2018 Ambulatory Surgery Center (ASC) Market: Projected to Increase from $36 Billion in 2018, to $40 Billion by 2020 – ResearchAndMarkets.com

October 11, 2018

DUBLIN–(BUSINESS WIRE)–The “2018 Ambulatory Surgery Center Market” report has been added to ResearchAndMarkets.com’s offering.

The ambulatory surgery center (ASC) market was estimated to reach $36 billion in 2018, and is projected to increase to $40 billion by 2020.

Drivers for revenue growth are: lower outpatient surgery costs in ASCs compared to other settings, improved safety driven by technological advancements, and the aging U.S. population.

There are more than 6,100 ASCs in the U.S, and as of 2016, 5,519 were Medicare-certified. Approximately 70% of ASCs are owned by independent physician groups. The top five industry leaders own less than 20% of ASC market share.

Shift To Outpatient Continues

As of 2017, more than half of outpatient surgeries were performed in an ASC setting, up from 32% in 2005.

Based solely on population growth forecasts, outpatient procedure volumes are predicted to increase 14% from 2016 to 2026. However, analysts predict this number will be higher (16%) due to the growing shift in surgical procedures from inpatient to outpatient settings.

Each year, the Centers for Medicare and Medicaid Services (CMS) evaluates a list of approximately 1,700 procedures that are designated as inpatient-only. With improvement in medical technologies, an increasing number of procedures are being removed from this list, allowing them to be performed in outpatient settings. In 2018, six procedures were removed from this list.

ASCs Cut Costs For Payers, Patients

Commercial payers were 64% of the ASC payer mix in 2017, followed by Medicare at 19%. In an effort to reduce costs and increase value, payers are driving the shift in procedures from high-cost settings to more cost-effective ASCs. For example, joint replacement in a hospital outpatient department (HOPD) costs an average of $40,000 versus $18,000 in an ASC. The same is true for cataract surgery with an average cost of $1,745 in an HOPD and $976 in an ASC.

Patients also benefit from these savings. As ASC volumes increase in coming years, total out-of-pocket expenses for procedures could fall by as much as $5 billion.

Key Topics Covered

  1. Executive Summary
  2. Ambulatory Surgery Center Market Overview
  3. Outpatient Volumes Projected To Increase 16% By 2026
  4. Growth In Outpatient Procedures To Drive Additional ASC Volume
  5. Removal Of Surgeries From Inpatient-Only List Increases Procedures Available To ASCs
  6. Most Operating Costs Spent On Supplies And Salaries
  7. Orthopedic Procedures Most Costly
  8. Commercial Insurance Continues To Make Up More Than Half Of ASC Payer Mix
  9. ASC Nurses Earn Higher Wages
  10. Gastroenterology, Ophthalmology Major ASC Specialties
  11. Orthopedics, Otolaryngology, Podiatry, Generate Highest Revenues
  12. Cataract Procedure Remains The Most Commonly Performed Surgery In ASCs
  13. ASCs Specializing In Cardiology Most Likely To Require Post-Surgery Hospitalization
  14. Patients Save Money Through ASC Utilization
  15. Price Transparency Beneficial To ASCs
  16. ASCs Gain At The Expense Of Hospitals
  17. In 2018, ASC Quality Reporting Program Adds Two Measures, Discontinues Three
  18. Number Of ASCs Higher For States Without CON Requirement
  19. Healthcare Execs To Pursue ASCs For M&A, Most ASCs Expect No Activity
  20. ASC Management Companies Expand Investment In 2018
  21. Health System Affiliation Not On The Horizon For Most ASCs
  22. One-Third Of ASCs Plan To Expand In 2019
  23. HOPD To ASC Conversion Potentially Beneficial To Hospitals

For more information about this report visit https://www.researchandmarkets.com/research/644v8f/2018_ambulatory?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
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For GMT Office Hours Call +353-1-416-8900
Related Topics: Surgical Procedures

TransEnterix Receives FDA 510(k) Clearance for 3mm Diameter Instruments

October 11, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Company received FDA 510(k) clearance for 3 millimeter diameter instruments, as well as additional 5 millimeter Senhance System instruments.

The clearance of the 3 millimeter diameter instruments will allow the Senhance to be used for microlaparoscopic surgeries, enabling surgeons to operate through tiny incisions considered virtually scarless for patients.

“The ability to perform microlaparoscopic procedures using 3 millimeter instruments represents an unparalleled shift in the world of robotic surgery and a capability exclusive to the Senhance system,” said Todd M. Pope, TransEnterix CEO. “The addition of 3 millimeter instruments will allow many high volume surgeries to be performed with smaller incisions, which supports our mission of advancing minimally invasive surgical capabilities within digital laparoscopy.

“Utilizing 3 millimeter micro instruments on a robotic system represents a new advancement in reducing the invasiveness of many surgeries,” said Dr. Steven D. McCarus, MD, FACOG, Chief of Gynecologic Surgery at Florida Hospital Celebration Health. “Patients find such small incisions to be virtually scarless and cosmetically desirable. Surgeons may find that using such tiny instruments with the precision and control of a digital interface makes microlaparoscopy a preferred option to treat more conditions.”

