Invibio Investing to Accelerate Innovation for Medical Device Companies

Invibio Biomaterial Solutions has implemented a series of investments to help achieve the best possible clinical outcomes and lower total healthcare costs, a challenge faced by both the medical profession and industry, including medical device companies, globally. By assisting medical device companies to change the way they develop new products Invibio is focused on accelerating the time-to-market of new innovations. To deliver on this and provide greater clinical efficacies, the company has invested in clinical-study expertise, component manufacturing facilities and component testing. The innovator of implantable PEEK-OPTIMA™ polymer is also launching a new website that efficiently provides information on materials and applications to OEMs and Health Care Professionals (HCPs), and a comprehensive journal with further scientific information and clinical evidence.

John Devine, Medical Business Director at Invibio Biomaterial Solutions explains the quandary of innovative medical device makers: “When faced with delivering a consistent quality of healthcare at the lowest cost, the market has yet to create an environment that encourages more ambitious solutions than simply preserving the status quo at a fractionally reduced price.”

Redefining the total cost of care

Defining “best clinical outcomes” while delivering healthcare at the lowest possible cost is challenging, because clinical outcomes are typically obtained through clinical studies, which are expensive and time-consuming. In addition, there could be variations in the level of clinical evidence by region and different types of stakeholders and their needs, which can, for example, depend on where they sit on the curve of the diffusion of innovation. As a consequence, the medical device industry faces a difficult task, when seeking to demonstrate that new product innovations are addressing these issues and, ultimately, improving patient care.

John Devine sums it up: “The majority of current cost metrics focus on up-front purchasing costs rather than the total cost of care. For example, no standards exist for accurately assessing complication rates, or measuring the cost of revision surgeries, and reflecting these in purchasing decisions.”

As a leading pioneer in the use of PEEK-OPTIMA polymer solutions in medical applications, Invibio is convinced it can deliver the greatest clinical and economic benefits in four key areas, Dental, Spine, Orthopedics, and Trauma.

Establish and maintain clinical efficacy

To help raise its own bar for patient care and provide even greater clinical efficacy, Invibio recently recruited a clinical study manager and is working with Health Care Professionals (HCPs), medical device manufacturers and other stakeholders to determine the clinical and economic impact of its solutions. The company has also brought in clinical relations expertise to interact with HCPs, hospitals and payers. Martin Court, Executive Director at Victrex, emphasizes: “Doing so ensures that the clinical evidence we develop is not only shared in the marketplace, but accurately supports the benefits our materials can offer patients and the entire healthcare community.” As a result of these enhanced research and clinical data capturing efforts, Invibio has become more certain of the effectiveness of its solutions.

Investments in component manufacturing and testing

In addition, the company´s investments have made it easier for medical device companies to innovate and change the way they develop new products. Court continues: ”Our investment in component manufacturing facilities and component testing, for example, gives us a greater role in the design, development and commercialization of trauma fracture plates made of PEEK-OPTIMA™ Ultra Reinforced, a carbon-fiber-reinforced polymer. We have also pledged more support for our customers’ new product development programs. In addition, we are continuing to help customers worldwide navigate the challenging, regulatory pathway toward product safety and efficacy. It’s a win-win for Invibio, our customers, and patients alike.”

“Invibio Insider” journal and a new website for additional insights

Invibio is also launching a new comprehensive annual journal, the “Invibio Insider”, the first edition of which offers a detailed insight into key topics that will help to pioneer progress in the medical arena. Focused topics are intended to provide a greater understanding of the levels of clinical evidence, and what that may mean in combination with the company´s strategic drive to improve patient and clinical outcomes. It also explores approaches for treating challenging patients, taking into account the HCP’s perspective, and showcases recent clinical evidence while also discussing its potential economic impact.

The company´s new website will serve as a hub for OEMs and Health Care Professionals (HCPs) alike. For OEMs, it is a go-to practical and educational resource for implantable PEEK related knowledge and clinical data, including product offerings, manufacturing, quality and partnering for custom-design and regulatory services. For HCPs, it aims to facilitate the clinical adoption of new medical devices made of the company´s high-performance polymer, by providing implantable PEEK-related knowledge, clinical data and information concerning the potential benefits of Invibio´s solutions for HCPs and ultimately their patients. With a new emphasis on clinical evidence and an easy to navigate online academy, Invibio is not only addressing the needs of different target groups, but also hoping to contribute to achieving the best possible clinical outcomes and lowering the total costs of care.

Further information is available on Invibio´s new website: https://invibio.com.

About Invibio Biomaterial Solutions 
Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in ~9 million implanted devices worldwide. INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved.

About Victrex plc
Victrex is an innovative world leader in high performance polymer solutions, focused on the strategic markets of automotive, aerospace, energy (including manufacturing & engineering), electronics and medical. Every day, millions of people use products and applications, which contain our materials – from smart phones, aeroplanes and cars to oil and gas operations and medical devices. With over 35 years’ experience, we develop world leading solutions in PEEK and PAEK-based polymers, and selected semi-finished and finished parts which shape future performance for our customers and our markets, and drive value for our shareholders. Find out more at http://www.victrex.com

MiMedx Market Leadership Well Positioned In Light Of FDA New Guidance Document

MARIETTA, Ga.Nov. 17, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the Food and Drug Administration (FDA) issued numerous Final and Draft Guidance documents.  Among them was the final Guidance document related to human tissue titled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use” (the “HCT/P Guidance”).  Additionally, “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies,” Draft Guidance for Industry was published (the “RMAT Guidance”).

In the final HCT/P Guidance document, FDA updated and clarified its previous draft Guidance documents regarding HCT/Ps. In summary, MiMedx views the final HCT/P Guidance document as generally beneficial to the Company, physicians and patients.  Bill Taylor, President and Chief Operating Officer, commented, “While there are a few items that are not consistent with the regulations, in general, we believe it should be viewed as a positive development in the industry.  MiMedx is by far the leader in clinical and scientific studies and related publications on placental tissue.  This places the Company years ahead of its competition.  Note that the Final Guidance is largely in line with the MiMedx expectations for both micronized and sheet products as discussed on the Company’s September 2016 conference call.  As expected, MiMedx’s sheet products are largely unaffected, but may require slight changes to the Company’s labeling and marketing documents.  MiMedx micronized products are the subject of our four ongoing IND/BLA clinical studies.”

In FDA’s news release announcing the final HCT/P Guidance document, the Agency also stated that it would “apply a risk-based approach to enforcement,” and “for the first 36 months following issuance of the final guidance document, the FDA intends to exercise enforcement discretion for certain products.”  In contrast, “the FDA does not intend to exercise such enforcement discretion for those products that pose a potential significant safety concern,” noting that “this risk-based approach allows product manufacturers time to engage with the FDA, and to determine if they need to submit a marketing authorization application.”  MiMedx has a proven track record of safety based on its experience in distributing over 1 million allografts. The Company’s products have been allowed to proceed to Phase 3 with its plantar fasciitis and Achilles tendonitis Investigational New Drug/Biologic License Application (IND/BLA) studies.

