28 Feb

InVivo Therapeutics to Present and Exhibit at Spine Summit 2017

CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that two INSPIRE study Principal Investigators, Dom Coric, M.D. and Michael Fehlings, M.D., Ph.D., will be giving oral presentations at the Spine Summit 2017 to be held March 8-11, 2017 in Las Vegas, NV. Dr. Coric will present “INSPIRE Study Update on 10 Subjects Implanted with a Bioresorbable Polymer Scaffold Following Acute Complete Thoracic Spinal Cord Injury,” and Dr. Fehlings will present “Magnetic Resonance Imaging (MRI) Does Not Distinguish between Contusion and Compound Cord Lesions Following Severe (AIS A) Traumatic Acute Thoracic Cord Injury: Intraoperative Microsurgical Observations from the INSPIRE Trial” during the Peripheral Nerve, Basic Science Breakout session on Saturday, March 11. Dr. Fehlings will also present during a What’s New Session on Friday, March 10. The session will include discussion of the Neuro-Spinal Scaffold™technology and INSPIRE study and will continue to raise awareness amongst leading spine neurosurgeons. Mark Perrin, Chairman and CEO, said, “The Spine Summit affords us the opportunity to build mindshare within the most pertinent group of surgeons for the Neuro-Spinal Scaffold. This meeting has proven to be one of the most fruitful in terms of bringing on board new INSPIRE sites, and we look forward to having a significant presence at this meeting.” The company will also have an exhibit booth to further foster relationships with the neurosurgical community. The meeting is the 33rd Annual Meeting of the AANS/CNS (American Associations of Neurological Surgeons / Congress of Neurological Surgeons) Joint Section on Disorders of the Spine and Peripheral Nerves and is being held in collaboration with the Korean Spinal Neurosurgery Society. About the Neuro-Spinal Scaffold™ Implant Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury. About InVivo Therapeutics InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffoldreceived the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com. Safe Harbor Statement Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the addition of new sites. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the ability to complete the INSPIRE study and submit an HDE; the company’s ability to receive regulatory approval for the Neuro-Spinal Scaffold; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2015, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics Brian Luque, 617-863-5535 Investor Relations bluque@invivotherapeutics.com

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28 Feb

MicroPort Orthopedics Announces Results of Clinical Study, 98.8% Implant Survivorship of its Medial-Pivot Knee System at 17 Years

February 28, 2017

ARLINGTON, Tenn.--(BUSINESS WIRE)--MicroPort Orthopedics Inc., a medical device company that develops and manufactures cutting edge joint replacement implants designed to help patients achieve full function faster, announced that The Knee has published a study evaluating long-term clinical and radiographic outcomes of the Medial-Pivot Knee System. The results demonstrate excellent clinical outcomes for both satisfaction (95%) and survivorship (98.8%) at 17 years with patients noting a great sense of stability and comfort during regular activities.1 It has been reported that approximately 20% of patients are not satisfied with the outcome of their total knee replacement as a result of residual pain and functional issues often attributed to implant design.2 MicroPort’s Medial-Pivot Knee System is uniquely designed to restore stability and normal knee kinematics to deliver reproducible outcomes that can improve function and drive patient satisfaction. “I am in my third year of using the Evolution® Medial-Pivot Knee System and this publication validates the results that I have seen in my practice,” says David Backstein, MD, MEd, FRCSC, Head of Orthopaedic Surgery at Mount Sinai Hospital in Toronto, Ontario. “In my experience, the functional outcomes for patients treated with this system have certainly been superior than the systems I’ve used in the past and patients have fewer complaints. When I see them at six or eight weeks follow-up, they're at a different stage of recovery than I was seeing previously with traditional implant designs. I've been exceptionally happy with the results and feel comfortable knowing I am implanting a prosthesis with 98.8% survivorship at 17 years.” The paper, titled, A Long Term Clinical Outcome of the Medial Pivot Knee Arthroplasty System was authored by George A Macheras et al. from the “KAT” General Hospital, Athens, Greece. In the study, 325 patients with knee osteoarthritis underwent Total Knee Arthroplasty (TKA) using the Medial-Pivot prosthesis. All patients showed a statistically significant improvement in the Knee Society clinical rating system, Western Ontario and McMaster Universities Osteoarthritis Index, and Oxford knee score. The majority of patients (94%) were able to perform age-appropriate activities with average knee flexion of 120° and 98% of patients reported relief of pain to be excellent, very good or good. Additionally, survival analysis showed a cumulative success rate of 98.8% at 17 years. About MicroPort Orthopedics Established in January 2014, MicroPort Orthopedics Inc. is a multinational producer of orthopedic products and a proud member of the MicroPort Scientific Corporation family of companies. From its headquarters in Arlington, Tennessee, MicroPort Orthopedics develops, produces, and distributes innovative orthopedic reconstructive products. The company’s U.S.-based manufacturing and logistics capabilities deliver high quality hip and knee products to patients and their doctors in over 60 countries, including the U.S., EMEA, Japan, Latin America, and China markets. For more information about MicroPort Orthopedics, visit http://www.ortho.microport.com/. About MicroPort MicroPort Scientific Corporation is a leading medical device company focused on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 20 seconds in thousands of major hospitals around the world, MicroPort maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient-oriented global enterprise that improves and reshapes patient lives through application of innovative science and technology. For more information, please refer to: http://www.microport.com. Forward-Looking Statements Some information contained on this website contains forward-looking statements. These forward-looking statements include, without limitation, those regarding our future financial position, our strategy, plans, objectives, goals and targets, future developments in the markets where we participate or are seeking to participate, and any statements preceded by, followed by or that include the words “believe,” “intend,” “expect,” “anticipate,” “project,” “estimate,” “predict,” “is confident,” “has confidence” and similar expressions are also intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of MicroPort’s management and are subject to significant risks and uncertainties. MicroPort Scientific Corporation undertakes no obligation to update any of the statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors that could cause actual future results to differ materially from current expectations include, but are not limited to, general industry and economic conditions, PRC governmental policies and regulations relating to the medical device manufacturing industry, competition in the medical device manufacturing industry, our ability to develop new products and stay abreast of market trends and technological advances, our goals and strategies, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, fluctuations in general economic and business conditions in China. This document is for information purposes only and does not constitute or form part of any offer or invitation to sell or the solicitation of an offer or invitation to purchase or subscribe for any securities of MicroPort Scientific Corporation, and no part of it shall form the basis of, or be relied upon in connection with, any agreement, arrangement, contract, commitment or investment decision in relation thereto whatsoever. Sources:

1. George A. Macheras et al. “A long term clinical outcome of the Medial Pivot Knee Arthroplasty System.” The Knee Journal, Published: January 29, 2017.

2. Thambiah, Matthew Dhanaraj et al. “Patient Satisfaction after Total Knee Arthroplasty: An Asian Perspective.” Singapore Medical Journal 56.5 (2015): 259–263. PMC. Web. 22 Feb. 2017.

All rights reserved. 12294 Copyright © 2015 MicroPort Scientific Corporation

Contacts

LaVoie HealthScience Sharon Correia, 617-412-8779 scorreia@lavoiehealthscience.com

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28 Feb

Synergy Biomedical Receives CE Mark for BIOSPHERE PUTTY

February 28, 2017

COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Synergy Biomedical, LLC, a developer of innovative bone graft products for spine and orthopedic surgery, announced today that it has received CE Mark clearance in the European Union for its next generation bone graft, BIOSPHERE PUTTY. Originally launched in the U.S. in 2013, BIOSPHERE PUTTY is a synthetic bone graft product that utilizes a unique form of bioactive glass in combination with a moldable phospholipid carrier. Based on the Company’s patented BioSphere Technology, BIOSPHERE PUTTY has been shown in vivo to significantly improve the healing potential of bioactive glass due to its spherical particle shape and optimized, bimodal size range. “Since its introduction, BIOSPHERE PUTTY has been very well received by surgeons due to its successful clinical use and excellent intraoperative handling,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy. “We are very pleased to receive our CE Mark and are looking forward to introducing a truly next generation, synthetic bone graft product to the European community.” Under its cleared European indication, BIOSPHERE PUTTY is intended to be used as a bone graft material for filling bony voids or gaps of the skeletal system. This includes the use of the product for interbody and posterolateral fusion, and general bone defect filling in the extremities and pelvis. The product may be used alone or in combination with autograft or allograft. “When it comes to selecting the best bone graft strategy for each patient, there are a wide array of options for surgeons. BIOSPHERE PUTTY is an elegant bone graft solution that is based on scientifically valid principles,” said Erik Westerlund MD, FACS, Director of the Ortho-Neuro Integrated Spine Surgery Program at St. Francis Hospital in the U.S. “It applies an advanced and refined understanding of bioactive glass to drive a purposeful cellular level response and to provide an ideal physical environment for even and predictable bone ingrowth. My clinical experience with BIOSPHERE PUTTY over the past two years has been excellent, with consistently successful long-term outcomes in a wide range of spinal applications. It is an extremely thoughtful and equally versatile bone graft solution.” BIOSPHERE PUTTY is the first of several bone graft products being developed by Synergy Biomedical that utilize patented bioactive glass spheres that have been shown to improve the bone healing potential of bioactive glass. BIOSPHERE PUTTY provides surgeons with a moldable bone graft material that is easy to use and compatible with a variety of bone grafting techniques. About Synergy Biomedical, LLC Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial based products to the orthopaedic and spinal markets. The Company’s BioSphere Technology represents a unique approach to advancing bone graft technology, and improving bone healing and patient outcomes.

Contacts

Synergy Biomedical, LLC Mark Borden, Ph.D. President/CEO 484-902-8141 www.synergybiomedical.com info@synergybiomedical.com

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28 Feb

joimax® Obtains Full Product Registration in Thailand, and is Now Active in 10 Asian Countries

February 27, 2017

IRVINE, Calif.--(BUSINESS WIRE)--joimax® further ensures its market access in Asia. The German based market leader of technologies and training methods for endoscopic minimally invasive spinal surgery is expanding its presence and recently has obtained full product registration from the Thai Food & Drug Administration (FDA). joimax® also has approvals in South Korea, China, Singapore, Indonesia, Hong Kong and Vietnam. For Malaysia, Taiwan and Japan, the certification for the product range is expected in 2017. “We are constantly pushing the registration process in Asia to extend the availability of joimax® products. Thus, joimax® is well prepared to further widen its market presence in Asia, demonstrating our commitment to the fastest growing region of the world,” states Wolfgang Ries, Founder and CEO of joimax®. For years, joimax® has been working with the Korean Wooridul group, the world’s largest Specialized Spine Hospital Network. Starting in 2017, joimax®, together with the Wooridul Hospital in Seoul, will offer International courses for Minimally Invasive Spinal Surgery (MISS). In a series of four courses, provided in basic and advanced level, the education of international spine surgeons is ensured. The first one, chaired by joimax® faculty Dr. Sang-Ho Lee, South Korea, recently took place. The one-week training programs offer surgeons the opportunity to learn percutaneous endoscopic techniques and other minimally-invasive procedures with lectures, operation observation and hands-on-workshops. Since 2004, more than 600 spine surgeons and specialists from 41 countries have participated in these courses at Wooridul. After the National Minimal Invasive Spinal Summit Forum, together with the 4th joimax® User Meeting in December, joimax® China, headquartered in Chengdu, will celebrate its 10th birthday in April 2017. On this occasion, numerous internationally well-known faculties will meet in Chongqing, China to share experience and expertise. Lectures and live surgeries are planned to be held in two hospitals and to be broadcasted via Internet. About joimax® Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS® (cervical) for decompression procedures, MultiZYTE® RT (e.g. for rhizotomy) and with MultiZYTE® SI for SI-Joint therapy or with EndoLIF® and Percusys® for endoscopic minimally-invasive assisted stabilizations, proven endoscopic systems are provided that, together, cover a whole variety of indications. In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax® technologies to operate through small incisions - under local or full anesthetic - via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

