
WARSAW, Ind. , Nov. 25, 2024 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) Premarket Approval Application (PMA) Supplement approval for the Oxford ® Cementless Partial Knee. The approval is based on safety and effectiveness data from an Investigational Device Exemption (IDE) study and non-clinical testing for cementless partial knee replacement (PKR). 1 The Oxford Cementless Partial Knee allows surgeons to perform a PKR with improved fixation, 2 better long-term implant survival rate 2,3 and improved efficiency in the operating room 4 (OR) compared to the Oxford Cemented Partial Knee procedure. Following more than 20 years of clinical experience and over 300,000 procedures across Canada , Europe , Middle East , Africa , and Asia , 5 the Oxford Cementless Partial Knee is now the only FDA-approved cementless partial knee implant in the U.S. "Cementless knee replacement procedures are increasingly preferred by surgeons seeking to improve surgical efficiency. The Oxford Cementless Partial Knee is coming into the U.S. with a proven track record of retaining more healthy anatomy with a less invasive approach and improved outcomes 6 as compared to a total knee replacement," said Joe Urban , President, Knees at Zimmer Biomet. "We are excited to address the unmet U.S. demand for a cementless partial knee with a new offering which has 20 years of clinical experience in more than 50 countries. 5 " Compared to traditional partial knee replacements that use bone cement to secure the implant in place, a cementless approach allows patients' natural bone growth to secure the implant for better long-term fixation. 2 The Oxford Cementless Partial Knee features a mobile bearing that can move with the femoral component throughout the entire range of motion to mimic natural knee movement. This design provides better range of motion, a more natural feel and a more stable implant-to-bone fixation for improved long-term implant survival. 2,3 The system's tibial and femoral components have a titanium and hydroxyapatite coating to promote bone growth into the implant 7 . The UK national joint registry has more than 33,000 patients treated with Oxford Cementless Partial Knees recorded with a 94.1% rate of implant survival at 10 years after surgery, 3 which is higher than the average 10-year survivorship for all other partial knees (89.9%). 3 Enthusiasm and usage of partial knee replacement continues to grow around the world as published research continues to demonstrate that PKR in appropriate cases provides improved patient outcomes compared to TKR. 6 "For younger and more active patients, the Oxford Cementless Partial Knee amplifies the benefits of a traditional partial knee replacement by offering knee flexion that resembles natural knee movement, and stronger adhesion of the implant to the bone for better long-term durability," said Adolph V. Lombardi Jr. , MD, FACS, President of JIS Orthopedics in New Albany, Ohio . "In my own practice, a cementless approach has increased OR efficiency by shortening my surgery time and reducing costs associated with cement preparation." Since its initial launch in England in 2004, the Oxford Cementless Partial Knee has become the preferred partial knee implant for Zimmer Biomet's European customers. 5 As part of the U.S. nationwide launch in Q1 2025, Zimmer Biomet will provide FDA-required training, focusing on the cementless surgical technique and proper patient selection. For patients in the U.S., the Oxford Partial Knee is the only implant with a lifetime limited warranty that covers the cost of Zimmer Biomet replacement implants.* Important Safety Information: The Cementless Oxford Partial Knee System is intended for use in unilateral knee procedures with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. It is intended to be implanted without the application of cement for patients whose clinical condition would benefit from a shorter surgical time compared to the cemented implant. The Oxford Partial Knee is not indicated for use in the lateral compartment or for patients with ligament deficiency, or for use in simultaneous bilateral surgery or planned staged bilateral procedures. Potential risks include, but are not limited to, loosening, dislocation, fracture, wear and infection, any of which can require additional surgery. For a full list of product indications, contraindications and warnings, as well as further information on product IDE data, please see the associated product Information for Use (IFU) and Surgical Technique available at https://labeling.zimmerbiomet.com/ For more information about the Oxford Cementless Partial Knee, visit www.zimmerbiomet.com/oxfordcementless . About Zimmer Biomet Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. We seamlessly transform the patient experience through our innovative products and suite of integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence. With 90+ years of trusted leadership and proven expertise, Zimmer Biomet is positioned to deliver the highest quality solutions to patients and providers. Our legacy continues to come to life today through our progressive culture of evolution and innovation. For more information about our product portfolio, our operations in 25+ countries and sales in 100+ countries or about joining our team, visit www.zimmerbiomet.com or follow on LinkedIn at www.linkedin.com/company/zimmerbiomet or X / Twitter at www.twitter.com/zimmerbiomet . Cautionary Statement Regarding Forward-Looking Statements This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet's expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see Zimmer Biomet's periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet's filings with the SEC. Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release. *Subject to terms and conditions set forth within the written warranty References: Media Heather Zoumas-Lubeski 445-248-0577 heather.zoumaslubeski@zimmerbiomet.com Kirsten Fallon 781-779-5561 kirsten.fallon@zimmerbiomet.com Investors David DeMartino 646-531-6115 david.demartino@zimmerbiomet.com Zach Weiner 908-591-6955 Zach.weiner@zimmerbiomet.com View original content to download multimedia: https://www.prnewswire.com/news-releases/zimmer-biomet-receives-fda-approval-for-oxford-cementless-partial-knee-only-cementless-partial-knee-replacement-implant-in-the-us-302315755.html SOURCE Zimmer Biomet Holdings, Inc.
