Sunday, February 28, 2016

News: OrthAlign, Inc. Announces Upcoming Commercial Launch of OrthAlign Plus(R) for Direct Anterior Total Hip Replacement

ALISO VIEJO, Calif., Jan. 19, 2016 (GLOBE NEWSWIRE) -- via PRWEB - OrthAlign, Inc., a privately held U.S.-based medical device company developing precision technologies, announced today the successful completion of its limited release phase of OrthAlign Plus® for Total Hip Arthroplasty use in the direct anterior hip approach. The product will commercially launch at this year's AAOS meeting in Orlando, March 2, 2016.

OrthAlign, Inc., a privately held U.S.-based medical device company developing precision technologies, announced today the successful completion of its limited release phase of OrthAlign Plus(R) for Total Hip Arthroplasty use in the direct anterior hip approach. The product will commercially launch at this year's AAOS meeting in Orlando, March 2, 2016

Recent statistics have shown that the direct anterior approach, despite being a more difficult surgery, is growing in popularity amongst surgeons, worldwide. OrthAlign Plus was designed to help surgeons more easily make that transition to direct anterior, while providing more clinically relevant positioning. It fits within the surgeon's normal workflow and does not require preoperative planning or imaging, as the proven landmarks of the anterior pelvic plane are directly accessible with the patient supine.

"In my first few cases using OrthAlign Plus, it became very evident that overall fluoroscopy time can be diminished by 70-80%. No fluoroscopy time is required with acetabular component insertion when using OrthAlign Plus and overall flow is not significantly disrupted by surgical technique. I've found that the overall accuracy of acetabular component placement is as good, if not more reliable then C-arm image intensification, without beam radiation," said William B. Lutes, D.O., Aurora Medical Center, Kenosha, WI. "I think OrthAlign Plus for direct anterior total hip replacements can revolutionize the technique and ensure accuracy that is unheard of, by today's standards."


E. Matthew Heinrich, MD (Orthopaedic Specialists of Austin, TX) states, "I'm very impressed with what OrthAlign has developed in addressing acetabular cup placement for direct anterior hip replacements. It's extremely user friendly, does not add additional time to the case compared to conventional navigation, and the increased level of accuracy is undeniable, based on my experience. I felt very comfortable with it, even after my first case. OrthAlign is definitely onto something."

"When we started development of OrthAlign Plus for use in total hip arthroplasty using the direct anterior approach, we set out to replicate the characteristics which have made KneeAlign® so successful: precise, simple, easy-to-use," said Nick van der Walt, OrthAlign's Vice President of Engineering. "We are delighted at the response from the first set of surgeons to use the product clinically. Their feedback to date confirms that the system is easy to use from the very first case and may reduce procedure time and dependence of fluoroscopy. This is a win for the patient, surgeon, staff and hospital."

OrthAlign will be offering the general marketplace its first hands-on experience of OrthAlign Plus for direct anterior total hip replacements at this year's AAOS meeting in Orlando, March 2-4, 2016, at booth #2571.

About OrthAlign, Inc.
OrthAlign is a privately held medical device and technology company, committed to providing orthopedic surgeons with cutting edge, user-friendly, surgical precision technology and products for alignment and positioning. We believe that our technology will raise the standard of care in Total Knee and Total Hip Arthroplasty surgeries by making consistent and measurable results accessible to all surgeons, hospitals, and patients. Our strategy is to leverage this technology to provide simple and precision-driven solutions for a broad range of orthopedic procedures. For more information regarding OrthAlign, please visithttp://www.orthalign.com.

"ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, and KNEEALIGN® 2 are [registered] trademarks of OrthAlign, Inc."

