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Nephros, Inc. OTCQB: NEPH Corporate Presentation Q2 2017 www.nephros.com

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Page 1: Nephros, Inc. OTCQB: NEPH - pcgadvisory.compcgadvisory.com/wp-content/uploads/2017/07/2017-Q1-NEPH-Corp-Pr… · Market Data Ticker (OTCQB) NEPH ... (i.e. Legionella, ... 1Estimate

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Nephros, Inc. OTCQB: NEPH

Corporate PresentationQ2 2017

www.nephros.com

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Safe Harbor Statement

Certain statements in this management presentation constitute “forward-looking statements”. Such statements include statements regarding the efficacy and intended

use of our technologies under development, the timelines and strategy for bringing such products to market and the availability of funding sources for continued

development of such products and other statements that are not historical facts, including statements which may be preceded by the words “intends,” “may,” “will,”

“plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not

guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond

our control. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include,

but are not limited to, the risks that: (i) we may not be able to find a strategic partner to successfully market our HDF system; (ii) our HDF system may not be accepted

by patients or health care providers in the U.S. marketplace; (iii) we may not be able to continue as a going concern; (iv) the voluntary recalls of point of use and DSU

in-line ultrafilters used in hospital water treatment applications announced on October 30, 2013 and the related circumstances could subject us to claims or

proceedings by consumers, the FDA or other regulatory authorities which may adversely impact our sales and revenues; (v) we face significant challenges in obtaining

market acceptance of our products, which could adversely affect our potential sales and revenues; (vi) product-related deaths or serious injuries or product

malfunctions could trigger recalls, class action lawsuits and other events that could cause us to incur expenses and may also limit our ability to generate revenues from

such products; (vii) we face potential liability associated with the production, marketing and sale of our products and the expense of defending against claims of

product liability could materially deplete our assets and generate negative publicity which could impair our reputation; (viii) to the extent our products or marketing

materials are found to violate any provisions of the FDC Act or any other statutes or regulations, we could be subject to enforcement actions by the FDA or other

governmental agencies; (ix) we may not be able to obtain funding if and when needed or on terms favorable to us in order to continue operations; (x) we may not have

sufficient capital to successfully implement our business plan; (xi) we may not be able to effectively market our products; (xii) we may not be able to sell our water

filtration products or chronic renal failure therapy products at competitive prices or profitably; (xiii) we may encounter problems with our suppliers, manufacturers and

distributors; (xiv) we may encounter unanticipated internal control deficiencies or weaknesses or ineffective disclosure controls and procedures; (xv) we may not obtain

appropriate or necessary regulatory approvals to achieve our business plan; (xvi) products that appeared promising to us in research or clinical trials may not

demonstrate anticipated efficacy, safety or cost savings in subsequent pre-clinical or clinical trials; (xvii) we may not be able to secure or enforce adequate legal

protection, including patent protection, for our products; and (xviii) we may not be able to achieve sales growth in key geographic markets. More detailed information

about the Company and the risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this management

presentation, is set forth in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and our other periodic

reports filed with the SEC. We urge you to read those documents free of charge at the SEC’s web site at www.sec.gov. We do not undertake to publicly update or revise

our forward-looking statements as a result of new information, future events or otherwise, except as required by law.

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Nephros Overview

Market Data

Ticker (OTCQB) NEPHPrice (6/7/2017) $0.3052 Week Range $0.24 - $0.60Market Cap $15 MMAvg Daily Trading (3 mo) ~53,000Common Shares O/S 53.6 MMInsider Ownership 57%

2016 Revenue $2.3 MMCash (3/31/2017) $0.8 MM

Commercial stage medical device company that develops and sells high performance liquid purification filters, as well as hemodiafiltration systems for the treatment of patients with End Stage Renal Disease.

Nephros ultrafilters are used primarily in medical applications. In dialysis centers, ultrafilters are used for the removal of biological contaminants from the water and bicarbonate concentrate feeding hemodialysis devices. In hospital settings, the filters are used as an aid in infection control by retaining bacteria (i.e. Legionella, Pseudomonas), virus and endotoxins from water used by patients. Nephros is also expanding its offerings to the commercial and military markets.

