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Who Makes Nitrile Gloves in the United States?

Nitrile Gloves

Nitrile gloves have become essential across multiple industries, including healthcare, industrial operations, and food service. More than 100 billion standard exam gloves are utilized annually in the United States.

For years, the global supply chain dominated the nitrile glove market. However, recent events, including the COVID-19 pandemic, have underscored the critical need for domestic manufacturing to ensure a stable and reliable supply. In this article, we get into the landscape of nitrile glove production within the United States.

Key Factors in Nitrile Glove Manufacturing

Several key factors influence the viability of nitrile glove manufacturing within the United States. Access to high-quality nitrile rubber is paramount. While the US possesses some domestic production capacity, a significant portion is still imported.

Statista reports that America contributes a mere 2.7% to the world’s natural rubber production. As a result, America relies heavily on imports to meet its rubber needs.

Additionally, the availability of skilled labor is crucial for operating complex manufacturing processes efficiently. Besides, energy costs and environmental regulations significantly impact production expenses. Finally, a robust supply chain infrastructure, including reliable transportation and logistics, is essential for delivering products to market.

How do FDA and ASTM standards affect the quality of nitrile gloves?

FDA and ASTM standards play a crucial role in ensuring nitrile gloves’ quality. The FDA requires gloves to meet medical safety standards, while ASTM defines durability and protection testing methods. Adherence to these standards guarantees gloves are reliable and safe for various applications.

Types of Entities Capable of Producing Nitrile Gloves

Entities capable of producing nitrile gloves include specialized glove manufacturers, large-scale industrial producers, and medical supply companies. These entities often have advanced facilities and technology to ensure high-quality production and compliance with safety and performance standards.

Established Medical and Industrial Equipment Manufacturers

Established medical and industrial equipment manufacturers significantly impact nitrile glove production. Companies like Ansell, Kimberly-Clark, and Cardinal Health are renowned for their experience and advanced manufacturing capabilities. They utilize state-of-the-art technology and strict quality control to produce high-quality nitrile gloves that meet rigorous safety standards.

Their long-term expertise ensures their products provide excellent protection and durability for critical healthcare and heavy-duty industrial applications.

Specialized Nitrile Glove Production Companies

The nitrile glove market has witnessed a surge in demand, prompting the emergence of companies solely dedicated to nitrile glove production. These specialized companies typically emphasize stringent quality control, product innovation, and cost efficiency. By concentrating exclusively on nitrile gloves, they can refine their production processes and cater to specific market niches.

Nephron Nitrile highlights that these gloves offer a second-skin fit for optimal tactile sensitivity. Ideal for various industries, they provide a reliable barrier against contaminants.

A key factor driving the growth of these specialized companies is the increasing emphasis on product differentiation. Consumers and businesses alike seek nitrile gloves with enhanced features such as improved tactile sensitivity, chemical resistance, or extended durability. A specialized nitrile glove manufacturer is well-positioned to develop and deliver these specialized products.

As demand rises, the nitrile glove manufacturer’s role becomes critical in meeting the evolving needs of various industries.

Chemical and Rubber Manufacturers

Chemical and rubber manufacturers are integral to the nitrile glove production process. These companies supply the essential raw materials, such as nitrile butadiene rubber (NBR), which is the backbone of nitrile gloves. Their expertise in chemical formulation and polymer synthesis produces high-quality NBR, which is known for its chemical resistance, flexibility, and strength.

However, there is a shortage of NBR for glove manufacturers in the US. The US Government states that NBR, essential for nitrile gloves, is insufficient in quantity and quality to meet its needs. Consequently, a non-availability waiver is being sought for NBR supply. US manufacturers estimate that it will take at least 20 months to fully source and manufacture all glove components, including NBR, domestically.

Custom Manufacturing Facilities

Custom manufacturing facilities specialize in producing nitrile gloves tailored to specific client needs. These facilities provide design, color, texture, and size flexibility, catering to niche markets needing specialized medical or industrial applications. A few leading manufacturers in this sector utilize advanced machinery and innovative production techniques.

Production Capacity and Technical Expertise

US nitrile glove manufacturers’ production capacity and technical expertise are crucial in meeting the high demand for gloves. Leading manufacturers boast state-of-the-art facilities equipped with advanced automation and precision machinery, enabling them to produce millions of gloves daily. These companies invest heavily in R&D to innovate and enhance glove quality, focusing on improved durability, chemical resistance, and user comfort.

Reuters reported that the US Department of Health and Human Services (HHS) has committed $572 million to five glove projects. This includes $81.3 million allocated to Japan’s SHOWA Glove Co. The investment aims to develop domestic capacities capable of producing over 600 million nitrile gloves per month, according to an HHS spokesperson.

How do advancements in manufacturing technology impact the quality of nitrile gloves?

Advancements in manufacturing technology enhance the quality of nitrile gloves by improving precision, consistency, and efficiency in production. Innovations like automated dipping and real-time quality control enhance durability, chemical resistance, and comfort, meeting higher safety and performance standards.