The HCT/P Guidance document addresses many aspects of HCT/Ps, with the two most relevant items to MiMedx being Minimal Manipulation and Homologous Use.  Minimal Manipulation relates to the way the tissue is processed and Homologous Use refers to the “intended use” as reflected by labeling, advertising, etc.

Taylor commented, “The HCT/P Guidance document clearly reiterates that products such as the MiMedx amniotic tissue in sheet form are considered to be minimally manipulated.  This is consistent with the previous FDA positioning and what has been communicated to MiMedx by FDA.”

The final HCT/P Guidance document also maintains FDA’s position that micronized amnion is more than minimally manipulated.  Parker H. “Pete” Petit, Chairman and Chief Executive Officer, said, “Although MiMedx still believes this is a flawed position and is not consistent with the HCT/P preamble and regulations, MiMedx has been following the IND/BLA pathway since 2014.  At present, MiMedx has four IND clinical trials under way for our micronized amniotic tissue, AmnioFix® Injectable.  Two of the studies are for plantar fasciitis (Phase 2B and 3), one for Achilles tendonitis (Phase 3), and the fourth is for osteoarthritis of the knee (Phase 2B).  Based on the work we have done over the past four years and the finalization of this guidance document, MiMedx believes that we are years ahead of our competition relative to our micronized product platform.”

Taylor stated, “With respect to Homologous Use, FDA was largely consistent between the draft and final guidance issued as they relate to amniotic tissue.  The Agency’s position remains that homologous use of amniotic tissue would include its use as a cover or to offer protection in repair and reconstruction procedures.  MiMedx will review this Guidance Document and our marketing materials regarding our sheet products and determine what adjustments, if any, will be required.  As stated in our September 6, 2016 shareholder call, with the completion of our multicenter Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU) trials, when combined with the rest of our compendium of clinical data including an EpiFix® comparative RCT, MiMedx is well-positioned to file for IND/BLAs for specific indications for EpiFix, if we find it desirable to do so.  Recall that both of these studies were designed as adequate and well controlled trials able to support a BLA by adhering to FDA’s Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment.”

In a statement on the RMAT Guidance release, FDA Commissioner Scott Gottlieb, M.D. stated, “The suite of four guidance documents we are making public today also delivers on important provisions of the 21st Century Cures Act, including our continued promise to fully implement the Regenerative Medicine Advanced Therapy (RMAT) designation program, which is designed to expedite the development and review of regenerative medicine advanced therapies.”

The RMAT designation as laid out in the 21st Century Cures Act offers companies with regenerative medicine products such as MiMedx a pathway for conditional and expedited approvals.  In Dr. Gottlieb’s statement, he clearly signals the FDA’s commitment to fully implement the RMAT program.

Petit commented, “Related to our IND/BLA studies, MiMedx reminds shareholders that it issued a press release announcing that we were allowed to proceed with our Phase 2B IND for osteoarthritis.  Supporting osteoarthritis as a serious condition, the FDA guidance included hypothetical examples of regenerative medicine therapies, one of which is severe osteoarthritis.  The MiMedx IND/BLA for osteoarthritis protocol inclusion criteria addresses severity levels 2 and 3 which clearly aligns with severe osteoarthritis.  We plan to explore every pathway afforded by the FDA.  We are in the process of evaluating the steps needed in order to file for the RMAT designation for AmnioFix injectable and will update shareholders once we determine our pathway.”

“In summary, the finalization of this HCT/P Guidance document is generally in a form that MiMedx anticipated, and it should facilitate our continued progression with our IND/BLA studies.  We expect to have completed the prerequisites and be in a position to file our first BLA within the next two years or earlier if we get the RMAT designation. Importantly, we do not expect our forecasted revenue to change. Reimbursement for our sheet allografts is established for wound care and studies are completed. With micronized and RMAT guidance, we believe this could be a pathway to reducing timelines and accelerate our five-year revenue growth. MiMedx is clearly the leader in our market sector; this reinforces and enhances our position in relation to the rest of the market,” concluded Petit.

MiMedx also reiterates its revenue guidance for the fourth quarter and full year 2017:

  • Fourth quarter of 2017 revenue forecasted to be in the range of $87 to $88 million
  • 2017 revenue guidance increased to the range of $320.6 to $321.6 million
  • Gross profit margins for 2017 expected to be in the range of 89% to 90%
  • GAAP EPS (FD) for 2017 projected to be in the range of $0.31 to $0.32
  • Adjusted EPS(FD)* for 2017 projected to be in the range of $0.31 to $0.32

About MiMedx
MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts.   MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding expectations for fourth quarter and full year 2017 revenue, full year 2017 gross profit margin, EPS and Adjusted EPS for 2017, statements regarding the significance of the draft guidance documents for MiMedx, the Company’s belief that it is years ahead of competitors in terms of its clinical study progress, and statements regarding the Company’s belief that it might qualify for RMAT designation for certain applications and that this could accelerate associated product revenues. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.  Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that actual fourth quarter and full year 2017 financials may not materialize as expected; the draft guidance documents may not be implemented as expected; unexpected results or concerns may arise from data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals; advantages in clinical studies progress may not translate into market advantage; and the Company may not qualify for RMAT designation for certain applications, or even if the Company obtains RMAT designation for certain applications, this may not translate into accelerated revenues.  For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

Fellowship Trained Orthopedic Spine Surgeon, Dr. Mark McFarland, Completes Successful Outpatient Surgery Using SpineFrontier’s (LES®) Technology

Orthopedic Surgeon Dr. Mark McFarland utilized SpineFrontier’s newly updated angled driver design – in accordance with A-CIFT SoloFuse-P technology – in a successful C4-6 anterior cervical discectomy and fusion on Tuesday, Nov. 14, at Mary Immaculate Hospital in Newport News, Va. The patient was discharged and on her way home within two hours of surgery, currently recovering with arm and shoulder pain resolution.

Dr. McFarland performed the surgery on a 68 year old female patient – who was experiencing radiating pain in both her shoulders and upper arms, along with neck pain and discomfort. She noticed the pain was much worse in the mornings and often radiated past her elbows, especially on the right side. MRI revealed a central broad based disc protrusion at C4-5, which resulted in moderate to severe central stenosis. Additionally, the MRI revealed a moderate posterolateral bone disc complex combined with an annular bulge at C5-6, which resulted in right foraminal narrowing and moderate central stenosis. Prior to undergoing surgery, the patient had failed conservative treatments, including epidural steroid injections, anti-inflammatory medications and home exercise programs.

Dr. McFarland remarked on the advantages of the A-CIFT SoloFuse-P and angled driver, crediting the “zero profile implant design” in providing “a great option for outpatient surgery.” “The newly updated angled driver further enhances the ease-of-use and simplicity of the system,” he said.

