Boston Scientific, a global medical technology leader, has acquired nVision Medical Corporation, a privately-held company focused on women's health. nVision developed the first and only device cleared by the US Food and Drug Administration to collect cells from the fallopian tubes, offering a potential platform for earlier diagnosis of ovarian cancer. Recent studies have confirmed that several major types of ovarian cancer appear to originate from the fallopian tubes.
Ovarian cancer is the fifth leading cause of cancer death among women. More than two million women in the US are at high risk for developing the disease, which occurs more frequently in those with a family history or with BRCA1 or 2 gene mutations. Women with ovarian cancer are often asymptomatic until late in the course of the disease. There are no recommended early screening tests and, to date, there has been no effective way to biopsy cells in the fallopian tubes. As a result, every year, approximately 300,000 women elect to have preventative removal of their ovaries and fallopian tubes to reduce the risk of developing ovarian cancer.
"We estimate the near-term market opportunity to be $500 million with the potential to grow to $2 billion as this device is used by more gynecologists to help even more women," said Dave Pierce, executive vice president and president, MedSurg, Boston Scientific. "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."
Initial clinical research has demonstrated that the nVision device effectively collects cells which, when tested, correlate with a post-surgery definitive diagnosis of ovarian cancer. Boston Scientific plans to conduct additional clinical research with the nVision device to further establish how the cells it collects from the fallopian tubes can be used to render a diagnosis prior to surgery and help in the decision-making process for women at increased risk for ovarian cancer.
"I started nVision with a goal of creating a tool to address an unmet need in women's health," said Surbhi Sarna, founder and chief executive officer, nVision. "I am proud of our achievements in advancing efforts to help with the early detection of ovarian cancer and look forward to working with Boston Scientific to move this technology forward."
Physicians often counsel women to take preventive action as the majority of ovarian cancer diagnoses are made at stage three or four of the disease, considering that the survival rate at stage three is approximately 30 per cent and at stage four is estimated to be 17 per cent. While removal of the ovaries and fallopian tubes can reduce the likelihood of developing cancer, it also increases the risk that women will develop cardiovascular issues or have cognitive impairment and prevents child bearing.
"We are excited to develop this technology that one day may play an important role in early detection of the disease and the prevention of unnecessary surgeries, while also serving as a foundation for our broader oncology initiatives in both diagnostics and therapeutics," said Professor Ian T. Meredith, AM, executive vice president and global chief medical officer, Boston Scientific.
The transaction consists of an upfront cash payment of $150 million, and up to an additional $125 million in potential clinical and commercial milestones over four years. The acquisition is expected to be immaterial on an adjusted basis in 2018 and 2019, and accretive thereafter (dilutive on a GAAP basis through 2020 and less accretive thereafter due to amortization expense and acquisition costs).