VISEON, Inc. Announces FDA Clearance of the Voyant System for Minimally Invasive Spine Surgery Access, Visualization, and Illumination

October 18, 2018

IRVINE, Calif.–(BUSINESS WIRE)–Viseon, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their Voyant System for Minimally Invasive Spine Surgery, featuring proprietary HD imaging sensor and illumination technology. The Voyant System is composed of a sterile single-use, disposable retractor device with integrated state-of-the-art visualization technology, and a reusable controller enabling digital intraoperative manipulation of the surgical site image, displayed on existing operating room HD flat-panel display monitors. The sterile device also allows the surgeon to adjust intraoperative depth of focus.

Viseon President and CEO Jeffrey Valko stated, “We believe the primary factor contributing to spine surgeons’ slow adoption of minimally invasive spine surgery has been inconsistent outcomes driven by the limited or lack of direct access to and visibility of the surgical anatomy. Traditional capital-intensive surgical microscopes and loupes have been in use for many years, and Viseon is offering state-of-the-art technology as a simple alternative.”

John Liu, MD, professor of clinical neurological surgery at the Keck School of Medicine of USC commented, “This system offers an alternative to surgical microscope and surgical loupes visualization for many minimally invasive spine surgery procedures, eliminating ergonomic consequences and multiple scope repositioning maneuvers and refocusing. It also is useful teaching in the OR, since everyone can see and learn from the procedure.”

About Viseon, Inc.

Viseon has developed a platform technology that has multiple opportunities for technological expansion, including wireless, neuro-monitoring and navigation, fluorescence, sensor integration and complementary robotic applications. The company has demonstrated clinical utility in posterior lumbar decompression and interbody fusion procedures and is expanding into lumbar lateral access and anterior cervical decompression fusion applications. The privately held medical device company is located in Irvine, California, founded in 2017, and recently completed an oversubscribed follow-on financing in October 2018.

For further information, please visit www.viseon-spine.com.

Contacts

Viseon, Inc.
Jeffrey J. Valko, (949) 662-3959

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

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

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

Bioventus Receives ANVISA Approval to Market DUROLANE® in Brazil and Selects Pfizer as Exclusive Distribution Partner

October 02, 2018

HOOFDDORP, Netherlands–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, has received approval from Agência Nacional de Vigilância Sanitária (ANVISA) to market DUROLANE, its single-injection joint-fluid osteoarthritis (OA) treatment, in Brazil. ANVISA has approved DUROLANE for the symptomatic treatment of mild to moderate knee and hip OA. In addition, Bioventus has selected Pfizer as its exclusive distribution partner for the market.

OA involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissuesHyaluronic acid (HA)-based products like DUROLANE, help manage pain in the knees and hips of patients with OA.

Pfizer has more than 100 sales representatives throughout Brazil and will offer DUROLANE as part of its arthritis pain management portfolio which also includes CELEBRA®, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID).

“Brazil is the largest market for patients seeking osteoarthritis pain solutions in Latin America and one of the larger markets worldwide,” said Tony Bihl, CEO of Bioventus. “Introducing DUROLANE here gives patients and physicians access to a proven pain reliever for knee OA, expands the footprint of Bioventus and underscores our continuing efforts to bring orthobiologic solutions to patients around the world.”

“We are very pleased Pfizer is adding DUROLANE to its pain management portfolio for OA patients in Brazil,” said John Nosenzo, Chief Commercial Officer, Bioventus. “The company’s sales representatives have tremendous knowledge regarding osteoarthritis pain solutions. In addition, they have deep relationships with physicians and hospitals, making this a natural fit for Bioventus.”

DUROLANE is based on a natural, safe and proven technology process called NASHA®. This process yields stabilized (HA) which is a naturally occurring molecule that provides the lubrication and cushioning in a normal jointIt has been proven to provide greater reduction in OA knee pain versus Synvisc-One®1* and longer lasting pain relief versus a steroid injection2. DUROLANE is also safe for repeated courses of therapy. Repeated use of DUROLANE does not increase the incidence of adverse events.2,3

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, and DUROLANE are registered trademarks of Bioventus LLC. NASHA is a registered trademark of Nestle Skin Health s.a. CELEBRA is a registered trademark of Pfizer. Synvisc-One and Synvisc are registered trademarks of Genzyme Corporation.

Summary of Indication for Use: Symptomatic treatment of mild to moderate knee or hip osteoarthritis. There are no known contraindications. You should not use DUROLANE if you have infections or skin disease at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Risks can include transient pain, swelling and/or stiffness at the injection site.,Indications presented are those approved in Brazil; indications and product offerings vary by country. Consult with your local Bioventus representative for approved use within your region of interest. Full prescribing information can be found in product labeling, at www.DUROLANE.com.

