Instylla Submits Premarket Approval for Embrace™ Hydrogel System

Instylla, Inc., a private clinical-stage company based in Bedford, Massachusetts, has taken a significant step forward in its quest to provide innovative solutions for peripheral vascular embolotherapy. The company recently submitted the final module of its premarket approval application (PMA) for the Embrace™ Hydrogel Embolic System (HES) to the U.S. Food and Drug Administration (FDA). This submission is a notable achievement as it encompasses the results of clinical studies essential for the embolization of hypervascular tumors.

Instylla's Embrace HES is an investigational device designed to treat hypervascular tumors by embolizing blood vessels that are 5 mm or smaller in diameter. This system is unique due to its composition and mechanism. It comprises two liquid precursors that, when injected into the blood vessels, solidify to form a soft hydrogel. This hydrogel effectively fills the vessel lumens, thereby facilitating the embolization process. One of the standout features of Embrace HES is that it does not rely on solvents, nor does it require precise sizing to match vessel diameters, which reduces the risk of catheter entrapment during procedures. The core ingredients of this system are water and polyethylene glycol (PEG), underscoring its innovative approach.

The submission of this final PMA module signifies a pivotal moment for Instylla. The company has previously completed modules concerning pre-clinical testing and manufacturing, and this recent submission marks the culmination of their comprehensive application to the FDA. The use of the FDA's modular submission program has been instrumental in this process, allowing Instylla to streamline and expedite the approval pathway. This structured approach has facilitated a more efficient journey towards bringing their novel solution to the market.

Amar Sawhney, the CEO of Instylla, Inc., and Managing Director of Incept, LLC, expressed his enthusiasm regarding this milestone. He highlighted the dedication and strategic execution of the Instylla team, emphasizing the importance of this achievement in the company's mission to innovate in the field of embolotherapy.

Founded in 2017 by Incept LLC, Instylla is committed to advancing the field of interventional radiology with its focus on developing resorbable embolic agents. The company's efforts are primarily directed towards applications in interventional oncology and peripheral vasculature. Despite being in the clinical stages, Instylla has garnered support from leading venture capital groups, highlighting the industry's confidence in its potential.

While the Embrace Hydrogel Embolic System is currently an investigational device and not yet available for sale, its development reflects a significant technological advancement in medical devices for tumor embolization. Instylla's progress in this domain promises to enhance treatment options for patients with hypervascular tumors, potentially improving outcomes and offering new hope for those affected by such conditions.

Instylla’s journey underscores its commitment to innovation and its strategic approach to navigating regulatory pathways. With the completion of its PMA application, the company stands poised to potentially revolutionize the landscape of embolotherapy, pending regulatory approval.