| Item 7.01 | Regulation FD Disclosure. |
On September 20, 2024, the Company issued a press release announcing that it has successfully defended against an opposition filed against a key patent for its direct-from-whole blood detection method in the European Union. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section.
On September 20, 2024, the Company announced that it has successfully defended against an opposition filed against a key patent for its direct-from-whole blood detection method in the European Union.
The opposition was filed in May 2023 with the European Patent Office (EPO) by bioMerieux and a strawman representing other undisclosed firm(s) against T2 Biosystems’ granted European Patent No. 3 443 124, which relates to a method for amplifying a target nucleic acid characteristic of a pathogen in a whole blood sample. This patent is part of T2 Biosystems’ intellectual property portfolio surrounding its proprietary direct-from-whole blood pathogen detection method. The Opposition Division of the EPO held a public hearing on September 19, 2024, and ruled such that T2 Biosystems’ strong IP position on the detection of pathogens directly from whole blood was maintained.
Forward-Looking Statements
This Current Report on Form 8-K (“Current Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our patent portfolio, and the potential of our direct-from-whole blood detection technology and products, as well as statements that include the words “expect,” “may,” “should,” “anticipate,” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-
