CITING THE MANY FDA ADVERSE EFFECTS TO KEYSTONE DENTAL - CHECK-CAP FOUNDER STRONGLY RECOMMENDS VOTING AGAINST THE KEYSTONE DENTAL MERGER ALSO RECOMMENDS VOTING FOR THE SYMETRYX BOARD NOMINEES
In This Article:
TORONTO, Dec. 8, 2023 /CNW/ - Further to its news release of November 28, 2023, Symetryx continues to urge its fellow Check-Cap Ltd. ("Check-Cap") (NASDAQ: CHEK) shareholders to VOTE AGAINST the Keystone Dental and FOR the Symetryx slate of highly qualified and independent director nominees. See Symetryx Today Issues Open Letter to Shareholders In Regard to the Upcoming Annual General Meeting (newswire.ca)
Keystone Dental ("Keystone") reported on November 22nd through a 6K filling with the Securities and Exchange Commission (the "SEC") under Check-Cap's SEC filing page, the following: On November 6, 2023, Keystone received a deficiency letter from the U.S. Food and Drug Administration (the "FDA") regarding its Paltop Short Implants in which the FDA requests additional information and raises certain concerns regarding Keystone's submission to the FDA.
While Keystone indicates it intends to proactively engage the FDA on this issue and present information to the agency, there is no guarantee that the FDA will agree with Keystone's determination that a new filing submission was not needed for these products. If the FDA determines that a new filing submission was needed for one or more of the referenced implant bodies, Keystone may be subject to enforcement action and/or it may be required to cease marketing the applicable product and withdraw or recall the subject product from the marketplace until a new submission is made and clearance is obtained (which may not happen in a timely manner or at all), issue corrective communications, or pay fines. This action by the FDA could potentially harm Keystone's business, financial condition and results of operations and, as a result, negatively impact your investment.
Keystone Dental may indeed be required by the FDA to make a new filing submission and provide clinical data to support the continued marketing of their product.
It is further worth noting hundreds of adverse events have been reported by Keystone Dental on implants to the FDA every year from 2019 until today. These large number of adverse events may drive clinicians to choose other brands with fewer concerns. See the FDA's website for information on the events reported by the FDA: See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm (and enter Keystone Dental to view the negative reports).
Symetryx is pleased to see that other stakeholders agree that the transaction with Keystone Dental DOES NOT provide the maximum value for shareholders. We once again urge all shareholders to reject the Keystone transaction by voting AGAINST Proposal #1, the Keystone transaction, and to support the Symetryx Board nominees by voting FOR each. Only with a new, independent Board do we believe, that we shareholders will have the best opportunity to realize the full value of our investment and not give it away to Keystone's investors.
