Sites Medical Licenses its OsteoSync™ Ti Technology to Integrity Implants for Incorporation into their FlareHawk™ Family of Expandable Implants

October 24, 2017

COLUMBIA CITY, Ind.–(BUSINESS WIRE)–Sites Medical, a firm specializing in value-driven innovation in orthopedics, today announced it has entered into a licensing agreement with Integrity Implants, to incorporate its proprietary OsteoSync™ Ti technology into Integrity’s novel multi-dimensional expandable interbody devices.

“We are thrilled to be partnering with Integrity Implants, a company with a high degree of innovation in the spine field and an accomplished leadership team,” said Greg Stalcup, President/CEO of Sites Medical. “We look forward to working with the Integrity team to combine our respective technologies to deliver a new generation of high performance, high value products to the market.”

OsteoSync™ Ti technology is a highly porous titanium scaffold designed to meet the needs of today’s patients from both clinical and economic standpoints. Its high friction coefficient ensures high initial implant stability and its open pore geometry and micro-texturing facilitate superior bone ingrowth. Preclinical testing has demonstrated bone attachment strength nearly twice that of titanium plasma spray and approximately seven times that of PEEK material at the 5-week follow up period, a performance differential that can impact clinical outcomes, especially in spinal fusion patients. OsteoSync™ Ti technology has also been engineered to reduce the potential for abrasion during implant insertion and associated debris-related inflammation, offering an additional measure of safety for the patient. The material is manufactured using highly innovative methods and offers substantial value in today’s cost-conscious healthcare environment.

“We are very excited to work with Sites Medical,” said Wyatt Geist, President & CTO of Integrity Implants. “As the market begins to recognize the need for implants that promote better short- and long-term stability, the Sites Medical OsteoSync™ Ti technology offers us an opportunity to provide proven bone ingrowth capability at cost-effective levels. Together with our unique expandable technology, our devices will offer state-of-the-art capabilities for surgeons to help promote better clinical outcomes. We look forward to showing our first devices featuring this unique technology at NASS.”

About Sites Medical

Sites Medical has recognized the shift in healthcare reimbursement paradigms and is entirely focused on Value-Driven Innovation in orthopedics. With its suite of proprietary orthopedic implant technologies and manufacturing process improvements, Sites aims to deliver improved clinical outcomes and reduced cost to all stakeholders. Additional information about the company can be found at www.sitesmedical.com.

About Integrity Implants

Founded in 2016, Integrity Implants focuses on unique expandable interbody technology. The FlareHawk family of expandable interbodies are the world’s first to expand in height, width and lordosis. Additional information about the company and product can be found at www.integrityimplants.com.

Contacts

Sites Medical
Greg Stalcup
gstalcup@sitesmedical.com
www.sitesmedical.com
or
Integrity Implants
Brad Sutika
bsutika@integrityimplants.com
www.integrityimplants.com

Implanet Presents JAZZ® Results at NASS Annual Meeting, Addressing Unmet Clinical Needs in Complex Spine Surgery

October 24, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces the first presentation of JAZZ® clinical US study data in adult spinal deformity surgery at the NASS Annual Meeting on October 26th, 2017.

Technical advances have enabled spinal deformity surgeons to correct severe spinal mal-alignment. However, proximal adjacent segment pathology, such as proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) remain serious issues. About 65% of surgeons use a PJK prevention strategy in over 40% of patients1. The diversity of strategies employed by surgeons to prevent PJK/PJF illustrates i) the desire to address the problem, and ii) the lack of effective options available to surgeons.

Dr. H. Francis Farhadi, The Ohio State University Wexner Medical Center, will present findings from his prospective study at the NASS Annual Meeting, on Thursday October 26th in Orlando. ‘Prospective Assessment of Early Clinical and Radiologic Outcomes Following Sublaminar Band Placement for Proximal Junctional Kyphosis Prophylaxis in Adult Spinal Deformity Surgery.’ The presentation P114 will take place as part of Poster Grand Rounds, The Learning Place, Exhibition Hall Entrance, Green Theater, Thursday, October 26th at 3:10PM.

