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K2M Group Holdings, Inc. to Release Second Quarter of Fiscal Year 2018 Financial Results on August 1, 2018

Posted On July 2, 2018 By OrthoSpineNews In Financial /  

LEESBURG, Va., July 02, 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 that second quarter of fiscal year 2018 financial results will be released after the market close on August 1, 2018.

Management will host a conference call at 5:00 p.m. Eastern Time on August 1, 2018 to discuss the results of the second quarter, and to host a question and answer session. Those who would like to participate may dial 866-393-4306 (734-385-2616 for international callers) and provide access code 4666247 approximately 10 minutes prior to the start of the call. A live webcast of the call will also be provided on the investor relations section of the Company’s website at http://Investors.K2M.com/.

For those unable to participate, a replay of the call will be available for two weeks at 855-859-2056 (404-537-3406 for international callers); access code 4666247. The webcast will be archived on the investor relations section of the Company’s website.

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 in 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 and hospital customers the merits of our products and to retain their use 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 payers; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to maintain adequate working relationships with healthcare professionals; 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 to our corporate headquarters and operations facilities or critical information technology systems or those of our suppliers, distributors or surgeon users; 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 remediate the material weaknesses in our IT general controls; 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 associated with the exit of the United Kingdom from the European Union; 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 a fiscal 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; 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 price; our lack of current plans to pay cash dividends; 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.

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SeaSpine Names Names Dennis L. Cirino Senior Vice President, Spinal Systems

Posted On July 2, 2018 By OrthoSpineNews In Spine, Top Stories /  

CARLSBAD, Calif., July 02, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced that it has appointed Dennis L. Cirino to the newly created position of Senior Vice President, Spinal Systems, effective immediately.

Mr. Cirino brings over 25 years of spine industry experience with numerous leadership roles in sales and marketing.  Prior to joining SeaSpine, Mr. Cirino spent eight years at NuVasive, Inc., where he served in roles of increasing seniority, most recently serving as vice president of market development for computer-assisted surgery. Prior to NuVasive, Mr. Cirino spent ten years at Medtronic, where he held senior marketing, development and marketing services positions focused on spinal systems, biologics, and pain stimulation. Mr. Cirino holds a Bachelor of Science in Business Administration from Duquesne University and a Master of Business Administration from the University of Notre Dame.

As Senior Vice President, Spinal Systems, Mr. Cirino will lead all aspects of the Company’s spinal implants activities and initiatives.  In this capacity, he will set direction for product innovation and development, marketing services, surgeon and sales education, and international strategy.

“Dennis’ deep experience building robust marketing programs, implementing international strategy, and driving surgeon education will serve us well as we leverage our recently launched and increasingly differentiated products, which are critical to accelerating our revenue growth,” said Keith Valentine, president and chief executive officer of SeaSpine. “His strong relationships in the spine industry further strengthen our surgeon-centric approach to product innovation and mission to deliver cost effective solutions to improve the quality of patient lives.”

“SeaSpine’s focus on innovation and clinical value coupled with its increasing investment in medical education and training has positioned the company as the spine company of choice among both surgeons and distributors,” said Mr. Cirino.  “I am thrilled to join this outstanding team and look forward to contributing to their powerful vision.”

Inducement Awards
As an inducement to accepting employment with the Company, on June 30, 2018, the Compensation Committee of the Company’s Board of Directors approved a restricted stock unit award to Mr. Cirino with respect to 39,619 shares of SeaSpine common stock, as well as restricted stock unit awards to seven new, non-executive employees with respect to an aggregate of 6,660 shares of SeaSpine common stock.  The awards are being granted under SeaSpine’s 2018 Employment Inducement Incentive Award Plan, which was adopted on June 29, 2018, and provides for the granting of equity awards to new employees of SeaSpine.  The awards will be granted effective on the date SeaSpine files a registration statement registering the common stock underlying the awards, which filing is expected to occur this month, and will vest in substantially equal installments on each of the first three anniversaries of the grant date.  The awards are intended to comply with Nasdaq Marketplace Rule 5635(c)(4).

