Retinopathy of Prematurity

Conference call and webcast to begin at 1:30 p.m. PT (4:30 p.m. ET) IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) will release third quarter 2024 financial results for the period ended September 28, 2024, after the market closes on Tuesday, November 5, 2024. The conference call to review the results will begin at 1:30 p.m. PT (4:30 p.m. ET) and will be hosted by Michelle Brennan, interim Chief Executive Officer, Micah Young, Executive Vice President and Chief Financial Officer and Bilal Muhsin, Chief Operating Officer. To register for the conference call and receive the dial-in number, please use the link below. Upon registering, each participant will be provided with details including the dial-in number and a registrant ID number. Reminders about the call will also be sent to registered participants via email. Conference Call Registration Link ( Please register to obtain the dial-in number) : A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the Company’s website. About Masimo Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET ® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies. 1 Masimo SET ® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates, 2 improve CCHD screening in newborns, 3 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs. 4-7 Masimo SET ® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world, 8 and is the primary pulse oximetry at all 10 top U.S. hospitals as ranked in the 2024 Newsweek World’s Best Hospitals listing. 9 In 2005, Masimo introduced rainbow ® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb ® ), oxygen content (SpOC™), carboxyhemoglobin (SpCO ® ), methemoglobin (SpMet ® ), Pleth Variability Index (PVi ® ), RPVi™ (rainbow ® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root ® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine ® Brain Function Monitoring, O3 ® Regional Oximetry, and ISA™ Capnography with NomoLine ® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters ® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7 ® , Radius PPG ® , and Radius VSM™, portable devices like Rad-67 ® , fingertip pulse oximeters like MightySat ® Rx, and devices available for use both in the hospital and at home, such as Rad-97 ® and the Masimo W1 ® Medical Watch. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris ® Gateway, iSirona™, Patient SafetyNet, Replica ® , Halo ION ® , UniView ® , UniView :60™, and Masimo SafetyNet ® . Its growing portfolio of health and wellness solutions includes Radius Tº ® and Masimo W1 Sport. Additional information about Masimo and its products may be found at . Published clinical studies on Masimo products can be found at . ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium. References Published clinical studies on pulse oximetry and the benefits of Masimo SET ® can be found here . Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO 2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology . 2010:112(2):282-287. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter . Spring-Summer 2012. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety . 2016 Jul;42(7):293-302. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696. Estimate: Masimo data on file. As ranked in the 2024 Newsweek World’s Best Hospitals listing, available here . Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo. Contacts Investor Contact: Eli Kammerman (949) 297-7077 ekammerman@masimo.com Media Contact: Evan Lamb (949) 297-3376 elamb@masimo.com

CHICAGO, Oct. 17, 2024 /PRNewswire/ -- The American Academy of Ophthalmology, in partnership with FundamentalVR, a global leader in immersive surgical training, today announced the launch of the Academy's VR Education program, a groundbreaking initiative that harnesses the power of virtual reality (VR) to transform ophthalmic education and surgical training. Supported by a generous $5 million grant from the Knights Templar Eye Foundation, the platform offers a free and open simulation platform for ophthalmologists and trainees around the world to expand their skill in diagnosing and treating eye diseases and conditions. Continue Reading Pediatric Retinopathy of Prematurity The first phase of the program focuses on pediatric ophthalmology, specifically retinopathy of prematurity (ROP). Retinopathy of prematurity is the leading cause of preventable blindness in children globally, affecting up to 30 percent of preterm infants in middle-income countries and between 5 and 8 percent in the United States. However, the opportunity for trainees to learn how to properly examine and treat babies with ROP is limited. Options are fewer outside of the United States, as many countries allow residents to perform only a limited number of procedures in children. The VR simulator allows practitioners to diagnose and treat ROP, using techniques including indirect ophthalmoscopy, laser therapy, and intravitreal injections, all within an immersive and lifelike virtual environment. The simulator offers both independent practice and multi-user guided instruction, offering comprehensive learning for trainees at all levels."Our partnership with FundamentalVR has been a significant step forward for the Academy in its mission to ensure the delivery of the highest-quality eye care for all," said Stephen D. McLeod, MD, CEO of the Academy. "We can now offer increased access to specialized training for ophthalmologists across the globe. And thanks to the generous funding from the Knights, it will be available for free."The immersive training not only accelerates competency but also significantly reduces the potential for complications in infants with this potentially blinding condition. Using the platform, ophthalmologists can train from anywhere, while detailed analytics offer personalized feedback to help refine their skills, ensuring they are well-prepared for real-world procedures."ROP is a complex and critical condition to manage, and this program is a significant step forward in equipping ophthalmologists with the skills they need to help deliver better patient outcomes," said Richard Vincent, Co-Founder and CEO of FundamentalVR. "By utilizing VR technology, we're giving ophthalmologists the tools to learn and practice safely, accelerating their expertise