NxStage

NxStage Medical, Inc. ( [2]) is an American company that develops, manufactures, and markets systems for the treatment of chronic kidney disease, acute kidney injury, and hypervolemia. It is a subsidiary of Fresenius Medical Care. System One, a portable hemodialysis system, is the company's primary product.[1]

History

The company was founded by C. David Finch, Jr., MD[3] and Jeffrey H. Burbank in December 1998.[4]

In 2003, the company launched System One in the critical care market. It received Food and Drug Administration clearance for home hemodialysis in June 2005.[5]

In October 2005, the company became a public company via an initial public offering.[6]

On November 2, 2005, the company received the Nixon Peabody/Smith&Nephew Medical Device Innovation Award in the Start-Up category from the Massachusetts Medical Device Industry Council (MassMEDIC).[7]

In December 2014, the company received Food and Drug Administration clearance for System One to be used overnight while patients are sleeping.[8]

In August 2017, the company received Food and Drug Administration clearance for System One for solo home hemodialysis, without a care partner, during waking hours.[9]

In February 2019, the company was acquired by Fresenius Medical Care.[10][11]

References

  1. NxStage Medical, Inc. 2017 Form 10-K Annual Report U.S. Securities and Exchange Commission^
  2. VersiHD with GuideMe Software Overview Animated Video YouTube, October 27, 2023, retrieved 1 June 2024^
  3. Marquis Who's Who. C. David Finch Jr. MD Elite American Physicians, 2014-01-10, retrieved 2019-10-24^
  4. Company Overview of NxStage Kidney Care, Inc Bloomberg L.P., 15 July 2023^
  5. NxStage Medical Receives FDA Clearance for Home Hemodialysis System Business Wire, June 29, 2005^
  6. NxStage Medical rolls out lower-priced IPO American City Business Journals, October 24, 2005^
  7. MassMEDIC Honors NxStage Medical with Innovation Award for Portable Home Hemodialysis System Business Wire, November 2, 2005^
  8. Don Seiffert. NxStage nabs first-ever FDA approval for overnight home hemodialysis American City Business Journals, December 29, 2014^
  9. NxStage Medical Announces FDA Clearance for Solo Home Hemodialysis Using NxStage® System One™ PR Newswire, August 28, 2017^
  10. TARA BANNOW. Fresenius Medical Care closes $2 billion NxStage acquisition Modern Healthcare, February 26, 2019^
  11. Fresenius Medical Care completes acquisition of NxStage Medical PR Newswire, February 26, 2019^