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News.com.au
11 hours ago
- News.com.au
Sounds serious: NYC noise pollution takes a toll
Tim Mulligan moved to central Manhattan so he could be closer to work and avoid a daily ordeal on the rattling, screeching subway, just one part of the urban noisescape that tests New Yorkers every day. "Even with your earbuds in, turned all the way up, you can't hear anything for the whole commute, and you're ruining your ears at that level," said Mulligan, a US Marines veteran who lives with PTSD. At his home close to New York's tourist hub Times Square, Mulligan has sealed his windows with high-density soundproof foam, draped them with double thick curtains and invested in earplugs to sleep. On the street he has resorted to noise-cancelling headphones, and he prefers bikes to the subway for getting around. New Yorkers and visitors to the megacity of 8.5 million people are bombarded with blaring sirens, loud locals, raucous bars and car horns almost constantly. A city-wide hotline received 750,000 noise complaints in 2024, the most commonly complained about quality of life issue. The city that never sleeps, perhaps because it can't, is one of the few built up US areas with a noise code regulating sound from vehicles, construction, businesses, and recreation. It has even installed cameras with sensors to detect and penalize violators. Nine-in-ten New Yorkers are at risk of hearing loss from daily exposure to noise levels exceeding 70 decibels, the healthy average, a Columbia University study conducted between 2010 and 2012 found. The report's author, professor Richard Neitzel, is now leading the first national study on noise in which 200,000 volunteers wear smart watches to track sound levels. "It looks like somewhere around one-in-four Americans are exposed to noise levels that could hurt their hearing over the long term," said Neitzel, a professor at the University of Michigan. - 'You can't undo it' - Among young people aged 18 to 25, the primary source of excess noise exposure comes from headphones. Overall, more people are exposed to high levels of environmental noise than to noise from their headphones, Neitzel added. Although the percentage of the population exposed to noise is similar to those exposed to air pollution, acoustic issues are not prioritized by residents and officials like air quality is, Neitzel said. There is clear evidence that excess noise is linked to poor sleep, cardiovascular issues, depression, cognitive decline, premature births and poor academic performance. Tinnitus, a permanent ringing in the ear affecting three out of 20 study participants, is increasingly prevalent. Loud music is even used to promote increased consumption, said Shane Newman, who manages a popular Mexican restaurant in Manhattan's trendy Hudson Yards development. "You have a drink in the music, it feels like a nice vibe and... they end up staying longer," he told AFP. Audiologist Michele DiStefano said the effects of noise on well-being have "not really been studied well enough." "The longer you have the exposure, and the higher the level, the (greater) degree of hearing loss you'll have" -- particularly for young people, she warned. "Once it does affect your hearing, you can't undo it, but you can actually prevent it," she said. "There's really a push to educate the younger generations on how you don't have to just have really loud noise at a concert -- it can be cumulative."
News.com.au
18 hours ago
- News.com.au
Biocurious: Clinical trial readouts show road to approval can be as exciting as the destination
In the medical device sector, sometimes trial news can excite investors more than the approval endgame At the application stage, devices have a much higher chance of being approved than drugs Investors can expect news from several companies with pivotal or late-stage trials For a drug or device maker, there's no prouder moment than when a health regulator – especially the US Food & Drug Administration (FDA) – approves their product to be unleashed on unsuspecting patients. It's like watching your kid graduate – and you can even tolerate the long-winded speeches. But don't confuse this coming-of-age moment with being the ultimate share price catalyst. For investors, the 'ker-ching' can be much earlier, such as with trial progress or even the FDA granting permission to begin a study. For instance, PainChek (ASX:PCK) shares had a nice run last October, after a positive validation study that supported the pain measurement app maker's US approval application. In late June Blinklab (ASX:BB1) shares soared after the autism test developer won ethics approval for a 1000-patient US trial. In the case of devices, FDA device approval tends to be less of a dramatic moment than for a drug go-ahead, because the chances of success are much higher. Most applicants avail of the 510(k) route, which means that a device only needs to be substantially equivalent to a legal equivalent. According to the contract research organisation Bioaccess, the FDA processes around 10,000 510(k) applications annually, with an approval rate of around 90%. Review times are also shorter: 120 days compared with 420 days for the de novo (new device) route. Here are