EOS imaging Appoints Pierre Schwich as Chief Financial Officer

Posted On July 17, 2017 By OrthoSpineNews In Financial, Top Stories /

July 17, 2017

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopaedic medical imaging, today announced the appointment of Pierre Schwich as Chief Financial Officer (CFO), effective immediately.

Marie Meynadier, CEO of EOS imaging, says: “We are pleased to welcome Pierre to our team. His extensive experience with healthcare and technology growth companies, listed in France and in the U.S., will contribute to the ongoing expansion of our business. He joins us at a key stage of our development and his skills will be extremely valuable as we execute on our growth strategy.”

Pierre Schwich brings over 20 years of experience in Financial Management at high growth, public and private companies in the healthcare and technology sectors. Before joining EOS imaging, he was CFO of Pharnext, where he successfully led the company’s initial public offering. He was previously Financial and Legal Director of Oceasoft, a company specialized in connected sensors, and CFO of Cellectis where he contributed to a private placement with U.S. investors. Pierre was also Deputy CEO, in charge of finances, of Genesys Conferencing, a public company listed in Paris and on the NASDAQ, with a strong activity in the U.S.

After graduating from the MinesParisTech Engineering School, Pierre began his career in the industrial sector (Corning, Danone, Hewlett-Packard) before turning to Private Equity, as Investment Director at 3i, then General Secretary of Siparex. He has developed an extensive experience in mergers and acquisitions, fund raising, LBO and business transfer operations, along with financial and administrative team management.

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

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Euronext GROWTH markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris

ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS^®, an innovative medical imaging system dedicated to osteo-articular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan and the European Union (EC). The Group posted 2016 revenues of €30.8 million and employs 132 people at December 2016, including an R&D team of 43 engineers. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Contacts

EOS imaging
Pierre Schwich
CFO
Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent
Ph: +33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
Press Relations
Annie-Florence Loyer
Ph: +33 (0)1 44 71 00 12 / + 33 (0)6 88 20 35 59
afloyer@newcap.fr
or
The Ruth Group (US)
Press relations / Joanna Zimmerman
Ph: 646-536-7006
jzimmerman@theruthgroup.com

Hundreds ensnared in Justice Department health-care fraud crackdown on $1.3 billion in false billings

Posted On July 14, 2017 By OrthoSpineNews In Regulatory, Top Stories /

By TERI SFORZA and TONY SAAVEDRA / July 13, 2017

A fake drug rehab in Palm Beach recruited addicts with gift cards, strip-club visits and even drugs, federal officials said Thursday, July 13, enabling the company to bill for more than $58 million in false treatments and tests.

It’s a scenario often repeated in Southern California, which was part of a massive crackdown on health-care fraud that netted hundreds of arrests across the nation Thursday, including charges against 115 doctors, nurses and licensed medical professionals, according to the U.S. Department of Justice.

Officials said it was the largest-ever health care fraud enforcement action by a Medicare Fraud Strike Force and involved the arrests of more than 400 people for alleged false billings totaling some $1.3 billion.

More than 120 of them were charged for prescribing and distributing opioids and other dangerous narcotics.

The names of all those arrested weren’t immediately available, and it did not appear that California was a primary focus of the action, despite recurring reports of fraudulent practices in Southern California’s large addiction-treatment industry.

In California, 17 people were charged with scheming to defraud Medicare of $147 million; and two of them were indicted for alleged involvement in a $41.5 million scheme targeting Medicare and a private insurer, the DOJ said.

The scheme involved submitting fraudulent claims – and receiving payments for prescription drugs – that were never filled by pharmacies or given to patients.

READ THE REST HERE

Stryker awarded $248.7 million in patent case against Zimmer

Posted On July 13, 2017 By OrthoSpineNews In Financial, Regulatory, Top Stories /

Nate Raymond / July 13, 2017

(Reuters) – A U.S. judge has increased the amount medical device maker Zimmer Biomet Holdings Inc must pay Stryker Corp for infringing patents on a surgical cleaning wand to $248.7 million following a ruling by the U.S. Supreme Court.