Dr. Farhadi commented: “We have seen encouraging results so far at one-year follow-up. Proximal junctional sublaminar banding appears safe and does not increase proximal junctional kyphosis following long-segment adult spinal deformity surgeries. We have not seen any cases of proximal junctional failure to date in over 60 patients enrolled. Longer term follow-up in a larger cohort of patients will be needed before we can make any definite conclusions on prevention of proximal junctional kyphosis.”

Ludovic Lastennet, CEO of Implanet, adds: “Implanet is a clinical solutions driven company, developing novel technology JAZZ® for the spine surgery community. This is an important first step in addressing with JAZZ® an unmet clinical need in complex spine surgery, aUS $200 Million market2. We are actively recruiting patients in multiple prospective studies to both strengthen and document the clinical evidence for the JAZZ platform as the option in the prevention of PJK.

About The Ohio State University Wexner Medical Center and Dr H.F. Farhadi

Ohio State University Wexner Medical Center is one of America’s top-ranked academic medical centers, with more than 900 beds. Their mission is to improve people’s lives in Ohio and across the world through innovation in research, education and patient care.

Dr H. Francis Farhadi, MD, PhD, FRCSC is Chief of the Degenerative and Deformity Spine Division, Director of the Spinal Surgery Fellowship Program, Department of Neurological Surgery.

About the North American Spine Society (NASS)

The North American Spine Society (NASS) is a medical society for health care professionals who specialize in spine care. Founded in 1985, it is the largest society in America. The organization’s goal is the promotion of evidence-based and ethical spine care. NASS does this with policies and actions aimed at promoting education, research and advocacy in health care fields related to the spine. NASS membership consists of about 8,000 health care professionals; such as orthopedic surgeons, neurosurgeons, physiatrists, anesthesiologists, researchers and other related practitioners. NASS publishes two major publications, the Spine Journal and SpineLine. The Spine Journal is the official peer-reviewed journal of the North American Spine Society, and was launched in 2001. SpineLine is a bimonthly clinical and news publication for spine care professionals; it is published both in print and in digital editions.

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris.

Disclaimer
This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward-looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

1 Results of the 2014 SRS survey on PJK/PJF give valuable insight into PJK/PJF management (SPINE Volume 40, Number 11, pp 829 – 840).
2 Health Advance study & company data.

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot
Tel. : +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau
Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen
Tel.: +1 917 385 21 60
implanet@alphabronze.net

Esaote Launches Q-Spine

FISHERS, Ind.Oct. 23, 2017 /PRNewswire/ — Q-Spine, a technology that provides biometrics of the spine, will be launched at North America Spine Society (NASS), October 25th – 28thQ-Spine is a software tool to assist spine surgeon, orthopedists and chiropractors in their planning therapy and surgical procedures by means of visualization and quantification of relative biomechanical changes between weight-bearing and recumbent MRI lumbar spine examination.

In addition to being showcased in Esaote North America booth #1337, luminary Orthopedic Spine Surgeon, Dr. D. Guyer, M.D. from Texas Back Institute will be presenting an Abstract on Q-Spine during the Innovative Technology Presentations Q-Spine: New MRI-Based Quantification Method for L-Spine Analysis (Non-CME) Room: W230CD, Wednesday, October 25, 20171:00 PM – 2:00 PM.

Clinical Benefits of Q-Spine:

  • Facilitates and simplifies the analysis of weight-bearing versus recumbent MRI by semi-automatic segmentation of the Lumbar-spine
  • Provides a numerical quantification of the relative changes
  • Reliable and coherent measures by taking out the “human factor”
  • Provides ability to evaluate patient follow-up with numerical evidence
  • Generates a PDF report to be attached to the medical report

Dr. Guyer states, “We are excited to present the Q spine software, which is a semi-automated software analysis used with the Esaote weight-bearing Brio G MRI scanner which reliably calculates spinal canal area, dural diameter, lumbar lordosis and sacral angles.  We believe this will demonstrate nerve compression which may not be diagnosed with supine MRI scanners and help surgeons manage sagittal alignment in their patients.”

