공시 • Jul 04
Pomerantz Law Firm Announces Filing of Class Action Against Insulet Corporation and Certain Officers Pomerantz LLP announced that a class action lawsuit had been filed against Insulet Corporation and certain officers. The class action, filed in the United States District Court for the District of Massachusetts, and docketed under 26-cv-13062, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Insulet securities between February 21, 2025 and May 26, 2026, both dates inclusive, seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials. The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Insulet's manufacturing controls and procedures were defective; (ii) the foregoing created a foreseeable heightened risk that one or more Insulet products would be found to be in violation of applicable safety regulations and/or pose a risk of injury; and (iii) as a result, Defendants' public statements were materially false and misleading at all relevant times. 공시 • Jul 02
Insulet Corporation to Report Q2, 2026 Results on Aug 05, 2026 Insulet Corporation announced that they will report Q2, 2026 results Pre-Market on Aug 05, 2026 공시 • Jun 26
Insulet Corporation Announces Appointment of Jonathan J. Mazelsky to Board of Directors, Effective July 1, 2026 Insulet Corporation announced the appointment of Jonathan (“Jay”) Mazelsky to the Company’s Board of Directors, effective July 1, 2026. Mr. Mazelsky joined the Board as an independent director. Mr. Mazelsky currently serves as Executive Chair of the board of directors of IDEXX Laboratories Inc. During Mr. Mazelsky’s 14-year tenure as an executive at IDEXX, he served as President and Chief Executive Officer from October 2019 to May 2026, Interim President and Chief Executive Officer from June 2019 to October 2019, and Executive Vice President responsible for IDEXX's North American Companion Animal Group Commercial Organization and key elements of its innovation portfolio, from August 2012 to June 2019. Before joining IDEXX, Mr. Mazelsky served as Senior Vice President and General Manager, Computed Tomography, Nuclear Medicine and Radiation Therapy Planning at Philips Healthcare, a subsidiary of Royal Philips Electronics (now Royal Philips), from 2010 to 2012. He also served in various strategic leadership roles at Philips from 2001 to 2010. Prior to joining Philips, Mr. Mazelsky operated in roles at Agilent Technologies, where he was Executive in Charge from 2000 to 2002, leading the integration of Agilent's Healthcare Group into Philips, and General Manager of Agilent's Medical Consumables Business Unit from 1997 to 2000. Earlier in his career, he worked in finance, marketing, and business planning at Hewlett Packard from 1988 to 1996. Mr. Mazelsky currently serves on the board of directors of Dentsply Sirona Inc. He holds an M.B.A. from the University of Chicago Booth School of Business and a B.A. in Mathematics from the University of Rochester. 공시 • Jun 09
Insulet Corporation Reveals New Data Supporting Omnipod 6 And Fully Closed-Loop Automated Insulin Delivery Systems Insulet Corporation announced new clinical results highlighting the next breakthroughs in tubeless Automated Insulin Delivery (AID) systems. Results from the STRIVE pivotal trial and the EVOLUTION 3 feasibility study, presented at the American Diabetes Association 86th Scientific Sessions in New Orleans, demonstrate meaningful improvements in glucose control for people with diabetes using Insulet’s future AID system — Omnipod 6 — and unique fully closed-loop (FCL) system for type 2 diabetes. The STRIVE pivotal trial was designed to evaluate the safety and efficacy of the next-generation Omnipod 6 algorithm. The randomized, crossover study included 132 participants across the U.S., including 98 with type 1 diabetes and 34 with type 2 diabetes. The type 1 cohort spanned a broad age range, including 29 participants aged 2 to <6 years, 36 aged 6 to <14 years, and 33 aged 14–70 years. Baseline glycemia was near recommended targets, with mean HbA1c values of 6.9% and 7.3% for type 1 and type 2 diabetes, respectively. Participants were randomized to use either the Omnipod 6 algorithm at the 100 mg/dL Target Glucose or the Omnipod 5 System at the 110 mg/dL Target Glucose for four weeks, followed by crossover to the alternate system for an additional four weeks. After the Crossover Phase, all participants entered a four-week or six-week Bolus Optional Phase to evaluate whether glycemic outcomes could be maintained with reduced user interaction, with a study goal of three or fewer boluses per day. The STRIVE study demonstrated clinically meaningful improvements in glycemic outcomes with Omnipod 6 during the Crossover Phase. Improved time in tight range (70–140 mg/dL) with Omnipod 6 vs. Omnipod 5: Type 1 diabetes (=14 years): 54% vs. 47% (+7 pts); Type 2 diabetes: 48% vs. 43% (+5 pts). Improved time in range (70–180 mg/dL) with Omnipod 6 vs. Omnipod 5: Type 1 diabetes (=14 years): 77% vs. 73% (+4 pts); Type 2 diabetes: 76% vs. 73% (+3 pts). Maintained safety profile: Time <54 mg/dL and <70 mg/dL were non-inferior. No instances of diabetic ketoacidosis or severe hypoglycemia. The STRIVE study demonstrated strong glycemic performance even when users bolused less during the Bolus Optional Phase. Strong time in range and time in tight range with fewer boluses: Type 1 diabetes (=14 years): 76% time in range and 54% time in tight range with 2.2 fewer boluses/day; Type 2 diabetes: 74% time in range and 46% time in tight range with 2.5 boluses per day. These findings suggest Omnipod 6 may be especially helpful for people with diabetes who do not always bolus. This will be further tested in the upcoming STRIVE 2 study, which will evaluate Omnipod 6 among people who bolus fewer than four times per day and are not meeting clinical targets for HbA1c. Insulet also shared results from EVOLUTION 3, the pre-pivotal study evaluating the safety and effectiveness of the Company’s breakthrough FCL system for adults with type 2 diabetes. EVOLUTION 3 enrolled a demographically diverse cohort comprised of 36 participants (adults aged 18–75 years old) with type 2 diabetes using insulin with HbA1c<14%. Participants were intensively managed with basal-bolus therapy and had high baseline utilization of continuous glucose monitoring. Yet they still had high baseline HbA1c of 8.1%. Insulet’s FCL for type 2 diabetes delivered 64% time in range, a 12% improvement with low hypoglycemia (0.15%) in a diverse, intensively managed population. Total daily insulin was reduced from 86U to 58U with no weight gain. Participants also reported high satisfaction (86% satisfied or highly satisfied) and reduced burden with FCL. This data is part of the broader clinical program used to support the development of the FCL AID system designed for people living with type 2 diabetes. The EVOLUTION 2 results were shared earlier this year at the 19International Conference on Advanced Technologies & Treatments for Diabetes, and Insulet recently announced the first enrollment of participants in EVOLVE, the randomized controlled pivotal trial supporting a planned 2027 510(k) filing to the FDA and expected 2028 commercial launch. Building on this experience from FCL for type 2 diabetes, early clinical work is underway to advance the science for FCL for type 1 diabetes as well. Insulet’s Omnipod 6 and FCL System for type 2 diabetes are investigational devices. Limited by federal (or United States) law to investigational use. These products have not been reviewed by the FDA or any other regulatory agency. 
