Ortho Dermatologics to Present New Data at the 2021 American Academy of Dermatology Annual Meeting

Six Poster Presentations Will Include New Analyses on ARAZLO ® , DUOBRII ® and SILIQ ®

Bausch Health Companies Inc. (NYSETSX: BHC) ("Bausch Health") and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the presentation of six posters during the virtual American Academy of Dermatology (AAD) Annual Meeting, which takes place April 23-25, 2021.

One presentation will feature new analyses of ARAZLO ® (tazarotene) Lotion, 0.045%, including new topline efficacy results from a post hoc analysis of two Phase 3 studies on participants with moderate-to-severe acne. Approved for patients nine years of age and older, ARAZLO has been commercially available since 2020. Two other presentations will highlight DUOBRII ® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%. Both will focus on new efficacy data, with one also providing an overview of the profound effect of psoriasis on quality of life for patients. The three remaining presentations will include analyses evaluating the long-term efficacy and safety profile of SILIQ ® (brodalumab) Injection. Please see below for warning about suicidal ideation and behavior with SILIQ.

"Ortho Dermatologics is committed to conducting research that further demonstrates the clinical benefits of our product portfolio," said Scott Hirsch , president, Ortho Dermatologics, and senior vice president and chief strategy officer, Bausch Health. "At this year's AAD meeting, we look forward to the opportunity to connect with dermatologists virtually to share new data on our latest acne medicine, ARAZLO, as well as new analyses on two of our prominent psoriasis medicines, DUOBRII and SILIQ."

The complete list of poster presentations that will be presented is as follows:

ARAZLO ® (tazarotene) Lotion

  • "Impact of Body Mass Index (BMI) on Efficacy of Three Topical Acne Treatments in Patients with Moderate-to-severe Acne." Cook-Bolden et al.

DUOBRII ® (halobetasol propionate and tazarotene) Lotion

  • "Fixed-Combination Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion for the Treatment of Plaque Psoriasis in Patients with 3-5% Body Surface Area (BSA) and Poor Quality of Life (QoL)." Stein Gold et al.
  • "Impact of Body Mass Index (BMI) on the Efficacy and Safety of Halobetasol Propionate 0.01%/Tazarotene 0.045% (HP/TAZ) lotion in patients with Plaque Psoriasis." Lebwohl et al.

SILIQ ® (brodalumab) Injection

  • "Achievement of Body Surface Area Treatment Targets in Clinical Trials of Brodalumab." Strober et al.
  • "Patient-Reported Psoriasis Symptoms Stratified by Sex and Level of Skin Clearance in Clinical Trials of Brodalumab." Hebert et al.
  • "Psoriasis Area and Severity Index Component Scores in Clinical Trials of Brodalumab." Lebwohl et al.

About Acne Vulgaris
Acne is the most common skin problem in the United States , which occurs when hair follicles become plugged with oil and skin cells, often causing whiteheads, blackheads or pimples to appear on the face, forehead, chest, upper back and shoulders. 1,2 Up to 50 million Americans have acne. 2 Depending on its severity, acne can cause emotional distress and scar the skin. 2

Important Safety Information for ARAZLO ® (tazarotene) Lotion, 0.045%

What is ARAZLO?
ARAZLO ® (tazarotene) Lotion, 0.045% is a prescription medicine used on the skin (topical) to treat people 9 years of age and older with acne, which can include blackheads, whiteheads, and other pimples.

It is not known if ARAZLO is safe and effective in children under 9 years of age.

Important Safety Information
ARAZLO is for use on skin only. Do not use ARAZLO in your eyes, mouth, the corners of your nose, or vagina.

What is the most important information I should know about ARAZLO?

  • ARAZLO may cause birth defects if used during pregnancy.
  • You must not be pregnant when you start using ARAZLO or become pregnant during treatment.
  • Use effective birth control during treatment.
  • Stop using ARAZLO and tell your healthcare provider right away if you become pregnant during treatment.

