Latest news with #vascularhealth
Yahoo
25-06-2025
- Health
- Yahoo
SmartVascular Dx™ Test: Enhancing Vascular Care in the Midwest
IRVINE, Calif., June 25, 2025 (GLOBE NEWSWIRE) -- MorningStar Laboratories, LLC., ('MSL' or 'the Company'), is a leading developer of precision diagnostic tests that address unmet clinical needs, is proud to announce its expansion in the Midwest with the introduction of the SmartVascular Dx™ test (formally known as the PULS™ Cardiac Test), a groundbreaking tool designed to improve vascular health outcomes. We are thrilled to announce that we are now officially included in the Medicare fee schedule, enabling us to offer national medical coverage. This effort reinforces our dedication to enhancing patient care and improving health outcomes in the region. As part of our commitment to improving patient care, MorningStar Laboratories has forged new partnerships with UnityPoint Health and the Advantage Benefits Team. This initiative aims to significantly increase access to innovative vascular services for patients throughout the Midwest. The SmartVascular Dx test stands at the forefront of preventative healthcare, enabling the early detection of vascular inflammation before clinical symptoms arise. This is especially crucial in the Midwest, where the prevalence of vascular disease presents a major public health challenge. By identifying potential issues earlier, we aim to empower healthcare providers to implement timely interventions that can save lives. 'We believe that early detection is key to effective treatment,' said Susie Lu, Chief Operating Officer & Director at MorningStar Laboratories. 'With the SmartVascular Dx test, we are empowering our physicians to intervene before serious health issues arise, ensuring better care for their patients.' We invite Midwest physicians to learn more about the SmartVascular Dx test and how it can be integrated into their practices. For additional information about the SmartVascular Dx test or to schedule a consultation, please contact MorningStar Laboratories at 949.267.7875 or visit Join us in our mission to enhance vascular care and improve the health of our communities. About MorningStar LaboratoriesMorningStar Laboratories ('MSL') is a specialty diagnostics development clinical laboratory company that develops, performs, and distributes unique medical tests combining science, technology, and proprietary analytics which aim to detect high-risk diseases with significant unmet medical needs. MSL's laboratory information systems use data from multiple sources, including proteomics, genetics, metabolic, biochemistry, phenotype, imaging, and a patented algorithm to address the most challenging clinical problems related to endothelial and vascular inflammatory issues. Morningstar Laboratories, a subsidiary of Smart Health Diagnostics Company, is a CLIA-Certified and CAP Accredited laboratory offering comprehensive and customized services in accordance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations and ISO 15189 standards. To learn more, visit MorningStar Laboratories at Facebook, X (formerly Twitter), and LinkedIn. Forward-Looking StatementsForward-looking statements in this press release are based on our future expectations, plans prospects, and assumptions regarding matters that are not historical facts, may constitute 'forward-looking statements' within the meaning of The Private Securities Litigation Reform Act of 1995. The words 'termed,' 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. Therefore, we caution you against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. Any forward-looking statement made by us in this document speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by law. Media Contactmjjohnson@ 866.299.8998Error 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
Yahoo
24-06-2025
- Business
- Yahoo
Breye Therapeutics announces successful completion of its Phase 1b trial with danegaptide in patients with diabetic retinopathy
Orally administered treatment was well tolerated, with early signs of clinical activity In models of non-proliferative diabetic retinopathy (NPDR), danegaptide has demonstrated protection against retinal capillary loss and vascular leakage Data support continued advancement into Phase 2 clinical evaluation COPENHAGEN, Denmark, June 24, 2025 /PRNewswire/ -- Breye Therapeutics ApS (Breye), a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of vascular eye diseases, today announces the successful completion of its Phase 1b clinical trial evaluating its lead candidate, danegaptide, in patients with non-proliferative diabetic retinopathy (NPDR) with associated edema. Diabetic retinopathy (DR) is a leading cause of vision loss globally, affecting millions of people with diabetes. While there has been successful development of intravitreally administered products, injected directly into the eye, for patients with late-stage disease, treatment options are currently limited for patients in the earlier or moderate stages. The intravitreal treatments are burdensome, often poorly tolerated and associated with low compliance, highlighting the critical need for effective and non-invasive alternatives. Danegaptide is a first-in-class oral small molecule with a novel mode of action, that stabilizes the vasculature and protects from cell-cell uncoupling, retinal capillary breakdown and vascular leakage caused by hyperglycemia. The orally administered treatment was well tolerated across all dose levels in the 24 patients enrolled, with no dose-limiting toxicities reported. Pharmacokinetic (PK) data confirmed that targeted exposures of danegaptide were reached as guided by preclinical data. Early signs of clinical activity were observed, as measured by retinal imaging outcomes, representing reductions in retinal vascular