Disclaimer

The alfapump® system is currently not approved in Canada for commercial use. DSR® therapy is still in development and is currently not approved in the United States or Canada. Any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. Sequana Medical makes no claims of safety or effectiveness of the DSR® therapy in the U.S. or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

Sequana Medical Privacy Policy

Last modified: January 15, 2025

Sequana Medical, Inc. (“Sequana Medical”, “we”, “us” or “our”) understands the importance of privacy to our customers, visitors, suppliers, business partners, employees and other individuals (“you”, “user”, or “data subject”). We are committed to protecting and respecting your privacy.

This Sequana Medical Privacy Policy (“Policy”) tells you how we protect and use information that we gather through our Services and this Sequana Medical website (the “Site”). This Site is intended for a U.S. audience. This Policy applies only to the website(s) on which it is posted and any services that link to or reference this Policy (“Services”). It does not apply to third-party platforms or to other Sequana Medical-operated websites or other Sequana Medical-operated platforms on which it is not posted. It also does not apply to information collected through other channels where this Policy is not linked to or referenced, such as over the phone or in person, or as part of a clinical study.

Some of the information we collect through this Site and our Services may be “Personal Information” as defined below, collected when you visit or use the Site or the Services.

This Policy may be supplemented or amended from time to time by additional privacy notices (“Privacy Notices”), provided at the time we collect your information. For example, certain pages of this Site may contain Privacy Notices providing more details about the information we collect on those particular pages, why we need that information, and choices you may have about the ways we use that information. In other cases, specific Privacy Notices may be required to comply with the privacy laws of one of the countries, provinces, or states in which we do business.

If you have a disability, you may request access to this Policy in an alternative format by contacting privacy@sequanamedical.com.

State-specific provisions:

    • Consumer Health Data Policy

    • Nevada Opt-Out Rights

    • California Privacy Addendum

    Your Consent

    By using this Site or the Services, you agree to the collection, use, disclosure, and transfer of your information as described in this Policy (and any Privacy Notices that apply to you). If you do not agree to the collection, use, disclosure and transfer of your information as described in this Policy (and any Privacy Notices that apply to you), you may not use this Site or the Services. If you have questions about this Policy, or any Privacy Notice, please contact us using the information provided below.

    You may withdraw your agreement for the collection, use, disclosure, and transfer of your information as described in this Policy (and any Privacy Notices that apply to you) by contacting us directly.

    Complete Agreement

    This Policy is part of the Terms of Use that govern your use of this Site and the Services. Except as written in any other disclaimers, policies, or other notices on this Site, this Policy and the Terms of Use are the complete agreement between you and Sequana Medical with respect to your use of this Site and the Services. Any terms we use in this Policy without defining them have the definitions given to them in the Terms of Use. There may be additional terms that apply to particular materials on or sections of this Site and the Services.

    Changes to this Policy

    Sequana Medical reserves the right to update or modify this Policy and any Privacy Notice, at any time and without prior notice, by posting the revised version of the Policy or Privacy Notice on this Site. These changes will only apply to the information we collect after we have posted the revised Policy or Privacy Notice on this Site.

    Your use of this Site and the Services following any such change constitutes your agreement that all information collected from or about you after the revised Policy is posted will be subject to the terms of the revised Policy. You may access the current version of this Policy at any time by clicking on the link marked “Privacy Policy” at the bottom of each page of the public areas of this Site.

    This Policy was last updated on January 15, 2025. The update included a complete revision of the Policy, including more details about how we collect and use Personal Information.

    Information We Collect

    Personal Information means any information relating to an identified or identifiable natural person (“Data Subject”); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person.

    Personal Information You Manually Provide.

    Sequana Medical collects the information you manually provide (e.g., using your keyboard, mouse, or touchpad) when you use this Site or the Services, such as if you complete a pre-screening questionnaire or similar questionnaire, contact us with questions, or otherwise interact with this Site or the Services, including creating an account. Some of the information you may choose to manually provide will be Personal Information including but not limited to:

      • Contact data: such as name, title, address, phone number, mailing address, and email.

      • Other identifiers: such as device ID or serial number, various types of personal health information (e.g., health insurance information, medical information, and the like), online identifiers, and other similar identifiers.

      • Communication data submitted by you: such as questions and feedback.

      • Demographic data: such as language, age, and gender.

      • Marketing preferences: such as e-mail subscription and frequency preferences.

      Examples of volunteering Personally Information on this Site or the Services include filling out a “Contact Us” form, creating an account, or sending Sequana Medical an email through this Site. By submitting information on the “Contact Us” form, you acknowledge that we may reply to you by email.

      Information Automatically Collected

      Sequana Medical collects information that is sent to us automatically by your web browser or mobile device. This information includes but is not limited to:

        • Product use and application data (including date and time of your visit)

        • IP address

        • The browser you are using (including name and version)

        • Your location and other geographic data

        • The website you came from and the website you visit after leaving

        • Pages viewed on the Site

        • Links clicked on the Site

        • Time spent on a particular page of the Site or the Site as a whole

        • Site data used to facilitate the use of the Site such as login and technical data

        The information we receive may depend on your browser or device settings. The information we receive from your web browser and device typically is not, in and of itself, personally identifiable. However, we may combine it with other information in an attempt to identify you or we may combine it with information that does identify you.

        Information Collected by Cookies and Other Technologies

        A cookie is a small piece of text sent to your browser by a website you visit. It helps the site remember information about your visit, which can make it easier to visit the site again and make the site more useful to you.

        We may use “cookies” and other technologies to collect information and support certain features of this Site. For example, we may use these technologies to:

          • Collect information about the ways visitors use this Site—which pages they visit, which links they use, and how long they stay on each page

          • Support the features and functionality of this Site—for example, to save you the trouble of reentering information already in our database or to prompt the settings you established on previous visits

          • Personalize your experience when you use this Site; and

          • Improve our marketing efforts, including through use of targeted advertising.

          The information we may collect using cookies and similar technologies is not, in and of itself, personally identifiable, but we may link it to Personal Information that you provide. If you do not wish to receive cookies, you may set your browser to reject cookies or to alert you when a cookie is placed on your computer.

          This Site uses “necessary” cookies which are used to enable basic features of this Site, such as securing your log-in activities or confirming and retaining your consent preferences, including if you opt-out from advertising cookies. These cookies do not store Personal Information.

          We also use “functional” cookies that enable functions of the Site, including content sharing features, collecting feedback, storing video playback preferences, and other third-party features.

          This Site uses “analytics” cookies, which are used to understand how visitors interact with the Site, calculate visitor, session, and other Site usage data for the Site’s analytics report. This cookie stores information anonymously.

          Our Site does not use advertising cookies.

          How We Use Your Information

          We may use the information we collect through this Site for various purposes, including the but not limited to:

            • To provide you with access to this Site and any related services.

            • To respond to your requests.

            • To personalize your access to this Site, for example, by telling you about new features that may be of interest to you, or to the extent you set up a Sequana Medical account, to allow you to properly use that account.

            • To develop records (including records of your Personal Information, e.g., for service or product support), including regarding your participation in product training programs we may provide.

            • To contact you with pertinent information about products, clinical trials, or important safety information, and about products and services of ours and of others.

            • For analytical purposes and to research, develop, and improve programs, products, services, and content.

            • To guide and inform marketing and sales activities.

            • To remove your personal identifiers. Once we have de-identified information, it is considered non-Personal Information and we may treat it like other non-Personal Information.

            • To enforce this Policy and other rules about your use of this Site.

            • To protect someone’s health, safety, or welfare.

            • To protect our rights or property.

            • To comply with a law or regulation, court order or other legal process, such as preventing, detecting and investigating security incidents and potentially illegal or prohibited activities.

            How We Share Your Information

            Sequana Medical will not share Personal Information about you collected from this website with an unrelated third party except as provided in this Policy. We may share for the following purposes.

            With Third–Party Vendors

            Sequana Medical shares information collected through this Site and the Services with third-party vendors who act for us or on our behalf. For example, we may use third-party vendors to design and operate this Site and the Services; to conduct surveys and clinical studies; and to help us with our promotional efforts (such as to operate our Mobile Messaging Program as described below). These third-party vendors may need information about you to perform their functions on our behalf. In general, we require our third-party service providers and vendors to restrict their use of any personally identifiable information received through our Site or the Services to the intended purposes.

            With Third-Party Social Media Platforms

            We may also use third-party social media platforms to offer you interest-based ads. To offer such ads, we may convert your email address into a unique value which can be matched by platform vendors with a user on their platform. Although we do not provide any Personal Information to these platform vendors, they may gain insights about individuals who respond to the ads we serve.

