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IVUS and iFR Technologies Receive Top-level Recognition in New ESC Guidelines, Reinforcing their Role In Optimizing Coronary Interventions and Patient Outcomes

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, acknowledged today the latest classification updates for the company’s key imaging and physiology technology in new guidelines for the management of chronic coronary syndromes from the European Society of Cardiology (ESC).

The latest updates to these ESC guidelines emphasize the robust clinical evidence supporting the use of intravascular ultrasound (IVUS) and instantaneous wave-free ratio (iFR), both of which have demonstrated significant benefits in improving patient outcomes through numerous large-scale randomized trials like DEFINE FLAIR and iFR SWEDEHEART. The updates were announced at the recent ESC Congress in London, five years after the last update in 2019, and simultaneously published in the European Heart Journal.

In the 2024 ESC Guidelines for management of chronic coronary syndromes, several Philips technologies for coronary artery disease (CAD) were included, reflecting their level of evidence and the evolution of clinical science establishing standards of care to optimize patient outcomes. Class guidelines denote the evidence a treatment or procedure is recommended or indicated for use, whereas the level of evidence is based on the amount of data available from randomized clinical trials and meta-analyses.

IVUS for intracoronary imaging upgraded to Class IA recommendation

“Meta-analysis of randomized clinical trials”—Stone et. al [3]—“had already shown that intracoronary image guidance of PCI improves patient outcomes and saves lives,” said Javier Escaned, MD, Head of the Interventional Cardiology Section at Hospital Clinico San Carlos, Madrid Spain. “But the IA recommendation for IVUS in the updated ESC guidelines is crucial, as it reflects expert consensus based on a definite body of evidence supporting the positive impact of IVUS, specifically for patients with anatomically complex lesions treated with PCI.”

Philips intravascular ultrasound (IVUS) technology is an innovative imaging tool used during coronary interventions that provides detailed, real-time cross-sectional images of the inside of blood vessels, allowing for precise assessment of vessel anatomy and plaque characteristics to optimize stent placement to improve outcomes. This technology has been upgraded to Class 1, Level of Evidence A, reflecting the growing body of evidence showing that intravascular imaging (IVI) improves patient outcomes. With the updated guidelines, IVUS is now recommended for percutaneous coronary intervention (PCI) on anatomically complex lesions, in particular left main stem [4], true bifurcations [5] and long lesions [6].

“The percentage of PCI considered to be complex is increasing, with current estimates around 40-50% or more [7] The increasing complexity of these interventions underscores the need for intracoronary imaging to be used much more frequently than it is today,” said Stacy Beske, Business Leader for Image Guided Therapy Devices at Philips. “Philips plug-and-play digital IVUS on IntraSight offers an easy and seamless way to bring the benefits of intracoronary imaging to patients and clinicians.”

iFR and FFR for physiologic measurement during PCI remains Class IA recommendation

A second Philips technology that was included in the new ESC Guidelines is Philips’ instantaneous wave-free ratio (iFR), a physiological measurement used during percutaneous coronary intervention (PCI) to assess the severity of a coronary artery stenosis without the need for inducing hyperemia, enabling real-time decision-making about the necessity of stenting. Philips iFR remains the gold standard for physiologic measurement during PCI [2] and is the only resting index called out as Class I recommendation, level of evidence A, alongside fractional flow reserve (FFR) [1,10].

This classification can be attributed to two of the largest physiological studies completed, DEFINE FLAIR and iFR SWEDEHEART, which involved more than 4,500 patients combined and evaluated the safety and effectiveness of iFR, demonstrating its non-inferiority to fractional flow reserve (FFR) [8, 9].

For patients with non-obstructive CAD, coronary function testing, such as coronary flow reserve, has been elevated to Class 1, Level of Evidence B. This technology addresses patients with non-obstructive CAD by identifying potentially treatable endotypes and offering a definitive diagnosis of microvascular disease that can direct medical treatment strategies. This change to the guidelines validates the growing prevalence and diagnosis of microvascular disease.

Philips CAD solutions consist of advanced clinical and workflow applications, therapeutic and diagnostic devices, and leading services, which work together to efficiently support every step of coronary procedures. From diagnosis to restoring vessel patency, the coronary suite ecosystem is designed to enhance performance and efficiency.

[1] 2024 ESC Guidelines for the management of chronic coronary syndromes. (European Heart Journal; 2024 – doi: 10.1093/eurheartj/ehae177)

[2] Lawton J. et al. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization. JACC. 2022;79(2):e21-e129.[3] Stone G, et al. Intravascular imaging-guided coronary drug-eluting stent implantation: an updated network meta-analysis. The Lancet, Volume 403, Issue 10429, 824 – 837

[4] The left main stem (LMS), also known as the left main coronary artery (LMCA), is a critically important artery that serves as the primary blood supply to a large portion of the heart

[5] True refer to a type of coronary artery bifurcation lesion where there is significant disease (stenosis or narrowing) involving both the main branch (main vessel) and the side branch (branching vessel) at the point where they diverge from each other

[6] Coronary artery blockages that extend over a longer segment of the artery

[7] Hanna, Wang, Kochar, et al. Complex Percutaneous Coronary Intervention Outcomes in Older Adults JAHA 2023; 12; 19.

[8] Gotberg M., Christiansen E.H., Gudmundsdottir I.J. Instantaneous wave-free ratio versus fractional flow reserve to guide PCI. N Engl J Med. 2017;376:1813–1823.

[9] Davies J.E., Sen S., Dehbi H.-M. Use of the instantaneous wave-free ratio or fractional flow reserve in PCI. N Engl J Med. 2017;376:1824–1834.

[10] Lawton J. et al. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization. JACC. 2022;79(2):e21-e129.

