Mobi-C SUPERIOR TO FUSION. Mobi-C Cervical Disc Only FDA Approved Cervical Disc for One & Two Levels CERVICAL DISC PRESS KIT GUIDE

Transcription

1 Mobi-C CERVICAL DISC PRESS KIT GUIDE Mobi-C Cervical Disc Only FDA Approved Cervical Disc for One & Two Levels SUPERIOR TO FUSION for two-level disc replacement

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3 Mobi-C CERVICAL DISC Table of Contents Purpose and Eligibility...2 Requesting a Press Kit...3 PRESS KIT CONTENTS - LDR Corporate Background Sheet...5 Spine Surgery and Spine Market Overview...6 Anatomy and pathology of the neck...6 Treatment options...6 U.S. anterior cervical spine market...6 Mobi-C Information...7 Mobi-C Basic Facts...7 How it Works...7 Clinical Trial Results, 24 month Primary Endpoint...8 Mobi-C Messaging Points...9 Physician Drafting Tools...10 Referral Physician Letter Template...10 Press Release Template...11 iframe Webpage...12 High Resolution Product Images Short video clips optimized for media use...16 HOW TO USE THE PRESS KIT How to Use a Press Kit...18 Press Release Opportunities...19 Use of Images and Video

4 Mobi-C CERVICAL DISC Mobi-C Press Kit Purpose of the Mobi-C Press Kit The purpose of the Mobi-C Press Kit is to better communicate to physicians and potential patients the features, benefits, and availability of Mobi-C. The Press Kit may be distributed to qualified surgeons to achieve this purpose. LDR does not engage in or facilitate the promotion of individual physician practices in exchange for commitments from physicians to utilize LDR s products. The Mobi-C press kit should not be used to misrepresent the data or device, or to support unapproved uses or in conjunction with unapproved claims. Who is Eligible for a Mobi-C Press Kit: Trained Mobi-C Surgeons Marketing representative for a trained surgeon s practice Marketing representative or media staff member for a healthcare/hospital facility affiliated with a trained Mobi-C surgeon (surgeon s name must be provided) NOTE: Sales representatives may NOT request press kits for surgeons or hospitals 2

5 Mobi-C Press Kit Requesting a Mobi-C Press Kit The Mobi-C Press kits can be requested in either of two locations: 1. Go to: Select the PRESS tab on the Mobi-C Cervical Disc home page (see below) Click on the SURGEON CUSTOMERS PRESS KIT (see below) OR 1. Go to: Select the United States and the Mobi-C product page Select the Press Kit tab on the Mobi-C product page (see below) Click on the click here to enter a request for a Mobi-C press kit (see below) 2. Enter all requested information, including agreement with the legal consent waiver by typing YES in the box provided at the bottom of the page. After typing YES a new button will appear that says Submit. Click on the Submit button to finalize and send your request. Note: Your request will not be received if the Submit button is not clicked. 3. A Mobi-C marketing staff member will review the request and if approved, a link to download the press kit will be sent to the address provided. NOTE: Requests will only be approved for Mobi-C trained surgeons and their affiliates. 3

