Author: OrthoSpineNews

FzioMed Announces 500,000 Units of Oxiplex® Shipped Worldwide

January 10, 2018

SAN LUIS OBISPO, Calif.–(BUSINESS WIRE)–FzioMed, Inc. a leading biomaterials company, is pleased to announce that Oxiplex sales have now passed the 500,000 unit mark.

Oxiplex is approved outside the United States in more than 70 countries and distributed under various brand names; including, Oxiplex, Oxiplex/SP, MediShield, and Interpose.

Oxiplex is an absorbable gel applied to neural tissues following spine surgery. Oxiplex creates a temporary physical barrier between adjacent tissues and has been shown in multiple peer reviewed studies to reduce leg pain, back pain, and neurologic symptoms.

“This milestone provides further evidence of the safety and effectiveness of Oxiplex in an ever increasing number of patients around the world,” said John Krelle, FzioMed’s President and Chief Executive Officer. “The fact that sales have continued to grow over many years in a real-world setting is a remarkable achievement and provides the impetus for our supportive FDA approved US IDE study. A large number of clinical sites around the country have expressed interest in the study, which will commence enrollment early this year.”

About FzioMed, Inc.

FzioMed, Inc. is a privately held medical device company that develops, manufactures and markets absorbable surgical biomaterials based on its patented scientific technology. For more information, please contact John Krelle at jkrelle@fziomed.com. You can also visit www.fziomed.com or contact investorrelations@fziomed.com.

FzioMed®, Oxiplex®, Oxiplex/SP® and Interpose® are registered trademarks of FzioMed, Inc.

Contacts

FzioMed, Inc.
John Krelle
jkrelle@fziomed.com

Bodycad Receives Medical Device License for Bodycad OnCall Personalized Cutting Guides

QUEBEC CITY, QUEBEC, CANADA, January 9, 2018 /EINPresswire.com/ — Bodycad announced today that it has received a Health Canada medical device license and clearance to sell the Bodycad OnCall™ personalized cutting guides. Bodycad is the first Canadian manufacturer to receive a license from Health Canada for a personalized orthopaedic bone resection device.

Bodycad’s OnCall Cutting Guide System is designed to optimize personalized restoration of difficult bone resection procedures such as deformity correction and oncology tumor resection. The system is based on proprietary 3D rendering of medical images of the patient’s anatomy. The device is delivered as a “procedure in box” that completely revolutionizes the way orthopaedic applications are delivered and utilized in the operating room environment.

“The personalized bone resection is created only after proper acquisition of data from the patient on an individualized level,” says Etienne Belize, MD, orthopaedic surgeon and assistant professor at Laval University. “The benefit of a personalized device is the possibility of a better fit to the individual, less trauma to the soft tissue, and potentially a faster recovery overall.”

Bodycad uses proprietary imaging algorithms to rapidly produce a precise 3D image of the patient’s anatomy. Its suite of Personalized Restoration Software enables a seamless integration of the image to personalized solution called the PREP (personalized restoration evaluation process). The efficient and rapid process is designed to increase patient satisfaction while improving economic quality metrics.

“Our proprietary software is based on 20 years of research in anthropometric data and has been specifically developed and optimized for personalization of orthopaedic surgical instruments, implants, and procedures.,” says Jean Robichaud, founder and CEO of Bodycad. “I am delighted to have Health Canada licensure and clearance to bring this important technological advancement to market. Our goal is to transform the way surgeons, patients and insurers think about the potential of mass customization to optimize patient care and bring True Personalization to the orthopaedic market place.”

About Bodycad

Bodycad is a Quebec City-based developer and manufacturer of personalized orthopaedics. Its personalized restorations offer patients a high level of conformity to their unique anatomy, with the potential for greater comfort, fit and durability that make the pursuit of orthopaedic perfection possible. Learn more at www.bodycad.com.

