Terms of Service

01 Acceptance of Terms

By accessing or using the Service, you ("User", "you") represent that you have read, understood, and agree to be bound by these Terms. If you are accessing the Service on behalf of an institution, hospital, or research organization, you represent that you have authority to bind that organization to these Terms, and these Terms apply to that organization as well.

If you do not agree to these Terms, you must immediately discontinue all use of the Service.

These Terms are in addition to, and do not supersede, any separate written agreement you may have executed with QuanTAVI regarding access to the Service.

02 Description of Service

QuanTAVI is a medical imaging software platform designed to assist with CT-based pre-procedural analysis for aortic valve interventions, including Transcatheter Aortic Valve Replacement (TAVR), Surgical Aortic Valve Replacement (SAVR), and Valve-in-Valve (ViV) procedures. The Service provides tools for:

• Multi-planar reconstruction (MPR) of cardiac CT data
• Aortic root segmentation and geometric measurement
• Valve sizing analysis and device selection support
• Calcium scoring and distribution visualization
• Access site planning and vascular assessment
• Procedural simulation and reporting outputs

The Service is provided on an access-controlled basis and may be updated, modified, or discontinued at any time without notice. Features described in marketing materials may not yet be available and are subject to change.

03 Research Use Only

By using the Service, you expressly acknowledge and agree that:

• QuanTAVI has not received clearance or approval from the U.S. Food and Drug Administration (FDA) as a medical device and is not CE marked for clinical use in the European Union.
• The Service is intended solely for research, training, feasibility studies, and educational demonstration purposes.
• Outputs, measurements, analyses, and recommendations generated by the Service must not be used, directly or indirectly, to inform clinical decisions, diagnose medical conditions, select implant devices for actual patients, guide intraoperative decisions, or substitute for the independent clinical judgment of a qualified healthcare professional.
• All measurements and visualizations produced by the Service should be treated as preliminary research outputs only and must be independently validated before any use in connection with patient care.
• Users accept full and sole responsibility for any consequences arising from use of the Service outside its intended research scope.

Any use of the Service for clinical purposes is a material breach of these Terms and is strictly prohibited.

04 Medical Disclaimer

QuanTAVI is not a medical device. The Service does not constitute the practice of medicine, nursing, or any other professional healthcare service. Nothing in the Service or these Terms constitutes medical advice.

The accuracy, completeness, and clinical applicability of measurements and analyses generated by the Service depend on the quality of input imaging data, correct user operation, and the inherent limitations of computational methods applied to complex anatomical structures. QuanTAVI makes no representations or warranties regarding the accuracy or reliability of any measurement, sizing recommendation, risk score, or other output generated by the Service.

Qualified healthcare professionals using the Service for research purposes should apply their independent clinical knowledge to evaluate all outputs critically. The Service does not replace expertise, institutional protocols, or device manufacturer instructions for use.

05 User Responsibilities

As a condition of access to the Service, you agree to:

• Authorized use only. Use the Service solely for its intended research and educational purposes, and in compliance with all applicable laws and regulations.
• Account security. Maintain the confidentiality of your access credentials and notify QuanTAVI immediately of any unauthorized access or suspected security breach.
• Patient data. Ensure that any patient data uploaded to or processed through the Service is de-identified in accordance with applicable data protection law (including HIPAA, GDPR, or equivalent local regulations) before processing, unless you have obtained explicit written authorization from patients and your institution.
• Institutional compliance. Obtain all necessary institutional approvals, ethics committee or IRB approvals, and data governance sign-offs required by your institution before using the Service with any patient-derived data.
• No reverse engineering. Not attempt to decompile, reverse engineer, disassemble, or otherwise attempt to derive the source code or underlying algorithms of the Service.
• No unauthorized distribution. Not share, sublicense, resell, or otherwise distribute access to the Service to third parties without prior written consent from QuanTAVI.
• Accurate information. Provide accurate and complete information when registering for or using the Service, and keep such information current.
• Feedback. Report any technical anomalies, unexpected outputs, or safety concerns to QuanTAVI promptly at [email protected].

06 Intellectual Property

The Service and all of its components — including but not limited to software code, algorithms, models, user interfaces, visualizations, workflows, documentation, trade names, trademarks, and service marks — are the exclusive intellectual property of QuanTAVI and are protected by applicable copyright, patent, trade secret, and other intellectual property laws.

These Terms grant you a limited, non-exclusive, non-transferable, revocable license to access and use the Service solely for research purposes as described herein. No other rights are granted. Nothing in these Terms transfers ownership of any intellectual property to you.

You retain ownership of any data you upload to the Service. By uploading data, you grant QuanTAVI a limited, non-exclusive license to process that data for the purpose of providing the Service to you. QuanTAVI will not use your uploaded data to train machine learning models without your explicit written consent.

Any feedback, suggestions, or ideas you provide regarding the Service may be used by QuanTAVI without obligation or compensation to you.

07 Data and Privacy

Your use of the Service is also governed by our Privacy Policy, which is incorporated into these Terms by reference. Please review our Privacy Policy to understand our data collection and handling practices.

You are solely responsible for ensuring that all data you process through the Service complies with applicable data protection, medical privacy, and research ethics requirements. QuanTAVI is not responsible for any failure by you to comply with applicable data protection obligations.

QuanTAVI implements reasonable technical and organizational security measures to protect data processed through the Service. However, no system is completely secure, and QuanTAVI does not guarantee the absolute security of data transmitted to or stored within the Service.

08 Limitation of Liability

The Service is provided "as is" and "as available" without warranties of any kind, either express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose, accuracy, completeness, or non-infringement.

To the fullest extent permitted by applicable law, QuanTAVI, its officers, directors, employees, affiliates, and licensors shall not be liable for any:

• Direct, indirect, incidental, special, consequential, or punitive damages;
• Loss of data, revenue, profits, or business opportunities;
• Personal injury, patient harm, or adverse clinical outcomes arising from use or reliance on the Service;
• Errors, inaccuracies, or omissions in Service outputs;
• Interruption, suspension, or termination of the Service;

even if QuanTAVI has been advised of the possibility of such damages. In jurisdictions that do not allow the exclusion or limitation of liability for consequential or incidental damages, QuanTAVI's liability is limited to the maximum extent permitted by law.

QuanTAVI's total aggregate liability to you for any claim arising under these Terms shall not exceed the total fees paid by you to QuanTAVI in the twelve (12) months preceding the claim.

09 Indemnification

You agree to indemnify, defend, and hold harmless QuanTAVI and its officers, directors, employees, affiliates, and licensors from and against any claims, liabilities, damages, losses, costs, and expenses (including reasonable attorneys' fees) arising out of or in any way connected with:

• Your use of the Service in violation of these Terms;
• Any clinical or patient-care use of the Service;
• Your violation of any applicable law or regulation;
• Your violation of any third party's rights, including privacy, data protection, or intellectual property rights;
• Any misrepresentation made by you in connection with your use of the Service.

10 Termination

QuanTAVI reserves the right to suspend or terminate your access to the Service at any time, with or without cause, and with or without notice, including but not limited to situations where:

• You violate any provision of these Terms;
• You use the Service for clinical or patient-care purposes;
• QuanTAVI determines, in its sole discretion, that continued access poses a risk to patient safety, data integrity, or regulatory compliance;
• QuanTAVI decides to discontinue the Service or a portion thereof.

Upon termination, your license to use the Service immediately ceases. Provisions of these Terms that by their nature should survive termination — including intellectual property rights, disclaimers, limitation of liability, and indemnification — shall survive.

You may terminate your use of the Service at any time by discontinuing access and notifying QuanTAVI at [email protected].

11 Governing Law and Dispute Resolution

These Terms shall be governed by and construed in accordance with the laws of the jurisdiction in which QuanTAVI is incorporated, without regard to its conflict of law principles.

Any dispute arising out of or relating to these Terms or the Service shall first be subject to good-faith negotiation between the parties. If such negotiation fails, disputes shall be resolved through binding arbitration or, where arbitration is not permitted by law, through the courts of competent jurisdiction in QuanTAVI's principal place of business.

You agree to resolve any claims on an individual basis and waive any right to participate in class action proceedings to the fullest extent permitted by applicable law.

12 Changes to Terms

QuanTAVI reserves the right to modify these Terms at any time. When we make material changes, we will update the "Last updated" date at the top of this page and, where appropriate, provide notice through the Service or via email.

Your continued use of the Service after any modification constitutes your acceptance of the revised Terms. If you do not agree with any changes, you must discontinue use of the Service.

We encourage you to review these Terms periodically to stay informed of any updates.

Contact

If you have questions about these Terms, wish to report a potential violation, or need to discuss your access to the Service, please contact us: