Effective Date: March 31, 2020
These Terms apply to HistoSonics, Inc.’s (“HistoSonics”) website (the “Site”). HistoSonics controls and operates the Site from the United States of America.
By accessing the Site or registering with HistoSonics, you agree to all the terms and conditions of these Terms. You acknowledge (a) that you have read and understood these Terms; and (b) that these Terms have the same force and effect as a signed agreement. If you do not agree to abide by all of the provisions contained in these Terms, you must not use or access the Site. You should read these Terms each time you visit our Site, as the conditions may change with or without notice.
The Site is intended for use by United States residents only. If you are a non-U.S. resident, you may access the Site solely at your own risk and are responsible for compliance with your local laws and regulations, if applicable. Any references to products or services on the Site do not imply that HistoSonics intends to announce or offer these products or services in your country.
The Site is not intended for anyone under the age of 18.
The materials on the Site are for your general educational information only. HistoSonics does not practice medicine or provide medical services or advice. The information on this website should not be considered medical advice. You should always talk to your healthcare professional for diagnosis and treatment. Products on the Site may be under development and may not be approved for sale or use by the relevant regulatory authorities. The inclusion of a product on the Site will not be considered an offer for sale.
Please review our Privacy Notice to understand how we collect and use data through the Site.
By using the Site, you agree:
1. not to disrupt or interfere with the security of, or otherwise abuse, the Site or any services, system resources, accounts, servers or networks connected to or accessible through the Site;
2. not to disrupt or interfere with any other user’s enjoyment of the Site;
3. not to upload, post, or otherwise transmit through or on the Site any viruses or other harmful, disruptive or destructive files;
4. not to upload, post, or otherwise transmit through or on the Site any third-party confidential information or third-party intellectual property;
5. not to use or attempt to use another’s account, service or system without authorization from HistoSonics, or create or use a false identity on the Site;
6. not to transmit through or on the Site spam, chain letters, junk mail or any other type of unsolicited mass email to people or entities who have not agreed to be part of such mailings;
7. not to divulge your username and password to others either on or off the Site;
8. not to attempt to obtain unauthorized access to the Site or portions of the Site which are restricted from general access; and
9. not use the Site to seek, provide or obtain specific medical advice, medical opinion or diagnosis as applied to a patient’s particular condition or situation.
You agree that you are solely responsible for actions and communications undertaken or transmitted under your account, and that you will comply with all applicable local, state, national and international laws and regulations, including but not limited to United States export restrictions, that relate to your use of or activities on the Site.
You expressly agree that you will not provide, discuss or refer to any particular patient, any particular patient’s medical condition or any other information, which could identify a particular patient (including but not limited to information considered protected health information (“PHI”) under the Health Insurance Portability and Accountability Act). You further expressly agree that you will not discuss, endorse or refer to “off label” uses of medical products, including any uses which have not been approved by the U.S. Food and Drug Administration or any other applicable regulatory agency.
We may also include certain information, reference guides and databases intended for use by licensed medical professionals. These tools are not intended to give professional medical advice. Physicians and other health care providers should always exercise their own clinical judgment for any given situation.
We may also include certain information for medical professionals practicing in our field of service in password protected areas of the Site. Access to those portions of the site is conditioned on registration and the provision of additional information as requested during the registration process. If you do not qualify, please do not attempt to register with us. Upon our review and acceptance of your registration information, HistoSonics will provide you with a User ID and password. The information you provide must be accurate and complete, and it is your responsibility to inform us of any changes to that information by emailing us at inquiries@histosonics.com. We reserve the right to discontinue access to any restricted area of the Site at any time, without notice to you, for any reason. The personal information provided by you is subject to our Privacy Notice.
HistoSonics reserves the right to modify or discontinue the Site (or any portion of the Site), temporarily or permanently, with or without notice to you, and is not obligated to support or update the Site. HistoSonics will not be liable to you or any third party in the event that HistoSonics exercises its right to modify or discontinue the Site (or any portion of the Site). Unless explicitly stated otherwise, any new features that augment or enhance the current Site will be subject to these Terms.
All of the trademarks, service marks and logos displayed on this Site are registered and unregistered trademarks of HistoSonics, its affiliates or subsidiaries, in the United States and other countries or third parties who have licensed their trademarks to HistoSonics or one of its affiliates or subsidiaries. All other trademarks and product names used herein are the property of their respective owners. In addition, all content, including but not limited to text, software, music, sound, photographs, video, graphics or other material contained on this Site or in commercially produced information presented to you through the Site by HistoSonics, its affiliates or HistoSonics’s third party licensors (“Content”) is protected by copyright, patents or other proprietary agreements and laws. You are only permitted to use Content as expressly authorized by HistoSonics, its affiliates or its licensors. Nothing contained herein transfers any right, title, or interest in the Site or the Content to you.
