Innoblative Designs, a company addressing clinical unmet needs for breast cancer patients, received U.S. Food and Drug Administration (FDA) for an investigational device exemption (IDE) to initiate a U.S. feasibility study for its SIRA RFA electrosurgical device in patients undergoing breast-conservation surgery (BCS).

SIRA is a single-use, disposable applicator for intraoperative ablation of the post-lumpectomy cavity during breast-conserving surgery. It touts a spherical design and circumferentially delivers radiofrequency (RF) energy, yielding reproducible ablation depths to the whole cavity.

This offers confidence that the margins where residual cancer may reside have been treated.

There are currently no RF devices designed for breast cancer. Conventional RF systems aren’t optimized to treat lumpectomy cavities, which often causes inconsistent treatment depths and ablations.

SIRA seeks to provide reduction in positive margin rates, reduce BCS reoperations, and offer a on-time non-ionizing therapeutic alternative to radiation therapy in select patients. It has the potential to lower healthcare costs and improve patient care, the company said.

“The SIRA device, specifically designed as an adjunct to BCS, addresses residual cancer in surrounding tissue at the time of the initial lumpectomy procedure. The technology provides a more palatable option for patients and aims to eliminate the need for subsequent radiation therapy or reoperations,” said Richard Stark, CEO of Innoblative. “We are thrilled to have secured IDE approval, a significant milestone for the company and a testament to the team’s hard work and dedication. We look forward to initiating the U.S. feasibility study to further validate our technology, which we believe will be a game-changer for breast cancer patients.”

In July 2024, the company achieved first-in-human use of SIRA, successfully treating a 64-year-old patient with stage II luminal A breast cancer.