St. Jude Medical Receives CE Mark Approval for Full Body MR Conditional Labeling for the Proclaim Elite Spinal Cord Stimulation System

Posted On December 8, 2016 By OrthoSpineNews In Neuro, Regulatory /

December 08, 2016

ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE mark approval for full-body magnetic resonance (MR) conditional labeling of the Proclaim^™ Elite Spinal Cord Stimulation (SCS) System. With the latest approval, patients who receive the Proclaim Elite SCS System can now undergo full-body magnetic resonance imaging (MRI) diagnostic scans within approved parameters. The full-body MR conditional labeling is the second upgrade available to patients outside the United States implanted with the Proclaim Elite System, following a 2015 approval for MR Conditional labeling for head and extremity MRI scans.

With the latest approval, patients living with chronic pain who have been implanted with the Proclaim Elite SCS System may now undergo full-body MRI diagnostic scans within approved parameters while retaining access to the treatments they need, such as the St. Jude Medical BurstDR^™ stimulation.

“Providing patients with a multitude of therapy options in one device has positively impacted the way we treat chronic pain patients today,” said Dirk Rasche, M.D., functional neurosurgeon, University Hospital of Schleswig-Holstein, Campus Lübeck, Germany. “Patients now do not only have access to both traditional SCS and BurstDR stimulation, they can also safely undergo MRI scans, a significant improvement for future neuromodulation therapy and diagnostic options.”

The Proclaim Elite SCS System offers patients a combination of the convenience of a device that doesn’t require recharging while offering access to St. Jude Medical BurstDR stimulation technology. BurstDR stimulation is a physician-designed form of SCS clinically proven to provide patients superior pain relief (as compared to tonic stimulation) by reducing their physical pain and addressing their emotional response to pain as measured by visual analogue scale (VAS) scoring. Unlike other stimulation designs, St. Jude Medical BurstDR stimulation works differently, utilizing intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns.

St. Jude Medical was the first company to provide patients suffering from chronic pain a single device featuring upgradeable and recharge-free therapy solutions. The company designed the Proclaim System with patient-centric solutions in mind. In addition, the Proclaim Elite SCS System’s Bluetooth^® wireless technology allows clinicians to program and adjust their patient’s SCS therapy with an Apple^™ iPad mini^™ mobile digital device.

“Historically, the need for future MRI scans could act as a barrier to patients who may benefit from SCS therapy,” said Dr. Allen W. Burton, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “Our new labeling for the Proclaim Elite SCS System ensures that patients can receive the treatment they need, while having peace of mind knowing their SCS system can be safely scanned with the diagnostic imaging they require.”

Nearly 95 million Europeans suffer from chronic pain, and the condition costs European health care systems a combined total of 300 billion Euro annually due to associated medical costs, lost work days and social security and welfare payments. SCS therapy can offer many patients meaningful pain relief and improvements in quality of life, yet for some patients the need for future MRI scans can act as a barrier to SCS therapy.

Full body MR-conditional labeling for the Proclaim Elite System was also recently approved by the Food and Drug Administration in the United States.

Note: Apple and iPad Mini are trademarks of Apple, Inc. Bluetooth is a trademark of Bluetooth SIG, Inc.

About St. Jude Medical

St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the company, including potential clinical successes, reimbursement strategies, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the company’s control and the risk factors and other cautionary statements described in the company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the company’s Annual Report on Form 10-K for the fiscal year ended January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended October 1, 2016. The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Contacts

St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations:
Justin Paquette, 651-756-6293
jpaquette@sjm.com

InVivo Therapeutics Appoints Melanie Morel-Ferris, C.P.A. as Interim CFO, Replacing Steven McAllister in Role

Posted On December 8, 2016 By OrthoSpineNews In Biologics, Neuro /

December 08, 2016

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced the resignation of Steven McAllister from the position of Chief Financial Officer effective December 31, 2016. He has indicated he will be transitioning to a new opportunity at a privately-held medical device company.

In connection with his departure, the Company has appointed Melanie Morel-Ferris, C.P.A. to assume the responsibilities and title of interim Chief Financial Officer, effective January 1, 2016. In this capacity, she will serve the role of the Company’s Principal Financial Officer and Principal Accounting Officer.

