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Sequel presents pivotal trial of the twiist(TM) Automated Insulin Delivery System in adults with insulin-treated type 2 diabetes at the ADA 86th Scientific Sessions. Investigational study marks Sequel's first pivotal data in type 2 diabetes, the largest population on insulin therapy and one of the most under-served by automated insulin delivery NEW ORLEANS, June 08, 2026 (GLOBE NEWSWIRE) - Sequel Med Tech, LLC, today announced results from a multi-center pivotal trial evaluating the safety and efficacy of the investigational twiist(TM) Automated Insulin Delivery (AID) System in adults with insulin-treated type 2 diabetes. Presented at the American Diabetes Association's 86th Scientific Sessions in New Orleans, the findings showed significant improvements in blood glucose levels from baseline by measuring HbA1c and time in range over 13 weeks, with no severe hypoglycemia events reported. Type 2 diabetes represents the largest population of people using insulin, yet it has historically had the fewest automated delivery options. Approximately 31 million U.S. adults have type 2 diabetes, and about 5.5 million (1 in 6)* are treated with insulin. Many people with type 2 diabetes still struggle to reach their blood sugar targets even with currently available medications, underscoring the need for more treatment options. This trial reflects Sequel's commitment to expanding access to automated insulin delivery to everyone who can benefit. Key Findings HbA1c, a key measure of long-term blood sugar control, on average improved by 0.7 percentage points (95% CI, −0.9 to −0.6; P<0.001 superiority), from a baseline mean of 8.1%, showcasing a statistically significant improvement. Participants who started with the highest HbA1c saw the greatest improvement, underscoring the potential impact for those at the highest risk for long-term complications. Time in Range. Participants also spent significantly more time with their blood sugar in a healthy range. Mean time in target glucose range (70-180 mg/dL) increased from 57% to 73%, an absolute improvement of 16 percentage points (95% CI, 14 to 18; P<0.001), which translates to nearly 4 additional hours per day in a healthy glucose range. Safety. No severe hypoglycemia events were reported during the study, and one case of diabetic ketoacidosis was reported that was not device related. Continuous Glucose Monitor (CGM) data showed low rates of hypoglycemia both before and during the study with time below 70 mg/dL decreasing from 0.66% at baseline to 0.36% at 13 weeks and time below 54 mg/dL remaining unchanged at 0.02%. Fourteen serious adverse health events were reported but were determined to be unrelated to the study device. Benefits were consistent across participant subgroups, including both users and non-users of metformin, or GLP-1 receptor agonists and/or SGLT-2i therapies. Patient-reported outcomes showed improved treatment satisfaction and sleep quality. "For people with type 2 diabetes who depend on insulin, progress has too often meant more: more decisions, more complexity, more to manage," said Dr. Joanna Mitri, Chief Medical Officer of Sequel. "We think it's time to change that. This isn't about asking more of the person; it's about the technology taking on more of the work, so care becomes more personal, more practical, and less demanding, without observing any increased risk of hypoglycemia. These data are an important step in building the evidence it takes to bring that kind of progress to a population that's been underserved for far too long." Trial Details The trial, led by Dr. Carol Levy and the twiist-T2D investigators, enrolled 307 adults with insulin-treated type 2 diabetes across 30 U.S. sites in a 13-week, single-arm study. Ninety-three percent of participants (286 of 307) completed the 13-week visit. The cohort was notably diverse: 26% Black or African-American and 13% Hispanic, with a mean age of 58 years (range 19-85), 47% female, a mean diabetes duration of 19 years, and a mean BMI of 34 kg/m[2]. Participants spanned a broad range of regimens including basal-bolus and basal-only insulin users, and both users and non-users of metformin, or GLP-1 receptor agonists and/or SGLT-2 inhibitors. "We saw meaningful glycemic improvement from Day 1 in glucose levels that was sustained through 13 weeks, with no severe hypoglycemic events. For people with insulin-treated type 2 diabetes, achieving better control without added risk of lows (hypoglycemia) is a meaningful step forward," said Carol Levy, MD, Professor of Medicine, Mount Sinai Diabetes Center Icahn School of Medicine at Mount Sinai. The twiist AID System is investigational for type 2 diabetes and is not cleared by the U.S. Food and Drug Administration for this use. twiist is currently FDA-cleared for people with type 1 diabetes ages 6 and older. About twiist The twiist(TM) Automated Insulin Delivery (AID) System supports confident, flexible type 1 diabetes management designed to fit real life. As the first automated insulin delivery system that directly measures the volume of insulin delivered with every microdose, twiist combines accuracy and precision to achieve a breakthrough in type 1 diabetes management. twiist offers the flexibility to address