Instylla

What Instylla does

Instylla, Inc. is a Bedford, Massachusetts-based, privately held medical device company founded in 2017 by Incept LLC that develops resorbable embolic agents for interventional radiology, with initial clinical applications in interventional oncology. The company's core technology is a water-based liquid embolic platform using polyethylene glycol (PEG) hydrogel chemistry: two low-viscosity liquid precursors are delivered simultaneously through a proprietary delivery kit and microcatheter, crosslinking intravascularly in under two seconds to form a soft, occlusive hydrogel that penetrates to the capillary level (vessels as small as 10 microns) and resorbs via hydrolysis over approximately 11 months. Its flagship product, the Embrace Hydrogel Embolic System (HES), received FDA Premarket Approval in August 2025 and is the first and only liquid embolic specifically approved for hypervascular tumor embolization in peripheral arteries, validated by a prospective, randomized, multicenter pivotal trial of 150 patients demonstrating 88.6% technical success and 99% freedom from major adverse events.

The company has a second commercial product, the Tembo Embolic System, which received FDA 510(k) clearance in January 2025 and consists of irregularly shaped, bioresorbable dry gelatin particles (85–255 µm) designed for embolization of hypervascular tumors and occlusion of blood vessels in the peripheral vasculature, with approximately 28-day absorption. Both products are supported by proprietary delivery accessories including the Instylla Delivery Kit and Microcatheter.

Instylla generates revenue through direct hardware sales of its FDA-approved embolic systems to hospitals and interventional radiology departments in the United States via a field sales model led by SVP of Sales Nathan Rhatigan. Commercial launch of Embrace HES began January 28, 2026, and the company is targeting the >150,000 hypervascular tumor embolization procedures performed annually in the US, with additional pipeline indications in peripheral hemostasis (HALT Study) and broader peripheral vascular embolotherapy. The company has raised approximately $85 million in total funding across a Series B (2020), equity financing (2023), and a 2025 exempt offering, and is led by CEO Sean Boyle (former VP/GM of Oncology at Becton Dickinson) with founder Amar Sawhney serving as Chairman.

Name

Instylla

Legal name

Instylla, Inc.

Website

https://instylla.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

Instylla is a Bedford, MA-based medical device company developing FDA-approved resorbable liquid and particle embolic systems for interventional radiology. It serves US hospitals and interventional radiologists treating hypervascular tumors and peripheral vascular conditions, with commercial launch beginning January 2026.

Ownership category

akta.pro rank

Product category

Interventional Radiology Embolic Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Thrombectomy, Embolic Protection & Stroke Intervention Devices (HLAHAFAJ)

Keywords

• Liquid embolic agents
• Interventional oncology devices
• Peripheral vascular embolization
• Resorbable embolic systems
• Medical device manufacturing

Headquarters

HQ city

Waltham

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations

Revenue model

1. Embrace™ Hydrogel Embolic System (HES) product sales: Sale of FDA-approved medical device for hypervascular tumor embolization. The Embrace HES received FDA Premarket Approval in August 2025 and commercial launch began January 28, 2026 with first procedure by Dr. Ripal Gandhi at Miami Vascular Specialists. Revenue generated through direct hospital and interventional radiology department sales in the US market.
2. Tembo™ Embolic System product sales: Sale of FDA 510(k)-cleared bioresorbable gelatin particle embolization agent for peripheral vascular embolization. Received FDA clearance January 28, 2025. The company plans to collaborate with leading interventional radiology experts to maximize clinical adoption.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Instylla develops and commercializes novel resorbable embolic agents for interventional radiology, focused initially on interventional oncology. Its flagship product, the Embrace™ Hydrogel Embolic System (HES), is an FDA-approved liquid embolic using two-component polyethylene glycol (PEG) hydrogel precursors that crosslink intravascularly to occlude hypervascular tumors. The company also markets the Tembo™ Embolic System, an FDA-cleared bioresorbable gelatin particle embolic. Products are sold directly to hospitals and interventional radiology departments.

Product overview

Instylla develops novel resorbable embolic agents for interventional radiology, initially focused on interventional oncology. The product portfolio centers on two main embolic platforms: the Embrace™ Hydrogel Embolic System (HES), an FDA-approved liquid embolic using polyethylene glycol hydrogel technology for hypervascular tumor embolization, and the Tembo™ Embolic System, an FDA-cleared bioresorbable gelatin particle product. Both systems are supported by proprietary delivery accessories including the Instylla Delivery Kit and Microcatheter. The HES provides persistent embolization that resorbs over approximately 11 months, while Tembo offers short-term resorption at approximately 28 days.