Ms. Morel-Ferris has served as the Company’s Controller since May, 2016. Prior to joining InVivo, Ms. Morel-Ferris served as the Corporate Controller of Astrodyne TDI, an electrical manufacturing company from July 2014 to May 2016. Prior to that, Ms. Morel-Ferris served as the Associate Director of Corporate Accounting of ARIAD Pharmaceuticals, Inc., a drug development company, from January 2014 to July 2014, and as a Senior Accounting Manager at ARIAD from January 2011 to December 2013. Ms. Morel-Ferris, who began her career at Deloitte, received a B.A. from Assumption College and is a Certified Public Accountant.

“We thank Steve for his significant contributions to InVivo over the last several years and wish him the best in his future endeavors,” Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said. “We also would like to congratulate Melanie on her promotion to interim Chief Financial Officer. The Board of Directors conducts regular succession planning exercises, and Melanie had been identified as a potential successor if and when the opportunity presented itself. She brings a wealth of financial experience to the position and will be a valuable addition to the executive team.”

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold^TM received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Contacts

InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com

RTI Surgical® Fills the Void in Anterior Cervical Discectomy and Fusion (ACDF) Procedures

Posted On December 8, 2016 By OrthoSpineNews In Biologics, Spine /

ALACHUA, Fla. (December 8, 2016) – RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, announced today that its C-Plus™ Peek* IBF System is now indicated for use with allograft, including its proprietary map3^® cellular allogeneic bone graft.

“This indication is important news because it now gives surgeons options that they didn’t have before,” noted Brian Hutchison, RTI president and chief executive officer. “Previously, the C-Plus Peek IBF System was indicated for use with only autograft, but now surgeons have more options and can tailor treatment to each individual patient’s needs.”

The map3 cellular allogeneic bone graft supports the body’s innate healing mechanisms and provides the scaffold and signals to support bone growth. The implant contains the three essential elements of bone formation (cortical cancellous bone chips supply an osteoconductive scaffold, demineralized bone matrix demonstrates verified osteoinductive potential and MAPC^®-class cells, a specific type of stem cell provide osteogenic and angiogenic signals to support the bone healing process). The C-Plus Peek IBF System is a PEEK interbody fusion system that offers multiple options and features designed to provide stability and anatomic restoration, facilitating fusion, when used with autogenous bone graft, and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft, in anterior cervical discectomy and fusion (ACDF) surgery.

“We are pleased to have received this indication for the C-Plus system, which expands our product portfolio that can be used with one of our key product innovations, map3 cellular allogeneic bone graft,” Hutchison said. “We can now offer surgeons an all-inclusive RTI portfolio with C-Plus implants, map3 allograft and the Aspect^® Anterior Cervical Plate (ACP) System, proving once more our commitment to providing surgeons with integrated offerings to help their patients.”

*PEEK-OPTIMA^® from Invibio^® Biomaterial Solutions
^® indicates U.S. trademark registration. All trademarks and/or images are the property of their respective owners or holders.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Abyrx® Announces Expansion of Exclusive, Worldwide License Agreement with Bezwada Biomedical; Completes $10M Equity Financing.

Posted On December 8, 2016 By OrthoSpineNews In Financial /

IRVINGTON, N.Y., Dec. 6, 2016 /PRNewswire/ — Abyrx^®, Inc., a privately-held specialty biosurgical products company, today announced the expansion of its exclusive, worldwide license agreement with Bezwada Biomedical, LLC to include the development, manufacture, and commercialization of Bezwada’s proprietary adhesive technology for soft tissue applications. Previously, in 2011, Abyrx and Bezwada announced a similar partnership for hard tissue (bone) applications. With this new partnership, Abyrx gains exclusive access to proprietary materials and manufacturing that it will use to develop products for surgical site hemostasis, sealing, and fixation.

In addition to its announcement of the new technology license with Bezwada, Abyrx also announced it recently completed a $10Mequity financing with strong support from inside investors. The new funds will be used to manage the growing demand for Abyrx’s bone putty products and to accelerate Abyrx’s pipeline development activities.

John J. Pacifico, Abyrx’s President and Chief Executive Officer, said the additional rights to use Bezwada’s technology for soft tissue applications and the new financing come as growth of Abyrx’s existing commercial business is accelerating. “We are very pleased by the support of our investors and thrilled to be broadening the scope of our manufacturing and technology platforms with Dr. Bezwada and his team to include new capabilities for soft tissue products,” Mr. Pacifico commented. “These new developments enhance the level of service we deliver to providers of care and deepen our relevance in the surgical procedures we support.”

