Instylla Initiates Commercial Launch with First Use of the Embrace™ Hydrogel Embolic System
Milestone marks the commercial use of the first and only liquid embolic approved for hypervascular tumor embolization supported by a prospective, randomized, controlled clinical trial BEDFORD, Mass., January 28th, 2026 – Instylla, Inc., a privately held company developing novel resorbable embolics for peripheral vascular embolization, today announced that Dr. Ripal Gandhi has completed the first […]
Instylla Gains U.S. FDA Premarket Approval for Embrace™ Hydrogel Embolic System
First and Only Liquid Embolic Approved for Hypervascular Tumor Embolization Supported by a Prospective, Randomized, Controlled, Clinical Trial BEDFORD, Mass., August 7, 2025 – Instylla, Inc., a privately held company developing novel resorbable embolics for peripheral vascular embolization, announced premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the company’s flagship product Embrace™ […]
Instylla Appoints MedTech Leader Sean Boyle as Chief Executive Officer
BEDFORD, Mass., Aug 5, 2025 – Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolization, has announced the appointment of Sean Boyle as Chief Executive Officer. A seasoned senior executive with over 15 years of leadership experience in the medical device industry, Mr. Boyle brings a proven history of driving transformative growth […]
Instylla Announces the Appointment of Daniel Davis to Board of Directors
BEDFORD, Mass., – Apr 15, 2025 – Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolization, has announced the appointment of Daniel Davis to its Board of Directors. Mr. Davis is Chief Strategy Officer at Imperative Care, where he has led growth, development, and strategic initiatives for its stroke and vascular technologies. […]
Instylla Completes Submission of Premarket Approval Application for Embrace™ Hydrogel Embolic System
BEDFORD, Mass., – March 11, 2025 – Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, announced that it recently submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval application (PMA) for the Embrace™ Hydrogel Embolic System (HES).
Instylla Announces FDA Clearance of Tembo™ Embolic System
BEDFORD, Mass., – Jan 28, 2025 – Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, has announced the FDA 510(k) clearance of the Tembo™ Embolic System. The Tembo Embolic System is a bioresorbable1 embolization agent comprised of irregularly shaped, dry gelatin particles of a size range from 85-255µm1…
Instylla Completes Enrollment of Landmark Hypervascular Tumor Pivotal Study
Clinical investigators achieve significant milestone by enrolling 150 patients with hypervascular tumors in pivotal randomized study. BEDFORD, Mass., – May 14, 2024 – Instylla, Inc., a privately held clinical-stage company focused on developing liquid embolics for peripheral vascular embolotherapy, today announced the completion of patient enrollment in the ongoing Instylla HES Hypervascular Tumor Pivotal Study. The Instylla […]
Instylla Announces Enrollment of Initial Patients in the Embrace™ Hydrogel Embolic System Global Randomized Multi-Center Clinical Trial
BEDFORD, Mass., March 30, 2021 /PRNewswire/ — Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, today announced the enrollment of the first patients in the Embrace Hydrogel Embolic System (HES™) global randomized clinical trial for the treatment of hypervascular tumors. As demonstrated previously in the completed First-in-Human (FIH) study, […]
Instylla Announces Completion of Series B Financing
Financing to see Instylla through US Pivotal and other clinical trials BEDFORD, Mass., Oct. 14, 2020 /PRNewswire/ — Instylla, Inc., a privately held company developing minimally invasive liquid embolic products designed for use in peripheral vascular embolotherapy today announced closure of $25.4 million Series B financing. Participants in this latest round of financing included the new investors Excelestar Ventures, Catalyst […]