Andrew McLeod
Bodycad
4185271388
email us here

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Stimwave Inks $50 Million to Fuel Nationwide Consumer Launch of World’s Only Opioid-Free Pain Management Microchip Stimulator

January 10, 2018

POMPANO BEACH, Fla.–(BUSINESS WIRE)–Stimwave LLC, a medical device manufacturer and independent research institute headquartered in Pompano Beach, Fla., has agreed to over $50 million in additional financing from undisclosed investors to fuel the consumer launch of the world’s first wireless, micro-technology, drug-free neuromodulation device for relief of chronic pain.

Stimwave offers the world’s only wireless micro-sized device cleared by the FDA to treat chronic neuropathic pain throughout the body, from back and leg pain addressed by spinal cord stimulation to peripheral nervous system (PNS) treatment for shoulder pain, wrist and elbow pain, knee pain, hip pain and more, allowing more patients to be treated than ever before with a viable, affordable alternative to help fight opioid usage across the country.

Representing a life-changing technological breakthrough for the more than 400 million people worldwide who endure daily chronic pain, the Stimwave Freedom Stimulators are also the smallest neuromodulation devices available, at a volume size of 0.25 cc compared to the next smallest form factors at 25 cc and greater – 100 times the footprint of Stimwave.

As part of the launch, Stimwave will host a consumer event featuring Cory Everson, six-time Ms. Olympia and world-renowned health and wellness advocate, at the First Annual Medical Conference for Recovery, Regeneration, and the Athlete at the Arnold Classic Sports Festival, taking place March 1, 2018 in Columbus, Ohio.

“The key to Stimwave pain management is the ability to allow the pain sufferer to control their pain wherever and whenever they want,” said Laura Tyler Perryman, Stimwave chairman and co-inventor. “Now patients are in control of how to manage their pain opioid free with wearable and wireless iOS devices, including smart phones and watches. Stimwave is mobile and truly personal, fitting seamlessly into consumer’s lifestyles — whether commuting, playing with kids, or simply relaxing at home. With Stimwave they can take control of their pain.”

The technology, developed by scientists and engineers led by Perryman, uses a tiny injectable microchip device that delivers small pulses of energy to electrodes near surrounding nerves, triggering a reaction that enables the brain to remap specific pain signals, thus providing pain relief.

The Stimwave electroceutical device contains no internal batteries or other toxic materials and can be placed at any peripheral nerve throughout the body or in the spinal column nerve bundles. The Stimwave device is fixed in place by an anchor, so it doesn’t move except with the body’s movement. It naturally stays “in line” with the body’s nerves, allowing a freedom of motion that is impossible with bulkier implanted devices. The Stimwave device is a permanent, long-term implant. The system features the ability to allow the patient to have a whole body 3T or 1.5T MRI without removing the implant, which is unique in the industry.

Please visit www.stimwave.com for more information.

About Stimwave

Stimwave LLC is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, injectable, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management.

Contacts

Glodow Nead Communications
Evan Nicholson, Rosemary O’Brien, Kati Stadum, and Sarah Rogers
415-394-6500
StimwavePR@glodownead.com.

4WEB Medical Announces Record Sales Growth in 2017

DALLASJan. 10, 2018 /PRNewswire/ — 4WEB Medical, the industry leader in 3D printed implant technology, announced today that the company posted 57% year-over-year growth for the 2017 fiscal year.  In addition, 4WEB’s fourth quarter results eclipsed the largest quarter in the company’s history for revenue, units sold, surgeon users, and case volume.  This achievement marks an impressive performance trend of seven quarters of consecutive growth.

“4WEB continues to drive growth with portfolio enhancements and new surgeon adoption of its truss implant technology.  In 2017 we achieved an 84% increase in surgeon users with over 300 surgeons having used our implants nationwide,” said Geoffrey Bigos, 4WEB Medical’s Vice President of Spine Sales.  “This accomplishment was attributed to an expansion of our sales management team, the growth of our existing product offering, and significant investments in new product development.”

