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NuVasive Extends Its Leadership As Lateral Spine Technology Innovator With New Lateral Single-Position Surgery Procedure

Posted On October 23, 2017 By OrthoSpineNews In Spine, Top Stories /  

SAN DIEGO, Oct. 23, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced new lateral solutions that enable surgeons to perform lateral single-position surgery and expand the Company’s comprehensive lateral portfolio.

Nearly 15 years ago, NuVasive revolutionized spine surgery through the development of XLIF®, the only lateral approach spine procedure proven with extensive clinical evidence and more than 400 peer-reviewed, XLIF-specific publications. NuVasive continues to innovate the XLIF procedure today by introducing lateral single-position approach to surgery and thereby increasing O.R. efficiency by reducing the number of times a patient has to be repositioned, expanding the benefits of lateral surgery to more spinal levels and decreasing the amount of time a patient is under anesthesia.

“NuVasive earned its reputation as the disruptive leader in spine when we created the lateral market 15 years ago, and we’ve remained relentlessly focused on advancing and expanding our technology to transform patients’ lives, surgical practices and hospitals’ ability to provide superior, best-in-care patient results,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “We are transforming spine surgery around the globe through our unique technology including lateral single position surgery, the most advanced interbody implants with advanced materials science, including porous PEEK and 3D-printed porous titanium, and integrated O.R. systems that support spinal alignment, radiation reduction and imaging.”

Lateral Procedural Solutions
NuVasive expands its lateral procedural solutions with Lateral ALIF, XLIF Crestline and Lateral MAS Fixation, enabling surgeons to treat pathologies from T6-S1 to deliver efficient, predictable clinical outcomes.

  • The Lateral ALIF procedure is built on a new retractor system designed to provide direct access to L5-S1 with the patient in a lateral decubitus position. With the characteristics of a traditional supine ALIF, Lateral ALIF enables the surgeon to perform lateral single-position surgery, saving time and improving efficiency in the OR.
  • Built on the XLIF platform, XLIF Crestline is a supplemental solution, designed to gain lateral access to challenging L4-L5 levels where an XLIF cannot be performed, such as high crest, anterior psoas or an anterior plexus. The off-angle procedure allows access to disc space traditionally reached through a posterior approach, and uses the Company’s leading technologies including NVM5®, MaXcess® and XLIF implants.
  • Lateral MAS Fixation is an adapted technique using Reline®, the Company’s best-in-class fixation system designed to preserve and restore spinal alignment. The surgical technique provides surgeon partners reproducible results and increased O.R. efficiency when utilized with the Company’s leading lateral procedural solutions portfolio.

“NuVasive continues to take ownership of the lateral surgery, making it better for us as surgeons and making it better for our patients,” said Dr. Brian Kwon, orthopedic surgeon at New England Baptist Hospital. “Using XLIF, XLIF Crestline and Lateral ALIF provides the advantage of maintaining your patient in a single position. If you look, most of lumbar fusion surgery has really been done at L4 to S1, and so the ability to have these procedures available is tremendous.”

Advanced Materials Science Portfolio
Paving the way in spine surface technology, the Company unveiled its Advanced Materials Science (AMS) portfolio designed to deliver enhanced osseointegration and biomechanics through innovative implant design. With leading advanced materials in surface, structure and imaging characteristics, the portfolio includes the Company’s recently launched Modulus™ XLIF, a 3D-printed porous titanium implant, and porous PEEK™ (polyetheretherketone) technology after last month’s acquisition of Vertera Spine. NuVasive is the only medical device company to offer porous interbody technology across both PEEK and titanium materials, thereby addressing the spectrum of surgeons’ needs and preferences for advanced interbody implants. The Company’s future plans include integrating the porous PEEK technology across all its procedural offerings

The expanded lateral solutions and AMS portfolio demonstrate the Company’s deep commitment to bold innovation. These advancements in spine care join NuVasive other breakthroughs like Integrated Global Alignment® (iGA), a platform of procedurally based technologies designed to enhance clinical and economic outcomes by increasing the predictability of achieving global spinal alignment, advanced neuromonitoring with the NVM5 system, and radiation reduction with LessRay®.