Q-Spine is available on Esaote’s G-Scan Brio a dedicated MRI system featuring a comprehensive set of coils and sequences to provide complete MSK MRI, from spine to extremities — plus the ability to perform unique weight-bearing studies.

About Esaote: With a consolidated turnover of EUR 270 million in 2016, the Esaote Group is a leader in the biomedical equipment sector, the areas of ultrasound, dedicated MRI and software for managing the diagnostic process. The Group currently employs 1,200 people. With its own production and research units in Italy and the Netherlands, Esaote is recognized as one of the top 10 diagnostic imaging companies in the world. Information on Esaote and its products is available at www.esaote.com.

Esaote@NASS2017:  Esaote will be exhibiting at NASS  2017, Orlando, FL October 25th – 29th, 2017

LOCATION: Booth #1337

Dr. D. Guyer, M.D. from Texas Back Institute will be presenting an Abstract on Q-Spine during the Innovative Technology Presentations – Q-Spine: New MRI-Based Quantification Method for L-Spine Analysis (Non-CME) Room: Room W230CD
Wednesday, October 25, 20171:00 PM – 2:00 PM

Information about the Esaote Group and its products is available at www.esaote.com

© Copyright Esaote 2017. Technology and features are system/configuration dependent. Specifications are subject to change without notice. Information might refer to products or modalities not yet approved in all countries. For further details, please contact your Esaote sales representative.

Contact ljoos@esaoteusa.com

SOURCE Esaote North America

Related Links

http://www.esaote.com

Astura Medical Receives FDA 510(k) Clearance For BRIDALVEIL OCT Stabilization System

CARLSBAD, CA – October 19, 2017 – Astura Medical, a high growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s BRIDALVEIL Occipital-Cervico-Thoracic (OCT) System.

“The FDA 510(k) clearance of our BRIDALVEIL OCT System, demonstrates the power of our innovation engine at Astura Medical and represents our best system released to date. We are excited for the opportunity to provide our rapidly expanding group of surgeon partners the most complete OCT technology offering on the market today, to further enhance their ability to provide the best in patient care,” said Thomas Purcell, Vice President.

Designed with the most complex and demanding cases in mind, BRIDALVEIL OCT provides a comprehensive offering of screw options (single-lead, dual-lead, high-top, and smooth shank) ranging from 3.5mm to 5.5mm in diameter that are compatible with either a 3.5mm or 4.0mm rod in titanium or cobalt chrome. The system also provides an extensive line of connectors, transition rods, and instrumentation options to allow surgeons the ability to seamlessly transition across multiple segments of the spine.

The launch of BRIDALVEIL OCT represents the 11th system launched since the company was founded in 2014. The company anticipates high demand for BRIDALVEIL OCT in addition to the robust growth seen in its current line of products.

Astura Medical will be showcasing BRIDALVEIL OCT, along with the Company’s other systems at Exhibit 565 during the 32nd North American Spine Society (NASS) Annual Meeting, taking place in Orlando, October 24-27th.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, mulit-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

For more information, please visit www.asturamedical.com or find us on LinkedIn.

 

Media Contact:

Steve Haayen

Astura Medical

858.472.8825

steve@asturamedical.com

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

SAN DIEGOOct. 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

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

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 FacebookTwitterInstagramLinkedIn 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

Exactech Enters Definitive Agreement with TPG Capital to Go Private

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

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

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

Misonix Enters into $11 Million License, Royalty and Manufacturing Agreement

FARMINGDALE, N.Y., Oct. 20, 2017 (GLOBE NEWSWIRE) — Misonix, Inc. (Nasdaq:MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today that it has entered into a license and exclusive manufacturing agreement with Hunan Xing Hang Rui Kang Bio-Technologies Co., Ltd., a Chinese corporation, under which Misonix has licensed certain manufacturing and distribution rights to its SonaStar product line in The People’s Republic of China (“PRC”), Hong Kong and Macau in exchange for payments totaling a minimum of $11 million.

The agreement calls for (i) upfront technology license fees and stocking orders of $5 million; (ii) minimum royalty payments from the sale of SonaStar products in the licensed territories of $2 million per calendar year in each of 2019, 2020, and 2021 and (iii) additional royalty payments based on product sales through August 2027. The Agreement also provides that Misonix will supply SonaStar products to Hunan Xing Hang Rui Kang Bio-Technologies Co., Ltd. at agreed prices during the transition period prior to their commencement of manufacturing, and provides for reimbursement of technology transfer costs to Misonix of up to $1 million.

Stavros Vizirgianakis, President and Chief Executive Officer of Misonix, said, “We look forward to working with the team at Hunan Xing Hang Rui Kang Bio-Technologies Co. to establish our SonaStar technology throughout The People’s Republic of China, Hong Kong and Macau. We will be focused on assisting them to effectively and efficiently manufacture the SonaStar product line once they complete the required manufacturing facilities. In the meantime, we will supply them the product they need to begin to establish the SonaStar product line in these important and fast-growing markets. This is an important technology that will result in better patient outcomes with cost-effective treatment modalities.”

Quan Li, Chairman of Hunan Xing Hang Rui Kang Bio-technologies Co., Ltd., said, “Working with Misonix represents a unique opportunity to add an important technology to our suite of products. SonaStar is an advanced technology engineered to provide powerful and precise ultrasonic aspiration with maximum control and ease-of-use. We are dedicated to bring these important benefits to our markets in The People’s Republic of China, Hong Kong and Macau.”

“We are extremely excited to be partnering with the team at Hunan Xing Hang Rui Kang Bio-Technologies Company to bring our SonaStar technology to The People Republic of China,” added Scott Ludecker, Senior Vice President of Sales and Marketing with Misonix. “Both organizations share a common commitment to improving the lives of patients with our therapeutic ultrasonic surgical technology.”

About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s website at www.misonix.com.

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2017, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking statements.

Corporate Contact
Joe Dwyer
Misonix, Inc.
631-927-9113
jdwyer@misonix.com

Investor Contact
Joe Diaz
Lytham Partners
602-889-9700
mson@lythampartners.com

RTI Surgical® Introduces TETRAfuse® 3D Technology Becoming First to Offer 3D Printed Interbody Polymer Optimized to Participate in Fusion

October 20, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, today announced the introduction of TETRAfuse® 3D Technology, providing surgeons a solution they have been seeking. From the beginning, surgeons have had to choose between bone in-growth, radiolucency or mechanical strength when selecting a spinal interbody implant. TETRAfuse 3D Technology is the first 3D printed polymer implant material that has demonstrated trabecular bone ingrowth while maintaining radiolucency and bone-like mechanical properties1.

“The 3D printing process creates a nano-rough surface on every aspect of the implant, not just the endplates,” noted Robert Watkins IV, M.D. of Marina Spine Center in Marina Del Ray, Calif. “This nano-rough surface facilitates bony ingrowth throughout the disc space from endplate to endplate, allowing deeper implant osseointegration.”

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.

“We are excited about the promise this cutting-edge technology holds for our surgeon customers and their patients,” said Camille Farhat, RTI chief executive officer. “Being the first to offer surgeons a 3D printed interbody polymer optimized to participate in fusion marks another significant milestone for RTI in our quest to continuously deliver relevant and innovative products without compromise.”

® indicates U.S. trademark registration. All trademarks and/or images are the property of their respective owners or holders.

Data on file at RTI Surgical, Inc. Animal and in vitro data may not be representative of clinical experience.

Clinical cases are unique and results may vary.

About RTI Surgical Inc.

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

Forward Looking Statement

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

Contacts

RTI Surgical Inc.
Roxane Wergin, 386-418-8888
Director, Corporate Communications
rwergin@rtix.com