HSS Researchers Receive Grant for Clinical Trial to Improve Outcomes for Rotator Cuff Tears

Posted On December 18, 2017 By OrthoSpineNews In Sports Medicine, Top Stories /

NEW YORK, Dec. 18, 2017 /PRNewswire-USNewswire/ — A multidisciplinary team led by Scott Rodeo, MD, and Christopher Mendias, PhD, at Hospital for Special Surgery (HSS) has been awarded the Orthopaedic Research and Education Foundation (OREF) Clinical Research Grant in Cellular Therapy in honor of James Urbaniak, MD in Collaboration with National Stem Cell Foundation (NSCF). The $800,000 grant will fund a clinical trial to determine if the use of stem cell therapy can improve outcomes for patients who suffer rotator cuff tears. To date, this is the largest grant given in OREF history.

Rotator cuff tears are one of the most prevalent musculoskeletal conditions yet surgical repair does not reverse muscle atrophy so patients may continue to feel weakness and pain even after surgery.

While surgical techniques have evolved over the years, there is still a high re-tear rate, which warrants more research to identify a better solution.

“The results of rotator cuff repair surgery are adversely affected by muscle atrophy and weakness, making it difficult for many patients to return to full function,” said Dr. Rodeo, co-principal investigator and sports medicine surgeon at HSS.

Previous studies have shown that stem cells that are harvested from body fat in the abdominal and thigh area can improve the regeneration of musculoskeletal tissues. These cells, known as stromal vascular fraction cells (SVFCs), contain a population of pluripotent stem cells that can differentiate into skeletal muscle and tendon tissue. These cells also secrete anti-inflammatory and tissue regeneration molecules.

The grant will move research ahead to a phase II clinical trial to evaluate the safety and efficacy of SVFCs in improving outcomes for patients who undergo arthroscopic surgical repair for rotator cuff tears.

“This study may be the first to determine if stem cells from a patient’s own adipose tissue can improve outcomes after rotator cuff repair,” said Dr. Mendias, co-principal investigator and associate scientist at HSS. “We believe that the patients who receive SVFCs may see improved function and demonstrate improved tissue healing on both clinical imaging and tissue histological studies.”

Over 50 patients will be enrolled in the study, with HSS following patients for two years to track strength and range of motion measurements, imaging assessments of muscle and tendon regeneration, and patient-reported outcome scores. In order to evaluate return to normal function, the primary outcome measure will be shoulder strength.

“If we demonstrate that this cell therapy is successful, then there is a clear justification for a pivotal phase III clinical trial in patients with rotator cuff tears,” added Dr. Rodeo. “We are very excited about the journey ahead.”

The other HSS investigators are Russell F. Warren, MD; Frank A. Cordasco, MD; Hollis G. Potter, MD; Matthew F. Koff, PhD; and Ogonna Kenechi Nwawka, MD.

About Hospital for Special Surgery
Hospital for Special Surgery (HSS) is the world’s leading academic medical center focused on musculoskeletal health. HSS is nationally ranked No. 1 in orthopedics and No. 3 in rheumatology by U.S. News & World Report (2017-2018), and is the first hospital in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. HSS has one of the lowest infection rates in the country. HSS is an affiliate of Weill Cornell Medical College and as such all Hospital for Special Surgery medical staff are faculty of Weill Cornell. The hospital’s research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. HSS has locations in New York, New Jersey and Connecticut.
www.hss.edu

SOURCE Hospital for Special Surgery

Wright Medical Group N.V. Announces Acquisition of IMASCAP SAS

Posted On December 18, 2017 By OrthoSpineNews In Extremities, Financial, Top Stories /

AMSTERDAM, The Netherlands, Dec. 14, 2017 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today announced the acquisition of IMASCAP SAS, a leader in the development of software-based solutions for preoperative planning of shoulder replacement surgery. The transaction ensures exclusive access to breakthrough software enabling technology and patents to further differentiate Wright’s product portfolio and to further accelerate growth opportunities in Wright’s global Extremities business.

Under the terms of the agreement with IMASCAP, Wright acquired 100% of IMASCAP’s outstanding equity on a fully diluted basis for total consideration, net of acquired cash, of €75.1 million or approximately $88.8 million, consisting of approximately €39.7 million, or approximately $46.9 million, in cash and approximately €13.2 million, or approximately $15.6 million, of Wright ordinary shares, payable at closing, and approximately €22.2 million, or approximately $26.3 million, in potential earnouts and milestone payments for new software modules and a potential future implant system.