Press Contact USA: joimax® Inc. Melissa Brumley, 001 949 859 3472 Melissa.brumley@joimaxusa.com

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28 Feb

Cellular Biomedicine Group Awarded $2.29 Million Grant from the California Institute for Regenerative Medicine (CIRM)

SHANGHAI, China and CUPERTINO, Calif., Feb. 27, 2017 (GLOBE NEWSWIRE) -- Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the “Company”), a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, announced today that the governing Board of the California Institute for Regenerative Medicine (CIRM), California's stem cell agency, has awarded the Company $2.29 million to support pre-clinical studies of AlloJoinTM, CBMG’s “Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem Cells for the treatment of Knee Osteoarthritis in the United States.

While CBMG recently commenced two Phase I human clinical trials in China using CAR-T to treat relapsed/refractory CD19+ B-cell Acute Lymphoblastic Leukemia (ALL) and Refractory Diffuse Large B-cell Lymphoma (DLBCL) as well as an ongoing Phase I trial in China for AlloJoinTM in Knee Osteoarthritis (KOA), this latest announcement represents CBMG’s initial entrance into the United States for its “off-the-shelf” allogeneic stem cell candidate AlloJoinTM.

The $2.29 million was granted under the CIRM 2.0 program, a comprehensive collaborative initiative designed to accelerate the development of stem cell-based treatments for people with unmet medical needs. After the award, CIRM will be a more active partner with its recipients to further increase the likelihood of clinical success and help advance a pre-clinical applicant’s research along a funding pipeline towards clinical trials. CBMG’s KOA pre-clinical program is considered late-stage, and therefore it meets CIRM 2.0’s intent to accelerate support for clinical stage development for identified candidates of stem cell treatments that demonstrate scientific excellence.

"We are deeply appreciative to CIRM for their support and validation of the therapeutic potential of our KOA therapy,” said Tony (Bizuo) Liu, Chief Executive Officer of CBMG. “We thank Dr. C. Thomas Vangsness, Jr., in the Department of Orthopaedic Surgery at the Keck School of Medicine of the University of Southern California and Dr. Qing Liu-Michael at the Broad Center for Regenerative Medicine and Stem Cell Research at USC, who helped significantly with the grant application process. The CIRM grant is the first step in bringing our allogeneic human adipose-derived mesenchymal stem cell treatment for knee osteoarthritis (AlloJoinTM) to the U.S. market.

Our AlloJoinTM program has previously undergone extensive manufacturing development and pre-clinical studies and is undergoing a Phase I clinical trial in China. In order to demonstrate comparability with cell banks previously produced in China for our U.S. IND filing, we are addressing the pre-clinical answers required for the FDA. With the funds provided by CIRM, we will replicate and validate the manufacturing process and control system at the cGMP facility located at Children’s Hospital Los Angeles to support the filing of an IND with the FDA. The outcome of this grant will enable us to have qualified final cell products ready to use in a Phase I clinical trial with Dr. Vangsness as the Principal Investigator and the Keck School of Medicine of USC as a trial site. Dr. Vangsness is familiar with both stem cell biology and KOA, and has led the only randomized double-blind human clinical study to investigate expanded allogeneic mesenchymal stem cells to date. Our endeavor in the U.S. market will further strengthen our commercialization pipeline.”

CBMG recently announced promising interim 3-month safety data from its Phase I clinical trial in China for AlloJoinTM, its off-the-shelf allogeneic stem cell therapy for KOA. The trial is on schedule to be completed by the third quarter of 2017.

About CIRM

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and to act with a sense of urgency commensurate with that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today's most promising stem cell technologies.

With $3 billion in funding and over 280 active stem cell programs in our portfolio, CIRM is the world's largest institution dedicated to helping people by bringing the future of medicine closer to reality.

For more information, please visit www.cirm.ca.gov.

About Knee Osteoarthritis

According to the Foundation for the National Institutes of Health, there are 27 million Americans with Osteoarthritis (OA), and symptomatic Knee Osteoarthritis (KOA) occurs in 13% of persons aged 60 and older. The International Journal of Rheumatic Diseases, 2011 reports that approximately 57 million people in China suffer from KOA. Currently no treatment exists that can effectively preserve knee joint cartilage or slow the progression of KOA. Current common drug-based methods of management, including anti-inflammatory medications (NSAIDs), only relieve symptoms and carry the risk of side effects. Patients with KOA suffer from compromised mobility, leading to sedentary lifestyles; doubling the risk of cardiovascular diseases, diabetes, and obesity; and increasing the risk of all causes of mortality, colon cancer, high blood pressure, osteoporosis, lipid disorders, depression and anxiety. According to the Epidemiology of Rheumatic Disease (Silman AJ, Hochberg MC. Oxford Univ. Press, 1993:257), 53% of patients with KOA will eventually become disabled.

About Cellular Biomedicine Group (CBMG)

Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. Our immuno-oncology and stem cell projects are the result of research and development by CBMG’s scientists and clinicians from both China and the United States. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. To learn more about CBMG, please visit www.cellbiomedgroup.com. Forward-looking Statements This press release contains forward-looking statements—including descriptions of plans, strategies, trends, specific activities, investments and other non-historical facts—as defined by the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently uncertain, and actual results could differ materially from those anticipated due to a number of factors, which include risks inherent in doing business, trends affecting the global economy (including the devaluation of the RMB by China in August 2015), and other risks detailed in CBMG’s reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," "continue" or similar terms or their negations. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.
Contacts:
Sarah Kelly 
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com

Vivian Chen
Managing Director Investor Relations, Citigate Dewe Rogerson
+1 347 481-3711
vivian.chen@citigatedr.com

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28 Feb

Globus Medical Reports Full Year and Fourth Quarter 2016 Results

AUDUBON, Pa., Feb. 27, 2017 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced its financial results for the fourth quarter and year ended December 31, 2016.

Fourth Quarter:

  • Worldwide sales increased 6.3% as reported to $151.6 million, or an increase of 6.5% on a constant currency basis
  • Fourth quarter net income was $24.3 million, or 16.0% of sales
  • Diluted earnings per share (EPS) were $0.25
  • Non-GAAP diluted EPS were $0.31
  • Non-GAAP adjusted EBITDA was 37.7% of sales

Full Year 2016:

  • Worldwide sales increased 3.5% as reported to $564.0 million, or an increase of 3.8% on a constant currency basis
  • Net income for the year was $104.3 million, or 18.5% of sales
  • Diluted EPS were $1.08
  • Non-GAAP diluted EPS were $1.19
  • Non-GAAP adjusted EBITDA was 37.4% of sales

David Paul, Chairman and CEO said, “Fourth quarter sales were $151.6 million, a year-over-year increase of 6.3%.  Despite our increased spending in support of our pending robotics and trauma launches, our adjusted EBITDA margins was an outstanding 37.7%.  We also delivered EPS of $0.25 and non GAAP EPS of $0.31.

"During the fourth quarter, we continued to make progress with product development, sales force development and integration of Alphatec's international business.  We also further expanded our in-house manufacturing capacity.  We are proud of our innovation and product development efforts, which resulted in a total of 17 new product launches in 2016.  We have addressed our sales force expansion challenges and are optimistic that we will return to more robust growth rates in the second half of 2017. We also remain confident in our long-term growth prospects and our ability to sustain industry-leading profitability by continuing to execute on our strategy of rapid product introduction, expansion of our U.S. and international sales footprints, and diligent expense control.”

Fourth quarter sales in the U.S. decreased by 2.7% compared to the fourth quarter of 2015, primarily due to one less selling day in the fourth quarter of 2016.  International sales increased by 109.0% over the fourth quarter of 2015 on an as reported basis and 111.8% on a constant currency basis.

Fourth quarter GAAP net income was $24.3 million, a decrease of 35.4% over the same period last year resulting from the one-time positive net income impact of $7.6 million in 2015 due to the settlement of outstanding litigation.  Diluted EPS for the fourth quarter was $0.25, as compared to $0.39 for the fourth quarter 2015.  Non-GAAP diluted EPS, which removes the impact of this litigation and acquisition related expenses, for the fourth quarter was $0.31, compared to $0.32 in the fourth quarter of 2015.

The company generated net cash provided by operating activities of $51.9 million and non-GAAP free cash flow of $37.7 million in the fourth quarter.  Cash, cash equivalents and marketable securities ended the quarter at $350.8 million.  The company remains debt free.

The company plans to request an extension to file its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 by filing Form 12b-25, Notification of Late Filing with the Securities and Exchange Commission.  The company concluded it is not able to compile all information necessary to complete its Form 10-K by March 1, 2017 without unreasonable effort or expense.  The company anticipates filing its Form 10-K for the fiscal year ended December 31, 2016 within the extension period.

2017 Annual Guidance The company projects 2017 full year sales of $625 million and and non-GAAP fully diluted earnings per share of $1.27.

Conference Call Information Globus Medical will hold a teleconference to discuss its 2016 fourth quarter and full year results with the investment community at 5:30 p.m. Eastern Time today.  Globus invites all interested parties to join the call by dialing:

1-855-533-7141  United States Participants 1-720-545-0060  International Participants There is no pass code for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at investors.globusmedical.com.

The call will be archived until Monday, March 6, 2017.  The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 6940-2658.

About Globus Medical, Inc. Globus Medical, Inc. is a leading musculoskeletal implant 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, provisions for litigation, technology in-licensing fee, 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.  Our management also uses non-GAAP adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections.  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/licensing 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, as well as one time licensing fees.

In addition, for the period ended December 31, 2016 and for other comparative periods, we are presenting non-GAAP net income and non-GAAP diluted earnings per share, which represents net income and diluted earnings per share excluding the provision for litigation, amortization of intangibles, acquisition related costs/licensing, prior period adjustment and the tax effects of such adjustments.  Prior period adjustments represent the cumulative impact of prior year adjustments related to depreciation, scrap and provision for excess and obsolete inventory, none of which were individually material to the related year's financial position or results of operations.  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/licensing, prior period adjustments and the tax effects of such adjustments, which we believe are not reflective of underlying business trends.  Additionally, for the periods ended December 31, 2016 and for other comparative periods, we also define the non-GAAP measure of free cash flow as 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 financial performance for comparative periods as it facilitates an assessment of funds available to satisfy current and future obligations and fund acquisitions.  Furthermore, the non-GAAP measure of constant currency sales growth 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.  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 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.

GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
Three Months Ended Year Ended
(In thousands, except per share amounts) December 31, 2016 December 31, 2015 December 31, 2016 December 31, 2015
Sales $ 151,590 $ 142,587 $ 563,994 $ 544,753
Cost of goods sold 39,002 34,940 134,705 132,333
Gross profit 112,588 107,647 429,289 412,420
Operating expenses:
Research and development 13,643 9,672 44,532 36,312
Selling, general and administrative 60,839 52,802 222,156 210,241
Provision for litigation 100 (11,701 ) 3,156 (11,268 )
Amortization of intangibles 1,805 389 3,478 1,561
Acquisition related costs 479 488 1,826 3,352
Total operating expenses 76,866 51,650 275,148 240,198
Operating income 35,722 55,997 154,141 172,222
Other income, net 755 236 3,138 583
Income before income taxes 36,477 56,233 157,279 172,805
Income tax provision 12,179 18,632 52,938 60,021
Net income $ 24,298 $ 37,601 $ 104,341 $ 112,784
Earnings per share:
Basic $ 0.25 $ 0.39 $ 1.09 $ 1.19
Diluted $ 0.25 $ 0.39 $ 1.08 $ 1.17
Weighted average shares outstanding:
Basic 95,862 95,273 95,647 95,046
Diluted 96,513 96,214 96,432 96,073
GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(In thousands, except par value) December 31, 2016 December 31, 2015
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $ 132,639 $ 60,152
Restricted cash 477 26,119
Short-term marketable securities 157,673 220,877
Accounts receivable, net of allowances of $2,771 and $2,513, respectively 91,983 77,681
Inventories 112,692 105,260
Prepaid expenses and other current assets 14,502 7,351
Income taxes receivable 3,800 8,672
Deferred income taxes 38,687
Total current assets 513,766 544,799
Property and equipment, net of accumulated depreciation of $166,711 and $139,144, respectively 124,229 114,743
Long-term marketable securities 60,444 48,762
Note receivable 30,000
Intangible assets, net 61,706 33,242
Goodwill 105,926 91,964
Other assets 928 590
Deferred income taxes 30,638
Total assets $ 927,637 $ 834,100
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable $ 17,472 $ 15,971
Accrued expenses 46,401 53,769
Income taxes payable 1,911 763
Business acquisition liabilities, current 14,108 12,188
Total current liabilities 79,892 82,691
Business acquisition liabilities, net of current portion 5,972 21,126
Deferred income taxes 7,876 13,260
Other liabilities 1,819 1,699
Total liabilities 95,559 118,776
Commitments and contingencies
Equity:
Common stock; $0.001 par value. Authorized 785,000 shares; issued and outstanding 95,930 and 95,320 shares at December 31, 2016 and December 31, 2015, respectively 96 95
Additional paid-in capital 211,725 192,629
Accumulated other comprehensive loss (8,642 ) (1,958 )
Retained earnings 628,899 524,558
Total equity 832,078 715,324
Total liabilities and equity $ 927,637 $ 834,100
GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Year Ended
(In thousands) December 31, 2016 December 31, 2015
Cash flows from operating activities:
Net income $ 104,341 $ 112,784
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 38,771 24,084
Amortization of premium on marketable securities 4,068 3,354
Write-down for excess and obsolete inventories 12,836 9,924
Stock-based compensation expense 11,382 9,639
Excess tax benefit related to nonqualified stock options (1,571 ) (2,050 )
Allowance for doubtful accounts 685 1,465
Change in fair value of contingent consideration 2,866 3,118
Non-cash settlement of accrued expenses (4,632 ) (8,405 )
Impairment of intangible assets 3,472
Change in deferred income taxes (3,810 ) 6,235
(Increase)/decrease in:
Restricted cash 25,641 (2,749 )
Accounts receivable (4,668 ) (4,193 )
Inventories (10,503 ) (19,327 )
Prepaid expenses and other assets 4,568 (1,203 )
Increase/(decrease) in:
Accounts payable (23 ) (3,825 )
Accounts payable to related-party (5,359 )
Accrued expenses and other liabilities (18,164 ) (878 )
Income taxes payable/receivable 6,634 (657 )
Net cash provided by operating activities 171,893 121,957
Cash flows from investing activities:
Purchases of marketable securities (287,263 ) (297,707 )
Maturities of marketable securities 281,885 188,702
Sales of marketable securities 52,802 57,728
Purchases of property and equipment (40,909 ) (50,760 )
Issuance of note receivable (30,000 )
Acquisition of businesses, net of cash acquired (76,068 ) (48,513 )
Net cash used in investing activities (99,553 ) (150,550 )
Cash flows from financing activities:
Payment of business acquisition liabilities (5,404 ) (1,200 )
Proceeds from exercise of stock options 5,874 5,477
Excess tax benefit related to nonqualified stock options 1,571 2,050
Net cash provided by financing activities 2,041 6,327
Effect of foreign exchange rate on cash (1,894 ) 153
Net increase/(decrease) in cash and cash equivalents 72,487 (22,113 )
Cash and cash equivalents, beginning of period 60,152 82,265
Cash and cash equivalents, end of period $ 132,639 $ 60,152
Supplemental disclosures of cash flow information:
Interest paid 35 9
Income taxes paid $ 50,087 $ 57,100
Supplemental Financial Information
Sales by Geographic Area:
(Unaudited) Three Months Ended Year Ended
(In thousands) December 31, 2016 December 31, 2015 December 31, 2016 December 31, 2015
United States $ 127,477 $ 131,051 $ 500,226 $ 498,191
International 24,113 11,536 63,768 46,562
Total sales $ 151,590 $ 142,587 $ 563,994 $ 544,753
Sales by Product Category:
(Unaudited) Three Months Ended Year Ended
(In thousands) December 31, 2016 December 31, 2015 December 31, 2016 December 31, 2015
Innovative Fusion $ 79,609 $ 73,631 $ 287,594 $ 288,062
Disruptive Technology 71,981 68,956 276,400 256,691
Total sales $ 151,590 $ 142,587 $ 563,994 $ 544,753
Liquidity and Capital Resources:
(Unaudited) December 31, 2016 December 31, 2015
(In thousands)
Cash and cash equivalents $ 132,639 $ 60,152
Short-term marketable securities 157,673 220,877
Long-term marketable securities 60,444 48,762
Total cash, cash equivalents and marketable securities $ 350,756 $ 329,791
Available borrowing capacity under revolving credit facility 50,000 50,000
Working capital $ 433,874 $ 462,108

The following tables reconcile GAAP to Non-GAAP financial measures.