NuVasive 2017 NASS Annual Meeting Participation Details
NuVasive will showcase its market-leading, procedurally-integrated technologies, including the new Lateral ALIF, Modulus XLIF and LessRay in NuVasive Booth #713 at the NASS Annual Meeting held October 25-28, 2017 in Orlando, Fla.

The Company also will host a surgical innovation lab demonstration presented by Robert Isaacs, MD, Mark Medley, MD, William D. Smith, MD, and J. Alex Thomas, MD, titled “Single Position Lateral Solutions to Treat L4-S1, Featuring Advanced 3D-Printed Implants and LessRay Radiation Emission Reduction Technology” on October 26, 2017 from 8:00 a.m. to 10:00 a.m. in the Green Lab at the Orange County Convention Center.

Visit here for more details and a schedule of events.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally invasive, 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.

Related Links

http://www.nuvasive.com

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K2M Acquires World’s First & Only FDA-Cleared Cervical Static Corpectomy Cage

Posted On October 23, 2017 By OrthoSpineNews In Spine, Top Stories /  

LEESBURG, Va., Oct. 23, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it has acquired from Cardinal Spine, a privately held medical device company, the PALO ALTO® Cervical Static Corpectomy Cage System. PALO ALTO, a cervical vertebral body replacement device, is the first and only static corpectomy cage in the world to receive a cervical 510(k) clearance from the U.S. Food & Drug Administration (FDA). In addition to PALO ALTO, K2M has also acquired the associated intellectual property and product inventory.

The PALO ALTO Cervical Static Corpectomy Cage System is indicated for use in the cervical spine in skeletally mature patients to replace diseased or damaged vertebral bodies, or for reconstruction to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. It is intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft, as an adjunct to fusion.

“K2M has always impressed me with their innovative technologies. I’m elated about PALO ALTO; the long-term clinical data showed a 96 percent fusion rate,” said Frank P. Castro Jr., MD, an orthopedic surgeon at Baptist Health Floyd in New Albany, Indiana, and founder of Cardinal Spine. “The trapezoidal design helps increase the graft-host surface contact area, while providing resistance to posterior cage migration.”

The PALO ALTO Cervical Static Corpectomy Cage System will be featured in a scientific session at the 2017 North American Spine Society(NASS) meeting. The presentation entitled, “Cardinal Spine, LLC: ACCF: 30-Month Follow-Up on C-VBR,” will be facilitated by Dr. Castro on Wednesday, October 25 from 2:29 to 2:35 p.m. in Room W230CD.

“We are excited to expand our complex cervical offerings by adding the first and only FDA-cleared static cervical vertebral body replacement device,” said K2M Chairman, President, and CEO Eric Major. “We look forward to fully integrating this clinically supported technology into our differentiated product portfolio, which when complemented by our comprehensive Balance ACS™ platform, allows surgeons to address the full range of spinal pathologies, and ultimately, to facilitate Total Body Balance in their patients.”

During NASS, K2M will showcase PALO ALTO, as well as several of its latest offerings, at Booth #509. For more information on K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

About K2M

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

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and our Quarterly Report filed with the SEC on August 2, 2017, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.  We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:

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

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

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TransEnterix Schedules Third Quarter 2017 Financial and Operating Results Conference Call for November 9, 2017

Posted On October 23, 2017 By OrthoSpineNews In Financial /  

October 23, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC) announced today that it plans to release third quarter 2017 financial and operating results after the market closes on Thursday, November 9, 2017. Todd M. Pope, President and Chief Executive Officer, and Joseph P. Slattery, Executive Vice President and Chief Financial Officer will host a conference call to discuss these results starting at 4:30 pm Eastern Time the same day. The call will be concurrently webcast.

To listen to the conference call on your telephone, please dial (844) 804-5261 for domestic callers and (612) 979-9885 for international callers, and reference conference ID 8898746 approximately ten minutes prior to the start time. To access the live audio webcast or archived recording, use the following link http://ir.transenterix.com/events.cfm. The replay will be available on the Company’s website.

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The Company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The Company also developed the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has received FDA 510(k) clearance and has been granted a CE Mark. For more information, visit the TransEnterix website at www.transenterix.com.

Contacts

For TransEnterix, Inc.
Investors:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media:
Joanna RIce, +1-951-751-1858
joanna@greymattermarketing.com

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Exactech Enters Definitive Agreement with TPG Capital to Go Private

Posted On October 23, 2017 By OrthoSpineNews In Financial, Top Stories /  

October 23, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech (Nasdaq: EXAC), a leading developer and producer of orthopaedic implant devices and surgical instrumentation for extremities and large joints, today announced that it has entered into a definitive merger agreement under which TPG Capital, the global private equity platform of alternative asset firm TPG, will acquire all of the outstanding shares of Exactech common stock. Exactech’s board of directors approved the agreement which provides for the payment of $42.00 per share in cash to all holders of Exactech common stock other than certain management stockholders who have agreed to exchange a portion of their shares for new equity securities in the transaction. Exactech founders Dr. Bill Petty and Betty Petty and CEO David Petty have agreed with TPG to vote all of their shares in favor of the merger and to exchange a significant portion of their shares for new shares in the parent entity immediately following the merger. Such share exchange will be made at the same $42.00 value being paid in cash to Exactech’s shareholders. The transaction values Exactech at $625 million and the cash purchase price represents a premium of approximately 31% over Exactech’s closing stock price on October 20, 2017.

Upon completion of the transaction, Exactech will be a privately-held company headquartered in Gainesville, Florida, and Exactech’s common shares will no longer be listed on the NASDAQ stock exchange. The transaction is expected to close in the first quarter of 2018, subject to customary closing conditions, including approval by Exactech’s shareholders and termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

“We believe that this agreement offers Exactech shareholders an opportunity to realize the company’s tremendous growth and capture the value that’s been created since going public 21 years ago, at a significant premium to the current share price,” said Jim Binch, Exactech’s lead independent director.

Exactech CEO David Petty added, “This agreement provides maximum value for our shareholders, who have shared our vision and supported our growth over the past two decades.”

Exactech was founded in 1985 by orthopaedic surgeon Dr. Bill Petty, his wife Betty and biomedical engineer Gary Miller, PhD, with the purpose of improving the quality of care for patients suffering from joint injury or disease, such as arthritis. The company employs more than 700 individuals including engineers, researchers, manufacturing professionals, and sales representatives, and distributes its products to more than 35 countries around the world.

“As long-term healthcare investors, we aim to identify and partner with strong companies that are in growing, attractive sectors,” said Todd Sisitsky, Managing Partner at TPG Capital. “With their strong commitment to patients and surgeons and a comprehensive product portfolio, Exactech has strategically built a platform poised for significant growth. We are thrilled to partner with CEO David Petty, the company founders, the Exactech management team and TPG Capital advisors Jeff Binder and Dan Hann to further realize Exactech’s exciting potential.”

“The basis of our investment thesis is that there are outstanding opportunities for nimble, innovative and responsive companies to invest in growth and compete with the larger competitors in the orthopaedic industry,” said Jeff Binder, Senior Advisor to TPG Capital. “I look forward to working with management to fully realize the potential of a company for which I have always had great respect.”

Over the past 10 years, TPG Capital has invested more than $8 billion in healthcare. Taking a growth-oriented approach to its partnerships, the platform has invested in companies across the entire healthcare continuum, including medical devices companies such as Biomet, Fenwal, Beaver-Visitec International and Immucor; global healthcare providers such as Surgical Care Affiliates, Healthscope and Parkway; pharmaceutical companies such as Par Pharmaceutical and Adare; and healthcare IT companies such as QuintilesIMS and Mediware.