IMASCAP’s Glenosys technology is the preoperative planning software behind Wright’s BLUEPRINT™ 3D planning software, which allows the surgeon to simulate the position of a shoulder prosthesis using CT image data. The surgeon is able to visualize the shoulder in 3D and rotate through the complete range of motion in any direction. Before the surgery, the surgeon can optimize the surgical plan adapted to the patient to choose the best implant from a range of possibilities. With its simple and intuitive interface, this virtual surgical plan is seamlessly translated into the operating room on the day of surgery offering the potential for reduced surgical time, better outcomes and less inventory.

Robert Palmisano, president and chief executive officer, commented, “Wright, and previously Tornier, has been involved with IMASCAP for many years with our BLUEPRINT case planning software, and we have seen first-hand the innovation, creativity and differentiated solutions that the IMASCAP team has developed. Software-enhanced solutions are the future, and with the acquisition of IMASCAP, we have the opportunity to take a significant lead in this area. We are thrilled that we had an opportunity to acquire IMASCAP, which is the company that has developed the technology behind our BLUEPRINT case planning software for our shoulder portfolio. This is a highly differentiated, enabling technology for the shoulder and has a number of potential applications to enhance our PROPHECY planning for ankles as well.”

Palmisano continued, “While our BLUEPRINT planning software is a significant differentiator today, IMASCAP has a rich pipeline of potential breakthrough technologies under development and patent-pending. We believe the future of orthopaedic implant surgery will include advanced elements of artificial intelligence and augmented reality. When fully developed, we believe such software enabled surgery will leapfrog the current mechanical approaches some orthopaedic companies have developed primarily for hip and knee replacement surgery.”

Palmisano further commented, “IMASCAP is led by its founder and CEO, Jean Chaoui. Jean has an impressive background, with degrees in Biomedical Engineering from Damascus University and Telecom Brittany (Masters & PhD) with a focus in Biomedical Imaging. Jean has received 11 patents and has written more than 30 scientific publications in the field of computer assisted surgery, and he has completed multiple projects in the areas of image and bio-signal processing, artificial intelligence and brain/computer interface. He is a recent recipient of the MIT Technology Review – Top 10 French Innovators under 35 and a Fellow in the Young Transatlantic Innovative Leaders Initiative, representing France. We are delighted that Jean and the entire IMASCAP team are joining Wright.”

Jean Chaoui, president and chief executive officer of IMASCAP, added, “We are delighted to have found an excellent strategic buyer in Wright, a company that shares IMASCAP’s commitment to technological leadership and who is deeply committed to the success of our technology. We believe that Wright, with its global leadership position in the extremities market and expertise in medical education and product development, is the ideal partner to realize the full potential of IMASCAP’s technology and product pipeline and will continue to provide the focus and investment to enable it to reach its full potential. Also, very importantly, this will provide our employees with enhanced opportunities for career growth and development. We look forward to an exciting future as part of Wright Medical.”

IMASCAP has no revenues; therefore, there is no impact to Wright’s previously provided full-year 2017 annual net sales guidance of $740 million to $745 million. Due to the timing of the closing, the company anticipates incurring minimal incremental expenses in 2017, and therefore is maintaining its current full-year 2017 non-GAAP adjusted EBITDA from continuing operations guidance range of $84 million to $88 million. The company currently plans to offer this important enabling technology at no cost to physicians who are implanting Wright’s shoulder products. Wright will provide additional information on the financial impact of this transaction and 2018 guidance on its fourth quarter 2017 earnings call, which is currently scheduled for February 27, 2018.

For more information on this transaction, please refer to the investor presentation that is available in the Investor Relations section of Wright’s website at www.wright.com.

Internet Posting of Information

Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com. The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving the quality of life for patients worldwide. Wright is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics. For more information about Wright, visit www.wright.com.

™ and ® denote trademarks and registered trademarks of Wright Medical Group N.V. or its affiliates, registered as indicated in the United States, and in other countries. All other trademarks and trade names referred to in this release are the property of their respective owners.

About IMASCAP SAS

IMASCAP SAS develops software for preoperative planning of shoulder replacement surgery. IMASCAP software system is the only system in the world allowing orthopaedic surgeons complete independence for planning, with nothing more than image data provided by CT scan of the patient. The software allows the surgeon to automatically conceive a surgical guide adapted particularly to the patient anatomy, which permits the surgeon to implant the prosthesis in a position that closely matched the software plan. The system has been developed in close collaboration with internationally recognized experts in the shoulder field, providing an innovative and practical solution to the operating room. IMASCAP is focused on applying its technical expertise to serve orthopaedic surgery by furnishing patient specific solutions and participating in the development of new generations of prostheses adapting this new and innovative technology. For more information please visit www.imascap.com.