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance™ Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward Looking Statements

This press release includes statements relating to the Senhance Surgical System and related instruments and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the ability to perform microlaparoscopic procedures using 3 millimeter instruments represents an unparalleled shift in the world of robotic surgery; whether the addition of 3 millimeter instruments will allow many high volume surgeries to be performed with smaller incisions and whether surgeons may find that using tiny instruments with the precision and control of a digital interface makes microlaparoscopy a preferred option to treat more conditions. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 8, 2018, and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

TransEnterix, Inc.
Investor Relations:
Mark Klausner, 443-213-0501
transenterix@westwicke.com
or
Media Relations:
Joanna Rice, 951-751-1858
joanna@greymattermarketing.com

Medacta International Adds Mpact 3D Metal Implants and Augments to Mpact System for Primary Hip Replacement and Revision Surgeries

October 11, 2018

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Medacta® International, the privately owned, global leader in innovative joint replacement and spinal technologies, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the Mpact 3D Metal™ Implants and Augments 3D Metal as enhancements to its Mpact® System for primary to complex hip revision procedures. The first stateside surgery utilizing the implant and augments was performed this summer by Tyler Goldberg, M.D., of Austin-based Texas Orthopedics, Sports & Rehabilitation Associates.

The new implants, Mpact 3D Metal Acetabular Two-Hole and Multi-Hole Shells, are hemispherical porous shells with multiple highly cross-linked polyethylene liner options. The implants’ ultra-porous material makes them ideal for more demanding primary patient cases or to address difficult revisions with compromised bone. They are complemented by the porous 3D Metal Augments, designed to act as a defect-filling implant in cases of severe bone loss to help increase implant stability. The augments come in a variety of shapes and sizes, giving surgeons intraoperative flexibility to address a wide variety of acetabular defects. Together, these additions strengthen Medacta’s Mpact System and provide surgeons with more options when addressing complex primary hip replacements, as well as revisions.

Dr. Goldberg’s primary case utilized the Mpact Two-Hole Shell. “I was impressed with how firm the Mpact 3D Metal Implant was upon initial impaction. The shell has exceptional grip, making primary fixation easy and solid,” Dr. Goldberg said of his experience. “Knowing the shell is of high porosity and solid nature gave me great confidence for durable bone ingrowth, and my patient is recovering very well.”

The Mpact 3D Metal Implants feature Medacta’s proprietary 3D Metal technology, constructed via additive manufacturing performed by a 3D printer. The result is enhanced initial stability due to a high coefficient of friction at the bone interface and favorable environment for bone without the need for an additional coating. The 3D Metal Shells and Augments have pore sizes of 600-800 micrometers and continuously interconnected open pores with a high-porosity level of 75 percent.

“Medacta continues to expand upon its product portfolios as we seek to help our surgeon partners address more patient cases than ever before, whether it’s a complex primary case or a difficult revision,” said Francesco Siccardi, Executive Vice President of Medacta International. “With the new Mpact 3D Shells and 3D Metal Augments, our Mpact System offers even greater versatility and continues to instill confidence, thanks to both the high-grade materials used and the built-in surgeon education and support system for which Medacta is well known.”

The Mpact 3D Metal Implants and Augments are compatible with several surgical techniques, including Medacta’s Anterior Minimally Invasive Surgery (AMIS®) approach to hip replacement. The muscle-sparing AMIS approach is supported by the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute, which provides surgeons with educational resources, training and mentorship as well as dedicated tools and instruments as they transition and practice the technique.

For more information, visit Medacta’s Mpact System webpage.

About Medacta International

Medacta® International is a world leading company, developer and supplier, specializing in joint replacement, spine surgery, and sports medicine solutions. Medacta’s revolutionary approach and responsible innovation, focusing on Minimally Invasive Solutions and Personalized Medicine, have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient matched technology. Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, operates in over 30 countries around the globe, and employs more than 930 people. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter and LinkedIn.

Contacts

For Medacta International
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

Catalyst OrthoScience Introduces 3-Peg Glenoid To Its Catalyst CSR™ Total Shoulder System

October 11, 2018

NAPLES, Fla.–(BUSINESS WIRE)–Catalyst OrthoScience Inc. (Catalyst), a cutting-edge medical device company focused on the upper extremity orthopedics market, today introduced the patent pending 3-Peg Glenoid implant to its innovative Catalyst CSR™ Total Shoulder System. The new implant was unveiled at the American Shoulder and Elbow Surgeons (ASES) 2018 Annual Meeting in Chicago, Ill.

Loosening of the glenoid component is the most common mode of failure in total shoulder arthroplasty1-3. An inability to achieve long-lasting, secure fixation within the glenoid bone that can withstand the effects of repeated eccentric loading and glenohumeral translation leads to failure4.

In order to address this, Catalyst has used a science-based approach to design the 3-Peg Glenoid implant with the specific goal of resolving these challenges. Key features include:

1. Immediate interference fit fixation in the strongest regions of the glenoid vault using a new backside anchoring element design.

