
Stereotaxis Announces First GenesisX Robotic System Order
'We are thrilled to announce the first firm order for GenesisX from a pioneering European hospital,' said David Fischel, Stereotaxis Chairman and CEO. 'Establishing the first GenesisX robotic lab is a critical milestone for us as we advance towards full commercial launch. We look forward to demonstrating the performance and reliability of GenesisX in the demanding clinical environment. GenesisX promises to transform the accessibility of Robotic Magnetic Navigation and is central to our mission of driving broad robotic adoption throughout endovascular surgery.'
GenesisX is the latest advance in endovascular surgical robotics, building upon the established benefits of Robotic Magnetic Navigation while significantly enhancing the accessibility of the technology for healthcare providers. GenesisX utilizes smaller magnets and incorporates magnetic shielding into its structure in place of the shielding otherwise installed in the walls of the operating room. It requires no structural anchoring through the floor and operates using standard 120/230V power outlets. A single fiber is routed from each robot to the system cabinet, which is 80% smaller than previous cabinets and can fit under a table in the operating room. GenesisX is smaller and lighter than any previous generation system, while maintaining the highest standards in speed, responsiveness, and efficient workflow.
GenesisX obtained CE Mark in Europe in 2024 and has been submitted to the FDA for 510(k) clearance in the United States. During 2025, Stereotaxis plans to gain regulatory approvals in Europe and the US for a portfolio of compatible EP and vascular catheters, demonstrate real-world use of GenesisX, enhance compatibility of GenesisX with various x-rays, and prepare supply chain, manufacturing, installation and commercial processes for a full launch.
About Stereotaxis
Stereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com
This press release includes statements that may constitute 'forward-looking' statements, usually containing the words 'believe', 'estimate', 'project', 'expect' or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company's ability to manage expenses at sustainable levels, acceptance of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, statements relating to our recent acquisition of APT, including any benefits expected from the acquisition, and other risks discussed in the Company's periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company's control and may be revised, modified, delayed, or canceled.
David L. Fischel
Kimberly Peery
Chief Financial Officer
314-678-6100
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Business Wire
12 minutes ago
- Business Wire
Essential Properties Realty Trust, Inc. Announces Pricing of $400 Million of 5.400% Senior Notes due 2035
PRINCETON, N.J.--(BUSINESS WIRE)--Essential Properties Realty Trust, Inc. (NYSE: EPRT; the 'Company') announced today that its operating partnership, Essential Properties, L.P. (the 'Operating Partnership'), has priced a public offering of $400 million aggregate principal amount of 5.400% Senior Notes due 2035 (the 'Notes'). The Notes were priced at 98.317% of the principal amount and will mature on December 1, 2035. The offering is expected to settle on August 21, 2025, subject to the satisfaction of customary closing conditions. The Notes will be fully and unconditionally guaranteed by the Company. The Operating Partnership intends to use the net proceeds from the offering (i) to repay amounts outstanding under its revolving credit facility and (ii) for general corporate purposes, including funding future investment activity. Wells Fargo Securities, Mizuho, BMO Capital Markets, BofA Securities, Capital One Securities, TD Securities and Truist Securities are acting as joint book-running managers for the offering. Barclays, BNP PARIBAS, Citigroup, Citizens Capital Markets, Goldman Sachs & Co. LLC, Huntington Capital Markets, Morgan Stanley, Regions Securities LLC, Scotiabank, Stifel and Wolfe Capital Markets and Advisory are acting as co-managers for the offering. The offering is being made pursuant to an effective shelf registration statement filed by the Company and the Operating Partnership with the Securities and Exchange Commission (the 'SEC'). A prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC. When available, a copy of the prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Wells Fargo Securities, LLC, 608 2nd Avenue South, Suite 1000, Minneapolis, MN 55402, Attention: WFS Customer Service, toll-free at 1-800-645-3751; or Mizuho Securities USA LLC, Attention: Debt Capital Markets, 1271 Avenue of the Americas, New York, NY 10020, at 1-866-271-7403, or by visiting the EDGAR database on the SEC's web site at This press release does not constitute an offer to sell or the solicitation of an offer to