MARLBOROUGH, Mass., April 16, 2018 /PRNewswire/ -- Boston Scientific (NYSE : BSX ) today announced that it has acquired nVision Medical Corporation, a privately-held company focused on women's health. nVision developed the first and only device cleared by the U.S. 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.¹

Ovarian cancer is the fifth leading cause of cancer death among women. More than two million women in the U.S. 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.^{2, 3} Women with ovarian cancer are often asymptomatic until late in the course of the disease.⁴  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.⁵

"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 percent and at stage four is estimated to be 17 percent.^1,6 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.¹

"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).   

About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

1. https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Salpingectomy-for-Ovarian-Cancer-Prevention
2. http://www.vervemagazine.in/people/surbhi-sarna-nvision-medical-ovarian-cancer
3. https://www.mayoclinic.org/diseases-conditions/ovarian-cancer/diagnosis-treatment/drc-20375946
4. https://www.aafp.org/afp/2016/0601/p937.html
5. http://journals.sagepub.com/doi/abs/10.2217/17455057.5.1.39
6. https://www.cancer.org/cancer/ovarian-cancer/causes-risks-prevention/risk-factors.html

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding our business plans, regulatory approvals, product development and product performance and impact.  If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. 

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors.  All of these factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter.  We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.  This cautionary statement is applicable to all forward-looking statements contained in this document.

Use of Non-GAAP Financial Measures

To supplement our consolidated financial statements presented on a GAAP basis, we disclose certain non-GAAP financial measures, including adjusted net income (earnings) per share that excludes certain charges and/or credits. These non-GAAP financial measures are not in accordance with generally accepted accounting principles in the United States and should not be considered in isolation from or as a replacement for the most directly comparable GAAP financial measures. Further, other companies may calculate these non-GAAP financial measures differently than we do, which may limit the usefulness of those measures for comparative purposes.

To calculate adjusted net income (earnings) per share we exclude certain charges (credits) from GAAP net income, including amortization expense, acquisition-related net charges (credits) and restructuring and restructuring-related net charges (credits). Please refer to Part II, Item 7 - Management's Discussion and Analysis of Financial Condition and Results of Operations in our most recent Annual Report filed on Form 10-K for an explanation of each of these adjustments and the reasons for excluding each item

The GAAP financial measures most directly comparable adjusted net income per share is GAAP net income and GAAP net income per share.

Management uses these supplemental non-GAAP financial measures to evaluate performance period over period, to analyze the underlying trends in our business, to assess our performance relative to our competitors, and to establish operational goals and forecasts that are used in allocating resources. In addition, management uses these non-GAAP financial measures to further its understanding of the performance of our operating segments. The adjustments excluded from our non-GAAP financial measures are consistent with those excluded from our operating segments' measures of net sales and profit or loss. These adjustments are excluded from the segment measures that are reported to our chief operating decision maker that are used to make operating decisions and assess performance.

We believe that presenting adjusted net income per share, in addition to the corresponding GAAP financial measures, provides investors greater transparency to the information used by management for its operational decision-making and allows investors to see our results "through the eyes" of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance.

CONTACTS:
Catherine Brady
Boston Scientific Corporation
(508) 683-4797 (office)
Catherine.brady@bsci.com

Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com

SOURCE Boston Scientific

Related Links

http://www.bostonscientific.com