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Investment Highlights

• Two business units, each of which has $100M+ revenue potential within 5 years• Water filters for hospitals, dialysis centers, commercial, and military applications• Hemodiafiltration (HDF) systems for patients with end stage renal disease (ESRD)

• Recent Progress (2015-2017)• Built new management team• 50% CAGR in sales and 10-fold customer growth• >50% gross margins• Strategic investor Wexford Partners continues to own ~55% of NEPH equity

• Near-Term Strategy: Focus on fast-growing Water Filter business• “Razor blade” strategy with standardized replacement form factors• Distributor-based sales model provides growth leverage• Enter non-medical markets through strategic partnerships• Cash flow breakeven expected in 2017

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Management Team

Daron Evans, MS, MBAPresident & CEO

§ Managing Director of PoC Capital§ CFO of Nile Therapeutics, Inc. (now CAPR)§ Johnson & Johnson, Arthur D. Little, Booz Allen & Hamilton§ B.S. in Chem Eng, M.S. in Biomed Eng, MBA @ Duke

Andy Astor, MBACFO

§ President and CFO of Open Source Consulting§ Sr. positions at E&Y, D&B, Asurion, EnterpriseDB, webMethods§ B.A. in Mathematics, MBA @ Wharton

Greg Collins, Ph.D.VP, R&D

§ Significant experience in design and development of medical devices§ Previously served as R&D Product Manager with National Medical Care (Fresenius

Medical Care)

Monet CarnahanDirector, Dialysis Products

§ 10 years as a Registered Nurse§ Performance improvement group at Fresenius Medical Care§ Editor of ANNA Journal

Hollie JohnsonDirector, Quality and Regulatory

§ 15 year of regulatory and quality experience§ Previously Swissray, Shulka Medical, TyRx (now Medtronic), Osteotech (now

Medtronic)

Shane SullivanDirector, NA Sales

§ Proven Sales, Sales Management and Business Development experience§ Regional Manager at Thermo Scientific

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New Products Drive Revenue Growth

$0$100$200$300$400$500$600$700$800

Quarterly Revenue2014-2017

510(k) & Launch S100 Point-of-Use

40%

510(k) & LaunchDSU/SSU (Hospital)

Launch Distributor

Sales Model

510(k) & Launch HydraGuard

(Hospital) and EndoPur (Dialysis)

100%

Expanded customer base from 50 to 500 in 3 years

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Nephros has Two Core Product Lines

Ultrafiltration Products

Ultrafiltration Products:Medical ultrafilters used in hospitals and dialysis

clinics and non-medical ultrafilters for commercial, military and recreational markets

HDF Systems

Hemodiafiltration System: Advanced renal replacement therapy for end-stage renal disease

patients

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NephrosUltrafilters

(0.005 μm pore size)

Conventional Microfilters

(0.2 μm pore size)

Clostridium Botulinum

Endotoxins Staphylococcal enterotoxin

Ricin toxin

Enterovirus

Viruses Rotavirus

Adenovirus

Bacteria

Nephros: Proprietary membrane technology

Nephros ultrafilter pore size: 40x smaller than conventional filters

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Filtration0.005 µm

Filter Life2-3X Competitors

Flow RateLow Pressure Drop

Nephros filters dramatically improve performance at a similar cost per day vs. conventional filters

Performance = Filtration, Flow, & Filter Life

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$500M+ Total Addressable Market:$400MM Hospital Segment

Hospitals Dialysis Clinics Commercial Military / Recreation

Number of U.S. Sites ~6,000 ~6,600 50,000+ N/A

Number of Filter Locations 1,000,000+ ~125,000 150,000+ 400-500,000+

contract units

Nephros Filter Life 3-6 Months 1 Year 3 – 12 Months 1,000L

Regulatory / Standards FDA FDA / CE Mark EPA NSF P248

U.S. Market Potential $400MM1 $40MM $50MM $75MM

% of Market Using Filters <10% 100% TBD

% of Market w/Nephros Filters >2% >3% TBD

1 2 3 4

• CamelBak®

License• Other OEM

discussions

1 Estimate based on the number of US hospitals multiplied by $2/day

Potential addressable market of 1,000,000 hospital filters per year

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New Products

Hospital Infection Control – 510(k) Portfolio

DSU-H SSU=HIn-Line Filters

S100Point-of-Use Filters

HydraGuard™Replacement Cartridges

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Pall-AquasafeTM Nephros DSU-H, SSU-H & S1001

