Nephros Receives FDA 510(k) Clearance of EndoPur(TM)

New Post Public Reply Private Reply Replies (0) Message Board
News Desk 2018
57
Nephros Receives FDA 510(k) Clearance of EndoPur(TM) Endotoxin 10" Filter

RIVER EDGE, NJ--(Marketwired - Mar 6, 2017) - Nephros, Inc. ( OTCQB : NEPH ) (the "Company"), a commercial stage medical device company that develops and sells high performance liquid purification ultrafilters and an on-line mid-dilution hemodiafiltration ("HDF") system for use with a hemodialysis machine for the treatment of patients with end stage renal disease, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to market its EndoPur™ Endotoxin 10" Filter. 

The EndoPur™ Endotoxin 10" Filter is designed to provide hemodialysis quality water to dialysis machines. This new product fits into existing filter cartridge housings of the reverse osmosis ("RO") water systems that provide dialysis clinics with high volumes of ultrapure water. The EndoPur™ offers dialysis clinics an endotoxin barrier with the smallest pore size on the market.

"With the FDA clearance of the EndoPur, we have achieved a significant milestone in the expansion of our dialysis water filter portfolio," said Daron Evans, President and CEO of Nephros. "We now can provide our industry-leading 5 nanometer pore-size endotoxin protection to all dialysis clinic RO systems, both large clinic-based and small portable. We expect to begin selling the EndoPur to customers in the second quarter of 2017." 

About Nephros, Inc.

Nephros is a commercial stage medical device company that develops and sells high performance liquid purification filters, as well as a hemodiafiltration system for the treatment of patients with end stage renal disease. Its filters, which it calls ultrafilters, are used primarily in medical applications. Nephros ultrafilters are used by dialysis centers for the removal of biological contaminants from the water and bicarbonate concentrate feeding hemodialysis devices. Additionally, Nephros ultrafilters are used in hospitals and medical clinics as an aid in infection control by retaining bacteria (e.g., Legionella, Pseudomonas), virus and endotoxin from water used by patients. For more information about Nephros, please visit the company's website at www.nephros.com .

Forward-Looking Statements

This release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the EndoPur Endotoxin 10" Filter, including its potential to provide hemodialysis quality water and the expected timing of our first customer sales, are not historical facts, including statements which may be accompanied by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Nephros Inc.'s reports filed with the U.S. Securities and Exchange Commission, including with respect to Nephros, its Annual Report on Form 10-K for the year ended December 31, 2015. Nephros, Inc. does not undertake any responsibility to update the forward-looking statements in this release.

Investors: PCG Advisory Group Kirin M. Smith Chief Operating Officer Direct: 646-863-6519 www.pcgadvisory.com

Scroll down for more posts ▼

Top 10 Most Recent News Articles

Walmart Tops 2026 Recall List: 81 Notices, Food Issues Lead

Updated Category News Views 72

Walmart Behind 81 Recalls: Scrutinizing 2026's Top Contender For an outfit that prides itself on shaking up shopping carts coast to coast, Walmart's stumble onto the recall hotseat this year is a head-scratcher. Imagine leading with 81 official recalls—that's more than a flash in the pan, it's the whole frying pan catching fire. Target and Costco aren't slouches, but...

Continue Reading
AppLovin Faces Serious Investor Lawsuit Deadline

Updated Category News Views 157

Investors' Trust Shaken: The AppLovin Controversy Well, what do we have here? Another day, another hefty lawsuit coming down the pike. The spotlight’s on AppLovin Corporation (NASDAQ: APP), where the Hagens Berman law sharks are sniffing blood in the water over what they claim are federal securities law violations. The core of this legal storm swirls around AppLovin's...

Continue Reading
Betterness Expands Health Networks with $3.5M Boost

Updated Category News Views 55

Defining a Health Revolution in the Heart of Miami Just when you think the fitness tech scene might be settling into its groove, along comes Betterness, Inc., shaking things up with another cool million in their pockets. I'm talking about their recent addition to their seed round, now sitting pretty at a robust $3.5 million. You can't ignore how they're taking a...

Continue Reading
Koppers Faces SEC Scrutiny After Earnings Miss

Updated Category News Views 124

Koppers' Third-Quarter Blues: Missing the Mark Koppers Holdings Inc. (NYSE: KOP) took a hard hit this quarter, missing Wall Street's earnings expectations by a mile. The adjusted earnings per share came in at just $0.77, while the suits down on Wall Street were expecting something closer to $1.34 to $1.37. Now, if you’re holding KOP in your portfolio, you're probably...