Is Nail Fungus a Health Concern

Nail Fungus

When it comes to personal health, many issues command immediate attention. A cough, fever, or injury are clear signs that something might be wrong. However, some conditions, like nail fungus, often go unnoticed or ignored. Nail fungus, medically termed onychomycosis, is a common issue that affects a significant number of people worldwide, particularly adults and the elderly. But is it just a cosmetic concern, or is nail fungus a real health problem? Let’s take a deep dive into understanding nail fungus, its causes, symptoms, treatments, and most importantly, whether it poses a serious health risk.

What is Nail Fungus?

Nail fungus is an infection caused by a group of fungi known as dermatophytes. These fungi thrive in warm, moist environments, such as showers, gyms, and swimming pools, making it easy for them to spread. The infection usually begins as a white or yellow spot under the tip of the fingernail or toenail and can slowly progress deeper into the nail bed. Over time, the nail may thicken, discolor, and become brittle or crumbly.

Toenail fungus is far more common than fingernail fungus due to the conditions in which feet are usually kept—warm, dark, and frequently damp, thanks to socks and shoes.

Causes of Nail Fungus

Fungal nail infections can arise for a variety of reasons. The primary culprits are:

  • Exposure to Fungi: The dermatophytes that cause nail infections are the same organisms responsible for athlete’s foot and ringworm. Walking barefoot in communal areas like locker rooms, swimming pools, or shared showers increases the likelihood of contracting these fungi.
  • Weakened Immune System: People with compromised immune systems, such as those with diabetes, HIV/AIDS, or those undergoing treatments like chemotherapy, are more susceptible to fungal infections.
  • Poor Foot Hygiene: Wearing tight shoes, not drying feet properly, and letting moisture accumulate create an ideal environment for fungi to thrive.
  • Age: As people age, their nails can become more brittle, making them more vulnerable to cracks, which provide a perfect entry point for fungi.
  • Injury: Trauma to the nail or the surrounding skin can weaken the protective barrier, giving fungi easier access to the nail bed.
  • Athlete’s Foot: The same fungi that cause athlete’s foot can spread to the toenails if not treated properly.

Symptoms of Nail Fungus

The symptoms of nail fungus can vary depending on the severity of the infection, but some common signs include:

  • Discoloration: The nail may turn white, yellow, brown, or even black.
  • Thickening: The nail can thicken, making it difficult to trim and sometimes painful to walk or wear shoes.
  • Crumbling Edges: Infected nails may become brittle and start to crumble around the edges.
  • Distorted Shape: The nail may become misshapen or detached from the nail bed, a condition known as onycholysis.
  • Odor: In some cases, the infection can cause a foul smell.

These symptoms can vary from mild to severe. In the early stages, it may just look like a minor cosmetic issue, but without proper treatment, the infection can spread and worsen.

Is Nail Fungus a Health Concern?

At first glance, nail fungus might not seem like a serious problem. After all, it’s not life-threatening, and many people view it as just a cosmetic issue. However, while nail fungus may not be an immediate danger to life, it can certainly have a significant impact on overall health and well-being.

  1. Risk of Secondary Infections

One of the most concerning aspects of nail fungus is the increased risk of secondary bacterial infections. When the nail becomes thickened, brittle, or detached from the nail bed, it creates an entry point for bacteria. For individuals with compromised immune systems, such as those with diabetes, these secondary infections can be particularly dangerous.

In extreme cases, fungal infections can lead to cellulitis, a bacterial infection of the skin and underlying tissues. If left untreated, cellulitis can spread to other parts of the body, including the bloodstream, leading to a potentially life-threatening condition known as sepsis.

  1. Complications in People with Diabetes

People with diabetes are at an increased risk of developing severe complications from nail fungus. Diabetes affects blood circulation, particularly in the feet, which can make it harder for the body to fight off infections. Additionally, diabetics often experience nerve damage (neuropathy), making it difficult to feel pain or discomfort. This means that even a minor fungal infection could go unnoticed and lead to severe complications, such as open sores, ulcers, or even the need for amputation in extreme cases.

For diabetics, what starts as a seemingly minor fungal infection can quickly become a serious health issue that requires immediate medical intervention.

  1. Impact on Quality of Life

Nail fungus can have a profound impact on a person’s quality of life. Beyond the physical symptoms like discomfort or difficulty walking, there is also a psychological component. People with nail fungus may feel embarrassed or self-conscious about the appearance of their nails. This can lead to decreased self-esteem and may cause individuals to avoid social activities, especially those involving bare feet, like swimming or going to the beach.

In severe cases, the physical pain from thickened nails and the difficulty in wearing shoes can impair daily activities, such as walking or exercising, reducing a person’s overall mobility and health.

  1. Potential for Spreading

Nail fungus is contagious. Although it typically spreads slowly, it can be passed on through direct contact or shared surfaces. If left untreated, it can also spread to other nails, the surrounding skin, or even other people. What begins as a localized infection on one nail can eventually spread to multiple nails, making treatment more challenging and time-consuming.

Additionally, the same fungi responsible for nail infections can cause athlete’s foot, which can be quite itchy and uncomfortable. Athlete’s foot can then spread back to the nails, creating a vicious cycle of fungal infections that become harder to treat over time.

Treatment Options for Nail Fungus

Treating nail fungus can be challenging, but there are several options available depending on the severity of the infection.

  1. Topical Treatments

Over-the-counter antifungal creams, ointments, and nail lacquers are available and can be effective for mild cases of nail fungus. However, because the nail acts as a barrier, these treatments often struggle to penetrate deeply enough to fully eradicate the fungus.

  1. Oral Medications

Prescription oral antifungal medications, such as terbinafine and itraconazole, are often more effective than topical treatments. These medications work by helping the nail grow out free from infection, though it can take several months for the infection to fully clear.

While oral medications can be effective, they may come with side effects, including liver damage and interactions with other medications, so they are not suitable for everyone.

  1. Laser Therapy

Laser treatment for nail fungus is a relatively new option that uses focused light to destroy the fungi without damaging the surrounding tissue. This method is non-invasive and often considered for patients who do not respond well to medications.

