SimBioSys receives milestone FDA clearance for its foundational digital precision medicine technology, TumorSight™, enabling expansion to future cutting-edge applications

CHICAGO--(BUSINESS WIRE)-- SimBioSys, a pioneering TechBio company unlocking the power of spatial biophysics with artificial intelligence (AI) and biophysical modeling to redefine precision medicine for cancer, announced today it has received its first U.S. Food and Drug Administration (FDA) 510(k) clearance to market its first software application on its cloud-based digital precision medicine platform, TumorSight™.

“This is a landmark moment for the SimBioSys team and our many collaborators. It is our springboard to begin fulfilling our mission to redefine precision medicine as we launch this first application and target further expansion in clinical utilities within breast cancer as well as across other solid tumors,” says Tushar Pandey, co-founder and CEO of SimBioSys.

This is the company’s first FDA 510(k)-cleared device from its exciting pipeline of products. TumorSight™ Viz utilizes standard-of-care medical imaging (DCE MRI) to generate stunning 3D spatial visualization and key insights, giving clinicians and their patients a more comprehensive understanding of their cancer and the potential options available to them. The technology utilizes AI to automatically segment the tumor and surrounding tissue to display the 3D visualization. Further, this TumorSight™ software application provides key insights such as tumor volume, tumor-to-breast volume, and tumor distance to key anatomical structures in the breast to quantify key metrics required in treatment planning.

Breast cancer is the most common cancer diagnosis among women in the United States, representing 30% of all newly diagnosed cancers each year. Unfortunately, clinicians are severely lacking tools, especially tools that fit in their clinical workflow, to support them in working with their patients to ensure they get the optimal personalized treatment for their situation. Recently at the 2023 San Antonio Breast Cancer Symposium, SimBioSys shared the positive impact that visualization capabilities could have for clinicians and their consultations with patients:

• 70% of clinicians surveyed indicated that the tool was very valuable or valuable in their treatment planning.
• 66% of clinicians said it was critical or valuable in their consultation with their patient.
• 90% of breast cancer patient opinion leaders (POLs) interviewed saw the tool as very important for clinicians shared decision making with their patients.
• 80% of POLs believed it would increase patient confidence in their surgical decisions and in their surgeons.

“With the significant increase in use of MRIs in early-stage breast cancer, we have a real opportunity to bring imaging to the forefront of precision medicine. Our first TumorSight™ application offers automated valuable insights to the cancer care team,” added Pandey. “Equipped with this information, clinicians can provide treatment that is truly personalized to each patient, and patients will feel more empowered in this important decision-making process.”

SimBioSys is dedicated to expanding the TumorSight™ platform, with plans to incorporate a suite of innovative tools for surgical planning, treatment optimization, and risk assessment. This comprehensive approach aims to deliver holistic support for the cancer care journey, epitomizing the promise of precision medicine.

About TumorSight™ Viz:

TumorSight™ Viz provides clinicians with 3D spatial visualizations of breast cancer using standard-of-care medical imaging (DCE MRI). Clear 3D “digital twin” renderings automatically display the tumor in the context of auto-segmented anatomical structures and provide key metrics used in the treatment planning process. TumorSight™ Viz received 510(k) FDA clearance in December 2023. Learn more at https://simbiosys.com/tumorsight-plan.

Intended Use and Indications for Use:

TumorSight™ Viz is intended to be used in the visualization and analysis of breast magnetic resonance imaging (MRI) studies for patients with biopsy proven early-stage or locally advanced breast cancer. TumorSight™ Viz supports evaluation of dynamic MR data acquired from breast studies during contrast administration. TumorSight™ Viz performs processing functions (such as image registration, subtractions, measurements, 3D renderings and reformats). TumorSight™ Viz also includes user-configurable features for visualizing and analyzing findings in breast MRI studies. Patient management decisions should not be made based solely on the results of TumorSight™ Viz.

About SimBioSys:

SimBioSys is a pioneering TechBio company leveraging artificial intelligence and biophysical modeling to harness the power of spatial biophysics to redefine precision medicine, transform patient care and defeat cancer. By seeing cancer more completely, SimBioSys aims to empower clinicians and researchers with a more informed understanding of a patient’s tumor to optimally assess all available options and deliver on the promise of truly individualized patient care. To learn more, visit us at https://www.simbiosys.com/.

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