Startup gains FDA clearance for breast surgery guidance system

SAVI Scout surgical guidance system--Courtesy of Cianna Medical

Cianna Medical has received clearance from the FDA for its SAVI Scout surgical guidance system. The startup already brought in $10 million in debt from GE Capital earlier this year earmarked to finance a rollout of the product, with a launch expected during the second quarter of 2015. This is Cianna's second marketed product in addition to its SAVI breast brachytherapy applicator.

The SAVI Scout surgical guidance system gives surgeons real-time audible and visual cues during breast lumpectomy and biopsy procedures to ensure that they are successfully removing all of the targeted tissue. It includes an electromagnetic wave reflective device (or reflector), a hand piece and a console.

Currently, a common method for identifying nonpalpable lesions for surgery is wire localization. This requires a radiologist to place a wire inside the breast to identify the target tissue. But the patient may have to wait for hours with the wire in place, which the company pointed out can be unpleasant for women and a scheduling challenge for hospitals. There is an alternative called radioactive seed localization, but it requires radioactive materials and the accompanying precautions those require for safe use.

But the SAVI Scout offers a new way for surgeons to track breast cancer removal. "We believe that SAVI Scout provides two major advantages: First, the reflector can be comfortably placed several days prior to surgery, on the day of surgery by a radiologist or in the operating room by a surgeon," Dr. Pat Whitworth, director of the Nashville Breast Center in Nashville, TN, said in a statement. "Second, the SAVI Scout hand piece can be used with retractors so, as the dissection proceeds, we receive immediate, real-time guidance for the lumpectomy."

He added, "We are finding SAVI Scout eliminates the need to stop for intraoperative ultrasound; we can now use imaging only before and after the resection. I expect it's going to be a welcome advance for surgeons and patients."

A pilot study of the SAVI Scout is ongoing at the Nashville Breast Center and the University of South Florida College of Medicine. Cianna expects the pilot data to show clinicians how the technology is working out and hopes to use the data to help launch the product, Cianna VP of Marketing Mike Numamoto told FierceMedicalDevices.

Cianna is presenting data at the San Antonio Breast Cancer Symposium this week that shows 100% surgical success for the use of the SAVI Scout in 24 patients. In all cases, the target tissue and reflector were successfully removed with clear margins comparable to radioactive seed location.

Of the 174,000 women who have breast surgery to remove cancerous tissue, about 30% will require repeat surgery because the cancer cells were not completely excised during the first procedure, the company said.

The Strut Adjusted Volume Implant (SAVI) technology is also the basis for Cianna's brachytherapy, which it says is more precise and targets radiation so as to minimize toxicity and side effects. This single-use device has been used by more than 20,000 patients. Surgeons and radiologists are the target market for both devices.

"It's complementary technology; they are both in the early breast cancer space," Numamoto said. "The brachytherapy device is for radiation after surgery. Scout will be used for the surgery."

Cianna investors include Novo Ventures, Novo A/S, Fog City Fund, Emergent Medical Partners and Saints Capital.

- here's the release

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