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March 30, 2017 OrthoSpineNews

NESS ZIONA, Israel, March 30, 2017 /PRNewswire

CollPlant (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products (recombinant human, “rhCollagen”), today provided a commercial and operational update in its annual reports.

Most recently, in November 2016, the Company announced the signing of an exclusive distribution agreement with Arthrex GMBH to distribute Vergenix™STR, CollPlant’s CE Mark-approved treatment for tendinopathy, in Europe, and has supplied Arthrex with first orders. Arthrex, an affiliate of Arthrex Inc., based in Naples, FL, is a leading orthopedics company and is widely considered to be the world leader in sports medicine. Additionally, since mid-2016, CollPlant signed a number of marketing agreements for Vergenix™FG, its wound care product, covering Italy, Switzerland and Turkey. Commercial treatments have been completed over several months in Switzerland and Italy, and physicians’ feedback regarding patient results have been very positive.

CollPlant has also reported extensively for the first time on the development of its collagen-based biological ink, bioInk, for use in 3D printing of organs and tissues. Specifically, the Company is developing rhCollagen-based bioInk formulations for indications including skin, orthopedics, ophthalmology, heart and lung. The Company’s goal for the coming year includes working with a strategic international partner to further develop a specific indication of this product.

CollPlant’s Highlights for 2016 and the start of 2017

  • Vergenix™FG – a wound filler based on the Company’s rhCollagen technology, for treatment of acute and chronic wounds: The product received CE Mark approval and distribution agreements have been signed in Italy, Switzerland and Turkey, including first orders, a portion of which were supplied in 2016. The initial target market for Vergenix™FG is estimated at $500 million annually. The Company has received positive feedback from physicians who have treated patients with the product in Europe.
  • Vergenix™STR – a gel based on the Company’s rhCollagen technology, indicated for the treatment of tendinopathy: The product was granted CE Mark approval following successful clinical trials, and an exclusive distribution agreement was signed with Arthrex covering Europe, India and Africa. To date, CollPlant has reported on two orders supplied to Arthrex, and the product is currently in the initial stages of penetrating the European market. First treatments have commenced in Europe. The target market for Vergenix™STR is estimated at about three million procedures per annum worldwide, with a value of $2 billion.
  • BioInk for 3D printing of organs and tissues – the Company is developing a biological ink (bioInk) based on its rhCollagen technology, intended for use with 3D printers, to print tissues and organs. In parallel, the Company is assessing potential joint ventures with international companies to further develop various applications such as skin, bones, ophthalmology, heart and lungs. The Company’s objective for this year is the development of a specific indication in order to achieve the creation of multilayer tissue combined with stem cells and other cells.  The segment of 3D printing addresses the entire global medical market.

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary rhCollagen, among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix™STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; and Vergenix™FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds. CollPlant’s business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Contact at CollPlant:
Eran Rotem
Chief Financial Officer
Tel: +972-73-2325600/612
Email: Eran@collplant.com
Contact at Rx Communications Group, LLC
Paula Schwartz (for US Investors)
Senior Vice President
Tel: +1-917-322-2216
Email: pschwartz@rxir.com

SOURCE CollPlan


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March 30, 2017 OrthoSpineNews

By Al Jones | March 29, 2017

PORTAGE, MI — Stryker Instruments division is undergoing an organizational restructuring that will mean a loss of jobs for an undisclosed number of people at the medical technologies company.

“After a thoughtful evaluation, we have determined that organizational changes are needed to help drive efficiencies across our business, including limited reductions in our workforce,” the company stated in a press release issued in response to inquiries Wednesday.

It went on to say, “These changes will allow us to invest in important areas to build new capabilities that will help us keep growing in Kalamazoo and continue meeting the needs of our customers.”

Stryker Instruments designs, manufactures and markets specialty surgical equipment, operating room products, orthopedic saws, drills and accessories. It also make advanced systems for such things as pain management and waste management.