  1. Nail Removal

In severe cases, where the nail is causing significant pain or has become too damaged to treat effectively, surgical removal of the nail may be recommended. Once the nail is removed, topical or oral antifungal treatments can be applied to the nail bed to prevent the fungus from returning.

  1. Home Remedies

Some people opt for home remedies like tea tree oil, vinegar soaks, or over-the-counter antifungal treatments. While these methods may provide relief for mild cases, they are generally less effective for more severe infections.

Prevention Tips

Preventing nail fungus is easier than treating it. Here are some simple tips to reduce the risk:

  • Keep your feet clean and dry.
  • Avoid walking barefoot in communal areas like locker rooms or public showers.
  • Wear moisture-wicking socks and change them regularly.
  • Trim nails straight across and keep them short to reduce the risk of trauma.
  • Disinfect nail clippers and other grooming tools after use.
  • Avoid sharing nail care tools with others.

Is Nail Fungus a Serious Health Concern?

While nail fungus may not seem dangerous at first glance, it can lead to more serious health issues if left untreated, especially for individuals with underlying health conditions like diabetes or weakened immune systems. The potential for secondary infections, physical discomfort, and impact on quality of life should not be underestimated. Though it may begin as a cosmetic concern, nail fungus has the potential to escalate into a significant health issue.

If you suspect you have nail fungus, it’s important to seek treatment sooner rather than later. With proper care and attention, nail fungus can be managed effectively, ensuring it does not progress into something more serious.

Contact Us Today

Here at NF Remedy, we understand the impact nail fungus can have on your health and confidence, and we’re here to help you take control of it. Our team specializes in effective, personalized treatments designed to tackle nail fungus at its root, giving you relief and restoring the natural look and feel of your nails. Don’t let nail fungus disrupt your life any longer—reach out to us today to schedule a consultation and learn more about our innovative solutions. Together, we can help you regain healthier, fungus-free nails!

Contact Us Today! https://www.nfremedy.com/

The Benefits of Going Natural: Healthier Solutions for Modern Ailments

Modern Ailments

As we strive for better health and wellness, natural remedies have become a popular option. While medical science and technology have made it easier to treat various conditions, many people are worried about the side effects and long-term consequences of synthetic medications.

This concern is leading more individuals to look into natural alternatives, steering them towards healthier and more sustainable lifestyles.

For instance, you can explore Saliomed.com to find examples of natural solutions that may help with modern health problems.

Going natural involves using plant-based remedies, making lifestyle changes, and adopting holistic approaches to treat both physical and mental health conditions. These methods are generally less invasive, cause fewer side effects, and work well with our body’s natural processes.

Here are three key reasons why people are opting for natural solutions for their health needs:

  1. Fewer side effects
  2. Holistic approach
  3. Sustainability

Choosing natural remedies can provide a path to better health that aligns with your body and the planet.

Harnessing the Power of Plants: Embracing Herbal Supplements

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Herbal supplements have been a cornerstone of traditional medicine in various cultures for centuries. They’re derived from plants or their parts—roots, leaves, flowers, seeds—and are known to support overall wellness without harsh chemicals.

Accessing herbal supplements online has made it easier than ever to incorporate these remedies into daily routines.

With an array of herbs available, it can be overwhelming to choose the right supplement. Popular choices include turmeric for inflammation, echinacea for immune support, and black pepper extract benefits like enhanced nutrient absorption and antioxidant properties.

Each herb offers unique advantages, often backed by scientific research as well as anecdotal evidence from users.

Personalizing Your Health Routine

One major advantage of herbal supplements is their flexibility. They can be customized to fit your specific needs and combined to tackle several health issues at once.

For example, if you have joint pain, you might take turmeric for inflammation while also using valerian root to help you sleep better. Unlike many conventional medications that often come with a long list of side effects, herbal remedies tend to work gently with your body.

It’s crucial, however, to use herbal supplements wisely. Consulting with healthcare professionals or a naturopath can ensure that you use these remedies safely and effectively. While “natural” doesn’t automatically mean risk-free, professional advice significantly reduces potential dangers.

Nutrition and Whole Foods: Building Blocks for Health

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Proper nutrition is key to staying healthy and preventing illnesses. A natural diet focuses on whole foods—like fruits, vegetables, whole grains, nuts, and seeds—which deliver essential nutrients without heavy processing. This way of eating supports your body’s functions both efficiently and sustainably.

Whole foods are packed with vitamins, minerals, antioxidants, and fiber. They help keep you healthy and lower the risk of chronic diseases like diabetes, heart conditions, and some forms of cancer.

For instance, including a supplement for heart health can bolster your diet when you’re unable to meet all nutritional needs through food alone.

Customized Nutrition Plans

Everyone has different nutritional needs depending on their age, activity level, health, and personal goals. By tailoring your diet, you can get the nutrients you need while avoiding harmful substances often found in processed foods. These include trans fats, refined sugars, and artificial additives that can harm your health over time.

Creating a balanced diet isn’t just about cutting out bad foods but also focusing on whole foods that provide the best nutrition. This helps keep your energy up, boosts your immune system, and improves mental clarity. It’s about building habits that support, rather than harm, your health.

Mindful Eating Practices

How you eat is just as important as what you eat. Mindful eating can improve digestion and make you enjoy your food more. Techniques like chewing your food well and savoring each bite can help reduce overeating and stomach issues.

Listening to your hunger cues can also help you maintain a healthy weight and avoid eating out of boredom or stress. Combining mindful eating with a diet rich in whole foods lets you get the most benefits from your meals.

Holistic Approaches: Beyond Just Physical Health

Holistic health means looking at your overall wellness instead of focusing on individual problems. This approach understands that physical health affects mental well-being, and vice versa. For instance, chronic stress can show up as tiredness or headaches.

Including practices like yoga, meditation, or even regular nature walks can improve both your mental calmness and physical energy.

Natural Supplements: Beyond Just Herbs

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While herbal remedies are very useful, natural supplements include more than just plant extracts.

  • Probiotics support gut health.
  • Omega-3 fatty acids promote brain function.
  • Magnesium can help regulate sleep cycles and muscle function.

Selecting the right natural supplements means understanding your unique needs and finding products that meet those requirements. Carefully sourced ingredients help ensure more predictable results without adding synthetic chemicals.

Achieving Balance Through Lifestyle Choices

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Good health isn’t just about pills or strict diets—it’s also shaped by the choices you make every day. Simple actions can greatly improve your overall well-being.

  • Regular Physical Activity: Staying active is essential for keeping your body moving well and your heart healthy. Even small amounts of exercise can help you feel energetic and strong.
  • Quality Sleep: Lack of sleep can weaken your immune system and affect your mental clarity. Building habits that promote good sleep can significantly improve your well-being.
  • Social Connections: Being part of supportive communities or social groups can help reduce feelings of loneliness, which can lead to health problems like depression.

Integrating these lifestyle choices creates a balanced approach to health, giving meaning and purpose to our daily lives.

Top 5 Patient Engagement Platforms Revolutionizing Healthcare

Patient Engagement Platforms

Patient engagement platforms are changing how healthcare is delivered by improving communication and handling administrative tasks.

These platforms can send appointment reminders, procedure instructions, messages, and surveys, making them essential in modern healthcare.

They help reduce missed appointments and administrative workload, allowing for better management of staff and more effective use of resources.

Patients benefit from better outcomes due to improved adherence to their treatment plans, while providers can manage patient interactions more efficiently.

Below are five patient engagement platforms that are making a big difference in healthcare today:

Top 5 Patient Engagement Platforms: A Quick Review

Top 5 Patient Engagement Platforms: A Quick Review

Let’s look at five leading platforms in healthcare: Relatient, Simple Interact, SolutionReach, Phreesia, and athenaCommunicator. We’ll compare their main features, benefits, and any downsides.

1. Relatient: Pros and Cons

Relatient stands out for its easy-to-use system and strong survey tools. Its simple interface allows healthcare providers to manage patient interactions effortlessly. The survey feature is particularly useful, making it easy to collect patient feedback.

However, Relatient has its drawbacks. The biggest issue is its limited forms capabilities. While it offers basic digital forms, it lacks more complex or customizable options. This limitation could be a problem for practices needing a wider variety of forms.

Despite this, Relatient remains a strong choice in the patient engagement platform market.

2. Simple Interact: Features

Simple Interact offers a range of services designed to boost patient engagement. It acts as an all-in-one front-office automation platform that can be customized to fit specific healthcare needs. A key feature is its fast turnaround time, which ensures a smooth experience for patients.

However, it lacks the self-booking appointment feature. Despite this, it achieves high patient participation, automatically confirming about 75% of appointments and reducing no-shows and missed appointments by 25%. This leads to better digital patient intake and higher satisfaction.

Simple Interact also excels in customer support, emphasizing that the people behind the technology play a crucial role in its effectiveness.

3. SolutionReach: Service Overview

SolutionReach offers a suite of services aimed at improving patient care and engagement. Key features include appointment reminders, messaging, procedure instructions, digital forms, and patient surveys. These tools help patients show up on time and prepared, reducing no-shows and missed appointments.

The platform also helps lower staffing needs and increases the use of healthcare providers.

However, some users have raised concerns about SolutionReach’s customer service. Despite this issue, the platform’s comprehensive tools continue to improve patient care and outcomes by enhancing adherence to treatment plans.

4. Phreesia: EHR Integration

Phreesia excels in integrating electronic health record (EHR) systems into its patient engagement platform. This seamless EHR integration reduces the need for manual data entry, enhancing productivity.

Phreesia’s platform connects effortlessly with EHR systems, allowing patient information to flow automatically. This ensures healthcare providers can quickly access updated patient records for accurate and timely diagnoses.

Additionally, Phreesia boosts patient engagement by giving patients access to their health data, encouraging them to take an active role in managing their health.

5. AthenaCommunicator: Usage and Limitations

AthenaCommunicator is a good fit for small practices, offering features like appointment reminders and patient surveys. These tools help reduce no-shows, increase provider utilization, and improve patient outcomes.

However, it has its limitations in customizability. Unlike athenaOne, it doesn’t offer as many options for tailoring to specific needs. This could be a drawback for practices seeking a more personalized solution.

While it provides basic patient engagement tools, it may not be as comprehensive as other platforms on the market.

Despite these limitations, AthenaCommunicator is an effective solution for smaller practices looking to improve patient engagement.

Summary

Patient engagement platforms such as Relatient, Simple Interact, SolutionReach, Phreesia, and AthenaCommunicator are changing the healthcare industry. They simplify tasks, boost communication, and help healthcare providers use their time more effectively.

These platforms offer much more than just reminders and surveys. They improve the overall healthcare experience, leading to better outcomes for patients.

By making healthcare more accessible and convenient, these tools are transforming how patients and providers connect and interact.

PureTech – Invented KarXT Receives U.S. Food and Drug Administration Approval for the Treatment of Schizophrenia in Adults

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that KarXT (xanomeline and trospium chloride), which was initially invented and advanced by PureTech, has received U.S. Food and Drug Administration (“FDA”) approval for the treatment of schizophrenia in adults.

The FDA approval triggers two separate milestone payments to PureTech totaling $29 million under agreements with Royalty Pharma and PureTech’s Founded Entity, Karuna Therapeutics, which was acquired by Bristol Myers Squibb (NYSE: BMY) (“BMS”) in March of 2024. Under these agreements, PureTech is also entitled to potential future payments related to additional milestones as well as approximately 2% royalties on net annual sales over $2 billion. Following the acquisition of Karuna, KarXT is now under the stewardship of BMS and will be marketed as Cobenfy.

Cobenfy was invented at PureTech by combining two biologically active molecules – xanomeline and trospium chloride – to address a tolerability challenge that had held back a potential new class of medicines for the treatment ofneuropsychiatric conditions, such as schizophrenia. Consistent with its unique model of drug development, PureTech advanced Cobenfy by founding Karuna Therapeutics, which later became a publicly traded company on Nasdaq.

Eric Elenko, PhD, Co-founder and President of PureTech said: “The FDA approval of Cobenfy is a significant milestone in our mission to transform the lives of patients with devastating diseases. Our initial hypothesis was that we could overcome the tolerability issues that had hindered the development of an otherwise promising drug, xanomeline, and we were able to test and validate this concept early on. We are immensely proud that our dedication to this program has led to the first major innovation in decades for those living with schizophrenia, and I am equally pleased that our unique approach to R&D has delivered yet another novel therapeutic to patients. Congratulations to the teams at Karuna and BMS on this historic accomplishment.”

The FDA approval of Cobenfy is further validation of PureTech’s model and a hallmark of how it creates value both clinically and financially. PureTech’s monetization of equity holdings in Karuna, including gross proceeds from the BMS acquisition of Karuna, and a strategic royalty agreement with Royalty Pharma have enabled PureTech to generate approximately $1.1 billion to date after directing $18.5 million toward Karuna’s founding and Cobenfy’s development.PureTech’s business model is designed to repeat and scale this type of outcome, and proceeds from the success of Cobenfy have enabled PureTech to self-fund the advancement of several programs – including LYT-100 (deupirfenidone), LYT-200 (anti-galectin-9 mAb), and the GlyphTM platform supporting the pipeline of Seaport Therapeutics.

Bharatt Chowrira, PhD, JD, Chief Executive Officer of PureTech said: “Congratulations to the Karuna and BMS teams for delivering a groundbreaking treatment to people with schizophrenia. The FDA approval of Cobenfy is a testament to our unique R&D engine, which has now produced three FDA approved therapeutics. We’ve applied this approach across our portfolio, from our late-stage Internal Program LYT-100 (deupirfenidone) to our newly launched Founded Entity, Seaport Therapeutics, and we will continue to leverage this successful drug development model as we enter our next phase of innovation.”

PureTech’s next wave of innovation continues to focus on validated biologic and small molecule modalities with human clinical data in diseases with significant unmet need. LYT-100 (deupirfenidone) is PureTech’s wholly-owned program in development for the treatment of idiopathic pulmonary fibrosis (IPF), a rare progressive lung disease with no cure. The LYT-100 program leverages extensive prior clinical data and follows the same blueprint used with Cobenfy to unlock the full therapeutic potential of an efficacious but poorly tolerated medicine. PureTech anticipates topline data from the Phase 2b clinical trial of LYT-100 in patients with IPF by the end of the year, as well as additional readouts from its oncology program, LYT-200 (anti-galectin-9 monoclonal antibody).

Important Safety Information

CONTRAINDICATIONS

COBENFY is contraindicated in patients with:

  • urinary retention
  • moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment
  • gastric retention
  • history of hypersensitivity to COBENFY or trospium chloride. Angioedema has been reported with COBENFY and trospium chloride.
  • untreated narrow-angle glaucoma

WARNINGS AND PRECAUTIONS

Risk of Urinary Retention: COBENFY can cause urinary retention. Geriatric patients and patients with clinically significant bladder outlet obstruction and incomplete bladder emptying (e.g., patients with benign prostatic hyperplasia (BPH), diabetic cystopathy) may be at increased risk of urinary retention.

COBENFY is contraindicated in patients with pre-existing urinary retention and is not recommended in patients with moderate or severe renal impairment.

In patients taking COBENFY, monitor for symptoms of urinary retention, including urinary hesitancy, weak stream, incomplete bladder emptying, and dysuria. Instruct patients to be aware of the risk and promptly report symptoms of urinary retention to their healthcare provider. Urinary retention is a known risk factor for urinary tract infections. In patients with symptoms of urinary retention, consider reducing the dose of COBENFY, discontinuing COBENFY, or referring patients for urologic evaluation as clinically indicated.

Risk of Use in Patients with Hepatic Impairment: Patients with hepatic impairment have higher systemic exposures of xanomeline, a component of COBENFY, compared to patients with normal hepatic function, which may result in increased incidence of COBENFY-related adverse reactions.

COBENFY is contraindicated in patients with moderate or severe hepatic impairment. COBENFY is not recommended in patients with mild hepatic impairment.

Assess liver enzymes prior to initiating COBENFY and as clinically indicated during treatment.

Risk of Use in Patients with Biliary Disease: In clinical studies with COBENFY, transient increases in liver enzymes with rapid decline occurred, consistent with transient biliary obstruction due to biliary contraction and possible gallstone passage.

COBENFY is not recommended for patients with active biliary disease such as symptomatic gallstones. Assess liver enzymes and bilirubin prior to initiating COBENFY and as clinically indicated during treatment. The occurrence of symptoms such as dyspepsia, nausea, vomiting, or upper abdominal pain should prompt assessment for gallbladder disorders, biliary disorders, and pancreatitis, as clinically indicated.

Discontinue COBENFY in the presence of signs or symptoms of substantial liver injury such as jaundice, pruritus, or alanine aminotransferase levels more than five times the upper limit of normal or five times baseline values.

Decreased Gastrointestinal Motility: COBENFY contains trospium chloride. Trospium chloride, like other antimuscarinic agents, may decrease gastrointestinal motility. Administer COBENFY with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention. Use COBENFY with caution in patients with conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis.

Risk of Angioedema: Angioedema of the face, lips, tongue, and/or larynx has been reported with COBENFY and trospium chloride, a component of COBENFY. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, discontinue COBENFY and initiate appropriate therapy and/or measures necessary to ensure a patent airway. COBENFY is contraindicated in patients with a history of hypersensitivity to trospium chloride.