Continue Reading
AI-Driven Software Growth Faces Profitability Hurdles

Updated Category News Views 115

AI and Growth: A Tale of Two Strategies Is AI the superhero we’ve been waiting for, or just another fad? The KeyBanc Capital Markets' 2026 AI x Software Benchmark throws more questions into the ring than it answers. This benchmark isn't just numbers on a page; it's a pulse check on how AI is reshaping the software landscape. Seeing AI-native firms grow at a dizzying 34%...

Continue Reading
MV Transportation Celebrates Leadership Nomination for FTA

Updated Category News Views 72

MV Throws Support Behind Aesch for FTA Role In this wild world where public transit feels the heat from financial burdens, MV Transportation's recent move to support Mark Aesch for the Federal Transit Administration's top spot isn’t just a nod of approval—it's a full-blown trumpet blast. They're not just doling out a basic endorsement here; they're practically waving...

Continue Reading
Maritime Launch's Bold Q3 Surge Amid Space Race

Updated Category News Views 193

Rockets, Revenue, and a Bold New Path You ever hear about a spaceport tucked away in the toes of Nova Scotia, making waves with its third-quarter earnings? Well, that's exactly what's cooking over at Maritime Launch Services. These folks have managed to turn a zero into hero in a flash, reporting $5.6 million in revenue and a snug $3.5 million in net income for Q3 2026....

Continue Reading
NueSynergy Secures Top Spot in HSA Provider Rankings

Updated Category News Views 162

NueSynergy Earns its Stripes in 2026 It seems these days, healthcare costs are rising faster than you can say 'deductible.' In this chaotic landscape, a good HSA provider is worth its weight in gold. Enter NueSynergy, whose efforts have once again been acknowledged by Morningstar, a big name in the world of investment research. What Sets NueSynergy Apart? NueSynergy isn't...

Continue Reading
Where Winds Meet Celebrates 1st Anniversary With New Region

Updated Category News Views 92

A Staggering Universe Deepens: Hutuo's Introduction Just when you think you've seen it all, NetEase Games and Everstone Studio go and launch Hutuo, a compelling addition to the already sprawling universe of Where Winds Meet. On the occasion of its first global anniversary, this epic Wuxia ARPG throws players into the mud-soaked, steel-clashing chaos of a warzone, testing...

Continue Reading
Timken Maintains Robust Dividend Streak in 2026

Updated Category News Views 134

Timken Keeps Dividend Train Rolling You want to talk consistency? Timken Company just declared its quarterly dividend like clockwork. As a stockholder, that might just be your morning coffee fix before anything else. Notably, Timken's been on the NYSE since 1922, having cranked out 418 consecutive dividend payouts. That's like your grandpa never missing a Sunday golf...

Continue Reading

Top 5 Most Recently Viewed Articles

Kichler and Progress Lighting Launch Unified Exhibit at KBIS 2026

Updated Category News Views 140

Unified Lighting Design Experience at KBIS 2026 Join Kichler and Progress Lighting as they unveil a fresh and innovative lighting showcase at KBIS 2026. The collaborative effort of these two leading brands marks a significant milestone in their ongoing commitment to revolutionizing modern living spaces through exceptional design. For the very first time, they will jointly...

Continue Reading
Blend Labs to Announce Year-End Financial Results Soon

Updated Category News Views 255

Blend Labs Announces Upcoming Financial Results Blend Labs, Inc. (NYSE: BLND), recognized as a leader in digital banking solutions, is preparing to release its financial results for the fourth quarter and full year of 2024. This announcement comes as the company continues to excel in providing innovative banking technologies to various financial institutions. Schedule for...

Continue Reading
Psilera Inc. Receives NIH Grant for Innovative Alcohol Treatment

Updated Category News Views 132

Psilera Inc. Advances Alcohol Use Disorder Research Psilera Inc. is making significant strides in the field of neuroplasticity as it embarks on a groundbreaking study focused on treating Alcohol Use Disorder (AUD). This endeavor is backed by a notable Small Business Innovation Research Grant, which aims to propel the development of a novel neuroplastogen toward...

Continue Reading
Fazoli’s Unveils Exciting New Lasagna Roll Options for Fans

Updated Category News Views 287

Fazoli’s Innovates with New Lasagna Roll Offerings Fazoli’s, America’s favorite fast and fresh Italian restaurant chain, is kicking off the new year with an exciting culinary twist. The restaurant is thrilled to introduce its all-new Lasagna Rolls, available for a limited time. This fresh take on a classic dish is set to delight pasta enthusiasts looking for...

Continue Reading
Leadership Transitions at NBHWC: A New Era for Coaching

Updated Category News Views 135

Leadership Transitions at NBHWC The National Board for Health and Wellness Coaching (NBHWC) has announced significant leadership changes that position the organization toward a future focused on enhancing health and wellness coaching. This move underscores a commitment to advancing the profession through evidence-based educational standards and increased accessibility for...

Continue Reading