2017

Invibio Biomaterial Solutions has implemented a series of investments to help achieve the best possible clinical outcomes and lower total healthcare costs, a challenge faced by both the medical profession and industry, including medical device companies, globally. By assisting medical device companies to change the way they develop new products Invibio is focused on accelerating the time-to-market of new innovations. To deliver on this and provide greater clinical efficacies, the company has invested in clinical-study expertise, component manufacturing facilities and component testing. The innovator of implantable PEEK-OPTIMA™ polymer is also launching a new website that efficiently provides information on materials and applications to OEMs and Health Care Professionals (HCPs), and a comprehensive journal with further scientific information and clinical evidence.

John Devine, Medical Business Director at Invibio Biomaterial Solutions explains the quandary of innovative medical device makers: “When faced with delivering a consistent quality of healthcare at the lowest cost, the market has yet to create an environment that encourages more ambitious solutions than simply preserving the status quo at a fractionally reduced price.”

Redefining the total cost of care

Defining “best clinical outcomes” while delivering healthcare at the lowest possible cost is challenging, because clinical outcomes are typically obtained through clinical studies, which are expensive and time-consuming. In addition, there could be variations in the level of clinical evidence by region and different types of stakeholders and their needs, which can, for example, depend on where they sit on the curve of the diffusion of innovation. As a consequence, the medical device industry faces a difficult task, when seeking to demonstrate that new product innovations are addressing these issues and, ultimately, improving patient care.

John Devine sums it up: “The majority of current cost metrics focus on up-front purchasing costs rather than the total cost of care. For example, no standards exist for accurately assessing complication rates, or measuring the cost of revision surgeries, and reflecting these in purchasing decisions.”

As a leading pioneer in the use of PEEK-OPTIMA polymer solutions in medical applications, Invibio is convinced it can deliver the greatest clinical and economic benefits in four key areas, Dental, Spine, Orthopedics, and Trauma.

Establish and maintain clinical efficacy

To help raise its own bar for patient care and provide even greater clinical efficacy, Invibio recently recruited a clinical study manager and is working with Health Care Professionals (HCPs), medical device manufacturers and other stakeholders to determine the clinical and economic impact of its solutions. The company has also brought in clinical relations expertise to interact with HCPs, hospitals and payers. Martin Court, Executive Director at Victrex, emphasizes: “Doing so ensures that the clinical evidence we develop is not only shared in the marketplace, but accurately supports the benefits our materials can offer patients and the entire healthcare community.” As a result of these enhanced research and clinical data capturing efforts, Invibio has become more certain of the effectiveness of its solutions.

Investments in component manufacturing and testing

In addition, the company´s investments have made it easier for medical device companies to innovate and change the way they develop new products. Court continues: ”Our investment in component manufacturing facilities and component testing, for example, gives us a greater role in the design, development and commercialization of trauma fracture plates made of PEEK-OPTIMA™ Ultra Reinforced, a carbon-fiber-reinforced polymer. We have also pledged more support for our customers’ new product development programs. In addition, we are continuing to help customers worldwide navigate the challenging, regulatory pathway toward product safety and efficacy. It’s a win-win for Invibio, our customers, and patients alike.”

“Invibio Insider” journal and a new website for additional insights

Invibio is also launching a new comprehensive annual journal, the “Invibio Insider”, the first edition of which offers a detailed insight into key topics that will help to pioneer progress in the medical arena. Focused topics are intended to provide a greater understanding of the levels of clinical evidence, and what that may mean in combination with the company´s strategic drive to improve patient and clinical outcomes. It also explores approaches for treating challenging patients, taking into account the HCP’s perspective, and showcases recent clinical evidence while also discussing its potential economic impact.

The company´s new website will serve as a hub for OEMs and Health Care Professionals (HCPs) alike. For OEMs, it is a go-to practical and educational resource for implantable PEEK related knowledge and clinical data, including product offerings, manufacturing, quality and partnering for custom-design and regulatory services. For HCPs, it aims to facilitate the clinical adoption of new medical devices made of the company´s high-performance polymer, by providing implantable PEEK-related knowledge, clinical data and information concerning the potential benefits of Invibio´s solutions for HCPs and ultimately their patients. With a new emphasis on clinical evidence and an easy to navigate online academy, Invibio is not only addressing the needs of different target groups, but also hoping to contribute to achieving the best possible clinical outcomes and lowering the total costs of care.

Further information is available on Invibio´s new website: https://invibio.com.

About Invibio Biomaterial Solutions
Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in ~9 million implanted devices worldwide. INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved.

