Mazor Robotics to Report Third Quarter Financial Results on November 7, 2017

Oct. 24, 2017

CAESAREA, Israel–(BUSINESS WIRE)– Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical robotic guidance systems, announced today that it will report financial results for the third quarter ended September 30, 2017, before the U.S. markets open on Tuesday, November 7, 2017.

The company will host a conference call to discuss these results on Tuesday, November 7, 2017, at 8:30 AM ET (3:30 PM IST). Investors within the United States interested in participating are invited to call 800-298-0498. Participants in Israel can use the toll-free dial-in number 1 80 924 6042. All other international participants can use the dial-in number 719-457-2654. For all callers, refer to Conference ID 5718138.

A replay of the event will be available for two weeks following the conclusion of the call. To access the replay, callers in the United States can call 1-866-375-1919 and reference the Replay Access Code: 5718138. All international callers can dial +1 719-457-0820, using the same Replay Access Code. To access the webcast, please visit www.mazorrobotics.com and select ‘Investor Relations.’

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary robotic technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in a precise manner. For more information, please visit http://www.MazorRobotics.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20171024005310/en/

Contacts

EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
or
Doug Sherk, 415-652-9100
dsherk@evcgroup.com

 

Source: Mazor Robotics Ltd.

Ortho Sales Partners Announces the Addition of Matt Stuttle as Senior Vice President

Ortho Sales Partners, a global leader in orthopedic sales commercialization services, is excited to announce the addition of Matt Stuttle as Senior Vice President. This addition continues the momentum of Ortho Sales Partners in assisting clients by providing access to some of the industry’s top talent. Mr. Stuttle will instantly bring immense value to our clients from around the globe.

Matt has been in the medical industry for over 18 years. He began his career in sales and management with Forest Pharmaceuticals prior to transitioning to medical devices in 2003. Since then he’s held roles of increasing responsibility and executive management positions at Kyphon (acquired by Medtronic in 2008 for $4.3B), Paradigm Spine, Spine Wave and most recently Spineart.

Throughout his career Matt has lead sales organizations through enormous revenue growth in both private and public sectors. Prior to joining Ortho Sales Partners Matt was U.S. Vice President for Spineart, a global spine implant company based in Switzerland. During his tenure at Spineart he was instrumental in developing the US infrastructure, commercialization, distribution, product launch and market development strategies while providing necessary operational guidance. Under his leadership the organization received FDA approval for several new technologies subsequently introduced into the U.S. market while doubling U.S. sales.

Matt was also previously U.S. Vice President for Paradigm Spine where he built and scaled the initial U.S. sales and distribution infrastructure. Matt led the organization though key product launches while also assisting in management of the IDE clinical trial for Coflex, now FDA approved and market leading technology worldwide. Under his leadership the company grew from $0 to over $13M.

“It’s an honor to join such a tremendous group of experienced professionals with such a vast breadth of expertise. Ortho Sales Partners is well positioned to assist a broad scope of clients throughout various stages of growth and scale. Whether a startup company or well-established organization, OSP has the knowledge, resources and team to assist in providing real tangible value while mitigating unnecessary operational risk,” said Matt Stuttle.

“I have had the pleasure of knowing and working with Matt for the past 12 years and I am thrilled to have someone of his caliber join Ortho Sales Partners,” said Josh Sandberg President, Ortho Sales Partners. “We have been able to create a disruptive change to the supply chain in orthopedics over the past couple of years and with this addition, we are able to further advance the initiatives that we have been working on. We welcome Matt as a core member of our team and look forward to the contributions he will add to our team.”

About Ortho Sales Partners

Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations such as:

  •     A surgeon with a product idea and limited financial wherewithal to properly execute a sales plan.
  •     OUS companies looking to establish or enhance their presence in the United States.
  •     Companies with recent FDA approval in need of a strategic sales plan validated against current market conditions.
  •     Established companies looking for sales and marketing horsepower to properly launch a new product.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis from industry stalwarts from some of the highest growth companies.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US. (http://www.orthosalespartners.com)

FzioMed Receives FDA Approval for Small Confirmatory Study of Oxiplex® in Patients Undergoing Lumbar Surgery for Disc Herniation

October 23, 2017

SAN LUIS OBISPO, Calif.–(BUSINESS WIRE)–FzioMed, Inc., a biomaterials company celebrating 21 years in business, has received approval from FDA to conduct a small confirmatory study of Oxiplex® in the United States.

Oxiplex® is an absorbable, synthetic viscoelastic gel that is applied following partial discectomy, with the intent to reduce postoperative leg pain, back pain and neurologic symptoms.

“We have been working with FDA for many years to bring this technology to the US,” said John Krelle, President and CEO of FzioMed, “and we are confident that a new level of cooperation with FDA will finally enable patients in this country to experience the benefits of Oxiplex following the large number of lumbar surgeries performed here.”

Multiple US and OUS studies have already demonstrated the benefits of Oxiplex® and this study will target patients with higher levels of back and leg pain who do not always experience the level of pain relief offered by surgery alone.

FzioMed is pleased to be working with Musculoskeletal Clinical Regulatory Advisers (MCRA) as both regulatory advisor and CRO on this study, which will be posted on Clinicaltrials.gov when open for enrollment.

About FzioMed, Inc.

FzioMed, Inc. is a privately held medical device company that develops, manufactures and markets absorbable surgical biomaterials based on its patented scientific technology. For more information, please contact John Krelle at jkrelle@fziomed.com. You can also visit www.fziomed.com or contact investorrelations@fziomed.com.

FzioMed®, Oxiplex®,Oxiplex/AP®, Laresse® and Dynavisc® are registered trademarks of FzioMed, Inc.

Contacts

FzioMed, Inc.
John Krelle
jkrelle@fziomed.com

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

SI-BONE’s New iFuse-Navigation™ Set* and iFuse-3D™ Fenestrated SI Joint Fusion Implant to be Featured at NASS 2017

SAN JOSE, Calif.Oct. 23, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (iFuse), a triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced its new iFuse-Navigation Set* and proprietary 3D printed iFuse-3D fenestrated triangular titanium implant, will be featured at this year’s North American Spine Society (NASS) annual meeting in Orlando, FL.  The new iFuse-Navigation Set was designed to allow surgeons using the O-armTMimaging system and StealthStationTM navigation system to perform the iFuse procedure for MIS SI joint fusion.

In addition to the new iFuse-Navigation Set, the company will also showcase its new iFuse-3D Implant. This novel implant combines the patented triangular shape of the iFuse ImplantTM with a proprietary 3D-printed porous trabecular surface and unique patented fenestrated design which is intended to enhance bony ongrowth, ingrowth, through growth and intra-articular fusion.

The company will also be hosting Dr. David Polly**, Chief of Spine Surgery at the University of Minnesota, on Thursday, October 26th from 3:10 pm to 3:40 pm at its booth (#1518) in the NASS exhibit hall.  Dr. Polly will present and discuss his experience utilizing navigation with the iFuse Procedure as well as his clinical experience with the new iFuse-3D Implant.

“We are excited to have Dr. Polly join us at our booth and we’re grateful that he has offered to take time to share his clinical experience with the iFuse Implant System® and navigation as well as provide his initial perspective on the new iFuse-3D Implant,” said Tony Recupero, Chief Commercial Officer at SI-BONE.  “We have made great progress this past year toward advancing the diagnosis and treatment of SI joint disorders and we look forward to this year’s NASS meeting to help build on that progress and create even greater awareness about the condition and access to our procedure.”

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs.  Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes.  Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions.  The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution.  The iFuse ImplantTM was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain.  Patients with sacroiliac joint dysfunction experience pain that can be debilitating.  SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

*Pending 510(k), not available for sale in USA.
**Dr. Polly was an investigator on a clinical research study sponsored by SI-BONE. He has no financial interest in SI-BONE.

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. iFuse-Navigation and iFuse-3D are trademarks of SI-BONE, Inc.  ©2017 SI-BONE, Inc. All Rights Reserved.  All other trademarks are property of their respective owners.

10016.102317

  1. Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
  2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
  3. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
  4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
  5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

 

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.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

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

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

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