Document
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
April 12, 2019
Date of Report (Date of earliest event reported)
Penumbra, Inc.
(Exact name of registrant as specified in its charter)
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Delaware | 001-37557 | 05-0605598 |
(State or other jurisdiction of incorporation or organization) | (Commission File No.) | (I.R.S. employer identification number) |
One Penumbra Place
Alameda, CA 94502
(Address of principal executive offices, including zip code)
(510) 748-3200
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
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☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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Item 7.01. | Regulation FD Disclosure. |
Penumbra, Inc. (the “Company”) is participating in a call with certain investors today, April 12, 2019. During the call, the Company plans to disclose that on March 18, 2019, the U.S. Food and Drug Administration (the “FDA”) granted the Company FDA 510(k) clearance for the REAL Immersive System, an immersive virtual reality and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of virtual environments and full presence tracked avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a seated position in a clinical environment and prescribed and supervised by a medical professional trained in rehabilitation therapy.
The information appearing in this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. This report will not be deemed an admission as to the materiality of any information in the report that is required to be disclosed solely by Regulation FD.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| Penumbra, Inc. |
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Date: April 12, 2019 | By: | /s/ Johanna Roberts |
| | Johanna Roberts |
| | Executive Vice President, General Counsel and Secretary |