Privacy Policy

Privacy Notice

Last updated: September 25, 2024

Enterra Medical and its subsidiaries (“Enterra Medical”, “we”, “us” or “our) conduct business within the United States, the United Kingdom, the European Union (“EU”) and the European Economic Area (“EEA”). We understand the importance of privacy to our customers, visitors, suppliers, business partners, employees, and other individuals (“you”, the “user”, or “data subject”). We are committed to protecting and respecting your privacy.

This Enterra Medical privacy policy (“Policy”) applies only to information collected through the website on which it is posted (“Site”) as well as any other applications (apps), events, newsletters, communications, or services provided by or on behalf of Enterra Medical that link or reference this Policy (“Services”). It does not apply to third-party platforms or to other Enterra Medical-operated websites or other Enterra Medical-operated platforms where it is not linked or referenced. 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 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.

Some of the information we collect through this Site or using our Services may be “Personal Data” as defined below. 

Among other things, this Policy describes:

• What information we collect about you
• How and on what basis we use the information we collect
• How we collect your Personal Data
• How long we keep your Personal Data
• How we share the information we collect
• How we protect your information
• How you can access and control your information
• How you can contact us

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

Your acknowledgment of this Policy

 By using this Site, including your choices regarding cookie settings, or using the Services, you are acknowledging and agreeing to the collection, use, disclosure, and transfer of your information as described in this Policy (and any additional 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. 

Where any of your Personal Data is processed based on your consent, you may revoke your consent to 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 for use of the Site

This Policy is part of the Terms of Use that govern your use of this Site. A link to our Terms of Use is provided at the bottom of each page of this Site.

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 Enterra Medical with respect to your use of this Site. 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.

Changes to this Policy

Enterra 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 or 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” at the bottom of each page of the public areas of this Site.

What is Personal Data?

Personal Data 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.

How do we collect your Personal Data?

How we collect Personal Data will depend upon the nature of your dealings with us. We collect and use non-Personal Data differently from Personal Data. Whenever it is reasonable and practical to do so, we will collect your Personal Data directly from you. We may also collect Personal Data from third parties, including in the course of providing products to you such as from our distributors, your healthcare practitioners, your caregiver/family member, guardian, publicly available information and databases supplied by third parties.

If you are one of our suppliers, distributors or a healthcare professional that uses our products, your Personal Data may be collected from you, your employer, other employees, or third parties. Similarly, if you are a prospective employee, we may collect information through third parties such as recruiters.

If you choose not to provide some Personal Data to us, this may affect our ability to provide products or services to you.

Information We Collect

Generally, Personal Data we collect may include but is not limited to:

• Name and contact details
• Details of your company, industry, role and accreditations
• Information from your visits to our websites, including the IP address, type of browser, device (including unique device identifiers) and operating system you use, network information, access times, pages viewed, links clicked on, cookie information;
• Details of products you have inquired about or that we have supplied to you, including any additional information necessary to deliver those products and to respond to your inquiries;
• Credit information, payment, credit card and debit card or bank account information for product deposits, purchases or refunds;
• Information that you provide to us directly through one of our websites, apps or that you email to use; and
• Information you provide in customer surveys, interviews or case studies.

Product User Data

If you are a someone who uses our products including clinical trial participants: we may collect additional specific information about your use of our products and you, such as your gender, date of birth, your medical history and conditions, treatment, device information, family and social history, medical inquiries you or your physician make, and adverse events you report. We may receive some of this information from third parties, such as our distributors or your health care professional. Some of this information may be, but is not always, anonymized, or de-identified. If you are a clinical trial participant, your information will be used in accordance with the informed consent and applicable law.

Suppliers, Customers or Other External Stakeholder Data

If you are a supplier, customer, distributor, or a healthcare professional that implants our products: we may collect additional specific information including information about your professional details, practice specialty and areas of interest, membership of professional associations, product usage and your dealings with us.

If you are an employee, contractor or applicant: we may collect additional specific information including your gender, date of birth, contact details, information collected in our employment records, including tax file number, job application, reference checks, curriculum vitae/resume, records of training, documentation of performance appraisals and disciplinary matters, employment terms, and medical condition or history. We may receive some of this information from third parties such as recruiters or from reference checks.