This article was originally distributed on PRWeb. For the original version including any supplementary images or video, visit 

OrthAlign, Inc.
James Young Kim
+1 949.525.9027

Published at Nasdaq GlobeNewswire

News: Johnson & Johnson Announces Actions To Strengthen Medical Devices Leadership Position In Evolving Healthcare Marketplace

Image result for DePuys
NEW BRUNSWICK, N.J., Jan. 19, 2016 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced restructuring actions in its Medical Devices businesses to better serve the needs of customers and patients in today's evolving healthcare marketplace.  The company is undertaking actions to strengthen its go-to-market model, accelerate the pace of innovation, further prioritize key platforms and geographies, and streamline operations while maintaining high quality standards.

The company's Consumer Medical Devices businesses, Vision Care and Diabetes Care, are not impacted by these actions.
"As a market leader, we are committed to leveraging our breadth and scale to shape the future of the medical device industry, for the benefit of those we serve," said Gary Pruden, Worldwide Chairman, Johnson & Johnson Medical Devices. "The bold steps we are taking today are to evolve our offerings, structure and footprint and increase our investment in innovation.  These actions recognize the changing needs of the global medical device market and will deliver more value to customers, increasing our competitive advantage and driving growth and profitability for our business."
The actions are expected to result in annualized pre-tax cost savings of $800 million to $1.0 billion, the majority of which is expected to be realized by the end of 2018, including approximately $200 million in 2016. The savings will provide the company with added flexibility and resources to fund investment in new growth opportunities and innovative solutions for customers and patients.  In connection with its plans, the company expects to record pre-tax restructuring charges of approximately $2.0 billion to $2.4 billion, which will be treated as special items, of which approximately $600 million will be recorded in the fourth quarter of 2015.  The company confirmed the full-year 2015 guidance it provided on October 13, 2015 for sales of $70.0 billion to $71.0 billion and adjusted earnings for the full-year 2015 of $6.15 to $6.20 per share, which excludes special items such as restructuring charges.*
The company estimates that the actions announced today will result in position eliminations of  approximately 4 to 6 percent of the Medical Devices segment's global workforce over the next two years, subject to any consultation procedures in countries where required.  Additional information regarding today's announcement can be found in the FAQ posted on www.investor.jnj.com/MDFAQ.  Further commentary will be provided during the company's fourth quarter earnings conference call scheduled for January 26, 2016.
In conjunction with this announcement, the company will use a new format for the reporting of sales in the Medical Devices segment.  Historical sales results in the new format are also available at www.investor.jnj.com/MDFAQ.
About Johnson & Johnson
Caring for the world one person at a time inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees at more than 265 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

About Johnson & Johnson Medical Devices Companies
Having made significant contributions to surgery for more than a century, the Johnson & Johnson Medical Devices Companies are in the business of reaching more patients and restoring more lives. The group represents the most comprehensive surgical technology and specialty solutions business in the world, offering an unparalleled breadth of products, services, programs and research and development capabilities directed at advancing patient care while delivering clinical and economic value to health care systems worldwide.

* Adjusted earnings is a non-GAAP financial measure and should not be considered a replacement for GAAP financial measures.
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 restructuring plans. 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: the ability of the company to successfully execute strategic plans; any required consultation procedures relating to workforce actions; the potential that the expected benefits and opportunities related to the restructuring may not be realized or may take longer to realize than expected; economic factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new or existing products; impact of business combinations and divestitures; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description 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 28, 2014, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Published at PR NewsWire

Thursday, February 25, 2016

News: Smith & Nephew Fourth Quarter Trading and Full Year 2015 Results

Smith & Nephew plc (LSE:SN, NYSE:SNN) results for fourth quarter and full year to 31 December 2015:

Fourth Quarter Highlightsi 

  • Revenue up 5% underlying. 1% reported growth after -6% FX and 2% acquisition impacts 
  • Established Markets revenue up 6%, our best quarterly performance since 2012 • Emerging Markets revenue growth of 2% with strong growth in most markets offset by China 
  • Sports Medicine Joint Repair revenue up 9%, driven by US and ArthroCare benefits • Another strong performance in Knee Implants with revenue up 6% 
  • Advanced Wound Management businesses deliver 8% revenue growth, led by US performance 2015 Full Year Highlightsi • Full year underlying revenue growth of 4%, twice that achieved in 2014. Reported growth flat after -8% FX and 4% acquisition impacts 
  • Trading profit margin up 80bps at 23.7%, reflecting Group Optimisation and ArthroCare synergies 
  • $203m accounting charge (before future insurance recovery) taken for metal-on-metal claims 
  • Proposed full year dividend distribution of 30.8¢ per share, up 4% year-on-year


Image result for smith and nephewOlivier Bohuon, Chief Executive Officer of Smith & Nephew, said: “The Group finished 2015 strongly, led by an excellent quarter in the US across Sports Medicine, Knee Implants and our Advanced Wound Management businesses. At the same time, we successfully continued to grow our businesses in Europe and the Emerging Markets. 

“For the full year we delivered higher underlying revenue growth, trading profit margin and adjusted earnings year-on-year. Our strategy is producing an improved performance through focused innovation, better commercial execution and greater efficiency. 

“We expect to deliver continued good underlying revenue growth in 2016 as we benefit from our investments in existing businesses, acquisitions and pioneering technologies.” 

News Analyst conference call 

An analyst meeting and conference call to discuss Smith & Nephew’s results will be held at 9.00am GMT / 4.00am EST today, Thursday 4 February. This can be heard live through the Smith & Nephew website at http://www.smith-nephew.com/results and a recording will be available on the site shortly afterwards. For those who wish to dial in to the call, details can be accessed on our website using the same link. 

Enquiries Investors 

Ingeborg Øie +44 (0) 20 7960 2285 Smith & Nephew Media 
Charles Reynolds +44 (0) 20 7401 7646 Smith & Nephew 
Ben Atwell / Deborah Scott / Matthew Cole +44 (0) 20 3727 1000 FTI Communications Notes i. Certain items included in ‘Trading results’, such as trading profit, trading profit margin, trading 

Published at SNN Investor

Friday, February 19, 2016

News: Histogenics Corporation Provides NeoCart® Phase 3 Clinical Trial Enrollment Update

WALTHAM, Mass., Feb. 02, 2016 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced that as of February 2, 2016 it had enrolled 123, or just over half, of the 245 patients required to complete enrollment of its ongoing NeoCart Phase 3 clinical trial.  This trial is being conducted under a Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA). 


“We are pleased with the progress we have made over the last several months in the enrollment of the Phase 3 clinical trial evaluating NeoCart, and believe that many of the enrollment enhancement strategies we put in place in 2015 are positively impacting our enrollment trends,” stated Adam Gridley, Chief Executive Officer of Histogenics.  “The recent positive momentum in enrollment and increased investigator engagement with our clinical team members gives us confidence that these enhancements are working.  In addition, the recently approved changes by the FDA in December 2015 to the Phase 3 clinical trial inclusion/exclusion criteria are being implemented at each of our clinical sites and may provide additional positive momentum.  We continue to expect to complete enrollment by the end of the second quarter of 2017,” continued Mr. Gridley.

The Phase 3 clinical trial is designed to evaluate the safety and efficacy of NeoCart as a first-line therapy for full thickness knee cartilage defects in skeletally mature adults ages 18 to 59 and to show superiority of NeoCart against the current standard of care, microfracture.  NeoCart is a cartilage-like, tissue engineered implant created from a patient’s own cartilage cells.  The patient’s cells are multiplied in Histogenics’ laboratory and then infused into a proprietary scaffold to allow them to organize and function like cartilage cells.  Before NeoCart is shipped to the surgeon for implantation, the cell and scaffold construct undergoes a bioengineering process that is designed to mimic a joint so that the implant, upon placement in the knee with a proprietary bioadhesive, is primed to begin functioning like healthy cartilage.