The ruling by U.S. District Judge Robert Jonker in Grand Rapids, Michigan, on Wednesday came after the Supreme Court in June 2016 ruled for Stryker in finding that judges should have more discretion to boost penalties in patent infringement cases.

Stryker declined to comment on Thursday. Zimmer did not immediately respond to a request for comment.

The ruling came in a lawsuit filed in 2010 by Kalamazoo, Michigan-based Stryker that claimed its competitor’s Pulsavac Plus device for cleaning wounds during orthopedic surgical procedures infringed three of its patents.

In 2013, a federal jury awarded Stryker $70 million in lost profits and found Warsaw, Indiana-based Zimmer’s conduct to have been willful.

Jonker later that year ruled Stryker deserved triple damages based on the “flagrancy and scope of Zimmer’s infringement.” With other fees, the award came to $228 million.

READ THE REST HERE

Paxeon Reconstruction Announces Successful 12-Month Clinical Follow Up and A Unique Value Solutions Program That Has Produced Over $1.3m in Savings

Posted On July 13, 2017 By OrthoSpineNews In Recon, Top Stories /

Paxeon Reconstruction, a manufacturer of best-in-class orthopedic products including derivative and emerging products, announces successful 12-month clinical data utilizing its Total Hip Arthroplasty (THA) system. Paxeon has partnered with some of the top Orthopedic Surgeons in the country and the results of the follow-up has shown Paxeon products to be easy to use and effective.

In today’s orthopedic environment, companies must not only provide quality products but also financially beneficial products. With that in mind, Paxeon Reconstruction has created a unique Value Solutions Program that has provided hospitals over $1.3m in savings through its first 12-months of clinical use. Physicians utilizing Paxeon’s THA system save on average $1,315.00 per case.

Dr. Kevin Pugh (Pikeville, KY) says “I have been using Paxeon Reconstruction’s Origin hip system for the past 14 months. During that time, I have successfully completed nearly 200 Total Hip Arthroplasties with the Origin stem and Logical acetabular cup with no implant failures or repeat operations. These implants have provided excellent outcomes for my patients. The instrumentation is very user friendly and easy for my staff to learn. My hospital is pleased with the excellent service provided by Paxeon, as well as the tremendous savings that Paxeon has provided on the implants. As a company Paxeon has been very good to work with, as they have been very receptive to my individual needs as a surgeon. I am extremely happy with their products and am excited to watch them grow as a world leader in total joint reconstruction innovation.”

Dr. Chris Christensen (Lexington, KY) added “I am continually impressed with the ease of insertion of the origin stem. Broaching is much less physically demanding than other bone removal broaching systems. Patient comfort postop is excellent. At one year and 300 stems, the hip has performed essentially perfectly.”

Due largely to the success of their product portfolio, Paxeon Reconstruction is advancing through high quality implants and a unique value proposition that offers unparalleled advantages for both the surgeons and their hospitals. Kyle Sineath, President of Paxeon Reconstruction says “It’s proof that improved clinical outcomes are available at a savings to physicians and facilities. By providing showing clinical outcomes and significant savings, Paxeon is positioned as the true leader in the valued solutions market.”

About Paxeon Reconstruction

Paxeon Reconstruction builds best-in-class orthopaedic products, including derivative and emerging products. We collaborate with hospitals, health systems and physicians to create alignment and utilization of value-based solutions combined with efficiency models for today’s changing healthcare environment. Paxeon Reconstruction offer the world’s most comprehensive portfolio of orthopaedic products and services for joint reconstruction. Paxeon Reconstruction has a celebrated clinical history, and has evolved to meet the needs of the changing orthopaedics marketplace. The history that weaves the fabric of the Paxeon Reconstruction is one that is rich with innovation and demonstrates sustained leadership in an ever-changing landscape of patient and professional needs.

