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For the first time in more than 40 years, a new hormone-free intrauterine device (IUD) is coming to market in the U.S.and its designed with patients comfort in mind, both during the insertion process and once its in place. The new IUD, called Miudella, comes from the pharmaceutical company Sebela Womens Health Inc. It was approved by the Federal Drug Administration (FDA) in late February, and is the second hormone-free IUD to be approved since 1984, when the copper-based option Paragard first became available. With the addition of Miudella, there will now be six IUD options available in the U.S. Not only does this advancement provide patients seeking a hormone-free IUD with more than one option, it also marks a potentially major improvement in IUD design. By reducing insertion pain and post-insertion bleeding and cramping, Miudella is addressing two potential side effects of IUD placement that many women feel have long been overlooked. A new option in an ultra-limited market According to Kelly Culwell, a board-certified OB-GYN and head of research and development at Sebela Womens Health, bringing an IUD to market, especially in the U.S., is a very expensive and time consuming proposition. Because of those barriers, she says, many pharma companies simply choose not to invest as much in studying womens health. There really isnt a generic IUD, and the reason for that is its a very time-intensive and cost-prohibitive development process, especially for companies that arent really putting a lot of money or time or effort into womens health development, Culwell explains. A lot of the bigger pharma companies are focusing on things that could bring in a lot more money; things like oncology or neurologyso there just hasn’t been a lot of innovation [in womens health overall]. These factors have resulted in a limited selection of IUD options in the U.S. compared to places like Europe, Culwell saysdespite the fact that IUDs are considered to be one of the most effective forms of birth control, preventing pregnancy 99% of the time or more. Currently, there are four hormonal IUDs on the market (three of which were made by the same company) and one hormone-free IUD. Hormonal IUDs work by releasing a progestin hormone into the body, which thickens the cervical mucus and prevents sperm from entering the uterus. For patients who are sensitive to hormones, though, this might not be the best option. These patients may want to opt for a hormone-free IUD, which uses copper to prevent pregnancy. The metal is toxic to sperm, killing them before they can make it through the uterus. The only currently available hormone-free IUD, Paragard, has a copper wire wound around the entire T-shaped structure of the device. But theres a major drawback to that design: Copper can initiate an uncomfortable inflammatory response in the patient, resulting in side effects like cramping and heavy bleeding. Miudella, which has been in development for about 15 years, seeks to improve on both this existing hormone-free IUD model and the construction and delivery of IUDs more generally. [Image: Sebela Women’s Health Inc.] Designing a more flexible IUD To start, Miudellas developers wanted to find a way to decrease the amount of copper on the device in an attempt to lessen the side effects caused by the metal. In the past, Culwell says, other companies have attempted a similar strategy, but found that lowering the dose of copper reduced the IUDs effectiveness. After extensive trial and error, the Miudella team found that placing copper strategically on three key points of the device could maintain effective pregnancy prevention rates while lowering the copper dose to less than half that of Paragard. The Miudella has copper placed right at the bottom of the IUD, which is at the internal part of the cervix, and then at the top of the arms, which is at each of the tubal openings, Culwell says. You don’t necessarily need copper throughout the entire uterine cavity, you just really need copper at the key places where the sperm will be going by, to basically prevent them from making their way to the egg. Miudella also bucks the standard material construction of IUDs. Currently, all of the IUDs on the market in the U.S. use a rigid, plastic T-frame that holds one stiff position. To account for the varying anatomies of the uterus, Miudella has swapped that plastic frame for one made of nitinol, an ultra-flexible metal alloy commonly used for procedures like cardiac stents and orthopedic implants. Nitinol is super elastic, Culwell says. It has shape memory properties, so it actually can conform nicely to varying sizes and shapes of uterus. A uterus can be narrow, it can be short, it can be wide, and so having something that’s not just a rigid T allows for some conformity there. Aiming for a less painful insertion process The nitinol frame allowed Miudellas developers to make some changes to the actual IUD insertion process, which can be painful for some womenso much so that, in 2022, TikTok saw an outpouring of stories from women who felt that their pain during the procedure had not been properly addressed. Just last August, the Centers for Disease Control and Prevention (CDC) issued its first-ever recommendation that patients should actually be counseled on pain management before the procedure, as well as permitting the use of topical lidocaine during the process. To increase patient comfort, Miudellas developers invented a new insertion tube designed for more gentle insertion. Because of nitinols compressive properties, the tube can be manufactured about a millimeter narrower than Paragards insertion tube. Additionally, while other IUD insertion tubes have a flat, blunt end, the Miudella tube comes with a tapered tip. [Photo: Sebela Women’s Health Inc.] To have it more tapered so that it would be more comfortable for the insertion process is actually a challenge, Culwell says. It’s a bit difficult to create this tapered tip that you could reproduce consistently, because then you also have to be able to get the IUD out without much resistance and force. There was a lot of experimentation on getting the tip of the insertion tube to be able to be nice and tapered, but also to allow easy passage of the IUD. In fact, there’s a proprietary way that that tapered tube is designed: It has slits in the side that decrease friction during the deployment process. Most other IUDs, due to the rigidity of their plastic frames, have to be loaded by the practitioner within five minutes of placement to hold their shape. In the case of Paragard, the device has to be manually loaded with the fingers by pushing the two arms of the IUD down into a tubetypically while the patient is actively waiting in the stirrups. The added benefit of Miudella’s unique tube and nitinol frame is that the device can be pre-loaded before it even arrives at the doctor’s office. Currently, Miudella has been approved for use up to three years, whereas Paragard is approved for up to 10. Culwell notes that the team at Sebela is in the process of studying Miudellas effectiveness for up to eight years of use. In her own practice as an OB-GYN, Culwell says, shes glad to see that the CDC has started to offer more guidance on pain management during IUD placement. Still, she believes that women have historically not been listened to when it comes to pain in particular, and that the pharma industry needs to invest more in innovating with patient comfort in mind. We’re continuing, as a community, to do more and more research on pain management for IUD inserts, Culwell says. I think it lagged behindfor way too long, but there was no research done on IUD pain. So, I think continued innovation and then continued informed consent and making sure that we really offer patients pain management techniques are key, because IUDs are terrific methods for people who want them, but it can’t be torture to get them in. That shouldnt be the trade-off.
