Innoblative Designs, Inc.

Innoblative Designs, Inc. is a private medical device company specializing in advanced energy-based surgical solutions for soft tissue coagulation and ablation. The company's flagship product, SIRA® RFA (radiofrequency ablation) Electrosurgical Device, is a single-use disposable applicator designed for intraoperative use during breast-conserving surgery (BCS). SIRA® provides localized margin control to reduce reoperation rates in post-lumpectomy cavity ablation. The device has received FDA 510(k) clearance and CE Mark approval, and was granted FDA Breakthrough Device Designation. Innoblative has received a Category III CPT code from the American Medical Association for SIRA® as an adjunct to breast conservation surgery. The company is actively conducting feasibility studies, including enrollment at the University of Texas Medical Branch, and has multiple platform devices in development. Products are designed for use in conjunction with radiofrequency electrosurgical generators. The company addresses unmet clinical needs in breast cancer treatment and other soft tissue disease management, targeting surgical teams in hospital operating rooms and outpatient surgical centers.