SpineFrontier’s A-CIFT SoloFuse-P is a Less Exposure Surgery (LES) technology designed with both patients and surgeons at the forefront. The A-CIFT SoloFuse-P standalone vertebral body fusion device is an LES system – featuring a simple, dual screw construct, a large graft window, large diameter screws and slim, agile instrumentation. Its zero-profile and all PEEK-OPTIMA® Natural design minimize tissue disruption.

Dr. McFarland currently practices at the Orthopaedic & Spine Center in Newport News, Va., where he focuses primarily on the care and treatment of injuries and disorders of the spine. Dr. McFarland graduated from Oklahoma State University Medical School in 1999. He completed his residency in orthopedic surgery at Ohio University and went on to complete an Orthopedic Spine Surgery Fellowship at the Florida Spine Institute in Clearwater, Fla. Dr. McFarland is a member of the American Academy of Orthopedic Surgeons and the American College of Osteopathic Surgeons. He received the “Graduating Physician Academic Excellence Award” and his research includes studies on vertebral compression fracture outcomes. Dr. McFarland has also been recognized as a “Hampton Roads Top Doc” for the past five years in a survey of physicians conducted by Coastal Virginia Magazine, among other honors.

About SpineFrontier Inc. 
SpineFrontier is a growing medical technology company that designs, develops and markets both implants and instruments for spine surgery based on the Less Exposure Surgery (LES®) Philosophy. These technologies are designed to allow for outpatient surgery due to minimal disruption of normal tissues. SpineFrontier believes LESS is more: LESS time in treatment and recovery is more time in action for patients and surgeons. SpineFrontier is headquartered in Malden, Mass. and was founded in 2006. SpineFrontier is a KICVentures portfolio company and the leader in LES technologies and instruments.

NuVasive To Participate In The 29th Annual Piper Jaffray Healthcare Conference

SAN DIEGONov. 16, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today that NuVasive management will be presenting at the Piper Jaffray 29th Annual Healthcare Conference at the Lotte New York Palace in New York City on Wednesday, November 29 at 8:30 a.m. ET / 5:30 a.m. PT.

A live webcast of the presentations will be available online from the Investor Relations page of the Company’s website at nuvasive.com. A replay of the presentations will remain available on the website for 30 days after the applicable live webcast.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

Federal Jury Returns $247 Million Verdict in Defective Hip Implants Case

DALLASNov. 16, 2017 /PRNewswire/ — A federal court jury in Texas returned a $247 million verdict on behalf of six people who suffered serious medical complications caused by the defective metal-on-metal hip implants made by Johnson & Johnson (NYSE: JNJ) and its subsidiary DePuy Orthopaedics Inc.

The one-man, seven-woman jury deliberated for 14 hours before reaching its verdict, which includes more than $78 million in compensatory damages for the six plaintiffs and more than $168 million in punitive damages assessed against Johnson & Johnson and DePuy.

The verdict, delivered November 16, 2017, follows claims filed by New York residents Ramon AliceaUriel BarzelKaren KirschnerHazel MiuraMichael Stevens, and Eugene Stevens who received DePuy’s Pinnacle Acetabular Cup System hip implant. The plaintiffs alleged that the devices had unreasonably high failure rates resulting in severe pain and inflammation, bone erosion, tissue loss and other problems. The victims further claimed that DePuy officials knew about the dangers of the Pinnacle hip implants but failed to warn doctors or patients.

“We thank this jury for sending a very strong message about the responsibility the defendants have to take care of their consumers,” said lead attorney Mark Lanier of The Lanier Law Firm in Houston. “Unfortunately, it took the defendants putting the plaintiffs through burdensome litigation before justice could be served. The companies should have done the right thing when these serious medical concerns became known many years ago.”

The trial was the fourth “bellwether” in the multidistrict litigation (MDL) consolidating more than 9,000 similar lawsuits nationwide. Bellwether trials are set to establish evidence and evaluate witness testimony that is representative of the issues involved in mass litigation. Two previous trials involving plaintiffs from California and Texas resulted in verdicts of $502 million and $1.04 billion.

The case, presided over by U.S. District Court Judge Ed Kinkeade of the Northern District of Texas, is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, No. 3:11-md-02244.

With offices in HoustonNew York and Los Angeles, The Lanier Law Firm is committed to addressing client concerns with effective and innovative solutions in courtrooms across the country. The firm is composed of outstanding trial attorneys with decades of experience handling cases involving pharmaceutical liability, asbestos exposure, commercial litigation, product liability, maritime law, and sports and entertainment law. Visit http://www.lanierlawfirm.com.

Contact:
J.D. Cargill
The Lanier Law Firm
713-659-5200 or jdc@lanierlawfirm.com

 

SOURCE The Lanier Law Firm

Related Links

http://www.lanierlawfirm.com

Titan Spine Announces the First Endoskeleton® Interbody Fusion Cases in Australia

November 16, 2017

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced the first surgeries in Australia using the Company’s proprietary Endoskeleton® interbody fusion devices and surface technology, marking the Company’s entry into a robust new market. The first two ALIF cases were performed successfully in October by Dr. Richard Laherty, MBBS FRACS CIME, spine surgeon at Queensland Neurosurgery and Spine Surgery at the Princess Alexandra Hospital near Brisbane.

Dr. Laherty commented, “I have been keeping up on the wealth of studies Titan Spine has published on their proprietary surface technologies over the years that have consistently shown the ability to create a superior osteogenic environment over other materials and surfaces. I was pleased to finally have the opportunity to use the Endoskeleton® titanium devices featuring Titan’s unique surface technology at the macro, micro and cellular level for these procedures. In the first few weeks following these initial cases, we have observed favorable patient outcomes in both cases, and I look forward to offering the Endoskeleton® devices to more of my patients moving forward.”

Titan Spine received registration approval from the Australian Therapeutic Goods Administration (TGA) in June 2014 to commercially market its full line of Endoskeleton® interbody fusion devices in the country.

Kevin Gemas, President of Titan Spine, added, “Over the past few years we have focused our attention primarily in the U.S. and portions of the EU to educate on and demonstrate the value of our titanium devices featuring our differentiated surface technology. After securing the CMS new technology ICD-10 code, expanding our U.S. sales force, and achieving strong domestic revenue acceleration, we are also now focusing on select OUS markets, such as Australia, that we feel can add to our top and bottom lines. We anticipate tremendous growth in this new region to drive substantial growth for Titan in the coming quarters and beyond.”

Titan Spine offers a full line of Endoskeleton® titanium implants that feature its proprietary surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and cellular levels. This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.1,2,3 All Endoskeleton® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of unique interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S., portions of Europe, and Australia through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.