ECA Medical Instruments Sees Major Gains & Market Adoption Of New Sterile-Packed, Disposable Instrument Kits for Orthopaedics

Posted On July 12, 2017 By OrthoSpineNews In Extremities, Top Stories /

July 12, 2017

Thousand Oaks, CA.—ECA Medical Instruments, the leading designer and manufacturer of single-procedure torque-limiting and fixed-driver surgical instruments and procedural kits for the medical industry and surgeons worldwide, has designed and produced sterile-packed, surgery ready disposable instrument kits for a wide range of trauma and extremity implants used by surgeons for fracture and joint degeneration repair.

Tailored to implant manufacturer specifications these kits are being rapidly adopted across the marketplace to reduce cost, eliminate reprocessing, improve patient safety and provide perfect fixation of implants while reducing risk of surgical site infection.

The fully disposable kits include the full complement of instruments needed by surgeons and OR teams including cannulated fixed drivers, torque limiters, cannulated countersinks and depth gauge instrument, drill guides, guide wires and drill bits. The cannulated instrument design permits minimally invasive surgery (MIS), which reduces OR time, blood loss and patient recovery times. All the instruments are packaged in sterile pack and fully disposable trays.

“We recently launched the industry’s first sterile-packed instrument set for securing cannulated titanium screws and also have deployed sterile pack kits and instruments for hand and wrist repair as well as joint arthroplasty and spine implant product lines,” said James Schultz, ECA’s executive vice president, sales & marketing.

ECA Medical Instruments Disposable Instrument Kits

“Single-use instrument kits coupled with sterile packed implants are clearly the way of the future for high volume and relatively low complexity orthopaedic surgeries in both the hospital and outpatient setting,” he said. “We’re excited to partner with major OEMs in the ortho and spine industry and bring these new instrument kits to market.

Single-procedure instruments and procedural kits are providing surgeons and patients alike with a pristine set of ready for surgery instruments for securing a wide range of medical device implants. Sustained benefits include elimination of reprocessing costs, improved OR efficiency, reduced risk of surgical site infection and reduction in hospital and ASC inventory management.

ECA is a one stop shop OEM instrument company providing implant firms with complete product design and development, product and packaging validations, CE Mark and dock to stock operations. This reduces OEM costs and accelerates time to market.

About ECA Medical Instruments

ECA Medical Instruments®, a LongueVue Capital Partners company, was founded in 1979 and located in Thousand Oaks, CA. ECA is the industry leader in single-procedure torque-limiting instruments and surgical fixation kits. The company has manufactured and delivered over 32 million precision torque instruments to the world’s leading producers of CRM, neuromodulation, cardiovascular and orthopaedic and spine implants resulting in over 500 million precision surgical actuations. Every 20 seconds of every day an ECA torque instrument or procedural kit is used to secure a medical implant—one patient at a time. ECA is an ISO 13485, CE Mark certified and FDA registered company and was named Business of the Year 2012 by the Pacific Coast Business Times. www.ecamedical.com

FIDIA PHARMA USA Inc. Continues to Expand U.S. Presence as Fidia Farmaceutici S.p.A. Leads European Orthopedic Biomaterials Market

Posted On July 12, 2017 By OrthoSpineNews In Biologics, Top Stories /

July 11, 2017

PARSIPPANY, N.J.–(BUSINESS WIRE)–Fidia Farmaceutici S.p.A., a world leader in the research, development and manufacturing of hyaluronan (HA)-based products, and its wholly owned subsidiary, FIDIA PHARMA USA Inc., are projecting continued growth in 2017. The global viscosupplementation market is anticipated to increase to over $2.64 billion by 2021, according to a research study by RnR Market Research¹.

Fidia Farmaceutici S.p.A. now leads the orthopedic biomaterials market in Europe after increasing its market share over the past few years. The largest segment of the biomaterials market internationally is HA viscosupplementation, to inject lubricating fluid into a joint. The company’s strong presence in the HA viscosupplementation market, with its product HYALGAN^®, and Fidia’s entrance into the German market have contributed to the expansion.