some device (or quasi device) plays with advanced trials – typically- pivotal ones – that could move the share price dial. Emvision runs with Emu trial EMvision Medical Devices (ASX:EMV) in enrolling up to 300 suspected stroke victims in a pivotal trial of its stroke detection device Emu, across six local and US sites. Emu is a portable bedside scanning unit that's much lighter than a conventional computed tomography (CT) unit. The company is also developing an even small version, First Responder. As its name suggests, this one's for ambulance use. The trial sites are all high calibre research centres handling high stroke volumes. The stroke patients will receive the standard of care and an Emu scan. Given the device is a trail blazer, Emvision is girding for approval under the de novo route. After that, the company hopes the agency will approve First Responder approval under the 510(k) channel. Emu/First Responder will determine whether a stroke is a blockage (ischaemic)or a bleed (hemorrhagic). This will decide the type of treatment and it's crucial to get the diagnosis right. The company expects a six-to-12-month recruitment period. Micro-X also is on strike with strokes Meanwhile, x-ray imaging house Micro-X (ASX:MX1) plans to launch trails of its portable stroke unit, Head CT, across three local hospitals in the current half. The trials will entail suspected stroke victims being subject to standard CT imaging, then overlaid with the Micro-X scan that deploys a more effective 'cold cathode' method. Aiming for 'several hundred' scans, the studies only need to prove that the Micro-X tech is just as good as the conventional ones, Funded by $8 million from the Australian Stroke Alliance, the study supports a proposed 510(k) application next year, in view of a US launch in 2027. The company expects the trials to run for nine months. Micro-X had multiple applications for its tech, bomb and baggage screening. As part of a 'strategy re-set' the company is focused on medical applications. Micro-X has commercialised two mobile digital radiology devices: the first-generation Nano and a sturdier iteration called Rover. Heart patients move like Jagger In the past, heart patients too old or too sick for surgical aortic valve replacement – or open-heart surgery – in effect were given a death sentence. Transcatheter Aortic Valve Replacement (TAVR) procedures enable malfunctioning valves to be replaced in a non-invasive, 20-minute procedure. TAVR recipients include Arnold Schwarzenegger and Mick Jagger – and they're still rockin'. TAVR also applies to replacing artificial valves that have an effective operating life of five years or so. Anteris Technologies (ASX:AVR) is on track to commence a pivotal trial of its Duravr device in the current quarter, pending FDA approval. The company says it's qualified 79 sites globally for the trial, which will enroll patients with a 'broad array of risk profiles'. The trial will be designed to provide the 'primary clinical evidence' for the FDA to mull premarket approval. In parallel, Anteris is pursuing European clearance. More than Imagion-ation Shares also can pop on the strength of trial approval alone. In the drug/device sphere, Imagion Biosystems (ASX:IBX) awaits clearance to carry out a phase II study of its cancer imaging agent, Magsense for Her-2 positive beast cancers. For use with magnetic resonance imaging (MRI), Magsense improves cancer detection by adding 'molecular specificity'. In lay terms, this avoids painful, error-prone biopsies. This month, Imagion formed an alliance with Michigan's Wayne State University School of Medicine. In part, the institution's MRI gurus will help to devise an optimal dose to be used in the study. Trip the light fantastic Invion (ASX:IVX) highlights how the trial journey, rather than the destination can evoke investor excitement. Invion is advancing photodynamic therapy (PDT) for tumor types including non-melanoma skin cancers and ano-genital cancers. Someone has to do it. The idea is that light-activated photosensitisers leave the healthy tissue unharmed, but zap the diseased stuff. Thus, PTD is a promising non-toxic, non-invasive alternative to chemotherapy, radiation or surgery. Invion shares early last December rocketed more than 300% after the company said it had enrolled its first patient in its Queensland based phase I/II skin cancer trial. The adaptive study now is poised to enter is second stage. The next Sirtex? OncoSil Medical (ASX:OSL) is equated with a less developed version of the targeted liver cancer radiation treatment house Sirtex, acquired for $1.9 billion in 2018 by Chinese interests. Relative commercial immaturity aside, Oncosil targets the difficult pancreatic cancer. Oncosil is trialling its eponymous targeted treatment with the standard-of-care chemo, Folfirinix. The study, TRIPP-FFX, has completed recruitment and investors should expect data in early 2026. The study pertains to patients with locally advanced pancreatic cancer. The trial has recruited 'at least' 88 patients across 15 local and European hospitals. So - there you have it. While bonanza share gains are never guaranteed, investors know where to look for surprise pit stops along the circuitous approval journey.
ABC News
4 days ago
- ABC News
Bindi Irwin sparks endometriosis conversation after sharing her story
Bindi Irwin is urging women not to accept endometriosis pain as normal. The 27-year-old's post on social media in 2023 detailing her diagnosis with endometriosis has been liked more than one million times. This week, Ms Irwin stated that after 13 years of fighting for answers, 51 endometriosis lesions, a cyst, two surgeries, and a hernia, it was now time to heal. She said she felt "utterly ashamed" of her pain as her endometriosis symptoms were constantly dismissed. Like many women, Ms Irwin said this eroded her self-esteem, and she was speaking out to help reduce the stigma and secrecy around discussing the condition. Endometriosis is a disease in which tissue similar to the lining of the uterus grows in other parts of the body. About one in 10 of those assigned female at birth have endometriosis. Ebony Nykiel, 26, from Queensland's Sunshine Coast, said Bindi's post resonated with her. She said it took 13 years for her diagnosis of endometriosis. Ms Nykiel said she had her first period at 10, and from the start, her painful symptoms were dismissed by others. Her eventual diagnosis was "bittersweet". She said it was validating to learn she "wasn't crazy" but that she was left with limited treatment options. Ms Nykiel said it wasn't just a woman's issue. "It's everyone's issue," she said. Ms Irwin said she was "slowly, slowly" regaining her strength. "I can FINALLY (sic) say that I'm feeling better. Genuinely healing. I can function in everyday life without wanting to throw up or pass out from the pain," she wrote on social media. "I cannot express the gravity of my emotions as I am beginning to recognise myself again. "I felt utterly ashamed as a teenager and young adult being told that my pain was just part of being a woman. "I felt lesser. I felt hurt. I felt weak." She said others should not have to endure isolation along with the trauma caused by endometriosis. "Young girls and women shouldn't feel alone with pain in the driver's seat of their lives," Ms Irwin said. "We need to take away the stigma of talking about women's health. It's time to have open discussions and make change on a global scale." Jessica Spain, a social worker and PhD candidate at the University of the Sunshine Coast, is researching the experiences of women and girls in regional Queensland accessing an endometriosis diagnosis. She said it was "so common" for them to be dismissed or for their pain to be normalised, misdiagnosed, or mistreated. Miss Spain said it could take six to eight years to be diagnosed. Accessing care, she said, was even more challenging for those who were Aboriginal and Torres Strait Islander, transgender, non-binary, living with a disability, or in a regional area. "The stigma around it has kept women under wraps for hundreds and thousands of years," she said. "Females are the experts in their own bodies and we know when something's wrong." She said women were often told they were being dramatic or that it was stress-related. Miss Spain said she found Ms Irwin's post empowering. "Endometriosis doesn't discriminate," Miss Spain said. "It's so powerful for her to speak up about that because that will resonate with so many people." Monica Forlano, from Endometriosis Australia, said it was a full-body and potentially lifelong health condition. She said, historically, the female body was not studied in the same way as men's bodies. "It essentially just comes down to medical misogyny," she said. "We know so little about it, it's still a mystery, an enigma." She said that through more funding, research, and awareness, the future was likely brighter for those living with the disease. Ms Forlano said she hoped to see endometriosis discussed more widely in schools with boys and girls of all ages. "It shouldn't be a life-defining condition. People can thrive," Ms Forlano said. "They just need to be seen and heard and listened to."