“We have been very impressed by Abyrx’s ability to advance our technology platforms from lab-scale production to finished products that solve unmet needs,” stated Rao Bezwada, Ph.D., President and Chief Executive Officer of Bezwada Biomedical. “Given Abyrx’s history of success in developing and commercializing new products, and the support Abyrx continues to receive from the venture capital community, we are excited about our future with Abyrx and we are dedicated to ensuring Mr. Pacifico and his team have everything they need to achieve their objectives for the bone and soft tissue marketplaces.”

Abyrx and Bezwada recently initiated development programs to advance their new products towards commercialization. Both Abyrx and Bezwada believe they have a significant opportunity to address the limitations of other marketed products for soft tissue hemostasis, sealing, and fixation because of the high rate of reactivity and unique tunability of the Bezwada polymer technology.

The terms of the $10M equity financing were not disclosed but the company named members of its executive team as participants in addition to Canaan Partners, MedEdge, and BB BIOTECH VENTURES through their respective entities.

ABOUT ABYRX

Founded in 2013, Abyrx develops, manufactures, and provides specialty biosurgical products for use during surgical procedures. Abyrx’s products are protected by over forty issued and pending patents covering a broad range of compositions and methods.

Abyrx is located in Irvington, New York. For more information, please visit www.abyrx.com.

ABOUT BEZWADA BIOMEDICAL

Bezwada Biomedical designs and manufactures raw materials for use in the production of biocompatible polymers. Bezwada’s technology is protected by over thirty issued and pending patents covering a broad range of compositions and methods.

Bezwada Biomedical has laboratories, production facilities, and offices in India and Hillsborough, NJ. For more information, please visit www.bezwadabiomedical.com.

SOURCE Abyrx, Inc.

International Cartilage Repair Society Launches First Global Patient Registry to Expand Knowledge Base Worldwide

Posted On December 8, 2016 By OrthoSpineNews In Sports Medicine /

ZURICH, December 7, 2016 /PRNewswire/ —

The International Cartilage Repair Society (ICRS) has launched the first global, web-based patient registry, offering a unique international data pool for articular cartilage injury, history and treatment worldwide.

The Registry will dramatically expand the body of evidence available to clinicians, companies and health funders, providing pooled data that can be harnessed to better understand the most effective, safe, economical and clinically-relevant treatments, devices and practices in the treatment of acute cartilage damage and early osteoarthritis. “This is a fast-moving field with many new techniques”, said Dr Kenneth R. Zaslav, President of the ICRS. “The Registry will allow us to coordinate care and research between our members, and it will help companies see relevant problems sooner, and thereby get a feeling for usage of their technologies. In addition, our hope is that the Registry will serve as a pooled data source for comparing treatments thereby facilitating more rapid enrolment in prospective, randomised studies – in turn shortening the overall time for improvements in patient care.”

Crucially, the Registry uses a simple, intuitive web-based interface to harness the data. First, a patient adds themselves electronically and consents to inclusion in the Registry. The clinician then inputs the clinical data, after which the Registry contacts the patient to record their outcome scores and any complications. Along with new data, the Registry is also able to assimilate existing data sets, thereby immediately bolstering the potential for longer-term follow-up of patients who have previously been in trials, or those already part of smaller registries. “Within the first year of the Registry we will be able to incorporate 10-year data for some patients and techniques”, noted Dr Leela Biant, Chair of the ICRS Registry Steering Committee. Furthermore, in conjunction with core, pooled data sets the Registry software allows clinicians to bolt on additional scores or unique outcome measures relevant to them.

At launch the Registry is available in English with six additional languages planned for the spring of 2017. Current data is restricted to the knee with the ankle, hip and shoulder being incorporated in the near future.

FOR MORE INFORMATION PLEASE VISIT:

http://cartilage.org/society/icrs-patient-registry/

The purpose of the ICRS is charitable: The society envisages the scientific research and the exchange of knowledge among physicians, scientists, patients and researchers of the industry in the field of Cartilage Repair.

CONTACT
Cartilage Executive Office (CEO) GmbH
Email: ceo@cartilage.org
Web: http://cartilage.org/

SOURCE The International Cartilage Repair Society (ICRS)

curasan receives approval for orthopedic product in the strategically important US market

Posted On December 8, 2016 By OrthoSpineNews In Biologics, Regulatory /

Kleinostheim, 7 December 2016 – curasan AG, a leading specialist for medical products in the field of orthobiologics, has received the market clearance of the Food and Drug Administration (FDA) and thus the authorization to market its synthetic bone regeneration material CERASORB Ortho FOAM in the United States.