6 Mobi-C CERVICAL DISC PRESS KIT CONTENTS 4

7 Corporate Background Vision Corporate Fact Sheet LDR combines passion and innovation to improve spine care. Mission LDR Holding Corporation Research Boulevard, Suite 200 Austin, Texas LDR Holding Corporation is a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders. LDR's primary products are based on its exclusive VerteBRIDGE fusion and Mobi non-fusion technology platforms and are designed for applications in the cervical and lumbar spine. These technologies enable products that are less invasive, provide greater intraoperative flexibility, offer simplified surgical techniques and promote improved clinical outcomes for patients as compared to existing alternatives. LDR received approval from the U.S. Food and Drug Administration (FDA) in August 2013 for the Mobi-C cervical disc replacement device, the first and only cervical disc replacement device to receive FDA approval to treat both one-level and two-level cervical disc disease. For more information regarding LDR Holding and the Mobi-C Cervical Disc, visit or Founded LDR Medical, SAS LDR Spine USA, Inc LDR Holding Corporation Products Avenue L Lateral Cage ROI-A ALIF Cage ROI-A Oblique ALIF Cage ROI-T TLIF Cage ROI Lumbar Partial Vertebral Body Replacement ROI-C Cervical Cage ROI-C Lordotic Cervical Cage MC+ Cervical Cage Management Caution: Mobidisc is currently not available for sale in the United States Christophe Lavigne- Founder, President and CEO Hervé Dinville- Founder, Executive Vice President, Research and Development Patrick Richard- Founder, Executive Vice President, General Manager, LDR Medical James Burrows- Executive Vice President, Chief Operating Officer Robert McNamara- Executive Vice President, Chief Financial Officer André Potgieter- Executive Vice President, U.S. Sales Joe Ross- Executive Vice President, Global Marketing Eric Vigneron- Deputy General Manager, LDR Medical Scott Way- Executive Vice President, General Counsel and Compliance Officer Global Offices Ownership and Financing Public, NASDAQ- Symbol LDRH Mobidisc Lumbar Disc Mobi-C Cervical Disc Easyspine Pedicle Screw System SpineTune TL Pedicle Screw System BF+ and BF+(Ph) Synthetic Bone Substitute United States Research Boulevard Suite 200 Austin, Texas France Hôtel de bureau 1 4, rue Gustave Eiffel Rosières Près Troyes, FRANCE +33 (0) Brazil Av. Pereira Barreto, º Floor Room 192 to 196 Torre Sul-Bairro ParaÍso Santo André / São Paulo-Brazil CEP China Unit 06, Level 16, Building A Beijing Global Trade Center #36 North Third Ring Road East, Dongcheng District Beijing, China, LDR B 4 REV K

8 Mobi-C CERVICAL DISC Spine Surgery and Spine Market Overview Anatomy and Pathology of the Neck The cervical spine has discs between each bone that provide cushioning for movements and body loads. The discs and bones in a healthy neck allow bending from side to side and front to back, and turning left to right. Disc problems can start from over-use, an accident, or just the wear and tear of daily life. Degenerative changes in the discs may result in damage that can cause pain. When a disc degenerates it can have tears or cracks that lose water, which cause it to become thinner and provide less padding to absorb movement. Degenerated discs can also bulge (herniate) and pinch the spinal cord or nerves, which causes loss of feeling, weakness, pain, or tingling down the arms and hands. Treatment options Before artificial discs were available, patients would often receive an Anterior Cervical Discectomy and Fusion (ACDF) procedure to alleviate the pain from a herniated disc. In a fusion surgery, the disc is removed and either a bone spacer or a plastic implant will be placed in the disc space to restore disc height and remove pressure on the pinched nerves or spinal cord. A metal plate and screws can be placed on the front of the neck to hold the implant in place. The result of this procedure will be a segment that no longer moves, or is fused. The potential downside of a fusion procedure, in addition to the loss of motion, is that it can create additional stress on the spinal levels above and below it. This can cause degeneration at those levels and potentially result in another future surgery. An artificial disc like Mobi-C is an option instead of a fusion that will also be placed inside the disc space to restore height and remove pressure on the pinched nerves. However, the Mobi-C device is designed to allow the neck to maintain normal motion and potentially prevent the adjacent levels from degenerating, possibly preventing future surgeries. The U.S. anterior cervical spine market: (source: Global Data Market Report 2013) In the U.S. the prevalence of symptomatic cervical disc disease was estimated at 1.1 million people in There are over 266,000 anterior cervical procedures performed each year. It is estimated that 30,000 of the 266,000 anterior cervical procedures in 2012 were artificial disc procedures. Cervical disc replacement procedures are anticipated to experience rapid growth in the near future. Growth in the next 5 years will be due to multiple factors: The number of FDA approved devices on the market doubled from 2012 to 2013 A large and growing library of clinical evidence demonstrating the long term safety and efficacy of cervical disc replacement Expanding approved indications to include two-level cervical disc replacement (only Mobi-C) The demonstration of cervical disc replacement as a superior treatment to fusion for treatment at two levels (Mobi-C) Improved outcomes of TDR over fusion including, but not limited to, reduced re-operation rate, adjacent segment degenerations rate & surgeries, and return to work Expanded private insurance coverage for cervical total disc replacement 6