individual dosing needs by automatically adjusting basal insulin delivery via the twiist Loop(TM) algorithm (based on the diabetes community-driven Tidepool Loop) using real-time CGM data, and offers unique features like activity presets, the widest[1] glucose target range, and the ability to edit carb entries or meal timing. twiist is underpinned by its proprietary iiSure(TM) Technology which includes checkpoints to help ensure accurate insulin delivery and detect potential blockages up to nine times faster than other AID systems[2]. twiist is cleared for people ages six and up with type 1 diabetes, available with a prescription. For important safety information, please visit twiist.com/safety. For additional details, visit www.twiist.com. About Sequel Med Tech Headquartered in Manchester, N.H., Sequel Med Tech, LLC is developing the next generation of transformative drug-delivery advancements. Sequel's approach is to look at disease management holistically to advance systems that make living with disease simpler and easier for all. Its FDA-cleared innovation, the twiist(R) Automated Insulin Delivery (AID) system, integrates novel technologies to reimagine insulin delivery and sets a new standard for drug delivery. Sequel is bringing the latest developments in science and technology to help drive more accessible drug delivery. For more information, visit sequelmedtech.com and twiist.com. Forward-Looking & Investigational Statement This release describes investigational use of the twiist AID System in type 2 diabetes. The system is not FDA-cleared for type 2 diabetes, and nothing herein should be interpreted as a claim of safety, efficacy, availability, or regulatory approval for that use. Media Contact * Seagrove SIMM Market Model Updated March 2026 1. When comparing user guides of all commercially available AID systems in the United States as of January 2026 2. When comparing user guides of all commercially available AID systems in the United States as of January 2026 - (at 1U/hr or 2 U/hr)

Sequel Med Tech's twiist(TM) recognized for Diabetes Management innovation in 2026 MedTech Breakthrough Awards program. GlobeNewswire | MedTech Breakthrough Yesterday at 8:05am PDT LOS ANGELES, May 07, 2026 (GLOBE NEWSWIRE) - MedTech Breakthrough, an independent market intelligence organization that recognizes the most innovative companies, technologies and products in the global digital health and medical technology market, today announced that Sequel Med Tech, LLC's twiist(TM), has been selected as winner of the "Best New Technology Solution for Diabetes Management" award in the 10th annual MedTech Breakthrough Awards program. The 2026 MedTech Breakthrough Award recognizes the breakthrough innovation of Sequel Med Tech's twiist Automated Insulin Delivery (AID) System powered by Tidepool, which empowers the type 1 diabetes community through unmatched personalization in diabetes management[1]. The twiist Loop algorithm, based on the community-driven Tidepool Loop - which was developed by people with diabetes for people with diabetes - enables the system to automatically adjust basal insulin delivery based on continuous glucose monitor (CGM) readings, predicted glucose levels, and personalized settings. twiist is the first and only AID system designed to directly measure the volume of insulin delivered with every micro-dose, alerting users to potential blockages up to nine times faster than other AID systems[2]. This measurement is made possible by proprietary iiSure(TM) sound wave technology, which helps ensure accuracy, predictability, and advanced occlusion detection. twiist also includes pre-meal and activity presets, which change glucose target ranges to help prevent high and low blood sugar levels as well as the ability to go back and modify a carb entry or mealtime so the system can adapt when plans change and help keep glucose levels on track. Designed to be highly personalized, twiist allows for a range of customizable glucose targets between 87-180 mg/dL, empowering people ages 6+ to tailor twiist to their personal goals and routines with the widest and lowest glucose target range available in any AID system.[1] Additionally, twiist is compatible with a growing number of CGMs, including Abbott's FreeStyle Libre 3 Plus sensor and Senseonics' Eversense 365, giving users choice and flexibility in managing their diabetes. "People living with type 1 diabetes make countless decisions about their care, every day. With twiist, we set out to ease some of that burden by bringing together precise insulin delivery, meaningful personalization, and more choice in how people manage their diabetes. Early feedback is encouraging: users have reported more confidence day to day," said Alan Lotvin, Co-Founder and CEO of Sequel Med Tech. "We're grateful to MedTech Breakthrough for recognizing twiist, and we look forward to continuing this work." Now celebrating its 10th anniversary, the MedTech Breakthrough Awards program has spent a decade recognizing the companies driving meaningful progress and improving patient care across the global health and medical technology industry. The program spans a wide range of categories - including Telehealth, Clinical Administration, Patient Engagement, Electronic Health Records (EHR), Virtual Care, Medical