K2M Introduces First-of-Its-Kind SAHARA™ AL Expandable Stabilization System

Posted On June 20, 2017 By OrthoSpineNews In Spine, Top Stories /

LEESBURG, Va., June 20, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance^™, today announced the introduction of the SAHARA^™ AL Expandable Stabilization System, the Company’s first expandable offering within its interbody portfolio. SAHARA AL is the only lordotic expandable interbody device with integrated screw fixation on the market to help achieve spinal balance.

The SAHARA AL Expandable Stabilization System represents a technological advancement over static interbody options, allowing for in-situ lordotic adjustment to match a patient’s sagittal profile through one fusion device. SAHARA AL is a zero-profile device with multi-screw fixation, designed to provide stability to the anterior column, while featuring a comprehensive range of lordotic adjustments of up to 26 degrees. It is indicated as a standalone device for lordotic angles of 15 degrees or less. SAHARA AL is manufactured from commercially pure grade II titanium, titanium alloy, and cobalt chrome.

“The anterior-lumbar interbody fusion (ALIF) approach allows for greater segmental lordosis correction and implant fixation than other alternative interbody approaches,” said Christopher Good, MD, FACS an orthopedic surgeon and Director of Scoliosis and Spinal Deformity at The Virginia Spine Institute in Reston, Virginia. “With variable in-situ lordotic adjustment, the SAHARA AL implant helps achieve sagittal balance and segmental reduction not generally attainable by ALIF cages with fixed lordotic angles.”

SAHARA AL features K2M’s innovative tifix^® Locking Technology, which offers benefits such as allowing repeated screw adjustment up to three times, without compromising the locking feature. In addition, SAHARA AL features a comprehensive offering of footprints and heights to best fit patient anatomy.

“The introduction of the SAHARA AL Expandable Stabilization System marks a significant addition to our interbody portfolio as our first expandable offering in this category and the only device of its kind on the market today,” said Eric Major, President and CEO of K2M. “This latest milestone—coupled with the launch of our comprehensive, next-generation Balance ACS^™ platform earlier this year—further reinforces our commitment to developing differentiated technologies with the goal of facilitating Total Body Balance.”

Balance ACS (BACS^™) is a comprehensive platform applying three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes in spine patients. 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.

For more information on the SAHARA AL Expandable Stabilization System and K2M’s complete product portfolio, visit www.K2M.com. For more information about Balance ACS, visit www.BACS.com.

About K2M

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

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in our industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due to sales of additional shares by our pre-IPO owners or otherwise; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

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

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

Media Contact: Zeno Group on behalf of K2M Group Holdings, Inc. Christian Emering, 212-299-8985 Christian.Emering@ZenoGroup.com Investor Contact: Westwicke Partners on behalf of K2M Group Holdings, Inc. Mike Piccinino, CFA, 443-213-0500 K2M@westwicke.com

ConforMIS Announces FDA 510(k) Clearance for iTotal Hip System

Posted On June 20, 2017 By OrthoSpineNews In Recon, Regulatory, Top Stories /

BILLERICA, Mass., June 20, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers knee replacement implants customized to fit each patient’s unique anatomy, today announced it has received FDA 510(k) clearance of the Company’s primary iTotal Hip replacement system.

“Having treated over 50,000 patients with customized knee replacement implants, ConforMIS brings over a decade of experience in patient-specific technology to the hip replacement market,” said Mark Augusti, Chief Executive Officer and President of ConforMIS. “FDA clearance of iTotal Hip demonstrates the ability to apply our proprietary iFit® image-to-implant technology to other joints. There has been a trend towards personalized healthcare and we believe patients expect and deserve personalized treatment.”

The ConforMIS iTotal Hip system features proprietary iFit technology similar to that used to design, manufacture and deliver customized knee implants. The system utilizes ConforMIS’s patient-specific technology, single-use 3D printed instruments and just-in-time delivery model to create a system that requires limited reusable instruments.

“Standard hip replacement surgery can be challenging, presenting risks of dislocation, discrepancies in leg length and limited reproducibility,” said Scott Ball, MD, Department of Orthopaedic Surgery, University of California, San Diego and a member of the iTotal Hip design team. “With the ability to achieve a better match to a patient’s own anatomy, the iTotal Hip system aims to address these shortcomings and improve patient outcomes.”