About Victrex plc
Victrex is an innovative world leader in high performance polymer solutions, focused on the strategic markets of automotive, aerospace, energy (including manufacturing & engineering), electronics and medical. Every day, millions of people use products and applications, which contain our materials – from smart phones, aeroplanes and cars to oil and gas operations and medical devices. With over 35 years’ experience, we develop world leading solutions in PEEK and PAEK-based polymers, and selected semi-finished and finished parts which shape future performance for our customers and our markets, and drive value for our shareholders. Find out more at http://www.victrex.com

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Federal Jury Returns $247 Million Verdict in Defective Hip Implants Case

Posted On November 16, 2017 By OrthoSpineNews In Regulatory, Top Stories /

DALLAS, Nov. 16, 2017 /PRNewswire/ — A federal court jury in Texas returned a $247 million verdict on behalf of six people who suffered serious medical complications caused by the defective metal-on-metal hip implants made by Johnson & Johnson (NYSE: JNJ) and its subsidiary DePuy Orthopaedics Inc.

The one-man, seven-woman jury deliberated for 14 hours before reaching its verdict, which includes more than $78 million in compensatory damages for the six plaintiffs and more than $168 million in punitive damages assessed against Johnson & Johnson and DePuy.

The verdict, delivered November 16, 2017, follows claims filed by New York residents Ramon Alicea, Uriel Barzel, Karen Kirschner, Hazel Miura, Michael Stevens, and Eugene Stevens who received DePuy’s Pinnacle Acetabular Cup System hip implant. The plaintiffs alleged that the devices had unreasonably high failure rates resulting in severe pain and inflammation, bone erosion, tissue loss and other problems. The victims further claimed that DePuy officials knew about the dangers of the Pinnacle hip implants but failed to warn doctors or patients.

“We thank this jury for sending a very strong message about the responsibility the defendants have to take care of their consumers,” said lead attorney Mark Lanier of The Lanier Law Firm in Houston. “Unfortunately, it took the defendants putting the plaintiffs through burdensome litigation before justice could be served. The companies should have done the right thing when these serious medical concerns became known many years ago.”

The trial was the fourth “bellwether” in the multidistrict litigation (MDL) consolidating more than 9,000 similar lawsuits nationwide. Bellwether trials are set to establish evidence and evaluate witness testimony that is representative of the issues involved in mass litigation. Two previous trials involving plaintiffs from California and Texas resulted in verdicts of $502 million and $1.04 billion.

The case, presided over by U.S. District Court Judge Ed Kinkeade of the Northern District of Texas, is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, No. 3:11-md-02244.

With offices in Houston, New York and Los Angeles, The Lanier Law Firm is committed to addressing client concerns with effective and innovative solutions in courtrooms across the country. The firm is composed of outstanding trial attorneys with decades of experience handling cases involving pharmaceutical liability, asbestos exposure, commercial litigation, product liability, maritime law, and sports and entertainment law. Visit http://www.lanierlawfirm.com.

Contact:
J.D. Cargill
The Lanier Law Firm
713-659-5200 or jdc@lanierlawfirm.com

SOURCE The Lanier Law Firm

Kuros Announces Management Changes

Posted On November 16, 2017 By OrthoSpineNews In Biologics, Top Stories /

Schlieren (Zurich), Switzerland, November 16, 2017

Kuros Biosciences AG announced today the promotion of Dr. Joost de Bruijn to Chief Executive Officer (CEO), effective December 4, 2017. Dr. de Bruijn is co-founder and current managing director of Kuros Biosciences BV (formerly known as Xpand Biotechnology BV), a wholly owned subsidiary of Kuros. Dr. Ivan Cohen-Tanugi has decided to step down as CEO and member of the Board of Directors. Further, Kuros’ founding CEO and current President, Didier Cowling, will retire from the Executive Management team to serve as a senior advisor to the CEO and continue to serve as a Director on the company’s Board.

During the course of 2017, Kuros has made significant progress with its lead program MagnetOs, a novel synthetic bone graft substitute designed to regenerate bone in the implanted site in the body, which received clearance in the US and in Europe for commercial sale. Currently, the Company is preparing the launch of the product.

Dr. Christian Itin, Chairman of the Board commented: “We welcome Joost as the new CEO of Kuros and are looking forward to his leadership of the Company. With his intimate knowledge of our key products, and the orthobiologics space, he is very well positioned to take the Company to its next stage.”

Dr. Joost de Bruijn commented: “I am delighted and honored by the trust of the Board to take on the role of CEO. We have significant opportunities with MagnetOs and KUR-111/KUR-113 to build an outstanding orthobiologics company and, together with the team, I look forward to bringing our products to market and building value for patients and shareholders.”

Dr. Christian Itin added: “We would like to thank Dr. Ivan Cohen-Tanugi for making progress towards commercial launch during a transitional year highlighted by product approvals and wish him all the best in his future endeavors. Also, the Board would like to thank Didier Cowling for his valued and dedicated service to the Company as its founding CEO and for supporting the Company to reach commercial stage.”

About Joost de Bruijn

Dr. Joost de Bruijn founded Xpand Biotechnology BV in 2005 and was managing director ever since. He holds the positions of Professor of Biomaterials at Queen Mary University of London, UK (since 2004) and Professor of Regenerative Medicine and Entrepreneurship at Twente University, the Netherlands (since 2011). In 2007, he founded Progentix Orthobiology that signed an exclusive development agreement with NuVasive in 2009 for a novel family of calcium phosphate synthetic bone substitutes. Prior to founding Xpand he was Research Director Bone at IsoTis for seven years, during which he specialized in bone tissue engineering technologies that were brought to clinical application. Dr. de Bruijn has more than 20 years of experience in academia and the life science industry. He has published 165 papers in peer-reviewed journals, and is the inventor of 24 patent families. Dr. de Bruijn is scientific editor and reviewer for numerous international biomaterials, tissue engineering and regenerative medicine journals. He received his PhD from Leiden University in 1993.

For further information, please contact:

Kuros Biosciences AG

Harry Welten

Chief Financial Officer

Tel: +41 44 733 46 46

harry.welten@kurosbio.com

About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

Media Release (PDF)

Kuros Biosciences Ltd, Wagistrasse 25, CH-8952 Schlieren

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New England Baptist to open spine center thanks to largest donation in its history

Posted On November 14, 2017 By OrthoSpineNews In Spine, Top Stories /

11-14-2017 – By Jessica Bartlett – Reporter, Boston Business Journal

New England Baptist Hospital will create a new spine institute, thanks to a $3 million gift from one of its board members.

Jeffrey Libert, a trustee of the hospital, recently gifted the hospital $3 million on behalf of his family to form the Libert Family Spine Institute, which will look to create a new singular door for patients suffering from back pain and find approaches and treatments beyond surgical interventions.

The donation is the largest in the hospital’s history, and is on top of $2 million Libert had already donated to the hospital for medical education and research.

“With the largest number of spine surgery patients regionally, and a significant volume of non-surgical patients, NEBH is uniquely positioned to enhance clinical care by leveraging data with predictive analytics to improve existing treatments and design better options for patients with spine disease or injury,” said Dr. Scott Tromanhauser, chief of spine surgery, chief medical quality officer and director of research administration for the hospital, in a statement. “By establishing this institute, we will be able to make a significant difference in how back pain is treated.”

READ THE REST HERE

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IntraFuse Receives FDA 510(k) Clearance for FlexThread™ Fibula Pin System

Posted On November 14, 2017 By OrthoSpineNews In Extremities, Regulatory, Top Stories /

LOGAN, Utah, November 1, 2017 – IntraFuse, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for its FlexThread™ Fibula Pin System.

The IntraFuse FlexThread™ Fibula Pin System provides percutaneous fixation of distal fibula fractures, primarily Danis-Weber B type fractures, or trans-syndesmotic fractures. The simple and elegant design is easy to insert and cost competitive with today’s standard-of-care internal fixation hardware. Incorporating IntraFuse’s proprietary FlexThread™ technology, the distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod. Upon insertion of the implant into the fibula, the rigid rod portion of the implant spans and supports the fracture and the flexible screw portion bends as needed to thread into the intramedullary canal. With internal screw fixation on one side of the fracture and cross screw fixation through the rod on the other side of the fracture, proper bone alignment and length can be maintained during the healing period. Additionally, the FlexThread™ Fibula Pin is compatible with either screw or flexible fixation of the syndesmosis joint as needed.

To accommodate the anatomic size range of fibulas, the FlexThread™ Fibula Pin is available in three different screw diameters, each with two length options. Using routine intramedullary and screw fixation techniques, bone preparation is a simple, three step sequence: place guide wire, ream, tap. Optional fracture site compression is achieved concurrent with insertion of the implant, and delivery of cross fixation screws is facilitated by a guide that connects directly to the implant inserter.

The FlexThread™ Fibula Pin provides anatomic, intramedullary fixation that may have potential clinical advantages over fibula plating systems, including: reduced risk of hardware related pain, reduced rate of hardware removal, less risk of wound complications, infection and other morbidities due to a less invasive procedure, and less disruption of the periosteum which facilitates faster healing.

“Intramedullary fixation is the standard-of-care today for most fractures of the large, long bones of the body due to superior clinical outcomes versus plating systems, yet plating systems are still the standard-of-care for the smaller, long bones of the extremities,” states Wade Fallin, CEO of IntraFuse. Fallin continues, “FlexThread™ is a platform technology that can address the unique requirements for intramedullary fixation of small bone fractures where off-axis entry into the bone canal is required, or where the bone is curved. Now cleared for both clavicle and fibula fractures, the FlexThread™ technology is in further development for additional indications.”

IntraFuse is a development stage medical device company incubated and operated by Surgical Frontiers. Inquiries regarding distribution and commercialization partnerships are welcome.

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use. Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Wade Fallin

CEO

wade@surgicalfrontiers.com

www.surgicalfrontiers.com

800-230-3710