Challenges in US Nitrile Glove Production

A major challenge is the reliance on imported nitrile butadiene rubber (NBR), which introduces supply chain vulnerabilities and fluctuating costs. Maintaining stringent quality standards while scaling up production to meet rising demand, especially during health crises, is also difficult. Also, labor shortages and increasing operational costs further complicate the production process.

These challenges require continuous investment in technology and workforce training to maintain production efficiency and product quality amidst global pressures.

How do regulatory compliance issues affect the production process?

Regulatory compliance issues impact the production process by requiring manufacturers to adhere to stringent safety, quality, and environmental standards. This necessitates rigorous testing, documentation, and continuous monitoring, which can increase production costs and complexity. However, compliance ensures that the final products are safe, reliable, and meet market expectations.

Opportunities for New Entrants

The US nitrile glove market offers significant opportunities for new entrants, driven by rising demand in the healthcare, industrial, and consumer sectors. The COVID-19 pandemic underscored the need for a robust domestic supply chain, spurring investment in local production. Emerging companies can capitalize on advancements in automation and sustainable practices to stand out.

For instance, focusing on eco-friendly gloves made from recyclable materials or those with enhanced comfort and protection can help capture niche markets.

Future Trends and Developments

The future of nitrile glove manufacturing in the US promises significant advancements driven by technological innovations and sustainability efforts. Trends such as automation and artificial intelligence will enhance production efficiency and consistency. Also, there is a growing focus on developing eco-friendly gloves using biodegradable materials and recyclable packaging to reduce environmental impact.

Manufacturers are also investing in advanced research to improve glove performance, such as enhanced puncture resistance and better tactile sensitivity. Precedence Research estimates that the US market for nitrile gloves was projected to grow at a CAGR of 7.2% from 2023-2032. This growth underscores the potential for ongoing innovation and expansion, enabling US manufacturers to meet global demands and stay competitive.

Nitrile Glove Industry’s Future

The US nitrile glove manufacturing industry features a diverse array of players. As demand for high-quality nitrile gloves increases, opportunities for new entrants and eco-friendly products will shape the industry’s future.

With strong market growth projections, the US is well-positioned to maintain its competitive edge. This ensures a steady supply of essential protective gloves. These gloves are essential for protecting health and ensuring safety across multiple industries.

RetiSpec Closes $10M USD to Advance Commercialization of its AI-Driven Eye Test for Detection of Alzheimer’s Disease

RetiSpec Inc., an innovator in AI-driven eye diagnostics for brain health, announced the successful closing of its $10M USD Series A financing. This funding will enable RetiSpec to accelerate the commercialization of its groundbreaking technology aimed at early detection of Alzheimer’s disease.

The Series A financing was led by iGan Partners and included new strategic investors, Eli Lilly and Company and Topcon Healthcare, Inc., along with existing investors, Gentex Corporation, the Alzheimer’s Drug Discovery Foundation’s Diagnostics Accelerator, Verge HealthTech Fund, University of Minnesota’s Discovery Capital, Ontario Brain Institute, Centre for Aging + Brain Health Innovation, and private investors. This financing brings RetiSpec’s total fundraising to $17M USD.

RetiSpec’s clinically validated test aims to help healthcare providers predict amyloid burden, a core biomarker of Alzheimer’s disease. The test is now available for Research Use Only, it is expected to be utilized in routine clinical office visits globally in the near future. RetiSpec’s AI solutions applied to non-invasive retinal images, provide real-time assessments at the point of care. The company’s goal is to also develop additional AI-driven diagnostics for neurodegenerative diseases and side effects of Alzheimer’s therapeutics.

In related developments, RetiSpec will take part in the upcoming Bio-Hermes-002 study sponsored by the Global Alzheimer’s Platform Foundation (GAP). The study aims to investigate the relationship between novel markers of Alzheimer’s disease, including RetiSpec’s test, and the gold standard for diagnosis across a sample of 1,000 cognitively normal and impaired participants. Bio-Hermes-002 is expected to include an unprecedented number of participants from traditionally underrepresented populations in Alzheimer’s studies in order to benefit everyone impacted by Alzheimer’s and related dementias.

Along with the financing, RetiSpec is pleased to welcome Lance Patton, Chief Commercial Officer at Topcon Healthcare, Inc., to its board of directors. His 28 years of expertise in driving adoption of diagnostic imaging technologies via eyecare settings will be invaluable as RetiSpec continues to scale and bring its innovative solutions to market.

“The closing of this Series A financing is a testament of the significant strides we’ve achieved and marks a major step forward in our mission to enable widespread early and accurate detection of neurodegenerative disease markers with our innovative AI-driven eye test,” said Eliav Shaked, Co-founder and CEO of RetiSpec. “We are thrilled to welcome such strong new investors, alongside existing investors, such as Gentex, who have been key contributors throughout our journey. Together, this investment will allow us to accelerate the commercialization of our AI-driven eye test, which has the potential to transform patient outcomes and enable early, accurate, and equitable access to treatment”.