leakage and improvements in anatomical parameters. Ulrik Mouritzen, Chief Executive Officer of Breye Therapeutics, said: "These results continue to support danegaptide's potential as an oral, non-invasive therapeutic solution for patients in the earlier stages of diabetic retinopathy. As we now prepare to advance into Phase 2 clinical evaluation, our focus is on validating these findings using regulatory-accepted clinical outcomes to progress our mission of developing safe and effective treatment options for these patients to preserve their vision before the onset of irreversible damage. Additionally, we believe this treatment solution may also support the maintenance of treatment response after induction therapy with intravitreally administered products." Prof. Carl Regillo, MD, Director of Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University in Philadelphia, Member of the Breye Therapeutics Scientific Advisory Board, commented: "An oral approach like danegaptide has the potential to fundamentally shift how we treat moderate to severe-stages of diabetic eye disease, offering patients a much-needed and non-invasive treatment solution for the large group of patients with NPDR." The Phase 1b trial was a multicenter, open-label, dose-escalation study assessing the safety, tolerability, pharmacokinetics (PK) and early signs of biological activity of danegaptide in patients with NPDR and associated diabetic macular edema (DME), a complication of NPDR. Conducted across 11 clinical sites in the UK, Germany and the US, the study confirmed a favourable safety profile, plasma levels within the targeted therapeutic range and early signs of clinical activity. A subsequent Phase 2 trial is planned to evaluate danegaptide in a targeted NPDR patient population using the regulatory endpoint of ≥2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS). Breye is actively fundraising to support this next phase of development. About Breye Therapeutics Breye Therapeutics is a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of vascular eye diseases. Breye is developing a pipeline of oral therapies for diseases of the eye, such as intermediate age-related macular degeneration and glaucoma, so more patients can maintain their sight, autonomy, and quality of life. Its lead candidate, danegaptide, is the first oral drug designed to treat diabetic retinopathy in its earlier stages and has a novel mechanism of action designed to stop and reverse disease progression. It is currently progressing through clinical development, with Phase 1b successfully completed and a Phase 2 trial planned to demonstrate clinical proof-of-concept. Breye is backed by Novo Holdings and Sound BioVentures, and has received financial support from the BioInnovation Institute, the Danish Growth Foundation (Vækstfonden), and the Danish Innovation Foundation (Innovationsfonden). For more information, please visit: View original content: SOURCE Breye Therapeutics
Yahoo
24-06-2025
- Business
- Yahoo
Breye Therapeutics announces successful completion of its Phase 1b trial with danegaptide in patients with diabetic retinopathy
Orally administered treatment was well tolerated, with early signs of clinical activity In models of non-proliferative diabetic retinopathy (NPDR), danegaptide has demonstrated protection against retinal capillary loss and vascular leakage Data support continued advancement into Phase 2 clinical evaluation COPENHAGEN, Denmark, June 24, 2025 /PRNewswire/ -- Breye Therapeutics ApS (Breye), a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of vascular eye diseases, today announces the successful completion of its Phase 1b clinical trial evaluating its lead candidate, danegaptide, in patients with non-proliferative diabetic retinopathy (NPDR) with associated edema. Diabetic retinopathy (DR) is a leading cause of vision loss globally, affecting millions of people with diabetes. While there has been successful development of intravitreally administered products, injected directly into the eye, for patients with late-stage disease, treatment options are currently limited for patients in the earlier or moderate stages. The intravitreal treatments are burdensome, often poorly tolerated and associated with low compliance, highlighting the critical need for effective and non-invasive alternatives. Danegaptide is a first-in-class oral small molecule with a novel mode of action, that stabilizes the vasculature and protects from cell-cell uncoupling, retinal capillary breakdown and vascular leakage caused by hyperglycemia. The orally administered treatment was well tolerated across all dose levels in the 24 patients enrolled, with no dose-limiting toxicities reported. Pharmacokinetic (PK) data confirmed that targeted exposures of danegaptide were reached as guided by preclinical data. Early signs of clinical activity were observed, as measured by retinal imaging outcomes, representing reductions in retinal vascular leakage and improvements in anatomical parameters. Ulrik Mouritzen, Chief Executive Officer of Breye Therapeutics, said: "These results continue to support danegaptide's potential as an oral, non-invasive therapeutic solution for patients in the earlier stages of diabetic retinopathy. As we now prepare to advance into Phase 2 clinical evaluation, our focus is on validating these findings using regulatory-accepted clinical outcomes to progress our mission of developing safe and effective treatment options for these patients to preserve their vision before the onset of irreversible damage. Additionally, we believe this treatment solution may also support the maintenance of treatment response after induction therapy with intravitreally administered products." Prof. Carl Regillo, MD, Director of Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University