Cianna Medical Inc. said its latest clearance from the Food and Drug Administration for its SAVI SCOUT reflector to be used for long-term implant makes its SCOUT system the first and only wire-free radar breast tumor localization system for long-term implant use. Chief Executive Jill Anderson anticipates greater hospital adoption.
“In the 20 months this technology has been available it has been adopted by more than 170 medical centers across the U.S.,” she said, adding that 2018 revenue should double to approximately “north of $35 million.”
The surgical guidance system provides real-time audible and visual indicators that allow surgeons to precisely locate nonpalpable breast lesions during a lumpectomy or biopsy surgery. It first received FDA clearance in 2014.
The company has added over 20 people this year, growing its team to 70 at its Aliso Viejo-based headquarters.
Anderson said it plans to add another 10 in customer support next year.
Breast Conservation
SAVI SCOUT is the first medical device to use radar in human tissue. Anderson said the company chose radar because of its reliability, allowing surgeons to lock in on the exact location of a tumor with approximately plus or minus one millimeter of accuracy.
She added that the technology sets a new standard for lumpectomy procedures, which traditionally involve wire localization—inserting a wire into the breast on the day of surgery.
In addition to discomfort and anxiety—patients seeing wires sticking out of their breasts—there’s also the risk that the wire could move, resulting in re-excisions.
Enter the SCOUT system, comprised of a reflector and a hand piece used to locate the reflector that’s placed in the target tissue prior to surgery. During the procedure the surgeon uses radar to locate the reflector and plan the incision. The reflector is removed with the target tissue.
Breast cancers found by mammography or other imaging are not always palpable. If that were the case, patients would have to have a procedure called wire-localization.
The significance of the long-term implantation clearance—the device was originally approved for implantation seven days before the surgery—is cost reduction. “You eliminate the entire procedure to replace wire implantation,” Anderson said.
Collaboration
Cianna received FDA clearance last year for the reflector to be placed at the lumpectomy site up to 30 days prior to surgery.
Anderson said Northwell Health, New York state’s largest integrated health system with 22 hospitals and 550 outpatient facilities, has implemented Cianna’s wire-free radar localization in patients at at least 10 sites. The two have collaborated since July 2016.
The company also closed major contracts with local players. Health systems with significant Orange County presence include seven-hospital St. Joseph Hoag Health in Irvine and Kaiser Permanente—the nation’s largest HMO provider, with operations in Anaheim and Irvine.
10 Years
Cianna was founded in 2007 when its SAVI Brachytherapy technology was spun out of BioLucent Inc. A breast brachytherapy, or radiation therapy, is applied after a lumpectomy to kill any remaining cancer cells in the breast. The device allows physicians to more precisely deliver radiation from inside the breast via a bundle of catheters.
Anderson said the company has a very supportive investment group led by Novo Ventures in San Francisco and it doesn’t plan to raise additional capital in the near term.
“Our investors have stayed with us for seven to 10 years,” she said. Novo Ventures is the venture capital arm of the Novo Group, a nearly 100-year-old Danish foundation with a healthcare portfolio valued at over $50 billion.
Other investors in Cianna include Fog City Fund, Emergent Medical Partners and Saints Capital. The company has raised more than $50 million to date, according to Crunch Base.
Anderson said there would be more announcements in 2018.