Risk of Use in Patients with Narrow-angle Glaucoma: Pupillary dilation may occur due to the anticholinergic effects of COBENFY. This may trigger an acute angle closure attack in patients with anatomically narrow angles. In patients known to have anatomically narrow angles, COBENFY should only be used if the potential benefits outweigh the risks and with careful monitoring.

Increases in Heart Rate: COBENFY can increase heart rate. Assess heart rate at baseline and as clinically indicated during treatment with COBENFY.

Anticholinergic Adverse Reactions in Patients with Renal Impairment: Trospium chloride, a component of COBENFY, is substantially excreted by the kidney. COBENFY is not recommended in patients with moderate or severe renal impairment (estimated glomerular filtration rate (eGFR) <60 mL/min). Systemic exposure of trospium chloride is higher in patients with moderate and severe renal impairment. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate and severe renal impairment.

Central Nervous System Effects: Trospium chloride, a component of COBENFY, is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported with trospium chloride, including dizziness, confusion, hallucinations, and somnolence. Monitor patients for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how COBENFY affects them. If a patient experiences anticholinergic CNS effects, consider dose reduction or drug discontinuation.

Most Common Adverse Reactions (≥5% and at least twice placebo): nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastroesophageal reflux disease.

Use in Specific Populations:

  • Moderate or Severe Renal Impairment: Not recommended
  • Mild Hepatic Impairment: Not recommended

COBENFY (xanomeline and trospium chloride) is available in 50mg/20mg, 100mg/20mg, and 125mg/30mg capsules.

Please see U.S. Full Prescribing Information , including Patient Information .

Alveo Technologies Launches Academic Partnership Program to Drive Innovation in Point-of-Need Molecular Diagnostics with Global Virus Network as Inaugural Partner

Alveo Technologies, Inc. (Alveo), a leader in molecular sensing and diagnostics with its proprietary IntelliSense molecular detection technology platform, today announced the launch of an academic arm of its partner program in collaboration with the Global Virus Network (GVN), along with faculty at the Johns Hopkins University’s School of Public Health. The program now includes two new partnering approaches: a research use only (RUO) program focused on enabling innovative research through universities and academic partners and a deeper collaboration with Alveo that has the shared aim of commercializing tests in countries where there is a significant unmet need.

Global Virus Network (GVN) and faculty at John’s Hopkins University’s Bloomberg School of Public Health are initially focused on equipping their network with access to Alveo’s highly sensitive and easy-to-use platform to support the research and development of “in region, for region” testing. The primary goal of this effort is to enable institutions and developing countries with a highly sensitive and easy-to-use platform to proactively detect and track illness at the local level — and, ultimately, in the regional populations at large. Enabling testing at the point of need is paramount given the challenges of collecting and transporting samples to laboratories to provide results.

GVN was instrumental in helping to conceive the academic partner program, and its participation was announced at the GVN’s Annual Scientific Meeting in Durban, South Africa. “The world desperately needs accessible molecular tests for pathogens that afflict developing countries,” said Dr. Sten Vermund, President of the GVN. “This partnership will enable accessible ‘in-region, for-region’ test development, manufacturing, and deployment for devastating, yet neglected infectious diseases. The ability to identify hotspots before they spread will help us as a global community to avoid future pandemics.”

The GVN and its 80+ scientific sites, which include Johns Hopkins School of Public Health, will help countries develop tests on Alveo’s open platform, which is well suited for challenging environments thanks to the devices’ ruggedness and portability. The platform provides precise results comparable to polymerase chain reaction (PCR) in terms of accuracy and sensitivity without requiring shipment of samples to a lab for processing. Alveo provides on-location results within 30-45 minutes or less.
Alveo’s rugged device continues to complete tests and produce accurate results despite extreme temperatures, high humidity, shaken, or even dropped. The platform can upload geotagged results to the cloud, providing researchers and authorities with near real-time information on a pathogens’ spread, regardless of where in the world the test is run. Researchers can proactively collect, detect and track outcomes in Alveo’s cloud-based software solution, so test results can be accessed and aggregated from anywhere in the world.

“Many molecular testing platforms fall short in meeting the needs of remote and under-resourced regions worldwide, relying on expensive equipment, skilled and highly trained technicians and cumbersome sample transportation,” said Erik Tyrrell-Knott, Chief Business and Strategy Officer at Alveo Technologies. “Alveo is focused on helping the molecular testing world catch up with the modern world – making testing fast, sensitive, easy to use, and affordable. This partner program, with GVN’s member institutions, will enable scientists to take their cutting-edge research out of the lab and deliver it effectively to impacted populations.”

“I reached out to Alveo Technologies in our search for a diagnostics company that is open to rich, disruptive collaboration,” observed Dr. Maggie Linn Bartlett, program director for the Global Virus Network and faculty at the John Hopkins Bloomberg School of Public Health. “Together, Alveo and GVN have created a Partner Development Kit that enables GVN members to independently develop tests on Alveo’s be.well™ platform. Initial collaboration units have been placed with Professor Deborah Williamson of the MRC University of Glasgow Centre for Virus Research, Dr. Al Ozonoff of Broad Institute of MIT and Harvard and my lab at Johns Hopkins Bloomberg School of Public Health. I’m excited to finally solve a problem that has been unaddressed for far too long.”

For more information on the program visit: https://www.alveotechnologies.com/partner.

Medtronic Expands AiBLE Spine Surgery Ecosystem with New Technologies and Siemens Healthineers Partnership

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced today at the North American Spine Society (NASS) 39th Annual Meeting in Chicago the commercial launch of several software, hardware, and imaging innovations. These enhancements are designed to advance AiBLE™, the Medtronic smart ecosystem of innovative navigation, robotics, data and AI, imaging, software and implants that enable more predictable outcomes in spine and cranial procedures. In line with its commitment to increasing the quality of care for patients with spinal conditions, Medtronic also announced a partnership with Siemens Healthineers to explore opportunities to further expand access to advanced pre- and post-operative imaging technologies for spine care.