“Fidia is building upon its structure and experience to expand its business and strengthen its presence in the U.S. and globally,” said Aldo Donati, president, FIDIA PHARMA USA. “Fidia Farmaceutici has invested in research and development of hyaluronic acid-based products for more than 70 years. Today, Fidia is growing its product portfolio with new, innovative solutions to meet challenges in the field of osteoarthritis using science, our legacy and our drive.”

In the United States, FIDIA PHARMA USA Inc. offers HYMOVIS^® and HYALGAN^®, which are viscoelastic hyaluronan injection treatments for osteoarthritis (OA) knee pain that may help to delay total knee replacements².

More than 20 million Americans suffer from knee OA. By 2030, 20 percent of Americans over the age of 65 will be at risk for developing OA, according to the U.S. National Library of Medicine. The rise in OA of the knee diagnoses is reported to be attributed to an increase in life expectancy, obesity and sedentary behavior³.

The United States continues to hold the largest market share in the global viscosupplementation market. Growth is anticipated to be based off of the latest health care infrastructure, well-established reimbursement, aggressive marketing efforts on supply, and trends toward early intervention and demand for nonsurgical OA treatment.

HYMOVIS^® is a breakthrough in HA-based intra-articular (IA) therapy for the treatment of OA knee pain. Specifically engineered to fulfill a need of having a true viscoelastic hydrogel that is non-crosslinked and naturally derived from non-avian sources, HYMOVIS^®maintains enhanced properties of improved lubrication to decrease friction, exhibits greater elasticity in recovering its original structure even after repeated mechanical stresses, and demonstrates increased residence time in the knee joint*. HYMOVIS^® is delivered as an IA injection in a convenient two-dose regimen, with each injection given one week apart.

HYALGAN^® is a solution that contains a natural substance called hyaluronate, which is normally found in the fluid that lubricates and cushions the knee joint. HYALGAN^® is injected into the knee to relieve pain due to osteoarthritis. It is a five-injection regimen given at weekly intervals that provides long-lasting pain relief for up to six months. Some patients get benefits with three injections given at weekly intervals as reported in the published literature in which patients were followed for 60 days.

About FIDIA PHARMA USA Inc.

FIDIA PHARMA USA Inc. is a wholly owned subsidiary of Italian pharmaceutical manufacturer Fidia Farmaceutici S.p.A., an established leader in the hyaluronic acid market segment. FIDIA PHARMA USA Inc. is focused on expanding Fidia’s position in the U.S. and Canadian market, while upholding the company’s mission to provide consumers with innovative products that offer quality, safety and performance. FIDIA PHARMA USA Inc. is headquartered in Parsippany, N.J. For more information, please visit www.fidiapharma.us.

About Fidia Farmaceutici S.p.A.

Fidia Farmaceutici Fidia Farmaceutici is an Italian company founded in 1946 with proven expertise in Neuroscience, acquired over the years thanks to an activity of Research and Development unique in the Italian pharmaceutical scenario. It is also a top leading company in marketing products based on hyaluronic acid, which have many applications in the biomedical field, in areas such as rheumatology, orthopaedics, wound care, tissue repair and dermo-aesthetics, with worldwide leadership in viscosupplementation. Fidia Farmaceutici is part of the Milanese P&R Holding group. The company is well established in Italy, with R&D activities carried out both in Abano (where the company’s headquarter is located) and at the Research Unit in Noto (Sicily, Italy). The turnover will amount over 300 million Euros in 2017, of which 70% generated in international markets. Fidia Farmaceutici’s products are marketed in over 100 countries, through wholly-owned subsidiaries – in USA, Kazakhstan, Germany, Spain, Russia and the Middle East – and a comprehensive network of international partners and distributors. Thanks to its investment in R&D, it has managed to create a time-honored legacy of products, with over 900 patents to its name.

Indications: HYALGAN® and HYMOVIS® are indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g. acetaminophen).