You may not use, download, upload, copy, print, display, perform, reproduce, publish, license, post, transmit, frame, mirror on another Web service, use any meta tags, inline any graphics or distribute any Content or information from the Site in whole or in part without the express written permission of HistoSonics. Requests for such permission should be made to inquiries@histosonics.com. Any rights not expressly granted herein are reserved.
Certain product, service, or company designations for third parties may be mentioned in the Site for identification purposes only. Such designations are often claimed as trademarks or service marks. In all instances where HistoSonics is aware of a claim, the designation appears in initial capital or all capital letters. However, you should contact the appropriate companies for more complete information regarding such designations and their registration status.
HistoSonics may allow online submission of resumes in response to job postings on the Site. You agree not to post any false or inaccurate biographical information. Recruiters representing candidates may not send candidates’ resumes in response to job postings on the Site; HistoSonics will not pay any recruiter fees. There is a risk that your resume may be lost or intercepted by a third party if you submit it to HistoSonics through the Site. HistoSonics cannot be held responsible for any loss arising from the transmission or use of resumes obtained through the Site. Your personal information is subject to our Privacy Notice. In addition, HistoSonics may contract with a third-party service provider to host the resume submission page. Submission of resumes through such third-party services is subject to the third-party’s terms of use and privacy policy.
We have created, or may create in the future, certain areas, such as message boards and chat rooms, within the Site (collectively, “Forums”) where you can upload and share thoughts, comments, product reviews, pictures, videos and the like (collectively, “User Content”).
By submitting User Content for posting at a Forum, you also (1) confirm that you are entitled to post or transmit User Content; (2) agree that you are solely responsible for all User Content that you submit for posting; (3) represent that you have the legal right to post such content, including the express, documented permission of any individuals whose image, likeness, or information is included in your User Content, and (4) grant to HistoSonics an irrevocable, worldwide, nonexclusive, perpetual, fully sub-licensable, transferable, royalty-free right and license to use your User Content in any way on any media (including on the Site, on any other Site owned or operated by HistoSonics, on social media sites associated with HistoSonics or its affiliates, and print or digital materials). Third-party copyrighted materials (text, images) may not be used without the express permission of the relevant copyright owners, or without attributing the content to said owners. We reserve the right at any time to discontinue, temporarily or permanently, your ability to upload User Content and/or your ability to access User Content with or without notice, at our sole discretion. You agree that we shall not be liable to you or to any third party for any suspension or discontinuance of acceptance of User Content.
Neither HistoSonics nor its employees accept or consider unsolicited ideas, including ideas for new products or technologies, processes, materials, marketing plans, or new product names. Please do not send your unsolicited ideas or any original materials to HistoSonics or to anyone at HistoSonics. If, despite this request, you still send HistoSonics your ideas and materials (including by posting User Content to the Site), you irrevocably assign to HistoSonics, free of charge, all worldwide rights, title and interest in all copyrights and other intellectual property rights in the information or materials you submit. We will be free to use any ideas, concepts, know-how, or techniques contained in or derived from any User Content for any purpose whatsoever, including developing, manufacturing, and marketing products.
User Content must be appropriate for the Forum, and we may reject User Content at the time of submission or after it has been posted, with or without notice or explanation, solely at our discretion. Without limiting the reasons for which User Content may be rejected by us, we may reject, edit or remove any User Content that:
– contains PHI or inappropriate personal information, or seeks or provides specific medical advice, medical opinion or diagnosis as applied to a patient’s particular condition or situation.
– attacks or harasses an individual
– is threatening, racist, abusive, or hateful
– uses violent language or suggests violent acts
– is obscene, sexually explicit, or crude
– is advertising or spam
– contains defamatory statements
– describes or encourages illegal activity of dangerous behavior
– is not related to HistoSonics products or services or relevant to the audience for HistoSonics products and services
Although we may moderate User Content, HistoSonics is not responsible for the accuracy of any User Content. All User Content is the sole responsibility of the person who posted the Content. You understand and agree that you will evaluate, and bear all risks associated with, the use of any User Content, including any reliance on the accuracy, completeness, or usefulness of such User Content. To the extent you find any User Content to be objectionable, you may notify HistoSonics, but your sole recourse is to stop viewing such User Content.