Devices and beyond - honoring the innovations reshaping how care is delivered worldwide. This year's program drew a record-breaking number of nominations from leading companies and startups across more than 20 countries, reflecting the growing global impact and momentum of the digital healthcare industry. "8.4 million Americans with diabetes rely on insulin to survive, yet many lack access to tools to ensure precise insulin delivery," said Steve Johansson, managing director, MedTech Breakthrough. "Through twiist, Sequel is providing extraordinary support in advancing the care of people with diabetes. twiist adapts to life in ways that no other pumps can, enabling flexibility and control. For providing choice and recognizing that type 1 diabetes management is different for everyone, we're awarding twiist with 'Best New Technology Solution for Diabetes Management.'" twiist is available nationwide through pharmacy channels with a flexible access model. Flexible access allows most people to start twiist for $0 the 1st month and no more than $50 each month thereafter.* About MedTech Breakthrough Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is devoted to honoring excellence and innovation in medical & health technology companies, products, services and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough healthcare and medical companies and products in categories that include Patient Experience & Engagement, Health & Fitness, Medical Devices, Clinical Administration, Connected Healthcare, Medical Data, Healthcare Cybersecurity and more. For more information visit MedTechBreakthrough.com. Tech Breakthrough LLC does not endorse any vendor, product or service depicted in its recognition programs, and does not advise technology users to select only those vendors with award designations. Tech Breakthrough LLC recognition consists of the opinions of the Tech Breakthrough LLC organization and should not be construed as statements of fact. Tech Breakthrough LLC disclaims all warranties, expressed or implied, with respect to this recognition program, including any warranties of merchantability or fitness for a particular purpose. About twiist The twiist(TM) Automated Insulin Delivery (AID) System supports confident, flexible diabetes management designed to fit real life. As the first AID system that directly measures the volume of insulin delivered with every micro-dose, twiist combines adaptability, accuracy, and precision to achieve a breakthrough in type 1 diabetes management. twiist offers the flexibility to address individual dosing needs by automatically adjusting basal insulin delivery via the twiist Loop(TM) algorithm (based on the diabetes community-driven Tidepool Loop) using real-time CGM data, and offers unique features like activity presets, the widest[1] glucose target range, and the ability to edit carb entries or meal timing. twiist is underpinned by its proprietary iiSure(TM) Technology, which includes checkpoints to help ensure accurate insulin delivery and detect potential blockages up to nine times faster than other pumps[2]. twiist is cleared for people ages six and up with type 1 diabetes, available with a prescription. For important safety information, please visit twiist.com/safety. For additional details visit www.twiist.com. [1] 1.Sequel Med Tech - twiist Automated Insulin Delivery (AID) System Powered by Tidepool User Guide; 2. Insulet - Omnipod 5 Automated Insulin Delivery System User Guide; 3. Medtronic - MiniMed 780G system User Guide; 4. Beta Bionics - iLet Bionic Pancreas System User Guide; 5. Tandem Diabetes Care - t:slim X2 Insulin Pump User Guide; 6.Tandem Diabetes Care - Tandem Mobi System User Guide. [2] Calculation based on a comparison of the following IFUs. The following reported 1 U/hr basal rate: Sequel Med Tech - twiist Automated Insulin Delivery (AID) System Powered by Tidepool User Guide; Insulet - Omnipod 5 Automated Insulin Delivery System User Guide; Medtronic - MiniMed 780G system User Guide; Beta Bionics - iLet Bionic Pancreas System User Guide. The following reported 2 U/hr basal rate: Tandem Diabetes Care - t:slim X2 Insulin Pump User Guide; Tandem Diabetes Care - Tandem Mobi System User Guide. * The twiist(TM) Savings Program offers U.S. residents with commercial insurance a $0 Starter Kit and Refill Kits for $50 or less (may be higher with high-deductible plans). The maximum benefit is $200 per Refill Kit. Call 1-877-489-4478 or your insurer to verify coverage. About Sequel Med Tech Headquartered in Manchester, N.H., Sequel Med Tech, LLC is developing the next generation of transformative drug-delivery advancements. Sequel's approach is to look at disease management holistically to advance systems that make living with disease simpler and easier for all. Its FDA-cleared innovation, the twiist(TM) Automated Insulin Delivery (AID) system, integrate novel technologies to reimagine insulin delivery and sets a new standard for drug delivery. Sequel is bringing the latest developments in science and technology to help drive more accessible drug delivery. For more information, visit sequelmedtech.com and twiist.com. Media Contact Steve Johansson [email protected] 213.255.3658 This is a paid placement. For further inquiries, please contact GlobeNewswire directly.