Healthcare Professional Disclaimer

Intended Audience

The information on this website is intended for licensed healthcare professionals, medical researchers, clinical investigators, and qualified investors. It is provided for general informational and educational purposes only.

This website is not intended for use by patients or the general public for making personal medical decisions. If you are a patient, please consult your physician or other qualified healthcare provider regarding your medical condition and treatment options.

Not Medical Advice

The content provided on this website does not constitute medical advice, diagnosis, or treatment recommendations. Nothing on this website is intended to create a physician-patient relationship. The information presented should not be used as a substitute for professional medical judgment, diagnosis, or treatment.

Healthcare professionals should rely on their own clinical judgment, the needs of their individual patients, and applicable standards of care when making treatment decisions. Any clinical data, research findings, or technology descriptions presented on this website are for informational purposes only.

Clinical & Scientific Information

Clinical data, study results, and scientific literature referenced on this website are presented to provide context about the clinical landscape of surgical margin management and intra-operative brachytherapy. Such information:

• May include preliminary, pre-clinical, or investigational data that has not been independently verified
• Should not be interpreted as a guarantee or prediction of clinical outcomes
• Does not represent claims of safety or efficacy for the BrachyClip® device
• May reference third-party publications and studies that were not conducted by or on behalf of BrachyClip

Individual patient outcomes may vary. Past performance of any medical technology or treatment is not indicative of future results.

Regulatory Status

BrachyClip® is in the development and/or investigational stage. Regulatory clearances and approvals are subject to the requirements of the applicable regulatory authorities in each jurisdiction.

• The device has not received FDA 510(k) clearance, PMA approval, or De Novo classification
• The device has not received CE marking under the EU Medical Device Regulation (MDR)
• Any descriptions of the device, its technology, or intended use are subject to change based on ongoing development and regulatory feedback

Nothing on this website should be construed as a representation that the device has received regulatory approval or is available for commercial sale in any jurisdiction.

Professional Judgment

Healthcare professionals are responsible for exercising their own independent professional judgment in evaluating and using any information provided on this website. BrachyClip does not assume any liability for actions taken or not taken based on the information presented herein.

The practice of medicine involves complex decisions that must account for the individual patient's condition, medical history, preferences, and the healthcare provider's clinical experience. Information on this website is not a substitute for such individualized assessment.

Forward-Looking Statements

This website may contain forward-looking statements regarding the BrachyClip® device, including statements about potential clinical applications, market opportunities, regulatory pathways, and future development plans. These statements are based on current expectations and involve risks, uncertainties, and assumptions.

Actual results may differ materially from those expressed or implied in any forward-looking statements. BrachyClip undertakes no obligation to update or revise any forward-looking statements.

Adverse Event Reporting

Healthcare professionals who become aware of any adverse events or safety concerns related to an investigational device should report them to the study sponsor and to the appropriate regulatory authority (e.g., the FDA via MedWatch).

Contact Us

For questions about the information on this website or about the BrachyClip® device, please contact us: