The Centers for Medicare and Medicaid Services shut down access to the Affordable Care Act marketplace to two health insurance agencies. Here's a look at what's happened.FREMONT, Calif.--(BUSINESS WIRE)--Dec 23, 2024-- Tivic Health® Systems, Inc. (Nasdaq: TIVC), a health tech company developing and commercializing bioelectronic medicine, today released its annual CEO letter to shareholders. Dear Fellow Shareholders: As we conclude 2024 and look forward to 2025, I’d like to take this opportunity to recap some of the important developments this year and share some of our expectations for 2025. Improvements in Commercial Business: Tivic’s Future is in Vagus Nerve Stimulation (VNS) While we continue to improve the performance of our commercial business, some of the most important news this year pertains to our focused entry into Vagus Nerve Stimulation (VNS). VNS has been steadily emerging as a transformative technology in medicine, mostly based on surgically implanted simulators. Polaris Research forecasts that the VNS market will be worth $21B in the next five years, growing at a CAGR of 10.6%. Implanted stimulators have been approved for—or are nearing approval for—treatment of depression, epilepsy, chronic stroke rehabilitation and rheumatoid arthritis in the US and additional conditions overseas. The companies behind these devices are driving both practitioner awareness and adoption and reimbursement pathways. Our strategy is to build on this momentum, focusing on achieving the same or better results using non-invasive stimulation approaches. Our non-invasive cervical approach to VNS (ncVNS) offers a less capital-intensive pathway to market while generating similar biological and clinically meaningful effects. In fact, our non-invasive VNS system has shown best-in-industry effects on outcomes like heart rate variability and achieved “comparable-to” or “better-than” results when compared to invasive implants. In May 2024, we completed a pilot study with Feinstein Institute of Bioelectronic Medicine and demonstrated that our ncVNS approach was able to drive clinically meaningful changes in brain, cardiac, and nervous system activity, consistent with vagus nerve engagement. We are now underway with our second collaborative study that is designed to further optimize ncVNS parameters and their impact on vagus nerve activation. This includes electrode positioning, frequency, and amplitude of stimulation. Results thus far have been positive, increasing confidence as we plan to move into clinical trials with the target populations of medical interest in 2025. These investments to tune the device specifications have both yielded meaningful improvements in efficacy markers and created new intellectual property (IP) that we are protecting on a global scale. The study has been fully enrolled and data from the study will be announced following study completion next year. In parallel with our clinical work, we have worked with seasoned advisors to aggressively evaluate the VNS landscape. This in-depth analysis has involved both primary and secondary research and uncovered targeted opportunities for our ncVNS approach exceeding $30B in annual market opportunity. Today, Tivic has a robust U.S. and international IP portfolio that includes a total of 16 issued patents and 10 pending patents spanning the U.S., Europe, India and China. We expect to continue to grow this base, for broad international protection of our innovations. We are confident that our investment in research and development, combined with a deep understanding of the regulatory processes, commercial drivers and medical needs, will serve us well as we transform Tivic to drive greater degrees of success. Equally as important, we are seeing positive trends in the industry as a whole. Industry awareness of VNS and the accompanying insurance coverage continues to improve. We expect that patient demand for these drug-free therapeutics, supported by appropriate financial access, will accelerate as information about VNS makes its way into mainstream media. VNS and bioelectronic medicine more broadly are expected to play a growing role in the future of healthcare. Looking back at 2024: Company Priorities for 2025 Looking at both the improvements in the base business and the advances we made with vagus nerve stimulation (VNS), we have a lot to be proud of in 2024. I am even more pleased we accomplished all of this while slashing our net operating loss by more than 30%. As we look to 2025, We anticipate that the advancement of our clinical programs for ncVNS will be key to increasing long-term shareholder value. In addition, the board and I continue to evaluate a range of options to maximize shareholder returns, including taking the necessary steps to ensure we regain Nasdaq listing compliance. I would like to recognize the exceptional efforts of the lean and dedicated Tivic Health team. I thank them for their relentless drive and hard work. Together, with our investors, collaborators, and supporters, we are striving to build a company that can transform the future of medicine and make a lasting, positive impact on the lives of people around the world. We are excited about the opportunities that lie ahead, and we look forward to continuing this journey with all of you in 2025. Sincerely, Jennifer Ernst Chief Executive Officer About Tivic Health Tivic Health is a commercial health tech company advancing the field of bioelectronic medicine. Tivic Health’s technology platforms leverage stimulation of the trigeminal, sympathetic, and vagus nerve structures. Tivic Health’s non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic Health’s first commercial product ClearUP TM is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP TM is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. For more information visit http://tivichealth.com @TivicHealth Forward-Looking Statements This press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumption that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading “Risk Factors”; as well as the company’s subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law. View source version on businesswire.com : https://www.businesswire.com/news/home/20241223565460/en/ CONTACT: Investor Contact: Hanover International, Inc. ir@tivichealth.com KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: HEALTH MEDICAL DEVICES BIOMETRICS NEUROLOGY HEALTH TECHNOLOGY CLINICAL TRIALS BIOTECHNOLOGY SOURCE: Tivic Health Systems, Inc. Copyright Business Wire 2024. PUB: 12/23/2024 04:54 PM/DISC: 12/23/2024 04:54 PM http://www.businesswire.com/news/home/20241223565460/en
MOUNTAIN VIEW, Calif. (AP) — MOUNTAIN VIEW, Calif. (AP) — Intuit Inc. (INTU) on Thursday reported fiscal first-quarter earnings of $197 million. On a per-share basis, the Mountain View, California-based company said it had net income of 70 cents. Earnings, adjusted for one-time gains and costs, were $2.50 per share. The results surpassed Wall Street expectations. The average estimate of nine analysts surveyed by Zacks Investment Research was for earnings of $2.36 per share. The maker of TurboTax, QuickBooks and other accounting software posted revenue of $3.28 billion in the period, which also topped Street forecasts. Eight analysts surveyed by Zacks expected $3.14 billion. For the current quarter ending in January, Intuit expects its per-share earnings to range from $2.55 to $2.61. The company said it expects revenue in the range of $3.81 billion to $3.85 billion for the fiscal second quarter. Intuit expects full-year earnings in the range of $19.16 to $19.36 per share, with revenue ranging from $18.16 billion to $18.35 billion. This story was generated by Automated Insights ( http://automatedinsights.com/ap ) using data from Zacks Investment Research. Access a Zacks stock report on INTU at https://www.zacks.com/ap/INTUAustrian far right sweeps victory in regional election
A massacre of more than 200 people in Haiti this month followed a gang-ordered manhunt that saw victims, many of them elderly, pulled from their homes and shot or killed with machetes, the UN said Monday. The victims were suspected of involvement in voodoo and accused by a gang leader of poisoning his child, with the suspects taken to a "training center" where many were dismembered or burned after being killed. A civil society organization had said at the time that the gang leader was convinced his son's illness was caused by followers of the religion. "On the evening of December 6, (Micanor Altes) ordered the members of his gang -- around 300 -- to carry out a brutal 'manhunt.' They stormed into about ten alleys of the (Port-au-Prince) neighborhood and forcibly dragged the victims out of their homes," said the report, authored jointly by the UN office in Haiti, BINUH, and the UN Human Rights Commissioner (OCHR). In the days that followed, the gang returned to the neighborhood, abducting adherents from a voodoo temple, targeting individuals suspected of tipping off local media and slaughtering people seeking to escape. Some of the bodies "were then burned with gasoline, or dismembered and dumped into the sea," the report concluded. A total of 134 men and 73 women were killed in total over six days, the report said. A mosaic of violent gangs control most of the Haitian capital Port-au-Prince. The impoverished Caribbean country has been mired for decades by political instability, made worse in recent years by gangs that have grown in strength and organizational sophistication. Despite a Kenyan-led police support mission, backed by the United States and UN, violence has continued to soar. "According to BINUH and OHCHR, since January 2024, more than 5,358 people have been killed and 2,155 injured," the report said. "This brings the total number of people killed or injured in Haiti to at least 17,248 since the beginning of 2022." The UN Security Council "strongly condemned the continued destabilizing criminal activities of armed gangs and stressed the need for the international community to redouble its efforts to provide humanitarian assistance to the population." A spokeswoman for UN Secretary-General Antonio Guterres said "these crimes touched the very foundation of Haitian society, targeting the most vulnerable populations." Voodoo was brought to Haiti by African slaves and is a mainstay of the country's culture. It was banned during French colonial rule and only recognized as an official religion by the Haitian government in 2003. While it incorporates elements of other religious beliefs, including Catholicism, voodoo has been historically attacked by other religions. gwBrie Larson Debuts Marvelously Dramatic Pixie Cut for New RoleMetaverse in Education Market Future Trends, Size, Share, Growth Factors, Industry Analysis, Advance Technology And Forecast - 2028
Maverick McNealy birdies last hole to finally win on PGA Tour. hen asked why he didn’t begin writing novels until his 30s, the celebrated Czech author Milan Kundera said he didn’t have the requisite experience when he was younger. “This jerk that I was, I wouldn’t like to see him,” he added. Many of us look back at our former selves and wince to recall our immaturity. We vary quite a lot in the degree to which we feel friendly toward, and connected to, both our former and our future selves. Psychologists call this trait self-continuity, and suggest that it carries enormous weight in determining our long-term well-being. In recent years, increasing research has shown that a sense of coherence between our past and present selves can bolster mental health and, particularly, . Our connection to our future selves, on the other hand, can sway on our future welfare, from to . Self-continuity, says Cornell University gerontologist Corinna Löckenhoff, who researches the trait, gives us “an understanding of where we came from and where we’re going. It gives us direction and purpose and identity.” The 19th-century psychologist William James compared human experience to being perched on a saddle “from which we look in two directions into time.” But modern researchers have found that the ability—or willingness—to look meaningfully in either direction varies from person to person, just like other psychological traits such as being extroverted or introverted. “Some people feel a great degree of overlap and continuity with their future selves, and some people don’t even think about that self, and it feels almost like a stranger,” says psychologist Hal Hershfield of the University of California, Los Angeles. Most studies of self-continuity look to the future, not the past. Researchers typically measure future self-continuity by asking people how similar they feel to an imagined future self. In a 2009 study of 164 people, for example, Hershfield and his team employed a series of Venn diagrams, with two circles overlapping to various degrees. Participants were asked to pick the circle pair best describing . People’s responses ranged from almost no overlap to almost complete overlap. The differences between people depend on a hodgepodge of factors, in addition to basic influences of nature and nurture. Studies have reported that , whose expected time horizons are shorter, tend to have a greater sense of self-continuity, as do members of , which, as some scholars speculate, tend to have a more holistic, connected world view. But researchers have found that people struggling with , tend to feel less connected to their future selves. The degree of coherence we feel with ourselves over time can support or sabotage us. People with a sturdier connection with their future selves may be more likely to pay for future benefits, and vice versa. The comedian Jerry Seinfeld illustrates the conflict in his riff about how Morning Guy always suffers for the carpe-diem antics of Night Guy: “You get up in the morning, your alarm, you’re exhausted and groggy,” he says. “Oh, I hate that Night Guy! See, Night Guy always screws Morning Guy. ...” The same tension is evident in the broader and more serious failure by many Americans to save for retirement. In a 2022 survey of more than 1,100 retirees, 70 percent said . Hershfield says this emerging crisis is what drew him to focus his research on self-continuity and its behavioral consequences. He and others have found that people with more self-continuity are more likely to engage in behaviors that deliver future benefits, including not only saving for retirement but also taking better care of their health in the present. People with stronger self-continuity are also more likely to behave ethically and responsibly, Hershfield’s research suggests. In a 2012 study, he and colleagues measured the self-continuity of 85 Northwestern University students, then followed up with a test to assess their ethical conduct. Only 50 percent of those who scored low in self-continuity showed up for the follow-up, they found, compared with 73 percent of those who scored high. What’s more, of the low scorers who did show up, 77 percent were willing to lie to an anonymous partner to earn more money when tested with a “ ,” while only 36 percent of the high scorers would do so. A stronger sense of connection with one’s future self may also push people toward environmentally responsible behavior. In a 2022 study, researchers recruited 175 undergraduate students at an unnamed United States public university, randomly assigning them into three groups: one that was encouraged to visualize themselves at age 60, and the others told to visualize themselves, or another person, at the present time. Afterward, all of the students played a game where they could take simulated fish from a pool. The students who focused on their future selves limited the number of fish they took each round , the experiment revealed, while those who focused on the present were more likely to quickly exhaust the pool. For more than a decade, scientists have searched for ways to manipulate self-continuity in study participants to try to get them to behave more prudently. They have reported success with a variety of approaches, including having people interact with a of themselves, sometimes with the help of . Most recently, a new program called developed at the Massachusetts Institute of Technology, offers young people a chance to chat with an online, AI-generated simulation of themselves at age 60. A recent found that users who interacted with their future selves reported “increased future self-continuity” and, perhaps as a consequence, significantly less anxiety, compared with those who did not. Future You is a high-tech version of a technique long practiced by high school teachers and counselors who encourage students to write letters to their future selves, as if writing to a pen pal. In a pilot study of high school students in Japan, social psychologist Anne E. Wilson, at Wilfrid Laurier University in Ontario, took the exercise one step further. She and her colleague Yuta Chishima instructed students who had written the letter to their future selves to respond to it as they imagined their future selves might. Writing a letter back from the future made the students feel , the researchers found. A month later, students who had written back from their future self’s perspective reported “more intensive career planning and a greater willingness to study hard at school even when temptations beckon,” compared with students who wrote only the single letter, . To be sure, there are times when a shorter horizon may be useful, researchers from the University of Southampton in the United Kingdom note in the 2023 . For example, too strong a sense of continuity with one’s past self might hamper efforts in the present to abandon “sunk costs”—investments already made in a doomed plan or project—they report. The same may apply to quitting a such as . “A bad past could be like an anchor for someone,” says Wilson. “Like, ‘If I’ve failed at this in the past, it means I’m going to fail at this in the future.’ “On the other hand,” adds Wilson, “a bad past could be something that we learn from and then figure out different strategies for the future, so we don’t keep making the same mistakes.” Perhaps like Milan Kundera, who so forcefully repudiated the man he was in his 20s, and died at 94 in 2023, after a long and celebrated writing career. Posted on is a journalist and author and co-author of 12 nonfiction books, including the ADHD family memoir, . Cutting-edge science, unraveled by the very brightest living thinkers.
MGX Deadline: Rosen Law Firm Urges Metagenomi, Inc. (NASDAQ: MGX) Stockholders with Large Losses to Contact the Firm for Information About Their RightsWASHINGTON — A powerful government panel on Monday failed to reach consensus on the possible national security risks of a nearly $15 billion proposed deal for Nippon Steel of Japan to purchase U.S. Steel, leaving a decision to President Joe Biden, a longtime opponent of the deal. The Committee on Foreign Investment in the United States, known as CFIUS, sent its long-awaited report on the merger to Biden, who formally came out against the deal in March of this year and now has 15 days to reach a final decision, the White House said. A U.S. official familiar with the matter, speaking on condition of anonymity to discuss the private report, said some federal agencies represented on the panel were skeptical that allowing a Japanese company to buy an American-owned steelmaker would create national security risks. Both Biden and President-elect Donald Trump courted unionized workers at U.S. Steel and vowed to block the acquisition amid concerns about foreign ownership of a flagship American company. The economic risk, however, is that Nippon Steel also has the financial resources to invest in the mills and upgrade them, possibly helping to preserve steel production within the United States. The interagency committee reviews such deals with an eye toward potential national security risks. Monday was the deadline to approve the deal, recommend that Biden block it or extend the review process. The Washington Post earlier reported CFIUS' submission of its report. Get the latest breaking news as it happens. By clicking Sign up, you agree to our privacy policy . Under the terms of the approximately $14.9 billion all-cash deal, U.S. Steel would keep its name and its headquarters in Pittsburgh, where it was founded in 1901 by J.P. Morgan and Andrew Carnegie. It would become a subsidiary of Nippon Steel, and the combined company would be among the top three steel-producing companies in the world, according to 2023 figures from the World Steel Association. Biden, backed by the United Steelworkers, said earlier this year that it was "vital for (U.S. Steel) to remain an American steel company that is domestically owned and operated.” Logo of Nippon Steel on the exterior of Blast Furnace No. 1 at the company's Kashima Plant in Kashima, Japan on Friday, Dec. 6, 2024. Credit: AP/Ayaka McGill Trump has also opposed the acquisition and vowed earlier this month on his Truth Social platform to “block this deal from happening.” Trump proposed to revive U.S. Steel's flagging fortunes “through a series of Tax Incentives and Tariffs.” The steelworkers union has said it doesn’t believe Nippon Steel would keep jobs at unionized plants, make good on collectively bargained benefits or protect American steel production from cheap foreign imports. “Our union has been calling for strict government scrutiny of the sale since it was announced. Now it’s up to President Biden to determine the best path forward,” David McCall, the steelworkers' president, said in a statement Monday. “We continue to believe that means keeping U.S. Steel domestically owned and operated.” In the face of political opposition, Nippon Steel and U.S. Steel had waged a public relations campaign to win over skeptics. A staff enters doorway next to Nippon Steel logo at the company's Kashima Plant in Kashima, Japan on Friday, Dec. 6, 2024. Credit: AP/Ayaka McGill U.S. Steel said in a statement Monday that the deal “is the best way, by far, to ensure that U.S. Steel, including its employees, communities, and customers, will thrive well into the future.” A growing number of conservatives had publicly backed the deal, as Nippon Steel began to win over some steelworkers union members and local officials around its blast furnaces in Pennsylvania and Indiana. Many backers said Nippon Steel has a stronger financial balance sheet than rival Cleveland-Cliffs to invest the necessary cash to upgrade aging U.S. Steel blast furnaces. Nippon Steel pledged to invest $2.7 billion in United Steelworkers-represented facilities, including U.S. Steel’s blast furnaces, and promised not to import steel slabs that would compete with the blast furnaces. It also pledged to protect U.S. Steel in trade matters and to not lay off employees or close plants during the term of the basic labor agreement. Earlier this month, it offered $5,000 in closing bonuses to U.S. Steel employees, a nearly $100 million expense. Nippon Steel also said it was best positioned to help American steel compete in an industry dominated by the Chinese. The proposed sale came during a tide of renewed political support for rebuilding America’s manufacturing sector, a presidential campaign in which Pennsylvania was a prime battleground, and a long stretch of protectionist U.S. tariffs that analysts say has helped reinvigorate domestic steel. Chaired by Treasury Secretary Janet Yellen, CFIUS screens business deals between U.S. firms and foreign investors and can block sales or force parties to change the terms of an agreement for the purpose of protecting national security. The committee’s powers were significantly expanded in 2018 through an act of Congress called the Foreign Investment Risk Review Modernization Act, known as FIRRMA. In September, Biden issued an executive order that expands the factors that the committee should consider when reviewing deals — such as how the deal impacts the U.S. supply chain or puts Americans’ sensitive personal data at risk. Nippon Steel already has manufacturing operations in the U.S., Mexico, China and Southeast Asia. It supplies the world’s top automakers, including Toyota Motor Corp., and makes steel for railways, pipes, appliances and skyscrapers.