“We expect to leverage synergies with sales representatives, surgeons and hospitals upon limited launch, which is anticipated for 2019,” added Augusti. “We are excited about the opportunity iTotal Hip represents in expanding our product portfolio to address a broader orthopedic market with our proprietary technology.”

In the United States, approximately 400,000 hip replacements were performed in 2016. The global hip joint reconstruction market is projected at over $6B.

A photo accompanying this announcement is available at:

http://www.globenewswire.com/NewsRoom/AttachmentNg/a2f06ce1-6e8f-4f5e-b521-0a2f9b95aef4

Stryker announces definitive agreement to acquire NOVADAQ Technologies Inc.

Posted On June 19, 2017 By OrthoSpineNews In Financial, Top Stories /

By GlobeNewswire

Kalamazoo, Michigan – June 19, 2017- Stryker Corporation (NYSE:SYK) announced today a definitive agreement to acquire NOVADAQ Technologies Inc. (NASDAQ:NVDQ; TSX:NDQ) for US$11.75 per share, or US$701 million with a net purchase price of US$654 million, reflecting net cash of approximately US$47 million. NOVADAQ is a leading developer of fluorescence imaging technology that provides surgeons with visualization of blood flow in vessels, and related tissue perfusion in cardiac, cardiovascular, gastrointestinal, plastic, microsurgical, and reconstructive procedures. NOVADAQ was founded in 2000 and is headquartered in Mississauga, Canada.

“This acquisition aligns with Stryker’s focus on enabling our customers to see and do more by enhancing cross-specialty surgical visualization,” stated Timothy J. Scannell, Group President, MedSurg and NeuroTechnology. “NOVADAQ’S unique innovative technology complements Stryker’s advanced imaging portfolio and expands our product offerings into open and plastic reconstructive surgery. NOVADAQ’S innovative technology can reduce post-procedure complication rates and the cost of care for a broad variety of surgical treatments.”

“This transformative transaction recognizes the exceptional value we have built at NOVADAQ. Moreover, we believe it creates a strong opportunity for NOVADAQ, its customers, partners, shareholders, and employees,” said Rick Mangat, President and Chief Executive Officer of NOVADAQ. “I am proud of the impact our SPY and PINPOINT technology has made throughout the world in breast reconstruction and colorectal surgery, as well as other minimally invasive applications, and look forward to the additional progress we can make as part of Stryker’s organization.”

The transaction is structured as an arrangement under the Canada Business Corporations Act, subject to customary closing conditions, including approval by NOVADAQ’S shareholders and the Ontario Superior Court of Justice, the expiration or termination of the Hart-Scott-Rodino Antitrust Improvements Act waiting period and clearance under the Competition Act (Canada). The transaction is expected to close at the end of the third quarter and is expected to be dilutive to Stryker’s 2017 adjusted net earnings per diluted share by $0.03 – $0.05. There is no change to Stryker’s 2017 estimated adjusted net earnings per diluted share, which is in the range of $6.35 – $6.45. For 2018, this transaction is expected to be neutral to Stryker’s earnings and accretive thereafter.

Covington & Burling LLP and Osler, Hoskin & Harcourt LLP are serving as outside legal counsel for Stryker in connection with this transaction.

Forward-looking statements

This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for our products; changes in foreign exchange markets; legislative and regulatory actions; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; potential supply disruptions; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the ultimate total cost with respect to the Rejuvenate and ABG II matter; the impact of investigative and legal proceedings and compliance risks; resolution of tax audits; the impact of the federal legislation to reform the United States healthcare system; changes in financial markets; changes in the competitive environment; our ability to integrate acquisitions, including the acquisition of NOVADAQ; and our ability to realize anticipated cost savings. Additional information concerning these and other factors is contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

Contacts

For investor inquiries please contact:

Katherine A. Owen, Stryker Corporation, 269-385-2600 or katherine.owen@stryker.com

For media inquiries please contact:

Yin Becker, Stryker Corporation, 269-385-2600 or yin.becker@stryker.com

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Stryker Corporation via Globenewswire

Medicrea Announces FDA Clearance and Initial Experience with PASS® TULIP Top-Loading Fixation

Posted On June 16, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

June 16, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today that it has received FDA 510(k) Clearance and performed first surgeries with PASS^® TULIP top-loading fixation including world-first patient-specific hybrid constructs.