Personal Data You Manually Provide through this Site

Enterra Medical collects the information you manually provide (e.g., using your keyboard, mouse, or touchscreen) when you use this Site. For example, we collect the information you provide if you choose to complete a pre-screening questionnaire entitled, “Am I a Candidate?” or similar questionnaire, contact us with questions, or otherwise interact with this Site. Some of the information you may choose to manually provide will be Personal Data 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. 

Information Automatically Collected through this Site

Enterra Medical collects information through this Site that is sent to us automatically by your web browser or mobile device. This information may include 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 as well as your cookie 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 that either does, or may, identify you. 

Information Collected by Cookies and Other Technologies through this Site

We 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 collect using cookies and similar technologies is not, in and of itself, personally identifiable, but we may link it to Personal Data that you provide. If you do not wish to receive cookies, you may choose to reject cookies in your cookie settings when you visit our Site. You may also set your browser to reject cookies or to alert you when a cookie is placed on your computer. Although you are not required to accept cookies when you visit this Site, you may be unable to use all of the functionality of this Site if you or your browser rejects cookies.

Information Collected by Third-Party Cookies through this Site

In addition to the cookies Enterra Medical delivers to your computer or mobile device through this Site, certain third parties (Tracking and Performance Cookies) may deliver cookies to you for a variety of reasons. For example, we may use a web analytics tool that helps us understand how visitors engage with our Sites.

Other third parties may deliver cookies to your computer or mobile device for the purpose of tracking your online behaviors over time and across nonaffiliated websites and/or delivering targeted advertisements either on this Site or on other websites.

You have choices about the collection of information by third parties on our Sites. You may use the cookie pop-up banner on the Site to decline non-essential cookies. Additionally, you may download an Opt-out Browser Add-on to opt-out of Google Analytics by clicking here. Similarly, to opt-out of cookies used for interest-based advertising by similar services globally, click here or here. 

You will be directed to an industry-developed website that contains mechanisms for choosing whether each listed entity may collect and use data for online behavioral advertising purposes. It may be that some of the third parties that collect interest-based information on this Site do not participate in the industry-developed opt-out website, in which case the best way to avoid third-party tracking of your online behaviors may be through your browser settings and deletion of cookies. Please note that the industry-developed opt-out mechanisms are device and browser specific. If you wish to opt-out from having interest-based information collected by participating entities across all devices and browsers, you need take the steps outlined above from each device and browser.

How We Use Your Information

Collected through this Site

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

• When needed for our legitimate interests:
  • To provide you with access to this Site.
  • To respond to your requests.
  • To personalize your access to our Site.
  • To develop records (including records of your Personal Data) such as to enable you to create an account or request information from us.
• When you give your consent:
  • 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 remove your personal identifiers. Once we have de-identified information, it may be considered non-Personal Data and if so we may treat it like other non-Personal Data.
• 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.

Collected through our Services

Generally, the purpose for which we collect Personal Data will be apparent from the way in which we collect it or will be disclosed before or at the time of collection. We may use your information, including Personal Data to:

• Provide you and your healthcare professionals with product support.
• Respond to and fulfill queries and requests you, your healthcare professional and our distributors and suppliers may make.
• Administer, improve and promote our products.
• Analyze the performance of our products.
• Improve our services and services of our third-party suppliers and distributors.
• Monitor the safety of our products and record, analyze and respond to and act on medical queries, complaints and safety reports and to report as required to regulatory bodies and other relevant companies which market and sell our products.
• Notify you of matters concerning the safety of our products which we consider you should be notified of or to notify you as may be required by law or regulation.
• Generate and maintain customer lists for the purposes of our own market research and to enable us or our distributors to undertake marketing to you and others.
• Perform clinical trials and other research organized by us which you have agreed to be involved in.
• Administer patient support, health awareness/management programs or other similar programs organized by us.
• Organize and administer conferences, symposia, seminars or other events and meetings.
• Generate and maintain our investor information to comply with legal requirements and to enable reporting to investors.
• Provide you with information such as our press releases.
• To maintain our register of shareholders and investor communication lists and to make offers and communicate with our shareholders and investors.
• Comply with applicable laws, regulations, guidance, codes of conduct, product approvals, license requirements and ethical requirements including to comply with demands or requests made by regulators, governments, courts and law enforcement authorities.Provide you and your healthcare professionals with product support. 