New advancements in the AiBLE Spine Surgery ecosystem build upon the company’s commitment to procedural innovation and execution, and include the following:

O-arm™ 4.3 software, which introduces advanced navigation volumes, dose reduction, and enhanced image confirmation. With this release, Medtronic now offers the industry’s longest 3D scan length for cone-beam CT images, which allows surgeons to capture additional spine levels in one scan and streamline their workflow. O-arm™ is the first and only intraoperative imager that uses AI, with 70% less radiation dose compared to the standard protocol, while maintaining image quality1. Medtronic Implant Resolution (MIR) further enhances decision-making by reducing metal artifacts around select screws, enabling confident final screw placement.

UNiD™ Adaptive Spine Intelligence (ASI), a Medtronic integrated service and software platform that leverages AI and predictive models to help surgeons deliver patient-specific surgical plans and implants, now includes MRI Vision, which integrates with CoLumbo from Smart Soft Healthcare into the UNiD™ workflow. This new tool employs computer vision technology to automatically analyze lumbar MRIs to segment, label, and measure key aspects related to common pathologies. MRI Vision will allow spine surgeons using UNiD™ ASI to access automated PDF reports and annotated DICOMs (Digital Imaging and Communications in Medicine) in the UNiD™ Hub to identify and quantitatively measure areas of interest such as muscle area with fat infiltration, key spinal alignment angles, key characteristic related to stenosis, and more. UNiD™ is powered by more than 28,000 patient procedures and continues to grow in adoption worldwide.

Mazor™ robotic guidance system with 5.1 software is the first and only spinal robotic system that integrates AI, bone cutting, and graft delivery. Mazor enables comprehensive preoperative and intraoperative planning that goes beyond screw placement to include complete construct design with screws, rods, interbodies, and bone removal. The newest version of 5.1 software introduces Maximum Intensity Projection (MIP), which supports improved image quality.

New implant innovation with ModuLeX™ Spinal System, which offers increased visualization of the surgical area while allowing the operative flexibility to create an optimized construct for the patient. ModuLeX™ is the next generation of the Medtronic CD Horizon™ product family, a 40-year leader in spinal fixation.
Global corporate partnership to complement Medtronic imaging offerings
Medtronic also unveiled a global partnership with Siemens Healthineers during the meeting. The two companies anticipate comarketing the Siemens Healthineers Multitom Rax™ imaging system and integrating the platform into the Medtronic AiBLE™ ecosystem for spine surgery. The companies also anticipate collaborating across technology development, marketing, and commercial activities to advance clinical outcomes.

The Multitom Rax™ offers a unique combination of imaging technologies that can be used across musculoskeletal conditions, including spinal patients. With standing, weight-bearing imaging, cone-beam CT, and supine X-ray capabilities, the Multitom Rax™ supports the commitment Medtronic has to advancing the standard of care across the care continuum.

“Partnering with Siemens Healthineers advances our commitment to reduce variability and improve outcomes for spinal patients,” said Skip Kiil, president of Medtronic Cranial & Spinal Technologies, which is part of the Medtronic Neuroscience Portfolio. “We are thrilled with the prospect of working with the industry leader in imaging and to leverage the depth of imaging experience and expertise, commercial footprint, and shared commitment to data science to advance our AiBLE strategy and shared pursuit of better patient outcomes.”

The envisioned partnership will be an evolution of the AiBLE™ ecosystem which integrates connected care and predictive technology to advance surgery.

“We are excited about the prospect of partnering with Medtronic to bring our solution to spine centers and empower spine surgeons and neurosurgeons to be more precise in the operating room,” said Verena Schoen, Executive Vice President X-ray Products at Siemens Healthineers. “Multitom Rax™ delivers geometrically accurate images which allows precise measurements of the patient’s vertebrae. Especially optimized for spine imaging, it not only contributes to faster diagnosis and treatment planning, but also to surgical execution and post-surgical control.”

About the Cranial & Spinal Technologies Business at Medtronic
As the market leader, Medtronic is transforming the standard of care in spine and cranial surgery worldwide by putting patients first and solving complex conditions for spine and neurosurgeons. With 150 products covering more than 20 pathologies, we serve over 4 million patients annually. Continuing our legacy of innovation, the AiBLE™ ecosystem is the culmination of everything Medtronic has built in Cranial & Spinal Technologies over the past two decades. By integrating advanced technologies and a patient-centric approach, we provide a customizable health solution for the primary challenges in cranial and spine surgery: the need for increased predictability and precision, more efficient workflows, and better surgical outcomes. For more information, visit www.Medtronic.com/AiBLE

Delray Medical Center is First Hospital in South Florida to Enroll a Patient in PICASSO Trial

PICASSO Trial

Delray Medical is the first hospital in South Florida to enroll a patient in the PICASSO trial.  The trial, which is in the critical third phase, is aimed at improving management for patients with tandem occlusions. This achievement is thanks to interventional neurologists Drs. Nils Mueller-Kronast and Dennys Reyes at Delray Medical Center, who are committed to improving stroke care through innovative research.

The enrollment of the first South Florida patient at Delray Medical Center is a critical step forward for the region’s involvement in this important study. The findings from the PICASSO Trial have the potential to significantly impact how stroke patients with tandem occlusions are treated, providing clearer guidance for physicians and better outcomes for patients.

“Not only are we one of only four Comprehensive Stroke Centers in Palm Beach County, but we are one of the leaders in the area that’s helping advance stroke care, something that we are extremely proud of,” said Delray Medical Center CEO, Heather Havericak.  “We are giving our patients the best chance at a quality outcome, which is always our number one priority.”

Tandem occlusions occur when a stroke in the brain is accompanied by a narrowing or blockage in the neck artery, limiting blood flow to critical areas. The PICASSO Trial, which has been enrolling patients across the country, is designed to determine the most effective way to treat this condition. The trial compares two distinct treatment approaches: stenting the artery to keep it open or performing angioplasty, a minimally invasive procedure that uses a balloon to restore blood flow.