and confidence while ultimately reducing complications in infants at risk of blindness.""Case Western was lucky to be one of a few residency programs to trial this simulation program," said Douglas Rhee, MD, professor and chair of the department of Ophthalmology and Visual Sciences at Case Western Reserve University. "We were impressed by the quality of the virtual environment. Our trainees will definitely benefit from this unique opportunity to confront ROP diagnosis and management without risk to the child. These simulation technologies are vital in uncommon and rare cases."Following the launch of the ROP simulator, the AAO VR Education program will expand to include modules on other key areas of pediatric ophthalmology. For those who don't have access to a VR headset, a desktop version of the ROP simulator will be available later this year. About the American Academy of Ophthalmology The American Academy of Ophthalmology is the world's largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, we protect sight and empower lives by setting the standards for ophthalmic education and advocating for our patients and the public. We innovate and support research to advance our profession and to ensure the delivery of the highest-quality eye care. Our EyeSmart® program provides the public with the most trusted information about eye health. For more information, visit aao.org. About FundamentalVR Global leader in immersive surgical training, FundamentalVR was founded with the mission to accelerate human capability in surgery and medicine through virtual technologies to improve patient outcomes. The company's innovative approach accelerates the industry shift towards digital surgery, addressing the competency gap in training for intelligent operating rooms. Its purpose-built Fundamental Surgery platform allows for full rehearsal of medical and surgical procedures, and its patented HapticVR® technology mimics the physical touch, weight, resistance and feedback of surgical actions and accurately simulates the sensations of soft tissue, bone textures and muscle. With over 15,000 competency-building sessions conducted globally and accredited by and affiliated with institutions like AAO, AAOS and Royal College of Surgeons of England, FundamentalVR remains committed to elevating performance and training skilled surgeons and OR teams at scale. For more information, please visit FundamentalVR.com SOURCE American Academy of Ophthalmology; FundamentalVR WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Regeneron suffered a setback in its defense of blockbuster eye drug Eylea, startling investors. Three months after a federal judge in West Virginia sided with Regeneron, blocking the market entry of two biosimilars for blockbuster eye disease drug Eylea, the same judge has rejected the company’s attempt to block Amgen’s Eylea biosimilar.In an order issued under seal—which would explain his decision—Judge Thomas Kleeh of the U.S. District Court for Northern District of West Virginia denied Regeneron’s request for a preliminary injunction which would prevent Amgen’s Pavblu from entering the market.The knockoff, which replicates the original 2 mg version of Bayer and Regeneron’s Eylea, was approved by the FDA last month. In its complaint against Amgen, which was filed in January of this year, Regeneron listed 32 patents it claimed were infringed. Upon the decision, the company immediately filed an appeal."We are disappointed in the court decision that was specific to Amgen only. Importantly, this decision has no effect on previous decisions against other biosimilars manufacturers of Eylea," Regeneron said in an emailed statement. "We continue to believe that Amgen is infringing our patent rights, and this decision denying our request for a preliminary injunction is not the final word in this litigation. We have appealed this decision, and we also look forward to presenting our case at trial."The New York-based company’s regulatory exclusivity for Eylea—which was originally approved in 2011 to treat wet age-related macular degeneration (AMD)—expired in May, according to the complaint.As Regeneron's case plays out, Amgen could now pursue an "at-risk" biosimilar launch. Under such an approach, the biosimilar maker would be liable for damages should Regeneron ultimately prevail in establishing patent infringement.In the wake of the injunction decision, Regeneron’s shares dropped roughly 9% between Monday and Tuesday, an indicator of the company’s reliance on Eylea.With U.S. sales of $5.9 billion in 2023, the vascular endothelial growth factor (VEGF) inhibitor accounted for 44% of Regeneron revenue of $13.1 billion.An Amgen spokesperson said that the company will "announce our launch timing in due course,"  Eylea’s market share has been dented by Roche’s longer-acting Vabysmo, which requires dosing as little as every four months as opposed to every other month for Eylea. Regeneron has since countered with a high-dose (8 mg) version of Eylea. In the second quarter, Eylea HD accounted for $304 million of the $1.53 billion generated overall by the Eylea franchise. The Amgen ruling runs counter to Kleeh’s decisions three days apart in June when he granted Regeneron’s requests for preliminary injunctions, blocking the sale of Biogen and Samsung Bioepis’ Eylea biosimilar Opuviz and Biocon’s Eylea copycat Yesafili until 2027. The court ruled that both knockoffs infringed Regeneron patents.Opuviz and Yesafili were approved by the FDA in May as interchangeable biosimilars, meaning that a pharmacist can freely switch them out for the reference product. Regeneron’s defense of Eylea is a high-priority endeavor for the drugmaker. Four weeks ago, the company filed a lawsuit in New Jersey against Sandoz and its Eylea biosimilar. The company also is jousting with South Korea-based Celltrion and Germany-based Formycon over their Eylea biosimilars.Eylea works by inhibiting the growth of abnormal blood vessels in the retina and reducing fluid leakage. This mechanism helps in managing and treating conditions that lead to vision loss. In addition to its AMD nod, Eylea has been endorsed by the FDA to treat diabetic macular edema (DME), retinal vein occlusion (RVO), diabetic retinopathy (DR) and retinopathy of prematurity (ROP).