Vascular Surgery

vascular surgery

Vascular surgery is a branch of medicine that deals with the diagnosis and treatment of diseases affecting the blood vessels. It has a significant historical relevance, with advancements and milestones that have shaped the field over time.

One of the earliest recorded instances of vascular surgery dates back to the ancient Egyptians, who attempted to treat vascular disorders using various techniques. However, it wasn’t until the 20th century that significant progress was made in the field.

In the early 1900s, the development of blood transfusion techniques and the understanding of blood types laid the foundation for safer surgical procedures. This knowledge paved the way for the first successful vascular surgery procedures.

In 1912, Alexis Carrel, a French surgeon, introduced the technique of vascular anastomosis, which involves connecting blood vessels together. This breakthrough allowed for the repair and reconstruction of damaged blood vessels, leading to improved outcomes for patients.

During World War II, vascular surgery saw further advancements. Surgeons gained valuable experience in treating vascular injuries caused by shrapnel and gunshot wounds. This experience led to the development of new techniques and approaches to manage vascular trauma.

In the 1950s and 1960s, the introduction of synthetic graft materials revolutionized vascular surgery. Surgeons could now bypass blocked or damaged blood vessels using artificial grafts, improving blood flow and saving lives.

The field continued to evolve with the introduction of minimally invasive techniques in the 1980s. Endovascular procedures, such as angioplasty and stenting, became viable alternatives to open surgery for certain vascular conditions. These less invasive procedures offered reduced recovery times and improved patient outcomes.

Today, vascular surgery encompasses a wide range of procedures, including bypass grafting, endovascular repair of aneurysms, and treatment of peripheral artery disease. Ongoing research and technological advancements continue to shape the field, with a focus on improving patient outcomes and minimizing invasiveness.  Vascular surgeons must continue to receive on-going CME credits to stay proficient in their field.

In conclusion, vascular surgery has a rich historical relevance, with milestones and advancements that have shaped the field over time. From ancient Egyptian attempts to modern-day minimally invasive procedures, the field has come a long way in improving the diagnosis and treatment of vascular diseases.

Providence St Joseph Hospital Performs World’s First Spine Surgery Using eCential Robotics’ Open Spine Robot, with Spineart Compatible Implants

Providence St Joseph Hospital announced it has successfully performed the world’s first robotic spinal surgery using a new open spine platform by eCential Robotics to implant a Spineart medical device.

eCential Robotics, a surgical robotics company which developed the open surgical platform and Spineart, a leader in spine surgery innovation, are collaborators in a new age of open technology sharing that allows cross-functional use of implantation devices and robotic surgical platforms.
“In our relentless pursuit of innovation and excellence in patient care, we were eager to utilize the solutions provided by Spineart and eCential,” said Erick Westbroek*, M.D., Providence St Joseph spinal surgeon. “The integration of Spineart’s advanced implant system with eCential’s open robotic platform will enable us to perform minimally invasive surgeries with high predictability, reproducibility and outcomes.”
Providence St. Joseph Hospital has become the first clinical institution in the world to be equipped with the state-of-the-art robot, and the recent surgeries are the first in the United States to be used successfully in conjunction with Spineart implants.
“St. Joseph Hospital has built a strong reputation for world-class surgical care, and our patients often travel from far and wide to seek treatment and care from our stellar spine and orthopedic surgeons, who are armed with cutting-edge technology,” said Brian Helleland, chief executive of Providence St. Joseph Hospital and the Orange County/High Desert area. “These advances provide yet another sophisticated platform for our surgeons to do what they do best.” 
“We are thrilled to announce the installation of this state-of-the-art robot at St. Joseph Hospital,” said Jerome Trividic, CEO of Spineart. “We believe this advancement will greatly benefit our customers, hospitals, surgeons, and patients by enhancing surgical precision and improving patient outcomes.”
St. Joseph’s surgical cases for eCential Robotics are a first-in-human use of its unified robotic technology, as well as the start of eCential operations in the US. It also marks the introduction of cutting-edge solutions that address the evolving needs of surgeons and patients worldwide.
“We are pleased to see the adoption of our technology in the US,” Clément Vidal, CEO of eCential Robotics. “There is strong interest and momentum for our open solution because it allows surgeons to select the optimal implant system for each patient while providing financial advantages to hospitals. Our platform is described as the smartphone of surgical robots.”

New Studies Validate the Value of Brainomix AI Technology Across US Stroke Networks

Brainomix, a pioneer in artificial intelligence (AI) imaging solutions, announced new data from studies that were presented this week at the US-based Society of Neurointerventional Surgery’s (SNIS) Annual Meeting in Colorado Springs. The latest research, in collaboration with the Mayo Clinic, West Virginia University, and Boston Medical Center, highlighted some of the cutting-edge, AI-enabled technology that the Oxford-based company has developed within its pipeline for the Brainomix 360 Stroke platform, representing groundbreaking capabilities that will enable physicians to extract maximal value from universally available non-contrast CT scans across stroke networks.

The FDA-cleared Brainomix 360 Stroke platform is powered by state-of-the-art AI algorithms that provide real-time interpretation of brain scans to aid treatment and transfer decisions for stroke patients, with the aim of enabling more patients to receive the right treatment, in the right place, at the right time.

Dr Michalis Papadakis, CEO and Co-Founder of Brainomix, said: “The studies presented this week at SNIS symbolize our ongoing commitment to scientific excellence and reflect the successful partnerships that we have forged with leading academic institutions across the United States to jointly explore the frontiers of stroke AI imaging. Together we are identifying exciting opportunities that may expand the capabilities of physicians to better manage stroke patients across all levels of stroke networks with our technology.”

Dr Ansaar Rai, Professor and Chair, Department of Neuroradiology & Neurointerventional Surgery, West Virginia University, said: “The studies presented this week at SNIS highlight the clinical value of the Brainomix 360 Stroke platform, particularly relating to the e-ASPECTS and Triage Stroke algorithms that assess non-contrast CT scans, which are universally available to all stroke centers across the US. The results indicate that these algorithms generate clinically relevant results for frontline stroke physicians that could help them to better manage stroke patients eligible for mechanical thrombectomy across all centers within a network.”

Key studies presented at SNIS included:

  • “AI Derived Clot Characteristics Predict Recanalization Success in Large Vessel Acute Stroke Patients Undergoing Mechanical Thrombectomy” was a research collaboration between Brainomix and West Virginia University in which baseline non-contrast CT (NCCT) scans from patients with large vessel occlusion (LVO) were analyzed with Brainomix 360 e-ASPECTS to identify hyperdense clots and quantify their length. The results showed that clot biomarkers from NCCT are predictors of successful recanalization and could facilitate the planning of mechanical thrombectomy (MT) procedures.
  • “Large Vessel Occlusion Detection in Acute Ischemic Stroke Using Non-Contrast CT” was a multisite collaboration with the Mayo Clinic, West Virginia University, and Boston Medical Center validating Triage Stroke as a reliable tool for LVO detection. The authors concluded that when coupled with clinical information such as NIHSS, the tool may help centers to identify thrombectomy candidates, especially those with constrained resources and basic imaging.
  • “How Dark Is Too Dark? Using Net-Water Uptake to Predict Futile Recanalization Following Mechanical Thrombectomy” was another multisite collaboration, this one between the Mayo Clinic, West Virginia University and Brainomix. Ischemic core volume and depth of hypoattenuation using Net Water Uptake (NWU) were quantified from baseline CT scans using Brainomix 360 e-ASPECTS, with results showing that NWU extracted automatically from routine imaging may help identify patients at risk of futile recanalization – especially those with large cores.

 

Delray Medical Center | 1st Hospital in Florida to Use Innovative Treatment for Abdominal Aortic Aneurysm

Delray Medical Center is the first hospital in Florida to treat a patient with the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System.  The procedure was performed by Dr. Joseph Ricotta, Chairman of the Vascular Surgery Program at the hospital, as well as National Medical Director of Vascular Surgery and Endovascular Surgery for Tenet Healthcare.

The procedure is an innovative potential treatment for small to mid-sized infrarenal abdominal aortic aneurysms (AAA), a dangerous bulge or ballooning in the section of the aorta located in the abdomen below the kidneys and part of the largest blood vessel carrying blood from the heart to the rest of the body. If an AAA ruptures or leaks, it causes bleeding in the abdomen – a life-threatening medical emergency requiring immediate medical attention.

Current surgical or endovascular AAA treatments are reserved for AAAs larger than 5.5 cm in diameter for men and 5.0 cm for women, in symptomatic patients, or in rapidly expanding aneurysms. To date, randomized clinical trials have shown no survival advantage for repair of aneurysms with a diameter less than 5.5 cm. For that reason, smaller AAAs are traditionally monitored with serial ultrasounds or computed tomography (CT) surveillance. The patients enrolled in the Nectero EAST clinical trial included women with AAAs between 3.5cm-4.5cm and men with AAAs between 3.5cm-5.0cm.

The Nectero EAST system delivers a single-dose of 1,2,3,4,6-pentagalloyl glucose (PGG) directly at the site of the AAA which is designed to prevent aneurysm growth or rupture and can allow patients to avoid future surgery for aneurysm repair. The drug is administered through a dual-balloon delivery catheter via the femoral artery. The procedure can be conducted under local anesthesia, takes under an hour to complete, and leaves no implant behind.

“We are proud that Dr. Ricotta, a highly respected member of the Delray Medical Center Medical Staff, was selected to participate in this important clinical trial and we congratulate him on being the first surgeon in Florida to achieve this medical milestone,” said Heather Haverciak, the hospital’s CEO. “If proven safe and effective, this therapy has the potential to profoundly impact patients living with aneurysmal disease.”

AAAs, which occur in nearly 5% of the population, represent a significant public health problem[1]. In the US, 4,500 deaths per year are attributed to AAA ruptures[2].  An additional 1,400 deaths annually result from attempted AAA repair2. About 1.1 million patients in the US are estimated to have small- to mid-sized AAAs (3.5 – 5.0 cm in diameter).