References: 1. McGrath AF, McGrath AM, Jessop ZM, et al. A comparison of intra-articular hyaluronic acid competitors in the treatment of mild to moderate knee osteoarthritis. J Arthritis. 2013; 2(1):108. doi:10.4172/2167-7921.1000108. 2. Leighton R, Åkermark C, Therrien R, et. al. NASHA hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014; 22(1):17-25. 3. DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2017.

Contacts

Bioventus LLC
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

TransEnterix Receives CE Mark Approval for Senhance Ultrasonic Instrument System

October 01, 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 CE Mark approval for its Senhance Ultrasonic Instrument System.

Advanced energy devices, including ultrasonic devices, represent some of the most versatile and critical tools for surgeons in minimally invasive surgery. These instruments deliver controlled energy to effectively ligate and divide tissue, and minimize thermal injury to surrounding structures.

“Advanced energy devices are an important tool for laparoscopic surgeons because of their applicability within a wide range of procedures,” said Todd M. Pope, TransEnterix CEO. “We believe the addition of the Senhance Ultrasonic will help drive broader penetration of Senhance and help advance digital laparoscopy in Europe and other countries that accept CE Mark around the world.”

“Ultrasonic energy devices are critical tools in managing complex surgeries while minimizing bleeding and trauma to surrounding tissue,” said Prof. Dietmar Stephan, M.D., Head of Minimally Invasive and Robotic Surgery at St. Marien Hospital in Siegen, Germany. “In certain procedures, use of such advanced energy has become standard of care. The addition of this capability to the Senhance Digital Laparoscopic platform is a significant expansion of clinical applicability.”

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 the Senhance Ultrasonic Instrument System 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 Senhance™ Ultrasonic advanced energy capability will broaden the potential applicability of Senhance surgery in CE Mark countries, whether the Senhance Ultrasonic will help drive broader penetration of Senhance and help advance digital laparoscopy in Europe and other countries around the world that accept CE Mark, and whether the addition of the ultrasonic energy device to the Senhance Digital Laparoscopic platform is a significant expansion of Senhance’s clinical applicability. 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

Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology 3D-Printed Lateral Interbody Fusion System

REDLANDS, Calif. and AUSTIN, TexasSept. 26, 2018 /PRNewswire/ — Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera® X Lateral Interbody Fusion System.

Tesera X is the latest product to utilize Renovis’ proprietary 3D-printed porous architecture, which is made using additively manufactured titanium alloy, and features a low modulus, load-sharing design with a randomized pore structure to mimic cancellous bone. A 550-micron average pore size and 68% porosity combined with micro-surface roughness within the structure makes for an ideal environment for bone ongrowth and ingrowth.

Tesera X completes Renovis’ 3D-printed titanium interbody product portfolio, which also includes implants for ALIF, TLIF, PLIF, ACDF, and standalones. The company is hoping to take advantage of the recent consolidations in the spine market.

For more information on the Tesera porous structure, visit www.teseratrabeculartechnology.com, or visit the company website to learn about our systems for spine, total joint replacement and trauma applications at www.renovis-surgical.com.

About Renovis Surgical

Renovis Surgical Technologies, Inc. was founded in 2009 with the mission to be a leading manufacturer of advanced medical devices, striving to continuously exceed customer expectations in service, quality, reliability, and value. The company is headquartered in Redlands, California, with engineering & manufacturing operations in Austin, Texas.

For additional information on the Company, please visit www.renovis-surgical.com.

Media Contact: sales@renovis-surgical.com, 1 (800) RENOVIS

SOURCE Renovis Surgical Technologies, Inc.

Related Links

http://www.renovis-surgical.com

Stryker announces 510(k) clearance of SpineJack® Implantable Fracture Reduction System

KALAMAZOO, Michigan, USA, Sept. 26, 2018 /PRNewswire/ — Stryker announced today that it has received FDA 510(k) clearance to market the SpineJack Implantable Fracture Reduction System.  The SpineJack system is indicated for use in the reduction of painful osteoporotic vertebral compression fractures.

In the SAKOS clinical study, the SpineJack system demonstrated superiority to balloon kyphoplasty (BKP) for the endpoints of freedom from adjacent level fracture and midline vertebral height restoration.  The SpineJack system also showed substantial and sustained improvement in both pain (VAS) and function (Oswestry Disability Index) over BKP.

Available in three sizes to accommodate different vertebral body sizes, the SpineJack titanium implant is inserted and expanded, and PMMA bone cement is injected at low pressure to stabilize the restored vertebral body.

The SpineJack system has been commercially available in Europe since 2008 and over 70,000 units have been implanted worldwide.  The company plans to execute a limited launch of the device for the remainder of 2018.

For more information, please visit Stryker’s booth #1401 at the annual meeting of the North American Spine Society in Los Angeles September 26th– 29th, or at www.stryker.com.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

Media contact
Jennifer Lentner 
jennifer.lentner@stryker.com

SOURCE Stryker

Related Links

http://www.stryker.com