Pore Size 200nm 5nm

Filter Life 30-60 days 90-180 days

Flow Rate Comparable

Cost per Day Comparable

Regulatory Single productFDA 510(k) cleared

All productsFDA 510(k) cleared

Sales Model Direct sales, plus partnered with Nalco

Distributor model: Garrett-Callahan,

Chem-Aqua, HOH, TQM, Others

1 Intended to be used to filter EPA quality drinking water; retain bacteria, viruses and endotoxin; provide ultrapure water for patient washing and drinking; produce water suitable for wound cleaning, cleaning of equipment used in medical procedures and washing of surgeon’s hands; not intended to provide water that can be used as a substitute for USP sterile water

Multiple Competitive Advantages

DSU-H

SSU-HS100

HydraGuard™

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Hospital Market: ASHRAE 188-2015 May Drive Market Growth

- Applies to all “human-occupied buildings, excluding single family residential”

- Facilities must have a “Hazard Analysis and Critical Control Point” team and risk management plan

- If an infection, or suspected infection, occurs, then the facility must:- Disinfect facility with

chemicals, heat, or both- Use point of use filtration at

certain taps and faucets

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$500M+ Total Addressable Market:$40MM Dialysis Segment

Hospitals1 Dialysis Clinics Commercial Military / Recreation

Number of U.S. Sites ~6,000 ~6,600 50,000+ N/A

Number of Filter Locations 1,000,000+ ~125,000 150,000+ 400-500,000+

contract units

Nephros Filter Life 3-6 Months 1 Year 3 – 12 Months 1,000L

Regulatory / Standards FDA FDA / CE Mark EPA NSF P248

U.S. Market Potential $400MM $40MM1 $50MM $75MM

% of Market Using Filters <10% 100% TBD

% of Market w/Nephros Filters >2% >3% TBD

1 2 3 4

• CamelBak®

License• Other OEM

discussions

Potential to dominate the $40MM dialysis market segment

1Estimate based on the number of US dialysis clinics multiplied by $1.5/day

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Dialysis Water Quality – 510(k) Portfolio

DSU-D SSU-D SSU-MiniIn-Line Filters

EndoPur™10” EndoPur™20” EndoPur™30”Replacement Cartridges

New Products

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Dialysis Market: Filter Locations

DSU-D SSU-D

10”/20”/30”Cartridge

SSU-DSSU-Mini

Water Lines

Bicarbonate Concentrate

Lines

RO Loop Endotoxin

Filter

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$500M+ Total Addressable Market:$50MM Commercial Segment

Hospitals Dialysis Clinics Commercial Military / Recreation

Number of U.S. Sites ~6,000 ~6,600 50,000+ N/A

Number of Filter Locations 1,000,000+ ~125,000 150,000+ 400-500,000+

contract units

Nephros Filter Life 3-6 Months 1 Year 3 – 12 Months 1,000L

Regulatory / Standards FDA FDA / CE Mark EPA NSF P248

U.S. Market Potential $400MM $40M $50MM1 $75MM

% of Market Using Filters <10% 100% TBD

% of Market w/Nephros Filters >2% >3% TBD

1 2 3 4

• CamelBak®

License• Other OEM

discussions1Estimate of Nephros’ addressable market within their pore size

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Commercial Market: Strategic Partnershipw/ maker of AETHER® filters

AETHER® Water System Filtration1. Pre-filter2. Carbon Filter 3. Scale Filter4. Bacterial Filter (Nephros)

AETHER® filtration is used in restaurants, hotels, and convenience

stores for ice machines, coffee stations and soda fountains

Introducing the NanoGuardTM-E

New Product

Nephros 5nm membrane in a cartridge that plugs into an Everpure® manifold, allowing food service to have 510(k)-level protection

from bacteria and viruses

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Commercial Market: Bringing dialysis-quality water to industrial customers

§ Cooling towers – reduce total suspended solids (TSS) and bacteria levels in cooling water to increase the number of cycles water can be used in the system

§ Data centers: thermal inversion cooling watero Flushable ultrafilter extends product lifeo High flow requirements (25-50 GPM) o Removes copper colloidal and organic particleso Product in pilot testing

§ Restaurants/Home Point of Entry System: o Flushable feature allows for 12 month product lifeo Medium flow requirement (5-10 GPM)o Remove particulates, including any bacteriao Expect to initiate limited roll-out in Q3 2017

Nephros’ current hospital distributors also provide water treatment services to all manner of industrial customers, from aluminum stamping

to egg processing = existing distribution channel

Nephros filter systems target total suspended solids and bioburden

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$500M+ Total Addressable Market:$75MM Military Segment