About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: Mr. Cirino’s ability to leverage the Company’s recently launched products to accelerate revenue growth and Mr. Cirino’s ability to strengthen the Company’s product innovation and ability to deliver cost effective solutions to improve the quality of patient lives.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients; the Company’s ability to attract new, high-quality distributors; pricing pressure; supply shortages; the Company’s ability to continue to invest in medical education and training, product development, and/or sales and marketing initiatives at levels sufficient to drive future revenue growth; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact
Lynn Pieper
(415) 937-5402
ir@seaspine.com

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Arthrosurface receives FDA Clearance of Patellofemoral WaveKahuna Arthroplasty System

Posted On June 29, 2018 By OrthoSpineNews In Regulatory /  

FRANKLIN, Mass., June 29, 2018 /PRNewswire/ — Today, Arthrosurface, Inc., a leading provider of minimally invasive, motion preserving joint restoration systems, announces their recent FDA 510(k) Clearance to market the Patellofemoral (PF) WaveKahuna Arthroplasty System. The PF WaveKahuna Arthroplasty System is a line extension to The Company’s previously cleared and commercially marketed family of HemiCAP® Patellofemoral & PF Wave Systems.

Shane Shankle, VP of US Sales expressed, “As a market leader in Patellofemoral Arthroplasty, we are very excited to round out our line with the PF WaveKahuna System. The larger implants will allow a surgeon to choose from a wide range of size offerings to better serve the patient’s needs and allow them to maintain their quality of life.”

The PF WaveKahuna restores the unique articular surface geometry of the Patella and Femoral Trochlea while maintaining the patient’s native anatomy. It’s innovative, extended lateral aspect and trochlear geometry is designed to address challenging Patellofemoral tracking and stability conditions as well as providing increased coverage of the trochlear groove. Furthermore, the novel patella design combines the clinical benefits of both the anatomic and dome patella implants from the PF Wave System. Additionally, the PF WaveKahuna femoral component is designed to mate with the currently marketed Arthrosurface PF Wave Fixation Component. The existing surgical technique is unchanged, with the addition of a superior ream step.

“The FDA clearance comes shortly after data recently presented at ESSKA confirmed significantly improved postoperative outcomes with high patient satisfaction and no progression of knee arthritis at 5 years follow-up. The timing could not be better,” said Dawn Wilson, VP of Quality & Regulatory.

About Arthrosurface: Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. Arthrosurface is the inventor and market leader in joint preservation with inlay arthroplasty. Our product offerings include joint preservation implants, instruments and orthobiologics. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 14 years. For more information, please visit our website at www.arthrosurface.com

 

SOURCE Arthrosurface, Inc.

Related Links

http://arthrosurface.com

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Catalyst OrthoScience Adds Brian K. Hutchison to Board of Directors as Executive Chair, Interim CEO

Posted On June 28, 2018 By OrthoSpineNews In Recon /  

June 28, 2018

NAPLES, Fla.–(BUSINESS WIRE)–Catalyst OrthoScience Inc., a cutting-edge medical device company focused on the upper extremity orthopedics market, today announced the addition of Brian K. Hutchison to its board of directors as executive chair. Hutchison will also serve as interim chief executive officer of the company until a permanent CEO is in place.

Hutchison replaces Robert M. Kaufman, who has served as chairman and CEO of Catalyst OrthoScience since August 2017.

“We are pleased to have Brian join our board and immediately step in as executive chair and interim CEO,” said Steven Goldberg, M.D., founder of Catalyst OrthoScience. “He brings a wealth of experience in orthopedics and executive leadership to our company at a critical stage of growth.”

“I am excited to join the Catalyst board of directors as executive chairman and interim CEO,” Hutchison said. “In the coming months I will be focused on assessing the company’s structure and filling the gaps on the leadership team, including recruiting a permanent CEO. I believe the Catalyst CSR™ Total Shoulder System is one of the best shoulder replacement technologies on the market today, and I look forward to continued sales growth as we expand our market presence.”

