b'In The First Circuit emphasized that the registration statement expressly highlighted the risk of serious injury and death in the event of a malfunction, and observed that, contrary to plaintiffs characterizations, FDA did not determine that the device was reasonably likely to result in serious injury or death.January 2017, investors filed a putative class action complaint in the District of Massachusetts, alleging vio-lations of Sections 11 and 15 of the Securities Act of 1933 (1933 Act), against ReWalk, the companys officers and directors, and the underwriters for ReWalks IPO, based on defendants alleged failure to disclose in the IPO registration statement sufficient information about FDAs requirement for a post-market surveillance study. The amended complaint added claims pursuant to the 1934 Act, alleging that defendants issued materially mislead-ing statements after ReWalks IPO that failed to disclose the companys non-compliance with FDAs Section 522 requirements. In August 2018, the district court grant-ed defendants motion to dismiss the 1933 Act claims, holding that the amended complaint failed to identify a false statement in the registration statement. The court denied the motion as to the 1934 Act claims without prejudice, reasoning that because the lead plaintiff had purchased shares only in September 2014 (at the time of the IPO)before the alleged misstatements that formed the basis of the 1934 Act claimsthat plaintiff could not assert the remaining claims. Accordingly, the court allowed plaintiffs an opportunity to seek appoint-ment of a substitute lead plaintiff or otherwise establish standing. Plaintiffs thereafter moved to amend the complaint and add a second named plaintiff for purposes of the 1934 Act claim. In May 2019, the district court denied plain-tiffs motion to amend, deemed defendants motion to dismiss renewed, and dismissed the amended com-plaint without prejudice. The court reiterated its holding that lead plaintiff did not have standing to assert claims under the 1934 Act, and rejected his arguments that he could cure the lack of standing by adding a second named plaintiff.'