Committed to innovative surgical solutions
Committed to innovative surgical solutions
Advancing the Standard of Care in Breast-Conserving Surgery.
Innoblative is committed to building a robust foundation of clinical evidence for the SIRA® RFA Electrosurgical Device through collaboration with world-class institutions and rigorous scientific study.
We are proud to announce that the Institutional Review Board (IRB) at the University of Texas Medical Branch (UTMB) has approved our feasibility pilot study evaluating ablation following lumpectomy.
This prospective study is designed to assess the safety and feasibility of delivering ablation therapy following breast-conserving surgery. The goal is to generate important clinical data that may help inform future treatment strategies and improve outcomes for patients undergoing lumpectomy.
IRB approval represents a key milestone in our clinical development program and reflects our commitment to rigorous scientific evaluation and collaboration with leading academic institutions.
Visit ClinicalTrials.gov NCT07206121We are pleased to announce that ethics committee approval has been granted for an investigator-initiated trial (IIT) in Italy evaluating post-lumpectomy ablation in patients undergoing breast-conserving surgery.
By creating an additional zone of tumor destruction around the lumpectomy cavity, the approach aims to improve local tumor control while generating clinical evidence to explore whether radiation therapy (RT) may be safely reduced or de-escalated in selected patients.
This study represents an important step in expanding the global clinical evidence supporting intraoperative ablation as an adjunct to breast-conserving surgery. Investigator-initiated research plays a critical role in advancing innovation and evaluating new strategies that may reduce treatment burden while maintaining strong oncologic outcomes for patients with early-stage breast cancer.
AMA Category III CPT® Code: The American Medical Association has approved a dedicated CPT code for intraoperative radiofrequency ablation of the breast cavity.
Read Press ReleaseFDA Breakthrough Device Designation: Received for the SIRA® RFA Electrosurgical Device, recognizing its potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases.
