Innoblative Designs has begun its first-in-human clinical experience, successfully treating a 64-year-old patient with stage II luminal A breast cancer.

The Chicago-based company’s SIRA device aims to provide a better treatment option for breast conserving surgery (BCS) candidates. It has a single-use, disposable applicator to intraoperatively ablate soft tissue, including potential residual cancer following a lumpectomy.

The SIRA electrode has a spherical shape that circumferentially delivers radiofrequency (RF) energy to the whole cavity and yields reproducible ablation depths, according to the company. The SIRA device possesses U.S. Food and Drug Administration (FDA) breakthrough status for use in BCS.

Multiple long-term clinical studies have shown RF ablation can reduce reoperations and local recurrence in breast cancer treatment. Conventional RF devices aren’t optimized to treat lumpectomy cavities, however, and can cause variable treatment depths and incomplete ablations.

The initial lumpectomy case was performed by Dr. Cem Yilmaz, Breast Surgeon and Founding Director of the Istanbul Oncology Hospital in Istanbul, Turkey. Dr. Yilmaz said he was able to completely ablate the cavity post-lumpectomy without complications.

“This is incredibly exciting as it allowed me to easily address residual cancer in the surrounding tissue at the time of the initial procedure, eliminating the need for my patient to undergo subsequent radiation therapy or reoperations,” Dr. Yilmaz told the press. “I believe this will be a game-changer with the potential to make breast conservation surgery a more palatable option for patients.”

“Thank you to Dr. Yilmaz and his team for the seamless completion of this first-in-human case,” said Richard Stark, CEO of Innoblative. “This is an exciting time as Innoblative transitions to a commercial company. We look forward to expanding upon this early clinical experience which brings us one step closer to delivering this meaningful technology to breast cancer patients.”