Dr. Ricotta, a nationally and internationally recognized expert in the field of vascular and endovascular surgery, earned his undergraduate degree at Yale University and his medical degree from Jefferson Medical College. He completed his residency in general surgery at Johns Hopkins Hospital and was a traveling scholar and specialist registrar in vascular surgery at Oxford University in England. In addition, he completed a vascular and endovascular surgery fellowship at the Mayo Clinic in Rochester, Minnesota, followed by an advanced endovascular surgery fellowship at the Cleveland Clinic. He is the first surgeon in the U.S. to use endovascular robotics to perform minimally invasive vascular surgery and has authored more than 300 publications and delivered more than 500 lectures on the national and international stage.  He has been named a Castle Connolly “America’s Top Doctor” multiple times and earned a position on Newsweek’s “America’s Best Vascular Surgeons 2024” list.

[1] The impact of gender on presentation, therapy, and mortality of abdominal aortic aneurysm in the United States, 2001–2004. McPhee JT, Hill JS, Eslami MH. J Vasc Surg. 2007;45:891–9

 

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Teva Pharmaceuticals and Sanofi Announce Accelerated Timeline for Anti-TL1A Phase 2b Program in Patients with Inflammatory Bowel Disease

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Sanofi today announced an update to the timing for the anti-TL1A, duvakitug (formerly known as TEV-’574/SAR447189) program investigating the human IgG1-λ2 monoclonal antibody targeting TL1A for moderate-to-severe IBD.

Patient enrollment in the RELIEVE UCCD (ulcerative colitis and Crohn’s disease) Phase 2b trial has completed early due to significant acceleration in patient recruitment. As a result, Teva and Sanofi now anticipate having topline results for both UC and CD in Q4 2024, and detailed results will be presented in a scientific forum in 2025. This adjustment replaces the previously planned interim analysis for the second half of 2024, which will not be conducted. Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug for moderate-to-severe UC and CD patients.

About the Collaboration

On October 3, 2023, Teva and Sanofi entered into an exclusive collaboration to co-develop and co-commercialize Teva’s duvakitug (anti-TL1A) for the treatment of UC and CD, two types of IBD. Under the terms of the agreement, in partial consideration of licenses granted to Sanofi, Teva received an upfront payment of $500 million shortly after closing and may receive up to $1 billion in development and launch milestones. Each company will equally share the remaining development costs globally and net profits and losses in major markets, with other markets subject to a royalty arrangement. Sanofi will lead the development of the Phase 3 program. Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world.

About Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a chronic autoimmune disorder characterized by chronic inflammation of the gastrointestinal (GI) tract. The two main types of IBD are ulcerative colitis (UC) and Crohn’s disease (CD).1 UC and CD are chronic inflammatory conditions of the GI tract characterized by repetitive cycles of relapses and remission. Prolonged inflammation can lead to damage within the GI tract, including fibrosis, a common complication of IBD characterized by an excessive accumulation of scar tissue in the intestinal wall, which may cause narrowing and obstruction. Common symptoms of both conditions include persistent diarrhea, rectal bleeding, abdominal pain, loss of appetite, and weight loss. There is currently no cure for IBD – the goal of treatment is to induce and maintain remission and prevent flares.2 Globally, approximately 4.9 million cases of IBD have been identified, with incidence rising in several regions.3

About RELIEVE UCCD

RELIEVE UCCD is a 14-week Phase 2b, randomized, double-blind, dose-ranging study to determine the pharmacokinetics, efficacy, safety, and tolerability of duvakitug (anti-TL1A) in adults with ulcerative colitis (UC) or Crohn’s disease (CD). In the trial, patients who meet pre-specified inclusion criteria are randomized to subcutaneously receive either one of two duvakitug (anti-TL1A) dose regimens or placebo in a 1:1:1 ratio (stratified by diagnosis [UC or CD] and previous exposure to advanced IBD therapy [biologics and small molecules]) for 14 weeks. Participants who complete the 14-week induction period have the option to enter the long-term extension (LTE), consisting of a 44-week maintenance period for responders and a re-induction period for non-responders. Primary efficacy endpoints for both the 14-week and 44-week LTE study are number of participants with moderate-to-severe UC who show clinical remission (as defined by the modified Mayo score) and the number of participants with moderate-to-severe CD who show an endoscopic response (as defined by the endoscopic score for CD). The trial includes sites in the U.S., Canada, Europe, and Asia.4,5

About Duvakitug (Anti-TL1A)

Duvakitug (anti-TL1A) is a potential best-in-class human IgG1-λ2 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15 (TNFSF15). TL1A signaling is believed to amplify inflammation and drives fibrosis associated with inflammatory bowel disease (IBD); thus, targeting TL1A with duvakitug may mitigate the over-active immune response in these conditions. Duvakitug (anti-TL1A) is currently in Phase 2b clinical trials for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD), two types of inflammatory bowel disease. The safety and efficacy of duvakitug (anti-TL1A) have not been reviewed by any regulatory authority.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace, including our ability to achieve expected results from investments in our product pipeline including to successfully develop and commercialize our duvakitug (anti-TL1A, TEV’574) asset for the treatment of ulcerative colitis and Crohn’s disease, two types IBD; our exclusive collaboration with Sanofi; the risk that we will incur significant costs in connection with the development of anti-TL1A (duvakitug), which may exceed any revenue generated by duvakitug (anti-TL1A); risks that regulatory approvals and other requirements may delay the development and commercialization of our duvakitug (anti-TL1A); our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