Non-GAAP Financial Measures

To supplement the company’s consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles, the company uses certain non-GAAP financial measures in this release, including . EBITDA, as adjusted, from continuing operations. The company’s non-GAAP adjusted EBITDA from continuing operations target is measured by adding back to net loss from continuing operations charges for interest, income taxes, depreciation and amortization expenses, non-cash share-based compensation expense and non-operating income and expense. Additionally, the company’s adjusted EBITDA from continuing operations target excludes possible future acquisitions; other material future business developments; and due diligence, transaction and transition costs associated with acquisitions and divestitures. Further, this adjusted EBITDA from continuing operations target excludes any expenses, earnings or losses related to the divested large joints business, legacy Wright’s divested OrthoRecon business and legacy Tornier’s divested ankle replacement and silastic toe products. The company’s management believes that the presentation of non-GAAP financial measures provides useful information to investors. These measures may assist investors in evaluating the company’s operations, period over period. Wright’s non-GAAP financial measures exclude such items as non-cash interest expense related to the company’s 2017 convertible notes, 2020 convertible notes and 2021 convertible notes, net gains and losses on mark-to-market adjustments on and settlements of derivative assets and liabilities, write-off of unamortized debt discount and deferred financing charges following the partial settlement of 2017 convertible notes and 2020 convertible notes, mark-to-market adjustments on CVRs, transaction and transition costs and tax impacts from changes in the realizability of net operating losses, all of which may be highly variable, difficult to predict and of a size that could have substantial impact on the company’s reported results of operations for a period. It is for this reason that the company cannot provide without unreasonable effort a quantitative reconciliation to the most directly comparable GAAP measures for its 2017 financial guidance regarding non-GAAP adjusted EBITDA from continuing operations. Management uses the non-GAAP measures in this release internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets. Investors should consider non-GAAP financial measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “look forward,” “continue,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the future anticipated success and benefits of the company’s software-based solutions for preoperative planning of shoulder replacement surgery and the company’s anticipated financial results for 2017, including net sales from continuing operations and adjusted EBITDA from continuing operations. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the failure to realize the full anticipated benefits of the company’s software-based solutions for preoperative planning of shoulder replacement surgery; risks involved in the acquisition of IMASCAP and the anticipated registration of the resale of the Wright ordinary shares issued in connection therewith; failure to integrate the legacy Wright and Tornier businesses and realize net sales synergies and cost savings from the merger with Tornier or delay in realization thereof; operating costs and business disruption as a result of the merger, including adverse effects on employee retention and sales force productivity and on business relationships with third parties; integration costs; actual or contingent liabilities; failure of the company’s recent U.S. sales force additions, focus on core product portfolio and incentives to drive U.S. lower extremities and biologics sales or delay in realization thereof; adverse effects of diverting resources and attention to providing transition services to the purchaser of the large joints business; the adequacy of the company’s capital resources and need for additional financing; the timing of regulatory approvals and introduction of new products; physician acceptance, endorsement, and use of new products; failure to achieve the anticipated benefits from approval of AUGMENT^® Bone Graft; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims and product recalls; pending and threatened litigation; risks associated with the metal-on-metal master settlement agreement and the settlement agreement with the three settling insurers; risks associated with the subsequent metal-on-metal settlement agreements and ability to obtain the additional new insurance proceeds contingent thereon; risks associated with international operations and expansion; fluctuations in foreign currency exchange rates; other business effects, including the effects of industry, economic or political conditions outside of the company’s control; reliance on independent distributors and sales agencies; competitor activities; changes in tax and other legislation; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 25, 2016 filed by Wright with the SEC on February 23, 2017 and in other subsequent SEC filings by Wright, including Wright’s Quarterly Report on Form 10-Q for the quarterly period ended September 24, 2017 filed by Wright with the SEC on November 2, 2017. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Investors & Media:

Julie D. Tracy
Sr. Vice President, Chief Communications Officer
Wright Medical Group N.V.
(901) 290-5817
julie.tracy@wright.com

Wright Medical Group N.V.

PolarityTE™ Announces Application of SkinTE™ on First Patients

Posted On December 15, 2017 By OrthoSpineNews In Biologics, Top Stories /

SALT LAKE CITY, Dec. 15, 2017 (GLOBE NEWSWIRE) — PolarityTE, Inc. (NASDAQ:COOL) announced that human use of SkinTE™ is underway, and the product is now on patients, at multiple centers, within a variety of wound types and indications including acute and chronic wounds, burn wounds, surgical reconstructions and scar revisions. In addition, several patients with healed skin grafts, the gold standard treatment, have undergone removal of those grafts and replacement with SkinTE. Multiple medical centers have scheduled additional procedures through the end of 2017, and the Company expects an increasing number of applications during the first half of 2018 to meet market demand for the product. As clinical application grows, results and outcomes from the first group of treated patients are expected to be published throughout the first half 2018, addressing the many different patient populations treated.