Contacts

Company
Titan Spine
Andrew Shepherd, 866-822-7800
ashepherd@titanspine.com
or
Media
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com

Kuros Announces Management Changes

Schlieren (Zurich), Switzerland, November 16, 2017

Kuros Biosciences AG announced today the promotion of Dr. Joost de Bruijn to Chief Executive Officer (CEO), effective December 4, 2017. Dr. de Bruijn is co-founder and current managing director of Kuros Biosciences BV (formerly known as Xpand Biotechnology BV), a wholly owned subsidiary of Kuros. Dr. Ivan Cohen-Tanugi has decided to step down as CEO and member of the Board of Directors. Further, Kuros’ founding CEO and current President, Didier Cowling, will retire from the Executive Management team to serve as a senior advisor to the CEO and continue to serve as a Director on the company’s Board.

During the course of 2017, Kuros has made significant progress with its lead program MagnetOs, a novel synthetic bone graft substitute designed to regenerate bone in the implanted site in the body, which received clearance in the US and in Europe for commercial sale. Currently, the Company is preparing the launch of the product.

Dr. Christian Itin, Chairman of the Board commented: “We welcome Joost as the new CEO of Kuros and are looking forward to his leadership of the Company. With his intimate knowledge of our key products, and the orthobiologics space, he is very well positioned to take the Company to its next stage.”

Dr. Joost de Bruijn commented: “I am delighted and honored by the trust of the Board to take on the role of CEO. We have significant opportunities with MagnetOs and KUR-111/KUR-113 to build an outstanding orthobiologics company and, together with the team, I look forward to bringing our products to market and building value for patients and shareholders.”

Dr. Christian Itin added: “We would like to thank Dr. Ivan Cohen-Tanugi for making progress towards commercial launch during a transitional year highlighted by product approvals and wish him all the best in his future endeavors. Also, the Board would like to thank Didier Cowling for his valued and dedicated service to the Company as its founding CEO and for supporting the Company to reach commercial stage.”

About Joost de Bruijn

Dr. Joost de Bruijn founded Xpand Biotechnology BV in 2005 and was managing director ever since. He holds the positions of Professor of Biomaterials at Queen Mary University of London, UK (since 2004) and Professor of Regenerative Medicine and Entrepreneurship at Twente University, the Netherlands (since 2011). In 2007, he founded Progentix Orthobiology that signed an exclusive development agreement with NuVasive in 2009 for a novel family of calcium phosphate synthetic bone substitutes. Prior to founding Xpand he was Research Director Bone at IsoTis for seven years, during which he specialized in bone tissue engineering technologies that were brought to clinical application. Dr. de Bruijn has more than 20 years of experience in academia and the life science industry. He has published 165 papers in peer-reviewed journals, and is the inventor of 24 patent families. Dr. de Bruijn is scientific editor and reviewer for numerous international biomaterials, tissue engineering and regenerative medicine journals. He received his PhD from Leiden University in 1993.

For further information, please contact:

Kuros Biosciences AG

Harry Welten

Chief Financial Officer

Tel: +41 44 733 46 46

harry.welten@kurosbio.com

About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

Media Release (PDF)

 

Kuros Biosciences Ltd, Wagistrasse 25, CH-8952 Schlieren

Diamond Orthopedic, LLC Closes $3.5MM in Seed Funding

Diamond Orthopedic, LLC, a medical device company that offers a revolutionary fixation technology to achieve better patient outcomes at a lower total cost, announced today it has successfully closed its $3.5 million seed round of equity funding. The capital raise, led by MagnaSci Fund L.P., is the Company’s first equity offering since its inception on March 1, 2017.

Diamond’s signature technology is a faceted threadform that has been deployed in an FDA cleared faceted bone screw. As evidenced by significant bench testing, the new threadform design demonstrates superior performance as compared to conventional helical threadforms.

With its initial capital raise complete, experienced management team, seasoned advisory board, and patented new technology, Diamond Orthopedic is positioned for success in the nearly $50 billion orthopedic market. Diamond Orthopedic has exclusive rights to market and sell over 2,500 FDA cleared SKUs of cortical, cancellous, headless compression, and external fixation screws.

“We are excited about the ability to launch our faceted bone screw technology with this round of capital investment,” says Board Chairman Charlie Federico. “With the market encouragement we’ve received thus far, we look forward to providing surgeons and patients with this superior technology.”

Diamond’s patented faceted threadform is designed to reduce friction and compressive stress at the bone-screw interface. Lower compressive stress and the reduced insertion torque required to drive the screw and/or threaded pins into bone reduces the potential for microfractures. When paired with the viscoelastic properties of bone, the faceted threadform demonstrates superior fixation as compared to conventional helical threadforms. Many promising applications of the faceted threadform exist within the orthopedic market, especially in cases where compromised bone is a factor.

“Faceted bone screws offer superior fixation performance in both healthy and compromised bone,” says CEO Roy Bivens. “We are very excited about the possibilities for this technology in a multitude of applications, from specific procedures where superior fixation is paramount, such as triple arthrodesis, to the full spectrum of applications ranging from healthy-boned athletes to compromised bone, such as osteoporotic and osteopenic bone.”

He adds “our faceted technology has the potential to change numerous paradigms within orthopedics, including uni-cortical fixation possibilities.”

About Diamond Orthopedic 
Diamond Orthopedic, LLC, headquartered in Charlotte, NC, is a medical device company that offers a revolutionary fixation technology to achieve better patient outcomes at a lower total cost. Diamond Orthopedic is the exclusive provider of faceted threadform technology for orthopedic applications worldwide. With proven superiority over traditional helical threadforms, Diamond Orthopedic is the new fixation standard in orthopedics.

Media Contact:

Guillaume Viallaneix
MedTech Momentum
Phone: 407-960-2994
Email: guillaume(at)medtechmomentum(dot)com

Diamond Orthopedic Contact:

1600 Camden Road
Charlotte, NC, 28203
Phone: 704-585-8270
Email: info(at)diamondortho(dot)com

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 risk factors contain certain forward-looking statements that involve risks and uncertainties. These statements relate to the Company’s future plans, objectives, expectations and intentions. The Company’s actual results could differ materially from those discussed in these statements. It is difficult to accurately predict the impact of each of these risks on the Company due to the dependence on many factors outside the Company’s control. These risks and uncertainties include, but are not limited to, factors affecting our financial 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 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. 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.

Bioengineered Robotic Hand With Its Own Nervous System Will Sense Touch

Credit: Florida Atlantic University

BOCA RATON, Fla.Nov. 15, 2017 /PRNewswire-USNewswire/ — The sense of touch is often taken for granted. For someone without a limb or hand, losing that sense of touch can be devastating. While highly sophisticated prostheses with complex moving fingers and joints are available to mimic almost every hand motion, they remain frustratingly difficult and unnatural for the user. This is largely because they lack the tactile experience that guides every movement. This void in sensation results in limited use or abandonment of these very expensive artificial devices. So why not make a prosthesis that can actually “feel” its environment?