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SAIC Board of Directors Declares Cash DividendBOISE — Armando Gonzalez knows it sounds crazy. But winning state championships has never been the No. 1 goal of his program. Yet, the Rigby head coach just racked up his fourth state title in just his eighth season at the helm following a 41-21 win over Eagle Saturday in the Class 6A State Final at Albertsons Stadium. "We take care of our conference, beating our rival Madison and winning in the playoffs in the first round. And once we do that, I tell the kids, 'We're playing with house money. We're at the roulette table with house money and let's just go have fun and see if we're good enough,'" Gonzalez told the Post Register. "They don't have to look at the scoreboard and they can just enjoy the moment. It's like their playing sixth-grade football again. That's what we've bought into and that's why we've been succesful over the last six, seven years." The Trojans (11-1) have now equaled rival Highland for the most succesful run in Class 6A history. They join the Rams as the only team in classification history to win four state titles in six years. Highland did it from 1997 to 2002. Rigby hadn't won a single state championship prior to Gonzalez's arrival from Southern California in 2017. “It’s never been about state championships,” said Gonzalez, who also hoisted up the trophy in 2019, 21, 22. “Randy Waite, the previous coach, did an excellent job elevating the level of play and commitment level of these kids, so that they knew what it took to play consistently at a high level against good quality teams.” Led by the dynamic running back duo of Jerzey Duenes and Amani Morel, the Trojans did so again Saturday night against Eagle. Just a week earlier, the Mustangs had stunned Coeur d'Alene, which handed Rigby its only loss (24-14) in the season opener all the way back on Aug. 23. But thanks to a ground attack that racked up 335 of their 425 yards of total offense, the Trojans avoided the upset themselves. They piled up 107 rushing yards alone in a fourth quarter that began with a weather delay and them down 21-20. The Mustangs had just taken the lead on a 1-yard touchdown run by Noah Burnham, who finished the game with 140 yards on the ground, with 20 seconds remaining in the third quarter. With lightning in the area, both teams were sent to the locker room, though. A 35-minute delay ensued before play was resumed. And when it did, Rigby took command. Just three plays after the delay ended, Parker Graham hauled in a 25-yard touchdown pass from Jacob Flowers as the Trojans regained the lead for good at 28-21 with 11 minutes and 23 seconds remaining. But just to be sure, Morel scored on a 30-yard run with 6:20 to go. Duenes then put the final nail in the coffin with a 20-yard touchdown run with just a little more than a minute left in regulation. “Right after warm up, we hit it with the tempo,” Duenes said. “As fast as we can go. As we talked about in there, Coach G (Gonzalez) said we are built for this.” Duenes led the way with 190 yards and the score. Morel, who transferred in from nearby Skyline where he was a first-team all-state running back a year ago, had 116 and a pair of touchdowns, including a 3-yard run at the beginning of the second quarter to give Rigby a 20-14 lead. “The longer this game went, the more it was going to tilt in our favor,” Gonzalez said. “This is what we do all year long. These kids work so hard to get us to this point. No one has any idea what goes on behind the scenes. They just see all the state championship appearances and trophies.” The Trojans jumped out to a 13-0 lead midway through the first quarter. They scored on the game's opening drive of the game after Flowers hit Kasyn Thomas in the back of the endzone for a 4-yard touchdown pass. Tayden Outhenthapanya followed that up by blocking an Eagle punt and Quinn Bennett scooped it up for a 5-yard touchdown return to give Rigby a double-digit lead less than seven minutes into the game. But the Mustangs (9-3) responded with a 21-7 run that gave them the lead not once, but twice. Austin Ramsey dropped a 27-yard dime to Gavin Crawford at the 5:02 mark of the second quarter before Aaron Zrno popped off for a 92-yard kickoff return to give them their first lead of the game at 14-13 on the opening play of the second half. However, the Trojans outscored them 28-7 the rest of the way, including a 21-0 fourth-quarter run that left no doubt on who the best team in the state was this year − state championship aspirations or not. "Coach G makes sure there's a brotherhood and then we all love each other," Duenes said. "We do it for each other. "It's always for those boys out there."
WILMINGTON, N.C. (AP) — WILMINGTON, N.C. (AP) — NCino, Inc. (NCNO) on Wednesday reported a loss of $5.3 million in its fiscal third quarter. The Wilmington, North Carolina-based company said it had a loss of 5 cents per share. Earnings, adjusted for stock option expense and amortization costs, were 21 cents per share. Javascript is required for you to be able to read premium content. Please enable it in your browser settings.
WILMINGTON, N.C. (AP) — WILMINGTON, N.C. (AP) — NCino, Inc. (NCNO) on Wednesday reported a loss of $5.3 million in its fiscal third quarter. The Wilmington, North Carolina-based company said it had a loss of 5 cents per share. Earnings, adjusted for stock option expense and amortization costs, were 21 cents per share. The results surpassed Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for earnings of 16 cents per share. The company posted revenue of $138.8 million in the period, which also beat Street forecasts. Five analysts surveyed by Zacks expected $137.1 million. For the current quarter ending in January, nCino expects its per-share earnings to range from 18 cents to 19 cents. The company said it expects revenue in the range of $139.5 million to $141.5 million for the fiscal fourth quarter. NCino expects full-year earnings in the range of 75 cents to 76 cents per share, with revenue ranging from $539 million to $541 million. This story was generated by Automated Insights ( http://automatedinsights.com/ap ) using data from Zacks Investment Research. Access a Zacks stock report on NCNO at https://www.zacks.com/ap/NCNODoucette: Ice fishing unsafe, not a good idea until the new year
( MENAFN - EIN Presswire) Fusion Frequencies at Miami Paramount World Center FilmGate Miami and WideWorlds joined forces during Miami Art Week to present Fusion Frequencies on the iconic LED screen at the Miami Paramount World Center. Jen Gordon FilmGate Miami +1 850-841-9020 email us here Visit us on social media: Facebook X LinkedIn Instagram YouTube Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above. MENAFN13122024003118003196ID1108991954 Legal Disclaimer: MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.Pie crimes and misdemeanors: Thieves nab $30,000 worth of pies from Michelin-star chef
Congressional bicameral team pushes for insurance, pharmaceutical reform
Woman who falsely accused Duke lacrosse players of rape in 2006 publicly admits she lied(The Center Square) – Legislators in Washington, D.C., have taken a number of steps over the past few days to push for insurance and pharmaceutical reforms to be passed before the end of the year. On Wednesday, a bicameral group of Republican and Democrat lawmakers held a press conference discussing the need for pharmacy benefit manager reform to protect small pharmacies across the country and “save lives.” “Whether you are a Republican, Democrat, or an independent, we all want the same thing. We want accessible, affordable, quality health care,” said Rep. Buddy Carter, R-Ga. “We’re not here today to just discuss one bill or to discuss just one patient’s story. We're here because there's broad, bipartisan pharmacy benefit manager, or PBM, reform that is needed to save lives.” Pharmacy benefit managers are the middlemen responsible for managing the drug prices covered by health insurance plans. According to the Harvard Political Review , the problem with pharmacy benefit managers is that they “have vertically integrated with pharmacy chains and health insurers through massive conglomerates.” That then allows them to abuse their power to cut out small pharmacies and increase prices. Carter also signed a letter that was released last week calling on the Department of Justice to dig into the role pharmacy benefit managers played in the opioid epidemic. Reps. Raja Krishnamoorthi, D-Ill., Deborah Ross, D-N.C., and Cliff Benz, R-Ore., all joined him in signing that letter. “The opioid crisis has devastated communities in North Carolina and across the country, and PBMs may have fueled it by prioritizing profits over people,” Ross said on social media . “That’s why I joined a letter calling on the DOJ to investigate their role and hold these bad actors accountable.” The letter looked at recent reports on the largest pharmacy benefit managers, CVS Caremark, Express Scripts, and OptumRx which state