“Application of SkinTE across this wide spectrum of cutaneous defects demonstrates the broad utility of this novel product beyond burn care, and we look forward to the results for all of the amazing patients being treated with SkinTE,” said Dr. Denver Lough, Chief Executive Officer of PolarityTE. “We are confident and believe that SkinTE will replicate its preclinical success and help patients regenerate their own full-thickness, hair-bearing skin. We did not set out to bring another iteration to the field of regenerative medicine—we set out to change it entirely. Welcome to the Shift™.”

About SkinTE™ and FDA Tissue Establishment Registration
SkinTE™ is regulated by the FDA as an HCT/P solely under Section 361 of the Public Health Service Act and 21 CFR 1271. The FDA has specific regulations governing HCT/Ps. HCT/Ps that meet the criteria for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271 (361 HCT/Ps) are not subject to pre-market clearance or approval requirements, but are subject to post-market regulatory requirements.

SkinTE is processed and marketed in accordance with the FDA’s requirements for human tissue and current good tissue practices (21 CFR 1271) and is manufactured by American Association of Tissue Banks (AATB)- and Foundation for the Accreditation of Cellular Therapy (FACT)-accredited facilities.

Important Safety Information
Poor general medical condition or any pathology that would limit the blood supply and compromise healing, as well as nonvascular surgical sites, should be considered when selecting patients for SkinTE, as such conditions may compromise successful outcomes or lead to sub-optimal results.
Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures must be taken. Unused or expired tissue product should be discarded according to local, state, federal and institutional requirements. Utilization of the SkinTE construct, process and/or technology is limited to healthcare professionals and facilities that are capable of handling such tissue products.

Proper aseptic procedural and/or surgical handling is mandatory when using SkinTE. Failure to ensure proper aseptic technique may result in contamination of the tissue product and wound bed. Contamination of the tissue product and/or wound bed due to failure to ensure aseptic technique could result in local, regional, or systemic infection, partial or complete failure of graft take, healing, and/or regeneration, serious injury, and/or death. Failure to follow instructions may lead to sub-optimal outcomes and/or product failure.

Potential adverse effects may include but are not limited to the following: local tissue, wound bed, regional tissue, or systemic infection, hypersensitive, allergic, or other immune response to the product or trace amounts of antibiotic retained from primary harvest, deleterious effects on potential surrounding or adjacent autologous, allogeneic, or xenogenic grafts, skin substitutes, or other reconstructions including infection and/or failure of adjacent grafted material to take and heal, requirement for further surgical operation(s) and/or debridement, or death.

About PolarityTE™
PolarityTE™, Inc. is a regenerative medicine company, and the first to successfully regenerate full-thickness tissue. The Company’s novel regenerative medicine platform and proprietary technology employs a patient’s own cells for the healing of full-thickness, functionally-polarized tissues. If clinically successful, the PolarityTE™ platform will provide medical professionals with a truly new paradigm in wound healing and reconstructive surgery by utilizing a patient’s own tissue substrates for the regeneration of skin, bone, muscle, cartilage, fat, blood vessels and nerves. The PolarityTE™ platform leverages natural and biologically-sound principles which are readily adaptable to a wide spectrum of organ and tissue systems. This revolutionary technology, paired with the Company’s world-renowned clinical advisory board, position PolarityTE™ to drastically change the field and future of translational regenerative medicine. More information can be found online at www.PolarityTE.com.

Forward Looking Statements
Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements contained in this release relate to, among other things, the Company’s ongoing compliance with the requirements of The NASDAQ Stock Market and the Company’s ability to maintain the closing bid price requirements of The NASDAQ Stock Market on a post reverse split basis. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “should'” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions as of the date of this release. The Company’s actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and other filings with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

Investor Contact
John Stetson
InvestorRelations@PolarityTE.com
(385) 237-2365

Media Contacts
Scott Santiamo
Russo Partners LLC
Scott.Santiamo@RussoPartnersLLC.com
(718) 344-5843
David Schull
Russo Partners LLC
David.Schull@RussoPartnersLLC.com
(858) 717-2310

Source: PolarityTE, Inc.