Advisors

J.P. Morgan Securities LLC is acting as the financial advisor to Exactech. Greenberg Traurig, P.A. (Miami) and Greenberg Traurig, LLP (NYC) are serving as Exactech’s legal advisor. Ropes & Gray is acting as legal advisor to TPG Capital.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

About TPG

TPG is a leading global alternative asset firm founded in 1992 with more than $73 billion of assets under management and offices in Austin, Beijing, Boston, Dallas, Fort Worth, Hong Kong, Houston, London, Luxembourg, Melbourne, Moscow, Mumbai, New York, San Francisco, Seoul, and Singapore. TPG’s investment platforms are across a wide range of asset classes, including private equity, growth venture, real estate, credit, and public equity. TPG aims to build dynamic products and options for its investors while also instituting discipline and operational excellence across the investment strategy and performance of its portfolio. For more information, visit www.tpg.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements regarding Exactech’s proposed business combination transaction with TPG Capital, all statements regarding Exactech’s expected future financial position, results of operations, cash flows, dividends, financing plans, business strategy, budgets, capital expenditures, competitive positions, growth opportunities, plans and objectives of management, and statements containing the words such as “anticipate,” “approximate,” “believe,” “plan,” “estimate,” “expect,” “project,” “could,” “would,” “should,” “will,” “intend,” “may,” “potential,” “upside,” and other similar expressions. All Statements in this press release that are not historical facts, are forward-looking statements that reflect the best judgment of Exactech based upon currently available information.

Such forward-looking statements are inherently uncertain, and shareholders and other potential investors must recognize that actual results may differ materially from Exactech’s expectations as a result of a variety of factors, including, without limitation, those discussed below. Such forward-looking statements are based upon management’s current expectations and include known and unknown risks, uncertainties and other factors, many of which Exactech is unable to predict or control, that may cause its actual results, performance or plans to differ materially from any future results, performance or plans expressed or implied by such forward-looking statements. These statements involve risks, uncertainties and other factors discussed below and detailed from time to time in Exactech’s filings with the Securities and Exchange Commission (the “SEC”).

Risks and uncertainties related to the proposed merger include, but are not limited to, the risk that Exactech’s shareholders do not approve the merger, potential adverse reactions or changes to business relationships resulting from the announcement or completion of the merger, uncertainties as to the timing of the merger, adverse effects on Exactech’s stock price resulting from the announcement of the merger or the failure of the merger to be completed, competitive responses to the announcement of the merger, the risk that regulatory, licensure or other approvals required for the consummation of the merger are not obtained or are obtained subject to terms and conditions that are not anticipated, litigation relating to the merger, the inability to retain key personnel, and any changes in general economic and/or industry-specific conditions.

In addition to the factors set forth above, other factors that may affect Exactech’s plans, results or stock price are set forth in its most recent Annual Report on Form 10-K and in its subsequently filed reports on Forms 10-Q and 8-K.

Many of these factors are beyond Exactech’s control. Exactech cautions investors that any forward-looking statements made by it are not guarantees of future performance. Exactech disclaims any obligation to update any such factors or to announce publicly the results of any revisions to any of the forward-looking statements to reflect future events or developments.

Additional Information and Where to Find It

The Company will furnish to the SEC a report on Form 8-K regarding the proposed transaction described in this announcement, which will include the merger agreement. All parties desiring details regarding the merger are urged to review these documents, which will be available at the SEC’s website (http://www.sec.gov).

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. This communication may be deemed to be solicitation material in respect of the proposed merger. In connection with the merger, the Company will prepare and mail a proxy statement to its shareholders. In addition, certain participants in the merger will prepare and file with the SEC a Schedule 13E-3 transaction statement. These documents will be filed with or furnished to the SEC. Investors and shareholders are urged to read carefully and in their entirety these materials and other materials filed with or furnished to the SEC when they become available, as they will contain important information about the Company, the merger and related matters. In addition to receiving the proxy statement by mail, shareholders also will be able to obtain these documents, as well as other filings containing information about the Company, the merger and related matters, without charge, from the SEC’s website (http://www.sec.gov). In addition, these documents can be obtained, without charge, by sending an e-mail to investors@exac.com, along with complete contact details and a mailing address.

