NxStage Medical, Inc. (/ˈnɛkˌsteɪdʒ/ NEK-stayj[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. ^ a b "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. ^ Who, Marquis Who's (2014-01-10). "C. David Finch Jr. MD". Elite American Physicians. Archived from the original on October 24, 2019. 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" (Press release). 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" (Press release). Business Wire. November 2, 2005.
  8. ^ Seiffert, Don (December 29, 2014). "NxStage nabs first-ever FDA approval for overnight home hemodialysis". American City Business Journals.
  9. ^ "NxStage Medical Announces FDA Clearance for Solo Home Hemodialysis Using NxStage® System One™" (Press release). PR Newswire. August 28, 2017.
  10. ^ BANNOW, TARA (February 26, 2019). "Fresenius Medical Care closes $2 billion NxStage acquisition". Modern Healthcare.
  11. ^ "Fresenius Medical Care completes acquisition of NxStage Medical" (Press release). PR Newswire. February 26, 2019.
Allikas: https://en.wikipedia.org/wiki/NxStage
No tags for this post.