No Carolina / New York / Florida        Ph: 561.316.3330

Insulet Resumes Pivotal Study of its Next-Generation Product – Omnipod, Powered by Horizon™

What To Know

  • Insulet expects to commercialize Omnipod, Powered by Horizon, in the U.
  • in the first half of 2021, pending clearance by the FDA.

Insulet Corporation, the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System, today announced it has resumed its pivotal study of Omnipod, Powered by Horizon™, the Company’s personal smart-phone controlled automated insulin delivery system. The Company paused the study, which was approximately halfway through completion, in March.

“We are thrilled to continue our trial,” said Dr. Trang Ly MBBS FRACP PhD, Senior Vice President, Medical Director. “We have encouraging data from our clinical work to date and overwhelmingly positive feedback from participants and investigators. We are excited about what our next-generation Omnipod, Powered by Horizon, will offer people living with diabetes.”

Insulet expects to commercialize Omnipod, Powered by Horizon, in the U.S. in the first half of 2021, pending clearance by the FDA.

 

Latest

Unlocking New Hope: Alzheimer’s Patients Join Amyloid-Targeting Therapy Study

The study is designed to assess the clinical utility and workflow benefits of Swoop® system images acquired at infusion centers and clinics to help physicians detect amyloid-related imaging abnormalities (ARIA) in Alzheimer’s patients receiving amyloid-targeting therapy at the times specified in the labeling (before the fifth, seventh, and fourteenth infusions).

Indaptus Therapeutics Presents Positive Mechanism of Action Data at the American Association for Cancer Research Annual Meeting

Dr. Michael Newman, Indaptus’ Founder, Chief Scientific Officer, and lead author, commented, “The new data are consistent with our preclinical animal tumor model studies and provide evidence for our hypothesis that patented Decoy bacteria can activate a wide range of innate and adaptive human immune cells involved in fighting tumors.  This aligns with what we’ve observed in our ongoing Phase 1 clinical trial of Decoy20 – broad immune activation, as evidenced by transiently increased levels of many key cytokines and chemokines following single dose administration. These findings bolster our confidence in Decoy20's potential as a multifaceted immunotherapy.”

Enliven Therapeutics Announces Positive Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia

“We are excited to present the first look at the safety and clinical activity of ELVN-001, which we believe supports the potential for ELVN-001 to address the limitations of the available active-site TKIs,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “Across a wide dose range, ELVN-001 demonstrated activity in a heavily pre-treated patient population that includes post-asciminib patients, with a preliminary safety profile consistent with its highly selective design. Not only did all evaluable patients have improved or stable BCR::ABL1 transcript levels, but, importantly, 89% of all patients enrolled remain on study. We believe the initial data demonstrate the potential clinical utility of ELVN-001 for all types of patients, including those that are earlier in the treatment paradigm.”

Ferring Presents Pivotal Phase 3 Efficacy and Safety Data for Investigational Treatment, SI-6603 (condoliase), in Lumbar Disc Herniation at ASIPP 2024

The research, presented at the American Society of Interventional Pain Physicians (ASIPP) Annual Meeting, included a registrational Phase 3 trial and an integrated safety analysis of six clinical studies, as well as a real-world analysis of current treatment options and gaps in the clinical management of patients with newly-diagnosed LDH.

By using this website you agree to accept Medical Device News Magazine Privacy Policy