4WEB expects sustained growth in 2018 through continued adoption of its most recent product launches – a line of Hyperlordotic ALIF Implants and the Lateral Spine Truss System.  The company plans to further accelerate its commercial expansion strategy with two additional product launches this year, building upon the most comprehensive 3D printed implant portfolio on the market today. These high-impact product launches will include cervical and anterior lumbar implants with integrated fixation.

4WEB’s proprietary truss implant technology is an open architecture scaffold that uses the mechanics of the design to stimulate an osteogenic response in adjacent cellular material. The additive manufacturing process used to produce the proprietary implant line creates a hierarchical surface roughness that improves initial fixation, provides a stable environment for bone growth, and contributes to the osteogenic nature of the implant design.

Jim Bruty, 4WEB Medical’s Senior Vice President of Sales & Marketing added, “It is imperative to innovate products that solve clinical problems for surgeons and patients.  The advantages that the company’s truss implants provide, compared to the antiquated annular implant designs offered by our competitors, has been a driving factor in increased surgeon adoption and 4WEB’s 2017 growth.”

4WEB Medical is an implant device company founded in 2008 in Dallas, Texas. Thirty years of research in topological dimension theory led to the discovery of a novel geometry, the 4WEB, that can be used as a building block to create high-strength, lightweight web structures. The company leveraged this breakthrough along with cutting-edge 3D printing technology to develop 4WEB Medical’s proprietary truss implant platform. The 4WEB Medical product portfolio for spine includes the Cervical Spine Truss System, the Anterior Spine Truss System, the Posterior Spine Truss System, and the Lateral Spine Truss System. 4WEB is actively developing truss implant designs for knee, hip, trauma and patient specific orthopedic procedures.

For more information about 4WEB Medical, 4WEB’s Truss Implant Technology, and the Spine Truss Systems, please visit www.4WEBMedical.com.

SOURCE 4WEB Medical

Related Links

http://www.4webmedical.com

MCRA Assists SANUWAVE with Successful De Novo Decision: 3rd Wound Care De Novo Since 2010

WASHINGTONJan. 10, 2018 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) has announced its role in the successful de novo clearance by the U.S. Food and Drug Administration (FDA) on December 28, 2017 enabling SANUWAVE Health, Inc. to initiate commercialization of the dermaPACE System for the treatment of Diabetic Foot Ulcers (DFU) in the U.S.

SANUWAVE retained MCRA in January of 2015 to lead interactions and correspondence with the FDA for the dermaPACE. SANUWAVE withdrew a PMA submitted previously using data from the first DFU clinical study and recognized the need to enlist MCRA’s expertise. SANUWAVE’s Chairman of the Board and CEO, Kevin A. Richardson IIsaid, “We chose MCRA for their extensive regulatory experience and interaction with FDA over the past decade. They took clinical data from, essentially, a Not-Approvable PMA, and worked wonders in obtaining a de novo decision with basically the same clinical data. Their depth of knowledge and experience in regulatory and clinical science made them an excellent partner for working hand-in-hand with our team and the FDA.”

This significant achievement marks the third clearance of a de novo application for a wound care technology since 2010. Samuel Pollard, a Senior Regulatory Associate at MCRA, added “MCRA was excited to assist SANUWAVE on the strategy and execution of a viable US market solution to a unique regulatory challenge. MCRA’s US Regulatory and Clinical Research Organization (CRO) experience helped drive this device to a successful FDA decision. These successes demonstrate MCRA’s commitment to a surgeon-centric approach, which provides medical solutions that enable patients to regain a healthy lifestyle.”

About Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA)
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is the leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance. MCRA’s integrated approach of these key value creating initiatives, as well as orthopedic specialization, provides unparalleled expertise for its clients. MCRA has offices in Washington, DCManchester, CT, and New York, NY, and serves nearly 450 clients globally. MCRA has a demonstrated history of driving successful de novo and other regulatory submissions in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.

