Terms of Service

These Terms of Service ("Terms") govern your access to and use of the website, software, and medical devices operated or manufactured by EnoPace Inc. ("Company", "we", "us", or "our"). By accessing or using our products or website, you agree to be bound by these Terms.

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1. Company Information

Company Name: EnoPace Inc.

Address: 75 Park St, Lewiston, ME 04240, United States

Website: www.enopace.com

Email: support@enopace.com

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2. Nature of Services

EnoPace Inc. develops innovative, minimally invasive neurostimulation systems for the treatment of congestive heart failure (CHF). The company's flagship product, the Harmony™ System, is an RF-operated implantable neurostimulator designed to increase cardiac efficiency by reducing left-ventricular workload — without the need for open coronary surgery. All products and associated software are provided to support licensed cardiologists and healthcare institutions in the clinical care of qualifying heart failure patients.

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3. No Medical Advice Disclaimer

The information and outputs provided by EnoPace products and this website are not intended as a substitute for professional medical judgment, diagnosis, or treatment. Our products are tools designed to assist qualified cardiac care professionals — they do not replace clinical expertise. Always rely on the independent judgment of a licensed physician when making treatment decisions.

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4. User Eligibility and Conduct

Access to EnoPace products is restricted to licensed healthcare professionals and authorized institutional users only. By using our products, you represent that you are qualified and authorized to do so. You agree to:

Use our products only for their cleared or approved Intended Use;
Comply with all applicable federal, state, and local laws and regulations;
Maintain the confidentiality of your account credentials;
Promptly report any device malfunctions or adverse events to us and to the FDA as required;
Refrain from attempting unauthorized access to our systems, software, or data.

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5. FDA Regulatory Compliance

EnoPace products are medical devices regulated by the U.S. Food and Drug Administration (FDA). Products are cleared or approved only for their specific Intended Use as described in the accompanying product labeling. Use outside of cleared indications is the sole responsibility of the user. Users outside the United States are responsible for ensuring the applicable product holds required regulatory approvals in their jurisdiction — including CE Mark under the EU MDR where applicable — before clinical use.

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6. Intellectual Property Rights

All content, software, device designs, trademarks, and materials associated with EnoPace products and this website are the property of EnoPace Inc. or its licensors and are protected by applicable intellectual property laws. You may not reproduce, modify, reverse engineer, or distribute any part of our products or content without our prior written consent.

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7. Patient Data and Privacy

EnoPace is committed to protecting patient privacy. All patient data processed through our products is handled in accordance with the Health Insurance Portability and Accountability Act (HIPAA) and applicable privacy laws. Healthcare institutions must execute a Business Associate Agreement (BAA) with us prior to transmitting any Protected Health Information (PHI) through our products. We do not sell patient data to third parties.

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8. SMS Messaging – Promotional Marketing Only

By voluntarily providing your mobile phone number and opting in, you consent to receive promotional and marketing SMS messages from EnoPace Inc.

Message frequency may vary.
Message and data rates may apply.
Consent is not a condition of purchase or clinical use.
You may opt out at any time by replying STOP to [INSERT SHORT CODE].
Reply HELP to [INSERT SHORT CODE] for assistance or contact support@enopace.com.
No transactional, emergency, diagnostic, or account-critical messages are sent via SMS.

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Participating Carriers include - AT&T, T-Mobile, Metro PCS, Verizon Wireless, US Cellular, Google Voice, Cellular One, Cellcom, Cellular South, Interop, Clearsky

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Carriers are not liable for undelivered or delayed messages.

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9. Healthcare Emergency Notice

EnoPace products are not intended for emergency response outside of their specific cleared indications. If a patient is experiencing a cardiac or medical emergency, call 911 or your local emergency services immediately and follow your facility's emergency protocols.

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10. Third-Party Links

Our website and software may contain links to third-party websites or integrations. We are not responsible for the content, accuracy, privacy practices, or reliability of any third-party sites or services. Links are provided for convenience only and do not imply endorsement.

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11. Disclaimer of Warranties

Our website and non-device services are provided on an "as is" and "as available" basis without warranties of any kind, express or implied. Hardware products are covered by a limited one-year warranty as described in the applicable product documentation. To the fullest extent permitted by law, we disclaim all implied warranties, including warranties of merchantability, fitness for a particular purpose, and non-infringement.

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12. Limitation of Liability

To the fullest extent permitted by law, EnoPace Inc. shall not be liable for any indirect, incidental, special, or consequential damages arising from your use of our products or website. Our total liability shall not exceed the amounts paid by you to the Company for the applicable product in the twelve months preceding the claim.

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13. Governing Law

These Terms are governed by the laws of the State of Delaware, without regard to conflict of law principles. Any disputes arising under these Terms shall be resolved by binding arbitration, administered by JAMS under its Comprehensive Arbitration Rules. You agree that disputes will be resolved on an individual basis and not as part of a class action.

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14. Changes to These Terms

We reserve the right to modify these Terms at any time. Changes will be effective upon posting to our website or notification by email. Continued use of our products or website after the effective date of any modification constitutes your acceptance of the revised Terms.

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15. Contact Information

If you have questions regarding these Terms, product safety, or regulatory matters, please contact us:

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