Top-loading fixation is the global standard for posterior spinal instrumentation. Medicrea’s PASS^® TULIP provides a procedurally-integrated solution for surgeons to benefit from the Company’s UNiD™ ASI technology, a scientific, data-driven model for personalized spine care. The PASS^® TULIP components are fully compatible with Medicrea’s PASS LP^® to provide a unique hybrid approach in complex indications. The first-ever patient-specific hybrid spine surgery was successfully performed by Dr. Frank Schwab, Chief of Spine, at the Hospital for Special Surgery in New York.

“By using two compatible implant designs in a hybrid application, I am able to personalize a patient’s operation in a whole new way. The increased flexibility and precision help me to best achieve the patient’s optimal spinal alignment targeted by Medicrea’s patient-specific implants,” stated Dr. Schwab, who uses UNiD™ ASI technology to strategically plan cases supported by the UNiD™ LAB team. “Having these additional tools to achieve my surgical strategy translates to better alignment post-operatively and that’s clearly been shown to correlate with patient satisfaction and with long-term benefits of surgery.”

Denys Sournac, President and CEO, stated, “We are pleased to extend our distinctive Lifetime Warranty covering UNiD™ Rod constructs to include associated PASS^® TULIP components.” Mr. Sournac continued, “The addition of PASS^® TULIP to our comprehensive implant range will open new doors for Medicrea to gain market share for our UNiD™ ASI technology by lowering the barrier to entry for the large number of surgeons trained on top-loading instrumentation.”

PASS^® TULIP components are differentiated from traditional top-loading implants by a thoughtful proprietary design that allows a single implant to perform multiple clinical functions through a simple one-step maneuver. The anticipated result is increased surgical efficiency in implant placement as well as a reduction in the inventory required for a case and associated processing costs.

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved implant technologies, utilized in over 100k spinal surgeries to date. Operating in a $10 billion marketplace, Medicrea is an SME with 160 employees worldwide, which includes 55 at its USA Corp. subsidiary in NYC. The Company has an ultra-modern manufacturing facility in Lyon, France, housing the development and production of 3D-printed titanium patient-specific implants.

By leveraging its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reducing procedural complications and limiting time spent in the O.R.

For further information, please visit: Medicrea.com.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
ALTERNEXT Paris
ISIN: FR 0004178572
Ticker: ALMED

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

rea-medicrea-5a4276cf1b952a23a2381b1b66a95324546377b474c62e264272afb9a3c02711.jpg

Medicrea Receives FDA Clearance for the UNiD™ HUB, a Data-Driven Digital Portal for Adaptive Spine Intelligence

Posted On June 16, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

June 16, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today that it has received 510(k) Clearance from the Food & Drug Administration for UNiD™ HUB, a data-driven digital portal for the Company’s Adaptive Spine Intelligence.

“It is our belief that data science and analytics are critical components of improved patient outcomes and efficiencies. For that reason, Medicrea has stepped into a space unoccupied by traditional device manufacturers: Software development and Artificial Intelligence,” stated Denys Sournac, President and CEO of Medicrea. “The UNiD™ HUB represents Medicrea’s ability to lead the Spine industry with breakthrough innovations by offering a unique forward-thinking and holistic approach to personalized spinal surgery.”

The UNiD™ HUB is designed to support the surgeon workflow, identify tendencies and correlations and build predictive modeling to drive intelligent strategic decisions and create personalized implant solutions for surgery. The UNiD™ HUB software also serves to enhance the existing proprietary IT utilized by Medicrea’s UNiD™ ASI platform for digital surgical planning to create a seamless communication channel between the Company’s UNiD™ LAB biomedical engineers and Surgeon users to deliver UNiD™ TEK, patient-specific spinal implants manufactured by Medicrea through proprietary rod bending and 3D printing techniques.