9 Mobi-C Information Mobi-C Facts The Mobi-C cervical disc is one of the most widely used cervical discs in the world. First implanted in Orleans, France in November 2004, Mobi-C has been implanted in more than 17,000 spinal levels in 25 countries. Mobi-C entered an FDA clinical trial in 2006, in which 647 levels of Mobi-C were implanted. A total of 599 patients were involved in the clinical trial at 24 study centers across the U.S. This represents the largest clinical trial ever conducted in the U.S. for cervical disc replacement. Mobi-C received FDA approval in August of 2013, making it the first cervical disc with both one and two-level indications. Mobi-C is made with two Cobalt Chromium alloy endplates that are plasma sprayed with Titanium and coated with hydroxyapatite, and an Ultra High Molecular Weight Polyethylene plastic insert (UHMWPE). These are proven materials that have been used in orthopedic applications for over 60 years. Mobi-C is intended for adult patients (skeletally mature) with arm pain and/or neurological symptoms (such as weakness or numbness) with or without neck pain at one or two adjacent levels from C3 C7 in the cervical spine. Patients should have failed non-surgical care (such as physical therapy or medications) for at least 6 weeks, or shown signs of progressively worsening symptoms. Disc damage needs to be confirmed by a doctor s review of CT, MRI, or x-ray images. A doctor should always be consulted for proper indications and use of Mobi-C. Mobi-C How it Works Mobile Core Mobi-C is designed to replicate the natural motion of the cervical spine. Mobi-C contains patented Mobile Core Technology that allows the polyethylene core to slide and rotate inside the disc for self-adjustment to the cervical spine movements. This means that Mobi-C can react to the normal motion in the cervical spine. In addition, the mobile core is designed to reduce the stresses between the implant and adjacent bone, eliminating the more invasive fixation features found in other cervical disc replacement devices. Bone Sparing Mobi-C provides bone sparing fixation without chisel cuts into the small vertebral bodies of the cervical spine. Competitor s discs achieve their fixation by drilling keel cuts or screw holes into the bone, which can prevent safe implantation at two levels. Mobi-C was designed without a keel and therefore to be specifically applicable for both one and two-level indications. 7

10 Mobi-C CERVICAL DISC Mobi-C Information Mobi-C Clinical Trial Results, 24 month Primary Endpoint In the one-level study, Mobi-C demonstrated noninferiority to ACDF as reflected in the primary composite endpoint. In the two-level study Mobi-C demonstrated SUPERIORITY to ACDF in the primary composite endpoint. Key results from the two-level study include: Overall trial success was 69.7% for Mobi-C and 37.4% for fusion, which represents statistical superiority (p< ). The rate of secondary surgeries at the operated level for Mobi-C was 3.1% versus 11.4% for fusion. The percentage of subjects who demonstrated adjacent segment degeneration (determined by x-ray) was: 2.9% of Mobi-C patients compared to 18.1% of ACDF patients at the inferior adjacent level 13.1% of Mobi-C patients compared to 33.3% of ACDF patients at the superior adjacent level Mean return to work time was 20.9 days shorter for Mobi-C patients compared to fusion patients. 78.2% of Mobi-C patients showed improvement in Neck Disability Index (NDI) based on the FDA success criteria versus 61.8% of fusion patients. For detailed clinical results, see the Mobi-C Summary of Safety and Effectiveness document (SSED) available on the enclosed memory drive, or online at or or visit % of Randomized Pa ents with Available Data 80% 70% 60% 50% 40% 30% 20% 10% 0% TWO-LEVEL Overall Trial Success at 24 Months * 69.7% Mobi-C (p<0.0001) 37.4% ACDF *Fisher Exact test used to compare treatments to establish superiority. First and Only Approved Disc Replacement For One and Two Levels 8

11 Mobi-C Messaging Points Messaging Points 1. Mobi-C is the first and only cervical disc in the U.S. approved to treat more than one level of the cervical spine. It received FDA approval for one and two-level indications in August Mobi-C demonstrated statistical superiority compared to cervical spine fusion in overall study success when used in two-level patients. 3. Mobi-C has been implanted more than 17,000 times in 25 countries around the world since Mobi-C is differentiated from other cervical discs because of its bone sparing technique, which eliminates the need for bone chiseling and drilling, and optimizes it for two-level indications. 5. Patented Mobile Core Technology allows the Mobi-C disc to angulate and slide in multiple directions similar to natural cervical motion. 6. The greatest clinical benefit of artificial disc replacement with Mobi-C compared to cervical spine fusion were seen in two-level indications, particularly in reoperation rates and disability improvement. 7. In the Mobi-C clinical study, patients returned to work on average one week faster (one-level patients) and three weeks faster (two-level patients) compared to fusion patients. Lateral Translation Rotation A/P Translation ± 10 Lateral Bend ± 10 Flexion/Extension 9