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  1. What is inflammatory bowel disease (IBD)? Centers for Disease Control and Prevention. 2022. Available at: https://www.cdc.gov/ibd/what-is-IBD.htm. Accessed July 2024.
  2. McDowell, C., Farooq, U., & Haseeb, M. (2020). Inflammatory Bowel Disease (IBD). PubMed; StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK470312/. Accessed July 2024.
  3. Dharni, K., Singh, A., Sharma, S. et al. Trends of inflammatory bowel disease from the Global Burden of Disease Study (1990-2019). Indian Journal of Gastroenterology (2023). https://doi.org/10.1007/s12664-023-01430-z.
  4. A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s Disease (RELIEVE UCCD) https://clinicaltrials.gov/study/NCT05499130?term=TEV-48574&rank=2. Accessed July 2024.
  5. A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s Disease. https://clinicaltrials.gov/study/NCT05668013?term=TEV-48574&rank=1. Accessed July 2024.

Dr Robert Alexander Joins T3D Therapeutics’ Scientific Advisory Board

T3D Therapeutics, Inc., a clinical-stage drug development company engaged in the development of a new orally administered treatment for Alzheimer’s disease (AD), today announced that Dr. Robert Alexander has joined the Company’s Scientific Advisory Board.

CEO John Didsbury states,

“As we advance the clinical development of our drug candidate, T3D-959, beyond our completed Phase 2 PIONEER trial, Dr. Alexander’s expertise in Alzheimer’s drug development and regulatory affairs will be invaluable.”

Dr Robert Alexander is currently the Chief Scientific Officer of the Alzheimer’s Prevention Initiative at the Banner Alzheimer’s Institute and a Research Professor in the Department of Psychiatry at the University of Arizona School of Medicine-Phoenix. Previously, he held positions as VP in the neuroscience therapeutic area unit at Takeda, VP and head of clinical for the neuroscience and pain at Pfizer, VP of clinical for CNS and the pain innovative medicines unit (iMed) at AstraZeneca, as well as other positions in discovery medicine and neuroscience at GSK and Merck. Dr. Alexander received his M.D. degree from The University of Chicago Pritzker School of Medicine. He is certified by the American Board of Psychiatry and Neurology and specializes in psychopharmacology, having conducted or supervised clinical studies in a broad range of neurologic and psychiatric indications.

“The Phase 2 results of T3D-959 in mild-to-moderate AD patients are compelling and offer the strong potential to have a positive impact on this catastrophic disease. I am looking forward to assisting the Company to help advance this drug to market as expeditiously as possible,” said Dr. Alexander.

About T3D-959: T3D-959, a small molecule, delivered orally once daily, is a brain-penetrating PPAR delta/gamma dual nuclear receptor agonist designed to improve both glucose and lipid metabolism dysfunctions present in AD and other neurodegenerative disorders.

The Crossroads of a Revolution: Medical Device Design Meets Disruption | By Steve Levine, Senior Director, Virtual Human Modeling, Dassault Systèmes

Medical Device Design
Steve Levine, Senior Director, Virtual Human Modeling, Dassault Systèmes

The days of banking on a pill to deliver a “silver bullet” cure are ending – today’s medical treatments are far more complex. In an era where the fusion of technology and healthcare feels more like destiny than choice, cardiovascular, neurological and even orthopedic medicine have entered an extraordinary industry transformation. New players with waves of smart, AI-driven devices and cutting-edge delivery techniques are challenging the status quo, compelling medical design experts to embrace sophisticated engineering and manufacturing software tools once reserved for the world of automotive and aeronautics. Welcome to the next plateau of innovation, where the future of medical device design is being conceived.

Setting aside consumer-oriented “Healthtech” products coming from giants such as Apple, one need only look at the acceleration of novel device approvals from the FDA, a record number of 124 in 2023. This is a five-fold increase from the 25 granted 15 years earlier, whereas drug approvals have barely doubled and more than half of these require a device for delivery. Additionally, the agency has granted 921 “Breakthrough Device” designations, indicating the flood of completely new innovations emerging. More and more, the acceleration of these innovations is being driven through the use of virtual twins to test device performance before investing in expensive and time-consuming physical prototyping, thus avoiding sub-optimal designs. The result is not only new and innovative designs but also increased confidence in safety and efficacy before moving to physical prototypes for confirmation.

The impact of these new tools of medical device design, in comparison to large-scale manufacturing industries, is still in its infancy. But history has shown that those in the forefront will lead the way for a new age of high-value, accelerated, and more human-centric medical device technologies… with the commensurate ROI to show for it. Even the FDA has acknowledged its potential, as evidenced by its 10-year collaboration with the Living Heart Project and the publication of its most recent guidance document on the use of simulation.