Before using ARAZLO, tell your healthcare provider about all your medical conditions, including if you:

  • have eczema or any other skin problems.
  • are breastfeeding or plan to breastfeed. If you use ARAZLO while breastfeeding, use it for the shortest time needed. Do not apply ARAZLO directly to the nipple and surrounding area to avoid exposing your child to the medicine.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines can make your skin more sensitive to sunlight; ask your healthcare provider for a list of medicines if you are not sure. Especially tell your healthcare provider about other products you use on your skin (such as benzoyl peroxide), including moisturizers, creams, lotions, or products that can dry out your skin.

What should I avoid while using ARAZLO?

  • You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with ARAZLO.
  • Minimize exposure to sunlight; you could get severe sunburn.

If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with an SPF (sun protection factor) of 15 or more and wear protective clothing and a wide-brimmed hat to cover the treated areas.

  • Avoid using ARAZLO on skin with eczema or sunburned skin because it may cause severe irritation.

ARAZLO may cause side effects, including:
Skin irritation. ARAZLO may cause irritation including skin dryness, pain, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to use a moisturizer, adjust the dosing, or completely stop treatment with ARAZLO.

These are not all the possible side effects of ARAZLO. Call your doctor for medical advice about side effects. You may report side effects to Bausch Health US, LLC at 1-800-321-4576, FDA at 1-800-FDA-1088, or www.fda.gov/medwatch .

Please click here for full Prescribing Information, including Patient Information.

About Psoriasis
Psoriasis is an immune-mediated disease that speeds up the life cycle of skin cells, causing them to build up rapidly on the surface of the skin. The extra skin cells form raised, red, scaly patches that are itchy and sometimes painful. 3 People with psoriasis are also reported to be at increased risk of developing other serious clinical conditions such as cardiovascular and other noncommunicable diseases and to suffer substantial impairment of physical and psychological quality of life. 4 Plaque psoriasis is the most common type of psoriasis. 5

Important Safety Information for DUOBRII ® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%

What is DUOBRII ®   Lotion?
DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis. It is not known if DUOBRII Lotion is safe and effective in children.

Important Safety Information

  • DUOBRII Lotion is for use on the skin only; do not use it in your mouth, eyes, or vagina.

What is the most important Information I should know about DUOBRII Lotion?

DUOBRII Lotion may cause birth defects if used during pregnancy.
A negative pregnancy test must be obtained before females of child-bearing age start using DUOBRII Lotion and they must use effective birth control during treatment. Begin treatment during a normal menstrual period.

Stop using DUOBRII Lotion and tell your healthcare provider right away if you become pregnant while using DUOBRII Lotion.

Before you use DUOBRII Lotion, tell your healthcare provider if you:

  • have eczema or any other skin problems, including skin infections, which may need to be treated before using DUOBRII.
  • have diabetes, adrenal gland problems or liver problems.
  • are breastfeeding or plan to breastfeed. If you use DUOBRII and breastfeed, do not apply DUOBRII to your nipple area.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  • Especially tell your healthcare provider if you take corticosteroids by mouth or injection or use other skin products that contain corticosteroids.
  • Ask your healthcare provider for a list of medicines that may make your skin more sensitive to sunlight .

What should I avoid during treatment with DUOBRII?

  • To avoid a severe sunburn, avoid sunlight, including sunlamps and tanning beds, as much as possible, and use sunscreen, protective clothing and a hat while in sunlight. Talk to your healthcare provider if you get sunburn, and do not use DUOBRII Lotion until your sunburn is healed.
  • Avoid using DUOBRII on skin with eczema because it may cause severe irritation.