Released December 15, 2017

NuVasive Appoints Experienced Spine Executive Michael Piccirillo To Lead New Global Surgeon Education Platform

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

SAN DIEGO, Dec. 14, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today the expansion of its renowned surgeon education program into a Clinical Professional Development (CPD) global platform for surgeons that integrates surgical training with professional development. This new initiative will be led by Michael Piccirillo, a recognized expert in designing and executing spine educational curriculums and surgeon communities in more than 80 countries across the world.

In 2003, NuVasive revolutionized spinal surgery by introducing an innovative lateral approach with its XLIF® technology. To better serve the spine surgeon community, NuVasive created and delivered a new standard in surgeon training. Through new product design, surgeon education and a leading sales team, XLIF is now the world’s leading procedure for the lateral approach. NuVasive is again taking the lead and evolving its education platform to better match the lifelong training needs and challenges facing today’s and tomorrow’s communities of spine surgeons.

The NuVasive CPD team will support the Company’s surgeon partners for the lifetime of their careers. The new training programs will facilitate the development of a diverse set of competencies that spine surgeons will need in the future and will deliver challenging programs that are surgeon-oriented, personalized and fit within a systematic pathway. Additionally, a core component of the expanded platform is peer-to-peer engagement to encourage collaboration of ideas and innovation among the surgeon participants and drive further engagement.

“As a leader in disruptive spine technologies, our commitment to surgeon training and education programs has been a key differentiator for NuVasive and has enabled us to introduce less invasive approaches to spine surgery, while also adapting to surgeon needs in the changing landscape of the industry,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “The newly designed and expanded program is being rolled out globally to meet the needs of our surgeons and I’m excited to see the direction Michael is taking this critical and differentiating part of our business. Michael brings a wealth of knowledge and expertise in global educational strategy to NuVasive to make our CPD platform the most sought-after program available to surgeons around the world.”

Piccirillo joins NuVasive with more than 30 years of experience in developing strategy, building educational platforms and designing management solutions in the health care field. Piccirillo most recently served as managing partner at VALUGEN GmbH in Zurich. VALUGEN provides project-based services to help hospitals transform their spine centers into Centers of Excellence. While there, Piccirillo worked with a number of academic organizations to redesign their educational programs and created strategies for patient organizations. Before his time at VALUGEN, Piccirillo was the executive director at AOSpine and AOTrauma, the spine and trauma divisions of the AO Foundation, a Swiss-based non-profit organization which is partnered with and provides educational support for Synthes (DePuy Synthes). During his time at the AO Foundation, Piccirillo transformed both divisions into the largest communities of spine and trauma surgeons, respectively. Key to this success was the development of novel lifelong learning education and faculty programs, integrated research projects and the establishment of the World Forum and Global Spine Congress events. Piccirillo was also directly responsible for creating the AOSpine/AOTrauma competency curriculum, faculty development, and fellowships, as well as surgeon assessment programs.

“Tomorrow’s spine surgeon will be very different from yesterday’s and even today’s—not only will they need to be outstanding surgeons, but they will also need to be great managers and leaders. Education is critical in changing the behaviors, competencies and performance of tomorrow’s surgeon,” said Piccirillo. “I’m thrilled to join NuVasive with its documented history in creating a disruptive change to the traditional approaches to spine surgery and spine education. Our new education platform will continue this theme, and I’m particularly excited to implement a novel approach to facilitate a surgeon’s lifelong engagement with NuVasive.”

Picirillo graduated from London University with a degree in medical microbiology and supplemented his science training with specific professional courses as well as marketing and business administration courses to move into health care business management. He also received a diploma in marketing from the Chartered Institute of Marketing and a business administration degree from the University of Warwick.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

SOURCE NuVasive, Inc.

AlloSource Announces Raime Leeby Muhle As Chief Financial Officer

Posted On December 14, 2017 By OrthoSpineNews In Biologics, Top Stories /

CENTENNIAL, Colo., Dec. 14, 2017 /PRNewswire-USNewswire/ — AlloSource, one of the nation’s largest providers of cartilage, bone, skin, soft-tissue and cellular allografts for use in surgical procedures and wound care to advance patient healing, today announced the appointment of Raime Leeby Muhle as Chief Financial Officer.

With over 18 years of experience, her background spans from emerging high growth businesses to large and mature organizations. She has worked in a variety of industries including technology, distribution, manufacturing, and telecommunications. Leeby Muhle’s expertise in complex environments, as well as working cross-functionally, will help her lead the accounting, financial, and information technology teams at AlloSource. Leeby Muhle is taking over for current Chief Financial Officer, Olivia Thompson, who is transitioning into retirement to focus on project-based work.

