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Seal Beach, CA

Advancing a single-procedure alternative to radiation for early-stage breast cancer patients.

• Proven concept: Supported by two grants from the National Science Foundation including one for FDA submission
• Patient-centered innovation: Designed to eliminate toxicities, pain, fatigue, and cosmetic damage caused by radiation
• Greater access: Enables treatment in community hospitals and underserved regions where radiation is not feasible
• Simplified approach: Freezes cancer cells at time of surgery, removing the need for weeks of radiation treatments
• Experienced leadership: Team with more than 100 years of experience advancing medical devices for women’s healthcare

SenoGuard is developing an alternative to radiation therapy for women undergoing lumpectomies for early-stage breast cancer. Using a cryoablation technique, the technology is designed to destroy residual cancer cells by freezing them during surgery, eliminating the need for weeks of post-operative radiation sessions. The goal of this approach is to reduce treatment toxicity and side effects, avoid long-term cosmetic damage, and make breast-conserving therapy more accessible to a wider population of patients. The procedure is performed once, at the time of surgery, and does not require specialized radiation equipment or personnel, making it more feasible for community hospitals and global settings where access to radiation therapy is limited.

The current fundraising campaign is intended to support the final design testing of the device in preparation for FDA submission. SenoGuard has already completed successful animal studies demonstrating proof of concept and has received backing from the National Science Foundation through two grants. The company’s experienced team is focused on using these funds to finalize their prototype, validate its use with human tissue, and prepare a regulatory pathway for clearance. The company believes that its approach offers a practical treatment option to patients who would otherwise forgo lumpectomy due to the burdens of radiation. Additionally, the technology aims to expand the accessibility of breast-conserving treatment worldwide by offering a simplified and effective method that avoids the systemic costs and limitations of radiation.

Company Info

SenoGuard is developing a cryoablation device to replace radiation therapy after lumpectomy, aiming to improve accessibility, safety, and patient outcomes.

SenoGuard is developing a medical device alternative to radiation therapy for patients undergoing lumpectomy for early-stage breast cancer. The technology uses cryoablation—freezing cancer cells—at the time of surgery, eliminating the need for the traditional six weeks of post-surgical radiation. This approach is designed to be safer, more convenient, and less toxic, potentially allowing treatment at community hospitals where access to radiation facilities is limited. The device aims to benefit the significant portion of patients who currently must choose mastectomy due to the logistical, financial, or geographic barriers associated with radiation treatment.

The company has received two National Science Foundation grants, including $1 million for human specimen testing and preparation for FDA 510(k) submission. The cryoablation procedure is performed by the breast surgeon during lumpectomy, reducing follow-up requirements and enhancing completion rates of adjuvant treatment. By offering a one-time, intraoperative solution, SenoGuard addresses both medical and quality-of-life concerns, including the physical side effects and cosmetic changes often caused by radiation. The team includes industry veterans with experience bringing paradigm-shifting technologies to market and is targeting commercialization within 18–24 months of additional funding.