Contact

David W. Lown
General Manager
212.583.0250 ext. 2111
dlown@mcra.com

 

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

New Kleiner Spine Graft Delivery Tool Improves Outcomes for Patients, Surgeons, Hospitals and Payers

DENVERJan. 10, 2018 /PRNewswire/ — Kleiner Device Labs today announced full commercial availability of a new spinal bone graft delivery tool, the KG® 1, featuring a patented design that facilitates less-invasive procedures and has been proven in clinical testing to reduce spinal fusion failure rates by 68%1.

“In my own surgical practice, I was frustrated by unacceptable failure rates in spinal fusions and bad outcomes for my patients that were driven by existing graft delivery tools that jam, don’t distribute graft material to the right locations or quantity, or required excessive manipulation that creates soft tissue inflammation or damage. The round, end dispensing tools left me frustrated and with ‘am I done yet?’ questions,” said Jeff Kleiner, M.D., founder and CEO of Kleiner Device Labs.

“In testing, we found that the KG 1’s design solves all these problems, and use of the new tool, alone, improved my spinal arthrodesis rate from 75% to 92%1,” added Kleiner.

The benefits for patients include higher success rates and far fewer remedial second surgeries, less post-operative pain and infection risk, and less use of bone morphogenetic protein (BMP).

For surgeons, the KG 1 facilitates less-invasive procedures, faster surgeries, and reduces frustrations and guesswork in the OR.

Michael J. Rauzzino, M.D., of Front Range Spine and Neurosurgery in Denver, added, “I have found that I have been able to get a great deal more graft material into the disc space in a much more quantifiable and rapid fashion.  The delivery device has been very simple and easy to use and I have used it for both minimally invasive as well as in open applications.  It has been particularly helpful for me in the minimally invasive fusions we do, greatly increasing the amount of bone graft material that I have been able to get into the interspace.  I have also found it extremely helpful for our minimally invasive lateral approaches to the spine where due to the depth of the wound and the anatomy, it was difficult to get a good deal of bone graft into the interspace.”

Srdjan Mirkovic, M.D. of NorthShore Orthopaedic Institute in Chicago added, “Over the last five months in my T-lif and L-Lif operations, I have been able to expedite bone graft insertion for these procedures and avoid the problems that I encountered with round, end-dispensing bone funnels including cannula tip visualization, jamming, injury to the bony end plates of the disk space and failure to distribute bone graft in the disk space. I found that I was able to introduce more scaffold and cells and still have room for my fusion cage.  It has decreased my operating time, eliminated the frustration and challenge of interbody grafting and improved my early fusion results without using BMP.  It has worked well with all of the flowable graft extender and ground autograft that I have used.”

For hospitals and payers, facilitating surgeons’ use of the KG 1 can reduce the costs of spinal fusion surgery through reducing the number of remedial procedures, higher OR throughput and reduced use of BMP.

The patented KG 1 graft delivery tool includes a cannula, plunger and detachable funnel, which facilitates easier loading of graft material.  The KG 1’s unique shape allows easier entry into the disk interspace, minimizing soft tissue damage or irritation.  The bi-portal design ejects graft material to fill both sides of the disk space while leaving a central void for insertion of a fusion cage.  The KG 1 is disposable, guaranteeing sterility of the instrument and eliminating the system costs of cleaning and restocking.  Made of Lexan®, the KG 1 has been strength tested and proven beyond normal surgical applications.

The KG 1 is available commercially from the company and through authorized distributors, as well as to Veterans Administration and military healthcare facilities on the GSA schedule through Government Marketing & Procurement.

For KG 1 technical specifications, instructions for use, or clinical efficacy information, please go to the company’s web site.

Images of the KG 1 are available on Flikr,  here.

About Kleiner Device Labs
Kleiner Device Labs is creating new tools and devices to advance minimally invasive spine surgery and improve outcomes and costs for patients, surgeons, hospitals and payers.  Kleiner Device Labs is headquartered in Incline Village, California.  More information is available on the company’s web site at http://www.kleinerlabs.com/.

Lexan is a registered trademark of Sabic Global Technologies B.V.
KG is a registered trademark of Kleiner Device Labs/Spinal Surgical Strategies

1Kleiner, et. al., Med Devices and Tech, 2016

Media and Investor Contact:
Brad Samson
Kleiner Device Labs
brad.samson@kleinerlabs.com                                 
714.955.3951

 

SOURCE Kleiner Device Labs

Related Links

http://www.kleinerlabs.com/

Spine Industry Veteran Paul Graveline Joins Spinal Elements

January 10, 2018

CARLSBAD, Calif.–(BUSINESS WIRE)–Leading spinal solutions provider Spinal Elements today announced that Paul Graveline has joined the company as its Executive Vice President and Chief Commercial Officer. In his new role, Mr. Graveline will have responsibility for all of the commercial efforts of Spinal Elements.

“Paul is very well known in our industry and has a tremendous depth of experience in building and leading organizations,” said Jason Blain, President and CEO of Spinal Elements. “His leadership and experience will be an invaluable addition to our efforts as Spinal Elements continues to grow both in the United States and abroad. We are all very excited to have Paul on the Spinal Elements team.”

Mr. Graveline brings more than 20 years of experience in surgical spine technology. His past positions include Global Vice President of Sales for Zimmer Biomet Spine, Chief Operating Officer for Zimmer Spine, and Vice President of Sales for Stryker Spine.

“This is a talented group of people and the quality of the products is tremendous. With new expandable technologies, an interspinous process device, and a differentiated lateral access platform all launching this year, this is an exciting time to join Spinal Elements,” said Graveline, adding, “The technology we have available today combined with what is in our development pipeline makes this an amazing opportunity to create something special in our industry.”

About Spinal Elements

Spinal Elements is an outcomes-driven spinal surgical solutions company with locations in Carlsbad, CA and Marietta, GA. A leading designer, developer, manufacturer and marketer of innovative medical devices used in spinal surgical procedures, our mission is to combine leading medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. For more information, please visit www.amendia.com or www.spinalelements.com.

Contacts

for Spinal Elements
Laura Charlton (formerly Johnson)
(760) 450-7749 cell
laurajohnsonpr@yahoo.com

 

(Photo: Business Wire)

 

Globus Medical Reports Preliminary Fourth Quarter and Full Year Sales Results

AUDUBON, Pa., Jan. 09, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced preliminary unaudited sales results for the fourth quarter and full year ending December 31, 2017. The company anticipates fourth quarter 2017 sales of approximately $175.5 million, an increase of 15.8% over the fourth quarter 2016. Full year 2017 estimated sales are expected to be approximately $635.4 million, an increase of 12.7% over the prior year.

“We are very pleased to report record sales of $175.5 million for the fourth quarter, an increase of 15.8% over the fourth quarter of 2016,” said Dave Demski, Globus Medical Chief Executive Officer. “The growth in the quarter was 100% organic, as the anniversary of the Alphatec acquisition occurred in early September. US Spine sales continued the recent trend of mid-single-digit growth and our International business, led by Japan, showed significant improvement with 16.3% year-over-year growth. We are also encouraged by the strong robotic sales that contributed the rest of the growth in the fourth quarter. We are executing well in all aspects of our business and are excited by our prospects for 2018.”

“The recently announced tax legislation will lower our marginal income tax rates, providing additional cash to our business,” said Dan Scavilla, Senior Vice President and Chief Financial Officer, “We have made the decision to reinvest a portion of the anticipated savings by increasing our spending on Emerging Technologies by approximately $14 million in 2018, investing for long-term growth while still providing a meaningful lift in EPS to our shareholders.”

The company established full year 2018 guidance of $690 million in sales and fully diluted non-GAAP earnings per share of $1.50. This EPS guidance assumes a full year benefit of tax reform, renewed suspension of the medical device tax and increased investment in Emerging Technologies.