That is exactly what an interdisciplinary team of scientists from Florida Atlantic University and the University of Utah School of Medicine aims to do. They are developing a first-of-its-kind bioengineered robotic hand that will grow and adapt to its environment. This “living” robot will have its own peripheral nervous system directly linking robotic sensors and actuators. FAU’s College of Engineering and Computer Science is leading the multidisciplinary team that has received a four-year, $1.3 million grant from the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health for a project titled “Virtual Neuroprosthesis: Restoring Autonomy to People Suffering from Neurotrauma.”

With expertise in robotics, bioengineering, behavioral science, nerve regeneration, electrophysiology, microfluidic devices, and orthopedic surgery, the research team is creating a living pathway from the robot’s touch sensation to the user’s brain to help amputees control the robotic hand. A neuroprosthesis platform will enable them to explore how neurons and behavior can work together to regenerate the sensation of touch in an artificial limb.

At the core of this project is a cutting-edge robotic hand and arm developed in the BioRobotics Laboratory in FAU’s College of Engineering and Computer Science. Just like human fingertips, the robotic hand is equipped with numerous sensory receptors that respond to changes in the environment. Controlled by a human, it can sense pressure changes, interpret the information it is receiving and interact with various objects. It adjusts its grip based on an object’s weight or fragility. But the real challenge is figuring out how to send that information back to the brain using living residual neural pathways to replace those that have been damaged or destroyed by trauma.

“When the peripheral nerve is cut or damaged, it uses the rich electrical activity that tactile receptors create to restore itself. We want to examine how the fingertip sensors can help damaged or severed nerves regenerate,” said Erik Engeberg, Ph.D., principal investigator, an associate professor in FAU’s Department of Ocean and Mechanical Engineering, and director of FAU’s BioRobotics Laboratory. “To accomplish this, we are going to directly connect these living nerves in vitro and then electrically stimulate them on a daily basis with sensors from the robotic hand to see how the nerves grow and regenerate while the hand is operated by limb-absent people.”

For the study, the neurons will not be kept in conventional petri dishes. Instead, they will be placed in biocompatible microfluidic chambers that provide a nurturing environment mimicking the basic function of living cells. Sarah E. Du, Ph.D., co-principal investigator, an assistant professor in FAU’s Department of Ocean and Mechanical Engineering, and an expert in the emerging field of microfluidics, has developed these tiny customized artificial chambers with embedded micro-electrodes. The research team will be able to stimulate the neurons with electrical impulses from the robot’s hand to help regrowth after injury. They will morphologically and electrically measure in real-time how much neural tissue has been restored.

Jianning Wei, Ph.D., co-principal investigator, an associate professor of biomedical science in FAU’s Charles E. Schmidt College of Medicine, and an expert in neural damage and regeneration, will prepare the neurons in vitro, observe them grow and see how they fare and regenerate in the aftermath of injury. This “virtual” method will give the research team multiple opportunities to test and retest the nerves without any harm to subjects.

Using an electroencephalogram (EEG) to detect electrical activity in the brain, Emmanuelle Tognoli, Ph.D., co-principal investigator, associate research professor in FAU’s Center for Complex Systems and Brain Sciences in the Charles E. Schmidt College of Science, and an expert in electrophysiology and neural, behavioral, and cognitive sciences, will examine how the tactile information from the robotic sensors is passed onto the brain to distinguish scenarios with successful or unsuccessful functional restoration of the sense of touch. Her objective: to understand how behavior helps nerve regeneration and how this nerve regeneration helps the behavior.

Once the nerve impulses from the robot’s tactile sensors have gone through the microfluidic chamber, they are sent back to the human user manipulating the robotic hand. This is done with a special device that converts the signals coming from the microfluidic chambers into a controllable pressure at a cuff placed on the remaining portion of the amputated person’s arm. Users will know if they are squeezing the object too hard or if they are losing their grip.

Engeberg also is working with Douglas T. Hutchinson, M.D., co-principal investigator and a professor in the Department of Orthopedics at the University of Utah School of Medicine, who specializes in hand and orthopedic surgery. They are developing a set of tasks and behavioral neural indicators of performance that will ultimately reveal how to promote a healthy sensation of touch in amputees and limb-absent people using robotic devices. The research team also is seeking a post-doctoral researcher with multi-disciplinary experience to work on this breakthrough project.

“This National Institutes of Health grant will help our interdisciplinary team of scientists address an important challenge that impacts millions of people worldwide,” said Stella Batalama, Ph.D., dean and professor of FAU’s College of Engineering and Computer Science. “By providing a better understanding of how to repair nerve injuries and trauma we will be able to help patients recover motor functionality after an amputation. This research also has broad applications for people who suffer from other forms of neurotrauma such as stroke and spinal cord injuries.”

The early stages of this project were supported by FAU’s Institute for Sensing and Embedded Network Systems (I-SENSE). Researchers also are working in collaboration with I-SENSE and FAU’s Brain Institute, two of the University’s research pillars, focused on institutional strengths.

About FAU’s College of Engineering and Computer Science:

Florida Atlantic University’s College of Engineering and Computer Science is committed to providing accessible and responsive programs of education and research recognized nationally for their high quality. Course offerings are presented on-campus, off-campus, and through distance learning in bioengineering, civil engineering, computer engineering, computer science, electrical engineering, environmental engineering, geomatics engineering, mechanical engineering and ocean engineering. For more information about the college, please visit eng.fau.edu.

About Florida Atlantic UniversityFlorida Atlantic University, established in 1961, officially opened its doors in 1964 as the fifth public university in Florida. Today, the University, with an annual economic impact of $6.3 billion, serves more than 30,000 undergraduate and graduate students at sites throughout its six-county service region in southeast Florida. FAU’s world-class teaching and research faculty serves students through 10 colleges: the Dorothy F. Schmidt College of Arts and Letters, the College of Business, the College for Design and Social Inquiry, the College of Education, the College of Engineering and Computer Science, the Graduate College, the Harriet L. Wilkes Honors College, the Charles E. Schmidt College of Medicine, the Christine E. Lynn College of Nursing and the Charles E. Schmidt College of Science. FAU is ranked as a High Research Activity institution by the Carnegie Foundation for the Advancement of Teaching. The University is placing special focus on the rapid development of critical areas that form the basis of its strategic plan: Healthy aging, biotech, coastal and marine issues, neuroscience, regenerative medicine, informatics, lifespan and the environment. These areas provide opportunities for faculty and students to build upon FAU’s existing strengths in research and scholarship. For more information, visit fau.edu.

Media Contact:
Gisele Galoustian
Media Relations Director, Research
ggaloust@fau.edu
Phone: 561-297-2676

This news release was issued on behalf of Newswise(TM). For more information, visit http://www.newswise.com.

