By accessing or using the Aortic Sciences platform, software, and related services (collectively, the "Platform") — including registering for an account, using any calculator, or generating, viewing, or sharing any report — you ("User") agree to be bound by these Terms of Use ("Terms"). Each such use constitutes your acceptance of the then-current Terms. If you do not agree to these Terms in their entirety, you must immediately discontinue use of the Platform and may not generate, share, or rely upon any report.
These Terms constitute a legally binding agreement between you and Aortic Sciences, a corporation organized under the laws of the State of New York.
The Platform is intended solely for use by licensed medical professionals, including but not limited to physicians, nurse practitioners, physician assistants, and other credentialed healthcare providers who are legally authorized to practice medicine in their applicable jurisdiction ("Authorized Users").
The Platform is designed to assist Authorized Users in conducting clinical consultations with patients regarding aortic adverse event risk. All outputs, calculations, risk assessments, and reports are intended exclusively as a clinical consultation tool to support — not replace — the independent medical judgment of a licensed healthcare professional.
By registering for or using the Platform, you represent and warrant that you are a licensed medical professional or credentialed healthcare provider authorized to practice in your applicable jurisdiction, that you are accessing the Platform solely in that professional capacity, and that the Platform is not intended for, and you will not use it for, patient self-assessment or use by members of the general public.
THE PLATFORM DOES NOT PROVIDE MEDICAL ADVICE, DIAGNOSIS, OR TREATMENT.
All risk assessments, projections, multipliers, and recommendations generated by the Platform are:
The Platform is intended to operate as non-device Clinical Decision Support software under Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act. It applies published, guideline-derived methodology to clinical values manually entered by an Authorized User, presents risk information and options for the Authorized User's independent review, and does not acquire, process, or analyze medical images or signals from any diagnostic or signal-acquisition device.
The Platform is not a medical device, is not FDA cleared or approved, and is not intended to replace or direct the Authorized User's independent clinical judgment. Every risk factor multiplier, source, and the cumulative calculation are disclosed to the Authorized User so that the basis for any figure can be independently reviewed.
Aortic Sciences has not sought or obtained any review, clearance, licence, certification, or approval from Health Canada or any other Canadian federal or provincial regulator for the Platform, and makes no representation as to the Platform's regulatory classification or status in Canada. The Platform is made available to Authorized Users in Canada — whether for product evaluation or for use in clinical consultation, at the Authorized User's discretion — solely on the basis that the Authorized User understands and accepts that no such Canadian regulatory review or approval has been obtained. The Authorized User retains full and independent clinical responsibility for any decision they make and is responsible for determining whether their use of the Platform is permitted under applicable Canadian federal and provincial law and the requirements of their institution and licensing body.
THIS PLATFORM IS NOT DESIGNED FOR USE IN MEDICAL EMERGENCIES.
In the event of a suspected aortic dissection, rupture, or any other acute cardiovascular emergency, Authorized Users must immediately direct patients to call 911 or the applicable local emergency services number, or transport the patient to the nearest emergency department.
The risk calculation methodology employed by the Platform is based upon published peer-reviewed medical literature. Primary sources include Elefteriades & Davies (Ann Thorac Surg 2002), Coady et al. (1999), Hagan et al. IRAD (JAMA 2000), Pape et al. (JACC 2007), and ACC/AHA 2022 Guidelines.
RISK FACTOR MULTIPLIERS, GROWTH RATE DEFAULTS, AND CALCULATION PARAMETERS ARE SUBJECT TO CHANGE AT ANY TIME. Aortic Sciences reserves the right to update, revise, or recalibrate any risk factor multiplier, base annual rate, growth rate default, cumulative risk formula, combined-multiplier cap, threshold value, or other calculation parameter or methodology, at its sole discretion and without prior notice. Users are responsible for reviewing the current methodology prior to clinical use. Changes to the methodology do not affect previously generated reports.