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Neom, the insane urban development project in Saudi Arabia, appears to be sinking faster than the giant holes they keep digging in the middle of nowhere. Increasing delays and soaring cost overruns have led to project cancellations and a general scaling back of the original vision. Now a Wall Street Journal report has uncovered an internal audit that reveals evidence of deliberate manipulation of finances by management to justify rising cost estimates to investors. The sense of impending disaster is even more shocking when you look at the only crazy structure that is now standing in Neom: an unbelievably giant palace. New satellite images obtained by Business Insider via US space company Maxar Technologies have revealed the gigantic complex, which appears to feature at least 16 buildings (plus other buildings in the property), four swimming pools, private beaches, extensive gardens, a marina, 10 helipads, and its own golf course. The palace is thought to be owned by Saudi Arabian ruler Mohammed bin Salman, and its only one of five palaces that will be built for the royal family in the 10,230-square-mile region known as Neom. The development of Neom is supposed to become Saudi Arabia’s transitional path from an oil economy towards one based on technology, advanced manufacturing, green energy, and tourism. It includes a 110-mile-long vertical city called the Linewhich has since been scaled back to just over one milealong with other futuristic settlements that will allegedly include everything from hydrogen processing plants to luxury hotels. Bin Salman chairs the boards of Neom and its sub-projects, frequently approving architectural choices seemingly impossible to build, like this giant 30-story-high chandelier conceptualized by a Marvel concept artist because, reportedly, the Prince likes The Avengers. Fraud is in the air These lavish personal palaces and flashy renderings offer a stark contrast to the financial reality of the project. Initially, its promoters were looking to attract $500 billion in public and private capital, but Neom is reportedly having a hard time getting the money. The delays and cost overruns kept mounting and, in 2024, bin Salman fired Neoms CEO of six years, Nadhmi al-Nasr, putting in a new team tasked with turning the project around in place. Now the WSJ has uncovered an internal audit that reveals evidence of deliberate manipulation of finances by management to justify rising cost estimates. Capital expenditure for building Neom to its end-state by 2080 was estimated at $8.8 trillion, more than 25 times the annual Saudi budget. According to the paper, the high costs due to the remote location, ambitious design, and unrealistic projections seem insurmountable, despite executives hiding rising costs by inflating profit assumptions. The audit shows that the crown prince encouraged Neom to use the internal rate of return (IRR) to assess project profitability, leading to concerns about the projects financial viability. Then revenue estimates were increased to cover cost overruns, leading to a higher internal rate of return. Along the way, the Neom staff suggested a few cost-cutting measures, like reducing the height of The Line, but the crown prince rejected this. He ordered to find cost savings elsewhere. And when a project manager challenged the unrealistic cost estimates, he was removed. The WSJ reports that McKinsey helped create financial models, validated projections, and served as both planner and validator, raising potential conflicts of interest. Despite the audit findings, a Neom spokeswoman told the WSJ that the project remains on track and is demonstrating tangible progress. On social networks and YouTube, the organization and its top brass keep posting videos claiming progress. I follow them. They always look like the same holes in the middle of nowhere. We wont have to wait long to see if the Prince and his organization can actually realize these pharaonic visions or if they will just end digging the most expensive hole in history. The Lines first phase is supposed to open its first half-mile section, including a stadium, in 2034. Just nine years away. That will be the year the World Cup starts in Saudi Arabia, right in that stadium. No matter if it gets finished on time or not, I’m sure bin Salman will be watching the kick off game from one of the hundred (Im guessing given its size?) living rooms in his cozy new palace.
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While the rest of the nation watched in horror, bad weather turned deadly and quickly wreaked havoc. Houses were ravaged, and tens of thousands of residents were displaced. Thats Los Angeles since the historic wildfires struck in January, destroying more than 16,000 structures and leaving thousands of people homeless. It was also western North Carolina in late September after Hurricane Helene created raging rivers that flooded some houses and swept others away. Nearly 74,000 homes in the area were damaged or destroyed, around 10,000 of which were in Buncombe County, where the city of Asheville is located. Every disaster is unique, and these two were markedly different. But from a housing perspective, they have some important similaritiesand L.A. leaders can learn from what Buncombe County has already gone through in its recovery. Among other things, both regions have been hot real estate markets with ever-increasing property values that have been gradually pushing lower-income people out. Catastrophes like fires and hurricanes can, paradoxically, cause housing prices to rise over time: Supply is tighter, speculators may capitalize on newly vacant properties, and investors and residents often rebuild bigger than before. That makes it imperative to get residents into safe homes as quickly as possible, before conditions change that might make that unfeasible. From left: Before and after roof repair [Photo: Asheville Area Habitat for Humanity] Buncombe County is still in the early stages of its response; the disaster was so overwhelming that simply accounting for everyone and filing initial claims has taken months. But the Federal Emergency Management Agency has come, state legislators have allocated aid and are debating more, and federal assistance seems to be on its way, though given the Trump administrations focus on government downsizing, its unclear when it will arrive or whether the amount will be even close to whats needed. The governments of Asheville and Buncombe County have been very responsive, observers say. But whats been truly critical is the work of community organizations, which have cooperated with one another in an unprecedented way to help thousands of renters and homeowners begin returning to their homes. Its been a grassroots effort of seeing what the community needs and how to respond, says Lukas Ray, communications and engagement officer at Mountain Housing Opportunities, an affordable housing group. Its a collaboration: Put your head down and work together. In some ways, the region was well-positioned for a disaster, if such a thing is possible. Weeks before the hurricane, the city had released a 100-plus-page affordable housing plan that it spent a year hammering out with local housing and social service agencies. So when the storm hit and brought mass unemployment with it, they knew just how vulnerable many of the areas renters were, and made preventing displacement a priority. [Photo: Asheville Area Habitat for Humanity] An eviction moratorium would have been ideal, but thats a state-level decision that officials in Raleigh failed to enact. However, more than $5 million in rental assistance has been a boon to the 1,000-plus households who received it. Some of those funds came from the city and county, but most were raised through private donations and distributed by a church. Rental assistance was recommended [in the affordable housing plan] to prevent further displacement, said Susan Bean, housing and transportation director at MountainTrue, a grassroots environmental group. That made it easierit was a need that was clear. Another of the plans recommendations was to expand home repair resources for low-income homeowners, work that was already underway pre-Helene. Following COVID-19, the areas Habitat for Humanity affiliate had aimed to streamline the work of a few home repair organizations, using bespoke software and a universal intake form. The initiative, Asheville Regional Coalition for Home Repair, or ARCHR, was on the verge of a soft rollout when the storm hit, and the coalition quickly took it live. Theyve since received more than 300 applications from low-income households. “We see a lot of roof issuestrees on roofs, wind damage, or roofs that were already in disrepair before the storm, said Joel Johnson, home repair director at the Asheville Area Habitat for Humanity. ARCHR is a one-stop shop that allows each group to tackle the job its best at, whether thats roof repair or access issues or water damage. And as an organized, coordinated entity, its better positioned to receive government funding and individual donations. [Photo:Asheville Area Habitat for Humanity] ARCHR is also part of a bigger-picture effort thats getting underway. In the early months after the hurricane, community stakeholders talked to leaders from places like Louisiana, Florida, and eastern North Carolina that had experienced similar disasters. They recommended Buncombe County form a long-term recovery group, a collaborative body composed of key nonprofits, local governments, and community funders that includes subgroups focusing on case management, rental assistance, repairs, and construction. This is a local way to respond to a disaster, to provide a coordinated process, says Sarah Roth, interim director of emergency operations at United Way of Asheville and Buncombe County, which is helping lead the process. The groups look different in every community. Buncombe Countys long-term recovery group is still figuring out its mission and scope. Leaders are seeking a fiscal sponsora tax-exempt nonprofit organization that can accept funding on their behalfso they can hit the ground running when government assistance finally arrives. In the meantime, theyre sharing real-time data with policymakers and advocating for on-the-ground needs. The housing groups are concerned that damaged or destroyed properties may be replaced by more expensive structures. In response, said David Bartholomew, an attorney with Pisgah Legal Services, Were all looking to make sure that when theres opportunity, we get in there and can take advantage. One group is already doing that. In December, the nonprofit BeLoved Asheville bought an 8-acre parcel of land in Swannanoa, one of the regions hit hardest by the storm, for $1.6 million in community donations. Its leaders plan to build a small enclave of at least 15 two- and three-bedroom houses for very-low-income people. Their purchase is timely. While Buncombe Countys real estate prices have remained stable so far, theyre likely to rise soon as the weather warms and investors begin eying vacant properties. Property values could look very different next year. L.A. housing leaders may want to take note. The speed, creativity, and collaboration could serve them well, too, as they launch a recovery effort that, as in Buncombe Countys case, is predicted to last around a decade.
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