The innovative product made of resorbable ceramic and porcine collagen can now be used for bone defect treatment in extremities and pelvis on the US market as well as in all other countries where the FDA certification is recognized. curasan has been actively preparing the market launch of the product in recent months. Back in May, Shane Ray, an experienced orthopedic regenerative medicine sales and marketing executive, was appointed as the President of the US subsidiary curasan, Inc. “The FDA approval of CERASORB Ortho FOAM is an extremely important milestone for us in the re-orientation of our US business, which will open up a potential market worth more than US$ 900 million,” emphasized Michael Schlenk, CEO of curasan AG. “Even before the approval, major customers indicated during exploratory discussions that the flexible and mouldable version of CERASORB meets the demands of the US customers perfectly, much more so than any of our other products.”

Ahead of the market launch of the product the American subsidiary also successfully completed its structural reorganization in the fourth quarter to align the ability to be successful in dental and orthopedics business within North America. Being able to report this important strategic milestone in the fourth quarter is due to the profound expertise of our internal approval department, which was optimally prepared for the dialogue with the FDA and could answer all of their questions quickly. I’m very proud of our team!”

Your contact at curasan AG:
Andrea Weidner
Head of Corporate Communications
+49 6027 40 900-51
andrea.weidner@curasan.com

Your contact at curasan Inc.:
Beth Lloyd
+001 (919) 941-9770

office@curasan.com

About curasan AG:

curasan AG develops, manufactures and markets biomaterials and other medical products in the field of bone and tissue regeneration. A pioneer in its industry, curasan is specialized primarily on synthetic bone grafting materials for dental and orthopaedic applications. Numerous patents and a comprehensive list of scientific documentation prove the clinical success of the products and the highly innovative strength of curasan. Surgically active dentists, implantologists and oral, maxillary and dentofacial surgeons, as well as orthopaedics, traumatologists and spinal column surgeons worldwide benefit from the broad range of the premium quality and user-oriented portfolio offered by the technology leader. curasan maintains its own high-tech facilities for research, development and manufacturing in Frankfurt/Main, Germany, which are approved by the Food and Drug Administration (FDA) and other international authorities. In addition to its headquarters, the company has a subsidiary, curasan Inc., in the Research Triangle Park, near Raleigh, N.C., USA. The shares of curasan AG are listed in the General Standard at the Frankfurt Stock Exchange.

Sartorius-90m-IntelliCyt-acquisition-adds-cell-analysis-capabilities.jpg

JLL Partners and Water Street Announce New Investment in Medical Device Services Provider

Posted On December 7, 2016 By OrthoSpineNews In Financial /

CHICAGO and NEW YORK, Dec. 7, 2016 /PRNewswire/ — Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, and JLL Partners, a leading middle-market private equity firm, announced today that they have acquired MedPlast, Inc. Headquartered in Tempe, Arizona, MedPlast is a leading global services provider to the medical device industry.

MedPlast offers a range of engineering and manufacturing capabilities that support the world’s leading original equipment manufacturers (OEMs) with producing diagnostic, orthopedic, surgical and other medical products. The company employs more than 1,800 engineers, technicians and assembly workers who specialize in technical molding, advanced processing, device assembly and implantables with expertise in plastics. Over the past five years, MedPlast has expanded its operations to encompass 11 ISO-certified facilities across the United States, China, Mexico and the United Kingdom.

“MedPlast has well-established and trusted relationships with the world’s leading medical manufacturers who value the company’s high-quality standards that meet their demanding industry regulations. We will work with MedPlast’s team to expand its suite of capabilities into new areas to form a comprehensive, integrated portfolio of end-to-end product solutions,” said Peter Strothman, partner, Water Street.

A $40 billion-dollar market, medical device services continues to grow as increasing numbers of original equipment manufacturers turn to outsourcing providers to generate cost and time efficiencies. It is a highly fragmented sector with hundreds of providers offering design, engineering, manufacturing supply chain and logistical services.

“MedPlast stands out for its health care expertise, extensive global footprint and breadth of high- quality capabilities,” said Daniel Agroskin, partner, JLL Partners. “Together with Water Street, we will invest our expertise and resources to expand MedPlast’s services into high-value areas and build on its strong base of long-term customer relationships.”

