NEPHROS INC current report, 28 April 2016

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Business Context and Reporting Period

Company: Nephros, Inc.
Filing Type: Form 8-K (Current Report)
Date of Report: April 28, 2016
Subject: Update on FDA regulatory status for the EndoPurTM ultrafilter product line.

Key Financial Metrics

This filing is a Current Report (Form 8-K) regarding a specific regulatory event. It does not contain financial statements, revenue figures, profit data, cash flow, margins, debt levels, or liquidity metrics. The filing text does not provide a clear value for any financial indicators.

Material Changes and Regulatory Events

  • FDA Submission Conversion: The FDA determined that the Special 510(k) application for the 20", 30", and 40" EndoPur filter sizes must be converted to a Traditional 510(k) submission.
  • Reason for Change: The FDA requested additional information regarding the 20", 30", and 40" filter sizes and the reusable external filter housing.
  • Company Action: Nephros converted the submission for the 20", 30", and 40" sizes to Traditional 510(k) status following discussions with the FDA.
  • Excluded Size: The 10" filter size remains eligible for the Special 510(k) process and will be filed separately.

Guidance, Outlook, and Risks

Launch Timeline Outlook

  • 10" Filter Size: Targeted for launch in early Q3 2016, subject to FDA clearance.
  • 20", 30", and 40" Filter Sizes: Targeted for launch in early Q4 2016 due to the longer review process associated with Traditional 510(k) submissions.

Risks and Contingencies

The filing includes standard forward-looking statement disclaimers. Key risks identified include:

  • Delays in the regulatory approval process.
  • Changes in business, economic, and competitive conditions.
  • Availability of capital and financing.
  • Dependence on third-party manufacturers.
  • Regulatory reforms and uncertainties in litigation.

Investor Verification Checklist

  • Verify the specific additional information requested by the FDA for the Traditional 510(k) conversion.
  • Monitor the filing date of the separate Special 510(k) for the 10" filter size.
  • Review the company's cash reserves to ensure they can sustain operations through the extended Q4 2016 launch timeline for larger filter sizes.
  • Check subsequent 8-K filings for any further FDA correspondence or delays.