2. Tapered walls on the bearing surface to reduce the effects of eccentric loading, which can contribute to implant loosening.

3. Quick, accurate placement of the implant using a streamlined procedure resulting in potential time and cost savings.

“The 3-Peg Glenoid is a great addition to our Catalyst CSR system, and it gives surgeons the option between the existing glenoid with two pegs or the new 3-Peg option,” said Brian Hutchison, executive chairman and CEO of Catalyst. “We have had a number of surgeons use the 3-Peg Glenoid with great results so far.”

Designed by surgeons for surgeons, the Catalyst CSR system represents the next evolution in shoulder surgery. The system includes a multi-planar stemless design which preserves bone and an elliptical humeral component that mimics the natural shoulder anatomy. Additionally, the surgical technique and instrumentation were designed to simplify the glenoid exposure and consistently deliver a precise and accurate shoulder reconstruction.

To learn more about the new 3-Peg Glenoid and the Catalyst CSR system, visit Catalyst at booth J at the ASES meeting, Oct. 11 – 14, 2018.

About Catalyst OrthoScience Inc.

Catalyst OrthoScience develops and markets surgical implants that make orthopedic surgery less invasive and more efficient for both surgeons and patients. Catalyst was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D., who saw the need to make shoulder replacement surgery less invasive and give patients a more natural-feeling shoulder after surgery.

The company’s first offering, the Catalyst CSR Total Shoulder System, represents the next evolution in stemless total shoulder arthroplasty. The Catalyst CSR is a single-tray, bone-preserving total shoulder arthroplasty system containing a precision elliptical humeral head and less invasive glenoid component, using specialized ergonomic instrumentation designed for consistent anatomic joint line restoration and glenoid insertion. The Catalyst CSR system can be used in both inpatient and outpatient settings and was cleared for use by the FDA in 2016.

Catalyst OrthoScience has a growing portfolio of 10 granted U.S. patents with several more pending nationally and internationally. The company is headquartered in Naples, Fla., and its products are available across the U.S. For additional information on the company, please visit www.CatalystOrtho.com.

References

1. Wirth et al. Complications of total shoulder replacement arthroplasty. JBJS 1996: 603-16.

2. Franta et al. The complex characteristics of 282 unsatisfactory shoulder arthroplasties JSES 2007: 555-62.

3. Bohsali et al. Complications of total shoulder arthroplasty JBJS 2006: 2279-92.

4. Matsen et al. Glenoid component failure in total shoulder arthroplasty. JBJS 2008: 885-96.

Contacts

Catalyst OrthoScience Inc.
Brent Narkiewicz
bnarkiewicz@catalystortho.com
or
Surgence Communications Strategies
Wendy Crites Wacker, APR, CPRC, 352-494-2129
wendy@surgencecs.com

Medicrea Third Quarter 2018 Sales

October 11, 2018

LYON, France and NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED ; OTCQX Best Market – MRNTY & MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD™ ASI (Adaptive Spine Intelligence) proprietary software platform, services and technologies, publishes its sales for the 3rd quarter ended September 30, 2018.

€ millions 2017 2018 Change

Change at constant
exchange rate

Q3

6.4

7.3

+14%

+14%

YTD September 21.1 24.2 +15% +19%

Sales amounted to € 7.3 million for the third quarter of 2018, up 14% compared to the third quarter last year, and totaled 24.2 million euros at the end of September, up 19% at constant exchange rates compared to the same period of 2017.

In the USA, the use of UNiD™ patient-specific services and implants has increased significantly in recent months. In the third quarter of 2018, the number of personalized UNiD™ surgeries increased by 90%, bringing the cumulative increase to 62% since the beginning of 2018.

Medicrea has returned to the path of sustained growth since the beginning of the year as anticipated, with an acceleration especially in UNiD™ surgeries in the United States.

“The number of UNiD™ surgeries in the United States is growing strongly, but another important indicator seems even more promising: 16 new US surgeons have integrated our personalized UNiD™ approach to their activity by performing their first patient-specific surgery over the last quarter. This demonstrates the relevance of the solution we offer, which will gradually become the reference by replacing the traditional approach of spine surgery,” commented Denys Sournac, President and CEO of Medicrea.

“The milestone of 3,000 surgeries performed with UNiD ASI ™ patient-specific implants is expected to be reached by the end of the year. We now have a unique database, enriched continuously and allowing more accurate predictive modeling. In a market that commoditizes implants and prioritizes the optimization of clinical outcomes for the well-being of patients, our planning solutions set a new standard that we must rely on to offer all of our services and products in order to accelerate the development of our revenue “says Denys Sournac.

Medicrea will be attending the 53rd Spine Research Society (SRS) Conference taking place in Bologna, Italy, from October 10 to 13, during which the company will present a new study demonstrating that patients implanted with UNiD ASI ™ patient-specific rods are 2.6 times more likely to be optimally corrected.

Next publication: 2018 Annual Sales on January 15, 2019 after market.

About Medicrea (www.medicrea.com)

Through the lens of predictive medicine, Medicrea leverages its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data. The Company is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 200 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Connect with Medicrea
FACEBOOK INSTAGRAM TWITTER WEBSITE YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED
LEI: 969500BR1CPTYMTJBA37

Medicrea is traded on
OTCQX Best Market
Tickers: MRNTY & MRNTF

Contacts

Medicrea
Denys SOURNAC
Founder, Chairman and CEO
dsournac@medicrea.com
or
Fabrice KILFIGER
Chief Financial Officer
fkilfiger@medicrea.com
Tel: +33 (0)4 72 01 87 87

K2M Receives FDA Clearance Including Surgical Guidance that Enhances MESA® Platform Using Patient-Specific Rods & Rails

LEESBURG, Va., Oct. 10, 2018 (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 at the Scoliosis Research Society 53rd Annual Meeting & Course, in Bologna, Italy a U.S. Food and Drug Administration (FDA) 510(k) clearance that also provides for the Dual Differential Correction (DDC) Philosophy & Technique. The DDC philosophy combines rod rigidity and degree of bend with the MESA® Platform Technology, to help achieve quality outcomes in patients with sagittal imbalance. In addition, MESA can be used with the BACS® Patient-Specific Rods to help surgeons create pre-contoured rods, rails, and templates that match the surgeon’s preoperative plan.

Todd Ritzman, MD, Akron Children’s Hospital, explained, “Given the growing recognition of the importance of sagittal plane correction in idiopathic scoliosis, it is a valuable aid to objectively determine rod contour based off of a given patient’s pelvic incidence to help optimize surgical correction in the sagittal plane. The days of ‘eyeballing’ the rod contour are over.”

K2M’s MESA Platform Technology features top-loading and low-profile screws and Zero-Torque Technology® that one-step locks without applying torsional stress to the spine. The MESA Platform includes the MESA 2 Deformity Spinal System, a state-of-the-art solution for the most difficult correction maneuvers in complex spine surgery.

K2M manufactures BACS Patient-Specific Rods and Rails using a machine rolling method, replacing the manual three-point bending method that often reduces rod fatigue strength. By incorporating data from BACS Surgical Planner—part of K2M’s comprehensive BACS Digital Platform— rods and rails can be manufactured with complex multi-contoured designs. BACS Patient-Specific Rods and Rails can be used with the MESA, EVEREST®, and DENALI® Spinal Systems.

BACS provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

K2M to Appear at SRS 2018

At the meeting, K2M executives will be onsite to discuss the Company’s differentiated spinal solutions, including its MESA Platform Technology, 3D-printed devices featuring Lamellar 3D Titanium Technology, and comprehensive Balance ACS® (BACS) Platform.

“K2M is a proud Double Diamond Sponsor of SRS 2018,” said John P. Kostuik, MD, Chief Medical Officer, Co-founder, and Member of the Board of Directors at K2M, and Past President of the SRS. “This year, we are excited to build upon our culture of innovation by showcasing our leading spinal solutions, most notably our Dual Differential Correction Philosophy & Technique—used in conjunction with our world-class MESA Platform Technology and Balance ACS Platform—so surgeons can correct complex spinal deformities across all three anatomical planes and help eliminate the need for further derotation maneuvers.”

For more information on K2M and Balance ACS, visit www.K2M.com and 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

The foregoing contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  We intend for these forward-looking statements to be covered by the safe harbor provisions of the federal securities laws relating to forward-looking statements.  These forward-looking statements include statements relating to the expected timing, completion and effects of the proposed merger, as well as other statements representing management’s beliefs about, future events, transactions, strategies, operations and financial results, including, without limitation, our expectations with respect to the costs and other anticipated financial impacts of the merger; future financial and operating results of K2M Group Holdings, Inc. (“K2M”); K2M’s plans, objectives, expectations and intentions with respect to future operations and services; required approvals to complete the merger by our stockholders and by governmental regulatory authorities, and the timing and conditions for such approvals; the stock price of K2M prior to the consummation of the transactions; and the satisfaction of the closing conditions to the proposed merger.  Such forward-looking statements often contain words such as “assume,” “will,” “anticipate,” “believe,” “predict,” “project,” “potential,” “contemplate,” “plan,” “forecast,” “estimate,” “expect,” “intend,” “is targeting,” “may,” “should,” “would,” “could,” “goal,” “seek,” “hope,” “aim,” “continue” and other similar words or expressions or the negative thereof or other variations thereon.  Forward-looking statements are made based upon management’s current expectations and beliefs and are not guarantees of future performance.  Such forward-looking statements involve numerous assumptions, risks and uncertainties that may cause actual results to differ materially from those expressed or implied in any such statements.  Our actual business, financial condition or results of operations may differ materially from those suggested by forward-looking statements as a result of risks and uncertainties which include, among others, those risks and uncertainties described in any of our filings with the Securities and Exchange Commission (the “SEC”).  Certain other factors which may impact our business, financial condition or results of operations or which may cause actual results to differ from such forward-looking statements are discussed or included in our periodic reports filed with the SEC and are available on our website at www.K2M.com under “Investor Relations.” You are urged to carefully consider all such factors.  Although it is believed that the expectations reflected in such forward-looking statements are reasonable and are expressed in good faith, such expectations may not prove to be correct and persons reading this communication are therefore cautioned not to place undue reliance on these forward-looking statements which speak only to expectations as of the date of this communication.  We do not undertake or plan to update or revise forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections, or other circumstances occurring after the date of this communication, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized.  If we make any future public statements or disclosures which modify or impact any of the forward-looking statements contained in or accompanying this communication, such statements or disclosures will be deemed to modify or supersede such statements in this communication.

Additional Information and Where to Find It

This communication does not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities or a solicitation of any vote or approval.  In connection with this proposed acquisition, K2M has filed a definitive proxy statement and has filed or may file other documents with the SEC.  This communication is not a substitute for any proxy statement or other document K2M has filed or may file with the SEC in connection with the proposed transaction.  INVESTORS AND SECURITY HOLDERS OF K2M ARE URGED TO READ THE PROXY STATEMENT AND OTHER DOCUMENTS THAT HAVE BEEN (OR MAY BE) FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN IMPORTANT INFORMATION.  The definitive proxy statement will be mailed to stockholders of K2M.  Investors and security holders may obtain free copies of these documents and other documents filed with the SEC by K2M through the website maintained by the SEC at www.sec.gov.  Copies of the documents filed with the SEC by K2M will be available free of charge on K2M’s internet website at www.K2M.com or upon written request to: Secretary, K2M Group Holdings, Inc., 600 Hope Parkway, SE, Leesburg, Virginia 20175, or by telephone at (703) 777-3155.

Participants in Solicitation

K2M, its directors and certain of its executive officers may be considered participants in the solicitation of proxies in connection with the proposed transaction.  Information regarding the persons who may, under the rules of the SEC, be deemed participants in such solicitation in connection with the proposed merger will be set forth in the definitive proxy statement filed with the SEC on October 5, 2018.  Information about the directors and executive officers of K2M is set forth in its Annual Report on Form 10-K for the fiscal year ended December 31, 2017, which was filed with the SEC on March 1, 2018, its proxy statement for its 2018 annual meeting of stockholders, which was filed with the SEC on April 20, 2018, its Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2018 and June 30, 2018, which were filed with the SEC on May 2, 2018 and August 2, 2018, respectively, and its Current Reports on Form 8-K or Form 8-K/A, which were filed with the SEC on January 8, 2018, January 9, 2018, February 28, 2018, March 29, 2018, May 1, 2018, June 11, 2018, June 14, 2018, June 18, 2018, August 1, 2018, August 30, 2018, and October 5, 2018.

These documents can be obtained free of charge from the sources indicated above.  Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, is contained in the definitive proxy statement and other relevant materials filed with the SEC.

K2M Group Holdings, Inc.
600 Hope Parkway, SE
Leesburg, Virginia 20175
Tel. (703) 777-3155
www.K2M.com

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

Wright Medical Group N.V. Completes Acquisition of Cartiva, Inc.

AMSTERDAM, The Netherlands, Oct. 10, 2018 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today announced it has completed its acquisition of Cartiva, Inc. (Cartiva), an orthopaedic medical device company focused on treatment of osteoarthritis of the great toe.  The transaction adds a differentiated PMA-approved technology for a high-volume foot and ankle procedure and further accelerates growth opportunities in Wright’s global Extremities business.

Wright previously announced on August 27, 2018 that it had entered into a definitive agreement to acquire 100% of Cartiva’s outstanding equity on a fully diluted basis for a total price of $435 million in cash.

Wright will provide updated full-year 2018 guidance, including the impact of the Cartiva acquisition, on its third quarter 2018 earnings call, which is scheduled for November 7, 2018.

Robert Palmisano, president and chief executive officer, commented, “We are delighted to welcome Cartiva as a member of the Wright family.  With approximately 120,000 procedures for great toe arthritis performed each year in the U.S., we believe that this technology provides a proven alternative to fusion that reduces joint pain without sacrificing the foot’s natural movement and retains mobility and range of motion.”

Cartiva’s Synthetic Cartilage Implant (SCI) is indicated for treating arthritis at the base of the great toe and received U.S. Premarket Approval in July 2016.  The SCI is composed of a biocompatible, durable, low-friction organic polymer that functions similarly to natural cartilage and can be implanted in about 35 minutes.  Unlike fusion, Cartiva reduces joint pain without sacrificing the foot’s natural movement and retains mobility and range of motion.  Due to a less restrictive rehabilitation protocol, Cartiva patients typically return to function and activities of daily living faster than patients who undergo a fusion procedure.  Additional regulatory approvals have been obtained in Canada, EU, Brazil, Chile and Australia.

About Wright Medical Group N.V.