that they “colluded and conspired to steer patients towards OxyContin in exchange for $400 million.” OxyContin is a trade name for the narcotic oxycodone hydrochloride, a painkiller available by prescription only. This and the general “lack of transparency” is just one of the many complaints that legislators aired on Wednesday. “My colleagues who are joining me today, Democrats and Republicans ... all recognize that PBMs are decreasing the accessibility, the affordability, and therefore the quality of health care in America,” Carter said. “We have an opportunity, right now, to advance bipartisan legislation that increases reporting requirements, which would heighten transparency and shine a light on the opaque practices of these PBMs.” Carter was also joined by Sen. James Lankford, R-Okla., who is leading the effort to get legislation passed in the U.S. Senate. “This year, we're losing about one pharmacy a day in America,” Lankford said. “We want leadership to be able to take this up and to bring it up in the end-of-year package ... Stop holding up legislation that is bipartisan, bicameral, and solving a problem that Americans need solved.”
Wolves head coach Gary O’Neil insists he is happy to look fans in the face and take the criticism which comes his way after his team were jeered off after losing 4-0 to Everton at Goodison Park. It was the fourth time this season they had conceded four or more and the performance showed why they have the Premier League’s worst defence. When O’Neil and the players went over to acknowledge the visiting supporters there were boos for a run of two wins in 14 league matches. “Whatever the fans think of me, there is definitely no-none working harder than me and I will continue to do so until someone tells me not to,” said O’Neil, who is under increasing pressure with his side second bottom of the table. “I go over there to see them because I appreciate every one of the Wolves fans. They have given me unbelievable support since I arrived at the football club,” he said. “We managed to produce some unbelievable stuff last season with a team that was heavily tipped by most of the nation for relegation. We managed to enjoy it together. “Now it is tough. I was happy to go over there and look them right in the face and take any criticism they want to throw at me. “I accept responsibility for my part in that. Whatever criticism they want to throw at me will not change how I feel about them. “Everyone at this football club needs to do more. We will get back to be ready to fight again on Monday (another crucial game against West Ham, whose manager Julen Lopetegui’s tenure is hanging by a thread). “I will work with everything I have. I will back myself to get the most out of the group. I understand the drive for change (but) you never know how much of a percentage of supporters it is.” Veteran Ashley Young ended Everton’s 370-minute wait for a goal with a 10th-minute free-kick, his first league goal for more than two years, and on-loan Lyon midfielder Orel Mangala blasted home his first for the club to establish a 2-0 half-time lead. Two Craig Dawson own goals secured Everton’s biggest home league win since April 2019, but manager Sean Dyche insisted their issues up front were far from sorted. He said: “It’s our fifth clean sheet in the last eight so the consistency has been there in one degree, we just haven’t been scoring goals. That’s been the hardest thing to find consistently and we haven’t solved it yet. “Goals change everything, they change opinions. That’s what football is like.” The victory was hugely important in a month in which, having been hammered 4-0 at Manchester United, they face top-six sides Liverpool, Arsenal, Chelsea, Manchester City and Nottingham Forest and undoubtedly eased some of the pressure on Dyche and his players. “I’ve told them how proud I am of them,” he added. “The challenges come thick and fast on and off the pitch and they just keep going. “It’s only a step and there are many more to go but it’s a good step and a positive step. “It’s a temporary moment in time because the next one is a big one (Saturday’s Merseyside derby).”Cowboys G Zack Martin, CB Trevon Diggs out vs. CommandersYour Secret Weapon This Holiday Shopping Season Could Be... ChatGPT?
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