Sedana Medical Achieves U.S. FDA Fast Track Status: A Major Step Towards Improved Health Care Access

Sedana Medical AB (publ) (SEDANA: FN Stockholm) is thrilled to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for their Sedaconda ACD-S device, allowing for the evaluation of isoflurane for sedation of mechanically ventilated patients in the intensive care (ICU) setting. This is a major step forward in providing safe and effective sedation to those in need of critical care.

The Fast Track process is designed to revolutionize the development and review of therapies that can help treat serious conditions and address unmet medical needs. This expedited process gives patients access to important new treatments faster, providing them with the opportunity to receive the care they need. Through frequent communication with the FDA, clinical programs with Fast Track Designation may benefit from Accelerated Approval or Priority Review. Additionally, with Rolling Review, completed sections of the New Drug Application can be submitted for review, eliminating the need to wait until all sections are completed.

The FDA’s decision to grant Fast Track Designation to Sedana Medical’s product candidates is a testament to their potential to provide meaningful benefits to ventilated patients in intensive care. We are thrilled to be working closely with the FDA to make our therapy available to US patients as soon as possible, and this news is a major milestone in our journey to serve our highest potential market.

Sedana Medical is making strides towards a revolutionary combination of their medical device, Sedaconda ACD, and the pharmaceutical isoflurane for sedation of mechanically ventilated intensive care patients in the United States. Two identical Phase III studies, INSPiRE-ICU 1 and 2, are currently being conducted with the goal of confirming the efficacy and safety of inhaled sedation with isoflurane delivered via Sedaconda ACD in intensive care. This could be a groundbreaking development for the medical industry!

Sedana Medical is in talks with the FDA to explore how the development program can benefit from the FTD. If all goes according to plan with an expedited patient enrolment and successful trials, the company is on track to submit its NDA in 2024 with a launch in early 2025.

About the studies INSPiRE-ICU 1 and INSPiRE-ICU 2 (SED003 and SED004)

The INSPiRE-ICU studies are two groundbreaking phase III trials that will determine the efficacy and safety of a novel sedation approach for adult ICU patients on mechanical ventilation. The trials will compare inhaled isoflurane delivered via the Sedaconda ACD to the traditional intravenous infusion of propofol. This is a major step forward in improving patient care in the ICU setting.

We’re enrolling 470 adult patients across 25-30 sites in the US for our studies. Joining us on this exciting journey and contributing to our research is easy – just sign up and we’ll have you enrolled by 2023!

The primary endpoint of our study is to measure the amount of time spent in the desired level of sedation, using the Richmond Agitation Sedation Scale (RASS). We will also be assessing secondary endpoints such as opioid use, wake-up time, cognitive recovery after sedation, and the quality of spontaneous breathing. To ensure the accuracy of our results, assessments will be done by blinded assessors and must meet the standards of the FDA.

About Sedana Medical

Sedana Medical AB (publ) is revolutionizing the way we approach and manage sedation, with a pioneering combination of medical device and pharmaceutical technology. The Sedaconda ACD device and the Sedaconda (isoflurane) pharmaceutical provide inhaled sedation for mechanically ventilated patients in intensive care, delivering a more comfortable and safe experience for patients and medical teams alike. With Sedana Medical, sedation is no longer something to fear, but rather a vital tool for improving patient care and quality of life.

Sedana Medical is proud to offer its products directly to customers in Benelux, France, Germany, Great Britain, the Nordic, and Spain. For customers in other parts of Europe, Asia, Australia, Canada, and South- and Central America, the company is proud to partner with external distributors to bring its products to them.

Sedana Medical, a Stockholm-based medical technology company founded in 2005, has seen great success since its listing on the Nasdaq First North Growth Market (SEDANA). With a strong mission to develop innovative medical solutions for health care providers, Sedana Medical is a leader in the industry, committed to making a meaningful impact on patient care.

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