These preliminary results are unaudited and are based on management’s initial analysis of operations for the periods ended December 31, 2017, and are therefore subject to change. The company expects to announce its fourth quarter and full year 2017 financial and operating results in late February.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Non-GAAP Financial Measures
To supplement our financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), management uses certain non-GAAP financial measures. For example, non-GAAP adjusted EBITDA, which represents net income before interest income, net and other non-operating expenses, provision for income taxes, depreciation and amortization, stock-based compensation, provision for litigation, and acquisition related costs, is useful as an additional measure of operating performance, and particularly as a measure of comparative operating performance from period to period, as it is reflective of changes in pricing decisions, cost controls and other factors that affect operating performance, and it removes the effect of our capital structure, asset base, income taxes and interest income and expense. Provision for litigation represents costs incurred for litigation settlements or unfavorable verdicts when the loss is known or considered probable and the amount can be reasonably estimated, or in the case of a favorable settlement, when income is realized. Acquisition related costs represents the change in fair value of business-acquisition-related contingent consideration; costs related to integrating recently acquired businesses including but not limited to costs to exit or convert contractual obligations, severance, and information system conversion; and specific costs related to the consummation of the acquisition process such as banker fees, legal fees, and other acquisition-related professional fees. Our management also uses non-GAAP adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections.

In addition, for the period ended December 31, 2017 and for other comparative periods, we are presenting non-GAAP net income and non-GAAP diluted earnings per share, which represent net income and diluted earnings per share excluding the provision for litigation, amortization of intangibles, acquisition related costs and the tax effects of such adjustments. The tax impact of these non-GAAP adjustments is calculated based on the consolidated effective tax rate on a GAAP basis, applied to the non-GAAP adjustments, unless the underlying item has a materially different tax treatment, in which case the estimated tax rate applicable to the adjustment is used. We believe these non-GAAP measures are also useful indicators of our operating performance, and particularly as additional measures of comparative operating performance from period to period as they remove the effects of litigation, amortization of intangibles, acquisition related costs, and the tax effects of such adjustments, which we believe are not reflective of underlying business trends. Additionally, for the periods ended December 31, 2017 and for other comparative periods, we also present the non-GAAP measure of free cash flow, which represents the net cash provided by operating activities, adjusted for the impact of restricted cash, less the cash impact of purchases of property and equipment. We believe that this financial measure provides meaningful information for evaluating our overall liquidity for comparative periods as it facilitates an assessment of funds available to satisfy current and future obligations and fund acquisitions. Finally, we utilize the non-GAAP measure of constant currency sales growth, which is calculated by translating current year sales at the same average exchange rates in effect during the applicable prior year period. We believe constant currency sales growth provides insight to the comparative increase or decrease in period sales, in dollar and percentage terms, excluding the effects of fluctuations in foreign currency exchange rates.

Non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth are not calculated in conformity with U.S. GAAP within the meaning of Item 10(e) of Regulation S-K. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for financial measures prepared in accordance with U.S. GAAP. These measures do not include certain expenses that may be necessary to evaluate our liquidity or operating results. Our definitions of non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth may differ from that of other companies and therefore may not be comparable. Additionally, we have recast prior periods for non-GAAP net income and non-GAAP diluted earnings per share.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

Histogenics Corporation Announces Receipt of $10 Million Up-front Payment for Japanese NeoCart Agreement

WALTHAM, Mass., Jan. 09, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, announced that it has received the $10 million up-front payment from MEDINET Co., Ltd. (MEDINET), under the previously announced agreement for the development and commercialization of NeoCart® for the Japanese market.  Per the terms of the agreement, the up-front payment was due within ten days of entering into the agreement.  Histogenics and MEDINET announced entering into the agreement in December 2017, which included up to $87 million in total milestones and tiered royalties on sales, and a goal of commercializing NeoCart in Japan in 2021, if approved.

“Our partnership with MEDINET for NeoCart is off to a strong start, and we’re pleased to receive the initial $10 million payment.  The clinical and operations teams at both companies have initiated work to prepare for the upcoming confirmatory Phase 3 clinical trial in Japan,” stated Adam Gridley, President and Chief Executive Officer of Histogenics.  “Histogenics is also rapidly evaluating partnerships in other potential regions for NeoCart as part of our strategy to leverage our robust restorative cell therapy platform globally.”

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications.  For more information on Histogenics and NeoCart, please visit www.histogenics.com.

About MEDINET Co., Ltd.

MEDINET is a pioneering leader in the development and commercialization of cancer immuno-cell therapies.  MEDINET is also rigorously preparing to enter into the regenerative medical product market to leverage its long clinical and translational medicine history responding to the expected aging of the population.  MEDINET went public in October, 2003 on the MOTHERS, Tokyo Stock Exchange.  For more information, visit http://www.medinet-inc.co.jp/english/.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws.  Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements.  Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; NeoCart’s regulation as a Regenerative Medical Product; the market size and potential patient population in Japan; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov.  Additional factors may be set forth in those sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017, to be filed with the SEC in the first quarter of 2018.  In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.



K2M Group Holdings, Inc. Reports Preliminary Fourth Quarter and Full Year 2017 Financial Results

LEESBURG, Va., Jan. 08, 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 preliminary financial results for the fourth quarter and full year ended December 31, 2017.

Fiscal Year 2017 Financial Summary:

• Full year 2017 revenue of $257.5 million to $258.1 million, up approximately 9% year-over-year on a reported and constant currency basis
• The Company continues to expect full year 2017 net loss and Adjusted EBITDA will be within the range of its previously provided guidance

Fourth Quarter Revenue Summary:

• Total Q4 revenue of $67.3 million to $67.9 million, up approximately 9% to 10% year-over-year, or 8% to 9% on a constant currency basis

  • Domestic Q4 revenue of $51.7 million to $52.0 million, up approximately 9% year-over-year, comprised of:
    – U.S. Complex Spine growth of approximately 8% year-over-year
    – U.S. Minimally Invasive Surgery (MIS) growth of approximately 15% year-over-year
    – U.S. Degenerative growth of approximately 8% year-over-year
  • International Q4 revenue of $15.6 million to $15.9 million, up approximately 11% to 13% year-over-year, or 8% to 10% on a constant currency basis

“Our preliminary financial results for calendar year 2017 reflect total revenue growth of approximately 9% year-over-year, above the high-end of our guidance range,” said Chairman, President, and Chief Executive Officer, Eric Major. “We delivered approximately 9% growth in the U.S. in 2017—well above-market growth rates—driven by solid execution against our strategic goal of increasing market share by introducing new and innovative spinal implant solutions and expanding our distribution footprint. We have supplemented this organic growth activity with exciting product introductions in both the complex spine and degenerative categories.  Looking out to 2018, we are excited about the opportunity of our first-of-its-kind MOJAVE™ PL 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology™ and our YUKON™ OCT Spinal System that can be used with the PALO ALTO® Cervical Static Corpectomy Cage System, the first and only static corpectomy cage in the world to receive a cervical 510(k) clearance. We also announced an important strategic collaboration with Brainlab, one of the world’s leading imaging and navigation companies, that we believe will represent additional implant sales opportunities in the second half of 2018.  Our Brainlab collaboration will complement our recent launches of the BACS® platform and the EVEREST® Minimally Invasive XT Spinal System.”

Mr. Major continued, “We remain confident in our ability to drive above-market growth in the U.S., fueled by our continued focus on leading the spine market by introducing new and innovative spinal implant solutions to help surgeons care for patients around the world who suffer from debilitating spinal pathologies. We expect our revenue to increase 9%–10% in 2018 with improved profitability.”

The financial estimates presented above are preliminary and remain subject to management’s final review as well as audit by the Company’s independent registered public accounting firm. The Company intends to report complete fourth quarter and full-year 2017 financial results in late February.  Details regarding the timing of the release of those results, as well as details of a conference call and publicly available webcast, will be announced in a subsequent press release.

About K2M

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

Forward-Looking Statements

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 and retain their use of our products; pricing pressures and our ability to compete effectively generally in our industry; 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 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, 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 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; 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; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; 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 and our Quarterly Report filed with the SEC on November 1, 2017, 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.