When a 64-year-old woman with Stage II luminal A breast cancer entered an operating room in Istanbul, Turkey, in July 2024, she became the first patient treated with Innoblative Designs' investigational SIRA RFA Electrosurgical Device following a lumpectomy. For CEO Rick Stark and his team, this milestone marked the culmination of years of research, engineering, clinical collaboration, and regulatory preparation.
"It was an emotional and humbling moment," Stark recalls in a recent interview with The Lens. "When you work on a technology for years, you spend so much time discussing design, regulatory strategy, clinical plans, financing, and execution. But the first time it is used in a patient, everything becomes very real. What went through my mind was the patient. This is ultimately why we do the work."
That moment had been years in the making.
Innoblative is developing a technology designed for use immediately following a lumpectomy, when surgeons have removed the visible tumor but cannot yet know whether microscopic cancer cells remain at the surgical margin. If pathology later shows positive margins, many patients must return for another operation before continuing treatment.
"Positive margins remain persistent because the problem is not simply surgical skill," Stark explains. "It's biology, anatomy, and the limitations of real-time intraoperative assessment."
Breast cancer remains a major global health concern. Many patients undergo breast‑conserving therapy, which typically involves lumpectomy followed by several weeks of radiation. Roughly one in five patients requires a second procedure to address residual cancer, and radiation therapy can involve side effects that affect quality of life, according to Innoblative.
For patients, a second surgery often means another round of anesthesia, more recovery time, additional time away from work and family, and a longer wait before moving on to the next phase of treatment. For many women, radiation therapy may also follow, bringing weeks of frequent appointments and, for some, long drives to treatment centers.
"A second surgery is a major burden," Stark says. "It extends the emotional journey for a patient who has already been told she has breast cancer and is trying to move forward with treatment."
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