Four pillars of virtual design 

Digital twin-based engineering, also known as virtual twin engineering, is the use of a computer-based 3D functional replica of a physical asset, system, or process. With this methodology, as a new product concept moves from initial sketch to design and eventually commercial manufacturing, advanced modeling and simulation techniques are used throughout the process. Designers and engineers are able to collaborate on a common platform as they analyze and optimize the performance. Once the performance is achieved, the real-world counterpart is created and tested. The results are fed back to the virtual twin for refinement of the model and subsequent optimization of the design.

For Medical Devices, virtual twin engineering provides numerous benefits beyond improved design and operational efficiency, spreading to the full lifecycle of the product. It can be used for accelerated approvals, optimized treatment protocols, predictive maintenance, and faster response when problems do arise. By leveraging virtual twin technology, organizations make informed decisions, reduce costs, minimize risks, and accelerate innovation.

The Psychology of Everyday Things by Don Norman is required reading in most university engineering programs. His insights can be boiled down to four key factors, which also happen to be the cornerstones of virtual twin engineering:

  • Make things visible: Full-time 3D modeling is accessible to all team members.
  • Provide good mapping: The relationship between an action and the response can be tested.
  • Create appropriate constraints: Common design parameters can guide designers throughout product development and testing.
  • Design for error: If there is a way to use the device wrongly — or dangerously — a user will find it. Using virtual twin engineering, potential design or usage flaws can be identified and worked out before uncovering them in the market.

User-centered design 

Taking this further, in this new era, it is not simply regulatory approval, but ultimately the end-user experience, whether it be the doctor or the patient that will govern success. An early research project on User Centric Design (UCD) by JD Gould and C. Lewis introduced three principles: 1) focus on users and tasks early and throughout the design process; 2) measure usability empirically; 3) design and test usability iteratively.

A UCD program using contemporary design tools and a virtual twin approach not only enables all three elements but also supports the collaboration critical to ensure the user experience is considered throughout the development process.  Lacking these collaborative processes, teams often stay siloed and information-sharing is limited. “At best [the lack of collaboration creates] unnecessary delays in design and development due to interruptions and iterations that could have been avoided had end-user insights and feedback been researched and incorporated early,” notes Jeff Morang, lead human factors engineer at BlackHӓgen Design, a Florida-based mechanical device engineering firm.

Competitive pressure

From a patient perspective, competition usually results in better quality and more affordable devices. To the industry, it pushes companies into an intense race to get to the market first and keep ahead as competitors enter the market. A global marketplace, tighter regulatory controls, skyrocketing cost of clinical data, and the visibility of product recalls are fierce headwinds for innovation. Add to that increasing design complexities — with multiple subsystems using both electronic and digital connectivity, the industry now must adapt to be able to address costly design flaws early, while they are still cost-effective to fix.

In the high-risk world of medical device development, the pathways to success are being redrawn. The old paradigm of design-build-tests is yielding the benefits of virtual twin experience-driven strategies as the new frontier. Ones that weave together every phase of the lifecycle, allowing powerful simulations that scrutinize the performance, safety, and quality of medical devices before expenses climb. Virtual twin simulation allows devices to be designed at a fraction of the time and cost generally needed while allowing companies to explore and test all possible variables for improved patient safety, quality, and efficacy. It’s a game where we all win.

Editor’s Note: Steven M. Levine, PhD is the Sr. director of virtual human modeling at Dassault Systèmes. Dr. Levine has more than 30 years of experience in the development of computational tools that translate cutting-edge science into product innovations. He currently leads Virtual Human Modeling at Dassault Systèmes and is the Founder and Executive Director of the Living Heart Project.He is responsible for a Life Science incubator of startup healthcare companies within the 3D EXPERIENCE Labs, building a marketplace of digital healthcare services,and serves on several company boards. Dr. Levine was elected into the College of Fellows in the American Institute for Medical and Biological Engineering (AIMBE) and holds a PhD in Materials Science from Rutgers University.  He began is career in health tech at the San Diego based startup Biosym that went public as Accelrys in 2004 and acquired by Dassault Systèmes in 2014.

 

Europe $3.53 Bn Sleep Apnea Devices Markets 2024-2032 by Types, Therapeutic Devices, Diagnostic Devices, End User, and Company Analysis

The “Europe Sleep Apnea Devices Market Report by Types, Therapeutic Devices, Diagnostic Devices, End User, and Company Analysis 2024-2032” report has been added to ResearchAndMarkets.com’s offering.

Europe sleep apnea devices market turned into US$ 1.81 billion in 2023 and is expected to reach US$ 3.53 billion by 2032, with a CAGR of 7.70% from 2024 to 2032.

