Company:Penumbra (medical company)

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Short description: Californian 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 aneurysm.[6]

History

Penumbra manufactures several medical devices but specializes in the neuro/vascular market and creates devices that help treat aneurysms and ischemic stroke.[7][8]

In 2014, Penumbra launched its Apollo system, a device that “enables minimally invasive removal of deeply seated tissue and fluids in the brain,” allowing for otherwise inoperable blood clots to be removed.[9][10]

In 2015 the company issued an IPO on the NYSE.[11] In 2018 the company acquired 40% of the outstanding shares of virtual reality joint venture MVI Health.[12] In 2017 the company acquired the Italian distributor Crossmed.[13]

Criticism

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.[14] 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.[15][16][17][excessive citations] According to the Foundation for Financial Journalism, this is a significant dilemma.[18]

A request has been sent to The SEC and U.S. Food and Drug Administration to launch an investigation.[19] A scientist who has published research articles showing the reliability of Penumbra's medical products is (allegedly) an internet fabrication.[20]

Recalls

In 2011 the company recalled its Penumbra Coil 400.[21] In 2017 the company recalled a 3D revascularization device.[22] In 2020 the company recalled one of its catheter used during heart surgery due to increased risk of mortality and serious injury.[23][24][25][excessive citations]

References

  1. ↑ "Penumbra Company Profile". https://www.bloomberg.com/profile/company/PEN:US. 
  2. ↑ "Penumbra Company Profile". https://www.reuters.com/companies/PEN. 
  3. ↑ "Big Penumbra expansion in Alameda". 3 February 2020. https://www.eastbaytimes.com/2020/02/03/penumbra-picks-new-site-east-bay-headquarters-tech-medical-real-estate/. 
  4. ↑ AVALOS, GEORGE (February 3, 2020). "Penumbra picks new site for East Bay headquarters". East Bay Times. https://www.eastbaytimes.com/2020/02/03/penumbra-picks-new-site-east-bay-headquarters-tech-medical-real-estate/. 
  5. ↑ "Penumbra Inc (NYSE:PEN)". CNN. https://money.cnn.com/quote/profile/profile.html?symb=PEN. 
  6. ↑ "Penumbra Company Profile". https://www.reuters.com/companies/PEN. 
  7. ↑ Fink, Victoria. "This Innovative Startup Is Transforming the Way Doctors Treat Stroke PatientsThis medical-device startup wants to transform health care.". FROM THE APRIL 2016 ISSUE OF INC. MAGAZINE. https://www.inc.com/magazine/201604/victoria-finkle/founders-40-2016-penumbra-adam-elsesser.html. 
  8. ↑ "Penumbra - A Cheap Medical Device Company With Growth Potential (NYSE:PEN) | Seeking Alpha" (in en). 16 September 2015. https://seekingalpha.com/article/3513506-penumbra-cheap-medical-device-company-growth-potential. 
  9. ↑ "Penumbra announces launch of Apollo system" (in en-US). 2014-07-04. https://www.nsmedicaldevices.com/news/penumbra-announces-launch-of-apollo-system-040714-4310173/. 
  10. ↑ Admin. "The Apollo™ System" (in en-US). https://altairhealth.com/neurovascular/the-apollo-system/. 
  11. ↑ Primack, Dan. "Penumbra goes public tomorrow. Hear from its CEO today". https://fortune.com/2015/09/17/penumbra-ipo-ceo-interview/. 