Important Safety Information: HYALGAN® and HYMOVIS® are contraindicated in patients with known hypersensitivity to hyaluronate preparations or gram positive bacterial proteins (HYMOVIS® only) or patients with infections/skin diseases in the area of the injection site/joint. The safety and effectiveness of HYMOVIS® has not been tested in pregnant women, nursing mothers or children. See package insert for full prescribing information including adverse events, warnings, precautions, and side effects at www.Hyalgan.comand www.Hymovis.com. Rx Only

HYMOVIS^® and HYALGAN^® are registered trademarks of Fidia Farmaceutici S.p.A., Abano Terme, Italy. ©2017 FIDIA PHARMA USA Inc., Parsippany, NJ, a wholly owned subsidiary of Fidia Farmaceutici S.p.A. FID523-06.2017

*Data on file – Preclinical studies may not be indicative of human clinical outcomes.

Rx Only

¹ http://www.rnrmarketresearch.com/medipoint-viscosupplementation-global-analysis-and-market-forecasts-market-report.html

² Turajane T, Tanavaree A, Labpiboonpong V, Maungsiri, S. Outcomes of intra-articular injection of sodium hyaluronate for the treatment of osteoarthritis of the knee. J Med Assoc Thai. 2007;90(9):1845-1852.

³ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3612336/

Contacts

FIDIA PHARMA USA Inc.
Carolyn Kong, 1-973-507-5120
ckong@fidiapharma.us

K2M Group Holdings, Inc. Announces Long-Term Exclusive Distribution Agreement with Mitsubishi Corporation Subsidiary Japan Medicalnext Co., Ltd.

Posted On July 12, 2017 By OrthoSpineNews In Spine, Top Stories /

LEESBURG, Va., July 10, 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 signing of a new, long-term, exclusive agreement with Mitsubishi Corporation subsidiary Japan Medicalnext Co., Ltd., a wholly-owned entity of MC Healthcare, Inc. and a prominent supplier of medical devices in Japan, for the distribution of K2M’s innovative spinal technologies.

Pursuant to the agreement, Japan Medicalnext is the exclusive distributor of K2M’s spine products in Japan. The terms of the agreement include a long-term partnership of up to seven years. With more than 250 employees—including 50 orthopedic sales professionals—in seven offices located throughout the country, Japan Medicalnext has significant experience in medical device distribution, including the Japanese spinal surgery market.

“We are pleased to announce a new, long-term exclusive distribution agreement with Japan Medicalnext and look forward to this partnership enhancing our potential to increase our market share beyond our existing relationships in Japan’s estimated $300 million spine market,” said K2M President and CEO Eric Major. “We are excited that the management of Japan Medicalnext has a wealth of spine experience within Japan and are applying their market expertise with their established infrastructure to help grow our business in this region.”

In April, K2M secured registrations from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for several of its innovative products, including its MESA^® and EVEREST^® Spinal Systems, and will continue to seek additional product registrations over the next year.

For more information about K2M, visit www.K2M.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; in adequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; 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; 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.

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

Regenexx Announces Successful Merger with Harbor View Medical

Posted On July 12, 2017 By OrthoSpineNews In Biologics, Top Stories /

July 11, 2017

BROOMFIELD, Colo.–(BUSINESS WIRE)–Regenexx, a Colorado-based stem-cell-treatment network and pioneer in the invention of interventional orthopedics, today announced that it successfully merged with Harbor View Medical, a leader in orthopedic stem cell therapy and part of the Regenexx network, which became effective in May 2017. As part of the transition, Jason Hellickson has assumed the CEO role. This merger positions Regenexx to further expand its National Network to better serve patients and our corporate partners.

Regenexx Corporate will be headquartered in Des Moines, IA, while Regenexx’s Affiliate Program and Research and Development will be lead out of the company’s Broomfield, CO location. Dr. Christopher Centeno, founder of orthopedic stem cell treatments and leader of interventional orthopedics in the United States and pioneer of the Regenexx patented procedures, will continue his role as Chief Medical Officer and remain in clinic operations in Broomfield, and continues the advancements of regenerative medicine through the largest research and data collection effort in orthopedic regenerative medicine.

“As the most advanced non-surgical orthopedic care available in the United States, I’m excited to continue our mission to producing the best possible patient outcomes through interventional orthopedics,” said Jason Hellickson, CEO, Regenexx. “In addition to individual personalized care, we will continue to provide both employers and their employees with cost savings results and successful interventions to orthopedic surgery.”

Since joining the Regenexx Network in late 2014, Hellickson has reengineered clinic operations which increased capacity by more than 300 percent while offering a streamlined approach beneficial to both patients and clinic staff. He is the innovator and leader of the Regenexx Corporate Program that enables large employers access to the Regenexx procedures. Since adding Regenexx procedures to their self-funded health and workers’ compensation plans, corporate partners have saved as much as 83 percent in their orthopedic surgical expenses, totaling in the many millions of dollars. In his new role, Hellickson will continue to architect the Regenexx national clinical operations to create more streamlined approaches to patient care and expand Regenexx clinics nationwide.

“We look forward to continuing the build-out of Regenexx clinics, streamlining affiliate networks of more than 50 clinics nationwide, and adding additional clinics in major metropolitan areas including Chicago, Atlanta, Dallas, Philadelphia, and Charlotte under Jason’s helm,” said Christopher Centeno, MD. “We’re excited about the experience and enthusiasm that Jason brings to Regenexx.”

Regenexx is the world leader in interventional orthopedics using orthobiologics and has been issued many patents for it’s evidence-based stem cell and blood platelet treatments used for back pain, joint pain, arthritis and acute orthopedic injuries. The benefits of interventional orthopedics are so revolutionary that seventy percent of orthopedic issues currently treated with surgery could instead be handled using regenerative methods. Mesenchymal stem cells are multipotent, adult stem cells that are therapeutic agents in the repair and regeneration of muscle, tissue, cartilage and bone. Regenexx procedures use a patient’s own bone marrow-derived stem cells, or blood platelets, through a blood draw, to customize needle-based, precisely-guided procedures to treat common orthopedic conditions. Its procedures have been proven to have the same or better outcomes compared to their surgical alternative.

For more information on the Regenexx Corporate Program call: 888-547-6667. For general information on Regenexx, please visit www.Regenexxcorporate.com. For a map of current Regenexx clinics and providers click here.

About Regenexx and the Regenexx Physician Network
The Regenexx® Procedures are the nation’s most advanced non-surgical stem cell and blood platelet treatments for common joint injuries and degenerative joint conditions, such as osteoarthritis and avascular necrosis. These stem cell procedures utilize a patient’s own stem cells or blood platelets to help heal damaged tissues, tendons, ligaments, cartilage, spinal disc, or bone.

For more information on Regenexx, please visit: http://www.regenexx.com

Contacts

For Regenexx
Kaitlyn Ethier
kethier@matternow.com

VEXIM: Continued Growth and Adoption of the SpineJack® in Q2 2017

Posted On July 11, 2017 By OrthoSpineNews In Financial, Spine, Top Stories /

July 11, 2017

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News:

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces its consolidated sales results for the second quarter, as of June 30^th, 2017.

“VEXIM sales performance in the second quarter is in line with our expectations. VEXIM is growing substantially in all regions in Europe and around the world. We expect a strong growth of our business in the second half of the year, meeting our business objectives and aiming at financial break-even for the year 2017“, said Vincent Gardès, CEO of VEXIM.

Continued growth in the second quarter 2017

Revenues in millions of euros (IFRS, as of June 30^th)

Quarterly sales

Half-year sales

Region

Q2 2017

Q2 2016

Variation (%)

H1 2017

H1 2016

Variation (%)

Europe

5.0

4.2

+20%

9.3

7.9

+18%

International¹

0.7

0.4

+50%

1.0

0.7

+60%

Total

5.7

4.6

+23%

10.3

8.6

+21%

€5.7 million in sales, VEXIM continues to expand in all geographies

In Europe, VEXIM’s business continues to grow substantially reaching €9.3 million in the first half of 2017, representing a 18% growth compared to the same period in 2016. Since 2016, sales have increased in all countries and are progressing according to plan.