The PICASSO National Steering Committee praised the team at Delray Medical Center for their dedication to advancing stroke care. “Dr. Mueller-Kronast and Dr. Reyes have shown outstanding commitment to the field, and we are excited that Delray Medical Center is the first in South Florida to enroll a patient in this important study.”

Unveiling the Hidden Artistry: How Data Annotation Transforms Medical Imaging into AI Masterpieces

Data Annotation

In the grand tapestry of modern medicine, artificial intelligence is weaving threads that are redefining diagnostics and patient care. But behind the scenes of every groundbreaking AI model lies a silent artist: the meticulous craft of data annotation. This unsung hero transforms ordinary medical images and videos into rich, informative datasets that teach AI how to “see” like a seasoned physician.

The Alchemy of Data Annotation in Medicine

Imagine medical imaging as a vast gallery of abstract art—X-rays, MRIs, CT scans—each telling a story that’s not immediately obvious. Without guidance, AI models are like novices wandering through this gallery, unsure of what to make of the complex visuals. Data annotation acts as the curator, highlighting critical features through precise medical labeling. It marks the subtle shadows that hint at tumors, the faint lines indicating fractures, and the intricate patterns of vascular networks. This process turns enigmatic images into annotated masterpieces that AI can interpret and learn from.

An example of annotated medical image (source: “Annotating Medical Data – Authors: Katharina Grunberg, Oscar Jimenez-del-Toro, Andras Jakab, Markus Krenn)

Innovatiana: Merging Medical Insight with Technological Precision

What sets Innovatiana apart is its unique blend of medical expertise and technological prowess. Their team isn’t just composed of data scientists and data labelers; it includes experienced physicians who understand the nuances of clinical imagery. These medical professionals bring a depth of knowledge to the data annotation process that pure technologists might miss.

Working on advanced annotation platforms (V7, Encord or other DICOM viewers), Innovatiana’s experts delve into each image with a clinician’s eye and a technologist’s precision. They ensure that annotations aren’t just accurate but also clinically relevant. This symbiosis of skills results in datasets that are exceptionally robust, providing AI models with high-quality material to learn from.

Turning Pixels into Prognoses

The annotated datasets crafted by Innovatiana serve as the foundation for AI applications that are transforming healthcare:

  • Early Detection Marvels: AI models trained on these datasets can identify diseases at stages so early they’re often missed by the human eye, such as microscopic tumors or the earliest signs of degenerative conditions.
  • Customized Treatment Blueprints: By recognizing patterns unique to each patient, AI can help devise personalized treatment plans that increase the chances of success.
  • Efficiency in the ER: Automated image analysis accelerates diagnostic times in emergency settings, allowing medical staff to make quicker, more informed decisions.


A New Renaissance in Medicine

We’re on the cusp of a medical renaissance, where AI doesn’t replace the physician but augments their capabilities. Data annotation is the catalyst in this transformation, turning raw data into enlightened knowledge. Innovatiana stands at this exciting frontier, their teams blending the art of medicine with the science of technology to push the boundaries of what’s possible.

Conclusion: The Craft Behind the Innovation

While AI garners the spotlight, it’s important to acknowledge the craft that makes it all possible. The detailed work of medical labeling and expert data annotation is the bedrock of effective AI models in healthcare. Innovatiana embodies this craft, ensuring that the future of medicine is not just smart, but also deeply informed by human expertise. As we look ahead, it’s clear that the fusion of medical insight and technological innovation will continue to yield breakthroughs that enhance patient outcomes around the world.

 

New Study Shows Durability of Minimally Invasive Procedure to Combat Knee Pain

A new study shows that a minimally invasive treatment for osteoarthritis (OA) in the knees may have a lasting benefit of at least 2 years.

Published today in the Journal of Vascular and Interventional Radiology during Pain Awareness Month, the study of genicular artery embolization (GAE) followed 40 patients with moderate-to-severe symptomatic knee OA after their GAE treatment and measured pain scores throughout the 24-month study period. The patients were not candidates for total knee replacement.

“Knee osteoarthritis is a leading cause of adult disability and, until now, most minimally invasive treatment options have been proven to provide only short-term relief, measured in weeks or months,” said Siddharth A Padia, MD, FSIR, the lead author of the study and professor of radiology at UCLA Health. “For patients who are not candidates for knee replacement surgery, our study shows that GAE provides durable benefit to many patients, measurable for up to 2 years, a great leap forward in offering this cohort lasting relief.”

OA was once considered just a “wear and tear” process, but there is increasing evidence that the growth of new, abnormal synovial blood vessels causes painful inflammation, greatly contributing to OA symptoms throughout the body. GAE targets this abnormal blood flow to reduce inflammation, quickly improving patients’ pain.

To deliver treatment, interventional radiologists create a pinhole-size incision in the hip and insert a small catheter into the arteries in the arthritic knee. They, then, inject tiny particles to normalize the blood supply to inflamed and painful areas of the knee. The outpatient procedure takes approximately 1 to 2 hours, followed by a 2-hour recovery period.

For this prospective, single-arm study, researchers defined clinical success as a greater than 50% reduction in OA symptoms using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). A previous study of this cohort found that 25 of the patients (66%) reported improvement at 1 year. Of those 25, 18 patients (72%) have since reported continued relief of symptoms at 2 years. Overall, 18 of the original 38 patients (47%) who remained in the study throughout the 2-year follow up period reported a greater than 50% reduction in OA symptoms over the 2 years. No long-term adverse effects were reported.

“GAE is a promising therapeutic option for patients with osteoarthritis in the knee, allowing patients to return to their normal activities without lengthy recovery times,” said Padia. “We believe further investigation with larger cohorts and randomized controls should be conducted so we can validate these findings, refine patient selection and optimize the management of OA related knee pain.”

Read the full study at jvir.org.