DUOBRII may cause side effects, including:

  • If too much DUOBRII passes through your skin it can cause adrenal glands to stop working
  • Cushing's syndrome, a condition from too much exposure to the hormone cortisol
  • High blood sugar (hyperglycemia)
  • Effects of growth and weight in children
  • Skin irritation. If you get too much skin irritation at the site of application, your healthcare provider may tell you to interrupt or stop using DUOBRII or to use it less often.
  • Vision problems, including an increased chance of developing cataracts and glaucoma. Tell your healthcare provider about any vision problems during treatment.

The most common side effects of DUOBRII Lotion include : redness, itching, swelling, burning, stinging, application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash. To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch .

Please click here for full Prescribing Information.

Important Safety Information for SILIQ (brodalumab) Injection

What is SILIQ?
SILIQ ® injection is a prescription medicine used to treat adults with moderate to severe plaque psoriasis:

  • who may benefit from injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light treatment) and
  • who have tried another systemic therapy that didn't work or stopped working

It is not known if SILIQ is safe and effective in children.

What is the most important information I should know about SILIQ?

Suicidal thoughts or behavior: Some patients taking SILIQ have had suicidal thoughts or ended their own lives.  This risk is higher if you have a history of suicidal thoughts or depression.  It is not known if SILIQ causes these thoughts or actions.  Get medical help right away if you or a family member notices that you have any of the following symptoms:

  • new or worsening depression, anxiety, or mood problems
  • thoughts of suicide, dying, or hurting yourself
  • attempt to commit suicide, or acting on dangerous impulses
  • other unusual changes in your behavior or mood

Your healthcare provider will give you a SILIQ patient/wallet card about symptoms that need medical attention right away.  Carry the card with you during treatment with SILIQ and show it to all of your healthcare providers.

Serious Infections : SILIQ may lower the ability of your immune system to fight infections and may increase your risk of infections:

  • Your healthcare provider should check you for tuberculosis (TB) before starting treatment with SILIQ and may treat you for TB before starting SILIQ if you have TB or a history of it
  • You and your healthcare provider need to watch closely for signs and symptoms of infection during treatment with SILIQ, including fever, sweats, chills, shortness of breath, stomach issues, muscle aches, cough, sore throat or trouble swallowing, warm/red/painful skin sores, burning while urinating or more frequent urination

Who should not use SILIQ?
Do not use SILIQ if you have Crohn's disease.  Tell your healthcare provider if you develop diarrhea, bloody stools, stomach pain or cramping, sudden or uncontrollable bowel movements, loss of appetite, constipation, weight loss, fever or tiredness as these may be symptoms of Crohn's disease.

Before starting SILIQ, tell your healthcare provider if you:

  • have a history of mental health problems, including suicidal thoughts, depression, anxiety, or mood problems
  • have an infection that does not go away or keeps coming back
  • have TB or have been in close contact with someone with TB
  • have recently received or are scheduled to receive an immunization (vaccine). You should avoid getting live vaccines while being treated with SILIQ
  • are or plan to become pregnant, or are breastfeeding or plan to do so. It is unknown if SILIQ can harm your unborn or newborn baby

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use SILIQ?
  See the detailed "Instructions for Use" that come with your SILIQ for information on the right way to store, prepare, and give your SILIQ injections at home, and how to properly throw away (dispose of) used SILIQ prefilled syringes.  Use SILIQ exactly as your healthcare provider tells you to use it.

What are possible side effects of SILIQ?
SILIQ may cause serious side effects.  See "What is the most important information I should know about SILIQ?" and "Who should not take SILIQ?"

The most common side effects of SILIQ include:


Joint pain

Muscle pain


Headache

Injection site reactions


Tiredness

Flu


Diarrhea

Low white blood cell count (neutropenia)


Mouth or throat pain

Fungal infections of the skin


Nausea


Call your doctor for medical advice on side effects.  You are encouraged to report negative side effects of prescription drugs to Bausch Health at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch .

Click here for accompanying full Prescribing Information, including Boxed Warning about suicidal ideation and behavior, and Medication Guide.