Hutchison brings more than 30 years of healthcare industry experience to the Catalyst OrthoScience board. Most recently, Hutchison retired after serving 15 years as CEO of RTI Surgical Inc. (NASDAQ: RTIX). At RTI Surgical, he grew annual revenue from $55 million to $300 million, positioning the company as a leader in advanced biologic products. As CEO, Hutchison successfully merged RTI Surgical with Tutogen Medical in 2008 and in 2013 acquired Pioneer Surgical Technologies. Over his tenure, he secured multiple rounds of financing that included a $25.8 million investment in 2002 and a $22.2 million investment in 2005.

Before RTI Surgical, Hutchison held various positions at Stryker Corporation, including serving as vice president of worldwide product development and distribution, senior vice president and chief operation officer of the Howmedica Osteonics Division and president of the Stryker Medical Division.

Hutchison currently serves on the board of directors of Zavation Medical Products and the University of Florida Research Foundation. He received a bachelor’s degree in accounting from Grand Valley State University and attended Harvard Business School’s Program for Management.

About Catalyst OrthoScience Inc.

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

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

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

Contacts

Catalyst OrthoScience Inc.
Brian K. Hutchison
bhutchison@catalystortho.com
or
Surgence Communications Strategies
Wendy Crites Wacker, APR, 352-494-2129
wendy@surgencecs.com

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Episurf Medical submits IDE application to the US FDA for the Episealer® knee implant

Posted On June 28, 2018 By OrthoSpineNews In Regulatory /  

JUN 28, 2018

Episurf Medical (NASDAQ: EPIS B) today announces that the company has reached an important milestone on its strategy to reach the US market. The Investigational Device Exemption (IDE) application that the company has been working on is ready for filing. The application will now be filed to the US Food and Drug Administration (FDA) prior to the end of the second quarter.

An approved IDE allows a medical device to be used in a clinical study in order to collect safety and effectiveness data for submission to the FDA. Episurf Medical is filing the IDE application for the Episealer® knee implant to get approval to initiate a clinical study in the US. The IDE must be approved by the FDA before the study is initiated.

“Episurf has performed thorough work to get the extensive submission package in place. The Episealer® technology is gaining a lot of interest among the potential study investigators and we are continuing the work of getting sites ready for participation” comments Dr. Mike Kelly, Special US Study Advisor to Episurf Medical.

“We are looking forward to getting feedback on the study design from the FDA and continue the constructive dialogue we have had with the FDA in the preparatory phase. We are eager to take the next steps towards the US market and this is a very important milestone in that respect. I think the pieces are falling in place for us. Simultaneously as we are executing on a very clear regulatory strategy in the US, we have a growing business in Europe, where we also have a high level of activity when it comes to clinical activities. Our strategy is very clear, the clinical results are very strong, and this is such an important step. Finally, I am very proud of the team that delivered this in time, it’s been a lot of hard work behind this” comments Pål Ryfors, CEO, Episurf Medical.

For more  information, please contact:

Pål Ryfors, CEO, Episurf Medical

Tel:+46 (0) 709 62 36 69

Email: pal.ryfors@episurf.com

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalised treatment alternatives. Episurf Medical’s Episealer® personalised implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CEST on 28 June 2018.

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Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology™ Hyperlordotic ALIF Interbody Spinal Fusion System

Posted On June 28, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

REDLANDS, Calif. and AUSTIN, Texas, June 28, 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® SA Hyperlordotic ALIF Interbody Spinal Fusion System.

Tesera SA is a porous titanium stand-alone anterior lumbar interbody fusion system featuring a four-screw design and a locking cover plate to prevent screw backout. Implants are now available in 7˚, 12˚, 17˚, 22˚ and 28˚ lordotic angles with varying heights and footprints for proper intervertebral height and lordosis restoration, along with advanced instrumentation designed to reduce operative steps.

All Tesera implants utilize additive manufacturing (3D printing) and a proprietary, patent-pending design to create a roughened, highly porous surface structure that allows for bone attachment and in-growth to the implant, maximizing strength, stability and biologic fixation. Renovis now offers multiple 3D-printed, porous titanium implant systems for interbody spinal fusion, including anterior cervical, anterior lumbar, as well as posterior lumbar options.

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.

