Zimmer Biomet Announces Leadership Transition

Posted On July 11, 2017 By OrthoSpineNews In Recon, Top Stories /

WARSAW, Ind., July 11, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, announced that David C. Dvorak has stepped down as President and Chief Executive Officer and a member of the Board of Directors, effective today. To assist with the transition, Mr. Dvorak will serve in an advisory capacity to the Company for a period of time. The Board has appointed Daniel P. Florin, Senior Vice President and Chief Financial Officer, to serve in the additional role of Interim CEO and a member of the Board of Directors until a permanent successor has been named.

The Zimmer Biomet Board is retaining a leading executive search firm to identify and evaluate candidates for the permanent CEO role.

Mr. Dvorak said, “Serving alongside Zimmer Biomet’s dedicated employees over the past 16 years and leading the Company as CEO for ten of those years has been a privilege and a highlight of my professional career. Our collective efforts grew employment from approximately 3,000 in 2001 to 18,000 today and built a Fortune 500 company. I am particularly proud of what we have accomplished working together with surgeons and clinicians to help millions of patients globally improve their quality of life.”

Larry C. Glasscock, Chairman of the Board of Zimmer Biomet, commented, “During David’s ten-year tenure as CEO, Zimmer Biomet has transformed into a truly global leader in musculoskeletal healthcare. Through a combination of organic growth and strategic acquisitions, Zimmer Biomet’s revenue has doubled and the Company has established a leading portfolio of technologies, solutions and personalized services. With this strong platform in place, there is tremendous opportunity for Zimmer Biomet. On behalf of the Board, I thank David for his many important contributions to our Company and industry over the years and wish him much success in the future.”

Mr. Glasscock continued, “We are fortunate to have a leader of Dan’s caliber and experience to step into the CEO role on an interim basis while the Board conducts its search process. Dan’s knowledge of Zimmer Biomet and his achievements here and at other medical device companies make him an excellent choice to support the Company through this interim period. We appreciate his willingness to take on this expanded role.”

Mr. Florin said, “Zimmer Biomet has a talented and dedicated team and an unmatched portfolio. I am honored to assume the Interim CEO role and I look forward to working closely with the Board, senior leadership team and our sales force as we strive to support our customers and enhance stockholder value.”

About Dan Florin

Dan Florin was appointed Senior Vice President and Chief Financial Officer of Zimmer Biomet in June 2015 and has over 16 years of executive experience in the medical device industry. He previously served as Senior Vice President and Chief Financial Officer of Biomet from June 2007 to June 2015. Prior to joining Biomet, Mr. Florin served as Vice President and Corporate Controller of Boston Scientific Corporation from 2001 until 2007. Before being appointed Corporate Controller in 2001, Mr. Florin served in financial leadership positions within Boston Scientific Corporation and its various business units. Mr. Florin previously worked for C.R. Bard from October 1990 through June 1995, and Deloitte from September 1986 to October 1990. Mr. Florin holds a Bachelor’s degree in Business Administration with a concentration in Accounting from the University of Notre Dame and an Executive MBA from Boston University.

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements that address expectations, plans or projections about the future, including statements about Zimmer Biomet’s management transition plans, growth prospects and business strategy, are forward-looking statements. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC. Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in its periodic reports. Accordingly, such forward-looking statements speak only as of the date made. Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.

The ASC CerviKit by Xenco Medical Expands Nationwide with Disposable Spinal Systems for Ambulatory Surgery Centers

Posted On July 11, 2017 By OrthoSpineNews In Spine, Top Stories /

July 11, 2017

SAN DIEGO–(BUSINESS WIRE)–Xenco Medical has announced the nationwide expansion of the ASC CerviKit, the compact delivery and storage platform for the company’s breakthrough, entirely disposable Anterior Cervical Discectomy and Fusion (ACDF) systems engineered from a highly durable composite polymer. The ASC CerviKit includes all of Xenco Medical’s single-use cervical implant families and is designed to be both lightweight and easily transportable. Designed to address the space constraints of ambulatory surgery centers, the systems in the ASC CerviKit offer a streamlined approach to the ACDF procedure as breakthrough single-use, composite polymer cervical implant systems. Comprising Xenco Medical’s pre-loaded Cervical interbodies and pre-loaded cervical plates as well as the supporting, single-use instruments, the ASC CerviKit is indicative of a larger movement in healthcare towards streamlined, efficient care.

With the single-use, composite polymer instrument and implants locked together in the sterile package, the Xenco Medical systems are designed to both increase efficiency in the OR as well as eliminate the internal logistics associated with the autoclave process. Existing at the intersection of materials science and biomechanical engineering, Xenco Medical’s single-use spinal systems are the first polymer-based devices of their kind. In addition to Xenco Medical’s cervical interbodies, The ASC CerviKit stores Xenco Medical’s newly launched Merge Cervical Plate system, a single-use platform using the company’s Snap-Align technology. The Merge Cervical Plate allows the surgeon to choose whether to attach the plate to the interbody prior to implantation or to connect in situ.

“Eliminating the costs, labor, and time associated with the autoclave process, the single-use systems in the ASC CerviKit have had extraordinary success in reducing logistical inefficiencies at outpatient surgery centers,” said Xenco Medical Founder and CEO Jason Haider.

Unlike the traditional metal instruments that are reused in hundreds of patients until a mechanical failure, Xenco Medical’s single-use systems are perfectly calibrated and sterile-packaged for patient-specific use. Made from a highly reinforced composite polymer, Xenco Medical’s patient-specific spinal systems have previously made news for outperforming aluminum metal in maintaining structural integrity.

About Xenco Medical

Xenco Medical is an American medical technology company committed to disruptive innovation for the purposes of creating a safer surgical environment. Through Xenco Medical’s line of disposable, sterile-packaged spinal systems, Xenco Medical seeks to ensure that the outcome of spine surgeries reflect the ability of the surgeons rather than the limitations of their instruments. For more information on Xenco Medical, visit www.xencomedical.com.

Contacts

Xenco Medical, LLC
Maicy Lunes
858-202-1505
mlunes@xencomedical.com

Back Pain Centers of America Announces Stryker’s Spine Division as a Finalist in the Awards of Excellence, “Technology Innovation” Category

Posted On July 11, 2017 By OrthoSpineNews In Spine, Top Stories /

ATLANTA, GA (PRWEB) JULY 11, 2017

Back Pain Centers of America (BPC), which connects people searching for solutions to their neck and back pain with a reputable physician in their area, announces that Stryker’s Spine division is a finalist in the 2017 Awards of Excellence for the Technology Innovation Award. This award is one of three categories of awards being presented in our 2017 series. The Technology Innovation Award recognizes the top innovations advancing the field of orthopedic medicine, and Stryker’s Spine Division is being honored for its LITe BIO Delivery System.

The LITe BIO Delivery System is a uniquely designed hand-held device used to facilitate delivery of bone graft material to spinal surgery sites. The first-of-its-kind design of the LITe BIO Delivery System provides surgeons with a single-handed method to deliver any type of autograft, allograft, or synthetic bone graft material without obstructing visibility. The innovative delivery tool provides tactile, visual, and audible confirmation of bone graft delivery, and the mallet-free system eliminates the impaction of bone graft.

“We are pleased to be recognized as a finalist in the Technology Innovation Award category,” said John Mayor, Vice President, Global Marketing for Stryker’s Spine division. “The new LITe BIO Delivery System combines three key features—a low-profile design, the versatility to accommodate any graft material, and direct visualization to aid in the precise placement of the graft. The LITe BIO Delivery System’s design offers a combination of features that no other bone graft delivery system on the market possesses.”

“We created this award category to recognize innovation and advances in medicine and technology,” said Brent Wheeler, president of Back Pain Centers of America. “We applaud Stryker’s Spine division for its innovation in addressing existing challenges in spinal fusion procedures.”

More information about the LITe BIO Delivery System can be found here.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at http://www.stryker.com.

About Back Pain Centers of America
Back Pain Centers of America (BPC) has helped people find safe, reliable relief for chronic pain since 2009. The call centers match patients searching for relief for neck and back pain to reputable, board-certified healthcare practices in their geographic area. BPC has the largest network of minimally-invasive spine centers in America. This service is free to patients. For more information, please visit http://www.backpaincenters.com. Also follow BPC on LinkedIn, Facebook, or Twitter.

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InVivo Therapeutics Appoints Richard Toselli, M.D. as Chief Medical Officer

Posted On July 10, 2017 By OrthoSpineNews In Biologics, Neuro, Top Stories /

July 10, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced the appointment of Richard Toselli, M.D., as Chief Medical Officer, effective July 5, 2017. Dr. Toselli, a fellowship-trained spinal neurosurgeon, will assume all responsibilities related to the company’s clinical and regulatory strategy.

Prior to joining InVivo, Dr. Toselli served as Chief Medical Officer for Cochlear Limited. In that role, he was responsible for global clinical, regulatory, and medical affairs teams reporting to the CEO. Prior to that, Dr. Toselli served five years at Sanofi in various levels of increasing responsibility, including Vice President of Global Medical Affairs – Immunology and Inflammation, Biologics Division; Vice President of Global Medical Affairs and Head of the Biosurgery Discovery Performance Unit; and Vice President of Global Medical Affairs, Biosurgery. Before his time at Sanofi, he served as Chief Medical/Technology Officer for Covidien Surgical, and earlier held various roles at DePuy Spine including Director of Medical Affairs, Worldwide Vice President of Research and Development, and Worldwide Vice President of Clinical Evidence and External Relations. He subsequently held the position of Vice President of Evidence-Based Medicine at Johnson & Johnson for the device sector.

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “We are pleased to welcome Rich to the InVivo team during this pivotal moment in the company’s history. His deep industry experience paired with his medical training as a spine trauma neurosurgeon make him an invaluable asset as we look to finish enrollment of our pivotal probable benefit study and file for marketing approval.”

Dr. Toselli’s previous academic positions include Assistant Professor at Brown University, Associate Professor, Director of Spine Center, and Associate Chief of Staff at the University of North Carolina (UNC), and Associate Professor at the University of Vermont. He holds a bachelor of arts from Providence College, his medical degree from Brown University, and a masters of business administration from the UNC’s Kenan-Flagler Business School. Dr. Toselli is a board-certified neurological surgeon.

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 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.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, the progress of the clinical program and the timing of the completion of enrollment in the INSPIRE Study and of the filing of an application for marketing approval. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended March 31, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

Ortho Development Corporation signs exclusive distribution agreement with China Pioneer Pharma Holdings Limited

Posted On July 10, 2017 By OrthoSpineNews In Recon, Top Stories /

DRAPER, Utah, July 5, 2017 – Ortho Development^® Corporation (ODEV) is pleased to announce the signing of an agreement with China Pioneer Pharma Holdings Limited (CPP) as the exclusive distributor of ODEV’s Balanced Knee^® System in the People’s Republic of China.

China has recently surpassed Japan as the second largest market for orthopedic medical devices in the world. With an aging population and improvement in health insurance policies, the demand for total knee replacement procedures in China has been increasing rapidly. “Our strategic vision includes expanding distribution beyond the U.S. and Japanese markets into high-growth, emerging markets like China,” said Brent Bartholomew, President of ODEV. “We have been seeking the right distribution partner in China for quite some time, and are delighted to be working with an established, reputable partner like CPP.”

CPP is one of the largest comprehensive marketing, promotion and channel management service providers dedicated to importing pharmaceutical products and medical devices in China. Their portfolio includes ophthalmology, pain management, cardiovascular, respiratory, gastroenterology, immunology, orthopedics and other therapeutic areas, and a range of medical devices covering various medical specialties, including ophthalmology, odontology and wound care, etc. As of 31 December 2016, CPP sold products through its nationwide marketing, promotion and channel management service networks to approximately 30,000 hospitals and other medical institutions and over 108,000 pharmacies across all provinces, municipalities and autonomous regions in China.

Ortho Development’s Balanced Knee^® System (BKS) includes implants and instrumentation for primary and revision total knee replacement procedures. The design is based on proven technology with over 17 years of successful clinical results and more than 70,000 implanted worldwide. BKS implants are offered in a wide range of sizes and options to allow optimal anatomical fit for a variety of patients. The system has a patented locking mechanism specifically designed to minimize the micro-motion between the plastic tibial insert and the titanium tibial base plate implants. Simple and intuitive instrumentation facilitates reproducibility in the hands of every surgeon and aides in proper intraoperative balancing of the knee joint.

The medical device registration in China for the BKS has already been completed, and CPP intends to begin marketing the product immediately. Following the tender and bidding process with specific hospitals, CPP expects the first knee replacement procedures in China with BKS will occur in early 2018.

About Ortho Development Corporation

Ortho Development Corporation was founded in 1994 and is a privately held company located in Draper, Utah, U.S.A. The company is passionate about designing and manufacturing the best, clinically proven, high-performance orthopedic devices in the world. The primary product focus is total knee and hip joint replacement; and also includes trauma fracture repair, and spine treatment. Ortho Development products are distributed through a growing network of independent sales reps and distributors and are used by hundreds of surgeons at world-renowned orthopaedic hospitals and teaching universities, as well as in a widespread number of regional and community hospitals. The company’s majority shareholder is Japan Medical Dynamic Marketing, Inc. (Japan MDM), a publicly-traded, Japanese medical device distribution company.

Amendia Announces Corporate Name Change to Spinal Elements to Reflect Commitment to Spinal Surgical Market

Posted On July 10, 2017 By OrthoSpineNews In Spine, Top Stories /

July 07, 2017

MARIETTA, Ga.–(BUSINESS WIRE)–Amendia, Inc.—a leading designer, developer, manufacturer, and marketer of innovative medical devices used in spinal surgical procedures—announced today that it is rebranding itself as Spinal Elements. The change reflects the company’s dedication to developing novel medical device technologies, biologics, and instrumentation to create positive surgical outcomes.

“Adopting the name Spinal Elements reflects our commitment to delivering innovative, best-in-class products and providing surgeon customers with the solutions they need to treat to their spinal patients,” said Chris Fair, CEO of Spinal Elements. “During the acquisition of Spinal Elements, Inc., one of the key attributes we identified was the deep brand awareness the company had developed over the past decade. This announcement highlights that awareness and signals to our customers that we will continue to be a leading innovator in the spine industry.”

Spinal Elements will continue to market its legacy Amendia-branded products, which have provided patients and healthcare providers with industry-leading spinal surgical solutions for nearly a decade, and will also maintain all of the leading-edge products acquired during its recent acquisition of Spinal Elements, Inc.

“We know surgeons want access to the most advanced spinal surgical technology to manage their patients’ outcomes,” said Jason Blain, President of Spinal Elements. “To that end, we will continue to provide them with the innovative tools they need to best navigate their patients’ care programs.”

The rebranding will be implemented across the company’s products and services over the course of 2017.

About Spinal Elements

Spinal Elements is an outcomes-driven spinal surgical solutions company with locations in Carlsbad, California and Marietta, Georgia. A leading designer, developer, manufacturer, and marketer of innovative medical devices used in spinal surgical procedures, our mission is to develop novel medical device technologies, biologics, and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. For more information, please visit www.amendia.com or www.spinalelements.com.

Contacts

For Spinal Elements
Laura Charlton (formerly Johnson)
760.450.7749
laurajohnsonpr@yahoo.com

Corin USA expands headquarters in Hillsborough County, creating 100 new jobs

Posted On July 7, 2017 By OrthoSpineNews In Recon, Top Stories /

7/6/2017

TAMPA, Fla. – Corin, a global manufacturer of orthopedic devices and high-tech solutions to improve surgical procedures, today announced that it will expand its US headquarters in Tampa. The company will up to 100 new high-wage jobs in marketing, operations, sales and other administrative roles and invest $500,000 in its new offices by 2022.

“We are fortunate to have such strong growth, which has enabled rapid expansion of our staff and facilities,” said Paul Berman, president of Corin USA. “Tampa has been and will continue to be a corridor of technological and healthcare innovation, which creates a strong base for talent and collaborative partnerships with other adjacent industries.”

Corin USA is a wholly-owned division of the 34-year-old British medical device company Corin Group LLC, located in Cirencester, UK. Corin USA was established 14 years ago in Tampa and is home to the company’s business activities in the US. Sales, marketing, clinical, regulatory, finance, and operations and logistics groups supporting the sales and marketing of Corin’s medical devices and technologies throughout the US are located at its regional office in Tampa.

Corin USA, which employs 30 individuals locally and over 100 across the US, moved this month from offices on West Cypress Street to 7,000 square feet of new space at 12750 Citrus Park Lane, Suite 120, Tampa, FL 33625.

As a leader in orthopedic innovation, Corin has pioneered a number of landmark developments since its inception in 1985. The company has improved the quality of life of hundreds of thousands of patients across the world through the introduction of its groundbreaking products.

In March 2017, Corin introduced its revolutionary Optimized Positioning System (OPS™) System at the American Academy of Orthopaedic Surgeons (AAOS) in San Diego. The technology may lead to one of the most significant changes to the way hip replacements are performed in more than 30 years.

The first-ever functional, patient-specific hip replacement procedures using OPS were performed in the US in November 2016, shortly after FDA clearance. More than 3,000 procedures have been done already in Europe and Australia, where the system was previously approved for use.

“No two patients are the same, so Corin is offering a patient-specific solution that gives the surgeon the information and tools necessary to enable an optimal hip replacement procedure based on each individual patient’s unique anatomy,” said Berman. “Feedback from surgeons who have used OPS has been excellent and interest in the system from the orthopedic community is very high.”

The Tampa Hillsborough Economic Development Corporation assisted Corin USA with its real estate property search as well as connections to workforce training programs and expedited permitting services.

“Hillsborough County’s life sciences sector is booming,” said Dr. Ken Atwater, chairman of the Tampa Hillsborough Economic Development Corporation and president of Hillsborough Community College. “The success that companies like Corin are enjoying is elevating our global reputation as an attractive location for others in this industry. Tampa offers Corin a highly skilled talent pool, close proximity to an exceptional international airport, and a business climate that supports their growth. We are proud to partner with Corin as they expand and thank them for bringing more great jobs to our community.”

Individuals interested in available jobs may refer to the company’s career website, here.

About Corin Group

Corin is a European orthopedic manufacturer based in the United Kingdom that markets its products throughout the world. Corin is committed to improving patient satisfaction with personalized technologies that optimize our clinically proven joint replacements; delivering a personal approach to our customers, combining the spirit of our local companies with the strength of our global, integrated organization; and empowering and rewarding our global talented teams to deliver excellence to our customers.

For further information about Corin, please visit www.coringroup.com.

About the Tampa Hillsborough Economic Development Corporation

The Tampa Hillsborough Economic Development Corporation is the lead designated economic development agency for Hillsborough County and the cities of Tampa, Plant City, and Temple Terrace. Established in 2009 as a partnership between the public sector and private corporate investors, the EDC works to develop and sustain a thriving local economy through the attraction, retention and expansion of high wage jobs and capital investment within targeted industry sectors.