“The Kalamazoo community has played an important role in our company’s history,” the company stated. “Our founder started the business here and today we have multiple manufacturing and corporate offices in the area. We are committed to strengthening that relationship through our upcoming expansion in Portage.”

Portage Mayor Peter Strazdas said he has not been told how many people will be affected by the restructuring and he hopes the company is working to find them other opportunities. But he said he understands that large corporations have ups and downs and hopes internal changes will help make Stryker a stronger company in the long run.

 

READ THE REST HERE


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March 30, 2017 OrthoSpineNews

QUEBEC CITY, March 29, 2017 /PRNewswire/ — Bodycad announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bodycad Unicompartmental Knee System, enabling the commercial launch of this truly personalized orthopaedic restoration. Bodycad is the first Canadian company to receive FDA clearance for a joint reconstruction implant system.

Bodycad’s revolutionary Unicompartmental Knee System is designed to optimize personalized restoration of the patient’s unique anatomical features and kinematics. The system is based on proprietary 3D rendering of medical images of the patient’s anatomy. The restoration is delivered as a “procedure in a box” that completely revolutionizes the way orthopaedic implant and instrument applications are delivered and utilized in the operating room environment.

“The personalized restoration is created only after proper acquisition of data from the patient on an individualized level,” says Etienne Belzile, MD, orthopaedic surgeon and assistant professor at Laval University. “The benefit of personalized restoration is the possibility of a better fit to the individual, less trauma to the soft tissue, and potentially a faster recovery overall.”

Bodycad uses proprietary imaging algorithms to rapidly produce a precise 3D image of the patient’s knee. Its suite of Personalized Restoration Software enables a seamless integration of the image to implant process called the PREP (personalized restoration evaluation process). The efficient and rapid process is designed to increase patient satisfaction while improving economic quality metrics.

“Our proprietary software is based on 20 years of research in anthropometric data and is the first CAD/CAM software specifically developed for the personalization of orthopaedic implant and instrument design,” says Jean Robichaud, founder and CEO of Bodycad. “I am delighted to have FDA clearance to bring this important technological advancement to market. Our goal is to transform the way surgeons, patients and insurers think about the potential of mass customization to optimize patient care.”

About Bodycad

Bodycad is a Quebec City-based developer and manufacturer of personalized orthopaedics. Its personalized restorations offer patients a high level of conformity to their unique anatomy, with the potential for greater comfort, fit and durability that make the pursuit of orthopaedic perfection possible. Learn more at www.bodycad.com.

Contact

Andy McLeod
2035 rue du Haut-Bord
Quebec, Quebec, Canada
G1N 4R7
(418) 527.1388
info@bodycad.com

 


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March 29, 2017 OrthoSpineNews

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced another milestone achievement in its 60,000th completed joint arthroplasty case. This milestone reflects the continuing and rapid adoption of OrthAlign’s handheld precision alignment and positioning technology by surgeons throughout the world.

OrthAlign provides highly accurate, computer-assisted, handheld technologies for surgeons to receive real-time, actionable data for precise alignment and positioning of components in total knee, unicondylar knee, and total hip (both posterior and anterior) arthroplasty surgeries. Over 15 peer-reviewed clinical studies have been published to date, validating OrthAlign’s accuracy, simplicity of use, and benefits of use for the patient.

David W. Anderson, MD of the University of Kansas Medical Center in Kansas City, KS used KneeAlign to mark the 60,000th OrthAlign case milestone. “What I like about OrthAlign technology is that it is quick and easy to use and it doesn’t require all of the extra hassle and cost that comes with using robotics or other competing technologies,” said Dr. Anderson. “Furthermore, I’ve also noticed that my patients don’t have as much swelling when OrthAlign technology is used, as I don’t have to enter the femoral canal. I believe this is a good system for me, my OR staff, and most importantly, for my patients.”

“The global adoption rate of our products highlights the power of OrthAlign technology,” said Eric B. Timko, OrthAlign’s Chief Executive Officer and Chairman. “We are only scratching the surface with 60,000 cases and are confident that our efforts in expanding customer reach and portfolio expansion will further drive penetration of our technology. Congratulations to Dr. Anderson and the hundreds of other surgeons around the world who have adopted OrthAlign technology into their practices for better outcomes.”

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”


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March 29, 2017 OrthoSpineNews

WALNUT CREEK, Calif., Mar 29, 2017 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing, cervical-fusion technology, announced the addition of two industry veterans to the commercial leadership team.  Scott Lynch has joined the company to lead Global Marketing, and Michael Scott is assuming International leadership.  Together, Mr. Lynch and Mr. Scott have over 40 years of relevant industry experience.

Mr. Lynch joins the company with over 22 years of medical device and 15 years of spine industry marketing experience having previously served as Vice President of Global Marketing at DFINE, VertiFlex, and Zimmer Spine.

Mr. Scott joins Providence following over 16 years at ArthroCare as Vice President of OUS Sports Medicine, Vice President of Asia Pacific Commercial Operations, and US Vice President ENT Sales at Smith & Nephew.

Providence also announced recent 510(k) clearances from the FDA for the standalone use of the CAVUX™ Cervical Cage-L System as well as approval for its ALLY™ Facet Screws.  These new clearances are complimentary to the company’s flagship DTRAX® Spinal System and are all provided terminally sterile for single-use to ensure efficiency and consistency.

Scott Lynch and Michael Scott are important additions to our Executive Management team at Providence.  Their veteran leadership and successful experience with high growth businesses make them an ideal fit for Providence at this exciting stage of our business,” said Jeff Smith, CEO of Providence Medical Technology.  “With these new 510(k) clearances, we are pleased to offer our surgeon customers stand-alone anterior stabilization and posterior non-segmental stabilization for their cervical fusions.”

The CAVUX™ Cervical Cage-L System is manufactured from medical grade titanium and available in a variety of sizes.  The implant offers proprietary grit-blasted and acid-etched surfaces, a large space for allogenic and autogenous bone graft and includes self-drilling and self-tapping screws for additional, standalone fixation.

The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.  The titanium implants are available in a variety of sizes to accommodate patient anatomy and are intended to provide mechanical support and stability until spinal fusion is achieved.

Providence Medical Technology’s family of products for cervical spinal fusion includes instruments, intervertebral cages, orthopedic bone screws, and allograft bone.  All products are provided sterile for single use only.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company developing innovative solutions addressing the $2 billion worldwide cervical spine market. The company’s focus is on commercializing the DTRAX® platform of single-use, tissue-sparing instruments and CAVUX™ and ALLY™ implants for cervical fusion, as well as other technologies that improve cervical spine procedures for both physicians and patients.

For more information, visit www.providencemt.com

 

SOURCE Providence Medical Technology, Inc.


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March 29, 2017 OrthoSpineNews

March 28, 2017

RANCHO SANTA MARGARITA, Calif.–(BUSINESS WIRE)–Liquidmetal® Technologies, Inc. (OTCQB: LQMT; the “Company”),announced today that it has passed additional pre-screening biocompatibility tests for use in medical implants and is now pursuing collaborations with medical implant companies.

In February of 2017, LQMT received long-term implantation results from parts 3, 10, 6 and 11 of the ISO 10993 (Biological Evaluation of Medical Devices) suite of tests, which include evaluation of genotoxicity, sub-chronic systemic toxicity, and pyrogenicity. LQMT alloy LM105 passed all of these tests well within the allowable limits. These results, combined with previously completed tests from ISO 10993 parts 10, 11, 4, and 5 which cover sensitization, irritation, acute systemic toxicity, hemocompatibility and cytotoxicity, indicate that the Liquidmetal process is compatible with a wide range of medical device requirements including long term implants.

“The results of these tests are very exciting and it positions the Company well to engage medical device customers in a broad range of implantable device applications including, cardiac rhythm, cochlear, spinal, and orthopedic implants among others. The Company will now focus on partnering with medical implant manufacturers to identify specific applications to further explore the use of Liquidmetal,” said Paul Hauck, Executive Vice President of Sales and Marketing at LQMT.