MedPlast is the second collaboration between JLL Partners and Water Street. The firms recently worked together to build Bioclinica, Inc. into one of the world’s leading providers of specialty outsourced clinical trial solutions.

“Our partnership with JLL and Water Street is an important step toward achieving our goal of building MedPlast into an end-to-end services provider focused on the health care industry,” said MedPlast Chief Executive Officer Harold Faig. “For the past eight years, we have optimized our capabilities toward health care. This acquisition will give us access to expertise and resources to grow our core competencies into areas that will bring considerable value to our customers.”

Financial terms of the acquisition are not being disclosed.

About JLL Partners

JLL Partners is a leading middle-market private equity firm with a 28-year track record of adding value to complex investments through its financial and operational expertise. Since its founding in 1988, JLL Partners has committed approximately $5 billion across seven funds, and developed significant expertise in the health care sector. JLL Partners is a control investor and sources its deals from its deep network of industry contacts, applying its proven, value-oriented and growth-driven investment approach to provide limited partners with attractive risk-adjusted returns throughout all investment cycles. The firm is headquartered in New York. For more information about JLL Partners, visit jllpartners.com.

About Water Street

Water Street is a strategic investor focused exclusively on health care. The firm has a strong record of building market-leading companies across key growth sectors in health care. It has worked with some of the world’s leading health care companies on its investments including Johnson & Johnson, Medtronic, Smith & Nephew and Walgreen Co. Water Street’s team is comprised of industry executives and investment professionals with decades of experience investing in and operating global health care businesses. The firm is headquartered in Chicago. For more information about Water Street, visit waterstreet.com.

SOURCE Water Street Healthcare Partners

Integra LifeSciences Announces Expansion and Extension of Credit Facility to $1.5 Billion

Posted On December 7, 2016 By OrthoSpineNews In Financial /

PLAINSBORO, N.J., Dec. 07, 2016 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation(NASDAQ:IART) today announced that it has increased its credit facility with its bank group led by Bank of America, N.A.

The expanded and extended credit facility includes the following terms:

An increase in the credit facility from $1.1 billion to $1.5 billion, consisting of a $1 billion revolving line of credit and a term loan of $500 million;
An option to increase the aggregate size of the facility by at least $250 million with additional commitments;
No change in pricing terms or commitment fees to the existing facility; and,
Maturity of the credit facility is extended to December 7, 2021.

“We are pleased to announce this expansion and two-year extension of our credit facility under favorable credit terms,” said Glenn Coleman, Integra’s Chief Financial Officer. “This new agreement strengthens our balance sheet and provides increased financial flexibility to pursue our long-term growth strategy.”

Integra LifeSciences plans to use a portion of the term loan to repay the outstanding indebtedness under the existing credit facility and cover fees and expenses incurred in connection with the new credit facility. Borrowings from the new revolving facility will be used to refinance the Convertible Notes that are due December 15, 2016 and for general corporate purposes.

Integra LifeSciences does not expect this increase in credit facility to have a material impact on 2016 financial performance.

About Integra

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

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties and reflect Integra LifeSciences’ judgment as of the date of this release. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. These risks and uncertainties include market conditions and other factors beyond Integra LifeSciences’ control and the economic, competitive, governmental, technological and other factors identified under the heading “Risk Factors” included in item 1A of Integra LifeSciences’ 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. These forward-looking statements are made only as of the date thereof, and Integra LifeSciences undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Integra LifeSciences Holdings Corporation

Investor Relations: 
Angela Steinway
(609) 936-2268
angela.steinway@integralife.com 

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

Arthrosurface Names Industry Veteran Joe Darling as Executive Chairman

Posted On December 7, 2016 By OrthoSpineNews In Extremities, Sports Medicine /

FRANKLIN, Massachusetts, Dec. 7, 2016 /PRNewswire/ –Arthrosurface®, an orthopedic medical technology company focused on the orthopedic upper and lower extremities markets, has named Joe Darling as the Company’s Executive Chairman. Mr. Darling will join the company in this newly created position shaping the future strategic direction with respect to, and overseeing and directing, the company’s commercial activities and business operations. The company has added Mr. Darling to their Board of Directors.

Mr. Darling’s business career spans both the pharmaceutical and medical device markets including senior management positions with Abbott Laboratories, Wyeth Pharmaceuticals, and executive level positions with Baxter International as Vice President of Marketing and Health Systems, Senior Vice President and General Manager of Smith and Nephews Sports Medicine and Biologics business, Global President of Linvatec Corporation, and Executive Vice President, Corporate Commercial Operations with CONMED Corporation, and most recently as Chief Operating Officer with Interventional Spine, Inc.

