Penumbra (medical company)

Penumbra, Inc. is a medical device company[1][2] headquartered in Alameda, California.[3][4] The company was founded by Arani Bose and Adam Elsesser in 2004.[5] It manufactures devices for interventional therapies to treat vascular conditions such as stroke and aneurism.[6]

History

Penumbra initially focused on treatments for ischemic stroke.[7] In 2015 the company issued an IPO on the NYSE.[8] In 2018 the company acquired 40% of the outstanding shares of virtual reality joint venture MVI Health.[9][10] In 2017 the company acquired the Italian distributor Crossmed.[11][12]

Criticism of Penumbra

Criticism of Penumbra has followed various aspects of its products and business practices. In 2016 a lawsuit claimed the Penumbra Coil 400 caused brain damage after surgery.[13] The company's specialized catheter has been linked to the deaths of stroke patients, and it was a target of stock short sellers in 2020.[14][15][16] According to the Foundaiton for Financial Journalism this is a significant dilemma.[17]

A request has been sent to The SEC and U.S. Food and Drug Administration launch an investigation.[18] A scientist who has published research articles showing the reliability of Penumbra's medical products is (allegedly) an internet fabrication.[19]

Recalls

In 2011 the company recalled its Penumbra Coil 400.[20] In 2017 the company recalled a 3D revascularization device.[21] In 2020 the company recalled one of its catheter used during heart surgery due increased risk of mortality and serious injury.[22][23][24]

References
  1. "Penumbra Company Profile". Bloomberg.
  2. "Penumbra Company Profile". Reuters.
  3. "Big Penumbra expansion in Alameda". East Bay Times. Retrieved 23 December 2020.
  4. AVALOS, GEORGE (February 3, 2020). "Penumbra picks new site for East Bay headquarters". East Bay Times. Retrieved 15 December 2020.
  5. "Penumbra Inc (NYSE:PEN)". CNN.
  6. "Penumbra Company Profile". Reuters.
  7. Fink, Victoria. "This Innovative Startup Is Transforming the Way Doctors Treat Stroke PatientsThis medical-device startup wants to transform health care". Inc. FROM THE APRIL 2016 ISSUE OF INC. MAGAZINE. Retrieved 23 December 2020.
  8. Primack, Dan. "Penumbra goes public tomorrow. Hear from its CEO today". Fortune. Retrieved 29 December 2020.
  9. Fink, Charlie. "Sixense Focused On VR's Killer App". Forbes. Retrieved 28 December 2020.
  10. DENSFORD, FINK (2018). "Penumbra acquires 90% interest in MVI Health JV, launches thrombectomy devices". Mass Device.
  11. "Penumbra picks up Italian distributor Crossmed for $9m". Mass Device. July 2017.
  12. "PENUMBRA, INC. UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION". Securities and Exchange Commission. Retrieved 28 December 2020.
  13. Bellisle, Martha (March 26, 2016). "Lawsuit claims medical device caused brain damage after Bellevue surgery". The Associated Press.
  14. Farrell, Greg; Fineman, Joshua (December 9, 2020). "Catheter-Linked Death Jolts Penumbra, a Target of Short Sellers". Bloomberg (via Yahoo Finance).
  15. "Fake Author Allegation Spurs Drop in Catheter Maker Penumbra". Bloomberg. Retrieved 23 December 2020.
  16. Baker, Nathaniel (Nov 18, 2020). "Short-Sellers Grego, Cohodes Take Aim At Penumbra". Forbes.
  17. Boyd, Roddy. "Penumbra Inc.'s Catheter Fail: Broken Tips and Lost Lives". Foundation for Financial Journalism. Institute for Nonprofit News. Retrieved 29 December 2020.
  18. Stankiewicz, Kevin (Dec 8, 2020). "Shares of medical device maker Penumbra tank after short seller releases critical report". CNBC. Retrieved 15 December 2020.
  19. Farrell, Greg; Fineman, Joshua (December 9, 2020). "'Fake' Author Rap Sinks Shares of Catheter-Maker Penumbra". Bloomberg (via Yahoo Finance). Retrieved 15 December 2020.
  20. Pedersen, Amanda (July 24, 2017). "Risk of Wire Breakage Prompts Penumbra Recall". Medical Device + Diagnostic Industry (MD+DI). Retrieved 23 December 2020.
  21. "Penumbra Inc. Recalls 3D Revascularization Device Due to Wire Material That May Break or Separate During Use". U.S. Food and Drug Administration. Retrieved 23 December 2020.
  22. "Penumbra recalls JET 7 catheters with Xtra Flex technology". Neuro News. December 18, 2020.
  23. "Penumbra's Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers". U.S. Food and Drug Administration. Retrieved 23 December 2020.
  24. Wood, Shelley (December 16, 2020). "FDA: Penumbra JET 7 Clot Retrievers Recalled Following Deaths, Injuries". Cardiovascular Research Foundation.
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