Sleep apnea is a situation that may have an effect on human beings of all ages, and it regularly goes undiagnosed. In adults, obesity and excess weight are the main challenges behind sleep apnea. Additionally, life-related factors along with smoking, alcohol consumption, lack of bodily activity, and mental strain are contributing to the rising variety of sleep apnea cases in Europe. Due to the growing ailment burden and ongoing research and development efforts, the European marketplace for sleep apnea devices is predicted to grow progressively.

Europe’s old populace is the main reason for the growth in the prevalence of sleep apnea

Around 175 million European adults are anticipated to have sleep apnea, representing about 44% of the adult population. There is a rising demand for devices to diagnose and treat sleep apnea, and there is a trend toward home sleep testing for analysis.

As per the UK government report, “Future of an Older Population,” it’s projected that by 2040, nearly 1 out of every 7 individuals might be over 75. The document also predicts that by 2037, an anticipated 1.42 million more households might be led with the aid of individuals aged 85 or older, marking a 161% growth over 25 years. Furthermore, the proportion of the operating-age populace falling among the 50 and the state pension age is predicted to upward push from 26% in 2012 to 34% in 2050, representing a boom of over 5.5 million human beings.

As the same way, as said in a UN record on ageing regulations in France, like different European nations, is dealing with a constant and extensive rise in its elderly populace. In 2012, there were 15 million individuals aged 60 or older in France, projected to reach 24 million by 2060. As a result, the factors above will contribute to the local marketplace’s growth.

The upward thrust in patient empowerment ought to improve the demand for sleep apnea devices in Europe

Manufacturers are enhancing the layout and luxury of those devices to improve patient compliance. Economic stability and research funding for sleep issues can also affect the affordability and adoption of sleep apnea therapeutic devices in Europe. Increased research and development funding can pressure innovation within the marketplace.

The demand for transportable monitoring devices is growing, particularly among frequent travelers. These devices offer convenience, cost-effectiveness, and stepped-forward patients’ compliance. Manufacturers focus attention on enhancing patients’ comfort and integrating sleep health-monitoring features into wearable devices, which may additionally lead to the early identification of sleep apnea signs and symptoms.

Collaborations between sleep apnea device producers and sleep clinics can enhance patient care. The sleep apnea device marketplace contains Germany, the United Kingdom, France, Italy, Spain, and Russia. With its high incidence of sleep apnea, Germany has a sturdy healthcare system and a sturdy financial system that supports investment in medical devices and technology. Economic improvement and accelerated healthcare spending can positively affect the market for sleep apnea healing devices.

The Italian Association of Sleep Medicine states that there are over 300 sleep labs or clinics in Italy. This number has increased because of the growing awareness of sleep’s significance and the growing incidence of sleep problems.

Sleep laboratories play an essential role in diagnosing sleep apnea in Europe

Sleep labs are equipped with specialized devices for sleep studies, which include polysomnography and home sleep checking, essential for diagnosing and assessing sleep apnea. Growing recognition of sleep issues has brought about more human beings seeking diagnosis and treatment. Sleep labs provide domestic sleep testing services, making it handy for people to undergo sleep research at home, contributing to the popularity of sleep labs as a diagnostic choice.

Hospitals often function as the preliminary point of contact for individuals seeking treatment for sleep apnea. The close association between sleep laboratories and hospitals allows the transition from prognosis to remedy initiation, providing a comprehensive and coordinated healthcare approach. Sleep clinics and hospitals often adopt a multidisciplinary approach to treating sleep issues, collaborating with pulmonologists, sleep remedy professionals, neurologists, and other healthcare experts to ensure a comprehensive and holistic treatment plan for people with sleep apnea.

Key Attributes:

Report Attribute Details
No. of Pages 100
Forecast Period 2023 – 2032
Estimated Market Value (USD) in 2023 $1.81 Billion
Forecasted Market Value (USD) by 2032 $3.53 Billion
Compound Annual Growth Rate 7.7%
Regions Covered Europe

Company Analysis: Overview, Recent Developments, Financial Insights

  • Natus Medical Incorporated
  • ResMed Inc.
  • Somnomed
  • Apex Medical Corporation
  • Koninklijke Philips N.V.
  • Compumedics
  • Fisher & Paykel Healthcare
  • Nyxoah SA
  • Compumedics
  • Natus Medical Incorporated
  • Teleflex Incorporated
  • Fisher & Paykel Healthcare

Types – Market breakup from 2 viewpoints:

  • Therapeutic Devices
  • Diagnostic Devices

Therapeutic Devices – Market have been further sub segmented from 4 viewpoints:

  • CPAP Sleep Apnea Therapeutic Devices
  • Auto CPAP Sleep Apnea Therapeutic Devices
  • BiPAP Sleep Apnea Therapeutic Devices
  • Adaptive Servo-Ventilation (ASV)

Diagnostic Devices – Market have been further sub segmented from 5 viewpoints:

  • Polysomnography Devices (PSG)
  • Oximeter
  • Actigraphy Monitoring Device
  • Respiratory Polygraph
  • Sleep Apnea Screening Device

End User – Market breakup from 2 viewpoints:

  • Sleep Laboratories, Clinics & Hospitals
  • Home Care Settings/Individuals

For more information about this report visit here.

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