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

Orthocell Granted European Tendon Regeneration Patent

Posted On December 15, 2017 By OrthoSpineNews In Regulatory, Sports Medicine /

December 14, 2017

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce it has been granted a key European Patent. The patent is entitled ‘Culture medium, culturing method and use of tenocytes’ protecting the method of manufacturing tendon regeneration cells (Tenocytes) to form the Autologous Tenocyte Implantation (Ortho-ATI®) product. The patent expires in 2027 and provides additional important intellectual property (IP) to protect Orthocell’s tendon repair applications, now granted in EU, USA, China, Australia, Singapore, Hong Kong and New Zealand.

“Securing this patent for tendon repair in Europe is another milestone in strengthening our IP position as we drive our novel world leading tendon repair product into the global market. Orthocell is focused on building and maintaining patent protection for our regenerative medicine technologies and treatment processes,” Orthocell Managing Director Paul Anderson said.

Global IP protection for Ortho-ATI® further underpins the international rollout of Orthocell’s world leading tendon repair technology. Orthocell is well positioned to commercialise Ortho-ATI® with mature manufacturing facilities in place, proven safety and efficacy, published clinical data and a clear pathway to market.

Orthocell maintains an active program of patenting, with ownership of 29 granted patents across the Ortho-ATI®, Ortho-ACI® and CelGro® technologies, and related methods of treatment and manufacturing.

About Ortho-ATI®:

Ortho-ATI® is a world leading breakthrough in regenerative medicine – a novel, cell therapy developed to treat chronic degenerative tendon injuries (tendinopathy / tendonitis), it can be utilised in both surgical and non-surgical applications.

Tendon injury and its end point, tendinopathy, are a common cause of occupational and sporting disability reported to affect 1% to 3% of the general population every year
Significant financial burden to the public health care system expected to increase as the population ages, as a result, new treatments are required that are safe, effective and cost efficient
Ortho-ATI® meets the market need by enabling the accelerated regeneration of injured tendons, directly addressing the underlying cause of injury, replenishing degenerative tissue with healthy mature tendon cells (known as tenocytes)
Extensive clinical validation with published clinical data up to 4.5 years post treatment in leading peer reviewed journals, (e.g. American Journal Sports Medicine) clearly demonstrating durability and efficacy as the leading tendon regeneration treatment

Contacts

General enquiries
Orthocell Limited
Paul Anderson, +61 8 9360 2888
Managing Director
paulanderson@orthocell.com.au
or
Investor and Media enquiries
WE Buchan
Ben Walsh, + 61 411 520 012
bwalsh@buchanwe.com.au

OrthoPediatrics Corp. Appoints Samuel D. Riccitelli to its Board of Directors

Posted On December 15, 2017 By OrthoSpineNews In Extremities /

WARSAW, Ind., Dec. 15, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today the appointment of Samuel D. Riccitelli to its Board of Directors as an independent member, effective immediately. The appointment of Mr. Riccitelli brings the Company’s Board to 11 members. Mr. Riccitelli will be a member of the Governance Committee of the Board.

Terry Schlotterback, Chairman of the OrthoPediatrics Board of Directors, said, “Sam brings a wealth of direct experience to the OrthoPediatrics Board that includes building medical technology companies that transitioned from private to public ownership. He also has a strong understanding of the process of novel technology development. I am excited to welcome Sam to the Board of Directors and look forward to leveraging his extensive background in the healthcare industry.”

Mr. Riccitelli, age 58, has more than 30 years of experience in healthcare, including senior leadership positions at two publicly traded companies, and currently serves as Chairman of the Board of Directors of Precipio Diagnostics (NASDAQ:PRPO). From 2012 to 2017, he served as President and Chief Executive Officer, and as a Director, at Signal Genetics, Inc., a publicly traded molecular diagnostic company that was sold to miRagen Therapeutics. Mr. Riccitelli was also previously the Executive Vice President and Chief Operating Officer of Genoptix, Inc. (“Genoptix”), a publicly traded diagnostic company that was sold to Novartis in 2011. During his 10 year tenure at Genoptix, the company completed an initial public offering and grew sales to approximately $200 million in seven years.

From 1995 to 2001, Mr. Riccitelli served in a number of R&D and general management positions for Becton, Dickinson and Company, including as a Vice President and General Manager, and as a board member for BD Ventures, L.L.C., a venture capital fund of BDX. Mr. Riccitelli also served on the Board of Directors of Exagen Diagnostics, Inc., from 2011 to 2014. Mr. Riccitelli received a B.A. in Biology from Washington and Jefferson College and a M.S. Engineering degree from The University of Texas in Mechanical & Biomedical Engineering.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 23 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

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.