 

SOURCE Florida Atlantic University

Related Links

http://www.fau.edu

DJO Global Announces Financial Results for Third Quarter 2017

November 14, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced financial results for its public reporting subsidiary, DJO Finance LLC (“DJOFL”), for the third quarter ended September 30, 2017.

Third quarter Financial Highlights

  • Net sales grew 1.3% to $290.9 million, or 0.3% at constant currency rates.
  • Net loss attributable to DJOFL was $22.7 million compared to $22.6 million in the prior year period.
  • Adjusted EBITDA increased 5.5% to $66.8 million.

Business Transformation Progress

  • Company’s transformation remains on track to deliver 7% to 10% annual cost reduction by the end of 2018.
  • Transformation actions taken to date expected to contribute $33 million savings over the next four quarters.

“The third quarter was another period of significant progress on DJO’s overall business transformation,” said Brady Shirley, DJO’s President and Chief Executive Officer. “Nine months into our journey, we are starting to see tangible results from our team’s hard work. Throughout this year we have continued to grow our global brands and our year-to-date results show the impact of our transformation, with Adjusted EBITDA growing at over three times the rate of revenue growth—the first time in many years we have had such sustained productivity improvement. Our productivity momentum will enable us to invest for even stronger growth as we exit 2017 and begin 2018. With clear evidence that our strategy is working, we remain committed to the rigorous execution of the initiatives that are critical to improving our operations, growing our global business and improving our customer experience.”

Sales Results

DJOFL achieved net sales for the third quarter of 2017 of $290.9 million, reflecting growth of 1.3%, or 0.3% on a constant currency basis. The Company estimates that net sales were negatively impacted by approximately $3.0 million as a result of the severe hurricanes in the U.S. during the third quarter of 2017. For the third quarter 2017, domestic and international shipping days did not differ materially from the third quarter of 2016. For the nine months ending September 30, 2017, sales grew 1.8% over the comparable period in 2016 to $874.0 million, or 2.4% on a sales per day, constant currency basis. The nine months ending September 30, 2017 included one less shipping day compared to the same period in 2016.

Net sales for the Surgical Implant segment grew 14.1% in the third quarter of 2017 to $46.6 million. Sales across all three implant subcategories (knee, hip and shoulder) again grew at double digit rates compared to the prior year. For the nine months ending September 30, 2017, Surgical Implant sales grew 15.6% over the comparable period in 2016, to $146.2 million.

Net sales for DJO’s International segment were $76.9 million in the third quarter of 2017, reflecting growth of 6.9% compared to the third quarter of 2016, or 2.6% on a constant currency basis. Growth was driven by stronger sales in the Company’s direct markets, primarily France, Australia, and Scandinavia. For the nine months ending September 30, 2017, International sales grew 3.4% to $234.8 million, or 4.5% on a sales per day, constant currency basis over the comparable period in 2016.

Net sales for DJO’s Recovery Sciences segment were $39.3 million in the third quarter of 2017, a decline of 1.1% compared to the third quarter of 2016. Growth in the segment’s Chattanooga rehabilitation equipment and consumer product line were offset by a decline in Regeneration CMF product in the quarter compared to the prior year period. For the nine months ending September 30, 2017, Recovery Sciences sales grew 1.6% over the comparable period in 2016 to $116.6 million.

Net sales for DJO’s Bracing and Vascular segment were $128.0 million in the third quarter of 2017, a decline of 4.8%, compared to the third quarter of 2016, reflecting moderate weakness across the Company’s bracing and support products, as well as continued pressure in the Company’s Dr. Comfort product line. For the nine months ending September 30, 2017, Bracing and Vascular sales declined 3.6% from the comparable period in 2016 to $376.4 million.

Earnings Results

For the third quarter of 2017, DJOFL reported a net loss of $22.7 million, compared to a net loss of $22.6 million for the third quarter of 2016. As detailed in the attached financial tables, the results for the current and prior year third quarter periods and the current and prior year twelve-month periods were impacted by significant non-cash items, non-recurring items and other adjustments.

Adjusted EBITDA for the third quarter of 2017 was $66.8 million compared with Adjusted EBITDA of $63.3 million in the third quarter of 2016. For the nine months ending September 30, 2017, Adjusted EBITDA was $187.6 million compared with Adjusted EBITDA of $175.8 million in the first nine months of 2016. Including projected future savings from cost savings programs currently underway of $33.0 million as permitted under our credit agreement and the indentures governing our outstanding notes, Adjusted EBITDA for the twelve months ended September 30, 2017 was $280.1 million.

The Company defines Adjusted EBITDA as net (loss) income attributable to DJOFL plus net interest expense, income tax provision (benefit), and depreciation and amortization, further adjusted for certain non-cash items, non-recurring items and other adjustment items as permitted in calculating covenant compliance under the Company’s secured term loan and revolving credit facilities (“Senior Secured Credit Facilities”) and the indentures governing its 8.125% second lien notes and its 10.75% third lien notes. A reconciliation between net loss attributable to DJOFL and Adjusted EBITDA is included in the attached financial tables.

Net cash provided by continuing operating activities for the nine months ending September 30, 2017 was $61.7 million compared to $19.9 million for the same period of 2016. The improvement in cash flow was primarily attributable to working capital initiatives executed as part of the Company’s overall business transformation.

Conference Call Information

DJO has scheduled a conference call to discuss this announcement beginning at 4:30 pm, Eastern Time, Tuesday, November 14, 2017. Individuals interested in listening to the conference call may do so by dialing (866) 394-8509 (International callers please use (706) 643-6833), using the reservation code 22322226. A telephone replay will be available for 48 hours following the conclusion of the call by dialing (855) 859-2056 and using the above reservation code. The live conference call and replay will be available via the Internet at www.DJOglobal.com.

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation, enabling people to regain or maintain their natural motion. Its products are used by orthopaedic surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopaedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort® and Exos™. For additional information on the Company, please visit www.DJOglobal.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements relate to, among other things, the Company’s expectations for improved liquidity, estimated cost reductions associated with the execution of its business transformation plans and improved efficiencies. The words “believe,” “will,” “should,” “expect,” “target,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to the successful execution of the Company’s business transformation plans, including achievement of planned actions to improve liquidity, improvements in operational effectiveness, optimization of the Company’s procurement activities, improvements in manufacturing, distribution, sales and operations planning, and actions to improve the profitability of the mix of our product and customers. Other important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: business strategies relative to our Bracing and Vascular, Recovery Sciences, International and Surgical Implant segments; the continued growth of the markets the Company addresses and any impact on these markets from changes in global economic conditions; the impact of potential reductions in reimbursement levels and coverage by Medicare and other governmental and commercial payors; the Company’s highly leveraged financial position; the Company’s ability to successfully develop, license or acquire, and timely introduce and market new products or product enhancements; risks relating to the Company’s international operations; resources needed and risks involved in complying with government regulations and government investigations; the availability and sufficiency of insurance coverage for pending and future product liability claims; and the effects of healthcare reform, Medicare competitive bidding, managed care and buying groups on the prices of the Company’s products. These and other risk factors related to DJO are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 15, 2017. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.