Participants in Solicitation

The Company and certain of its directors, executive officers and other members of management and employees may, under SEC rules, be deemed to be “participants” in the solicitation of proxies from shareholders with respect to the merger. Information regarding the persons or entities who may be considered “participants” in the solicitation of proxies will be set forth in the proxy statement and Schedule 13E-3 transaction statement relating to the merger when it is filed with the SEC. Information regarding the directors and executive officers of the Company is set forth in the proxy statement for the Company’s 2017 Annual Meeting of Shareholders, which was filed with the SEC on March 24, 2017. Additional information regarding the interests of such potential participants will be included in the proxy statement and Schedule 13E-3 transaction statement and the other relevant documents filed with the SEC when they become available.

Contacts

Exactech
Investor Contact:
Jody Phillips, 352-377-1140
Executive Vice President of Finance & Chief Financial Officer
or
Media Contact:
TPG
Luke Barrett, 415-743-1550
media@tpg.com
or
Exactech
Priscilla Bennett, 352-377-1140
Priscilla@exac.com

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Stryker’s Spine Division to Launch Tritanium® C Anterior Cervical Cage at NASS 2017

Posted On October 23, 2017 By OrthoSpineNews In Spine /  

October 23, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division will introduce its Tritanium® C Anterior Cervical Cage, a 3D-printed interbody fusion cage intended for use in the cervical spine, at the North American Spine Society (NASS) Annual Meeting, Oct. 25-28, 2017, in Orlando, Fla. (booth No. 500).

The Tritanium C Anterior Cervical cage is the newest addition to Stryker’s expanding line of spinal implants constructed from its proprietary Tritanium Technology,1 a novel, highly porous titanium material designed for bone in-growth and biological fixation.1 The unique porous structure of Tritanium is created to provide a favorable environment for cell attachment and proliferation, as demonstrated in an in-vitro study,2* and the Tritanium material may be able to wick or retain fluid, in comparison to traditional titanium.3 It is inspired by the microstructure of cancellous bone4 and enabled by AMagine™, Stryker’s proprietary approach to implant creation using additive manufacturing, also known as 3D printing.

“After the terrific feedback and success we’ve seen with the Tritanium PL Posterior Lumbar cage, we are excited to introduce the Tritanium C Anterior Cervical Cage to spine surgeons this year at NASS,” said Bradley Paddock, President of Stryker’s Spine division. “Tritanium Cages feature ‘precisely randomized’4 pore formations, in contrast to other technologies with longitudinal channels and traverse windows that result in a uniform structure, as well as cages that offer porosity only on the surface. As a result, Tritanium implants are designed to become ‘one with bone’.”

“The ultimate goal with spinal implants is to get a solid fusion,” said Dr. Jocelyn Idema, a spine surgeon with Advanced Orthopaedics and Rehabilitation in Pittsburgh and Washington, Pa. “Spinal implants created with Tritanium Technology mimic the porosity of cancellous bone, which aids in fusion.”

Stryker’s Spine division also will present an abstract at NASS, titled, “Evaluation of Bony Fusion with Tritanium PL Used in Mini-Open Approach to Posterior Lumbar Interbody Fusion,” on October 26 at 1:41 p.m. ET, during the Innovative Technology Presentations.

The Tritanium C Anterior Cervical Cage received 510(K) clearance from the U.S. Food and Drug Administration in September 2017. It features an open central graft window and lateral windows to help reduce stiffness of the cage and minimize subsidence. In addition, the large graft window allows for bone graft containment. Engineered for stability,5,6 the cage has precisely angled teeth on the superior and inferior surfaces designed for bidirectional fixation and to maximize surface area for endplate contact with the cage. Its smooth posterior edges are designed to facilitate insertion and protect soft tissue and anatomy. The Tritanium C Anterior Cervical Cage is offered in a number of footprints, heights, and lordotic angles to accommodate a variety of patient anatomies.

Intended Use for U.S.

The Tritanium C Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc. The cage is to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach. For the full Indications for Use, please refer to the Tritanium C Anterior Cervical Cage Instructions for Use.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com and www.stryker.com/builttofuse/. Follow Stryker’s Spine division on Twitter @stryker_spine.

