Innoblative Receives U.S. IDE Approval for its Novel Electrosurgical Device for Breast Cancer Treatment

• Innoblative prepares to initiate its feasibility study, evaluating the safety and effectiveness of its SIRA^® RFA Electrosurgical Device, an FDA Breakthrough Device, for patients undergoing breast-conserving surgery
• Breast cancer is the most commonly diagnosed cancer globally¹

CHICAGO, April 10, 2025 /PRNewswire/ -- Innoblative Designs, Inc. (Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced today that the U.S. Food and Drug Administration has approved its Investigational Device Exemption (IDE) application, paving the way for the company to initiate its U.S. feasibility study. The study will evaluate the safety and effectiveness of the company's SIRA^® RFA Electrosurgical Device in patients undergoing breast-conservation surgery (BCS).

"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," commented 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."

Innoblative's SIRA device is a single-use, disposable applicator built for intraoperative ablation of the post-lumpectomy cavity during breast conserving surgery. With a unique spherical design, SIRA circumferentially delivers radiofrequency (RF) energy and yields reproducible ablation depths to the entire cavity. This provides greater confidence that the margins, where residual cancer may reside, have been treated. RF ablation has been shown in multiple long-term clinical studies to reduce reoperations and may reduce local recurrence in breast cancer treatment.² Currently, there are no RF devices specifically designed for breast cancer. Conventional RF systems are not optimized for treating lumpectomy cavities, often resulting in inconsistent treatment depths and ablations. The SIRA device aims to provide a reduction in positive margin rates, reduce BCS reoperations, and offer a one-time non-ionizing therapeutic alternative to radiation therapy in select patients, with the potential to reduce healthcare costs and improve patient care.

Breast cancer is a significant global health concern with documented impact in all countries.¹ Once diagnosed, patients are faced with difficult decisions regarding available treatment options. Breast conservation therapy (BCT), which includes breast-conserving surgery (BCS) plus radiation therapy, may be recommended. However, BCS is associated with a high rate of re-operation, with approximately one-in-five patients requiring a follow-up procedure within weeks of the initial excision to address residual cancer.³ In addition, subsequent radiation therapy can be difficult with frequent treatments over the course of several weeks or months, and the potential for a range of unpleasant side effects. Innoblative aims to provide an alternative treatment option that allows patients to avoid these concerns and alleviate fears of future recurrences.

The SIRA^® Device is investigational for use in BCS in the United States.

About Innoblative

Innoblative is a medical device company dedicated to innovating advanced-energy solutions that improve the way physicians treat breast cancer and other soft tissue diseases. For more information, visit Innoblative.com.

¹Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID: 33538338.
²Klimberg, VS. Long-Term Results of Phase II Ablation after Breast Lumpectomy Added to Extend Intraoperative Margins (ABLATE l) Trial. Journal of the American College of Surgeons 218(4):p 741-749, April 2014. doi: 10.1016/j.jamcollsurg.2013.12.032.
³Kim Y, Ganduglia-Cazaban C, Tamirisa N, Lucci A, Krause TM. Contemporary Analysis of Reexcision and Conversion to Mastectomy Rates and Associated Healthcare Costs for Women Undergoing Breast-Conserving Surgery. Ann Surg Oncol. 2024 Jun;31(6):3649-3660. doi: 10.1245/s10434-024-14902-z. Epub 2024 Feb 6. Erratum in: Ann Surg Oncol. 2024 Jun;31(6):3956. doi: 10.1245/s10434-024-15212-0. PMID: 38319511; PMCID: PMC11076367.

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SOURCE Innoblative Designs, Inc.