Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 18, 2014




(Exact Name of Registrant as Specified in its Charter)




Delaware   001-36419   87-0807313

(State or other jurisdiction of

incorporation or organization)



File Number)


(IRS Employer

Identification No.)

3910 Brickway Blvd.

Santa Rosa, California

(Address of principal executive offices)


(Zip Code)

(707) 543-8800

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


¨ 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))




Item 7.01 Regulation FD Disclosure.

On September 18, 2014, TriVascular Technologies, Inc. (Nasdaq: TRIV) (the “Company”) issued a press release (the “Press Release”) and filed a related Current Report on Form 8-K (the “Initial 8-K”) announcing the initiation of a voluntary field safety corrective action relating to a specified number of 29 mm aortic body size of Ovation Prime® aortic stent grafts. A copy of the Press Release was attached to the Initial 8-K as Exhibit 99.1.

In further considering the impact of the field safety corrective action on the Company’s business and financial condition, the Company determined that the recall of approximately 30 devices from distributors outside the United States and the removal of affected units from available inventory, as described in the Press Release, is not expected to have a material impact on the Company’s previously issued revenue guidance for the full year 2014 of approximately $32.0 to $36.0 million, as most recently confirmed during the Company’s second quarter 2014 earnings call. However, the Company believes that the removal of approximately 400 affected devices from its available inventory could result in possible short-term inventory constraints potentially resulting in a lower case volume during the next several weeks. Accordingly, the Company currently believes that its full year 2014 revenue guidance, while still remaining at approximately $32.0 to $36.0 million, may be closer to the lower end of the range. The Company plans to continue to evaluate and assess any additional impact on its business and financial condition as a result of this field safety corrective action.

Forward-Looking Statements

The foregoing information contains certain forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management, including statements about the anticipated impact of the field safety corrective action on the Company’s business, financial outlook, product development and manufacturing, as well as inventory availability. These forward-looking statements speak only as of the date thereof, and are subject to numerous risks and uncertainties, including the Company’s ability to successfully assess and minimize the impact of the field safety corrective action on its business; the Company’s ability to successfully commercialize its products; continued market acceptance of the Company’s endovascular aortic repair systems; the ability to manufacture the Company’s endovascular systems to meet demand; the level and availability of third party payor reimbursement, the ability to effectively manage anticipated growth; the ability to protect the Company’s intellectual property rights and proprietary technologies; the ability to operate the Company’s business without infringing the intellectual property rights and proprietary technology of third parties; the ability to develop new or complementary technologies; the regulatory requirements applicable to the Company and its competitors; competition in the industry; additional capital and credit availability, the ability to attract and retain qualified personnel; product liability claims; and general economic and worldwide business conditions. These factors, together with those that are described in greater detail in the Company’s filings with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q, may cause the Company’s actual results, performance or achievements to differ materially and adversely from those anticipated or implied by the forward-looking statements. The Company expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.


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.


Dated: September 18, 2014    

/s/ Michael R. Kramer

    Name:   Michael R. Kramer
    Title:   Chief Financial Officer