The application of risk factor multipliers represents the authors' interpretation and synthesis of published data. These multipliers have not been independently validated in a prospective clinical trial and should be interpreted accordingly.
The Platform provides designated fields for Authorized Users to manually record surgical risk estimates they have independently obtained from third-party clinical risk calculators and tools. Third-party risk estimates entered by the Authorized User may appear in Platform-generated reports solely as a record of that physician's independently obtained clinical data.
Any third-party risk estimates appearing in Platform-generated reports represent clinical data manually entered by the Authorized User and constitute that physician's own clinical input — not a calculation or output of Aortic Sciences. The Authorized User is solely responsible for independently accessing any third-party calculator and for the accuracy of any values entered. Aortic Sciences makes no representations regarding the accuracy, completeness, or currentness of any third-party calculator outputs or the data derived therefrom.
Reference to third-party tools within the Platform does not imply sponsorship, affiliation, endorsement, or approval by those organizations. All third-party trademarks, service marks, and logos are the property of their respective owners. Authorized Users are responsible for compliance with any terms of service applicable to third-party tools they use in connection with the Platform.
Aortic Sciences expressly disclaims all liability for any clinical decisions made in reliance upon data entered from third-party calculators. The Authorized User assumes sole responsibility for the accuracy of any third-party data entered into the Platform.
The Platform operates exclusively with de-identified clinical parameters. Authorized Users must not enter any personally identifiable information (PII) or protected health information (PHI) into any field of the Platform, including but not limited to patient names, dates of birth, Social Security numbers, medical record numbers, or any other direct patient identifiers.
The Platform is designed to be HIPAA Safe Harbor compliant. Risk assessments are generated from de-identified inputs including aortic size, growth rate, age bracket, sex, and clinical risk factors. Authorized Users are solely responsible for ensuring that all data entered into the Platform complies with applicable HIPAA, state, and institutional privacy requirements.
Authorized Users in Canada are solely responsible for ensuring that all data entered into the Platform is de-identified to at least the HIPAA Safe Harbor standard described above and complies with applicable Canadian federal and provincial health-information and privacy legislation, including the Personal Information Protection and Electronic Documents Act (PIPEDA) and any applicable provincial health-privacy statute, as well as the requirements of their institution and licensing body.
THE PLATFORM IS PROVIDED ON AN "AS IS" AND "AS AVAILABLE" BASIS WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED. Aortic Sciences expressly disclaims all warranties, including implied warranties of merchantability, fitness for a particular purpose, or non-infringement. The risk calculations are derived from population-level statistical data. Individual patient outcomes may vary materially from any population-based estimate.
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, AORTIC SCIENCES SHALL NOT BE LIABLE FOR any direct, indirect, incidental, special, consequential, or punitive damages arising out of use of the Platform, including any clinical decision made in reliance upon Platform outputs, any adverse patient outcome, or any errors or omissions in the risk methodology or calculations.
You agree to indemnify and hold harmless Aortic Sciences, its directors, officers, employees, and agents from and against any claims, damages, losses, costs, and expenses arising out of your use of the Platform, your violation of these Terms, or any clinical decision made in reliance on Platform outputs.
The Platform — including all software, source code, risk calculation methodology, risk factor multipliers, base annual rate tables, growth rate defaults, cumulative risk formulas, algorithms, report templates and layouts, user interface, text, graphics, and logos (collectively, the "Aortic Sciences Materials") — together with all intellectual property rights therein, is and shall remain the sole and exclusive property of Aortic Sciences and its licensors. The Aortic Sciences Materials are protected by United States and international copyright, trademark, trade secret, and other intellectual property laws.