buy nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the federal securities laws. When used in this press release, the words 'expect' and 'will,' or the negative of these words, or similar words or phrases that are predictions of or indicate future events and that do not relate solely to historical matters, are intended to identify forward-looking statements. You can also identify forward-looking statements by discussions regarding strategy, plans or intentions. Forward-looking statements involve numerous risks and uncertainties and you should not rely on them as predictions of future events. Forward-looking statements depend on assumptions, data or methods that may be incorrect or imprecise. The Company does not guarantee that the transactions and events described will happen as described (or that they will happen at all). You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this press release. While forward-looking statements reflect the Company's good faith beliefs, they are not guarantees of future performance. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law. In light of these risks and uncertainties, the forward-looking events discussed in this press release might not occur as described, or at all. Additional information concerning factors that could cause actual results to differ materially from these forward-looking statements is contained from time to time in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent Quarterly Reports on Form 10-Q. Copies of each filing may be obtained from the Company or the SEC. Such forward-looking statements should be regarded solely as reflections of the Company's current plans and estimates. Actual results may differ materially from what is expressed or forecast in this press release. About Essential Properties Realty Trust, Inc. Essential Properties Realty Trust, Inc. is an internally managed real estate investment trust that acquires, owns and manages primarily single-tenant properties that are net leased on a long-term basis to companies operating service-oriented or experience-based businesses. As of June 30, 2025, the Company's portfolio consisted of 2,190 freestanding net lease properties with a weighted average lease term of 14.3 years and a weighted average rent coverage ratio of 3.4x. In addition, as of June 30, 2025, the Company's portfolio was 99.6% leased to tenants operating 606 different concepts across 48 states.


NBC News
13 minutes ago
- NBC News
Time is running out for kids with a rare disease, parents say, unless the FDA acts
Gilbert Dryden probably only has enough medication to get him through the end of October, his mother, Madison, figures. Seven-month-old Gilbert has a rare genetic condition called Barth syndrome, one that can have dire consequences, like heart failure, extreme muscle weakness and a dramatically reduced life expectancy. Children who die early often don't see their fifth birthday. Two infant deaths were reported within the past week, according to the Barth Syndrome Foundation. What's been keeping Gilbert alive and functioning relatively well, according to his family, is an experimental drug called elamipretide, made by Stealth BioTherapeutics. Small studies have suggested it's safe and effective in treating the ultra-rare illness. Just 150 people in the U.S. have the condition. 'Our kids are dying. We have seen that this drug works,' said Kate McCurdy, a co-founder of the Barth Syndrome Foundation. 'This drug totally saves the lives of babies.' After a more than decade-long process to bring the drug to market, the treatment's approval has repeatedly hit roadblocks with the Food and Drug Administration. One setback occurred in the spring, when an FDA inspection found problems at a Stealth manufacturing facility. The problems weren't made public, but apparently weren't egregious enough to warrant regulatory action. The company said the issues have been resolved. In late May, after an advisory panel voted earlier (in October 2024) to recommend the therapy, the FDA declined to approve it. The agency didn't reveal why. An ultra-rare disease like Barth syndrome with an ultra-small population of patients who can be tested for clinical efficacy faces barriers for FDA drug approval. There aren't enough patients to do robust, randomized clinical trials, McCurdy said. 'It is virtually impossible to conduct trials that yield data that are conclusive beyond a reasonable doubt. Statistically, you just can't do that,' she said. Weeks later and following a meeting between Needham, Massachusetts-based Stealth and the FDA in late June, the real bombshell came: The company said the agency informed Stealth on Aug. 4 that it would need to resubmit a new drug application — for the third time. It could use a special pathway called 'accelerated approval' in that submission, but the manufacturing issue would extend the timeline to review elamipretide for at least another six months, according to the company. Stealth said that no additional clinical data or safety data was requested. But without any course correction in the process, the private company could run out of money. The delay is devastating to families like the Drydens. 'When we heard this news, we immediately went to the fridge to count how many vials we have left, because that's how long we have this medication. That's the only guarantee we have right now that Gilbert is not going to die,' said Madison Dryden, 35, of Aurora, Colorado. 'It's the highest level of desperation.' On Monday, Stealth announced that it did submit its third application for approval of elamipretide — asking for an accelerated pathway under a significantly tighter timeline than what the agency initially recommended. What is Barth syndrome? Madison Dryden and her husband, Andrew, weren't sure what was wrong with Gilbert in the hours and days after his Christmas Eve birth in 2024. 'His heart function was so low. He was so sick, his body and his feet were purple, his hands were purple,' Dryden said. 'He couldn't eat.' Gilbert was admitted to the neonatal intensive care unit and received lifesaving care as doctors urgently tried to figure out a diagnosis. Within a matter of days, Dryden said, Gilbert was airlifted to Children's Hospital Colorado with a heart that was struggling to adequately pump blood. The underlying cause was soon revealed: Barth syndrome. The disease impairs cells' mitochondria, which are kind of like tiny batteries that generate energy for cells to function correctly. The chromosomal disorder almost exclusively affects boys. Roughly 85% of early deaths occur before age 5. Those who survive longer are usually given heart medications and may need a heart transplant. Kids with Barth syndrome often rely on drugs like beta blockers and ACE inhibitors to keep their hearts functioning as well as possible. Gilbert was fortunate, at least initially. He found a lifeline through access to the treatment from Stealth. Elamipretide, a daily injection, works by helping to repair the damaged mitochondria. In clinical trials, like the one the Drydens participated in, patients showed a 45% improvement in muscle strength and a 40% improvement in heart function, according to the drugmaker. Most participants have safely remained on the drug for over eight years. In October 2024, an advisory committee to the FDA voted 10-6 in support of the therapy, paving the way for the agency to clear the first drug to treat Barth syndrome. The FDA isn't required to follow the advisory committee's guidance, but it almost always does. A spokesman for the Department of Health and Human Services, which oversees the FDA, wrote in an email that the 'FDA did carefully consider the advice of the advisory committee members, including their rationale for their vote. While there is often a high rate of agreement between FDA and advisory committee recommendations,' the spokesman said, 'there is not always concordance.' 'Compelling medical need' for approval After the advisory committee's recommendation, the FDA's rejection was unexpected. 'It is a small sample size,' said a former FDA official who was involved in the drug approval process. The person asked not to be identified in order to speak freely. But the former official was quick to point out that given the advisory committee recommendation for approval, the 'incredibly compelling medical need' of those living with Barth syndrome and the small sample of individuals who seemed to have benefited from the treatment, it certainly appeared that elamipretide was going to make it across the finish line. A lack of continuity in leadership, however, may have added to the already difficult challenge of guiding the treatment through the final hurdles, the former official said. The FDA has seen many top officials leave the agency in recent months. 'Those who have taken over are not as familiar, or perhaps it'd be more appropriate to say they're inexperienced with how one does drug approvals, how one drives things forward, and they're also somewhat fearful of the current environment,' the former official said. 'And I think that's led to an adverse outcome for some of these rare disease products.' The HHS spokesperson didn't immediately respond to a request Monday for comment about the agency's rejection of the drug or leadership issues. A Wall Street Journal Op-Ed recently offered a scathing evaluation of what's happening at the FDA, questioning whether the agency and Commissioner Marty Makary's stated goal of accelerating lifesaving drugs is matching the reality of their actions. The Journal said that there were averages of 52 annual drug approvals under the first Trump administration and 48 under President Joe Biden, but 'there have been only 22 in the first seven months of this year,' projecting to just 38 for the year. Elamipretide was cited in the Journal piece as a casualty of the current environment. The former FDA official pointed out that the treatment hit stumbling blocks under the previous administration, as well, but it was headed in the right direction. 'Now it feels like a hot potato that's been just thrown around,' the former official said. 'And this is just not right. It's just not right.' Families left with few alternatives The Drydens say the FDA decision pulled the rug out from underneath them — and many other families. Dr. Kathryn Chatfield, Gilbert's doctor and a specialist in pediatric cardiology and genetics at Children's Hospital Colorado, said the FDA's inaction leaves families with few alternatives. 'We just don't know what's going to happen,' Chatfield said. 'We're going to have to watch them really closely because they're at risk for recurrence of heart failure and rehospitalization and potentially decompensation to the point where they have to live in the hospital until they could get a heart transplant.' A transplant addresses the heart problem but doesn't alleviate ongoing muscular and skeletal problems. 'I can't be OK with sacrificing my child's life for a bureaucratic process,' Madison Dryden said. The latest hurdle to approval has Barth syndrome families and advocates alike, including some members of Congress, looking for more information and answers. 'Time is of the essence here, and we need to get these drugs to these patients as soon as possible,' said Rep. Buddy Carter, R-Ga., a member of the Energy and Commerce subcommittee on health. Carter spoke to NBC News days before the FDA requested a resubmission in early August and said he'd sent a letter to the agency asking for 'clarity' on elamipretide. 'There aren't that many options out there,' he said. 'In fact, for Barth Syndrome, this elamipretide is really the only drug that we know of that works.' Carter said that there are six families in Georgia alone he's been in contact with who have a loved one with the rare disease. He's hopeful that an 'accelerated pathway' request might prove a viable option for the families and for the company to continue its research. After the recent FDA decision, Carter told NBC News in a statement that he's 'disappointed' with the recommendation 'now that all issues appear to be resolved.' Carter said he's continuing to put pressure on the FDA and that 'patients will suffer with further delays.' He also acknowledged that the economics of a private company, like Stealth, attempting to continue developing a drug for such a small population of patients would be exceedingly difficult without FDA backing. He said he feels deeply for the families in the middle of a terrifying ordeal. 'I'd be calling everybody I could (too), making sure that my child or my grandchild had this medication,' he said in an interview. Madison Dryden and her husband are left with what they call a 'giant unknown' in the absence of approval, struggling for an explanation for their 7- and 3-year-old daughters as families are in a race against time to keep loved ones alive. 'They know that somebody is not giving permission for Gilbert to have his medicine, and that they keep saying no, and they're our kids — like they can't lose … we can't have them lose their baby brother to this,' she said.
Yahoo
20 minutes ago
- Yahoo
Home Depot Q2 Preview: Housing, Tariffs, and Rates in Focus
Home Depot (NYSE:HD) will report second-quarter results before the market opens on Tuesday, August 19, 2025. Wall Street expects EPS of $4.72 on revenue of $45.4 billion, both up modestly YoY. Shares are flat year to date but have gained more than 10% in the past month as investors bet that lower interest rates could spark renewed DIY demand. Investors often look to Home Depot as a proxy for the health of U.S. housing and remodeling activity, so management's tone on consumer behavior will be watched closely. After an on-and-off period of tariffs, they appear to be here to stay (at least for now), making commentary on whether shoppers pulled forward their purchases ahead of higher costs important. Investors will also want to hear management's view on how this demand could evolve through the rest of the year In Q1 FY25, company comps fell 0.3% while U.S. comps rose 0.2%, underscoring weakness in DIY against steadier Pro demand. Any stabilization in big-ticket categories could be viewed positively, especially if expected Fed rate cuts later this year provide support. However, after hitting record highs, home price appreciation has slowed, with some regions now seeing declines. According to more sellers are cutting asking prices in an attempt to attract buyers, whichcould weigh on homeowners' willingness to invest in upgrades. Margins will also be watched closely as wage inflation, shrink, and product mix offset gradual inventory normalization. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data