Institutional Terms of Use

1. Who We Are & Acceptance of Terms

This website (www.deepsensi.com), its subdomains, and associated digital services are owned and operated by DeepSensi PBC, a Delaware Public Benefit Corporation (“DeepSensi”, “we”, “us”, “our”), located at 8 The Green STE A, Dover, DE 19901, United States.

By accessing or using this website, you confirm that you have read, understood, and agree to be bound by these Terms of Use and our Privacy Policy. If you do not agree to these terms, you must immediately discontinue using this site. If you represent a healthcare institution, university hospital, academic medical center, or pharmaceutical enterprise, you represent and warrant that you possess full corporate authority to bind your organization.

2. Not Medical Advice: Clinical Decision Support (CDS) Character

NOTHING CONTAINED ON THIS WEBSITE OR PRODUCED BY THE DEEPSENSI PLATFORM CONSTITUTES DIRECT MEDICAL ADVICE, DIAGNOSIS, PROGNOSIS, OR TREATMENT PRESCRIPTION.

Precision Suite delivers systems biology decision intelligence as Clinical Decision Support (CDS) software for licensed physicians, reviewed by FDA under Pre-Submission Q262487 pursuant to section 520(o)(1)(E) of the FD&C Act. Regulatory status: deepsensi.com/regulatory In particular:

• The software provides transparent, multi-domain cognitive recommendations, literature-backed hypotheses, and cross-domain systems biology analyses exclusively to licensed, qualified healthcare providers;
• It presents the underlying biomedical citations, biochemical pathway rationale, and clinical evidence so that the treating physician can independently review, verify, and substantiate every inference;
• It does not execute autonomous clinical actions, does not acquire or directly drive in vitro diagnostic sensors, and does not replace human clinical expertise;
• Final Medical Authority: The treating physician maintains exclusive, independent, and uncompromised medical responsibility and legal authority for all diagnostic evaluations, laboratory workup orders, and therapeutic decisions.

Medical Emergencies: If you are a patient experiencing a medical emergency, call your local emergency services (911 in the United States, 112 in the European Union, 999 in the United Kingdom) or proceed immediately to the nearest hospital emergency department. Never delay seeking medical care because of information found on this website.

3. Regulatory Status & Active FDA Submissions

Regulatory status in the United States

DeepSensi Public Benefit Corporation develops two different kinds of software functions, and they are regulated differently.

Our investigational medical device configuration (DeepSensi Cognitive Medical OS) encompasses advanced clinical functions, including volumetric image feature extraction, 3D reconstruction, and autonomous emergency interlocks (docket Q262494). Functions requiring further regulatory clearances or approvals are currently unavailable and will be made available strictly once those respective official clearances are obtained.

Precision Suite is a separate software function. It gives a licensed physician an organized analysis of a patient's existing written records, with the sources behind each item, for the physician to review independently. Results go to the physician. A patient receives only what the physician chooses to share. Precision Suite does not analyze medical images or signals, is not intended for time-critical or emergency decisions, and makes no diagnostic accuracy claims. Precision Suite delivers systems biology decision intelligence as Clinical Decision Support (CDS) software for licensed physicians, meeting statutory non-device criteria under section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act following formal review under FDA Pre-Submission Q262487.

The DeepSensi Edge Node home station is a consumer product and is not a medical device. It does not include any clinical monitoring, detection, or alerting feature. Such features are in development, have not been authorized by FDA, and are not offered for sale.

Canada

Where we state at checkout that Precision Suite is available to residents of Canada, it is offered there, outside Quebec, on the basis of Health Canada's guidance on software as a medical device, under which software that meets all of the guidance's criteria is not regulated as a medical device. Health Canada has not reviewed this position. Results go only to a physician licensed in the patient's province or territory.

What this statement does not say

This statement reflects official written feedback received from the U.S. Food and Drug Administration (FDA) under Pre-Submission Q262487, confirming that current commercial diagnostic-support functions qualify as non-device CDS under Section 520(o)(1)(E). Functions requiring further regulatory clearances (including volumetric image feature extraction, 3D reconstruction, and autonomous emergency interlocks under Q262494) are currently unavailable and will be made available strictly once those respective official clearances are obtained.

• FDA Non-Device CDS (Section 520(o)(1)(E)): Written feedback received under Pre-Submission docket Q262487 confirming non-device Clinical Decision Support status for commercial diagnostic-intelligence functions.
• Investigational Medical Device Track (Docket Q262494): Covering volumetric imaging, 3D feature extraction, and autonomous interlocks. Functions requiring further regulatory clearances are currently unavailable and will be made available strictly once those respective official clearances are obtained.
• Decentralized Clinical Trial (DCT) Registries: Our 9 observational clinical trial registries, including EPI-RESOLVE™ (Protocol ID DS-CLIN-2026-EPI-RESOLVE), NEURO-RESOLVE™, IMMUNO-RESOLVE™, ONCO-SHIELD™, METABO-RESOLVE™, CARDIO-RESOLVE™, RARE-RESOLVE™, ENDO-RESOLVE™, and MIND-RESOLVE™, are designed as prospective observational decentralized registries and open to participants only under Institutional Review Board (IRB / Ethics Committee) oversight, ICH E6(R2)/E6(R3) Good Clinical Practice (GCP), and the FDA 2023 Guidance on Decentralized Clinical Trials.

4. Validation Benchmarks & Performance Figures

Performance statistics and diagnostic precision metrics (the method behind each figure is described on our Science page) and the safety architecture figures (the method is described at deepsensi.com/safety-architecture) published on this site reflect engineering benchmarks and retrospective evaluations conducted in accordance with the DeepSensi Standard (DSS-001 Platinum Standard).

Full methodology, statistical analysis plans, and validation cohorts are published in our peer-reviewed papers and whitepapers (WP-001 through WP-008). Retrospective analytical benchmarks do not constitute a legal guarantee or warranty of identical clinical results for individual patients across all prospective clinical settings.

5. Intellectual Property & The Open Standard

Trademarks: DeepSensi™, PopSIM™, White Space Engine™, LIMBO™, AutoResearcher-HYPO™, EPI-RESOLVE™, NEURO-RESOLVE™, IMMUNO-RESOLVE™, ONCO-SHIELD™, and associated brand insignia are trademarks of DeepSensi PBC (registrations active and pending worldwide).

Patent applications (Patent Pending) & trade secrets: The proprietary algorithms, tensor graph representations, multi-tenant consilium engines, and on-device identifier-removal pipelines are protected under patent applications (Patent Pending), trade secrets, and copyright law © 2026 DeepSensi PBC. All rights reserved. Access to this website confers no license, title, or interest in any patent, patent application, trademark, or trade secret.

The DeepSensi Standard (DSS-001): The DeepSensi Standard is published as an open, royalty-free architectural specification to foster scientific rigor and clinical safety across medical cognitive computing. Compliance with the open DSS-001 standard does not grant rights or licenses to the proprietary DeepSensi platform implementation.

6. Acceptable Use & Security Restrictions

You agree to use this website and associated services strictly for lawful, institutional, and clinical research purposes. You expressly agree that you will not:

• Reverse engineer, decompile, disassemble, or attempt to extract source code, model weights, or underlying algorithms of DeepSensi software;
• Deploy automated scrapers, web crawlers, data mining bots, or AI extraction tools against this site or documentation portals;
• Attempt to compromise, breach, or bypass authentication credentials, rate limiters, or network security perimeters;
• Input, submit, or upload actual Protected Health Information (PHI) or Personally Identifiable Information (PII) of patients into public web forms;
• Misrepresent your identity, clinical credentials, or affiliation with any healthcare or academic institution.

7. Scientific Literature, Citations & Third-Party Links

This website references peer-reviewed medical publications (including the New England Journal of Medicine, The Lancet, JAMA, Nature Medicine), biomedical databases (UniProt, OMIM, ChEMBL, PubChem, Orphanet), and external academic resources. Third-party citations and links are provided solely for scientific transparency. DeepSensi PBC exercises no editorial control over external domains and assumes no liability for external content.

8. Forward-Looking Statements & No Securities Offering

Certain statements on this website regarding regulatory milestones, clinical trial timelines, platform scaling, and strategic projections constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are based on current management expectations and are subject to scientific, clinical, competitive, and regulatory uncertainties.

Nothing on this website constitutes an offer to sell or a solicitation of an offer to purchase securities or investment interests in DeepSensi PBC. Official investor materials are provided exclusively via private confidential memorandum to accredited and institutional investors.

9. Disclaimer of Warranties & Limitation of Liability

THIS WEBSITE AND ALL INFORMATIONAL MATERIALS ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT.

TO THE FULLEST EXTENT PERMISSIBLE BY APPLICABLE LAW, IN NO EVENT SHALL DEEPSENSI PBC, ITS DIRECTORS, OFFICERS, EMPLOYEES, AFFILIATES, OR LICENSORS BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL DAMAGES (INCLUDING LOSS OF PROFITS, DATA LOSS, BUSINESS INTERRUPTION, OR CLINICAL ADVERSE EVENTS) ARISING OUT OF OR IN CONNECTION WITH USE OF THIS WEBSITE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

10. Governing Law, Exclusive Jurisdiction & Legal Notices

These Terms of Use shall be governed by and construed in accordance with the laws of the State of Delaware, United States of America, without giving effect to conflict of laws principles. Any legal suit, action, or proceeding arising out of or related to these terms shall be instituted exclusively in the Court of Chancery of the State of Delaware, or the United States District Court for the District of Delaware.

Severability: If any provision of these Terms is found to be unlawful, void, or unenforceable, that provision shall be deemed severable and shall not affect the validity and enforceability of remaining provisions.

Legal & Regulatory Inquiries:
General Legal Affairs: [email protected]
Regulatory & Compliance Office: [email protected]
General Corporate Inquiries: [email protected]
Corporate Address: DeepSensi PBC, 8 The Green STE A, Dover, DE 19901, United States.

Documents that apply to purchases and to personal information: Precision Suites Terms of Service, Refund and Cancellation Policy, Privacy Policy, Consumer Health Data Privacy Policy, function status.