About Liquidmetal Technologies

Rancho Santa Margarita, California-based Liquidmetal Technologies, Inc. is the leading developer of bulk amorphous alloys. Amorphous alloys are unique materials that are distinguished by their ability to be injection molded and die cast into high performance applications for a broad range of markets. For more information, go to www.liquidmetal.com.

Contacts

Liquidmetal Technologies, Inc.
Otis Buchanan
Media Relations
949-635-2120
otis.buchanan@liquidmetal.com


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March 29, 2017 OrthoSpineNews

TAIPEI, Taiwan, March 28, 2017 /PRNewswire/ — Medeon Biodesign, Inc., a Taiwan medical device company, is pleased to announce that the Company led and successfully closed the Series A investment of Panther Orthopedics, Inc., a San Jose, CA start-up pioneering innovative dynamic fixation solutions for orthopedic extremity applications.

The orthopedic extremity device market continues to expand rapidly, primarily due to procedure volume growth, lifestyle influences and favorable demographics. Nevertheless, the market need for better fixation products for both trauma and sports medicine in fracture fixation and joint stabilization applications is still under served. “Current options for fixation include cortical screw and suture button flexible fixation devices. However, many limitations associated with currently marketed products are not being addressed,” said Dr. Kathryn Stecco, CEO and co-founder of Panther Orthopedics. “We have developed an innovative platform for dynamic extremity fixation, which we believe will provide continuous compression during the healing period while still allowing micromotion. The intuitive design of our solutions is easy to use and intended to eliminate the need for most second surgery removal, providing significant benefits for both the patients and the entire healthcare system.”

“We are excited to lead the investment of Panther Orthopedics to address the long-standing need of better clinical fixation during the healing period for orthopedic extremity applications,” said Dr. Yue-Teh Jang, CEO of Medeon Biodesign. “We are impressed with the team’s extensive experience, profound knowledge of orthopedic applications and broad KOL networking. We are confident that the Panther Orthopedics’ unique and innovative dynamic fixation solutions will be very welcome by the clinical community in the near future.”

About Medeon Biodesign

Medeon Biodesign (TPEx: 6499) is a publicly traded company located in Taipei, Taiwan, and currently listed on Taipei Exchange. The company focuses on the development of medical devices for minimally invasive surgeries to treat diseases of sizable patient population, such as cardiovascular, peripheral vascular, orthopedic, neurosurgery, obesity, gastroenterology, hematology, nephrology, gynecology, urology, and plastic surgery. For more information, please visit www.medeonbio.com/en.

Contacts
Dr. Yi-Ju Chen
+886.2.2881.6686
ir@medeonbio.com

SOURCE Medeon Biodesign, Inc.

Related Links

http://www.medeonbio.com/en


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March 29, 2017 OrthoSpineNews

PLAINSBORO, N.J., March 28, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today announced full commercial availability of its Cadence® Total Ankle System, a new ankle prosthesis developed in partnership with four world leading foot and ankle surgeons – Dr. Tim Daniels (University of Toronto), Dr. David Pedowitz (Rothman Institute, Philadelphia, Pa.), Dr. Selene Parekh (Duke University, Durham, N.C.) and Dr. Christopher Hyer (Orthopedic Foot & Ankle Center, Westerville, Ohio).

More than 200 Cadence total ankle procedures have been successfully performed in seven countries, since initial clinical use more than a year ago.  During this period, instrumentation updates and enhanced surgeon training were introduced, designed to further improve quality, patient safety, and procedural efficiency of the system.

Integra completed corrective actions required to close an FDA recall related to the clarification of the system surgical technique, which addressed a small percentage of intra-operative posterior tibial fractures occurring due to technique error.  The recall required no return of product, and since the implementation of the clarified surgical technique, no subsequent posterior tibial fractures have occurred in more than 100 procedures.