The digital communication portal opened with the introduction of UNiD™ HUB instantly creates a sticky, user-friendly environment for surgeons to track and manage their open cases in both snapshot and detailed views, access their complete history with post-operative analyses and dialogue with a dedicated biomedical engineer in real time. Future functionalities will become available alongside the software’s wide release planned in October of 2017, for Eurospine in Dublin, Ireland on the 11-13 October and at the annual meeting of the North American Spine Society, held 25-28 October in Orlando, Florida.

Mr. Sournac continued, “As a media tool for surgeons, we have received very positive feedback from our UNiD™ ASI customers who have seen beta versions of the software and we are now ready to make the UNiD™ HUB digital portal immediately available to them. The software integrates well with their clinical habits and enhances their experience with UNiD™ ASI technology.” Mr. Sournac added, “This new generation of software will be more than a communication tool for surgeons – It will grant surgeons access to the same data analytics and machine learning technology that is curated by our data scientists to use the UNiD™ HUB as an unparalleled research engine and networking platform.”

UNiD™ HUB has been developed in desktop and mobile applications and is accessible from medical offices as well as on the go. For a first look at the UNiD™ HUB, a video preview is available for viewing here.

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved implant technologies, utilized in over 100k spinal surgeries to date. Operating in a $10 billion marketplace, Medicrea is an SME with 160 employees worldwide, which includes 55 at its USA Corp. subsidiary in NYC. 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 ALTERNEXT Paris ISIN: FR 0004178572 Ticker: ALMED

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

Image Stream Medical and Olympus introduce MedPresence™, the first Virtual Medical Presence Solution for the Hospital Enterprise

Posted On June 16, 2017 By OrthoSpineNews In Financial, Top Stories /

CENTER VALLEY, Pa. and LITTLETON, Mass., June 12, 2017 /PRNewswire/ — Olympus Corporation of the Americas (OCA) and Image Stream Medical, Inc. today announced the medical industry’s first enterprise virtual presence solution, MedPresence™. The system enables surgical and interventional clinicians to virtually connect and collaborate in ways that have not been possible, practical, or cost-effective before.

Specifically designed to help improve the delivery of patient care, MedPresence™ provides real-time sharing of procedural imagery, applications, and in-room frame of reference to create a context-rich, immersive experience. The system is intended to empower surgical and care teams to quickly and securely connect to clinical specialists, technicians, trainers, or manufacturer’s representatives from across the organization or around the world, and at any time – virtually.

“Our mission at Image Stream Medical is about innovating to create simple ways for clinicians to connect with each other and sources of visual insight. Our flagship EasySuite® product helps improve the workflows of in-room clinicians by connecting them with imaging sources and patient information. MedPresence™ is the next step in care team efficiency improvement, allowing hospitals to assemble teams of experts, no matter where they are located,” said Eddie Mitchell, Image Stream Medical CEO. “Leveraging virtual experts elevates care team expertise, and protects the patient care environment by reducing room crowding, eliminating security and access concerns, and lowering a patient’s infection risk. And we’ve taken a great deal of care to ensure that all MedPresence™ participants can interact and communicate naturally with one another in the same kinds of ways that they would with an in-room colleague. We know that supporting natural ways of interacting is key to improving teamwork and efficiency.”

The release of MedPresence™ follows the June 1 acquisition of Image Stream Medical, Inc. by Olympus Corporation of the Americas. The completion of this acquisition, along with the release of MedPresence™, marks the start of new collaborations from the two companies.

“Directly on the heels of Image Stream Medical joining the Olympus family, the release of MedPresence™ is a testament to the strength of their innovation. We believe MedPresence™ has the potential to dramatically improve the efficiency and level of expertise of surgical teams by enabling hospitals to assemble highly collaborative teams with virtual experts to support a host of clinical and operational scenarios such as remote clinical consultations, tele-mentoring, care standardization programs, in-case application support, and new equipment training,” said Todd Usen, president, Olympus Medical Systems Group, United States. “We are delighted to have Image Stream Medical on board and look forward to continuing to improve both hospital efficiency and patient care through technologies like MedPresence™.”