Our Legal Basis for Processing Personal Data

We may process the Personal Data we collect/receive under the following legal bases:

• Legitimate interest. We can process your Personal Data if (i) we have a genuine and legitimate reason; and (ii) are not harming any of your rights and interests. We will use your personal data in order to help us provide you with our services and to give you the most appropriate information, products and services and to provide you with the best experience when dealing with us. Whenever we process your personal data for our legitimate interests, we will consider and balance any potential impact on you and your rights under data protection law. 
• Consent. In some cases we will only process your information where you have given your consent. For example, if you sign up for email communications, provide your phone number for phone communication, or where you may be providing special categories of personal data (or “sensitive data”). Please note that we may have a different legal basis for processing (e.g., legitimate interest) so that consent is not needed. When our use and sharing is not readily apparent when you provide your information, we will provide additional information at the time we collect the information regarding our purposes and use of the information. 
• To fulfill our obligations to you under a contract. If you purchase a product from us, we may process your personal data in order to fulfill our contract with you. 
• As required by law. Where we are required to comply with our legal obligations, or to establish and defend our legal rights, or to prevent and detect crimes such as fraud. 

Examples of the legal basis we may rely on when processing your Personal Data and how they apply are contained in the chart below: 

How We Use Your Information

Our headquarters are in the United States, and we have offices, use service providers, and have distributors in other jurisdictions. As part of a global group of companies located in different countries, we may disclose your information to other companies in our corporate group, or to databases or servers overseas which may be provided to us by our third-party service providers. As a result, your Personal Data is sometimes shared with others and transferred and processed outside of your home country. We may share your Personal Data with:

• Companies within our group.
• Third parties who we have a business relationship with, including distributors, agents, suppliers, healthcare professionals and advisors. This would also include companies that provide technology services to us, our professional advisors, and auditors.
• Governments, regulators, courts, and law enforcement authorities.
• Other third parties in connection with any reorganization or sale of all or any part of our business.

We will not sell, share, or otherwise distribute Personal Data about you to any person, except as provided in this Policy and in accordance with applicable law and regulation. The circumstances in which we may disclose that information include where:

• We may share your information with selected third-party service providers in connection with our business operations, for example, email or cloud service providers.
• We expressly tell you at the time you supply the information, or it is expressly permitted under any agreement with you.
• The information is aggregated and/or no longer personally identifiable.
• It is necessary to provide you with the products which you have requested.
• It is requested by third parties for use in the ordinary operation of our business. We will only disclose your Personal Data to reputable third parties and only on a confidential basis.
• Disclosure is in response to demands or requests made by regulators, governments, courts, and law enforcement authorities.
• Permitted or required by law, regulation, or applicable guidance.

How We Protect your Information

Enterra Medical takes reasonable precautions to provide a level of security appropriate to the sensitivity of the information we collect. Although we seek to 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 electronically, whether by us or a third party.

Transfer and Storage of your Personal Data

We may store, collect, transfer, and process your Personal Data in a country other than your country of residence. These countries include the United States, the United Kingdom, or countries in the European Union. The data protection and other laws of countries to which your information may be transferred may be different in your country.

For Residents of Europe and the United Kingdom: The European Commission and the UK Information Commissioner’s Office (ICO), have the power to determine, based on the General Data Protection Regulation (“GDPR”) or UK GDPR respectively, whether a country offers an adequate level of data protection by making an ‘adequacy decision’. Neither the European Commission nor the UK ICO have adopted a currently active adequacy decision regarding the United States. Instead, with respect to any transfers of information to the United States, we rely on other legal bases to lawfully transfer personal data. We will implement appropriate measures to protect and
secure your Personal Data when it is transferred outside of your home country, in accordance with applicable data protection and privacy laws, including in the case of EU residents, with your consent or through the use of approved model standard contractual clauses along with supplementary measures, where determined necessary. The European Commission has determined that the transfer of Personal Data pursuant to the Standard Contractual Clauses along with supplementary measures provides for an adequate level of protection of your Personal Data. Similarly, the UK has adopted International Data Transfer Agreements. Under these standardized agreements, you have similar rights as if your Personal Data was not transferred.