“We are thrilled to welcome Raime to our executive team,” said Thomas Cycyota, AlloSource President and Chief Executive Officer. “Her financial expertise and leadership, as well as her passion for our mission, will help drive AlloSource’s growth as we continue to evolve the advanced allograft therapies we provide for surgeons.”

Leeby Muhle has held various senior-level roles with finance and operational responsibilities. Prior to AlloSource, she served in key leadership positions at Arrow Electronics and Level 3 Communications.

“AlloSource has such a unique impact on our communities, and I am committed to helping the company continue to grow and innovate,” said Leeby Muhle. “I look forward to putting my background and skills towards our goal of achieving greater results in advancing biological healing.”

About AlloSource
AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource’s products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world’s largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help patients heal from severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country’s most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org.

Media Contact
Megan Duggan
AlloSource
720. 382. 2766
mduggan@allosource.org

SOURCE AlloSource

Willamette Surgery Center First in Oregon to Receive Advanced Certification for Total Hip and Total Knee Replacement

Posted On December 14, 2017 By OrthoSpineNews In Recon, Top Stories /

SALEM, Ore., Dec. 12, 2017 /PRNewswire/ — Willamette Surgery Center, in partnership with Hope Orthopedics of Oregon, is the first facility in Oregon to receive advanced certification for outpatient total hip and total knee replacement. Advanced Certification for Total Hip and Total Knee Replacement from The Joint Commission focuses on all aspects of outpatient hip and knee replacement, from pre-operative consultation to rehab and follow up visits. This achievement goes above and beyond the Joint Commission Accreditation, which Willamette Surgery Center has achieved and maintained since opening in 1999.

The surgeons of Hope Orthopedics have performed 375 joint replacements at Willamette Surgery Center since the start of the program in 2014.

When asked about the success of the partnership program of Willamette Surgery Center and Hope Orthopedics, Dr. John Coen, Hope Orthopedics surgeon and head of the outpatient total joint replacement program says, “It is great to see validation of something the surgeons at Hope Orthopedics already knew – Willamette Surgery Center does a fantastic job caring for our patients. It is a pleasure for Hope Orthopedics to bring outpatient joint replacement to the people of the Willamette Valley, and Willamette Surgery Center does it right.”

Willamette Surgery Center underwent a rigorous onsite review to qualify for advanced certification. Joint Commission experts evaluated compliance with advanced care standards and total hip and total knee replacement requirements, including orthopedic consultation, and pre-operative, intraoperative and post-surgical follow-up care.

Advanced Certification assures the public that standardized processes are in place to reduce the risk of error and improve the delivery of safe patient care.

About Willamette Surgery Center and Hope Orthopedics: Willamette Surgery Center and Hope Orthopedics are based in Salem, Oregon. Their partnership to bring outpatient total joint replacement to the area began in 2014. You can see more in this video about the outpatient joint replacement process at Hope Orthopedics and WSC.

Founded in 1951, The Joint Commission seeks to improve health care for the public by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value. An independent, nonprofit organization, The Joint Commission is the nation’s oldest and largest standards-setting and accrediting body in health care. Learn more about The Joint Commission at www.jointcommission.org.

SOURCE Willamette Surgery Center

NuVasive To Acquire SafePassage

Posted On December 13, 2017 By OrthoSpineNews In Spine, Top Stories /

SAN DIEGO, Dec. 12, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, and SafePassage™, a privately-held provider of intraoperative neurophysiological monitoring (IONM) services, announced today that they have entered into a definitive agreement under which NuVasive will acquire SafePassage. Terms of the deal were not disclosed.

With the addition of SafePassage, NuVasive Clinical Services™ (NCS) solidifies its leadership position as the largest provider of outsourced IONM services with more than 550 neurophysiologists and oversight physicians in the U.S., allowing for the delivery of services to over 1,000 customers and 3,000 surgeons. This joining of forces strengthens the Company’s intraoperative neuromonitoring business line, which was formed in July 2016 when the Company acquired Biotronic NeuroNetwork and combined its service offerings with that of the Company’s subsidiary, Impulse Monitoring, Inc. Since then, NCS has further scaled the business, achieving operational efficiencies and driving better clinical outcomes. Following the acquisition of SafePassage, NCS is expected to support greater than 100,000 IONM cases annually in the U.S.

SafePassage is also complementary to the current NCS geographical footprint with limited overlap between existing healthcare accounts. The acquisition helps further accelerate the services business growth and enables deeper reach in key strategic markets while adding significant new coverage, particularly in the densely populated New York region and along the East Coast where NuVasive has traditionally had a strong spine procedural-selling presence.