in Philadelphia, Member of the Breye Therapeutics Scientific Advisory Board, commented: "An oral approach like danegaptide has the potential to fundamentally shift how we treat moderate to severe-stages of diabetic eye disease, offering patients a much-needed and non-invasive treatment solution for the large group of patients with NPDR." The Phase 1b trial was a multicenter, open-label, dose-escalation study assessing the safety, tolerability, pharmacokinetics (PK) and early signs of biological activity of danegaptide in patients with NPDR and associated diabetic macular edema (DME), a complication of NPDR. Conducted across 11 clinical sites in the UK, Germany and the US, the study confirmed a favourable safety profile, plasma levels within the targeted therapeutic range and early signs of clinical activity. A subsequent Phase 2 trial is planned to evaluate danegaptide in a targeted NPDR patient population using the regulatory endpoint of ≥2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS). Breye is actively fundraising to support this next phase of development. About Breye Therapeutics Breye Therapeutics is a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of vascular eye diseases. Breye is developing a pipeline of oral therapies for diseases of the eye, such as intermediate age-related macular degeneration and glaucoma, so more patients can maintain their sight, autonomy, and quality of life. Its lead candidate, danegaptide, is the first oral drug designed to treat diabetic retinopathy in its earlier stages and has a novel mechanism of action designed to stop and reverse disease progression. It is currently progressing through clinical development, with Phase 1b successfully completed and a Phase 2 trial planned to demonstrate clinical proof-of-concept. Breye is backed by Novo Holdings and Sound BioVentures, and has received financial support from the BioInnovation Institute, the Danish Growth Foundation (Vækstfonden), and the Danish Innovation Foundation (Innovationsfonden). For more information, please visit: View original content: SOURCE Breye Therapeutics
Medical News Today
20-06-2025
- Health
- Medical News Today
Dementia: Study links 3 vascular health risk factors to increased risk
New research finds a link between vascular health risk factors and increased dementia risk. MASTER/Getty Images There are many ways to help keep the vascular system healthy, such as not smoking and keeping blood pressure at a healthy level. A new study has found a link between certain midlife vascular risk factors — specifically high blood pressure, diabetes, and smoking — and risk for dementia. Scientists report the attributable vascular risk factors were higher in both female and Black participants, as well as non-carriers of the APOE ε4 gene, which is linked with an increased risk of Alzheimer's. The vascular system refers to all the blood vessels that run through the body. These vessels are in charge of moving oxygen throughout the body and removing waste products. Now, a new study recently published in the journal JAMA Neurology has found a link between certain midlife vascular risk factors — specifically high blood pressure, diabetes, and smoking — and risk for dementia. Scientists report the attributable vascular risk factors were higher in both self-identified female and Black participants, as well as non-carriers of the apolipoprotein ε4 (APOE ε4) gene . For this study, researchers analyzed medical data from about 7,700 participants from the Atherosclerosis Risk in Communities (ARIC) study, which ran from 1987-2020 with a 33-year follow-up. Participant risk factors were measured at ages 45-54, 55-64, and 65-74 years old. Researchers focused on three main vascular risk factors for this study: high blood pressure, diabetes, and smoking. 'There's been pretty consistent research for decades that indicates the importance of these three vascular risk factors in midlife (~ age 45-64 years) for elevating dementia risk, with less consensus on their associations in late-life (~ age ≥75 years),' Jason R. Smith, PhD, ScM, who was at the time of the study a researcher in the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health in Maryland and first author of this study, told Medical News Today . 'The prevalence of vascular risk factors also remains high in adults. So interventions for vascular factors beginning as early as midlife could potentially avert a big chunk of dementia risk,' he said. Upon analysis, researchers found that between 22–44% of dementia cases reported by participants by age 80 were attributable to midlife and late-life vascular risk factors. 'That 22-44% of population-level dementia risk by 80 years was attributed to at least one vascular risk factor from midlife through early late-life (ages 45-74 years) signals a major prevention gap,' Smith explained. 'Clinical and public health interventions targeting vascular risk beginning as early as midlife could delay or prevent a sizable fraction of dementia risk by 80 years.' 'The burden of dementia remains high,' he continued. 'It has a heterogeneous presentation and pathology, so targeting risk factors that are modifiable, more proximal to dementia expression (including hypertension, diabetes, and smoking), and that could potentially impact more than one underlying process giving rise to dementia, is paramount to reduce population-level dementia risk.' Additionally, scientists found that the vascular risk factor attributable risk was highest in participants who self-identified as female or Black, as well as those not carrying the APOE ε4 gene. 'Caution's warranted when interpreting these stratified analyses, given wide (confidence intervals),' Smith said. 'However, the analysis stratified by APOE carrier status suggests the absolute vascular contribution to dementia is larger among those at lower genetic risk for Alzheimer's disease.' 