Article contentCautionary Note Regarding Preclinical and Regulatory Status. Preclinical results, including work conducted with third-party research institutions, are not necessarily predictive of results in humans. A targeted 510(k) submission date is not a submission, and a submission is not a clearance. References to addressable markets describe total category size and do not represent any forecast of the Company’s revenue or market share. Additional information is available in the Company’s filings with the U.S. Securities and Exchange Commission at www.sec.gov.