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

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

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS    

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “could,” “may,” “will,” “believe,” “estimate,” “continue,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward looking statements in this release include, but are not limited to, statements about the anticipated clinical and financial performance of Cartiva’s products.  Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, failure to achieve the anticipated financial benefits of the Cartiva acquisition, unanticipated clinical performance issues with Cartiva products or the introduction of competitive products with clinical performance attributes that are superior to Cartiva products, failure to achieve wide market acceptance of the Cartiva products due to clinical, regulatory, cost, reimbursement or other issues, failure to achieve anticipated financial results for 2018, the failure of Wright’s 2017 U.S. sales force additions to achieve expected results, delay or failure to drive U.S. lower extremities or biologics sales to anticipated levels; continued supply constraints; failure to integrate the legacy Wright and Tornier businesses and realize net sales synergies and cost savings from the merger with Tornier or delay in realization thereof; operating costs and business disruption as a result of that merger, including adverse effects on employee retention and sales force productivity and on business relationships with third parties; integration costs; actual or contingent liabilities; adverse effects of diverting resources and attention to providing transition services to the purchaser of the large joints business; the adequacy of Wright’s capital resources and need for additional financing; the timing of regulatory approvals and introduction of new products; physician acceptance, endorsement, and use of new products; failure to achieve the anticipated commercial sales of our AUGMENT® Bone Graft and other new products; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims and product recalls; pending and threatened litigation; risks associated with the metal-on-metal master settlement agreement and the settlement agreement with the three settling insurers; risks associated with the subsequent metal-on-metal settlement agreements and ability to obtain the additional new insurance proceeds contingent thereon; risks associated with international operations and expansion; fluctuations in foreign currency exchange rates; other business effects, including the effects of industry, economic or political conditions outside of the company’s control; reliance on independent distributors and sales agencies; competitor activities; changes in tax and other legislation; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 31, 2017 filed by Wright with the SEC on February 28, 2018 and subsequent SEC filings by Wright, including without limitation its Quarterly Reports on Form 10-Q for the quarters ended April 1, 2018 and July 1, 2018. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Investors & Media:

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

EOS imaging Showcases hipEOS at the International Society for Technology in Arthroplasty (ISTA) in London

October 10, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Euronext, FR0011191766 – EOSI – Eligible PEA – SME), the pioneer of 2D/3D imaging and data solutions for orthopedics, will demonstrate its online hipEOS 3D surgical planning software at its booth during the International Society for Technology in Arthroplasty’s (ISTA) 31st Annual Congress, being held October 10-13 in London, UK. The ISTA Congress is dedicated to advancing the art and science of technology in joint replacement by connecting leading clinicians, engineers, researchers with industry members from around the globe to address new and foundational topics in arthroplasty.

Seven podium presentations and three posters will highlight the value of EOS as a unique solution along the THA care pathway. This will include clinical results related to the improvement of THA outcomes through a better inclusion of pelvis/spine relations, global body compensation mechanisms, standing and seated functional positions, and image-based quality control tools. In particular, teams from two of the top ten ‘Best Hospitals for Orthopedics”1, the Hospital of Special Surgery (HSS) and New York University (NYU), from Imperial College, London, and Pitié-Salpêtrière Hospital (Paris) will address how these improvements can be facilitated through EOS full body, weight-bearing and seated exams and of the hipEOS software.

The latest generation of the hipEOS software addresses the risk of implant impingement based on the planed size and position of the components in standing and seated EOS images. The software calculates the theoretical sitting position and offers a range of motion simulation to check for implant impingement based on each patient’s unique anatomy.

Marie Meynadier, Chief Executive Officer of EOS imaging, commented, “Our full body, low dose solution is being recognized across the globe as a superior alternative to traditional imaging. Our EOSapps suite of 3D surgical planning solutions offer an easy way to identify patients at risk, create a personalized plan, and discuss the procedure with patients. We are happy to see our solutions widely represented by worldwide leaders at ISTA and committed to developing innovative solutions that make these growing volume procedures easier and safer for the whole medical community.”

For more information, visit our booth or contact us at: contact@eos-imaging.com

ABOUT EOS IMAGING

EOS imaging is listed on Compartment C of Euronext Paris

ISIN: FR0011191766 – Ticker: EOSI

EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 33 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 280 installed EOS® platforms representing more than one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017. For more information, please visit www.eos-imaging.com.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

1 https://health.usnews.com/best-hospitals/rankings/orthopedics

Contacts

EOS imaging
Marie Meynadier
CEO
Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
The Ruth Group
Ph: 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com
or
Press Relations (US)
Kirsten Thomas
The Ruth Group Ph: 508-280-6592
kthomas@theruthgroup.com

SpineEX® Announces FDA Clearance of Sagittae® Lateral Lumbar Interbody Fusion Devices

FREMONT, Calif.Oct. 10, 2018 /PRNewswire/ — SpineEX, Inc., a medical device company that aims to provide innovative and minimally invasive implants, high-value disposables and instrumentation for spinal fusion surgeries, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Sagittae lateral lumbar interbody fusion (LLIF) device.

The LLIF procedure uses minimally invasive techniques that approach the spine from the side of the patient, allowing for a larger implant footprint, and less disruption to lower back muscles as compared to other approaches, which results in less blood loss and faster recovery.