12 Mobi-C CERVICAL DISC Physician Drafting Tools Referring Physician Letter Template Dear [Referring Physician], I am writing to introduce you to a new treatment available for patients suffering from cervical disc disease. The Mobi-C Cervical Disc is a disc replacement device that is the first and only cervical disc replacement approved to treat both one and two-level pathology. More importantly, in the prospective, randomized, multi-center controlled trial, disc replacement with Mobi-C at two contiguous levels demonstrated statistical SUPERIORITY as compared to traditional cervical fusion based on the primary composite endpoint. I have received thorough training on the use of the Mobi-C device and am now offering cervical disc replacement as an option for properly indicated patients. Mobi-C is a Cobalt Chromium alloy and polyethylene, mobile bearing disc specifically designed as a bone sparing, cervical intervertebral disc replacement for both one and two-level indications. In addition to the unique mobile bearing feature, I feel that Mobi-C offers a simplified surgical technique as compared to other, commercially available devices, all of which are approved for one-level use only. The Mobi-C Cervical Disc is intended for skeletally mature patients to replace one or two adjacent cervical discs in the neck (from C3-C7) following removal of the discs for conditions that result from diseased or bulging discs. The implanted device is designed to restore the distance between the two vertebrae (disc height) and allow motion at the operated spinal levels as the plastic core moves within the metal endplates. Unlike a fusion procedure, the Mobi-C Cervical Disc is designed to allow motion at the operated spinal levels. The effects of removing the diseased discs should include pain relief and improved function. I have enclosed materials that you may use to familiarize yourself with this procedure, the Mobi-C device and to share with your patients whom you feel might be candidates for anterior cervical surgery and possibly disc replacement. You may refer potential patients to my office directly at [XXX-XXX-XXXX]. Additional information regarding the Mobi-C Cervical Disc can be found at and www. cervicaldisc.com. The Summaries of Safety and Effectiveness for the Mobi-C clinical trials, P and P110009, are available at Thank you for your time and interest in new opportunities to improve patient care. I appreciate your willingness to consider me as a referral option for your patients suffering from the pain and disability associated with cervical disc disease. Sincerely yours, [XXXXX] 10

13 Physician Drafting Tools Press Release Template [Surgeon Name or Hospital Name] Performs Two-Level Cervical Disc Replacement Successful surgery with the first and only cervical disc approved in the U.S. to treat more than one level of the cervical spine CITY, STATE (Month XX, 2013) [Surgeon Name or Hospital Name] announced today that it has performed a two-level cervical disc replacement procedure utilizing a novel medical device recently approved by the FDA. The procedure, performed at [Hospital Name], was one of the first of its kind in the area. The device, the first and only cervical disc replacement FDA approved for both one and two-level applications, was the subject of a rigorous FDA Investigational Device Exemption (IDE) trial. In the study, the two-level cervical disc replacement procedure demonstrated an overall study success rate of 69.7% as compared to traditional cervical fusion results of 37.4%. At 24 months, those who received the two-level cervical disc replacement during the trial phase also returned to work on average three weeks earlier as compared to those patients who were treated with cervical fusion. The disc replacement patients also had lower rates of subsequent surgeries and reduced rates of ongoing degeneration at spinal segments adjacent to the surgery. [Quote from Surgeon or Hospital Representative] I am very happy to be able to offer my patients this state of the art procedure which is supported by the highest level of medical evidence available for a medical device, said Dr. of the. And for the first time I am able to offer the significant number of my patients who suffer from two-level cervical disease a superior treatment option to traditional cervical spine fusion. About [Surgeon and/or Facility] XXX 11