References

1. PROJ43909 Tritanium technology claim support memo
2. RD0000053710: Tritanium cell infiltration and attachment experiment
*No correlation to human clinical outcomes has been demonstrated or established
3. RD0000050927: Tritanium material capillary evaluation
4.

Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5475-5491
5. PROJ0000054458 | Tritanium C Insertion and Expulsion Marketing Memo.
6. PROJ44960: Coefficient of friction memo

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Content ID: TRICC-PB-1_15825

Photo courtesy of Stryker

Contacts

Sullivan & Associates
Barbara Sullivan, 714/374-6174
bsullivan@sullivanpr.com

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RTI Surgical® Showcases TETRAfuse® 3D Technology in Peer-to-Peer Cadaveric Training Symposium

Posted On October 23, 2017 By OrthoSpineNews In Biologics, Spine /  

Lacey Jones/October 23, 2017

RTI Surgical’s spine sales & marketing teams hosted a Spine Symposium and Cadaveric Training in Las Vegas on September 16, 2017. This symposium – which was the second spine-focused symposium of the year – provided orthopedic and neurological spine surgeons from across the U.S. with key information related to RTI implants and instrumentation.

Attendees were able to gain hands-on experience with RTI’s recently-introduced TETRAfuse® 3D Technology, which provides surgeons a solution they have been seeking. TETRAfuse 3D Technology is the first 3D printed polymer implant material that has demonstrated trabecular bone ingrowth while maintaining radiolucency and bone-like mechanical properties*.

TETRAfuse 3D Technology was developed to offer surgeons an interbody material that participates in the fusion process while maintaining bone-like mechanical properties and radiolucent imaging. Bringing these features together combines the osseointegrative advantages of titanium and allograft bone with the benefits surgeons experience with PEEK. RTI will soon announce the release of a family of products manufactured with TETRAfuse 3D Technology, providing a platform that will have many derivative products.

 

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Smith & Nephew to Buy Rotation Medical for Up to $210 Million

Posted On October 23, 2017 By OrthoSpineNews In Financial, Top Stories /  

By REUTERS/

LONDON — Medical technology group Smith & Nephew, which some investors believe should streamline operations to make itself a more attractive takeover target, said on Monday it was buying a U.S. sports injury business for up to $210 million (£159 million).

The British company, best known for its replacement hips and knees, will pay an initial $125 million to acquire unlisted Minnesota-based Rotation Medical, plus up to $85 million over the next five years if certain financial targets are hit.

S&N said the deal, which is expected to close late this year, would be neutral for earnings in 2018 and boost them in 2019.

Rotation has developed a novel tissue regeneration technology for shoulder rotator cuff repair that is already cleared for sale in the United States. A filing is being prepared for approval in Europe.

READ THE REST HERE

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Artoss Announces NanoBone® QD Bone Graft

Posted On October 23, 2017 By OrthoSpineNews In Biologics /  7

Press Release/October 23, 2017

Artoss, Inc. is pleased to announce NanoBone QD Bone Graft.

Paul Byerley, Managing Director of Artoss, Inc., the exclusive North American distributors for NanoBone in orthopaedic surgery, said, “To extend the usability of NanoBone, we put the perfect handling of NanoBone SBX Putty in an applicator designed for QD – quick delivery. This easy-to-use device facilitates rapid implantation of our advanced bone graft in a controlled and precise manner. Artoss developed NanoBone QD to provide these benefits in a cost-effective delivery system.”

Walter Gerike, Managing Director of Artoss GmbH said, “Nanotechnology is the key technology for the 21st century and Artoss is harnessing this potential for orthopaedic surgery. With the launch of NanoBone SBX Putty in 2016, we created a product that combines Applied NanoBiology™ for bone repair with perfect handling for the surgeon. NanoBone QD takes the product one step further by making it easier for the surgeon to implant.” NanoBone synthetic bone graft products have been used in Europe and the US for more than ten years in approaching 400,000 clinical cases across all indications and has been available in the United States since 2015.

Artoss, Inc. is launching NanoBone QD at the North American Spine Society Meeting this week. Visit them at Booth 1562 to learn more.

 

 

For further information, please contact:

Artoss, Inc.