Validated by an independent, nationally recognized security firm, MedPresence™ protects the integrity of sensitive information, featuring a fully encrypted, end-to-end security architecture. The patent-pending technology offers innovative features like automated masking of PHI, “on air” indicators, and one-button privacy mode enables real-time collaboration, while safeguarding patient and clinician privacy, as well as ensuring HIPAA compliance.

MedPresence™ and applications for advanced integration in procedure room environments will be on display in the Image Stream Medical booth #415 at the OR Manager Conference on October 2-4 in Orlando, FL.

About Image Stream Medical
Image Stream Medical is a leader in clinical visual collaboration solutions and focused on a single mission: to improve healthcare by connecting providers with the visual information and collaborative insight they need to deliver exceptional patient care. Since its founding in 1999, Image Stream Medical has achieved that goal by innovating healthcare environment integration solutions that make powerful capabilities easy to use. The result is a clinical workflow experience that is more intuitive, natural and efficient. Image Stream Medical, Inc. is a wholly owned subsidiary of Olympus Corporation of the Americas.

For more information, visit Image Stream Medical at www.imagestreammedical.com.

About Olympus Corporation of the Americas
Olympus Corporation of the Americas is a precision technology leader, designing and delivering innovative solutions in Medical and Surgical Products; Scientific Solutions; and Cameras and Audio Recorders. Our expertise in optical, digital and precision technologies provides the foundation for our innovations which look inside the human body to help prevent, diagnose and treat illness; further scientific research; and capture images of the world. Throughout our nearly 100-year history, Olympus has been recognized as a pioneer and innovator focused on contributing to society by making people’s lives healthier, safer and more fulfilling. Olympus Corporation of the Americas —a wholly owned subsidiary of Olympus Corporation in Tokyo, Japan—is headquartered in Center Valley, Pennsylvania and employs more than 5,000 employees throughout locations in North and South America.

For more information, visit Olympus at www.olympusamerica.com.

SOURCE Olympus Corporation of the Americas

SANUWAVE Appoints Interventional Concepts as Territory Sales Manager and Partner to Access Clinical Trial Participation in Colombia; Revenue Expected Before Year End

Posted On June 15, 2017 By OrthoSpineNews In Biologics, Top Stories /

SUWANEE, GA–(Marketwired – Jun 14, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company has appointed Interventional Concepts, Inc. to act as Territory Sales Manager for sourcing and screening of potential distributors and access to clinical trials participation for SANUWAVE’s products in Colombia.

André Mouton, V.P. International Sales and Relations of SANUWAVE, stated, “This decision to engage Interventional Concepts was made to increase our focus and visibility within South America. It is of the utmost importance that we partner with distributors that have influence and a good track record within the Colombian market. We also need speedy access to potential clinical trials to ensure we add value with our product offering as well as clinically proven outcome. These factors will lead to faster market entry and closer ties with identified Key Opinion Leaders (KOL’s),” concluded André Mouton.

Julio G. Martinez-Clark, Interventional Concepts’ CEO, stated, “Interventional Concepts is an ideal partner for SANUWAVE by providing regulatory and commercial support when introducing and expanding the company’s medical device portfolio in Colombia.”

“By partnering with Interventional Concepts, SANUWAVE will have access to a multidisciplinary team of life science professionals in Colombia that will facilitate SANUWAVE’s local market access efforts,” continued Mr. Martinez-Clark. “Our expertise in medical device clinical trials and commercialization, knowledge of the local market, and wide network of local contacts enable us to offer a wide range of services to forward-thinking companies like SANUWAVE. This partnership will allow SANUWAVE to successfully enter the market and achieve long-term growth and success in Colombia.”

SANUWAVE is using this occasion to further educate on our lead wound care product dermaPACE®. This Extracorporeal Shockwave Technology (ESWT) device, based upon electrohydraulic principles, is CE Marked and has enjoyed success in certain markets within the European Union treating a wide variety of skin conditions such as pressure ulcers, burns, post-operative wounds, and scar reduction. dermaPACE has been proven, in two US based clinical trials enrolling 336 subjects, to be safe and effective in the treatment of Diabetic Foot Ulcers. Within a few weeks of initial treatment, wounds treated with dermaPACE reduce in area at superior rates compared to control subjects. dermaPACE exhibits superiority in wound area reduction within 12 weeks of initial treatment and exhibits superiority in wound closure within 20 weeks of initial treatment. The use of dermaPACE allows the clinician to more easily, and more cost-effectively, manage wounds. More importantly, the patient’s quality of life improves significantly.

For more information on SANUWAVE’s technology, please read our blog, “Shock This”, on our website at www.sanuwave.com.

About Interventional Concepts, Inc.
Interventional Concepts is based in Miami, FL and was founded in 2010 by Dr. Pedro Martinez-Clark — an interventional cardiologist, an innovator, founder and advisor to MedTech companies — to help medical device companies conduct early-stage clinical trials and have access to the Colombian market. The company offers a wide range of market access services including market research and testing, product and trademark registration, regulatory legal representation, distributor search and selection, new entity set-up, and operations services for life science companies looking to enter and achieve long-term growth in Latin America — with a special focus on Colombia. Interventional Concepts has helped companies like Avinger, Mitralign, MitraSpan conduct clinical trials in Colombia; and companies like ClarVista Medical, CeloNova BioSciences, Abiomed, Volcano, and Mount Sinai’s Center For Personalized Cancer Therapeutics register their products and formulate a market access strategy in Colombia.

About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB: SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

CONTACT INFORMATION

Contact:
Interventional Concepts, Inc.
2520 Coral Way, Suite 2120
Miami, FL 33145 USA
Julio G. Martinez-Clark, CEO
jmclark@interventionalconcepts.net
+1 (954) 903-7210
www.colombiamarketaccess.com

Contact:
Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com
investorrelations@sanuwave.com

SANUWAVE Health, Inc.
Andre Mouton
Vice President International Sales and Relations
+1-615-823-9907 (Cell)
+1-678-569-0881(Fax)
Skype: andre.w.mouton
Andre.Mouton@sanuwave.com

Cretex Companies Acquires Leading Medical Packaging Services Provider

Posted On June 15, 2017 By OrthoSpineNews In Financial, Top Stories /

ELK RIVER, MN, June 13, 2017— Cretex Companies (www.cretex.com) today announced it has acquired Quality Tech Services (QTS), a supplier of outsourced packaging services to the medical device industry.

We are extremely pleased to have QTS join our Cretex Medical group of companies,” said Lynn Schuler, Chief Executive Officer of Cretex Companies, Inc. “QTS is widely recognized as a leading provider of validated assembly, kitting, and packaging solutions. Their experienced team, including packaging engineers and microbiologists, are experts in the end‐of‐line, critical processes that most companies don’t understand or do well. By adding QTS’s capabilities, we’ve made Cretex Medical an even better outsource partner for medical device companies.”

Located in Bloomington, MN, QTS specializes in cleanroom assembly, packaging and labeling, sterilization management, process development and validations, and material sourcing and supply chain management. They serve a broad set of Original Equipment Manufacturers (OEMs) in the orthopedic, neurology, pulmonary, dental, and other medical device markets.

Doug Wilder, President of QTS, said, “We’re very excited to become part of the Cretex Medical group. Medical device OEMs are increasingly looking for providers who bring end‐to‐end solutions. They are actively pruning their supplier base and rewarding those who can do more. Combining Cretex and QTS creates significant upside for our customers. Equally important, the combination will be great for our employees. The cultures of the two companies are very similar. Customer service, quality, and providing a positive work environment are values that we share. We’re anxious to get started.”

Terms of the acquisition were not disclosed.

About Cretex Companies, Inc.

Cretex, established in 1917, is a privately held, diversified manufacturing company headquartered in Elk River, Minnesota serving four major markets: medical, aerospace & defense, industrial, and infrastructure. Under the Cretex Medical brand, the company’s subsidiaries rms, rms Surgical, Meier, Spectralytics, JunoPacific, and QTS provide contract manufacturing and outsourcing services to medical device manufacturers (OEMs). Cretex Medical provides a full suite of capabilities, including precision machining, metal stamping and fabrication, laser processing, plastic injection molding, medical device assembly and cleanroom packaging. Cretex Companies employs about 2,000 people in 14 locations in Minnesota, California, Tennessee, and Wisconsin.

