(NXTM) 10th Anniversary ofSystem One; Unveil of Robust Pipeline & Launch Plans
Company continues decade-long commitment to innovation with breakthrough technologies
LAWRENCE, Mass., Aug. 6, 2015 — This summer, NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of dialysis products, is celebrating the 10th year anniversary of the Food and Drug Administration’s (FDA) clearance of the first and only portable home hemodialysis (HHD) system, the NxStage® System One™. In connection with the anniversary, NxStage unveiled details of new innovations from its robust pipeline including its next generation hemodialysis system, peritoneal dialysis (PD) system and next generation critical care system during its second quarter of 2015 financial results conference call this morning. In addition, NxStage announced that it expects to begin by launching its next generation hemodialysis system later next year.
“Over the last decade, NxStage’s model of innovation has yielded transformational technologies, including the System One, our dialysate preparation system, and a rich portfolio of integrated offerings and capabilities,” stated Jeffrey H. Burbank, Founder and Chief Executive Officer of NxStage. “We’re proud to have a portfolio that includes many of the industry’s ‘firsts’ in terms of technology and clearances that are having a wonderful impact on patient lives and advancing the standard of renal care.”
“As a clinician, I’ve seen that the life-changing benefits of HHD with the System One are truly remarkable,” said Renal Nurse Practitioner Lisa Koester of Barnes Jewish Dialysis Center in St. Louis, Missouri. “Because of this breakthrough technology, patients are able to get back to work, family and a more normal life.”
Burbank continued, “Our established track record of innovation is enabling strong growth, market expansion, customer diversification, and solid operating performance across our business, in addition to laying the groundwork for much more. I’m excited to deliver new breakthrough technologies for HHD, PD, critical care, as well as traditional three times weekly in-center therapy. These innovations are designed to give patients even more flexibility in meeting their clinical and lifestyle needs, as well as provide economic advantages to our customers. We expect these innovations to significantly expand our addressable market, from an estimated $1 billion to $5 billion in total, and fuel our long-term growth.”
To learn more about NxStage’s history of innovation, visit Our History of Innovation for a graphic timeline highlighting the Company’s milestone clearances.
NxStage will also host a conference call today at 9:00 a.m. Eastern Time to discuss its second quarter financial results and its technology pipeline. To listen to the conference call, please dial 877-392-9886 (domestic) or 707-287-9329 (international). The call will also be webcast LIVE and can be accessed via the investor relations section of the Company’s website at http://ir.nxstage.com. A replay of the conference call will be available through August 14, 2015 by dialing 855-859-2056 (domestic) or 404-537-3406 (international) and referencing conference ID 77465339. An online archive of the conference call can be accessed via the investor relations section of the Company’s website at http://ir.nxstage.com.
For more information about the System One, home hemodialysis or home nocturnal hemodialysis, please visit www.nxstage.com.
Despite the health benefits that home hemodialysis may provide to those with chronic kidney disease, this form of therapy is not for everyone. The reported benefits of home hemodialysis may not be experienced by all patients. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream and blood loss due to clotting or accidental disconnection of the blood tubing set. Certain risks are unique to the home. Treatments at home are done without the presence of medical personnel and on-site technical support. Patients and their partners must be trained on what to do and how to get medical or technical help if needed.
About the NxStage System One
The NxStage System One is the first and only portable hemodialysis machine cleared specifically by the U.S. Food & Drug Administration (FDA) for home hemodialysis and home nocturnal hemodialysis. Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients’ homes and give patients the freedom to travel with their therapy. When combined with the NxStage Pureflow SL Dialysis Preparation System, patients are able to further simplify, using ordinary tap water to create dialysis fluid. Unlike conventional hemodialysis systems, the System One requires no special infrastructure to operate. Under the guidance of their physician, patients can use the NxStage System One, with their trained partners, where, how and when it best meets their needs, including while they are sleeping – at home or on vacation and at a medically appropriate treatment frequency. The System One is also used to provide a range of flexible therapy options in more traditional care settings such as hospitals and dialysis centers. Its safety and efficacy have been demonstrated by experience with more than 10 million treatments with thousands of patients around the world. www.nxstage.com.
About NxStage Medical
NxStage Medical Inc. (Nasdaq: NXTM) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of ESRD and acute kidney failure. For more information on NxStage and its products, please visit the Company’s website at www.nxstage.com.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words “anticipate,” “believe,” “expect,” “estimate,” “plan,” and similar expressions are generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those that are discussed in NxStage’s filings with the Securities and Exchange Commission, including its most recent quarterly or annual report.
NxStage is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Media contact:
Kristen K. Sheppard, Esq.
ksheppard@nxstage.commailto:ksheppard@nxstage.com
Tel: (978) 332-5923
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