Non-GAAP Adjusted EBITDA Reconciliation Table:
(Unaudited) Three Months Ended Year Ended
(In thousands, except percentages) December 31, 2016 December 31, 2015 December 31, 2016 December 31, 2015
Net income $ 24,298 $ 37,601 $ 104,341 $ 112,784
Interest income, net (1,164 ) (406 ) (3,057 ) (1,304 )
Provision for income taxes 12,179 18,632 52,938 60,021
Depreciation and amortization 17,235 6,415 38,771 24,084
EBITDA 52,548 62,242 192,993 195,585
Stock-based compensation expense 2,945 2,704 11,382 9,639
Provision for litigation 100 (11,701 ) 3,156 (11,268 )
Acquisition related costs/licensing 5,280 488 6,931 3,577
Prior period adjustment, excluding depreciation (3,697 ) (3,697 )
Adjusted EBITDA $ 57,176 $ 53,733 $ 210,765 $ 197,533
Net income as a percentage of sales 16.0 % 26.4 % 18.5 % 20.7 %
Adjusted EBITDA as a percentage of sales 37.7 % 37.7 % 37.4 % 36.3 %
Non-GAAP Net Income Reconciliation Table:
(Unaudited) Three Months Ended Year Ended
(In thousands) December 31, 2016 December 31, 2015 December 31, 2016 December 31, 2015
Net income $ 24,298 $ 37,601 $ 104,341 $ 112,784
Provision for litigation 100 (11,701 ) 3,156 (11,268 )
Amortization of intangibles 1,805 389 3,478 1,561
Acquisition related costs/licensing 5,280 488 6,931 3,577
Prior period adjustment 1,765 1,765
Tax effect of adjusting items (3,054 ) 3,803 (5,166 ) 2,127
Non-GAAP net income $ 30,194 $ 30,580 $ 114,505 $ 108,781
Non-GAAP Diluted Earnings Per Share Reconciliation Table:
(Unaudited) Three Months Ended Year Ended
(Per share amounts) December 31, 2016 December 31, 2015 December 31, 2016 December 31, 2015
Diluted earnings per share, as reported $ 0.25 $ 0.39 $ 1.08 $ 1.17
Provision for litigation (0.12 ) 0.03 (0.12 )
Amortization of intangibles 0.02 0.04 0.02
Acquisition related costs/licensing 0.05 0.01 0.07 0.04
Prior period adjustment 0.02 0.02
Tax effect of adjusting items (0.03 ) 0.04 (0.05 ) 0.02
Non-GAAP diluted earnings per share $ 0.31 $ 0.32 $ 1.19 $ 1.13
Non-GAAP Free Cash Flow Reconciliation Table:
(Unaudited) Three Months Ended Year Ended
(In thousands) December 31, 2016 December 31, 2015 December 31, 2016 December 31, 2015
Net cash provided by operating activities $ 51,896 $ 44,080 $ 171,893 $ 121,957
Adjustment for impact of restricted cash 1 734 (25,641 ) 2,749
Purchases of property and equipment (14,208 ) (14,154 ) (40,909 ) (50,760 )
Non-GAAP free cash flow $ 37,689 $ 30,660 $ 105,343 $ 73,946
Non-GAAP Sales on a Constant Currency Basis Comparative Table:
(Unaudited) Three Months Ended Reported Growth Currency Impact on Current Period Constant Currency Growth
(In thousands, except percentages) December 31, 2016 December 31, 2015
United States $ 127,477 $ 131,051 (2.7 )% (2.7 )%
International 24,113 11,536 109.0 % $ (326 ) 111.8 %
Total sales $ 151,590 $ 142,587 6.3 % $ (326 ) 6.5 %
(Unaudited) Year Ended Reported Growth Currency Impact on Current Period Constant Currency Growth
(In thousands, except percentages) December 31, 2016 December 31, 2015
United States $ 500,226 $ 498,191 0.4 % 0.4 %
International 63,768 46,562 37.0 % $ (1,594 ) 40.4 %
Total sales $ 563,994 $ 544,753 3.5 % $ (1,594 ) 3.8 %
 
Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

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28 Feb

Dr. Lisa A. Fortier Joins TissueGen’s Scientific Advisory Board

DALLAS, TX--(Marketwired - Feb 27, 2017) - TissueGen® Inc., developer of ELUTE® fiber, a groundbreaking biodegradable fiber format for advanced drug delivery, today announced that Lisa A. Fortier, DVM, PhD, DACVS, has joined the company's scientific advisory board. Dr. Fortier is a professor of surgery at Cornell University with a particular interest in translational research including the prevention of post-traumatic osteoarthritis. In addition, her internationally renowned research investigates the clinical application of stem cells and biologics such as platelet-rich plasma and bone marrow concentrate for cartilage repair and tendinosis.

Dr. Fortier has received the Jacques Lemans Award from the International Cartilage Repair Society, the New Investigator Research Award from the Orthopaedic Research Society, and the Pfizer Research Award for Research Excellence from Cornell University. She is the vice president of the International Veterinary Regenerative Medicine Society, past president of the International Cartilage Repair Society, and director of the Equine Park at Cornell University.

"We are excited to welcome Dr. Fortier as a member of our scientific advisory board. Her invaluable expertise will guide our development of ELUTE fiber for controlled sustained delivery of sensitive biologics and pharmaceuticals in orthopedic applications," said Christopher Knowles, president, TissueGen.

TissueGen's ELUTE fiber directly replaces standard fibers in biodegradable medical textiles and may significantly improve clinical outcomes by delivering therapeutic agents directly at the surgical site. Through localized delivery of drugs at the site of implantation, ELUTE fibers may orchestrate the body's healing and regenerative processes.