DJO Finance LLC
Unaudited Condensed Consolidated Statements of Operations

(In thousands)

Three Months Ended Nine Months Ended
September September September September
30, 30, 30, 30,
2017 2016 2017 2016
Net sales $ 290,876 $ 287,040 $ 874,011 $ 858,798
Operating expenses:
Cost of sales (exclusive of amortization, see note 1) 122,325 122,533 366,779 361,090
Selling, general and administrative 122,066 114,788 391,967 358,344
Research and development 8,864 8,481 27,066 28,457
Amortization of intangible assets 15,852 18,994 50,713 57,657
269,107 264,796 836,525 805,548
Operating income 21,769 22,244 37,486 53,250
Other (expense) income:
Interest expense, net (43,691 ) (42,683 ) (129,446 ) (127,349 )
Other income (expense), net 824 (20 ) 2,008 732
(42,867 ) (42,703 ) (127,438 ) (126,617 )
Loss before income taxes (21,098 ) (20,459 ) (89,952 ) (73,367 )
Income tax provision (1,504 ) (2,166 ) (6,677 ) (11,156 )
Net loss from continuing operations (22,602 ) (22,625 ) (96,629 ) (84,523 )
Net income from discontinued operations 123 142 228 807
Net loss (22,479 ) (22,483 ) (96,401 ) (83,716 )
Net income attributable to noncontrolling interests (214 ) (99 ) (644 ) (461 )
Net loss attributable to DJO Finance LLC $ (22,693 ) $ (22,582 ) $ (97,045 ) $ (84,177 )

Note 1 — Cost of sales is exclusive of amortization of intangible assets of $6,981 and $20,942 for the three and nine months ended September 30, 2017 and $7,057 and $21,544 for the three and nine months ended September 30, 2016, respectively.

DJO Finance LLC
Unaudited Condensed Consolidated Balance Sheets

(In thousands)

September 30, December 31,
2017 2016
Assets
Current assets:
Cash and cash equivalents $ 39,018 $ 35,212
Accounts receivable, net 175,031 178,193
Inventories, net 158,928 151,557
Prepaid expenses and other current assets 24,218 23,650
Current assets of discontinued operations 511 511
Total current assets 397,706 389,123
Property and equipment, net 134,538 128,019
Goodwill 863,011 855,626
Intangible assets, net 622,460 672,134
Other assets 6,109 5,536
Total assets $ 2,023,824 $ 2,050,438
Liabilities and Deficit
Current liabilities:
Accounts payable $ 93,102 $ 63,822
Accrued interest 41,738 16,740
Current portion of debt obligations 14,593 10,550
Other current liabilities 130,941 113,265
Total current liabilities 280,374 204,377
Long-term debt obligations 2,372,850 2,392,238
Deferred tax liabilities, net 210,772 202,740
Other long-term liabilities 15,330 14,932
Total liabilities $ 2,879,326 $ 2,814,287
Commitments and contingencies
Deficit:
DJO Finance LLC membership deficit:
Member capital 841,907 844,294
Accumulated deficit (1,676,688 ) (1,579,642 )
Accumulated other comprehensive loss (22,551 ) (30,580 )
Total membership deficit (857,332 ) (765,928 )
Noncontrolling interests 1,830 2,079
Total deficit (855,502 ) (763,849 )
Total liabilities and deficit $

2,023,824

$ 2,050,438
DJO Finance LLC
Unaudited Segment Information

(In thousands)

Three Months Ended Nine Months Ended
September September September September
30, 30, 30, 30,
2017 2016 2017 2016
Net sales:
Bracing and Vascular $ 127,971 $ 134,421 $ 376,439 $ 390,388
Recovery Sciences 39,346 39,793 116,622 114,817
Surgical Implant 46,613 40,852 146,197 126,477
International 76,946 71,974 234,753 227,116
$ 290,876 $ 287,040 $ 874,011 $ 858,798
Operating income:
Bracing and Vascular $

27,060

$ 30,393 $

72,292

$

79,999

Recovery Sciences 11,322 7,683 30,938 22,184
Surgical Implant 9,126 7,908 27,328 21,190
International 14,894 11,657 42,013 35,299
Expenses not allocated to segments and eliminations (40,633 ) (35,397

)

(135,085

)

(105,422 )
$ 21,769 $ 22,244 $ 37,486 $ 53,250

DJO Finance LLC
Adjusted EBITDA

For the Three and Nine Months Ended September 30, 2017 and 2016
(unaudited)

Our Senior Secured Credit Facilities, consisting of a $1,055.0 million term loan facility (including a $20.0 million delayed draw term loan facility) and a $150.0 million asset-based revolving credit facility, under which $55.0 million was outstanding as of September 30, 2017, and the Indentures governing our $1,015.0 million of 8.125% second lien notes and $298.5 million of 10.75% third lien notes (collectively, the “notes”) represent significant components of our capital structure. Under our Senior Secured Credit Facilities, we are required to maintain a specified senior secured first lien leverage ratio, which is determined based on our Adjusted EBITDA. If we fail to comply with the senior secured first lien leverage ratio under our Senior Secured Credit Facilities, we would be in default. Upon the occurrence of an event of default under the Senior Secured Credit Facilities, the lenders could elect to declare all amounts outstanding under the Senior Secured Credit Facilities to be immediately due and payable and terminate all commitments to extend further credit. If we were unable to repay those amounts, the lenders under the Senior Secured Credit Facilities could proceed against the collateral granted to them to secure that indebtedness. We have pledged substantially all of our assets as collateral under the Senior Secured Credit Facilities and under the notes. Any acceleration under the Senior Secured Credit Facilities would also result in a default under the Indentures governing the notes, which could lead to the note holders electing to declare the principal, premium, if any, and interest on the then outstanding notes immediately due and payable. In addition, under the Indentures governing the notes, our and our subsidiaries’ ability to engage in activities such as incurring additional indebtedness, making investments, refinancing subordinated indebtedness, paying dividends and entering into certain merger transactions is governed, in part, by our ability to satisfy tests based on Adjusted EBITDA. Our ability to meet the covenants specified in the Senior Secured Credit Facilities and the Indentures governing those notes will depend on future events, some of which are beyond our control, and we cannot assure you that we will meet those covenants.

Adjusted EBITDA is defined as net income (loss) attributable to DJOFL plus interest expense, net, income tax provision (benefit), and depreciation and amortization, further adjusted for certain non-cash items, non-recurring items and other adjustment items as permitted in calculating covenant compliance and other ratios under our Senior Secured Credit Facilities and the Indentures governing the notes. We believe that the presentation of Adjusted EBITDA is appropriate to provide additional information to investors about the calculation of, and compliance with, certain financial covenants and other ratios in our Senior Secured Credit Facilities and the Indentures governing the notes. Adjusted EBITDA is a material component of these calculations.

