Periodic Reporting for period 1 - GO-Pen (The first universal and price-neutral insulin pen)
Berichtszeitraum: 2023-03-01 bis 2024-02-29
Description: The UNIPEN is developed as a universal, cost-neutral insulin pen with the end goal of being compatible with all insulin types.
The first pen focus is on fast-acting insulin delivery and aims to be a preferable alternative to traditional syringes. The pen has been through preliminary feasibility studies and usability tests to ensure it meets user needs in terms of ease, accuracy, and safety.
Objectives of Work Performed: The primary objectives were to finalize the design of a universal insulin pen, complete feasibility studies, optimize pen durability, and ensure usability. Regulatory objectives included preparing and submitting documentation for FDA 510(k) clearance, advancing quality system certification, and developing global strategies. Commercially, the objectives were to refine market strategies, establish partnerships, research sales logistics, and plan for a product launch in the USA.
The first pen focus is on fast-acting insulin delivery and aims to be a preferable alternative to traditional syringes. The pen has been through preliminary feasibility studies and usability tests to ensure it meets user needs in terms of ease, accuracy, and safety.
Objectives of Work Performed: The primary objectives were to finalize the design of a universal insulin pen, complete feasibility studies, optimize pen durability, and ensure usability. Regulatory objectives included preparing and submitting documentation for FDA 510(k) clearance, advancing quality system certification, and developing global strategies. Commercially, the objectives were to refine market strategies, establish partnerships, research sales logistics, and plan for a product launch in the USA.
Main Results: Key outcomes include the completion of a cost-neutral pen compatible with fast acting insulin, successful preliminary studies, and progress in cartridge and pen durability optimization. Regulatory milestones were achieved by submitting for FDA 510(k) clearance and obtaining ISO 13485 certification, which is crucial for engaging with professional distributors. Commercially, GO-Pen's market strategy was honed through insights from patients, healthcare providers, and payers. Notably, winning the American Diabetes Association Innovation Challenge 2023 and inclusion in StartupHealth's T1D Moonshot signifies recognition and alliance in the diabetes care innovation sector.
Potential Impact: The UNIPEN is set to redefine insulin delivery by offering an accessible, user-friendly alternative to syringes. Its market entry is supported by strategic partnerships and insights from various stakeholders in the healthcare system. The FDA submission and ISO certification are poised to enhance investor confidence and distributor engagement. The recognition from the American Diabetes Association and inclusion in the T1D Moonshot highlight GO-Pen's potential in impacting diabetes care globally. Having a one-story fits all approach is demonstrated on our website where we demonstrate some of the first taglines to be use with the pen (www.go-pen.com). In addition, there has been the significant regulatory advancement with the FDA's complete submission of a 510(k) in August 2023 for fast-acting insulin in the USA. The market strategy has been refined through insights from numerous patients, healthcare providers, and payers. GO-Pen's accolades, including winning the American Diabetes Association Innovation Challenge and inclusion in StartupHealth's T1D Moonshot, underscore its commitment to delivering an innovative insulin pen for all, while its ISO 13485 certification marks a crucial step in quality assurance and stakeholder engagement.