"The work that TissueGen is doing is very exciting and has the potential to redefine how biologics may be delivered in orthopedic applications," said Dr. Fortier. "I look forward to working with the company's scientific team as they develop clinical applications for ELUTE fiber that may enable the future of medicine."

Dr. Fortier received her DVM from Colorado State University and completed her PhD and surgical residency training at Cornell University. She is boarded with the American College of Veterinary Surgeons and practices equine orthopedic surgery at Cornell University and at the Cornell Ruffian Equine Specialists.

About TissueGen

TissueGen® Inc. is the developer of ELUTE® fiber, a groundbreaking biodegradable fiber format for advanced drug delivery, nerve regeneration, and tissue engineering. TissueGen has more than four decades of cumulative experience in extruding biodegradable polymer fibers with broad drug delivery capabilities. ELUTE fiber can directly replace standard fibers used in biodegradable textiles currently on the market and provide significantly improved clinical outcomes by delivering therapeutic agents directly at the site of the implant. By delivering pharmaceuticals and biologics at the site of implantation, ELUTE fiber enables medical devices to guide the body's healing and regenerative processes. For more information, please visit www.tissuegen.com.

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27 Feb

Global Hip and Knee Orthopedic Surgical Robots Industry Research Report 2016 to 2022

FEBRUARY 21, 2017 -  RESEARCHMOZ GLOBAL PVT. LTD. The 2016 study has 145 pages, 64 tables and figures. Worldwide Hip and Knee Orthopedic surgical robot markets are poised to achieve significant growth. The accuracy provided by the robot is not reproducible by the human surgeon, so ultimately all surgeons will want to perform the orthopedic implants using this technology. Robot assisted medial knee arthroplasty: orthopedic surgical robots are poised to take knee and hip surgery quality far beyond what has previously been available. The quality of knee arthroplasty is improved with robotic capability. All the advantages of surgical robots carry into the Stryker Mako orthopedic reconstruction surgical products.. When the knee and hip surgical robots are used, patients have less bleeding, reduction of post-operative pain, fewer re-admissions to hospital and faster recovery. Robots support high-precision surgery. A clinic in Switzerland, La Source, has reported a reduction in the average days of hospitalization from 10 to 6. Knee and hip surgical robots provide consistent reproducible precision. This capability is so significant for implant surgery that the robots are positioned to become the defacto standard of care for knee and hip surgery within five years. Any one getting a knee or hip replaced will demand attention to quality of life, to maintenance of lifestyle provided by a robot when they have a joint replacement. As next generation systems, hip and knee robotic units provide a way to improve traditional orthopedic hip and knee replacement surgery. Total hip replacement surgery has evolved dramatically as advances in technology have brought improved surgical techniques. Surgical robots are a significany [art of that advance. Once, the penetration achieves this 35% level, all orthopedic surgeons will demand that hospitals offer robotic orthopedic surgical capability because the outcomes are more predictable and better. If the hospital does not offer the robot, the surgeon will move to a more modern facility. Knee and Hip Surgical Robots have been impacted by the reduction in insurance payments. Payment reductions have forced hospitals to start acting as businesses. The cost of delivering care has become as much a factor as providing quality care when making decisions about patient improvement in condition. Cost-cutting has been made in the supply chain. Suppliers were examined closely for quality and cost.   READ THE REST HERE

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27 Feb

Orthofix International Reports Fourth Quarter and Fiscal 2016 Financial Results

February 27, 2017

LEWISVILLE, Texas--(BUSINESS WIRE)--

Orthofix International N.V. (OFIX) today reported its financial results for the fourth quarter and fiscal year ended December 31, 2016. For the fourth quarter of 2016, net sales were $108.5 million, loss per share from continuing operations was ($0.29) and adjusted earnings per share from continuing operations was $0.42. For fiscal year 2016, net sales were $409.8 million, earnings per share from continuing operations was $0.19 and adjusted earnings per share from continuing operations was $1.46.

“We are very proud of what we accomplished in 2016 and are encouraged by our momentum at year-end,” commented Brad Mason, President and Chief Executive Officer. “We improved our performance during the year in almost every aspect of our business and exited an era of heavy investment with a rebuilt infrastructure, robust compliance program, rigorous financial controls, strong balance sheet, excellent free cash flow and great momentum in our BioStim and Extremity Fixation businesses. Looking ahead to the next chapter for Orthofix, we are now well positioned and committed to execute on both organic and inorganic strategic opportunities focused on accelerating shareholder value creation.”

Financial Results Overview

Fourth Quarter

The following table provides net sales by strategic business unit (“SBU”):

Three Months Ended December 31,
(Unaudited, U.S. Dollars, in thousands) 2016 2015 Change

Constant Currency Change

BioStim $ 47,803 $ 44,993 6.2 % 6.2 %
Biologics 15,227 15,958 (4.6 %) (4.6 %)
Extremity Fixation 26,843 23,931 12.2 % 14.3 %
Spine Fixation 18,664 19,740 (5.5 %) (5.6 %)
Net sales $ 108,537 $ 104,622 3.7 % 4.2 %

Gross profit increased $2.0 million to $85.2 million. Gross margin decreased to 78.5% compared to 79.5% in the prior year period, primarily due to an increase in the mix of net sales from our Extremity Fixation SBU, which have lower margins than our regenerative products. Net margin (gross profit less sales and marketing expenses) was $36.5 million, a decrease of 5.1% compared to $38.5 million in the prior year period. The decrease in net margin was primarily due to higher sales and marketing expenses, driven by higher compensation costs, including commissions.

Net loss from continuing operations was $5.1 million, or ($0.29) per share, compared to net income of $2.1 million, or $0.11 per share in the prior year period. Adjusted net income from continuing operations was $7.7 million, or $0.42 per share, compared to adjusted net income of $7.6 million, or $0.40 per share in the prior year period.

EBITDA was $8.6 million, compared to $12.5 million in the prior year period. Adjusted EBITDA was $21.1 million or 19.4% of net sales for the fourth quarter, compared to $19.3 million or 18.4% of net sales in the prior year period.

Fiscal Year 2016

The following table provides net sales by SBU:

Year Ended December 31,
(Unaudited, U.S. Dollars, in thousands) 2016 2015 Change

Constant Currency Change

BioStim $ 176,561 $ 164,955 7.0 % 7.0 %
Biologics 57,912 59,832 (3.2 %) (3.2 %)
Extremity Fixation 102,683 96,034 6.9 % 9.6 %
Spine Fixation 72,632 75,668 (4.0 %) (4.0 %)
Net sales $ 409,788 $ 396,489 3.4 % 4.0 %

Gross profit increased $12.0 million to $321.9 million and gross margin increased to 78.6% compared to 78.2% in the prior year period. The increase in gross profit and gross margin was driven by an increase in sales, an increase in sales mix for our BioStim products, and lower fixed costs. Net margin was $140.6 million, an increase of 6.6% compared to $131.9 million in the prior year period. The increase in net margin was due to the higher gross profit, partially offset by higher sales and marketing expenses, including an increase in commissions as a result of the increase in net sales.

Net income from continuing operations was $3.5 million, or $0.19 per share, compared to net loss of $2.3 million, or ($0.12) per share in the prior year. Adjusted net income from continuing operations was $27.0 million, or $1.46 per share, compared to adjusted net income of $19.9 million, or $1.05 per share in the prior year.

EBITDA was $39.1 million, compared to $29.9 million in the prior year. Adjusted EBITDA was $79.3 million or 19.4% of net sales for the year, compared to $60.7 million or 15.3% of net sales in the prior year.

Liquidity

As of December 31, 2016, cash and cash equivalents were $39.6 million compared to $63.7 million as of December 31, 2015. The decrease in cash and cash equivalents is due primarily to the repurchase of shares and funding the settlements with the SEC. As of December 31, 2016, we had no outstanding indebtedness and borrowing capacity of $125 million. Cash flow from operations increased $1.1 million to $44.7 million, while free cash flow increased $10.7 million to $26.4 million.

2017 Outlook

For the year ending December 31, 2017, the Company expects the following results, assuming exchange rates are the same as those currently prevailing.

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27 Feb

Amedica Announces Results of Independent Femoral Head Wear Testing

SALT LAKE CITY, UT--(Marketwired - Feb 27, 2017) - Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, announced today that Researchers from the Department of Orthopaedic Surgery of Tokyo Medical University (Shinjuku-ku, Tokyo, Japan) led by Professor Kengo Yamamoto MD PhD recently completed a five million cycle (Mc) comparative hip simulator study examining the wear behavior of an advanced highly cross-linked and vitamin E stabilized polyethylene (E1® Zimmer-Biomet, Warsaw, IN, USA) against two different types of ceramic femoral heads -- MC2®silicon nitride (Amedica Corporation, Salt Lake City, UT, USA) and BIOLOX®delta (CeramTec, Plochingen, Germany). BIOLOX®delta is currently considered the "gold standard" for ceramic femoral head materials. While the polyethylene wear loss induced by both types of ceramic heads was extremely small (< 0.60 mg/Mc), mean wear associated with MC2®silicon nitride heads was approximately 15% lower than the BIOLOX®delta components. This independent wear study was conducted in accordance with international standards at the Medical Technology Laboratory of the Rizzoli Orthopaedic Institute (Bologna, Italy) by Professor Aldo Toni MD under the supervision of Dr. Saverio Affatato PhD (Rizzoli Institute) with consultation and support from Professor Giuseppe Pezzotti PhD (Ceramic Physics Laboratory, Kyoto Institute of Technology, Sakyo-ku, Kyoto Japan). Amedica and Zimmer-Biomet (Tokyo Office) provided the femoral heads and acetabular liners; however, neither company actively sponsored the research. The testing was independently conceived by Professors Yamamoto and Pezzotti, and funded by the Department of Orthopaedic Surgery of Tokyo Medical University. This is the first reported improvement in polyethylene wear performance by a ceramic other than BIOLOX®delta; and it is part of a series of planned comparative wear tests that will culminate at 12 Mc. Further details of this interim hip simulation test will be provided in a joint publication planned for release in a scientific journal. "We are thrilled, though not surprised, at the remarkable wear properties of silicon nitride femoral heads," said Dr. B. Sonny Bal, CEO and President of Amedica Corporation. "Our previous work, already published in peer-review forums, has shown superb phase stability of silicon nitride in vivo, plus oxygen-scavenging properties that may confer long-term protection to polyethylene acetabular liners, along with bacterial resistance inherent in silicon nitride, toughness that is superior to any other biomaterial, and resistance to corrosion. The present wear data reflect the considerable scientific work that went into a thorough understanding of the surface chemistry and composition of our femoral heads, with development of engineering processes and proprietary methods that lead to a consistent, ultra-smooth articulating surface. Taken together, this favorable combination of properties, supported by scientific data, reflect material science advancements that are necessary to differentiate total hip replacements in an otherwise commoditized market, and more importantly, toward extending the longevity of hip replacements beyond the second decade of life, post-implantation. These data will contribute to our continuing work and dialogue with the FDA to get the product approved for use clinically." About Amedica Corporation Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world's largest ceramic manufacturer. Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its OEM partnerships. For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com. Forward-Looking Statements This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties. For example, there can be no assurance that we will be able to maintain our listing on any NASDAQ market. Other factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica's Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 23, 2016, and in Amedica's other filings with the SEC. 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 INFORMATION

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