Shape Memory Medical

What Shape Memory Medical does

Shape Memory Medical is a privately held medical device company headquartered in San Jose, California, founded in 2009 to commercialize Shape Memory Polymer (SMP) technology for endovascular embolization. The company's core platform centers on a proprietary bioresorbable polymer that expands and conforms at body temperature, enabling devices that occlude targeted vasculature while integrating embolic material into the vessel. Its commercial product family includes the IMPEDE Embolization Plug, IMPEDE-FX, IMPEDE-FX RapidFill, and the TrelliX Embolic Coil, serving interventional radiologists and vascular surgeons across peripheral and neurovascular embolization indications in more than 40 countries.

The company is expanding its clinical footprint beyond standalone embolization, with the investigational FLAGSHIP False Lumen Embolization System targeting aortic dissection and the AAA-SHAPE Pivotal Trial evaluating sac management adjunct to endovascular aneurysm repair. Regulatory positioning includes the first FDA-cleared SMP-based vascular device, EU MDR Class III certification for the IMPEDE family, PMDA approval in Japan, and recent clearances in Singapore and Malaysia. Distribution is executed through regional partners and a sublicense with a global MedTech leader, supplemented by direct commercial activity in core markets.

Commercial economics follow a B2B medical device model: the company sells Class III implantable devices to hospitals and integrated delivery networks on a per-unit basis, with ASPs typical of vascular embolization products and revenue tied directly to procedure volumes. The company has cumulatively treated more than 3,000 patients as of March 2025, with total disclosed equity funding exceeding $50M, including a $38M Series C led by Earlybird Venture Capital in March 2024 and a $17M follow-on in April 2025.

Name

Shape Memory Medical

Legal name

Shape Memory Medical, Inc.

Website

https://shapemem.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

Shape Memory Medical is a San Jose-based medical device company developing Shape Memory Polymer-based embolization devices (IMPEDE family, TrelliX coils) for interventional radiologists and vascular surgeons across 40+ countries, with active expansion into aortic indications.

Ownership category

akta.pro rank

Product category

Endovascular Embolization 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)

akta.pro secondary industries

Peripheral Vascular Intervention (PAD Stents, Balloons, Atherectomy) (HLAHAFAE), Stroke & Vascular Neurology (HLAKAIAG)

Keywords

• Shape memory polymer devices
• Vascular embolization plugs
• Neurovascular embolic coils
• Bioresorbable endovascular devices
• Peripheral embolization products

Headquarters

HQ city

Santa Clara

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, Operations, Personnel, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. Medical Device Sales: Sale of proprietary shape memory polymer embolization devices to hospitals and healthcare facilities. Revenue generated from one-time device purchases by interventional radiology and vascular surgery departments. Products include IMPEDE Embolization Plug, IMPEDE-FX Embolization Plug, IMPEDE-FX RapidFill, and TrelliX Embolic Coil System.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Shape Memory Medical develops and commercializes implantable endovascular embolization devices built on a proprietary bioresorbable Shape Memory Polymer (SMP) platform, including the IMPEDE Embolization Plug family (IMPEDE, IMPEDE-FX, IMPEDE-FX RapidFill) for peripheral vascular embolization and the TrelliX Embolic Coil System for neurovascular and peripheral vessel occlusion. Devices are sold to hospital interventional radiology, vascular surgery, and neurointerventional departments through direct US sales and a global distributor network spanning 40+ countries.

Differentiator

Problem solved

Functional benefit

Brands

• Impede: IMPEDE Embolization Plug family of embolic plugs for peripheral vascular embolization procedures using shape memory polymer technology.
• Impede-FX
• Impede-FX RapidFill
• TrelliX
• AAA-SHAPE
• FLAGSHIP
• EMBO-PMS

