Hundreds of thousands of women a year undergo removal of their ovaries and fallopian tubes to reduce their risk of developing cancer, in part because no effective early-screening tool is available that can quantify the risk of developing a fatal malignancy.
Boston Scientific announced a $275 million deal on Monday that the device maker hopes can open up new health options for women, and tap into a potentially large commercial market.
Boston Scientific has acquired the California startup nVision, which owns the rights to a microcatheter device that already has regulatory clearance in the U.S. to access fallopian tubes and collect cells during a minimally invasive procedure. Boston Scientific, which has major operations in Minnesota, announced that it is paying $150 million up front and another $125 million in milestone payments over four years to acquire nVision.
"We are committed to expanding our women's health portfolio and driving clinical research that will help deliver innovative options for the prevention and treatment of gynecological cancer," Boston Scientific surgical tools division President Dave Pierce said Monday in a news release.
Boston Scientific sees a near-term market opportunity for about $500 million a year in sales of nVision devices, with the potential to grow up to $2 billion a year, as the device is more widely used and researched. The deal is expected to turn profitable for Boston Scientific on GAAP basis in 2020.
Although nVision's Mako 7 device obtained 510(k) clearance from the U.S. Food and Drug Administration in 2016, it is not yet for sale commercially. In fact nVision recently concluded enrollment for a 50-person observational pilot study of the device to test its performance in collecting cells from fallopian tubes for cancer testing.
"We are going to wait to market the product until we start to conduct additional research and also integrate the manufacturing and operations into Boston Scientific. In the U.S., we are targeting late 2018 to early 2019 to begin limited market evaluation," Boston Scientific spokeswoman Kate Haranis said via e-mail.
"After the next study is finalized, we plan to submit to the FDA for additional claims as a diagnostic tool for women at high risk of developing ovarian cancer."
NVision's initial research has shown that the device can effectively collect cells for testing that correlate with a definitive post-surgical diagnosis of ovarian cancer, Boston Scientific said.
The American College of Obstetricians and Gynecologists has said that although ovarian cancer has a relatively high mortality rate — it is the fifth leading cause of cancer deaths among women — existing ovarian cancer screening tools can create false-positive results that lead to unnecessary surgeries and related complications.
The majority of ovarian cancer diagnoses are made at stage 3 or stage 4, when the survival rate is 30 percent or less. Yet if ovarian cancer is detected and treated while still at stage 1, the five-year relative survival rate is 92 percent, according to the American Cancer Society.
Genetic screening tools can shed some light earlier in life, but they are not conclusive. The National Institutes of Health says that mutations in the BRCA1 and BRCA2 genes tend to increase ovarian cancer risk, but the presence of such a mutation does not guarantee that a cancer will form.
"No effective ovarian cancer screening methods currently exist," the NIH says. To be considered effective, such a screening tool would have to detect ovarian cancer at an early-enough stage to reduce the actual risk of dying from the cancer.
NVision CEO Surbhi Sarna founded her company in 2011 with the goal of creating better options for unmet needs in women's health, including tools for early detection of ovarian cancer.
Sarna and nine nVision employees will stay on with the company under the Boston Scientific brand, working from their existing offices in San Bruno, Calif., Boston Scientific said.