Adjusted EBITDA should not be considered as an alternative to net income (loss) attributable to DJOFL or other performance measures presented in accordance with accounting principles generally accepted in the United States of America (“GAAP”), or as an alternative to cash flow from operations as a measure of our liquidity. Adjusted EBITDA does not represent net income (loss) attributable to DJOFL or cash flow from operations as those terms are defined by GAAP and does not necessarily indicate whether cash flows will be sufficient to fund cash needs. In particular, the definition of Adjusted EBITDA under our Senior Secured Credit Facilities and the Indentures governing the notes allows us to add back certain non-cash, extraordinary, unusual or non-recurring charges that are deducted in calculating net income (loss) attributable to DJOFL. However, these are expenses that may recur, vary greatly and are difficult to predict. While Adjusted EBITDA and similar measures are frequently used as measures of operations and the ability to meet debt service requirements, Adjusted EBITDA is not necessarily comparable to other similarly titled captions of other companies due to the potential inconsistencies in the method of calculation.

The following table provides reconciliation between net loss attributable to DJOFL and Adjusted EBITDA (in thousands):

Twelve
Months
Three Months Ended Nine Months Ended Ended
September September September September September
30, 30, 30, 30, 30,
2017 2016 2017 2016 2017
Net loss attributable to DJO Finance LLC $ (22,693 ) $ (22,582 ) $ (97,045 ) $ (84,177 ) $ (299,172 )
Income from discontinued operations, net (123 ) (142 ) (228 ) (806 ) (560 )
Interest expense, net 43,691 42,683 129,446 127,349 172,176
Income tax provision (benefit) 1,504 2,166 6,677 11,156 (11,330 )
Depreciation and amortization 26,285 29,031 83,001 88,208 112,686
Non-cash charges (a) 1,204 338 2,312 2,941 181,770
Non-recurring and integration charges (b) 15,712 9,895 59,296 25,832 82,139
Other adjustment items (c) 1,249 1,938 4,160 5,302 9,413
66,829 63,327 187,619 175,805 247,122
Permitted pro forma adjustments applicable to the twelve month period only (d)
Future cost savings 32,967
Adjusted EBITDA $ 66,829 $ 63,327 $ 187,619 $ 175,805 $ 280,089

(a) Non-cash charges are comprised of the following:

Twelve
Months
Three Months Ended Nine Months Ended Ended
September September September September September
30, 30, 30, 30, 30,
2017 2016 2017 2016 2017
Stock compensation expense $ 483 $ 285 $ 1,329 $ 1,806 $ 2,711

Loss on disposal of fixed assets and assets held for sale, net

721 (4 ) 983 886 1,046
Impairment of goodwill (1) 160,000
Inventory adjustments (2) 18,013
Purchase accounting adjustments (3) 57 249
Total non-cash charges $ 1,204 $ 338 $ 2,312 $ 2,941 $ 181,770
(1) Impairment of goodwill and intangible assets for the twelve months ended September 30, 2017 consisted of goodwill impairment charges of $99.0 million and $61.0 million related to the CMF and Vascular reporting units, respectively. The impairment charge for our CMF reporting unit resulted from reductions in our projected operating results and estimated future cash flows due to disruption caused by our exit of the Empi business. The impairment charge for our Vascular reporting unit resulted from reductions in our projected operating results and estimated future cash flows due to a loss of revenue caused by disruption as we transitioned our Dr. Comfort therapeutic footwear manufacturing and distribution to a new ERP system and market pressure in the therapeutic shoe market.
(2) In the fourth quarter of fiscal 2016, current management implemented a new strategy relating to our procurement, manufacturing and liquidation philosophies in order to significantly reduce inventory levels. Historically, our strategy was to purchase inventory in large quantities to capture purchase discounts and rebates and provide an expansive mix of products for our customers. Our new strategy aims to integrate our supply chain services with customer demand through focused forecasted consumption and sales efforts, therefore limiting the range of SKUs we plan to offer. As a result of these changes, the Company recorded a charge to cost of sales and corresponding reduction in inventory of approximately $18.0 million. The E&O reserve expense in fiscal 2016 included $5.7 million related to the Company’s decision to discontinue certain SKUs mainly within the Bracing and Vascular product lines, $8.3 million related to holding inventory for shorter periods and the planned scrapping of long-dated inventory, $2.0 million related to new Surgical Implant products that changed the expected life cycle of its current product portfolio, and $2.0 million of slow moving consigned inventory within certain OfficeCare clinics for which management has decided not to strategically relocate.
(3) Purchase accounting adjustments consisted of amortization of fair market value inventory adjustments for all periods presented.

(b)

Non-recurring and integration charges are comprised of the following:

Twelve
Months
Three Months Ended Nine Months Ended Ended
September September September September September
30, 30, 30, 30, 30,
2017 2016 2017 2016 2017
Restructuring and reorganization (1) $ 11,391 $ 1,177 $ 50,441 $ 3,998 $ 64,089
Acquisition related expenses and integration (2) 879 2,873 1,457 8,855 2,952
Executive transition 914 (49 ) 954 1,048
Litigation and regulatory costs and settlements, net (3) 3,336 4,576 6,748 11,062 12,248
Other non-recurring items 287 895
IT automation projects 106 68 699 68 1,802
Total non-recurring and integration charges $ 15,712 $ 9,895 $ 59,296 $ 25,832 $ 82,139
(1) Consists of costs related to the Company’s business transformation projects to improve the Company’s liquidity and profitability and to improve the Company’s customer’s experiences.
(2) Consists of direct acquisition costs and integration expenses related to acquired businesses and costs related to potential acquisitions.
(3) For the twelve months ended September 30, 2017, litigation and regulatory costs consisted of $3.3 million in litigation costs related to ongoing product liability issues and $8.9 million related to other litigation and regulatory costs and settlements.

(c)

Other adjustment items are comprised of the following:

Twelve
Months
Three Months Ended Nine Months Ended Ended
September September September September September
30, 30, 30, 30, 30,
2017 2016 2017 2016 2017
Blackstone monitoring fees $ 1,750 $ 1,750 $ 5,250 $ 5,250 $ 7,000
Non-controlling interests 214 99 644 461 806
Other (1) (715 ) 89 (1,734 ) (409 ) 1,607
Total other adjustment items $ 1,249 $ 1,938 $ 4,160 $ 5,302 $ 9,413
(1) Other adjustments consist primarily of net realized and unrealized foreign currency transaction gains and losses.
(d) Permitted pro forma adjustments include future cost savings related to the exit of our Empi business and our business transformation initiative.

Contacts

DJO Global, Inc.
David Smith
SVP and Treasurer
760.734.3075
ir@djoglobal.com