Boston Scientific Acquires Resectr™ Tissue Resection Device from Distal Access, LLC
MARLBOROUGH, Mass., Nov. 15, 2016 /PRNewswire/ -- Boston Scientific (NYSE: BSX) has acquired the gynecology and urology portfolio of Distal Access, LLC, a Salt Lake City based company that designs minimally invasive medical devices. The portfolio includes the Resectr™ Tissue Resection Device, a single-use solution designed to effectively remove uterine polyps.
Uterine polyps can cause a variety of symptoms, including abnormal uterine bleeding and infertility. Nearly 80 percent of women will develop one or more polyps in their lifetime1 and polyps should be removed in order to determine if they are benign or contain malignant or pre-malignant cells. More than 400,000 polypectomies, the procedure to remove polyps, are performed annually in the United States. 2
"The Resectr device is exactly the type of innovation we need to help make healthcare more cost-effective and accessible for physicians and their patients," said David Pierce, senior vice president and president, Boston Scientific, urology and pelvic health. "This acquisition is part of our commitment to advance comprehensive solutions for women's health that can help physicians provide high-quality care."
The Resectr device is compatible with a broad range of hysteroscopes and enables physicians to treat patients with polyps in an office, hospital or ambulatory surgery center and reduces the need for investment in additional capital equipment required with traditional surgical tools used in this procedure. Used in conjunction with a diagnostic hysteroscope, the Resectr device offers the flexibility to treat polyps in a single office visit. Clinical studies have demonstrated that outpatient treatment of uterine polyps is a cost-effective alternative3 to inpatient treatment with similar clinical outcomes. 4
The Resectr device will be integrated into the Boston Scientific urology and pelvic health business which offers minimally invasive solutions for gynecologic surgery, including the Symphion™ System for uterine tissue removal and Genesys HTA™ System for the treatment of abnormal uterine bleeding. In addition, the urology and pelvic health portfolio includes products focused on kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction, male incontinence and pelvic floor disorders.
The acquisition of the gynecology and urology portfolio from Distal Access is immaterial to earnings per share (EPS) in 2016 and 2017 on an adjusted and GAAP basis. Specific terms of the transaction were not disclosed.
- Khan AT, Shehmar M, Gupta JK. Uterine fibroids: current perspectives. Int J Womens Health. 2014 Jan 29;6:95-114.
- MedTech 360 Market Analysis. Rep. Burlington: MedTech Reports, 2015. Print.
- Diwakar, L., Te Roberts, Nam Cooper, L. Middleton, S. Jowett, J. Daniels, P. Smith, and Tj Clark. "An Economic Evaluation of Outpatient versus Inpatient Polyp Treatment for Abnormal Uterine Bleeding." BJOG: An International Journal of Obstetrics & Gynaecology BJOG: Int J Obstet Gy 123.4 (2015): 625-31. Web.
- "AAGL Practice Report: Practice Guidelines for the Diagnosis and Management of Endometrial Polyps." Journal of Minimally Invasive Gynecology 19.1 (2012): 3-10. Web.
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 30 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.
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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 acquisitions, clinical trials and impact of data and product performance. 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 earnings per share. Adjusted earnings per share excludes goodwill and intangible asset impairment charges; acquisition-, divestiture-, litigation- and restructuring-related charges and credits; certain discrete tax items and amortization expense. Non-GAAP measures such as adjusted earnings per share are not in accordance with generally accepted accounting principles in the United States. The GAAP financial measure most directly comparable to adjusted earnings per share is GAAP earnings per share. The difference between our estimated impact of the acquisition on our GAAP and adjusted earnings per share relates to amortization expense on acquired intangible assets and acquisition-related net charges, which primarily include contingent consideration fair value adjustments, exit costs and other fees. These amounts are excluded by the Company for purposes of measuring adjusted earnings per share.
Management uses adjusted earnings per share along with other supplemental non-GAAP measures to evaluate performance period over period, to analyze the underlying trends in our business, to assess its performance relative to its competitors, and to establish operational goals and forecasts that are used in allocating resources. Non-GAAP financial measures, including adjusted earnings per share, should not be considered in isolation from or as a replacement for GAAP financial measures. We believe that presenting non-GAAP financial measures in addition to GAAP financial measures provides investors greater transparency to the information used by our management for its financial and operational decision-making and allows investors to see our results "through the eyes" of management. We further believe that providing this information better enables our investors to understand our operating performance and to evaluate the methodology used by management to evaluate and measure such performance.
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