Joe’s proven leadership skills have spanned many functional areas in general management including sales, marketing, R&D, operations, regulatory and quality, finance and human resources. “Mr. Darling is well known within the orthopedic market and brings a vast knowledge of the industry to Arthrosurface. We are excited to have Joe on board,” said Dana Callow, Managing General Partner of Boston Millennia Partners. “Joe’s depth of experience and leadership skills will provide the Arthrosurface team with the strategic direction and experience necessary to accelerate the global profitable growth of the company.”

“Joe has deep experience in the global development and launch of innovative orthopedic products and we are excited to have him join the Arthrosurface team,” said Steve Ek, CEO and Founder. “We look forward to utilizing Joe’s deep understanding of the orthopedic markets along with his extensive relationships across the industry.”

“I am pleased to join Arthrosurface and look forward to working with the Arthrosurface team as we reshape the strategic direction of the company” Mr. Darling said.

About Arthrosurface

Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. The product offerings include devices, instruments and biologics designed to preserve and restore the joints so patients can maintain an active lifestyle. The Company offers a variety of unique systems that provide less invasive technologies for surgeons that can be used to treat a wide range of joint conditions. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 13 years.

Paradigm Spine, LLC Announces Publication Of ISASS Guidelines Recommending Coverage Of Interlaminar Stabilization®

Posted On December 7, 2016 By OrthoSpineNews In Spine /

NEW YORK, Dec. 6, 2016 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis (LSS) announces publication of the International Society for the Advancement of Spine Surgery (ISASS) Policy Statement on November 10, 2016 by Richard Guyer, M.D., et al of “ISASS Recommendations/Coverage Criteria for Decompression with Interlaminar Stabilization – Coverage Indications, Limitations, and/or Medical Necessity” in the International Journal of Spine Surgery, a high-quality peer-reviewed journal published on behalf of ISASS. Please find a link to the article here: http://dx.doi.org/10.14444/3041.

Per the Policy Statement, lumbar decompression with interlaminar stabilization is recommended for coverage in carefully selected LSS patients without gross instability or in which the decompression procedure itself may create iatrogenic instability. The Policy Statement accurately notes that “there exists a population of patients who present with moderate to severe stenosis, with concomitant back pain, where decompression alone does not adequately address back pain.” Interlaminar stabilization after direct decompression is a non-fusion surgical option that can provide the additional stability over decompression alone without the rigidity of an instrumented fusion. The Policy recognizes the benefits of coflex compared to fusion and further states, “In select patients within the LSS continuum, decompression with interlaminar stabilization has proven to provide equivalent outcomes with a reduced cost compared to decompression plus fusion.”

As the only spine product that has achieved FDA Premarket Approval (PMA) for up to a Grade I spondylolisthesis with a concomitant decompression, the coflex^® Interlaminar Stabilization^® non-fusion device maintains motion, reduces both leg and back pain, and preserves foraminal height. Marc Viscogliosi, Chairman and CEO of Paradigm Spine, LLC comments, “We are excited to have the recognition and support of ISASS in this publication. The policy statement supports our goals of improving patient access, building awareness among physicians, payors and policy makers, making coflex a compelling covered treatment option for patients with stenosis.”

Hallett Mathews, M.D., MBA, EVP & CMO of Paradigm Spine, LLC commented “We are very happy that ISASS has issued these important guidelines and are confident that it will be immensely helpful to all physicians and patients. Surgeons, health insurers and policy makers rely on publications issued by societies for current information on leading industry developments, clinical advancements and for guidance in making choices on various treatment methods for their patients. As the publication appropriately states, with the growing population in the US, there is a rising incidence of LSS and varying options of therapeutic pathways. Therefore, it is becoming increasingly important for the new treatment alternatives available for LSS to be supported by strong clinical data from long term studies, as coflex has recently published its own five-year study results. Over the last four years, more than 1,000 physicians in the US have treated nearly 20,000 patients and now with these published guidelines by ISASS and having its own new CPT code becoming effective January 1, 2017, using coflex for interlaminar stabilization after a decompression is quickly becoming the preferred choice of treatment by many physicians in both an in-patient and out-patient setting.”

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

Month: December 2016

Contacts

Contacts

About RTI Surgical Inc.

Forward Looking Statement