SeaSpine Announces Full Commercial Launch of Mariner Posterior Fixation System

Posted On July 7, 2017 By OrthoSpineNews In Spine, Top Stories /

CARLSBAD, Calif., July 07, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the full commercial launch of Mariner® Posterior Fixation System.

The Mariner Posterior Fixation System is a pedicle based system featuring modular screw technology and accompanying instrumentation. Designed to reduce the number of trays needed for surgery, Mariner is intended to efficiently provide surgeons with multiple intra-operative options to facilitate posterior lumbar fixation. Mariner offers versatility and adaptability by providing surgeons with a variety of instrument and implant solutions for degenerative and complex spine pathologies, including choices in rod diameter, rod material, construct configuration, and deformity correction techniques. Key market differentiators include in-situ modularity, motion limiting heads, and rod versatility with both 5.5mm and 6.0mm offerings.

“In today’s hospital environment, the key is to have as many options as you can for your patient without overburdening your staff,” stated Douglas Orndorff, MD. “Mariner is versatile, yet simple to use. Ultimately, it helps me make intraoperative decisions seamlessly.”

Dr. Warren Yu, Director of Spine Surgery at George Washington Hospital commented, “Mariner’s state-of-the-art instrumentation and modular screw design provide me with the broad selection of implant configurations that I need to address the challenging patient anatomy I see in my adult spine practice – from basic degenerative to complex deformity cases.”

“The Mariner Poster Fixation System brings innovative features to the market and utilizes a modular design that increases surgeon flexibility while reducing the number of trays that need to be brought into the operating room,” stated Keith Valentine, Chief Executive Officer of SeaSpine. “The Mariner launch is an important enhancement to SeaSpine’s spinal hardware product offerings in the $1.8 billion posterior lumbar fixation market.”

About SeaSpine

SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal hardware solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal hardware portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal fusion hardware product development helps SeaSpine to offer its surgeon customers a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements

SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the design benefits of the Mariner Posterior Fixation System, including its potential to reduce the number of trays needed for surgery and provide surgeons with multiple intra-operative options to facilitate posterior lumbar fixation; and ability of the Mariner Posterior Fixation System to complete in the $1.8 billion posterior lumbar fixation market. Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the fact that the Mariner Posterior Fixation System has undergone only limited clinical validation and may not address adequately surgeon requirements; surgeons’ willingness to use the Mariner Posterior Fixation System; the risk of supply shortages, including as a result of our dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact
Lynn Pieper
(415) 937-5402
ir@seaspine.com

SeaSpine Holdings Corporation

Medacta Spine Delivers Strong Growth in Q1 2017 and Introduces Key New Products

Posted On July 7, 2017 By OrthoSpineNews In Spine, Top Stories /

July 06, 2017

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Medacta International, the privately held family-owned global leader in the design of innovative joint replacement and spine surgery products, today announced that the company’s USA Spine Division delivered strong growth in the first quarter of 2017 and introduced key new products that will continue to expand Medacta’s offerings in the spine field.

Coming off the appointment of a new medical director and important product launches, the Medacta USA Spine Division nearly doubled its sales revenue from the comparable quarter last year. The division released three new products in 2016, including the MySpine Low Profile Guide, receiving numerous accolades for their clinical success and high praise from the surgeons who use them.

Francesco Siccardi, Executive Vice President of Medacta International, commented: “Medacta always strives to produce exceptional products that are built around surgeon feedback and provide the best possible patient experience. The success of this team is a proof point for the Medacta way: a maintained focus on surgeon education and smart design.”

