Johnson & Johnson Opens First Satellite Center for Global Health Discovery in Asia Pacific at Duke-NUS to Advance Dengue Research

The new Satellite Center will work to accelerate discovery research against flaviviruses, including dengue, which impacts 400 million people each year

This effort will build on Johnson & Johnson's decade-long legacy and ongoing collaboration with Duke-NUS in early-stage dengue research

The Satellite Center is the first Asia Pacific site in Johnson & Johnson's network of research collaborations aimed at addressing entrenched and emerging pandemic threats

Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of the new J&J Satellite Center for Global Health Discovery (Satellite Center) at Singapore's Duke-NUS Medical School, jointly established by Duke University and the National University of Singapore (NUS) as a graduate-entry medical school and research powerhouse. As the first of the J&J Centers for Global Health Discovery (J&J Centers) in the Asia-Pacific region, the Satellite Center at Duke-NUS aims to help drive new solutions to address flaviviruses, which disproportionately impact communities across the region, by bringing together the talent and expertise of the world's largest healthcare company with that of a leading academic institution.

The launch of the newest Satellite Center at Duke-NUS comes at a critical time. More than 400 million people are infected with flaviviruses each year and half of the global population is at risk, with Asia experiencing nearly three-quarters of the global burden. A warming planet means that billions more people could be impacted in the coming decades as the animal vectors that carry flaviviruses spread beyond the tropical regions where they have traditionally thrived.

Flaviviruses, like dengue and Zika, cause significant illness and death, yet no specific antiviral therapeutics are currently available. The frequency of dengue outbreaks has grown considerably over the past two decades, as evidenced by surges in places like Singapore . After experiencing its worst outbreak in history in 2020, Singapore is facing another major outbreak this year with more than 8,000 cases recorded in the first six months of 2022, exceeding the number of cases reported in the whole of 2021.

" Singapore is one of the epicenters of the dengue threat as well as a leading innovation and research hub, making Duke-NUS a natural match for our vision to address flaviviruses by advancing innovative science," said Ruxandra Draghia-Akli , M.D., Ph.D., Global Head, Global Public Health R&D at Janssen Research & Development, LLC . "Together, we can each leverage our unique strengths to translate action in the lab into solutions at the last mile that can help protect people against one of the world's most significant and rising health threats."

The J&J Centers for Global Health Discovery (J&J Centers) are a pillar of Johnson & Johnson's efforts to advance early-stage, breakthrough science where research is needed most and health challenges are most acute. The latest Satellite Center builds on a longstanding collaboration between the Janssen Pharmaceutical Companies of Johnson & Johnson and Duke-NUS and marks the latest effort of the SingHealth Duke-NUS Academic Medical Centre to develop a collaborative Discovery District on its Campus to drive bench-to-bedside innovations. The collaboration will unite expertise from across the scientific community in the Asia-Pacific region to further cultivate Singapore as a hub of discovery research, while advancing R&D to address the unmet medical need of flaviviruses.

"The establishment of the Satellite Center at Duke-NUS builds upon our strong track record in flavivirus research and bench-to-bedside innovations, and will facilitate antiviral drug discovery for the prevention and treatment of flavivirus-associated diseases that are affecting communities in Southeast Asia and beyond. The collaboration is both timely, in view of the impending threat of climate change, and purposeful in realizing the School's vision of transforming medicine and improving lives," said Professor Patrick Casey , Senior Vice-Dean for Research at Duke-NUS .

Research at the Satellite Center at Duke-NUS will be led by Professor Subhash Vasudevan , Ph.D., Duke-NUS' EID Program, and Olivia Goethals , Ph.D., Principal Scientist, Global Public Health R&D, Janssen Pharmaceutica NV.

Crowdsourcing Innovation through the Flavivirus QuickFire Challenge

Complementing the efforts of the Satellite Center, Johnson & Johnson Innovation, together with Johnson & Johnson Global Public Health, is proud to launch the Global Health Discovery QuickFire Challenge: Flavivirus Infections . The Challenge invites innovators to submit potentially ground-breaking ideas aiming to treat, control, or prevent flavivirus disease. The innovator(s) with the best potential solution will receive grant funding from a total pool of $300,000 , virtual access to the JLABS Asia Pacific community, including a dedicated workstation for one year at JLABS @ Shanghai , and mentorship from experts at the Johnson & Johnson Family of Companies.

Applications will be accepted until August 12, 2022 . To apply for the Global Health Discovery QuickFire Challenge: Flavivirus Infections, please visit the application portal .

Johnson & Johnson's Efforts to Tackle Dengue

The Company's dengue compound discovery program started in 2007 to address the unmet medical need for treatment and prevention options for the dengue virus. The efforts at the new Satellite Center will build on more than a decade of work by Johnson & Johnson to accelerate innovation in the development of new potential preventive and therapeutic options for dengue.

In 2021, Johnson & Johnson announced the completion of a Phase 1, first-in-human clinical study evaluating a dengue-specific antiviral small molecule, with data from the study showing the antiviral to be safe and well-tolerated in humans. Additional preclinical data demonstrated the antiviral's favorable safety profile and effectiveness at preventing dengue in mouse and non-human primate models.