            In Aggregate or De-Identified Form

            We use information collected through this Site and Services to create a compiled, aggregate view of usage patterns. We may share aggregate information with third parties for various purposes including so they can better understand our user base. We may also share with third parties information about how particular individuals use this Site and the Services, but only on a de-identified basis (“Individualized Data”). Individualized Data is not personally identifiable, but it does reflect the usage patterns of a particular Site or Services user, as opposed to Site or Services users collectively. For clarity, we may use and share aggregated or de-identified data without restriction.

            As Part of a Business Transfer

            Your information may be transferred to successor organization if, for example, we transfer the ownership or operation of this Site or the Services to another organization or if we merge with another organization or liquidate our assets. If such a transfer occurs, the successor organization’s use of your information will still be subject to this Policy and the privacy preferences you have expressed to us.

            To Comply with Laws and Protect Our Rights and the Rights of Others

            We may disclose your information when we, in good faith, believe disclosure is appropriate to comply with the law, a court order or a subpoena. We may also disclose your information to prevent or investigate a possible crime, such as fraud or identity theft; to protect the security of this Site or the Services; to enforce or apply our online Terms of Use or other agreements; or to protect our own rights or property or the rights, property or safety of our users or others.

            As Described in a Privacy Notice or Click-Through Agreement

            We reserve the right to disclose your information as described in any Privacy Notice posted on a page of this Site or provided in connection with the Services where you provide that information. By providing your information on that page you will be agreeing to or consenting to the use and disclosure of your information as described in that privacy notice. We also reserve the right to disclose your information as described in any click–through agreement to which you have agreed.

            How We Protect Your Information

            Sequana Medical takes reasonable precautions to provide a level of security appropriate to the sensitivity of the information we collect. Although we use reasonable measures to help protect your information against unauthorized use or disclosure, we cannot guarantee the security of information provided over the Internet or stored in our databases and will not be responsible for breaches of security beyond our reasonable control.

            Transfer and Storage of Your Personal Information

            We may store, collect, transfer, and process your Personal Information in the United States. Privacy and data protection laws in the U.S. may be different than your country. By submitting your Personal Information, you agree and acknowledge such transfers, storage, and processing, including onward transfers.

            Retention of Your Information

            Sequana Medical retains the Personal Information collected on this Site and through the Services as long as necessary to fulfill the purpose for which it is collected or as permitted or required by applicable law.

            Children’s Privacy

            This Site is not targeted to children under the age of 18 and we do not knowingly collect or solicit Personal Information about such children. If we discover that a child has provided us with Personal Information online through this Website, we will take steps to delete this information as quickly as possible. If you believe we may have received Personal Information from a child under the age of 18, please contact us immediately at privacy@sequanamedical.com.

            Marketing E-mail Opt-out

            We may contact you to provide information about products, services and content that may be of interest to you. You may revoke your consent for the receipt of marketing communications that we send to you at any time by using the “unsubscribe” functionality included in our emails to you or by contacting us directly through privacy@sequanamedical.com.

            You should note that this will not affect all communications from us, for example, we are legally required to provide notices such as notification of a data breach in which case you should expect to receive a notification via email. We may also communicate with you for business purposes including to respond to communications from you, such as if you submit an online form on our Site or through our Services.

            Data Subject Rights

            Your rights will vary depending on which laws apply, and different laws may apply depending on where or your data is located. You may make a request to exercise any rights that you may have, and we will comply with any laws that apply. You may have the following rights:

              • Know. You may have the right to know about and confirm the existence of Personal Information about you, how we use or share it, what categories of Personal Information we process, our purposes of processing, and categories of parties we disclosed Personal Information to.

              • Access and portability. You may have the right to access your Personal Information, specific pieces of information, and know of third parties Personal Information was disclosed. You may have a right to obtain a copy of your data, including in a machine-readable format or have it transferred to someone else.

              • Correction. You may have the right to correct or amend your data if it is incomplete, inaccurate, or outdated.

              • Deletion or elimination. You may have the right to request your Personal Information be deleted or eliminated. Subject to applicable law, we may de-identify this data in certain circumstances.

              • Restriction. You may have a right to restrict processing of your data in some circumstances, such as if processing is excessive or unlawful, the accuracy of the data is contested, the controller no longer needs the data for its primary processing purposes but is needed for legal or compliance purposes, or if the data is sensitive Personal Information (e.g., health information) and it is being used for purposes beyond those reasonably necessary to perform services or provide goods requested.

