Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Disclaimer of Filing
The information in Items 2.02 and 7.01 of this current report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Forward Looking Statements
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Ra Medical’s future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern Ra Medical’s future expectations, strategy, plans or intentions. Forward-looking statements in this communication include, but are not limited to, Ra Medical’s expectations as to the timing and outcome of its Audit Committee investigation, the filing of its periodic reports, and its expected financial and operational results; Ra Medical’s expectations with respect to its search for a permanent CEO; Ra Medical’s intentions to analyze and correct issues with its DABRA catheter manufacturing and performance; and the potential impact of its cost savings initiatives. These statements are based on management’s current expectations, estimates and projections, are not guarantees of future outcomes or performance, and are subject to certain risks, uncertainties and other factors, some of which are beyond Ra Medical’s control and are difficult to predict, including, but not limited to, discovering additional information relevant to the Audit Committee investigation; the findings, conclusions and recommendations of the Audit Committee (and their timing); the Board and Ra Medical’s response to the Audit Committee’s findings, conclusions and recommendations; the review by Ra Medical’s independent registered public accounting firm of the Audit Committee’s findings, conclusions and recommendations
and Ra Medical’s financial statements; the risk that completing and filing reports with the SEC will take longer than expected; the risk that Ra Medical will not be able to timely characterize and correct its issues with its DABRA ca
theter manufacturing and performance; and the risk that cost savings will not materialize from Ra Medical’s cost savings initiatives. In addition, Ra Medical’s business is subject to numerous additional risks and uncertainties, including, among others, cha
llenges inherent in developing, manufacturing, launching, marketing, and selling products; risks associated with acceptance of DABRA and Pharos and procedures performed using such devices by physicians, payors, and other third parties; development and acce
ptance of new products or product enhancements; clinical and statistical verification of the benefits achieved via the use of Ra Medical’s products; the results from Ra Medical’s clinical trials, which may not support intended indications or may require Ra
Medical to conduct additional clinical trials or modify ongoing clinical trials; challenges related to commencement, patient enrollment, completion, and analysis of clinical trials; Ra Medical’s ability to manage operating expenses; Ra Medical’s ability t
o effectively manage inventory; Ra Medical’s ability to recruit and retain management and key personnel; Ra Medical’s need to comply with complex and evolving laws and regulations; intense and increasing competition and consolidation in Ra Medical’s indust
ry; the impact of rapid technological change; costs and adverse results in any ongoing or future legal proceedings (including with respect to ongoing securities litigation); adverse outcomes of regulatory inspections, reviews, or audits; and the other risk
s and uncertainties described in Ra Medical’s news releases and filings with the Securities and Exchange Commission. Information on these and additional risks, uncertainties, and other information affecting Ra Medical’s business and operating results is co
ntained in Ra Medical’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 and in its other filings with the Securities and Exchange Commission. The forward-looking statements in this communication are based on information available to Ra M
edical as of the date hereof, and Ra Medical disclaims any obligation to update any forward-looking statements, except as required by law.