"While there is an urgent need for new tools to address diseases like dengue, especially in the face of climate change, we believe we can accelerate research to move even faster," said Marnix Van Loock , Ph.D., Lead for Emerging Pathogens, Global Public Health R&D, Janssen Pharmaceutica NV . " Building on our shared legacies, the Satellite Center at Duke-NUS will help jumpstart the innovation we need to strengthen the R&D pipeline and address the burden of these diseases."

Duke-NUS has played a critical role in driving progress to tackle dengue, most recently by working with SingHealth's Investigational Medicine Unit to conduct a Phase 2a clinical trial evaluating Janssen's antiviral compound for the treatment of dengue.

About the J&J Centers for Global Health Discovery

Johnson & Johnson is committed to addressing the dual gap in innovation and health equity through the establishment of the J&J Centers for Global Health Discovery. In joining forces with other institutions, leveraging regional networks and growing in scope, they provide long-term opportunities to mentor much-needed talent in the discovery sciences and empower people worldwide to drive R&D to address some of the most pressing challenges in global health.

The first J&J Satellite Center for Global Health Discovery launched in July 2021 at the London School of Hygiene & Tropical Medicine (LSHTM), which is focused specifically on developing cutting edge science, from biology to data sciences, to help build the next generation of drug regimens needed to treat all forms of tuberculosis (TB).

In April 2022 , Johnson & Johnson launched the second Satellite Center for Global Health Discovery at the Holistic Drug Discovery and Development (H3D) Centre, University of Cape Town , in Cape Town, South Africa . Driven by some of the leading researchers in Africa and discovery science, the Satellite Center is focused on outpacing the rising threat of antimicrobial resistance (AMR) by accelerating innovation against multidrug-resistance Gram-negative bacteria (MDR-GNB), which are particularly concerning to public health.

While the past decade has seen a consistent decline in global funding for basic science, including discovery and pre-clinical development for neglected diseases, there are clear measures that can be taken to turn this tide. The J&J Centers are a crucial step in reversing this trend.

To learn more, visit jnj.com/global-public-health/discovery-centers .

About Johnson & Johnson

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com . Follow us at @JNJNews .

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism, & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.

Learn more at www.janssen.com . Follow us at www.twitter.com/JanssenGlobal . Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Forward-looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global healthcare reforms; trends toward healthcare cost containment; changes in behavior and spending patterns of purchasers of healthcare products and services; financial instability of international economies and legal systems and sovereign risk; increased scrutiny of the healthcare industry by government agencies; the Company's ability to satisfy the necessary conditions to consummate the separation of the Company's Consumer Health business on a timely basis or at all; the Company's ability to successfully separate the Company's Consumer Health business and realize the anticipated benefits from the separation; the New Consumer Health Company's ability to succeed as a standalone publicly traded company; and risks related to the impact of the COVID-19 global pandemic, such as the scope and duration of the outbreak, government actions and restrictive measures implemented in response, material delays and cancellations of medical procedures, supply chain disruptions and other impacts to the business, or on the Company's ability to execute business continuity plans as a result of the COVID-19 pandemic. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 2, 2022 , including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. Any forward looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

(PRNewsfoto/Johnson & Johnson)

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  • One-year clinical trial data for the next-generation, investigational, Sphere-360™ single-shot PFA catheter show impressive safety, performance, and efficiency results for paroxysmal Afib
  • Dual-energy (RF/PF), focal Sphere-9™ catheter demonstrates efficacy for linear ablation in persistent AFib
  • Medtronic continues legacy of leadership in innovation, showcasing arrhythmia management portfolio at Heart Rhythm Society annual meeting

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(PRNewsfoto/Medtronic plc)

Sphere-360 Study Safety and Performance

Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.

"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."

Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.

Sphere-9 for Linear Ablation

Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .

"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel , president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."

Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelect™ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. The Affera system together with the Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. Affera is available in Europe , Australia and New Zealand , with global expansion ongoing.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

  1. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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(PRNewsfoto/Medtronic plc)

The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

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More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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  • HRS Satellite Symposium will feature leading experts in electrophysiology, hypertension management and heart failure
  • Presentations will detail clinical results from prior studies demonstrating AVIM therapy's ability to immediately, substantially and persistently reduce systolic blood pressure, as well as improve cardiac function
  • Symposium will also feature presentation on the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)

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  • Breakthrough Device Designation ("BDD") applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk
  • BDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)
  • BDD status provides accelerated FDA engagement and reviews for AVIM therapy; it also supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) ("Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Device Designation ("BDD") for atrioventricular interval modulation ("AVIM") therapy.

Specifically, the BDD is for an implantable system (i.e., a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease ("ASCVD") risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications. Orchestra BioMed estimates that there are over 7.7 million patients in the U.S. that meet the criteria for the BDD for AVIM therapy. AVIM therapy is currently being evaluated under an FDA investigational device exemption ("IDE") in the BACKBEAT global pivotal study which is being conducted by Orchestra BioMed in collaboration with Medtronic. The BACKBEAT pivotal study is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of anti-hypertensive medication, a key subpopulation under the BDD for which Orchestra BioMed believes AVIM therapy may offer optimal clinical benefit.

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