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

SOURCE NuVasive, Inc.

FDA Panel Gives Thumbs Down to Spine Device

Posted On December 14, 2017 By OrthoSpineNews In Regulatory, Spine /

By Joyce Frieden, News Editor, MedPage Today/December 13, 2017

GAITHERSBURG, Md. — An FDA advisory committee voted 5-8 Tuesday, with one abstention, against recommending approval of the Barricaid prosthesis for partial anulus replacement in patients with herniated discs.

“There was a high rate of breakage of the device, a high rate of migration, and [there was] the unknown nature of [some endplate] lesions,” said Eli Baron, MD, of the Cedars Sinai Spine Center in Los Angeles, a member of the FDA’s Orthopaedic and Rehabilitation Devices Panel. Many of the users of the device would be younger patients, “most in their 30s and 40s, and we don’t know what will happen down the line.” He voted that the risks of the Barricaid device, which is manufactured by Intrinsic Therapeutics, outweighed its benefits.

But committee member Ty Subhawong, MD, of the University of Miami, disagreed. “[The device is] reasonably safe, and I think the major concerns were centered around the endplate lesions and while there were some theoretical concerns about harbingers of device failure …. the number of lesions observed was sufficient to reassure me that there is nothing catastrophic about these devices,” said Subhawong, who voted in favor of recommending approval. He added, however, that a post-approval study would be a good idea.

The committee also voted 12-1 that the device was shown to be effective in the patients it was indicated for, but by a vote of 5-9, they did not agree that the device was shown to be safe.

The Barricaid implant is a polymeric mesh that sits in the posterior intervertebral disc space; it is connected to a metallic anchor that is attached to the vertebral body, the FDA explained in a briefing document issued prior to Tuesday’s meeting. The implant comes with a delivery tool and manual surgical instruments, which are used in a posterior/posterolateral approach.

The Barricaid Anular Closure Device is a permanent implant used after a limited lumbar discectomy performed for treatment of lumbar radiculopathy. The device is designed to mechanically block an opening in the anulus, thereby maintaining the relative position of nucleus within the disc space to prevent reherniation following limited discectomy in patients with large anular defects at an increased risk of reherniation.

READ THE REST HERE

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

Stimwave Appoints Industry Veteran Jim Surek as Chief Commercialization Officer and Adds Konstantin Slavin, M.D. to Medical Advisory Board

Posted On December 14, 2017 By OrthoSpineNews In Extremities /

December 14, 2017

POMPANO BEACH, Fla.–(BUSINESS WIRE)–Stimwave LLC, a medical device manufacturer and independent research institute headquartered in South Florida, announced the appointment of Konstantin Slavin, M.D. to its medical board of advisors and the appointment of industry veteran Jim Surek to the position of chief commercialization officer. The expansion of the team is in direct response to an ever-increasing demand for its Freedom Spinal Cord Stimulation (SCS) System and StimQ Peripheral Nerve Stimulator (PNS) System for the treatment of chronic pain.

“Every day, increasing numbers of patients are seeking non-opioid solutions to managing chronic pain, and it is essential that we do everything we can to meet that demand and to serve those patients,” said Laura Tyler Perryman, co-founder and CEO of Stimwave. “The addition of Dr. Slavin and Jim Surek strengthens our executive management team to support our high growth and to meet these market needs.”

Dr. Slavin currently serves as professor of neurosurgery at the University of Illinois at Chicago and holds several leadership roles in professional societies, including serving as president of the American Society for Stereotactic and Functional Neurosurgery and as the director at large for the International Neuromodulation Society. He is a world-renowned expert in neuromodulation, most recently publishing his second edition of “Peripheral Nerve Stimulation” and “Neurostimulation: Principles and Practice.”

“This miniature, wireless stimulator minimizes the need for surgery in patients who are already suffering from pain, while allowing on-going care and full-body MRI scan capabilities providing a viable, non-opioid option for long-term pain management,” said Dr. Slavin. “I am pleased to join their prestigious board of experts in the field.”

A 25-year industry veteran, Jim Surek joins the Stimwave team as the company’s first chief commercialization officer. Surek received his Master’s in International Management from the Thunderbird School of Global Management. Beginning his career as a spinal implant sales representative at Medtronic in 1994, Surek rose through the ranks to vice president of sales and development before taking on the role of the first vice president of sales at Advanced Bionics in 2003, which ultimately sold to Boston Scientific. He went on to become the vice president of sales at Entellus Medical, Inc., which sold to Stryker earlier this month.