“The acquisition of SafePassage advances the NuVasive services strategy and expands our ability to transform how spine procedures are approached, measured and valued from a clinical and economic perspective,” said Skip Kiil, executive vice president, Global Commercial of NuVasive. “As the only spine company in the world with dedicated neuromonitoring services operating at this elevated scale, and now with increased case coverage, we are uniquely positioned to deliver greater value across our procedurally-integrated portfolio.

“Just as important, the highly trained and well-respected SafePassage leadership and clinicians have earned the industry reputation of being among the best in the business, and we’re excited to partner with them to provide consistent and quality care to hundreds of surgeons and thousands of patients each year,” continued Kiil.

“For more than a decade, the team at SafePassage has been dedicated to serving patients and surgeons with premium quality intraoperative neurophysiological monitoring services to improve patient outcomes and reduce economic risk for hospitals and surgeons,” said Dan Siegel, chief executive officer of SafePassage. “We are extremely passionate about our vision to eradicate preventable healthcare injury, the third leading cause of death in the United States, and I look forward to joining forces with NuVasive to further our mission worldwide.”

Financial
NuVasive expects the transaction to be accretive to the Company’s non-GAAP earnings per share (EPS) in 2018 and beyond. NuVasive also expects the transaction to support its longer-term targets for revenue growth and expansion of its non-GAAP operating and EBITDA margins. Additionally, the transaction is expected to meet the Company’s goals for return on invested capital for tuck-in acquisitions in three years, consistent with the Company’s previously stated acquisition criteria.

The transaction is expected to close in January 2018, subject to customary closing conditions.

About SafePassage
Founded in 2007 by surgeons, SafePassage’s 135 clinical specialists and support staff service approximately 12,600 cases annually. Privately held and based in New York City, SafePassage provides IONM and EEG services to surgeons and healthcare facilities across the eastern U.S. The Company is Joint Commission accredited since 2014, with recent renewal in 2017.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. Forward-looking statements include, but are not limited to, statements about the timing of the anticipated acquisition, the potential benefits and synergies of the anticipated acquisition, including the expected impact on future financial and operating results, and post-acquisition plans and intentions. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. The following important factors, among others, could cause actual results to differ materially from those set forth in the forward-looking statements: the satisfaction of conditions to closing the agreement, including the risk that any required conditions are not satisfied, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the acquisition; the loss of key employees; the risk that the businesses will not be integrated successfully; unexpected variations in market growth and demand for the combined company’s products and technologies; and the risk that benefits and synergies from the acquisition may not be fully realized or may take longer to realize than expected. Additional risks and uncertainties that may affect future results are described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

AAOS approves diagnostic and treatment criteria for osteoarthritis of the hip

Posted On December 13, 2017 By OrthoSpineNews In Recon, Top Stories /

ROSEMONT, Ill., Dec. 12, 2017 /PRNewswire-USNewswire/ — The American Academy of Orthopaedic Surgeons (AAOS) Board of Directors approved new Appropriate Use Criteria (AUC) for Management of Osteoarthritis of the Hip.

The AAOS AUCs provide clinicians with algorithms on how to optimally treat an orthopaedic injury or condition, including hypothetical scenarios and possible treatments, ranked for appropriateness based on the latest research and clinical expertise and experience.

The new AUC supports the Clinical Practice Guideline, “Management of Osteoarthritis of the Hip” that strongly recommends:

The use of pre-surgical treatments to ease pain and improve mobility, including corticosteroid injections, physical therapy and non-narcotic medication (specifically acetaminophen, non-steroidal anti-inflammatory drugs or tramadol) for pain.
Both anterior and posterior approaches for total hip replacement (THR) surgery.

In addition, the new criteria highlight when “hip replacement may be appropriate even when patients have modifiable risk factors, such as obesity, mental health disorders, smoking and diabetes,” said Robert H. Quinn, MD, AAOS AUC section leader on the Committee on Evidence-Based Quality and Value.

For example, “some patients, who have worked closely with their medical team to best mitigate these risk factors, might be considered on an individual basis” for surgery, said Dr. Quinn. “In these instances, the doctor and patient must weigh the benefits and risks of surgery. At the end of the day it’s one surgeon and one patient, and hopefully both are considering the optimal treatment, based on the patient’s particular condition and diagnosis.”

The AUC and CPG, “Management of Osteoarthritis of the Hip,” are available through the AAOS OrthoGuidelines website and mobile app.

More Information about the AAOS
With more than 38,000 members, the American Academy of Orthopaedic Surgeons is the world’s largest medical association of musculoskeletal specialists. The AAOS provides educational programs for orthopaedic surgeons and allied health professionals, champions and advances the highest quality musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments and related issues.