Sagittae is a personalized, adjustable expandable LLIF device designed to minimize impaction, maximize indirect decompression, and provide a large graft space optimal for lumbar fusion procedures. It is designed for up to 8mm of continuous in situ expansion, with up to 30° of continuous in situ lordotic adjustment. The large single graft chamber can be filled with bone graft material after insertion and adjustment to ensure even contact with both vertebral endplates.

The ability to personalize the device to each patient’s needs provides restorative independent height and lordotic angle with proper anatomical fit. Available in five sizes, all with independent parallel height or lordotic profiles, Sagittae provides several options for surgeons to address optimal sagittal balance, while minimizing burdensome implant inventory traditionally required for each procedure.

“Sagittae is a personalized, expandable spinal implant with intra-operative adjustability ability for any height and any lordotic angle needed in a patient’s specific anatomy. This new lateral cage minimizes the need to forcefully impact the cage into the disc space,” said Roy Chin, Executive Chairman and CEO of SpineEX.

Indications for Use 
The SpineEX Sagittae Lateral Lumber Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

About SpineEX, Inc. 
SpineEX is a medical device company that is focused on providing minimally invasive implants, high-value disposables and instrumentation for spinal fusion surgeries.

SOURCE SpineEX

CVS Health Acquisition of Aetna Moving Forward on Agreement with U.S. Department of Justice

WOONSOCKET, R.I.Oct. 10, 2018 /PRNewswire/ — CVS Health (NYSE: CVS) today announced that it has entered into an agreement with the U.S. Department of Justice (DOJ) that allows it to proceed with its proposed acquisition of Aetna (NYSE: AET). DOJ clearance is a key milestone toward finalizing the transaction, which is also subject to state regulatory approvals, many of which have been granted. CVS Health’s acquisition of Aetna remains on track to close in the early part of Q4 2018.

“DOJ clearance is an important step toward bringing together the strengths and capabilities of our two companies to improve the consumer health care experience,” said CVS Health President and Chief Executive Officer Larry J. Merlo. “We are pleased to have reached an agreement with the DOJ that maintains the strategic benefits and value creation potential of our combination with Aetna. We are now working to complete the remaining state reviews.”

Merlo added, “CVS Health and Aetna have the opportunity to combine capabilities in technology, data and analytics to develop new ways to engage patients in their total health and wellness. Our focus will be at the local and community level, taking advantage of our thousands of locations and touchpoints throughout the country to intervene with consumers to help predict and prevent potential health problems before they occur. Together, we will help address the challenges our health care system is facing, and we’ll be able to offer better care and convenience at a lower cost for patients and payors.”

Following the close of the transaction, Aetna will operate as a standalone business within the CVS Health enterprise and will be led by members of its current management team.

As part of the agreement reached with the DOJ, as previously announced, Aetna entered into an asset purchase agreement with a subsidiary of WellCare Health Plans, Inc. (NYSE: WCG) for the divestiture of Aetna’s standalone Medicare Part D prescription drug plans, which have an aggregate of approximately 2.2 million members. Aetna will provide administrative services to and will retain the financial results of the divested plans through 2019. DOJ’s clearance, subject to this limited divestiture, moves CVS Health closer to realizing the substantial synergies and value expected from the combination.

About CVS Health
CVS Health is a pharmacy innovation company helping people on their path to better health. Through its more than 9,800 retail locations, more than 1,100 walk-in medical clinics, a leading pharmacy benefits manager with approximately 94 million plan members, a dedicated senior pharmacy care business serving more than one million patients per year, expanding specialty pharmacy services, and a leading stand-alone Medicare Part D prescription drug plan, the company enables people, businesses and communities to manage health in more affordable and effective ways. This unique integrated model increases access to quality care, delivers better health outcomes and lowers overall health care costs. Find more information about how CVS Health is shaping the future of health at https://www.cvshealth.com.

Investor Contact:
Mike McGuire
(401) 770-4050
michael.mcguire@cvshealth.com

Media Contact:  
Carolyn Castel  
Carolyn.Castel@CVSHealth.com  
401-770-5717

No Offer or Solicitation

This communication is for informational purposes only and not intended to and does not constitute an offer to subscribe for, buy or sell, the solicitation of an offer to subscribe for, buy or sell or an invitation to subscribe for, buy or sell any securities or the solicitation of any vote or approval in any jurisdiction pursuant to or in connection with the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.  No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.