Subject to your continued compliance with these Terms, Aortic Sciences grants you a limited, non-exclusive, non-transferable, non-sublicensable, and revocable license to access and use the Platform solely for the clinical consultation purposes described herein. Except as expressly permitted, you may not: (a) copy, reproduce, modify, adapt, or create derivative works of the Aortic Sciences Materials; (b) reverse engineer, decompile, disassemble, or otherwise attempt to derive the source code or underlying calculation logic of the Platform (the disclosure of individual multipliers and their published sources within the Platform does not grant any right to extract, replicate, or repurpose the methodology as a whole); (c) resell, rent, sublicense, distribute, or otherwise commercially exploit the Platform; or (d) use any Aortic Sciences name, trademark, service mark, or logo without prior written consent.
Authorized Users may retain, store, and use reports generated by the Platform for legitimate clinical, counseling, and recordkeeping purposes. Aortic Sciences retains all right, title, and interest in the underlying methodology, calculation logic, and report templates reflected in any generated report.
The Platform is intended for use within the United States. It is also made available to Authorized Users in Canada, who may use it for product evaluation or for clinical consultation at their own discretion, subject to this Section and Section 3A.
Aortic Sciences has not sought or obtained any review, clearance, licence, certification, or approval from Health Canada or any other Canadian regulator, and makes no representation as to the Platform's regulatory classification or status in Canada. By registering for or using the Platform from Canada, the Authorized User acknowledges and accepts that no Canadian regulatory review or approval has been obtained, is solely responsible for determining whether their use of the Platform complies with applicable Canadian federal and provincial law and the requirements of their institution and licensing body, and retains full and independent clinical responsibility for any decision informed by the Platform. Personal information of Canadian Authorized Users is handled as described in the Privacy Policy, including its provisions on cross-border storage in the United States.
Users outside the United States and Canada access the Platform at their own risk and without any guarantee of compliance with the laws or regulations of any other jurisdiction. The Platform is not offered in the European Union, the European Economic Area, the United Kingdom, or any other jurisdiction outside the United States and Canada.
Governing Law & Venue. These Terms shall be governed by and construed in accordance with the laws of the State of New York, without regard to its conflict-of-laws principles. Any dispute, claim, or controversy arising out of or relating to these Terms or the Platform shall be brought exclusively in the state or federal courts located in New York County, New York, and you consent to the personal jurisdiction and venue of those courts. Nothing in this provision limits or waives any right or protection that cannot be limited or waived under the mandatory laws of your province or territory of residence, including applicable Canadian consumer-protection and privacy legislation.
Modifications to Terms. Aortic Sciences reserves the right to modify these Terms at any time. Revised Terms will be posted on the Platform with an updated "Last Updated" date. Your continued use of the Platform after revised Terms are posted constitutes acceptance of the modified Terms. Changes to the methodology or these Terms do not affect reports previously generated.
Assignment. Aortic Sciences may assign or transfer these Terms and its rights and obligations hereunder, in whole or in part, without restriction, including in connection with a merger, acquisition, reorganization, or sale of all or substantially all of its assets. You may not assign or transfer these Terms without the prior written consent of Aortic Sciences, and any attempted assignment in violation of this provision is void.
Severability. If any provision of these Terms is held by a court of competent jurisdiction to be invalid, illegal, or unenforceable, that provision shall be enforced to the maximum extent permissible and the remaining provisions shall remain in full force and effect.
No Waiver. No waiver of any provision of these Terms shall be effective unless in writing and signed by an authorized representative of Aortic Sciences. The failure of Aortic Sciences to enforce any right or provision of these Terms shall not constitute a waiver of that or any other right or provision.
Force Majeure. Aortic Sciences shall not be liable for any delay or failure in performance, or for any interruption or unavailability of the Platform, resulting directly or indirectly from causes beyond its reasonable control, including without limitation internet or telecommunications failures, hosting or cloud-service outages, equipment or power failures, acts of God, natural disasters, labor disputes, or governmental actions.
Entire Agreement. These Terms, together with the Privacy Policy, constitute the entire agreement between you and Aortic Sciences regarding the Platform and supersede all prior or contemporaneous understandings, agreements, representations, and communications, whether written or oral, regarding its subject matter.