Contact Info

Katie Welch Len

612‐720‐9374

Email: katiep@newsworthycommunications.com

GE Additive and Stryker Announce Additive Manufacturing Partnership

Posted On June 15, 2017 By OrthoSpineNews In Spine, Top Stories /

June 14, 2017

BERLIN–(BUSINESS WIRE)–GE Additive (NYSE: GE) and Stryker have entered a partnership agreement to support Stryker’s growth in additive manufacturing. The agreement covers new additive machines, materials and services for Stryker’s global supply chain operations. The announcement was made at GE’s Minds + Machines event, GE’s premier industrial internet event dedicated to software, innovation and the sharing of the most powerful digital industrial outcomes.

“GE and Stryker share a similar vision and both of us understand the transformative power of additive design and manufacturing,” said Vice President and General Manager of GE Additive, Mohammad Ehteshami. “We regard Stryker as one of the most experienced practitioners of metal additive, with a range of commercialised medical products. We will continue to innovate with new additive products, materials, and technologies, which will support their growth.”

Stryker has already invested in Concept Laser and Arcam machines. The company’s investment in additive manufacturing began in 2001 and, since then, Stryker has collaborated with leading universities in Ireland and the UK to industrialize 3D printing for the healthcare industry. Stryker recently opened a global technology development center with an additive technology manufacturing hub in Carrigtohill, County Cork, Ireland. Additive manufacturing allows Stryker to address design complexity and achieve previously unmanufacturable geometries.

“Working with GE Additive and leveraging their expertise is a very compelling proposition for Stryker,” said John Haller, Vice President of Global Supply at Stryker. “We believe this collaboration will accelerate our additive manufacturing journey and support our mission to make healthcare better.”

For many years, GE has been a leading end user and innovator in the additive manufacturing space. In addition to the $1.4 billion investment in Concept Laser and Arcam, GE has also invested approximately $1.5 billion in manufacturing and additive technologies over the past 10 years, developed additive applications across six GE businesses, created new services applications across the company, and earned 346 patents in powder metals used in the additive process. In 2016, the company established GE Additive to become a leading supplier of additive technology, materials and services for industries and businesses worldwide.

GE Additive is part of GE (NYSE: GE) – the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. GE Additive includes additive machine providers Concept Laser and ArcamEBM; along with additive material provider AP&C and additive service provider to the medical industry, DTI. As a notable user of additive technologies GE recognize the value and potential it brings to modern design and manufacturing. GE is organized around a global exchange of knowledge, the “GE Store,” through which each business shares and accesses the same technology, resources and intellect. GE delivers better outcomes for customers by speaking the language of industry. www.geadditive.com

About Stryker

Contacts

GE Additive
Rick Kennedy, +1 513.607.0609
rick.l.kennedy@ge.com

SPINEWAY records a new $1M order in the USA

Posted On June 15, 2017 By OrthoSpineNews In Spine, Top Stories /

Press Release – Ecully, 14 June 2017

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), has obtained a new order via its California partner amounting to $1M.

This order, recorded by the Group’s US subsidiary, Spineway USA Inc., will be fulfilled in the next few weeks. It concerns the Mont-Blanc, Twin Peaks, Blue Mountain and Ayers Rocks product lines and shows US surgeons’ increasing interest in Spineway’s products.

With $3M in orders received in eight months, Spineway confirms the rise of its US subsidiary and reconfirms its ambition to generate a significant portion of its revenue from the US market.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLAN FOR SMES)
Find out all about Spineway at www.spineway.com

Next communication:
2017 First Semester Sales – 18 July 2017, after market closes

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), received the OSEO Excellence award as well as the Deloitte Fast 50 award in 2011. Rhône Alpes INPI Patent Innovation Award (2013) – Talent INPI award (2015).
ISIN code: FR0011398874 – ALSPW


*Investor Relations* David Siegrist – Finance Director Tel: +33 (0)4 72 77 01 52 finance.dsg@spineway.com		*Financial Communication* Jérôme Gacoin / Solène Kennis Tel: +33 (0)1 75 77 54 68 skennis@aelium.fr

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http://www.globenewswire.com/NewsRoom/AttachmentNg/8e361d3c-34b3-4ec1-9234-125a04d93c00

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