(PRNewsfoto/Renovis Surgical Technologies)

Related Links

http://www.renovis-surgical.com

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EOS Imaging Announces First Private Practice Installation of an EOS® System in Germany

Posted On June 28, 2018 By OrthoSpineNews In Spine /  

June 27, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – PME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced the installation of an EOS® imaging system at ATOS Klinik Heidelberg, establishing it as first private practice in Germany to offer the low-dose 2D/3D imaging system.

The system will be available at the spinal surgery center, Zentrum für Wirbelsäulenchirurgie, a private practice led by Dr. Bernd Wiedenhöfer and Dr. Stefan Matschke, two specialists with 20 years of experience in spine therapy each. The practice specializes in non-surgical and surgical treatments of spinal disorders, providing diagnosis and therapy through cutting-edge medicine and state-of-the-art equipment, with an emphasis on patient safety.

“EOS imaging utilizes advanced scanning technology to allow ultra-low dose imaging of the entire body,” commented Dr. Wiedenhöfer. “Within a few seconds, the system provides a comprehensive overview of the patient in with up to 90% less radiation than a conventional X-ray and 100% reproduction of the ratios and angles. The resulting benefits for diagnosis and therapy of spinal pathologies are immense, and we are thrilled to now offer this vital technology.”

“Because the EOS® system provides a full-body 2D and 3D images, the patient can be assessed as a whole, which is not possible with a traditional X-ray,” added Dr. Matschke. “EOS® allows to accurately determine clinical parameters such as pelvic obliquity or sagittal disbalance, with valuable advantages for enabling physicians to provide the best treatment plans possible for our patients.”

“We have been working to expand the use of the EOS® system in private practices, which serve a significant patient population, as we feel it is important to also offer safe and effective imaging to patients outside the traditional hospital setting,” commented Marie Meynadier, Chief Executive Officer of EOS imaging. “This installation is particularly important for EOS, as it is the first private practice to offer the system in Germany, a key market for us with notable precedent for adopting advanced technologies.”

About EOS imaging
EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 31 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 250 installed EOS® platforms representing around one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017.

For more information, please visit www.eos-imaging.com.

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

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Contacts

EOS imaging
Marie Meynadier
CEO
Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
Press Relations (US)
Joanna Zimmerman
The Ruth Group
Ph: 646-536-7006
jzimmerman@theruthgroup.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
The Ruth Group
Ph: 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com

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NanoFUSE Biologics LLC Appoints Experienced Orthobiologics Executive Archie Yamada to Accelerate Global Revenue Growth

Posted On June 27, 2018 By OrthoSpineNews In Biologics, Top Stories /  

BOSTON (PRWEB) JUNE 27, 2018

NanoFUSE Biologics announced the addition of executive Archie Yamada to the team, a trained sales and marketing professional with 19+ years in the medical device industry with a focus on orthobiologics, orthopedic trauma/joints, and neurosurgical and craniomaxillofacial implants. He joins the NanoFUSE team as VP Product Business Development.

“Throughout my career, I’ve been heavily involved in the development and sales of orthopedic implants. While I enjoyed providing hardware implants to surgeons, what really motivates me is providing biologic solutions to meet patient needs,” said Yamada.

Yamada graduated with an MBA and honors in operations management from the University of Colorado, and a Bachelor of Arts in economics from Brigham Young University. He previously held positions as the Clinical Sales Director for Biologics & Cellular Technology at OsteoMed, Regional Sales Manager for Western U.S. & Canada at Skeletal Kinetics, Consultant and Regional Distributor for DePuy Synthes, as well as Asia Pacific and U.S./EU Sales Manager for Japan Medical Dynamic Marketing and Ortho Development respectively.

“With NanoFUSE, I was offered the opportunity to collaborate with a team dedicated to supplying cutting edge osteopromotive synthetics. Although this itself is interesting, upon learning NanoFUSE’s direction of not only staying at the forefront of cellular technology, but advancing and defining the biologics of tomorrow, I was ‘all in,'” said Yamada.

The NanoFUSE Biologics platform has the only FDA cleared combination of demineralized bone matrix (DBM) and synthetic bioactive glass technology, providing both osteoinductive and osteoconductive properties. The NanoFUSE DBM putty has been used successfully in +1000 cases by +200 surgeons in various orthopedic applications.

“The NanoFUSE acquisition was a strategic addition to our orthopedic and spine portfolio to provide surgeons a comprehensive product offering. Archie’s leadership is timely as we focus on accelerating revenues and establishing distribution in the U.S. and overseas. We expect strong market demand to continue with attractive returns for our investors, and are encouraged by the recent partnership by DePuy Synthes for Prosidyan’s FIBERGRAFT synthetic product,” said KICVentures Managing Partner & CFO Aditya Humad. NanoFUSE Biologics LLC is a KICVentures portfolio company.

About NanoFUSE Biologics LLC

The NanoFUSE Bioactive Matrix is a unique and proprietary blend of demineralized bone matrix (DBM) that combines the osteoinductive capabilities of DBM with the osteostimulative properties of bioactive glass. NanoFUSE Biologics LLC is a KICVentures portfolio company, distributed by SpineFrontier.

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GS Medical Announces New Product Launch and Successful Cadaver Workshop

Posted On June 27, 2018 By OrthoSpineNews In Spine /  

IRVINE, Calif., June 27, 2018 (GLOBE NEWSWIRE) — GS Solutions Inc., DBA GS Medical USA (GSM), a leader and innovator of surgeon-driven spinal technology that advances patient care, today announced the launch of the AnyPlus® Extended Tab Minimally Invasive Pedicle Screw system.

The AnyPlus® Extended Tab Minimally Invasive Pedicle Screw System was engineered to offer a less invasive surgical option for pedicle screw placement. The system incorporates anatomically driven solutions and ergonomic designs that allow for a simple, precise and efficient solution to spinal fixation, adding benefits to minimally invasive approach with less OR time.

“Getting the right feedback and insight from surgeon partners is at the forefront of our research and development,” Andrea Watt, Product Development Manager said. “We believe surgeons can drive engineering to develop cutting edge implants and instrumentation that continue to revolutionize the spine industry because they have the right experience and insight for the products and procedures.”

Succeeding the Q4 2017 launch of the AnyPlus® Direct Lateral Interbody Fusion system and the Anterior and Posterior Disc Prep Sets, both of which are currently being used successfully in surgeries, GSM experienced a strong start to the year with sales growth in Q1 2018 versus Q1 2017.

“As we continue to expand our portfolio of spinal solutions with innovative technology and build out a robust national distributor network, we expect to see solid, positive growth throughout the remainder of 2018,” said James Shin, CEO.

To complement the company’s expanding portfolio of solutions, GSM hosted a cadaver lab and bioskills course in early May in Las Vegas. The course featured presentations by current GSM surgeon users, and attendees were provided with technical, hands-on training on the various systems offered by GSM. The surgeons who attended expressed positive feedback on both the DLIF and percutaneous systems, as well as the strategic direction of the company.

“Given the rapid expansion of our portfolio of solutions, we recognize the continued need to partner with our surgeons and distributors to provide expert instruction on our spinal systems,” said Kurt Neesley, U.S. Sales and Business Development Director.

“We are committed to a platform for multi-faceted surgeon education, and we value the opportunity to collaborate with surgeons in a cadaveric setting,” Kurt said. “We look forward to working with surgeons and distributor partners to improve patient care with our new and advanced products and technology.”

GSM leadership and sales representatives plan to exhibit at NASS, September 26-29. To schedule a meeting with the team or to inquire about distributor partnership opportunities, please contact sales@gsmedicalusa.com.

Media Relations Contact:
Amanda Collins
I Phone: 949.380.6385 x213
FAX: 866.600.9712
6 Wrigley
Irvine, CA 92618
www.gsmedicalusa.com
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Ambulatory Services Market Size Worth USD 4,099.6 Billion by 2025: Grand View Research, Inc.

Posted On June 27, 2018 By OrthoSpineNews In Financial /  

SAN FRANCISCO, June 27, 2018 /PRNewswire/ —

The global ambulatory services market is expected to reach USD 4,099.6 billion by 2025, according to a new report by Grand View Research, Inc. Increase in the availability of technologically advanced products, increase in the incidence of chronic diseases, growth in ageing population, and technological advancements in surgeries to reduce cost & treatment time are among key factors likely to drive the market during the forecast period.