You may request more information about our data transfer methods by contacting us through the methods below.

Retention of Your Information

We will always keep Personal Data for the period required to comply with applicable laws, regulations, guidance, codes of conduct, product approvals, license requirements, ethical and safety requirements. We may also maintain your information as required to comply with any contract of which we are a party. Otherwise, we keep your Personal Data:

• For as long as needed to provide you with access to product and longer to assist us in best addressing any safety matters that may arise with respect to our products.
• Where you have contacted us with a question or request, for as long as necessary to allow us to respond to your question or request.

Children’s Privacy

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

Your Rights

Enterra Medical undertakes to respect the confidentiality of your Personal Data and to guarantee you can exercise your rights. You have the right under this Policy, and by law to:

• Request access to your Personal Data. The right to access, update or delete the information we have on you. Whenever made possible, you can access, update or request deletion of your Personal Data directly within your account settings section. If you are unable to perform these actions yourself, please contact us to assist you. This also enables you to receive a copy of the Personal Data we hold about you. 
• Request correction of the Personal Data that we hold about you. You have the right to have any incomplete or inaccurate information we hold about you corrected. 
• Object to processing of your Personal Data. This right exists where we are relying on a legitimate interest as the legal basis for our processing and there is something about your particular situation, which makes you want to object to our processing of your Personal Data on this ground. You also have the right to object where we are processing your Personal Data for direct marketing purposes. 
• Request erasure of your Personal Data. You have the right to ask us to delete or remove Personal Data when there is no good reason for Us to continue processing it. 
• Request the transfer of your Personal Data. We will provide to you, or to a third-party you have chosen, your Personal Data in a structured, commonly used, machine-readable format. Please note that this right only applies to automated information which you initially provided consent for us to use or where we used the information to perform a contract with you. 
• Withdraw your consent. You have the right to withdraw your consent on using your Personal Data. If withdraw your consent, we may not be able to provide you with access to certain specific functionalities of the Service. 
• To file a complaint to a Supervisory Authority. You have the right to complain to a Supervisory Authority about our collection and use of your Personal Data. For more information, if you are in the European Economic Area (EEA), please contact your local Supervisory Authority in the EEA. 

Exercising of Your GDPR Data Protection Rights (For residents of Europe or United Kingdom) 

You may exercise your rights of access, rectification, cancellation and opposition by contacting us:

Contact:

Enterra Medical, Inc.
EU-Representative (Art.27 GDPR)
Kalms Consulting GmbH
Rheinstraße 45-46
12161 Berlin, Germany
Email: EnterraGDPR@kalmsconsulting.com

Data protection officer contact information 

Bernard Bosley
5353 Wayzata Boulevard, Suite 400
St. Louis Park, MN 55416

1-855-768-3772 
bbosley@enterramedical.com

Please note that we may ask you to verify your identity before responding to such requests. If you make a request, we will try our best to respond to you as soon as possible.

Links to Other Websites 

This Policy applies only to the Enterra Medical-operated websites on which it is posted. Enterra Medical and its affiliates may operate different websites for different purposes and in different countries, where different laws may apply. If you visit another Enterra 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 Enterra 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. Enterra 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 Data

Contact Us

If you have any questions regarding this policy or about our privacy practices, or need to contact us for purposes related to this Policy, please contact us on the below details:

Email: info@enterramedical.com
Mail: Enterra Medical
5353 Wayzata Boulevard, Suite 400
St. Louis Park, MN 55416

If you are not satisfied with our response, we may require you to submit your complaint in writing by email at info@enterramedical.com with your contact details and details of your complaint.

Further Information on Privacy

You can additionally contact your local supervisory authority for more information about your privacy rights.