Visit AAOS, at:
Newsroom.aaos.org for bone and joint health news, stats, facts, images and interview requests.
Orthoinfo.org for patient information on hundreds of orthopaedic diseases and conditions. ANationinMotion.org for inspirational patient stories, and orthopaedic surgeon tips on maintaining bone and joint health, avoiding injuries, treating musculoskeletal conditions and navigating recovery.
Facebook.org/AAOS1
Twitter.com/AAOS1
Instagram.com/AAOS_1

SOURCE American Academy of Orthopaedic Surgeons

EIT Emerging Implant Technologies Announces Agreement with HCA

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

ROSWELL, GA (PRWEB) DECEMBER 11, 2017

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has now successfully completed the contracting process with HealthTrust related to an HCA contract and is now able to offer all interbody products for Cervical, ALIF, TLIF and PLIF procedures in the 177 hospitals and 119 freestanding surgery centers located throughout the United States.

EIT Cellular Titanium® is a 3D printed porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimize cell proliferation and bone ingrowth.

With the addition of this contract, EIT is poised to continue its aggressive growth pattern in the United States. EIT believes that this will create more unique opportunities to work with HCA surgeons to evaluate and take advantage of the validated structure and many other unique features that differentiate EIT from other 3D printed products.

The contract approval was pursued and successfully completed by Ortho Sales Partners. Josh Sandberg, President of OSP said, “This is a huge milestone that we have been able to help achieve at an unusually early stage in EIT’s development. That is a credit to the strength of this product offering and we are excited about the opportunity to work with HCA facilities in helping them lower the overall cost of these spine procedures.”

“EIT´s goal is to improve spine care using the advantages of 3D printing technology and cope with given pricing and reimbursement structures. We are delighted that HCA/HealthTrust is interested in working with EIT. This will help us to get quicker market access in the United States” said Guntmar Eisen, cofounder and CEO of EIT.

In addition to the contract, EIT is currently finalizing an action plan with HCA leadership to understand the economic impact this novel technology will have on fusion rates, implant costs and the need for high cost osteobiologics. Further details of this proposal will be announced at a later time.
________

About EIT

EIT is the first medical device manufacturer to exclusively focus on implants for spinal alignment, that are designed according to latest published science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014 by Hans Eekhof and Guntmar Eisen.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 12.000 EIT cases have been performed in over 15 markets globally.

Next-Generation High-Definition Visualization System for Minimally Invasive Surgery Introduced by DePuy Synthes

Posted On December 6, 2017 By OrthoSpineNews In Recon, Spine, Top Stories /

LAS VEGAS, Dec. 6, 2017 /PRNewswire/ — Today, the PUREVUE™ Visualization System was unveiled at the Orthopaedic Summit 2017: Evolving Techniques. This new offering from DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, is a state-of-the-art imaging platform for minimally invasive endoscopic surgery.

Approximately 18.6 million endoscopic procedures are performed each year in the United States.¹ In these procedures, case efficiency and patient outcomes are often linked to how well the surgeon can see the targeted anatomy.

The PUREVUE Visualization System combines a light source, image processer and local image management for a reduced operating room (OR) footprint, and includes intuitive touch-screen navigation and customizable settings for many minimally invasive surgery (MIS) applications. The autoclavable camera head features a proprietary sensor designed for endoscopy, that delivers native HD image acquisition for a clear view throughout the procedure that is further enhanced by multiple monitor options, including ultra-high-definition 4K. The forward-compatible system is also augmented by a wide range of visualization accessories.

“With Americans living longer and seeking shorter recovery times, the call for minimally invasive procedures is accelerating,” said Stephanie Chamberlain, Vice President and Global Platform Leader, DePuy Synthes Mitek Sports Medicine. “We are committed to bringing forward innovation that responds to evolving patient needs and the PUREVUE Visualization System is an example of how our advanced technologies enable high quality patient care.”

The PUREVUE Visualization System also completes the company’s capital equipment offering in arthroscopy, a type of endoscopic surgery focused on joint anatomy, which includes the VAPR VUE™ Radiofrequency System and the FMS VUE™ Fluid Management and Tissue Debridement System. Together, these solutions bolster Mitek Sport Medicine’s portfolio of implants and instrumentation used for a wide spectrum of arthroscopic soft tissue procedures.

About DePuy Synthes
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

¹ Perry, Anne F., et al. “Burden of Gastrointestinal Disease in the United States: 2012 Update” Gastroenterology. 2012 November; 143(5): 1179–1187.e3. doi:10.1053/j.gastro.2012.08.002 Update.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

DSUS/MTK/1117/1100(1)
December 2017

SOURCE DePuy Synthes

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