14 Mobi-C CERVICAL DISC iframe Webpage iframe webpage for insertion to an existing web site LDR has pre-designed a summarized Mobi-C webpage that can be easily inserted on any website. The page will include brief statements about the Mobi-C history, design attributes, and clinical study with live links back to the parent Mobi-C website for detailed information ( The look and feel of the existing website is maintained as all content is displayed in a designated frame within the website. For customers that choose to use this webpage (pictured below), the HTML code is as follows: (HTML code given here when press kit is downloaded) Provide this code to your web administrator to insert the full page on your existing webpage. There is no further work needed to implement this content. Mobi-C Cervical Disc Only FDA Approved Cervical Disc for One & Two Levels SUPERIOR TO FUSION for two-level disc replacement Watch it work Mobi-C History The Mobi-C cervical disc is one of the most widely used cervical discs in the world. First implanted in Orleans, France in November 2004, Mobi-C has been implanted in more than 17,000 spinal levels in 25 countries. A total of 599 patients were involved in the Mobi-C U.S. clinical trial, which represents the largest concurrent clinical trial ever conducted for cervical disc replacement. Mobi-C received FDA approval in August of 2013, making it the first cervical disc with both one and two-level indications. Mobi-C How it Works Mobi-C contains patented Mobile Core Technology that allows the polyethylene core to slide and rotate inside the disc for self-adjustment to the cervical spine movements. This means that Mobi-C can react to the normal motion in the cervical spine. Mobi-C provides bone sparing fixation without chisel cuts into the small vertebral bodies of the cervical spine, making it safe for implantation at two levels. Mobi-C Clinical Trial Results In the one-level study, Mobi-C demonstrated non-inferiority to ACDF as reflected in the primary composite endpoint. In the two-level study Mobi-C demonstrated SUPERIORITY to ACDF in the primary composite endpoint. Key results from the two-level study include: Overall trial success was 69.7% for Mobi-C and 37.4% for fusion, which represents statistical superiority (p< ). The rate of secondary surgeries at the operated level for Mobi-C was 3.1% versus 11.4% for fusion. The percentage of subjects who demonstrated adjacent segment degeneration (determined by x-ray) was: 2.9% of Mobi-C patients compared to 18.1% of ACDF patients at the inferior adjacent level 13.1% of Mobi-C patients compared to 33.3% of ACDF patients at the superior adjacent level 12 Mean return to work time was 20.9 days shorter for Mobi-C patients compared to fusion patients. 78.2% of Mobi-C patients showed improvement in Neck Disability Index (NDI) based on the FDA success criteria versus 61.8% of fusion patients. For indications and detailed clinical results, see the Mobi-C Summary of Safety and Effectiveness document (SSED) available on the enclosed memory drive, or online at or or visit

15 Images Mobi-C High Resolution Images (samples) 2014 LDR Spine USA, Inc. All rights reserved 2014 LDR Spine USA, Inc. All rights reserved 2014 LDR Spine USA, Inc. All rights reserved 2014 LDR Spine USA, Inc. All rights reserved 13

16 Mobi-C CERVICAL DISC Images Mobi-C High Resolution Images (samples) 2014 LDR Spine USA, Inc. All rights reserved 2014 LDR Spine USA, Inc. All rights reserved 2014 LDR Spine USA, Inc. All rights reserved 2014 LDR Spine USA, Inc. All rights reserved 2014 LDR Spine USA, Inc. All rights reserved 2014 LDR Spine USA, Inc. All rights reserved 14

17 Images Mobi-C High Resolution Images (samples) 2014 LDR Spine USA, Inc. All rights reserved 2014 LDR Spine USA, Inc. All rights reserved 2014 LDR Spine USA, Inc. All rights reserved 2014 LDR Spine USA, Inc. All rights reserved 15

18 Mobi-C CERVICAL DISC Mobi-C Video Clips List of Mobi-C Video Clips For customer information and background: 4 IDE Surgeon testimonial short clips 6 IDE Patient testimonial short clips Message from LDR co-founder about Mobi-C design (3 minute video) For media use short clips (<30 seconds each): Mobi-C vs Fusion comparison Mobi-C reoperation rates vs fusion Mobi-C IDE study overall trial success Mobi-C movement in the neck Mobi-C mobile core design and motion Mobi-C materials Mobi-C ease of insertion Mobi-C bone sparing design Mobi-C adjacent level degeneration rates vs fusion Mobi-C live x-ray 16