15900 155th St. NE

Foley, MN 56329

320-355-4321

info@artossinc.com

 

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Kapstone Medical Acquires Loukas Medical Assets

Posted On October 23, 2017 By OrthoSpineNews In Spine /  

CHARLOTTE, N.C. (PRWEB) OCTOBER 23, 2017

Kapstone Medical announced today they have acquired the assets of Loukas Medical, an independent orthopedic engineering firm based in Franksville, WI. Loukas Medical will expand Kapstone Medical’s portfolio with greater access to a diverse customer base, highly experienced engineering talent, and key intellectual property.

Loukas Medical has a history of assisting medical device companies in orthopedics and spine product development and manufacturing. James Rinner, Founder of Loukas Medical, is an inventor on 60 U.S. patents. Under the terms of the agreement, Jim will join Kapstone’s team of medical device experts in engineering, development, regulatory, quality and supply chain management.

“We are excited to welcome Jim to our team,” said John Kapitan, CEO and Founder of Kapstone Medical. “He is not only a highly talented and experienced engineer, but even more importantly to me, we share common corporate and personal values, paving the way for successful long-term collaboration.”

Kapstone Medical partners with medical device inventors and OEMs to rapidly develop and commercialize new medical devices inventions, on time and on budget. The company will be leveraging its produce development resources to develop and license a novel bone screw technology that Loukas designed and patented.

“The closing of this transaction opens new opportunities,” said Mr. Rinner. “We’re excited to be part of the Kapstone Medical team and look forward to creating value for our customers as we make a positive impact on the industry.”

John Kapitan & Jim Rinner will be attending the North American Spine Society (NASS) in Orlando, FL from October 25-28, 2017. If you would like to set up an appointment, please contact John at 704-516-5120.

For the latest news with Kapstone Medical follow them on LinkedIn.

About Kapstone Medical
Kapstone Medical has been helping innovators develop and safeguard their ideas since 2007. Kapstone is a privately held product realization firm headquartered in Charlotte, North Carolina. The company integrates a suite of in-house disciplines to give physician inventors, entrepreneurs and manufacturers of all sizes the opportunity to efficiently develop new ideas on time and on budget. Kapstone Medical’s range of services includes all aspects of product development, IP protection, regulatory, quality assurance, and supply chain management.

For more information please contact:
Guillaume Viallaneix
MedTech Momentum
phone: 407-960-2994
info(at)kapstonemedical.com

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Additional Payor Positive Coverage for A Novel & Proven Treatment For Lumbar Spinal Stenosis

Posted On October 23, 2017 By OrthoSpineNews In Spine /  

NEW YORK, Oct. 23, 2017 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis announces updated coverage by Health Alliance Plan of Michigan. An additional 500,000 lives in Michigan now have access to treatment of lumbar spinal stenosis using coflex.

Lumbar spinal stenosis (“LSS”), affecting 1.6 million patients annually, is a debilitating and degenerative disease in older patients (>50 yrs) often associated with significant leg and back pain, leg numbness and weakness, causing a significant reduction in an active lifestyle. Traditional surgical treatment options for LSS include a decompression that removes bone and soft tissue and may also require a fusion to stabilize the spine. The coflex® device is a non-fusion, motion preserving stabilization implant, that is FDA PMA approved for the treatment of lumbar spinal stenosis, and can be used in conjunction with a decompression or used in lieu of a spinal fusion.

To learn more about coflex® Interlaminar Stabilization®, please visit www.coflexsolution.com.

Marc Viscogliosi, Chairman & CEO – “With over 85 peer-review published articles, including landmark 5 year follow-up studies, medical society guidelines, and now with additional commercial insurance coverage, it is wonderful to be able to expand patient access to the coflex® technology.”

About Paradigm Spine, LLC
Paradigm Spine, LLC was founded in 2004 and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company’s signature product is the coflex® Interlaminar Stabilization®device, which has more than 20 years of clinical history and patients treated in more than 40 countries worldwide.

 

SOURCE Paradigm Spine, LLC

Related Links

http://www.paradigmspine.com

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