We expect to address these topics further in connection with our upcoming first quarter fiscal 2023 earnings call." Concurrently, we will be evaluating options to reduce our use of cash given this development. Based on our discussion with the Agency, our team and external advisors will determine the appropriate path forward. "We are evaluating the issues raised in the FDA's letter and plan to meet with Agency representatives regarding its contents. "We are disappointed by the FDA's response to our PMA application and continue to have confidence in our SurVeil DCB including its compelling performance in the TRANSCEND clinical study," said Gary Maharaj, Chief Executive Officer of Surmodics, Inc. 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 (FDA the Agency) related to its premarket approval (PMA) application for the SurVeil™ drug-coated balloon (DCB). SRDX, a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced it has received a letter from the U.S. To read this article on click here.Surmodics, Inc.
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Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. HRC stands above SRDX thanks to its solid earnings outlook, and based on these valuation figures, we also feel that HRC is the superior value option right now. By comparison, SRDX has a P/B of 5.37.īased on these metrics and many more, HRC holds a Value grade of B, while SRDX has a Value grade of C. The P/B is a method of comparing a stock's market value to its book value, which is defined as total assets minus total liabilities. SRDX currently has a PEG ratio of 24.78.Īnother notable valuation metric for HRC is its P/B ratio of 4.77. This popular figure is similar to the widely-used P/E ratio, but the PEG ratio also considers a company's expected EPS growth rate. We also note that HRC has a PEG ratio of 2.57. HRC currently has a forward P/E ratio of 21.63, while SRDX has a forward P/E of 247.77. Our Value category highlights undervalued companies by looking at a variety of key metrics, including the popular P/E ratio, as well as the P/S ratio, earnings yield, cash flow per share, and a variety of other fundamentals that have been used by value investors for years. Value investors also tend to look at a number of traditional, tried-and-true figures to help them find stocks that they believe are undervalued at their current share price levels. But this is only part of the picture for value investors. Investors should feel comfortable knowing that HRC likely has seen a stronger improvement to its earnings outlook than SRDX has recently. Right now, Hill-Rom is sporting a Zacks Rank of #2 (Buy), while SurModics has a Zacks Rank of #4 (Sell). The proven Zacks Rank emphasizes companies with positive estimate revision trends, and our Style Scores highlight stocks with specific traits. There are plenty of strategies for discovering value stocks, but we have found that pairing a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system produces the best returns. But which of these two stocks offers value investors a better bang for their buck right now? We'll need to take a closer look. Investors with an interest in Medical - Products stocks have likely encountered both Hill-Rom (HRC) and SurModics (SRDX).
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