Based on our discussion with the Agency, our team and external advisors will determine the appropriate path forward. Surmodics stated, “We are evaluating the issues raised in the FDA’s letter and plan to meet with Agency representatives regarding its contents. Although the information identified by the Agency to put the PMA application in approvable form would require additional testing and analysis, the letter did not question the human clinical data submitted nor request any further human clinical data. The letter stated that certain information within two general categories-biocompatibility and labeling-must be added by an amendment to the company’s PMA application to place it in approvable form. In the letter, the FDA indicated that the application is not currently approvable, while providing specific guidance as to a path forward. Food and Drug Administration related to its premarket approval (PMA) application for the SurVeil™ drug-coated balloon (DCB). WHAT IS THIS ABOUT: On January 19, 2023, Surmodics announced it had received a letter from the U.S. toll-free at 86 or email or for information on the class action. WHAT TO DO NEXT: To join the prospective class action, go to or call Phillip Kim, Esq. The Rosen Law Firm is preparing a class action seeking recovery of investor losses. SO WHAT: If you purchased Surmodics securities you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. ( SRDX) resulting from allegations that Surmodics may have issued materially misleading business information to the investing public. The Drought and Salt Tolerance gene ( DST) encodes a C 2H 2 zinc finger transcription factor, which negatively regulates salt tolerance in rice ( Oryza sativa).NEW YORK, Ma(GLOBE NEWSWIRE) - WHY: Rosen Law Firm, a global investor rights law firm, continues to investigate potential securities claims on behalf of shareholders of Surmodics Inc. Phylogenetic analysis of six homologues of DST genes in different plant species revealed that DST genes were conserved evolutionarily. Here, the rice DST gene was linked to an SRDX domain for gene expression repression based on the Chimeric REpressor gene-Silencing Technology (CRES-T) to make a chimeric gene ( OsDST-SRDX) construct and introduced into perennial ryegrass by Agrobacterium-mediated transformation. Integration and expression of the OsDST-SRDX in transgenic plants were tested by PCR and RT-PCR, respectively. Transgenic lines overexpressing the OsDST-SRDX fusion gene showed obvious phenotypic differences and clear resistance to salt-shock and to continuous salt stresses compared to non-transgenic plants. Physiological analyses including relative leaf water content, electrolyte leakage, proline content, malondialdehyde (MDA) content, H 2O 2 content and sodium and potassium accumulation indicated that the OsDST-SRDX fusion gene enhanced salt tolerance in transgenic perennial ryegrass by altering a wide range of physiological responses. To our best knowledge this study is the first report of utilizing Chimeric Repressor gene-Silencing Technology (CRES-T) in turfgrass and forage species for salt-tolerance improvement. The area of saline land worldwide is nearly 1 billion hectares, and accounts for 10 percent of the total land area 1, 2. Salinity stress has become one of the major abiotic factors that severely affects plant growth. Perennial ryegrass ( Lolium perenne L.) is an important cool-season grass in temperate regions worldwide. It is widely cultivated as a turfgrass and forage with favorable agronomic traits, including rapid establishment rate, strong tiller ability, strong trample resistance, as well as high yield 3. However, the growth of perennial ryegrass as turfgrass is hampered by the aggravation of soil salinization and the shortage of water resources. Therefore, it is necessary to improve the salt tolerance of perennial ryegrass. However, perennial ryegrass is a cross-pollinated, self-infertile plant, resulting in slow progress in breeding new varieties with conventional strategies. In recent years, genetic engineering has been widely used in plant genetic improvement and has showed obvious advantages.
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