About Ortho Dermatologics  
Ortho Dermatologics is one of the largest dermatology businesses dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Ortho Dermatologics portfolio is further complemented by Solta Medical, the maker of Fraxel ® , Thermage ® , Clear + Brilliant ® and Vaser ® ultrasonic assisted liposuction for aesthetic applications. More information can be found at www.ortho-dermatologics.com .

About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at www.bauschhealth.com .

Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

References

  1. American Academy of Dermatology. (2020). Skin conditions by the numbers. Retrieved from https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers . Accessed March 1, 2020.
  2. Mayo Clinic. (2020). Acne. Retrieved from https://www.mayoclinic.org/diseases-conditions/acne/symptoms-causes/syc-20368047 . Accessed March 1, 2020.
  3. Mayo Clinic. (2019). Psoriasis. Retrieved from https://www.mayoclinic.org/diseases- conditions/psoriasis/symptoms-causes/syc-20355840 . Accessed March 1, 2020 .
  4. World Health Organization. (2016). Global Report on Psoriasis. Retrieved from https://apps.who.int/iris/bitstream/handle/10665/204417/9789241565189_eng.pdf;jsessionid=81463A56 C4318AF777E56018DB67B563?sequence=1 . Accessed March 1, 2020 .
  5. National Psoriasis Foundation. About Psoriasis. Retrieved from https://www.psoriasis.org/about-psoriasis . Accessed March 1, 2020 .

®   /TM are trademarks of Ortho Dermatologics' affiliated entities.
  © 2021 Ortho Dermatologics' affiliated entities.
  ORD.0075.USA.21

Investor Contact:

Media Contact:

Arthur Shannon

Lainie Keller

arthur.shannon@bauschhealth.com

lainie.keller@bauschhealth.com

(514) 856-3855

(908) 927-1198

(877) 281-6642 (toll free)


(PRNewsfoto/Valeant Pharmaceuticals Interna)

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SOURCE Bausch Health Companies Inc.

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Bausch Health Companies Inc.

Bausch Health Companies Inc.

Formerly known as Valeant Pharmaceuticals, Bausch Health is a global specialty pharmaceutical, consumer health, and medical device company with a focus on branded products for the dermatology, gastrointestinal, and ophthalmology markets. The company reports revenue in five segments: Bausch+Lomb (45% of revenue), Salix Pharmaceuticals (24%), international pharma (14%), ortho dermatology (7%), and diversified products (10%). Bausch is the market leader in consumer visioncare in India and China and the fourth-largest visioncare company by sales in the United States.

Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that it will report financial results for its fourth quarter and full fiscal year 2025 on Wednesday, May 21, 2025 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's fourth quarter and full fiscal year 2025, which ended on Friday, April 25, 2025 .

Medtronic will host a video webcast at 7:00 a.m. CDT on May 21, 2025 , to discuss results for its fourth quarter and full fiscal year 2025. The webcast can be accessed at https://investorrelations.medtronic.com .

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Star Jones , award winning television personality & women's heart health advocate,   helps kick off heart health conversations this Mother's Day with the Medtronic 'Letter to My Mother' campaign

A new Medtronic-sponsored survey of women ages 30-50 reveals a significant gap in awareness and discussion around heart health among women and their mother-figures. Despite cardiovascular disease being the #1 killer of women in the U.S. many women are still unaware of the risk and the importance of heart health.

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Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

  • 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

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Affera™ family of technologies, including the next-generation Sphere-360™ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9™ combination mapping and dual-energy focal PFA catheter. Data were presented in High Impact Science Sessions at the Heart Rhythm Society 2025 Annual Meeting in San Diego ; the Sphere-360 study was simultaneously published in the Heart Rhythm Journal .

(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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Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery   in the U.S. presented as a late-breaker at the American Urologic Association annual meeting

Company confirms Hugo RAS system submission to the U.S. Food and Drug Administration

Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugo™ robotic-assisted surgery (RAS) system.

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Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle

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Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

(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).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

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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SOURCE Medtronic plc

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