Innoblative Designs
Revolutionizing Post-Lumpectomy Treatment

In the ever-evolving landscape of breast cancer treatment, radiofrequency ablation (RFA) is an innovative therapy that can be used to destroy unhealthy tissue. Unlike radical and modified radical mastectomy, which have a risk of increased post-operative complications, RFA enables breast surgeons to ablate target tissue, leaving healthy tissue unharmed.

Tapping into this potential by transforming the current RFA technology is Innoblative Designs, a revolutionary medical device startup. They have designed a new state-of-the-art SIRA^TM RFA electrosurgical device for patients undergoing BCS (breast conservation surgery, also known as a lumpectomy). This proprietary new technology is poised to simplify the treatment of breast cancer and soft tissue diseases, allowing surgeons to ablate the margins of the lumpectomy cavity during the initial lumpectomy procedure.

The presence of residual diseased tissue in the resection bed following surgery is a major challenge for lumpectomy procedures. The presence of residual cancer cells, only found in the pathology examination after the first surgery is complete, often requires an additional surgery. Approximately 20 to 25 percent of women have to undergo a re-excision surgery, causing patient distress, increasing the risk of surgical and post-surgical complications, and burdening the healthcare systems. To make matters worse, patients in rural areas and underserved communities have limited access to specialized care used to treat these residual cancer cells. Additionally, patients struggle with the financial constraint of undergoing multiple treatment procedures. Even when specialized follow-up care is recommended for patients, many are unable or unwilling to complete additional treatment due to the cost, length of time to access the care, or the potential side effects.

Innoblative Designs’ SIRA^TM aims to transform postlumpectomy treatment and reduce the need for reoperations among women suffering from breast cancer. The SIRA^TM device has been developed to augment the lumpectomy procedure and reduce the need for reoperations by intraoperatively performing a repeatable and uniform ablation in the existing surgical cavity. The SIRA^TM device ablates and kills the cells in the resection bed surface where most residual cancer cells are found.

“Our mission is to develop and commercialize novel products to intraoperatively ablate surgical margins post-excision for treating early-stage breast cancer. Developed by a team of surgeons and graduate students at Northwestern University, our SIRA^TM device aims to leverage RFA to reduce reoperations and local recurrence in breast cancer treatment,” says Richard Stark, CEO of Innoblative Designs.

The SIRA^TM device is designed with a distinctive spherical shape and advanced RFA capabilities to deliver radiofrequency energy circumferentially, creating comprehensive coverage of the breast cavity, to precisely target potential residual cancerous tissue. This unique spherical design offers surgeons more confidence in achieving consistent and reliable thermal effects, resulting in reproducible ablation depths.

A key distinction of the SIRA^TM device is its ability to minimize the need for reoperations. By intraoperatively ablating the surgical margins, it offers a promising solution to eliminate or significantly reduce residual disease while sparing patients from the physical, emotional, and financial burdens associated with additional surgeries. Through use of the SIRA^TM device, patients receive a faster and more patient-friendly treatment experience.

We aim to empower women with options for post lumpectomy treatment that reduces the need for invasive follow up surgeries. By giving women control over their treatment decisions, we strive to enhance their quality of life

The SIRA^TM device has received 510(k) clearance and a CE mark for soft tissue ablation. It has also recently received FDA Breakthrough Device Designation for the proposed indication of augmenting the lumpectomy procedure by ablating an approximate 1 cm margin, which is a significant step toward its launch in the breast cancer space.



Innoblative Designs is looking to conduct their first-inhuman trials this year for intraoperative use during lumpectomy procedures in a Phase-1 trial followed by a pivotal study.

“We aim to empower women with options for post lumpectomy treatment that reduces the need for invasive follow up surgeries. By giving women control over their treatment decisions, we strive to enhance their quality of life.” says Stark.