Additional Information and Where to Find It

In connection with the transaction, CVS Health filed a registration statement on Form S-4 with the Securities and SEC, which includes a joint proxy statement of CVS Health and Aetna that also constitutes a prospectus of CVS Health.  The registration statement was declared effective by the SEC on February 9, 2018 (the “Registration Statement“), and CVS Health and Aetna commenced mailing the definitive joint proxy statement/prospectus to stockholders of CVS Health and shareholders of Aetna on or about February 12, 2018 (the “Joint Proxy Statement/Prospectus“) and the special meeting of the stockholders of CVS Health and the shareholders of Aetna was held on March 13, 2018.  INVESTORS AND SECURITY HOLDERS OF CVS HEALTH AND AETNA ARE URGED TO READ THE DEFINITIVE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER DOCUMENTS FILED OR THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION.  Investors and security holders may obtain free copies of the Registration Statement and the definitive Joint Proxy Statement/Prospectus and other documents filed with the SEC by CVS Health or Aetna through the website maintained by the SEC at http://www.sec.gov.  Copies of the documents filed with the SEC by CVS Health are available free of charge within the Investors section of CVS Health’s Web site at http://www.cvshealth.com/investors or by contacting CVS Health’s Investor Relations Department at 800-201-0938.  Copies of the documents filed with the SEC by Aetna are available free of charge on Aetna’s internet website at http://www.Aetna.com or by contacting Aetna’s Investor Relations Department at 860-273-0896.

Cautionary Statement Regarding Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 (the “Reform Act“) provides a safe harbor for forward-looking statements made by or on behalf of CVS Health Corporation (“CVS Health“) or Aetna, Inc.  (“Aetna“).   This communication may contain forward-looking statements within the meaning of the Reform Act.  You can generally identify forward-looking statements by the use of forward-looking terminology such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “evaluate,” “expect,” “explore,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “view,” or “will,” or the negative thereof or other variations thereon or comparable terminology.  These forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond CVS Health’s and Aetna’s control.

Statements in this communication regarding CVS Health and Aetna that are forward-looking, including CVS Health’s and Aetna’s projections as to the closing date of the transactions contemplated by the Agreement and Plan of Merger, dated as of December 3, 2017 (“Merger Agreement“), among CVS Health, Aetna and Hudson Merger Sub Corp., a wholly-owned subsidiary of CVS Health (the “transaction“), the extent of, and the time necessary to obtain, the regulatory approvals required for the transaction, the anticipated benefits of the transaction, the impact of the transaction on CVS Health’s and Aetna’s businesses, the expected terms and scope of the expected financing for the transaction, the ownership percentages of CVS Health’s common stock of CVS Health stockholders and Aetna shareholders at closing, the aggregate amount of indebtedness of CVS Health following the closing of the transaction, CVS Health’s expectations regarding debt repayment and its debt to capital ratio following the closing of the transaction, CVS Health’s and Aetna’s respective share repurchase programs and ability and intent to declare future dividend payments, the number of prescriptions used by people served by the combined companies’ pharmacy benefit business, the synergies from the transaction, and CVS Health’s, Aetna’s and/or the combined company’s future operating results, are based on CVS Health’s and Aetna’s managements’ estimates, assumptions and projections, and are subject to significant uncertainties and other factors, many of which are beyond their control.  In particular, projected financial information for the combined businesses of CVS Health and Aetna is based on estimates, assumptions and projections and has not been prepared in conformance with the applicable accounting requirements of Regulation S-X relating to pro forma financial information, and the required pro forma adjustments have not been applied and are not reflected therein.  None of this information should be considered in isolation from, or as a substitute for, the historical financial statements of CVS Health and Aetna.  Important risk factors related to the transaction could cause actual future results and other future events to differ materially from those currently estimated by management, including, but not limited to: the timing to consummate the proposed transaction; the risk that a regulatory approval that may be required for the proposed transaction is delayed, is not obtained or is obtained subject to conditions that are not anticipated; the risk that a condition to the closing of the proposed transaction may not be satisfied; the outcome of litigation related to the transaction; the ability to achieve the synergies and value creation contemplated; CVS Health’s ability to promptly and effectively integrate Aetna’s businesses; and the diversion of and attention of management of both CVS Health and Aetna on transaction-related issues.

In addition, this communication may contain forward-looking statements regarding CVS Health’s or Aetna’s respective businesses, financial condition and results of operations.  These forward-looking statements also involve risks, uncertainties and assumptions, some of which may not be presently known to CVS Health or Aetna or that they currently believe to be immaterial also may cause CVS Health’s or Aetna’s actual results to differ materially from those expressed in the forward-looking statements, adversely impact their respective businesses, CVS Health’s ability to complete the transaction and/or CVS Health’s ability to realize the expected benefits from the transaction. Should any risks and uncertainties develop into actual events, these developments could have a material adverse effect on the transaction and/or CVS Health or Aetna, CVS Health’s ability to successfully complete the transaction and/or realize the expected benefits from the transaction.  Additional information concerning these risks, uncertainties and assumptions can be found in CVS Health’s and Aetna’s respective filings with the SEC, including the risk factors discussed in “Item 1.A.  Risk Factors” in CVS Health’s and Aetna’s most recent Annual Reports on Form 10-K, as updated by their Quarterly Reports on Form 10-Q and future filings with the SEC.

You are cautioned not to place undue reliance on any CVS Health’s and Aetna’s forward-looking statements.  These forward-looking statements are and will be based upon management’s then-current views and assumptions regarding future events and operating performance, and are applicable only as of the dates of such statements.  Neither CVS Health nor Aetna assumes any duty to update or revise forward-looking statements, whether as a result of new information, future events or otherwise, as of any future date.

SOURCE CVS Health

Related Links

http://www.cvshealth.com