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Ambulatory services are likely to witness high growth in the coming years due to increase in the number of surgeries, the availability of private & public funding, as well as the availability of same-day surgeries at low cost to offer better medical services. According to Healthcare Cost and Utilization Project (HCUP), in 2014, 17.2 million surgeries were performed in ambulatory surgical settings and 22 million surgeries in hospital outpatient settings. In addition, various mergers & acquisitions are anticipated to propel the market. For instance, in December 2015, Premier Emergency Medical Specialists was acquired by AmSurg. This acquisition was expected to help AmSurg enter the emergency medicine specialty.

Technological advancements pertaining to diagnosis and minimally invasive surgeries are likely to reduce complications and help shorten hospital stays. Homecare via e-visits and telehealth solutions have become viable components of ambulatory care. For instance, in January 2017, Arterys, Inc. received FDA approval to commercialize Arterys Cardio DL, the first technology that uses a cloud-based deep learning algorithm for cardiac imaging.

Browse full research report with TOC on “Ambulatory Services Market Size, Share & Trends Analysis Report By Type (Primary Care Offices, Emergency Departments, Surgical Specialty, Medical Specialty), By Region, And Segment Forecasts, 2018 – 2025“ at: https://www.grandviewresearch.com/industry-analysis/ambulatory-care-services-market

Further Key Findings From the Report Suggest:

  • Increase in government expenditure for the development of ambulatory facilities to increase accessibility and reduce treatment cost is expected to propel the market
  • Primary care offices accounted for the largest share of the market in 2016 due to cost-effective treatment and easy accessibility for diagnosis & treatment
  • Surgical specialty is anticipated to be the fastest-growing segment in the forecast period due to increase in the demand for minimally invasive procedures. In addition, the preference of patients for nonsurgical and minimally invasive surgeries has led to the growth of plastic surgery centers. According to American Society of Plastic Surgeons, in 2016, 7.6 million cosmetic procedures were performed on people aged between 40 and 54 years. In 2016, United Nations spent more than 15 billion dollars on esthetic surgical and nonsurgical procedures
  • Based on the region, North America held the largest market share and is expected to retain its dominance during the forecast period due to increase in the number of advanced diagnostic methods and rise in the number of cases related to orthopedics, ophthalmology, gastroenterology, plastic surgery, and chronic pain
  • The Asia Pacific region is likely to witness significant growth over the next decade due to increase in the incidence of angle closure glaucoma & myopia, increase in life expectancy, and growth in recognition of the need to develop emergency care outside traditional hospital settings
  • Some of the key players are Surgery Partners; Envision Healthcare; IntegraMed America, Inc.; Symbion, Inc.; Terveystalo; NueHealth; Aspen Healthcare; and Medical Facilities Corporation

Browse related reports by Grand View Research:

Grand View Research has segmented the global ambulatory services market based on type and region:

  • Ambulatory Services Type (Revenue, USD Million, 2014 – 2025)
    • Primary Care Offices
    • Emergency Departments
    • Surgical Specialty
      • Ophthalmology
      • Orthopedics
      • Gastroenterology
      • Pain Management/Spinal Injections
      • Plastic Surgery
      • Others
    • Medical Specialty
  • Ambulatory Services Regional Outlook (Revenue, USD Million, 2014 – 2024)
    • North America
      • U.S.
      • Canada
    • Europe
      • UK
      • France
      • Germany
      • Spain
      • Italy
      • Switzerland
      • Netherlands
      • Belgium
    • Asia Pacific
      • China
      • Japan
      • India
      • Australia
      • Thailand
      • South Korea
    • Latin America
      • Brazil
      • Mexico
      • Colombia
    • Middle East & Africa
      • South Africa
      • Saudi Arabia
      • United Arab Emirates

Explore the BI enabled intuitive market research database, The Grand Library, by Grand View Research, Inc.

About Grand View Research

Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of Californiaand headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.

Contact:
Sherry James
Corporate Sales Specialist, USA
Grand View Research, Inc.
Phone: +1-415-349-0058
Toll Free: 1-888-202-9519
Email: sales@grandviewresearch.com

Web: https://www.grandviewresearch.com

SOURCE Grand View Research, Inc.

 

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