  12. ↑ DENSFORD, FINK (2018). "Penumbra acquires 90% interest in MVI Health JV, launches thrombectomy devices". Mass Device. https://www.massdevice.com/penumbra-acquires-90-interest-in-mvi-health-jv-launches-thrombectomy-devices/. 
  13. ↑ "Penumbra picks up Italian distributor Crossmed for $9m". Mass Device. July 2017. https://www.massdevice.com/penumbra-picks-italian-distributor-crossmed-9m/. 
  14. ↑ Bellisle, Martha (March 26, 2016). "Lawsuit claims medical device caused brain damage after Bellevue surgery". The Associated Press. https://www.seattletimes.com/seattle-news/health/lawsuit-claims-medical-device-caused-brain-damage/. 
  15. ↑ Farrell, Greg; Fineman, Joshua (December 9, 2020). "Catheter-Linked Death Jolts Penumbra, a Target of Short Sellers". Bloomberg (via Yahoo Finance). https://finance.yahoo.com/news/catheter-linked-death-jolts-penumbra-205051995.html?guccounter=1&guce_referrer=aHR0cHM6Ly9lbi53aWtpcGVkaWEub3JnLw&guce_referrer_sig=AQAAAIzLD5Y0cku5ONNoHyVv1bbSn1EI5oNxSFhgaw6SjPM8j0Q9ol8s5bnTCs6iIxzia6VIA6UYB4o0xdzcTRKkCMZx15v3zVS1GSaAK44baeG2XnAgCHCvsOMkdc3itaVJ4cPoKJhTf3lvCZ5cuylMG_q8YxjcWJTg6kf2Tmo3EiJi. 
  16. ↑ "Fake Author Allegation Spurs Drop in Catheter Maker Penumbra". Bloomberg. https://www.bloomberg.com/news/articles/2020-12-08/-fake-author-allegation-spurs-drop-in-catheter-maker-penumbra. 
  17. ↑ Baker, Nathaniel (Nov 18, 2020). "Short-Sellers Grego, Cohodes Take Aim At Penumbra". https://www.forbes.com/sites/nathanielbaker/2020/11/18/short-sellers-grego-cohodes-take-aim-at-penumbra/?sh=6059c1eb80a2. 
  18. ↑ Boyd, Roddy. "Penumbra Inc.'s Catheter Fail: Broken Tips and Lost Lives". Institute for Nonprofit News. https://ffj-online.org/2020/09/14/penumbra-inc-s-catheter-fail-broken-tips-and-lost-lives/. 
  19. ↑ Stankiewicz, Kevin (Dec 8, 2020). "Shares of medical device maker Penumbra tank after short seller releases critical report". CNBC. https://www.cnbc.com/2020/12/08/shares-of-penumbra-tank-after-short-seller-releases-critical-report.html. 
  20. ↑ Farrell, Greg; Fineman, Joshua (December 9, 2020). "'Fake' Author Rap Sinks Shares of Catheter-Maker Penumbra". Bloomberg (via Yahoo Finance). https://finance.yahoo.com/news/fake-author-rap-sinks-shares-202233337.html. 
  21. ↑ Pedersen, Amanda (July 24, 2017). "Risk of Wire Breakage Prompts Penumbra Recall". Medical Device + Diagnostic Industry (MD+DI). https://www.mddionline.com/testing/risk-wire-breakage-prompts-penumbra-recall. 
  22. ↑ "Penumbra Inc. Recalls 3D Revascularization Device Due to Wire Material That May Break or Separate During Use". U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156554. 
  23. ↑ "Penumbra recalls JET 7 catheters with Xtra Flex technology". Neuro News. December 18, 2020. https://neuronewsinternational.com/penumbra-recalls-jet-7-catheters-with-xtra-flex-technology/#:~:text=The%20US%20Food%20and%20Drug,recall%20on%2015%20December%202020.. 
  24. ↑ "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". https://www.fda.gov/medical-devices/letters-health-care-providers/penumbras-urgent-voluntary-recall-jet-7-catheters-xtra-flex-technology-due-increased-risk-mortality. 
  25. ↑ Wood, Shelley (December 16, 2020). "FDA: Penumbra JET 7 Clot Retrievers Recalled Following Deaths, Injuries". Cardiovascular Research Foundation. https://www.tctmd.com/news/fda-penumbra-jet-7-clot-retrievers-recalled-following-deaths-injuries#:~:text=This%20is%20not%20the%20first,separation%20of%20the%20delivery%20wire.. 



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