Differentiator

Problem solved

Functional benefit

Brands

• Embrace Hydrogel Embolic System: FDA-approved liquid embolic system for hypervascular tumor embolization in peripheral arteries. Consists of two low-viscosity liquid precursors that crosslink to form a soft polyethylene glycol hydrogel.
• Tembo Embolic System

Products and services

• Embrace™ Hydrogel Embolic System (HES) FDA Premarket Approved (PMA) liquid embolic system consisting of two low-viscosity aqueous liquid precursors that crosslink intravascularly to form a soft polyethylene glycol (PEG) hydrogel for targeted hypervascular tumor embolization in peripheral arteries ≤5mm. Penetrates to capillary level (vessels as small as 10 microns), solidifies in less than 2 seconds, and resorbs via hydrolysis over approximately 11 months. Approved for hypervascular tumor embolization in peripheral arteries based on a 150-patient pivotal trial demonstrating 88.6% technical success.
• Tembo™ Embolic System FDA 510(k) cleared bioresorbable embolization agent composed of irregularly shaped, dry gelatin particles (size range 85–255µm dry; ~150–450µm hydrated) with approximately 28-day absorption time. Designed for embolization of hypervascular tumors and occlusion of blood vessels in the peripheral vasculature, including vascular malformations, uterine artery embolization, prostatic artery embolization, genicular artery embolization, and endoleak management. Compatible with microcatheters having an internal diameter ≥0.021 inches.

Quantifiable outcome

• 88.6% technical success rate vs 77.3% for standard of care (TAE/cTACE), confirmed by independent core lab
• +5 more outcomes

Named customers7 records

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Penumbra: Penumbra is a direct competitor in peripheral vascular embolization and mechanical thrombectomy, with established sales relationships among US interventional radiologists — the same call points Instylla is now targeting with Embrace HES. Penumbra's vascular embolization franchise competes head-to-head with Instylla's liquid embolic platform.
• Merit Medical Systems: Merit Medical sells a broad portfolio of embolization products (microspheres, coils, and delivery systems) directly to interventional radiologists and serves the same hypervascular tumor and peripheral embolization procedures that Instylla targets. It is a direct peer in the embolic device category.
• AngioDynamics: AngioDynamics manufactures and sells embolization products (including NanoKnife and related peripheral vascular devices) into interventional radiology call points. It is a smaller, more direct competitor to Instylla in peripheral embolization.
• Cook Medical: Cook Medical manufactures embolization coils, plugs, and accessories used in peripheral vascular embolization, serving the same interventional radiology customer base as Instylla. It is a direct peer competing for procedural share in tumor and peripheral embolization.
• Guerbet: Guerbet (and its acquired BTG/Liepold franchises) markets Embosphere and EmboGold microsphere embolics directly into interventional oncology and peripheral embolization procedures. It is a direct peer with overlapping indications and customer types for Instylla's Embrace HES.

Broad incumbents

• Boston Scientific: Boston Scientific markets the Embozene microsphere embolic franchise and is a broad incumbent in interventional oncology and peripheral embolization. Its scale, sales force, and existing value-analysis-committee approvals at hospitals make it a primary large-player competitor to Instylla's Embrace HES.
• Medtronic: Medtronic historically commercialized the Onyx liquid embolic system (now divested in some areas) and maintains a broad peripheral and neurovascular embolization portfolio. It represents a large incumbent competitor with established embolic technology and deep hospital relationships.
• Terumo (MicroVention): Terumo's MicroVention subsidiary develops and markets liquid embolics (including Onyx-related technology) for neurovascular and peripheral applications. It is a broad incumbent with R&D and commercial resources that could compete with or follow Instylla into resorbable liquid embolics.
• Stryker: Stryker, through its neurovascular and interventional franchises, markets embolization coils and related peripheral devices to interventional radiologists and neurosurgeons. It is a broad incumbent with overlapping procedure categories to Instylla's peripheral vascular embolization focus.
• Johnson & Johnson (Cerenovus): Johnson & Johnson's Cerenovus division markets neurovascular and peripheral embolization products, including coils and liquid embolics. It is a broad incumbent competitor with substantial resources and established hospital accounts in the embolization space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xtwitter.com/instylla
• LinkedInlinkedin.com/company/instylla

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds4 records

Investors8 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Instylla