In addition, if a Forum is provided within the Site, it may allow users to post questions to be answered by experts engaged by us. The opinions expressed by such experts are their own. We are providing access to the experts and their guidance in the Forum solely as an informational and educational service, and do not vouch for or endorse the accuracy of such opinions.
The Site may provide links to web sites operated by HistoSonics outside of the U.S. as well as web sites operated by third parties. Please refer to the separate terms of use, privacy policies, and other rules posted on these linked sites before you use them. Third-party links are provided merely as a convenience to you, and the inclusion of any link does not imply affiliation or endorsement by HistoSonics. HistoSonics does not review, monitor or check the accuracy of content published on third party sites, and is not responsible for the availability of, and content provided on, third party sites. If you choose to purchase any products or services from a third party, your relationship is directly with the third party and HistoSonics is not responsible for any loss or damage of any sort you may incur from dealing with any third party. Third-party web sites may contain information about uses of products that have not been approved or cleared by the U.S. Food and Drug Administration. HistoSonics does not endorse the off-label use of any of our products.
In general, in the absence of any other agreement with HistoSonics, you may link or hyper-link to the home page of the Site from your web site, subject to the following:
1. you notify us by email at inquiries@histosonics.comspecifying the URL of each page from which you will be linking to our home page;
2. you do not frame the Site or any portion of the Site;
3. you do not deep link into the Site (i.e., you do not link into any page other than the home page);
4. the link or hyper-link to the Site is not used in a way that suggests that HistoSonics endorses you or your web site;
5. the link is identified using a plain text rendering of the HistoSonics name and not any trademark or HistoSonics logo;
6. the link or hyper-link to the Site is not used or presented in any way that disparages HistoSonics or tarnishes, blurs, or dilutes the quality of HistoSonics’s names, trademarks, service marks, or any associated goodwill; and
7. you agree that we may terminate your right to link or hyperlink to the Site at any time for any reason or no reason.
Electronic Communications
When you communicate with HistoSonics through the Site or via other forms of electronic media, such as e-mail, you are communicating with us electronically. You agree that we may then communicate with you electronically, subject to local privacy laws, and that such communications, as well as notices, disclosures, agreements, and other communications that we provide to you electronically, are equivalent to communications in writing and shall have the same force and effect as if they were in writing and signed by the party sending the communication.
THE SITE AND ALL CONTENT, MATERIALS, INFORMATION, PRODUCTS AND SERVICES PROVIDED ON THE SITE, ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS. HISTOSONICS EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, AND SECURITY AND ACCURACY, AS WELL AS ALL WARRANTIES ARISING BY USAGE OF TRADE, COURSE OF DEALING, OR COURSE OF PERFORMANCE. HISTOSONICS MAKES NO WARRANTY THAT: (A) THE SITE WILL MEET YOUR REQUIREMENTS; (B) THE SITE WILL BE AVAILABLE ON AN UNINTERRUPTED, TIMELY, SECURE, OR ERROR-FREE BASIS; (C) THE RESULTS THAT MAY BE OBTAINED FROM THE USE OF THE SITE OR ANY SERVICES OFFERED THROUGH THE SITE WILL BE ACCURATE OR RELIABLE; OR (D) THE QUALITY OF ANY PRODUCTS, SERVICES, INFORMATION, OR OTHER MATERIAL OBTAINED BY YOU THROUGH THE SITE WILL MEET YOUR EXPECTATIONS.
ANY CONTENT, MATERIALS, OR INFORMATION DOWNLOADED OR OTHERWISE OBTAINED THROUGH THE USE OF THE SITE IS DONE AT YOUR OWN DISCRETION AND RISK. HISTOSONICS WIL HAVE NO RESPONSIBILITY FOR ANY DAMAGE TO YOUR COMPUTER SYSTEM OR LOSS OF DATA THAT RESULTS FROM THE DOWNLOAD OF ANY CONTENT, MATERIALS, OR INFORMATION.
NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM HISTOSONICS OR THROUGH THE SITE WILL CREATE ANY WARRANTY NOT EXPRESSLY MADE HEREIN.