Medacta’s latest innovation, the MectaLIF Anterior Hybrid Interbody Fusion Device, was cleared by the U.S. Food and Drug Administration (FDA) in February 2017 and will be an addition to the MectaLIF Cage product suite. The MectaLIF System aims to provide enhanced in situ stability, restoration of the native disc space height and lordosis, and long-term maintenance of the spinal balance. With the addition of the new hybrid configuration, the MectaLIF product line will now offer four different configurations (hybrid, anterior flush, anterior long, and anterior L5-S1), three footprints, two materials (PEEK or Titanium-coated PEEK (TiPEEK)), and hyperlordotic 20-degree cage options, allowing surgeons to target any patient-specific abnormalities they may encounter.

“The addition of the hybrid makes MectaLIF even more versatile,” said Dr. S. Raymond Golish, Medical Director of Medacta’s Spine Division. “We offer surgeons a wide variety of implants tailored to surgeon technique and patient anatomy to optimize outcomes.”

The addition of the MectaLIF hybrid configuration will enable personalized care for patients where additional stability is required and low profile construct is necessary to deal with difficult, tilted anatomies, by offering a flush caudal and long cranial profile in conjunction with low angle, diverging screws. In addition to the new configuration, the FDA cleared the hyper lordotic option and a 40x30mm footprint to further supplement the MectaLIF product suite and offer a wider array of options to patients.

About Medacta

Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

For Medacta International, Inc.
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

K2M Receives FDA Clearance & CE Mark for NILE® Proximal Fixation Spinal System

Posted On July 6, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

LEESBURG, Va., July 06, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a CE Mark for its NILE® Proximal Fixation Spinal System, a spinal system specifically designed for proximal construct augmentation. NILE Proximal Fixation addresses complex spinal deformity cases and consists of bands and connectors that may be used in conjunction with spinal rod constructs for attachment to the posterior vertebral structures at the proximal end of the construct. The CE Mark for NILE Proximal Fixation also includes the use of anchors, which are not cleared for use in the United States.

“I have used many band technologies for proximal construct augmentation from different companies and NILE Proximal is a huge leap forward in simplifying the design to achieve this goal,” said Greg Mundis, MD, a surgeon specializing in pediatric and adult spinal deformity surgery in the Department of Orthopedics at Scripps Clinic Medical Group in La Jolla, California. “K2M has made it elegant and efficient to place the connectors and tension the bands in a predictable fashion.”

I am excited about this addition to the NILE product family,” said John Ferguson, MD, an orthopedic spine surgeon in Auckland, New Zealand. “The implants are straightforward and easy to use. I think this product will be a very useful addition to many of my complex procedures.”

NILE Proximal Fixation has a versatile application in complex procedures, from scoliosis to adult degenerative. The NILE bands are manufactured from polyethylene terephthalate and can be used to provide additional fixation in a MESA® , MESA 2, EVEREST®, or DENALI® Spinal System construct through sublaminar passage or attachment to an anchor (OUS only). The band can then be integrated into the construct using the NILE transverse or medial offset connectors.

“Similar to our recent announcements around MOJAVE™ PL 3D Expandable, SAHARA® AL Expandable, and CAPRI™ Small 3D Static, we are incredibly proud to announce yet another innovative technology in NILE Proximal Fixation,” stated K2M President and CEO Eric Major. “This regulatory milestone—coupled with the recent launch of our Balance ACS™ platform— further emphasizes our focus on achieving three-dimensional spinal balance, and ultimately Total Body Balance, for patients.”

Balance ACS (BACS™) provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

For more information about the NILE Proximal Fixation Spinal System and K2M, visit www.K2M.com. For more information about Balance ACS, visit www.BACS.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving threedimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques, and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; in adequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC. We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements. The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forwardlooking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:

Zeno Group on behalf of K2M Group Holdings, Inc. Christian Emering, 212-299-8985 Christian.Emering@ZenoGroup.com

Investor Contact:

Westwicke Partners on behalf of K2M Group Holdings, Inc. Mike Piccinino, CFA, 443-213-0500 K2M@westwicke.com