              • Objection and optout. You may have the right to object to or opt-out of processing of Personal Information about you in certain circumstances. This can include cases where that data is used for direct marketing (including email or telephonic marketing), shared with third parties for their own marketing or for retargeting or cross-contextual marketing, sold to third parties, used to make certain automated or artificially-generated decisions or profiles about you, used for historical or scientific research, or used to contact you with automated/prerecorded voice telephonic messages in some cases.

              • Consent and cancelation of consent. You may have the right to consent, and to withhold or cancel that consent, for some practices, including processing of sensitive Personal Information (such as health information) or data on children, or where we use consent as our lawful basis for processing or transfer. If you cancel your consent, we will not further collect or process the Personal Information on the basis of that consent unless allowed or required by applicable law.

              • Nondiscrimination. We will not discriminate against you for exercising your rights. This does not necessarily include, where permitted by applicable law in your jurisdiction, cases where a difference in price or services offered is reasonably related to the value provided by Personal Information you provide, or where you consent to participate in a voluntary program offering incentives (such as a loyalty program).

              • Appeal. You may have the right to appeal decisions we make about the exercise of your rights. To submit an appeal to a decision we made about the exercise of your rights, you may send an email to privacy@sequanamedical.com. Please enclose a copy, or otherwise specifically reference our decision on your data subject request, to allow us to address your appeal. We will strive to comply with applicable law when we respond to your appeal.

              • Make a complaint. You may have the right to complain to regulators, such as your state attorney general, local data protection agency or authority, or other public bodies responsible for data protection and privacy enforcement. If you are not satisfied with our response to your request or if you have concerns about our data practices.

              Submitting a Request or Inquiry

                • If you want to submit a request or inquiry to us regarding privacy rights you may have, you or your authorized agent (someone acting on your behalf) can contact us using our contact information below. You do not have to create an account with us to submit a request.

                • Your request will be confirmed within ten days of receipt and we will respond within 45 days, unless shorter periods are required by law. If we need more than 45 days, we will notify you that your request is being delayed.

                • We can only respond to your request if it is verifiable. This means we are obligated to take reasonable steps to verify your identity or your authorized agent’s authority and your right to access the information you request. In the process of verifying your request, we may contact you to ask for additional information that will help us do so, including government-issued IDs containing your name and address, utility bills containing that same information, and/or unique identifiers like usernames. We will only use that additional information in the verification process, and not for any other purpose. Once we have received and verified the requested information from you, we will contact you with our response to your request, including any data, if applicable. If we do not hear from you or are unable to verify your identity for the request, we will contact you to inform you that we cannot process your request because we cannot verify your identity.

                • We do not charge a fee to process or respond to your verifiable consumer request unless it is excessive, repetitive, or manifestly unfounded. If we determine that the request warrants a fee, we will tell you why we made that decision and provide you with a cost estimate before completing your request.

                •  We will respond to reasonable requests in accordance with applicable law and subject to legal and contractual restrictions. We will not discriminate against you for exercising these rights.

                • There may be times where we cannot comply with your request. For example, if such disclosure would interfere with the privacy of others or if it would result in a breach of confidentiality. We will provide an explanation for our refusal to grant access.

                • Residents of WA, CA, NV, CT, please also see the respective Addendums for further details.

                Data Subject Rights Contact

                Sequana Medical US Inc
                265 Franklin Street , Suite 1702
                Boston, MA 02110

                +1 617-963-5280

                privacy@sequanamedical.com

                Links to Other Websites

                This Policy applies only to the Sequana Medical-operated websites on which it is posted and the Services to which it is linked or where it is referenced. Sequana Medical and its affiliates may operate different websites for different purposes and in different countries, where different laws may apply. If you visit another website, including an Sequana Medical website, please take a moment to review the privacy policy posted on that site to learn what information may be collected through that site and how it is processed. This Site may also contain links to websites that are not operated by or on behalf of Sequana Medical or its affiliates. These links are provided for your reference and convenience only and do not imply any endorsement of the products sold or information provided through these websites, nor any association with their operators. Sequana Medical does not control these websites and is not responsible for their data practices. Any information you provide to third parties on their websites is covered under their privacy and data collection policies and is not covered by this Policy. We urge you to review the privacy policy posted on any site you visit before using the site or providing any Personal Information.