19 HOW TO USE THE PRESS KIT 17

20 Mobi-C CERVICAL DISC Mobi-C Press Kit How to Use a Mobi-C Press Kit: Practice/Hospital Website Utilize spine surgery overview, spine market overview, Mobi-C messaging points, product images, anatomy images, and short video clips to create a page on a surgeon practice or hospital website to educate patients on disc replacement and Mobi-C Make an original video feature surgeon or patient testimonial comments Create a treatments section on the website featuring disc replacement Local Media Opportunities T.V., radio, newspaper, social media For television/radio interviews, local news channel, newspaper articles, blog posts, and social media (such as Facebook, Twitter, YouTube) Utilize the Mobi-C messaging points for highlights and main take-away talking points Target the new technology/science/medicine report for television, or health/lifestyle section of newspapers Provide short video clips as b-roll (background footage) to news stations Contact local radio stations for interviews on new technology and first uses Serve as a speaker at local events and panel discussions Hospital newsletter - feature first two-level disc procedure performed in that facility (by a particular surgeon) Physician Referral Activities Utilize referral physician letter template customize to a particular spine surgeon s practice by filling in the highlighted (yellow) sections Send to local primary care physicians, physical therapists, chiropractors, and other referral sources Shows dedication to patient care, willingness to work with local referral sources, and practice differentiation Follow up is recommended Enclosures that work well with this letter include: Mobi-C Patient Education brochure, Mobi-C product brochure, Mobi-C IDE Study Overview (see your local sales representatives for copies) 18

21 Mobi-C Press Kit Press Release Opportunities The purpose of a press release is to catch the media or public s attention. Utilize the enclosed press release template to announce new technology and first uses. Distributing a press release: Send out via to various contact lists: Including referring physicians and allied health professionals (physical therapists, chiropractors, etc.), as well as local media contacts. Copy and paste the press release into the body of the . It is also advised to attach a PDF file of the press release for future reference of the receiver, and blind copy (bcc) the contacts to protect privacy of the recipients. Publish to website or blog: This can easily be done by creating a dedicated page on any website called News, Press, or Media Room. Be sure to analyze the traffic statistics on this new page - many people will visit this specific page. Also, keep this section current as users will continually view this page looking for the most up-to-date information. Use a paid P.R. Service: Fee based services can target media specific to a trade or industry (i.e, healthcare, spine, etc). The press release will be sent to hundreds of journalists at one time, as well as online news services such as Yahoo! and Google. Costs vary depending on length of press release and which markets are used. Most P.R. services will upload, edit, and the release to as many outlets as chosen. Online Press Distribution Services: Business Wire Contact your closest local office for fees and account set-up. portal/site/home/contact/ PR News Wire for fees and account set up PR Web for fees and account setup Market Wire for fees and account setup 19

22 Mobi-C CERVICAL DISC Mobi-C Press Kit Use of High Resolution Images & Short Video Clips Images: A wide assortment of high resolution images of the Mobi-C Cervical Disc and anatomy drawings are included in the kit. They can be used for websites, Facebook pages, Twitter, blogs, or in conjunction with news stories, press releases, and television spots. Videos: The Mobi-C short video clips in this kit are cut to showcase the most important features of the Mobi-C Cervical Disc. Television news stations will ask for b-roll or cover video. These short video clips can be sent to the media outlet for that use. If creating a practice video, these clips can be utilized as additional content support. Feature practice videos on YouTube by creating a channel for the practice. 20

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24 LDR Spine USA, Inc. All Rights Reserved. United States Research Boulevard Suite 200 Austin, Texas France Hôtel de bureau 1 4, rue Gustave Eiffel Rosières Près Troyes, FRANCE +33 (0) China Unit 06, Level 19, Building A, Beijing Global Trade Center #36 North Third Ring Road East, Dongcheng District, Beijing, China, Brazil Av. Pereira Barreto, º Floor Room 192 to 196 Torre Sul-Bairro Paraíso Santo André / São Paulo-Brazil CEP LDR, LDR Spine, LDR Médical, Avenue, BF+, BF+(Ph), Bi-Pack, C-Plate, Easyspine, Laminotome, L90, MC+, Mobi, Mobi-C, Mobi-L, Mobidisc, ROI, ROI-A, ROI-C, ROI-MC+, ROI-T, SpineTune and VerteBRIDGE are trademarks or registered trademarks of LDR Holding Corporation or its affiliates in France, the United States, and other countries.