“I’m thrilled to return to the field of neuromodulation with Stimwave. It’s an exciting time to be a part of a great neuromodulation team and company setting the vision for the future for all pain patients across the country,” said Surek. “Stimwave’s technology brings the future forward through its miniaturization of the electronics and elimination of a bulky, potentially dangerous implantable battery. Now, physicians have a solution to treat a tremendously larger pain patient population, since more than 80 percent of patients either cannot receive treatment or refuse the surgery option to treat their pain.”

Stimwave’s devices use Wireless Pain Relief^®technology and are 95 percent smaller than any other neuromodulation device on the market and can be anchored through an injectable method. The device delivers small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief. Stimwave launched its FDA-cleared devices for the relief of chronic back and leg pain to a limited number of patients throughout 2015. In March 2016, Stimwave was granted FDA 510(k) for the relief of peripheral nervous system (PNS) pain, becoming the only neuromodulation device manufacturer cleared by the FDA to help reduce chronic neuropathic pain at most locations throughout the body, from back and leg pain addressed by spinal cord stimulation to PNS treatment for shoulder pain, wrist and elbow pain, knee pain, hip pain and more.

About Stimwave

Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacturing, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management. www.stimwave.com

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

Contacts

Glodow Nead Communications
Evan Nicholson, Rosemary O’Brien, Kati Stadum, and Sarah Rogers, 415-394-6500
StimwavePR@GlodowNead.com

Kuros Biosciences Announces Management Succession

Posted On December 14, 2017 By OrthoSpineNews In Biologics / 1

Schlieren (Zurich), Switzerland, December 14, 2017

Kuros announced today the appointment of Michael Grau as Chief Financial Officer (CFO) effective February 1, 2018. Michael Grau succeeds Harry Welten, who will step down as CFO on February 1, 2018 to focus on his board roles and part-time CFO functions in privately held companies. Harry Welten will remain on the Board of Directors of Kuros.

Kuros’ Chief Executive Officer Dr. Joost de Bruijn commented: “I am delighted to welcome Michael Grau to the executive team. Michael has extensive experience in corporate finance and auditing in private and public companies. With his strong operational background, we believe Michael brings highly relevant experience and financial leadership to the Company that will help us as we capitalize on new opportunities to becoming a leading commercial-stage orthobiologics company.”

Joost de Bruijn continued: “I am sincerely grateful to Harry for leading the company through capital raises, restructurings, mergers and acquisitions in the past seven years. Harry’s continued involvement will ensure a smooth transition to Michael.”

Kuros’ Chairman Christian Itin said: “We are grateful for Harry’s valuable contributions and services to the Company. As CFO, Harry restructured CHF 70 million in private and public debt and raised more than CHF 80 million in equity, ensuring that the company has a solid capital base and structure for its next steps of growth and start of commercialization. We wish Harry all the best for his future endeavors.”

Christian Itin continued: “With Michael’s extensive experience as CFO of several small- and medium-sized companies, accounting and fundraising background, we have found a highly capable successor to Harry to help lead the company during its next growth stage. Michael has more than 15 years of experience in the medtech and pharma field and is therefore extremely well suited to take up this position.”

Biographical background on Michael Grau

Michael Grau has an impressive track record of 25 years` experience in corporate finance, controlling, accounting and general management in diverse industries and, since 2001, with a focus on medtech, biotech and pharma. He was responsible for multiple capital market transactions, financing rounds and several merger and acquisition agreements for public and private companies. Most recently, Mr. Grau served as CFO of Proteros Biostructures, a biotech company focusing on enabling lead discovery, Correvio, a Geneva-based hospital specialty pharma company, and Endosense, another Geneva-based private medtech company. He started his career working for KPMG Pat Marwick. Mr. Grau holds a BA in European Finance and Accounting from Bremen University, Germany, and Leeds University, U.K., and an executive MBA from Henley Business School at the University of Reading, U.K. Mr. Grau is citizen of Germany.

For further information, please contact:

Harry Welten, MBA

Chief Financial Officer

Phone +41 79 750 15 64

harry.welten@kurosbio.com

Joost de Bruijn

Chief Executive Officer

Phone +31 621 21 7603

joost.de.bruijn@kurosbio.com

About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

News release (pdf)

Kuros Biosciences Ltd, Wagistrasse 25, CH-8952 Schlieren

OR-Willamette-Surgery-Center_6cba9cb7972df23fb20c293c497f2851.jpg

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

Author: OrthoSpineNews

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