About Histogenics Corporation
Histogenics is a leading regenerative medicine company developing and commercializing products in the musculoskeletal segment of the marketplace.  Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions to treat musculoskeletal-related conditions.  Histogenics’ first investigational product candidate, NeoCart®, is currently in Phase 3 clinical development.  NeoCart is an autologous cell therapy designed to treat cartilage defects in the knee using the patient’s own cells.  Knee cartilage defects represent a significant opportunity in the United States, with an estimated 500,000 or more applicable procedures each year.  NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage, characteristics not exhibited in other current treatment options.  For more information, please visit www.histogenics.com.

Forward-Looking Statements
Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,”  “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others: the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; the sufficiency of Histogenics’ cash resources and needs for additional financing; Histogenics’ ability to attract or retain key personnel; the technologies on which Histogenics’ channel partnering agreement with Intrexon Corporation is based are currently in preclinical and clinical stages of development; Histogenics will incur additional expenses in connection with its exclusive channel collaboration agreement with Intrexon Corporation and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2014 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, which are on file with the SEC and available on the SEC’s website atwww.sec.gov.  Additional factors may be described in those sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2015, to be filed with the SEC in the first quarter of 2016.  In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. 

CONTACT: Contact:
Investor Relations
Tel: +1 (781) 547-7909
InvestorRelations@histogenics.com
Published at Nasdaq GlobeNewswire

News: Amendia Inc. Launches the OmegaLIF™ Expandable Interbody Cage

Amendia, Inc. (http://www.amendia.com), a leading provider of balanced, innovative medical device solutions for the spine industry, announces today the launch of the OmegaLIF™ (ΩLIF™) expandable lumbar interbody device, an expandable interbody cage especially designed for use in intervertebral body spinal fusion procedures.
OmegaLIF™ (ΩLIF™)
The launch of OmegaLIF™ is another testament to Amendia’s constant commitment to developing and manufacturing exceptional spinal technology”, said Jeff Smith, CEO of Amendia Inc.
The OmegaLIF™ was created to provide a solution for skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2-S1. The device features a self-locking expansion mechanism that is infinitely adjustable, along with a cannulated bullet nose design for minimal impaction and ease of insertion. The OmegaLIF™ is streamlined and available in various implant sizes and angulations to fit a variety of patient anatomies and surgical preferences.
“The launch of OmegaLIF™ is another testament to Amendia’s constant commitment to developing and manufacturing exceptional spinal technology,” said Jeff Smith, CEO of Amendia Inc. “We’re confident that it will positively impact our mission of improving surgical outcomes and bettering the lives of patients with spinal disorders, while simultaneously increasing our product portfolio, allowing us to offer a complete, dynamic medical device line to spine surgeons.”
The OmegaLIF™ expandable lumbar interbody device is one of several upcoming product launches that Amendia has planned for 2016 – a concerted, year-long effort to lead the charge in designing and manufacturing disruptive spinal technologies for medical devices, paired with leading-edge biologics and instrumentation.
OmegaLIF™, along with Amendia’s line of cervical, lumbar, and interventional spinal devices, will be showcased at several upcoming events, including the American Society of Spine Radiology Conference, The Disorders of the Spine and Peripheral Nerves Spine Summit, and their upcoming surgeon training lab in Atlanta, Georgia.
ABOUT AMENDIA, INC. 
Headquartered in a state of the art manufacturing facility in Marietta, Georgia, Amendia is a leading provider of innovative medical devices used during spinal surgical procedures. Founded in 2008, Amendia’s mission is to exceed surgeon and patient expectations by creating balanced solutions with disruptive technologies for medical devices paired with biologics and instrumentation. Amendia’s vertically-integrated strategy focuses on improving surgical outcomes and the lives of patients with spinal disorders.

CONTACT 
Nikki Coleman, VP of Marketing and Education 
Tel: 770-575-5237 – Email: ncoleman(at)amendia(dot)com
Published at PRWeb

Wednesday, February 17, 2016

News: BONESUPPORT™ Reports Expansion Of Company's CERAMENT™ Drug Eluting Procedure Registry

LUND, SwedenFeb. 2, 2016 /PRNewswire/ -- BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today provided an update on the Company's CERAMENT procedure registry, established by BONESUPPORT in February 2014 as part of the proactive post-market surveillance process for the Company's novel antibiotic eluting injectable bone substitutes.  The CERAMENT|G registry now includes 230 cases conducted in 18 hospitals across 9 countries.  In addition, the registry has recently been updated to include CERAMENT V procedures.
The CERAMENT|G registry includes a variety of complex procedures, including bone tumors, primary and revision hip and knee prostheses, osteomyelitis and infected diabetic foot.  Moreover, the registry participants include a number of world-renowned surgeons, including Professor Carlo Romanò, Istituto Ortopedico Galeazzi, Milan Italy, Mr. Martin McNally, Nuffield Orthopaedic Centre in Oxford, United Kingdom and Professor Guido Wanner, University Hospital of Zurich, Switzerland.  The CERAMENTregistry provides the ability to add more hospitals, more indications and more product line extensions and is one of the most robust registries in the industry.
"This important registry offers hospitals the opportunity to share CERAMENT data with a view to analyzing inter-country or cross-country trends," said Professor McNally.  "I am pleased to be participating in, and contributing to this registry.  We have shown that CERAMENT|G is a safe and effective addition to the management of many complex indications, including chronic osteomyelitis, and look forward to generating further data to confirm this."
 "We are excited about the diverse set of procedures and compelling data being generated in our CERAMENT registry," saidRichard Davies, CEO of BONESUPPORT.  "This registry both ensures vigilance in the post-marketing surveillance for our products, and allows the data generated from these complex procedures to be collected and stored in a central location.  We intend to work with our surgeon participants to ensure publication of this data in the future."
About BONESUPPORT™
BONESUPPORT is an emerging leader of injectable bone graft substitutes for orthopedics, and trauma focusing on bone infection, instrument augmentation and spinal applications. CERAMENT is an injectable, synthetic bone substitute that mimics the properties of cancellous bone, allows for controlled resorption to support future bone ingrowth and is injectable under local anesthesia for minimally invasive surgery. CERAMENT|G and CERAMENT V are the first CE-marked injectable antibiotic eluting ceramic bone graft substitutes indicated to promote and protect bone healing in the management of osteomyelitis, (bone infections). CERAMENT's unique biologic properties deliver a consistent, pre-packed and ready-to-use formulation to facilitate optimal delivery. CERAMENT|G and CERAMENT V are not available in the United States.
CERAMENT is a fully developed product platform that is commercially available in the U.S., EuropeSE Asia and the Middle East. CERAMENT is revolutionizing the treatment of fragility and other fractures caused by disease and trauma. Scientific research of CERAMENT spans more than eleven years. Over fifty pre-clinical, and clinical studies have been conducted and more than 20,000 patients have been treated with CERAMENT.  The company was founded in 1999 and is based in Lund, Sweden with subsidiary locations in the US and Germany. To learn more about BONESUPPORT please visit www.bonesupport.com.
Investor and Press Inquiries:
Offer Nonhoff
Chief Financial Officer
Phone +46 46 286 53 60

Published at PRNewsWire

News: Active Implants Initiates Second Clinical Trial Evaluating NUsurface® Meniscus Replacement

MEMPHIS, Tenn.--()--Active Implants today announced that it has initiated its second clinical trial evaluating the investigational NUsurface® meniscus implant. The SUN (Safety Using NUsurface) trial will enroll approximately 120 patients with persistent knee pain caused by injured or deteriorating meniscus cartilage at up to 20 sites nationwide. NUsurface is an investigational meniscus replacement being evaluated as a treatment option to help patients delay or avoid total knee replacement.

SUN clinical trial of investigational NUsurface meniscus implant underway for pts w/persistent knee pain
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The meniscus is a tissue pad between the thigh and shin bones. Once damaged, the meniscus has a very limited ability to heal. Over 1 million partial meniscectomies to remove or repair a torn meniscus are performed in the U.S. every year, about the same as the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus surgery.
“A damaged meniscus has a very limited healing potential, oftentimes leading to knee replacement surgery,” said Henry Klyce, chief executive officer of Active Implants. “There is an unmet need in the orthopedic market for a treatment option – such as the investigational NUsurface Meniscus Implant – that can fill the gap between minimally invasive meniscus repair and total knee replacement.”
The following orthopedic centers are or will soon be recruiting patients, and additional sites will be added as needed:
  • Phoenix, Arizona – TOCA, The Orthopedic Clinic Association – Tom Carter, MD
  • Long Beach, California – Memorial Orthopaedic Surgical Group – Peter Kurzweil, MD
  • San Francisco, California – St Mary’s Medical Center – William Montgomery, MD
  • Boulder, Colorado – Colorado University Sports Medicine – Eric McCarty, MD
  • Denver, Colorado – Advanced Orthopedics & Sports Medicine Specialists – Wayne Gersoff, MD
  • Baton Rouge, Louisiana – Baton Rouge Orthopaedic Clinic – Robert Easton, MD
  • New Orleans, Louisiana – Ochsner Sports Medicine Institute – Deryk Jones, MD
  • Portland, Oregon – Oregon Sports Medicine – John Greenleaf, MD
  • Arlington, Texas – Baylor Orthopedic and Spine Hospital – Joseph Berman, MD
  • Salt Lake City, Utah – Salt Lake Regional Medical Center – Andrew Cooper, MD
All patients who meet study requirements and agree to enter the trial are offered the NUsurface Meniscus Implant as treatment. To learn more about the SUN study, please visit http://sun-trial.com or call (844) 680-8951.
Active Implants is also sponsoring the VENUS Study (Verification of the Effectiveness of the NUsurface® System), which has been underway at 10 sites in the U.S. since January 2015. Both the SUN and VENUS studies are being conducted to obtain regulatory approval from the U.S. Food & Drug Administration (FDA) to sell the device in the U.S.
About the NUsurface® Meniscus Implant
In the U.S., the NUsurface® Meniscus Implant (pronounced “new surface”) from Active Implants LLC is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. NUsurface is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissue. The NUsurface device mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. It is inserted into the knee joint through a small incision, and patients typically can go home soon after the operation. After surgery, patients undergo a six-week rehabilitation program. NUsurface has been used clinically in Europe since 2008 and Israel since 2011.
About Active Implants LLC
Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visitwww.activeimplants.com.
CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746

Published at BusinessWire

News: Seikagaku Announces Discontinuation of Development of SI-657, an Additional Indication for ARTZ


February 2, 2016 Seikagaku Corporation (Securities Code: 4548) 

Image result for Seikagaku Corporation
Seikagaku Corporation (Tokyo) today announced that it has decided to discontinue development of SI-657, an additional indication of enthesopathy for the joint function improving agent ARTZ . 



SI-657 was being developed jointly with Kaken Pharmaceutical Co., Ltd. (“Kaken Pharmaceutical”), the sales partner of ARTZ in Japan. Because SI-657 didn’t have clear and enough data to exhibit the expected efficacy in the results of a Phase III clinical trial in Japan, Kaken Pharmaceutical and Seikagaku have agreed to discontinue development for the additional indication of enthesopathy, following careful consideration of future development policy. 

Increasing added product value of ARTZ, Seikagaku will continue to focus its research and development on glycoscience and engage in efficient new drug development with GAGs (glycosaminoglycans) as target substances, and for orthopedic diseases, ophthalmic diseases, and immune and allergic diseases as target diseases. 

There will be no revision in the forecasts of consolidated results for the fiscal 2015 due to this matter.