The Cadence system has garnered positive feedback among its users for advancements in implant and instrument design, along with a streamlined surgical technique.  Cadence incorporates several features to accommodate various patient anatomies, reduce potential clinical complications, and address common challenges associated with ankle arthroplasty procedure.  Key implant features include:

  • Side-specific, anatomical tibial components, designed to avoid fibular impingement.
  • Side-specific, anatomical talar components, designed to minimize resected talar bone and to preserve vascularity in the ankle.
  • Bearing insert components manufactured from a highly crosslinked ultra-high molecular weight polyethylene (HXL UHMWPE) for improved wear characteristics, and patent pending-biased sagittal profile options to address patients with subluxed talar anatomy.

“I’ve implanted over 50 Cadence Total Ankle prostheses.  I am very impressed with the versatility, reliability, reproducibility, and short-term outcomes of this implant,” said Dr. Tim Daniels. “The streamlined and reliable operative instruments and techniques of this procedure, combined with an anatomical design, offer significant advantages over other ankle systems on the market today.”

The Cadence Total Ankle System was previously available in a limited market release. The Cadence system is now fully available in the United States, Canada, and select European countries.  Integra plans to initiate several global post-market clinical studies with the Cadence system to further support product efficacy.

About Integra
Integra LifeSciences is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care.  Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies.  For more information, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2015 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

CONTACT: Integra LifeSciences Holdings Company

Investors
Angela Steinway
609-936-2268
angela.steinway@integralife.com

Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com

Media
Laurene Isip
609-750-7984
laurene.isip@integralife.com

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March 29, 2017 OrthoSpineNews

(NEW YORK — April 1, 2017) Knee replacement surgery for patients with osteoarthritis, as currently used, provides minimal improvements in quality of life and is economically unattractive, according to a study led by Mount Sinai researchers and published today in the BMJ. However, if the procedure was only offered to patients with more severe symptoms, its effectiveness would rise, and its use would become economically more attractive as well, the researchers said.

“Given its limited effectiveness in individuals with less severely affected physical function, performance of total knee replacement in these patients seems to be economically unjustifiable,” said Bart Ferket, MD, PhD, Assistant Professor, Department of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai and lead author on the study. “Considerable cost savings could be made by limiting eligibility to patients with more symptomatic knee osteoarthritis. Our findings emphasize the need for more research comparing total knee replacement with less expensive, more conservative interventions, particularly in patients with less severe symptoms.”

About 12 percent of adults in the United States are affected by osteoarthritis of the knee. The annual rate of total knee replacement has doubled since 2000, mainly due to expanding eligibility to patients with less severe physical symptoms. The number of procedures performed each year now exceeds 640,000 at a total annual cost of about $10.2 billion, yet health benefits are higher in those with more severe symptoms before surgery.

A team of researchers from the Icahn School of Medicine at Mount Sinai and Erasmus University Medical Center in Rotterdam, the Netherlands, set out to evaluate the impact of total knee replacement on quality of life in people with knee osteoarthritis. They also wanted to estimate differences in lifetime costs and quality adjusted life years or QALYs (a measure of years lived and health during these years) according to level of symptoms.

They analyzed data from two U.S. cohort studies: one with 4,498 participants aged 45-79 with or at high risk for knee osteoarthritis from the Osteoarthritis Initiative (OAI), and the other involving 2,907 patients from the Multicenter Osteoarthritis Study (MOST). OAI participants were followed up for nine years and MOST patients were followed up for two years. Quality of life was measured using a recognized score of physical and mental function, known as SF-12, and using some osteoarthritis-specific quality of life scores.

They found that quality of life outcomes generally improved after knee replacement surgery, although the effect was small. The improvements in quality of life outcomes were found higher when patients with lower physical scores before surgery were operated on.

In a cost-effectiveness analysis, current practice was more expensive and in some cases seemed even less effective compared with scenarios in which total knee replacement was performed only in patients with lower physical function.

“Our findings show opportunity for optimizing delivery of total knee replacement in a cost-effective way, finding the patients who will benefit the most, delivering the treatment at the correct point in their disease progression, and optimizing the cost so we can deliver the benefit to all who need it,” said Madhu Mazumdar, PhD, Director of the Institute for Healthcare Delivery Science at the Mount Sinai Health System, Professor of Biostatistics, Department of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai, and co-author of the study.

Funding for the cohort studies used in the analysis was provided by the National Institutes of Health, Merck Research Laboratories, Novartis Pharmaceuticals Corporation, GlaxoSmithKline, and Pfizer. Dr. Ferket is supported by the American Heart Association. The researchers have no competing interests to disclose.

About the Mount Sinai Health System

The Mount Sinai Health System is an integrated health system committed to providing distinguished care, conducting transformative research, and advancing biomedical education. Structured around seven hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services—from community-based facilities to tertiary and quaternary care.

The System includes approximately 7,100 primary and specialty care physicians; 12 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. Physicians are affiliated with the renowned Icahn School of Medicine at Mount Sinai, which is ranked among the highest in the nation in National Institutes of Health funding per investigator. The Mount Sinai Hospital is in the “Honor Roll” of best hospitals in America, ranked No. 15 nationally in the 2016-2017 “Best Hospitals” issue of U.S. News & World Report.  The Mount Sinai Hospital is also ranked as one of the nation’s top 20 hospitals in Geriatrics, Gastroenterology/GI Surgery, Cardiology/Heart Surgery, Diabetes/Endocrinology, Nephrology, Neurology/Neurosurgery, and Ear, Nose & Throat, and is in the top 50 in four other specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 10 nationally for Ophthalmology, while Mount Sinai Beth Israel, Mount Sinai St. Luke’s, and Mount Sinai West are ranked regionally. Mount Sinai’s Kravis Children’s Hospital is ranked in seven out of ten pediatric specialties by U.S. News & World Report inBest Children’s Hospitals.”

For more information, visit http://www.mountsinai.org/, or find Mount Sinai on Facebook, Twitter and YouTube.


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March 29, 2017 OrthoSpineNews

SAN DIEGO, March 29, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the CoRoent® Small Interbody™ System indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. This marks the first U.S. clearance for a cervical cage to be used at up to four contiguous levels.

Cervical radiculopathy and myelopathy secondary to cervical degenerative discs are common diagnoses in adult patients and have been shown to cause significant disability and loss of productivity.1 As a result of this common condition, more than 200,000 cervical surgical procedures are performed in the U.S. per year.2

“This FDA 510(k) clearance is another key milestone for NuVasive as we continue to deliver new innovation to the spine market. The ability to treat multi-level cervical disc degeneration in patients displaying cervical radiculopathy and myelopathy is a meaningful advancement for spine surgeons,” said Jason Hannon, NuVasive’s president and chief operating officer. “This first and only clearance is an example of NuVasive’s commitment to defining the components necessary to properly address an unmet clinical need and expand our presence and competitive positioning in the cervical market.”

The NuVasive CoRoent Small Interbody System is an interbody cage manufactured from PEEK-Optima that provides stabilization of the spinal motion segment while fusion takes place. A hollow core allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft material to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The device includes marker pins composed of titanium alloy or tantalum.

The implants included in the CoRoent Small Interbody System clearance are CoRoent Small (S), CoRoent Small Lordotic (SL), CoRoent Small Lordotic Plus (SLP), CoRoent Small Hyperlordotic (SHL), and CoRoent Small Contoured (SC).

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

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

1Grasso G: Clinical and radiological features of hybrid surgery in multilevel cervical degenerative disease. Eur Spine J 2015;24(Suppl 7):S842-8.
2American Associated of Neurological Surgeons. Artificial cervical disc surgery. [AANS web site]. May 2016. Available at: http://www.aans.org/Patient%20Information/Conditions%20and%20Treatments/-Artificial%20Cervical%20Disc.aspx. Accessed March 27, 2017.

 

CONTACT: Investor Contact: Suzanne Hatcher, NuVasive, Inc., 858-458-2240, investorrelations@nuvasive.com, Media Contact: Stefanie Mazer, NuVasive, Inc., 858-320-5243, media@nuvasive.com