Instylla

About Instylla

Instylla, Inc. is a medical technology company focused on advancing the field of interventional radiology through the development of next-generation liquid embolic agents. Founded in 2017 by Incept LLC, a medical device incubator, the Bedford, Massachusetts-based firm operates in the peripheral vascular embolization market. The company was the brainchild of serial entrepreneur Dr. Amar Sawhney, a chemical engineer with an extensive track record of founding successful medical device companies such as Confluent Surgical, Augmenix, and Ocular Therapeutix. His journey as an immigrant from India and initial career rejections fueled a path of innovation, resulting in over 150 patents and the creation of multiple companies that have generated significant revenue and jobs.

Instylla's business model centers on the development and future commercialization of proprietary medical devices for physicians, specifically interventional radiologists. The company targets clinical applications in interventional oncology, such as treating hypervascular tumors, and peripheral hemostasis, which involves controlling arterial bleeding. A significant milestone was achieved in August 2025 when Instylla received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for its flagship product, the Embrace™ Hydrogel Embolic System (HES). This approval was based on a prospective, randomized, multicenter pivotal study involving 150 patients, which demonstrated the product's safety and effectiveness.

The Embrace HES is designed for the embolization of hypervascular tumors in peripheral arteries. It consists of two low-viscosity, water-based liquid precursors that, when simultaneously injected into blood vessels, polymerize to form a soft, polyethylene glycol (PEG) hydrogel. This process creates a durable occlusion that stops blood flow to the targeted area. Key features include its ability to achieve deep penetration into the tumor's vascular bed, the absence of organic solvents, and the elimination of the risk of catheter entrapment, a potential complication with other embolic agents. The hydrogel is biocompatible and does not have imaging artifacts, allowing for clear follow-up imaging. The company has also been developing the Tembo™ Embolic System, a bioresorbable embolization agent. Instylla has successfully raised capital through multiple funding rounds, securing a total of $63.8 million to support its clinical trials and commercialization efforts.