Legal & Medical Notice
Important information regarding Breathe Biologics, JadiCell™, investigational product information, scientific and medical content, clinical research, intellectual property, and use of this website.
About This Website
This website is operated by Breathe Biologics, Inc. and provides scientific, medical, corporate, investor, business-development, and educational information concerning the company and its investigational technologies.
Important: Information presented on this website is provided for scientific, medical, corporate, investor, and educational purposes. Nothing on this website should be interpreted as medical advice, a recommendation for treatment, or evidence that an investigational therapy has been approved for commercial use.
JadiCell™ Is an Investigational Cellular Therapy
Safety and efficacy have not been established for any indication.
JadiCell™ is an investigational cellular therapy and has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority for the treatment, prevention, diagnosis, or cure of any disease.
References to proposed mechanisms of action, biological pathways, disease applications, potential therapeutic activity, or potential clinical benefits may include scientific hypotheses that remain under investigation.
Scientific & Medical Information
Scientific and medical information presented on this website may include findings derived from peer-reviewed publications, clinical studies, preclinical research, translational studies, biomarker analyses, pharmacodynamic observations, scientific literature, public clinical-trial registries, and investigational hypotheses.
The website may also discuss mesenchymal stromal cell biology, regenerative medicine, inflammatory pathways, pulmonary disease biology, proposed mechanisms of action, and other areas of active scientific investigation.
Scientific knowledge evolves continuously. Early-stage, exploratory, mechanistic, translational, or biomarker findings should not be interpreted as establishing clinical efficacy.
Published Clinical Evidence
This website may discuss published clinical research involving investigational mesenchymal stromal cell therapy, including research involving JadiCell™ in patients with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS).
Findings from a specific patient population, disease setting, clinical protocol, or stage of development should not automatically be generalized to other populations, disease etiologies, or pulmonary conditions.
In particular, observations from studies involving COVID-19-associated ARDS should not be interpreted as establishing safety or efficacy in non-COVID ARDS, COPD, interstitial lung disease, pulmonary vascular disease, bronchiectasis, or any other disease or indication.
Regulatory & Investigational Status
References on this website to Investigational New Drug applications, clinical-trial authorization, clinical-development stages, or regulatory interactions describe investigational development activities.
Authorization to conduct clinical investigation under an IND does not constitute FDA approval of an investigational product and does not establish safety or efficacy.
Clinical-development plans, regulatory strategies, study designs, enrollment plans, endpoints, timelines, and development priorities may change based on scientific findings, regulatory feedback, operational considerations, financing, or other factors.
No Medical Advice
Information available through this website is not intended to establish a physician-patient relationship and should not be used to diagnose, treat, prevent, or manage any medical condition.
Patients and other individuals should seek the advice of a qualified healthcare professional regarding medical questions, diagnoses, treatment options, or healthcare decisions.
Do not disregard professional medical advice or delay seeking medical care because of information obtained from this website.
Clinical-Trial Information
Information concerning clinical trials is provided for informational and scientific purposes.
Clinical protocols, study designs, enrollment criteria, study locations, endpoints, enrollment status, regulatory status, and anticipated timelines may change.
Official clinical-trial registries and communications from study investigators should be consulted for the most current trial information.
Nothing on this website guarantees eligibility for, enrollment in, or access to any clinical trial.
Forward-Looking Statements
This website may contain statements regarding future expectations, plans, clinical development, regulatory activities, manufacturing, financing, commercialization, collaborations, intellectual property, market opportunities, strategic transactions, or other future events.
Such statements are forward-looking in nature and are subject to risks, uncertainties, assumptions, and other factors that may cause actual events or results to differ materially from those expressed or implied.
Forward-looking statements speak only as of the date on which they are made, and no assurance can be given that anticipated events, development milestones, regulatory outcomes, transactions, or other objectives will occur.
Intellectual Property
Unless otherwise indicated, website content—including text, graphics, logos, illustrations, scientific diagrams, videos, downloadable materials, page designs, and other materials—is owned by or licensed to Breathe Biologics and may be protected by applicable intellectual-property laws.
Breathe Biologics™, JadiCell™, associated logos, and other names or marks may constitute trademarks or proprietary marks of their respective owners.
Access to this website does not grant any license or right to any patent, trademark, copyright, trade secret, technology, know-how, manufacturing process, clinical data, or other intellectual property.
Third-Party Scientific Information
This website may reference or link to scientific journals, publications, clinical-trial registries, government agencies, universities, research institutions, professional organizations, and other third-party sources.
Such references are provided for scientific, educational, or informational purposes and do not imply endorsement of all statements, conclusions, products, services, or activities of those third parties.
Breathe Biologics does not control and is not responsible for the content, security, availability, accuracy, or privacy practices of third-party websites.
Medical Affairs & Scientific Exchange
Medical Affairs materials and scientific resources available through this website are intended to support balanced scientific exchange and professional education.
Scientific information may include published evidence, mechanistic rationale, disease-state information, translational research, biomarker observations, and investigational hypotheses.
Medical Affairs information should not be interpreted as promotional communication, a treatment recommendation, or evidence that an investigational product has been demonstrated to be safe or effective for a particular indication.
Healthcare Professionals
Healthcare professionals should exercise independent medical judgment and consult appropriate prescribing, regulatory, clinical-trial, and scientific sources when making healthcare decisions.
Patients & Caregivers
Patients and caregivers should consult qualified healthcare professionals regarding medical conditions and treatment decisions. This website does not provide individualized medical guidance.
Breathe Biologics, Inc.
Questions regarding this Legal & Medical Notice may be submitted through the Breathe Biologics Contact page.
www.BreatheBiologics.com