                Contact Us

                If you have any questions regarding this Privacy Policy or about our privacy practices, or need to contact us for purposes related to this Policy, please contact us at privacy@sequanamedical.com.

                Addendum: California Residents Privacy Notice


                Effective: MONTH DAY, YEAR

                “Do Not Track” Policy for California Online Privacy Protection Act (CalOPPA)

                Our Site does not respond to Do Not Track signals. However, some third-party websites do keep track of your browsing activities. If you are visiting such websites, you can set your preferences in your web browser to inform websites that you do not want to be tracked. You can enable or disable DNT by visiting the preferences or settings page of your web browser.

                California’s Shine the Light law

                Under California Civil Code Section 1798 (California’s Shine the Light law), California residents with an established business relationship with us can request information once a year about sharing their Personal Information with third parties for the third parties’ direct marketing purposes.

                If you’d like to request more information under the California Shine the Light law, and if you are a California resident, you can contact us using the contact information provided in this Policy.

                Addendum: Nevada Opt-Out Rights
                Your Nevada Opt-Out Rights

                We do not sell your Personal Information, but nevertheless we offer an opt out to sales of consumer data in an overabundance of caution as required by, and to ensure compliance with, Nevada law.  Verified requests under Nevada law (NRS 603A) to not make any sale of any covered information we have collected or will collect regarding a consumer, as defined in that law, may be sent to privacy@sequanamedical.com. Please include in any such request email “Request for Nevada Opt-Out” in the subject line and in the body of the message.

                Addendum: Consumer Health Data Policy
                (including Washington, Nevada, Connecticut)

                Effective: MONTH DAY, YEAR

                Various U.S. state laws provide protections for “consumer health data”. This addendum applies to such information by applicable law. Please see the “Exercising Your Rights” section below for instructions regarding how to exercise these rights.

                “Consumer Health Data” is used in this addendum as it is defined in the Washington My Health My Data Act (MHMDA) and other laws applicable to the same or similar data. It generally includes any information that is linked or reasonably linkable to an individual and that identifies that individual’s past, present, or future physical or mental health status. Excluded from Consumer Health Data are certain types of health information, such as when we must collect, use, and disclose health information to meet our regulatory obligations or as part of a clinical trial. We do not collect, share, or sell Consumer Health Data except as described in this Privacy Policy and this Addendum or with your consent.

                Categories of Consumer Health Data We Collect and Share

                We process limited Consumer Health Data and may collect Consumer Health Data from various categories including, individual health conditions, treatment, diseases, or diagnosis; dynamics interventions, health-related surgeries or procedures; use or purchase of prescribed medication; bodily functions, vital signs and symptoms; diagnoses or diagnostic testing, treatment, or medication; genetic data; precise location information that could reasonably indicate a consumer’s attempt to acquire or receive health services or supplies (i.e., geofencing); and data that identifies a consumer seeking health care services.

                Sources of Consumer Health Data

                We collect Consumer Health Data directly from you, including when you submit information through our website, or other services or platforms we operate.

                How Sequana Medical Uses Consumer Health Data

                We use consumer health data to provide consumers information and education about Sequana Medical’s products and help connect them to a provider that can provide them diagnosis and treatment options.

                How Sequana Medical May Share Consumer Health Data

                We may share Consumer Health Data, including the categories of Consumer Health Data, with Sequana Medical-affiliated companies, service providers acting on our behalf, and others, including health care providers that you select, as necessary to provide you with the products or services you request or your authorized representatives request on your behalf.

                Exercising Your Rights

                Based on applicable laws in your state, you may have the right to:

                  • Confirm whether Sequana Medical is collecting, sharing, or selling Consumer Health Data concerning you and to access this data, including:
                    • A list of all third parties and affiliates with or to whom Sequana Medical has shared or sold the Consumer Health Data
                    • Access an active email address or other online mechanism that you may use to contact these third parties
                  • Withdraw consent from Sequana Medical to collect and share your consumer health data
                  • Request to have Consumer Health Data concerning you deleted and exercise that right by informing Sequana Medical of your request for deletion
                  • Appeal if Sequana Medical does not address an attempt to exercise one or more of these rights to your satisfaction

                  You may request that Sequana Medical take the actions outlined in the paragraphs above to exercise rights you may have by submitting a request, at any time, to Sequana Medical. Sequana Medical will seek to respond within forty-five (45) days.

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