Outside of Europe, where quarterly sales increased 50% over the same period last year, VEXIM continues to see growing interest in the SpineJack® technology. As previously announced, VEXIM is in the process of launching SpineJack® products in Brazil and anticipates a continued strong growth in sales in the second part of 2017.

Financial reporting schedule:
2017 half-year results: September 14^th, 2017²

About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital³, and from OSEO public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the Masterflow^TM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 67 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on Euronext Growth Paris since May 3^rd 2012. For further information, please visit www.vexim.com

SpineJack®⁴, an innovative implant for treating Vertebral Compression Fractures
The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

Nom : VEXIM
Code ISIN : FR0011072602
Code mnémonique : ALVXM

¹ Cf. segment reporting applied since VEXIM switched to IFRS consolidated financial statements.
² Indicative date, subject to changes.
³ Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.
⁴ This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
Tel.: +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tel.: +33 1 44 54 36 66
Tel.: +33 6 48 82 18 94
vexim@alizerp.com

CrossRoads® Extremity Systems, LLC Announces Launch of the DynaFORCE™ Dynamic Compression Fixation System

Posted On July 11, 2017 By OrthoSpineNews In Extremities, Top Stories /

MEMPHIS, Tenn., July 11, 2017 /PRNewswire/ — CrossRoads^® Extremity Systems LLC., a privately held medical device company offering innovative foot & ankle fixation implant systems, announced that it has recently launched the first hybrid fixation system, DynaFORCE™. It represents the pinnacle of plate and nitinol clip fixation, featuring optimized dynamic compression, top loading insertion, and intraoperative placement flexibility with its unique implant and delivery instrument design.

Terrence Philbin, DO, from Columbus, OH, and Stuart Miller, MD, from Baltimore, MD were some of the first surgeons to use the new DynaFORCE system. Per Dr. Miller, “The plate and staple combination is brilliant. The exciting and innovative engineering of the implants and instruments has direct application to foot and ankle fixation.”

“The DynaFORCE system is very intuitive in the O.R.,” Dr. Philbin said. “The ability to use the dynamic compression staple in conjunction with a plate provides strong compression and stability. Another key benefit of nitinol fixation is the continuous compression you get after implantation. I look forward to utilizing DynaFORCE in multiple applications down the road.”

Designed to meet the needs of multiple applications in foot and ankle fixation, the DynaFORCE portfolio consists of a wide variety of plate and clip options that incorporate continuous adaptive compression.

Vernon Hartdegen, Co-Founder of CrossRoads, comments, “DynaFORCE represents our commitment to establishing a positive experience for foot and ankle surgeons and their patients. The early clinical results are exceptional, and the product adoption is rapidly accelerating. Early indications are that DynaFORCE will become the leading technology in foot and ankle fixation.”

DynaFORCE is currently wrapping up an alpha launch. Full US market availability is expected in August 2017.

About CrossRoads Extremity Systems

CrossRoads was founded in 2014 and is headquartered in Memphis, TN. CrossRoads has experienced rapid growth through creative product development and a strong distributorship network. CrossRoads’ goal is to provide a steady rhythm of novel and clinically relevant new products that distinguish us from other companies.

In addition to providing novel products, CrossRoads strives to find ways to help hospitals save money and improve efficiency. CrossRoads believes that as customers experience the EcoSMART™ model of using high quality, surgical grade instruments in sterile kits, and then realize the savings from instrument rebates; our EcoSMART Service will become the preferred model of surgeons, O.R. staff, and materials management.

For more information, please visit www.crextremity.com

Contact:
Vernon Hartdegen
SVP of Operations for CrossRoads Extremity Systems, LLC
pr@crextremity.com

SOURCE CrossRoads Extremity Systems, LLC.

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