Hospitals Dialysis Clinics Commercial Military / Recreation

Number of U.S. Sites ~6,000 ~6,600 50,000+ N/A

Number of Filter Locations 1,000,000+ ~125,000 150,000+ 400-500,000+

contract units

Nephros Filter Life 3-6 Months 1 Year 3 – 12 Months 1,000L

Regulatory / Standards FDA FDA / CE Mark EPA NSF P248

U.S. Market Potential $400MM $40MM $50MM $75MM1

% of Market Using Filters <10% 100% TBD

% of Market w/Nephros Filters >2% >3% TBD

1 2 3 4

• CamelBak®

License• Other OEM

discussions1Estimates of military spend and recreational filter market

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Military/Recreation Market: CamelBak®

license and OEM for other products

§ Our individual water purification devices enable soldiers to filter water from available sources instantly− Integrated into CamelBak® backpack product

§ Tested to NSF Protocol P248 for removal of biological toxins

§ Licensed to CamelBak® for profit sharing and royalties

§ Other OEM Military Products:o Roving Blue portable water purification system

(pre-filter to ozone purification module)o Additional companies testing Nephros products

Roving Blue

CamelBak M.A.P.S.

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Nephros has Two Core Product Lines

Ultrafiltration Products

Ultrafiltration Products:Medical ultrafilters used in hospitals and dialysis

clinics and non-medical ultrafilters for commercial, military and recreational markets

HDF Systems

Hemodiafiltration System: Advanced renal replacement therapy for end-stage renal disease

patients

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Nephros has the ONLY FDA Cleared HDF system available for use in the U.S.

FDA Cleared Mid-Dilution HDF System

OLpūr H2H Module:Converts standard HD Systems to Online HDF Systems

OLpūr MD220 Dialyzer:Patented mid-dilution design optimized for HDF treatment

standard hemodialysis machine

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U.S. Dialysis Market: Large and Growing

• ~400,000 patients1 receive hemodialysis (HD) per year in the U.S.• Patients are hemodialyzed 156 times annually (3 tx/wk, 52 wk/yr)• Medicare spent $87,561 per hemodialysis patient annualized in 2010• ~6,000 dialysis centers, 100,000 machines, 20 million dialyzer filters2

• In 2011 changes in Medicare reimbursement have changed practices− Medicare implemented a bundled payment system for the cost of the dialysis

treatment and dialysis-related drugs, reducing EPO over-use• A full capitation model is being evaluated by several insurance companies

− A full capitation model will provide a fixed payment for ALL dialysis patient care costs in a given year, including any hospitalizations.

− We expect full capitation to accelerate the adoption of HDFSource: United States Renal Data System (USRDS) and external market research1. ~600,000 patients with ESRD in 2010’ the US obesity and diabetes problem increases the incidence of end stage renal disease (ESRD)

patients2. 5% in the US would equate to a market with: ~5,000 H2H Modules, ~1,000,000 dialyzer filters sold annually

Total Annual U.S. expenditure on ESRD is $47.5 billion (2010 est.)

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The economic value of Online HDF

• HDF therapy is more expensive per treatment: ~ $4000 more year• Based on European data from the ESHOL Study, versus patients on normal HD

therapy, patients on HDF therapy could:− 28% fewer hypotensive episodes; 22% fewer hospital admissions

• Hospitalization is a key cost component− The average patient on dialysis was admitted 1.9 times per year and spent 12

days in the hospital in 2010− Each day in the hospital in the US costs an average of $4,293 (2013)

• To compete, HDF must be AT LEAST cost neutral by:− HDF Patients spending one (1) fewer days in hospital per year− Attracting one (1) additional commercial insurance patient per nine (9) patients

on HDF

Data Sources: United States Renal Data System 2012 Annual Report; ESHOL Study; International Federation of Health Plans 2013 Comparative Price Report

In collaboration with Vanderbilt, Nephros is working to generate the data to prove the economic value of HDF to the US Nephrologist community.