This Site may include forward looking statements that involve risks and uncertainties concerning our operations, prospects, strategies, financial condition, future economic performance and demand for our products or services, as well as our intentions, plans and objectives, that are beyond our control. These statements are based upon a number of assumptions and estimates which are subject to significant uncertainties, many of which are beyond our control. When used on our Site, words like “anticipates,” “expects,” “believes,” “estimates,” “seeks,” “plans,” “intends,” “will” and similar expressions are intended to identify forward-looking statements designed to fall within securities law safe harbors for forward-looking statements. The Site and the information contained herein do not constitute an offer or solicitation of an offer for sale of any securities. None of the information contained herein is intended to be, and will not be deemed to be, incorporated into any of our securities filings or documents. We wish to caution the reader that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with other factors.
IN NO EVENT WILL HISTOSONICS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES, OR DAMAGES FOR LOSS OF PROFITS, REVENUE, DATA OR USE, INCURRED BY YOU OR ANY THIRD PARTY, WHETHER IN AN ACTION IN CONTRACT OR TORT, ARISING FROM YOUR ACCESS TO, OR USE OF, THE SITE OR ANY SERVICES PROVIDED THROUGH THE SITE, EVEN IF HISTOSONICS WAS ADVISED THAT SUCH DAMAGES WERE LIKELY OR POSSIBLE. THIS LIMITATION ON LIABILITY APPLIES TO, BUT IS NOT LIMITED TO, THE TRANSMISSION OF ANY DISABLING DEVICE OR VIRUSES WHICH MAY INFECT YOUR EQUIPMENT, FAILURE OR MECHANICAL OR ELECTRONIC EQUIPMENT OR COMMUNICATION LINES, TELEPHONE OR OTHER INTERCONNECT PROBLEMS (E.G., YOU CANNOT ACCESS YOUR INTERNET SERVICE PROVIDER), UNAUTHORIZED ACCESS, THEFT, BODILY INJURY, PROPERTY DAMAGE, OPERATOR ERRORS, STRIKES OR OTHER LABOR PROBLEMS OR ANY FORCE MAJEURE. SOME JURISDICTIONS DO NOT ALLOW THE LIMITATION OR EXCLUSION OF LIABILITY. ACCORDINGLY, SOME OF THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU.
Your right to use the Site is personal to you. You agree not to reproduce, duplicate, copy, sell or resell the Site, without the express written consent of HistoSonics.
All information submitted to the Site, including but not limited to personally identifiable information, is treated in accordance with the HistoSonics’s Privacy Notice.
You agree to indemnify, defend and hold HistoSonics, its parents, subsidiaries, affiliates, shareholders, directors, officers, employees and agents, harmless from any claim, demand, liability, expense, or loss, including reasonable attorneys’ fees, made by any third party due to or arising out of, or in any way connected with your use of or access to the Site or your violation of these Terms.
HistoSonics controls this Site from within the United States of America. You may not access, download, use or export the Site or the Content in violation of U.S. export laws or regulations, or in violation of any other applicable laws or regulations.
In the event that any provision of these Terms is, in whole or in part, determined to be invalid, unenforceable or void for any reason, the determination will affect only the portion of the provision determined to be invalid, unenforceable, or void, and will not affect the remainder of that provision or the rest of these Terms in any way. You agree to allow a court or arbitrator to replace such an invalid, unenforceable, or void provision with a valid provision which is as similar as possible in substance to the invalid, unenforceable, or void provision. HistoSonics’ failure to act with respect to any breach by you does not constitute a waiver of our right to act with respect to subsequent or similar breaches.
These Terms will be governed by and construed in accordance with the laws of the State of Minnesota, without regard to its choice of law provisions. In the event of any conflict between foreign laws, rules and regulations and those of the United States, the laws, rules and regulations of the United States will govern. The United Nations Convention on Contracts for the International Sale of Goods will not apply to these Terms. You hereby consent to personal jurisdiction by the state and federal courts having jurisdiction over Hennepin County, Minnesota.
HistoSonics may assign its rights and duties under these Terms without such assignment being considered a change to the Terms and without notice to you. You may not assign these Terms without the prior written consent of HistoSonics.
These Terms, the Privacy Notice, any operating rules, policies, or procedures that may be posted from time to time by HistoSonics on the Site, and any modifications to the foregoing, constitute the entire agreement between the parties with regard to the subject matter hereof and supersede all prior understandings and agreements, whether written or oral, as to such subject matter. Nothing contained in these Terms will be deemed to constitute either party as the agent or representative of the other party, or both parties as joint venturers or partners for any purpose.
If you have any questions regarding these Terms or the Site, please contact HistoSonics at inquiries@histosonics.com.
Last updated on November 8, 2023
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The Edison® System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by persons who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions and a summary of clinical trial results, including reported adverse events.