'And that the vascular contribution was larger among those racialized as Black is likely due to a higher burden of vascular risk factors in this population,' he continued. 'More inclusive and representative research is urgently needed to understand the prevention potential of vascular risk reduction in different populations.' 'While this study is not designed to provide evidence on individual-level dementia risk reduction, promoting optimal vascular health as early as midlife could be vital for reducing population-level dementia risk by 80 years,' Smith added. 'What's good for the heart is good for the brain, and the earlier prevention starts, the better.' MNT spoke with Christopher Yi, MD, a board certified vascular surgeon at MemorialCare Orange Coast Medical Center in Fountain Valley, CA, about this study. Yi commented that this study reinforces an increasingly clear message: vascular health is brain health. 'My first reaction was that the findings were both striking and practical — nearly half of dementia cases by age 80 could be linked to modifiable vascular risk factors like high blood pressure, diabetes, and smoking,' he continued. 'It's especially notable that late-life vascular health appeared even more strongly associated with dementia risk than midlife health, which challenges the idea that 'it's too late' to make a difference after midlife.' Yi explained that vascular health affects dementia risk through several interconnected mechanisms. 'High blood pressure and vascular disease can damage the small vessels that supply the brain, leading to chronic ischemia (lack of oxygen) and brain tissue damage,' he detailed. 'Silent strokes and microinfarcts are common in people with uncontrolled hypertension and diabetes and can accumulate over time, impairing cognitive function without obvious warning signs.' 'Vascular risk factors promote inflammation and free radical damage, which contribute to neurodegeneration and Alzheimer's pathology. (And) chronic vascular dysfunction can make the blood-brain barrier leaky, allowing harmful substances to enter the brain and accelerate neuronal damage.' — Christopher Yi, MD For the next steps in this research, Yi said he would like to see more intervention trials, risk factor-specific analyses, mechanistic studies, and policy translation. 'Explore how these findings could support more aggressive screening and treatment of vascular risks in primary care, with cognitive outcomes in mind,' he added.
Daily Mail
15-06-2025
- Health
- Daily Mail
You're showering wrong! Doctor reveals common washing error that could be life-threatening
Take note of the temperature of your shower, as a few degrees too hot could result in a potentially life-threatening injury, a doctor has warned. According to German-based vascular health expert Dr Max Maddahali, 'excessively hot' showers can trigger a dangerous drop in blood pressure that could cause you to faint, risking serious injury and even death. The hot environment causes blood vessels to expand in the skin, an instinctive biological reaction to try and cool the body down. This process can—in some circumstances—trigger feelings of dizziness and even cause you to fall unconscious. Fainting can be dangerous at any time but doing in the bathroom could be extremely serious given the number of hard surfaces to hit your head on. As such, experts advise turning the shower down a few degrees if you find yourself feeling dizzy or installing a temperature lock to avoid the temptation entirely. Those particularly prone to feelings of dizziness in the shower—such as patients with an existing health condition—may want to have a grab bar, anti-slip or even a stool installed to provide quick support. Patients can also be recommended to get a wearable medical alert device, which can come as a bracelet, and can raise the alarm if a person falls or finds themselves injured. But Dr Maddahali said fainting wasn't the only health hazard you risked by having a hot shower. In a TikTok clip which has been viewed over 14million times, he also said it could also pose a risk to your skin, hair and even your immune system. Dr Maddahali said: 'There's some natural on your skin that are keeping your skin moist.' 'Hot water can wash them off completely so dryness can happen. 'Also, too hot water can cause hair damage.' Scalding water damages hair much in the same way it damages skin, by stripping it of natural oils that protect making it more vulnerable to damage. While Dr Maddahali didn't explain how hot showers weaken the immune system—our body's natural defence against dangerous virus and bacteria—some research suggests this is true. Hot water is more effective at removing a natural layer of 'good' bacteria that live naturally on the skin. Some experts suggest removing this layer leads to a less active immune system, which could reduce its ability to respond to actual threats. Social media users reacting to the clip said they would keep their steaming hot showers, despite the medic's advice. 'I respectfully will not take your advice,' one wrote. Another added: 'It is therapeutic, hot showers keep me sane.' Medics have provided a range of advice about showers over the years, from when to take them to what to never do in them. While the nation may be divided about if morning or evening showers reign supreme, experts have ruled a shower before bed to be superior. Dr Jason Singh, a primary care physician in Virginia, previously highlighted how an evening showers improved sleep quality, washing away pollutants, and hydrating dry skin. But experts have said you should 'never' urinate in the shower as it could train your brain into associating the act with the sound of running water and leading to incontinence.