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HDF System Status and Next Steps

OLpūr H2H Modules have provided over 2,000 treatments

over 15 months

OLpūr H2H Module software update

launched in Jan 2016

Partner with Vanderbilt to generate patient and work

flow data

2015 2016 2017

Build System 2.0• Incorporate Feedback

to Improve Work Flow• Engineer for

Scalability and Lower Treatment Costs

2018 2019

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Key Takeaways

• Two business units, each of which has $100M+ revenue potential within 5 years• Water filters for hospitals, dialysis centers, commercial, and military applications• Hemodiafiltration (HDF) systems for ESRD patients

• Recent Progress (2015-2017)• Built new management team• 50% CAGR and 10-fold customer growth• >50% gross margins• Strategic investor Wexford Partners continues to own ~55% of NEPH equity

• Short/Medium-Term Strategy: Focus on fast-growing Water Filter business• “Razor blade” strategy with standardized replacement form factors• Distributor-based sales model provides growth leverage• Enter non-medical markets through strategic partnerships• Cash flow breakeven expected in 2017

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Nephros, Inc.OTCQB: NEPH

Nephros, Inc.41 Grand Avenue, River Edge, NJ 07661

Phone: 201-343-5202http://www.nephros.com

Investor Relations Contact:Kirin Smith, COO, PCG Advisory Group

[email protected]

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Appendix

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Hospital Market: There is an App for That!

We built a tool to help our distributor sales force quote, sell and

track filter sales

Available on IOS and Android Phone/Pads

Over 4,800 Medical Facilities and Growing! Tools to help estimate quotes and to help know when to go back for the replacement sale!

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Potential to Dominate $40M US Dialysis Filter Market1

§ Superior Filtration: 5 nm nominal vs. 50 nm absolute

§ Superior Product Life: 12 months vs. 3 or 6 months

§ Same Cost/Day as Conventional Filters

§ Broad Regulatory Approval: FDA Cleared & CE Mark

§ Distribution via Dialysis Water Service companies who provide and maintain the water systems for dialysis clinics

§ Multiple Filter Locations in Each Dialysis Center:

o Final polish filter for portable RO unito In-line, between wall box and HD Stationo Endotoxin Cartridge in RO Loop

DSU-D on Portable RO

DSU-D after wall box 1 Estimates based on the number of US dialysis clinics multiplied by $1.50/day

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Patents and Regulatory Approvals

6 Water Application Patent Families§ DSU Patent – Currently issued in US, Mexico, Israel, Japan and Australia

(expires in 2026) and in application for rest of world§ 3 patents have been issued covering portable filter designs with integral pump

and a flush pump/field integrity test feature§ 2 additional patents are still pending related to filter design§ Ultrafilters contain “trade secret formula and know how” developed by

Medica SpA§ 510(k) clearance (US), Health Canada and CE mark approval for dialysis water

15 Blood Application Patent Families§ Patents issued in US, EU, Japan, Canada and BRIC specifically for MD220 filter

and H2H Module§ 12 additional patents have been issued covering aspects of Mid-dilution, HDF,

and Infusion Fluid§ 510(k) clearance (US) for HDF system, Health Canada and CE mark approval

for MD HDF filter.

We have 22 issued US patents

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The clinical value for Online HDF

Data Sources: Survival – RISCAVID study; CV Mortality – CONTRAST Study; Hospitalizations – ESHOL HDF Study

Hemodialysis (HD) Hemodiafiltration (HDF)How does it work? HD systems clear toxins from

blood via diffusion using a concentration gradient

HDF systems use diffusionand convection via a pressure gradient and filtration

Key Biomarker Changes Shown in Nephros Study (n = 28 Patients)Change in β-2-microglobulin during treatment

19 mg/L @ baseline 23 mg/L @ 12 wks treatment

C-reactive protein 1.5 mg/dl @ baseline 1 mg/dl @ 12 wks treatmentKey Data from Large European HDF Studies using Other HDF Systems

Survival (757 pts.) - 34% improvement vs HDCV Mortality (714 pts.) - 20% reduction vs HD

Hospitalizations (906 pts.) - 22% reduction vs HDCharlson Comorbidity Index Pts w/ higher index did better

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Conclusion and Catalysts

§ Ultrafilters: Hospital and Dialysis Clinic Water Markets• $100M+ U.S. market potential within 5 years• Three new 510(k) products launching in 2017

§ Ultrafilters: Commercial Market• Licensed technology to CamelBak® for military / recreation market• Strategic relationship with Biocon 1 for food service market• Everpure® compatible filter launching in February 2017• Working with distributors to evaluate new uses and new geographies for Nephros

filtration technology§ Hemodiafiltration (HDF) System

• $100M+ revenue potential with minimal market adoption of HDF system• Nephros working with Vanderbilt to generate additional quality of life and

pharmacoeconomic data

Ø Expanding ultrafilter product portfolio into common form factorsØ Entering non-medical filter markets through strategic partnerships