Products and services

• IMPEDE Embolization Plug Shape memory polymer embolization plug with an anchor coil, used to obstruct or reduce blood flow in the peripheral vasculature; for interventional radiologists treating peripheral vessels up to 10mm in diameter.
• IMPEDE-FX Embolization Plug Standalone shape memory polymer embolization plug used as an adjunct to the IMPEDE Embolization Plug for additional space filling in peripheral vascular embolization procedures.
• IMPEDE-FX RapidFill Preloaded 5-device cartridge that delivers 6.25 mL of shape memory polymer in a single application for large vessel or lesion embolization; for peripheral vascular embolization. Not available for sale in the United States or Japan.
• TrelliX Embolic Coil System Composite embolic device combining a shape memory polymer over a platinum-tungsten coil for catheter delivery; self-expands to a predefined volume upon contact with blood. Indicated for neurovascular and peripheral vessel abnormalities. Not approved for sale in the United States or Japan.

Quantifiable outcome

• 1,500th patient treated milestone reached August 2022
• +4 more outcomes

Named customers6 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Six partnerships are on record, tiered major and core.

• Getz HealthcaremajorChannel Partner/ Reseller/ Distributor · 10 October 2025Served as distribution partner driving regulatory approval process and distributing IMPEDE Embolization Plug product family (IMPEDE, IMPEDE-FX, IMPEDE-FX RapidFill) across Singapore and Malaysia as part of its pan-vascular portfolio. Also distributes in Hong Kong and Taiwan.
• Major Medical Device ManufacturercoreOEM/ Whitelabel/ Licensing Partner · 11 December 2023Second sublicense of Shape Memory Medical's intellectual property portfolio to another highly respected medical device manufacturer for an innovative application.
• Global MedTech Market LeadermajorOEM/ Whitelabel/ Licensing Partner · 6 July 2023Sublicense agreement for proprietary shape memory polymer technology for a narrow indication in a therapeutic area outside of Shape Memory Medical's cardiovascular, endovascular and neurovascular focus. Second sublicense of intellectual property portfolio.
• COSMOTEC CO, LTDmajorChannel Partner/ Reseller/ DistributorDistribution partner for Japan, a Group Company of M3 Inc. listed on Tokyo Stock Exchange. Championed PMDA approval process for IMPEDE products in Japan.
• Appleton Medical Service Inc.coreChannel Partner/ Reseller/ DistributorUS distributor for Shape Memory Medical products.
• State Of The Art Medical Products (SOTA)coreChannel Partner/ Reseller/ DistributorUS distributor for Shape Memory Medical products.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Penumbra: Penumbra offers the Ruby Coil and POD (Penumbra Occlusion Device) systems for peripheral and neurovascular embolization. It is a direct peer in the embolization device market, with overlapping customer base in interventional radiology and neurointerventional radiology.
• Merit Medical Systems: Merit Medical offers the EmboCube and EmboZphere embolic bead products plus Bear (vascular plugs) and Bear Vac. It is a direct peer in peripheral vascular embolization and competes with the IMPEDE family for the same hospital procurement budgets.

Broad incumbents

• Cook Medical: Cook Medical manufactures vascular embolization coils and the MReye Flipper and Tornado coils, plus a broad vascular intervention portfolio. It is a broad incumbent competing with Shape Memory Medical in peripheral embolization and serves the same interventional radiology departments.
• Boston Scientific: Boston Scientific's peripheral intervention division offers embolization products including Interlock and VortX coils, plus access and closure devices. It competes with Shape Memory Medical's IMPEDE family in peripheral embolization procedures and serves the same interventional radiology customer base.
• Stryker: Stryker's Neurovascular division offers Target detachable coils and other neurovascular embolization products. It is a direct competitor in neurovascular embolization where TrelliX Embolic Coil is positioned.
• Medtronic: Medtronic offers a broad embolization portfolio including Concerto detachable coils (acquired via Covidien) and peripheral embolization plugs. Several Shape Memory Medical executives, including the CCO, came from Medtronic's peripheral vascular and embolization business, and the companies compete in the same call points.
• Terumo (MicroVention): MicroVention (a Terumo subsidiary) is a leading neurovascular embolization company with hydrocoil and platinum coil systems for intracranial aneurysms and AVMs. It directly competes with TrelliX Embolic Coil in the neurovascular embolization space.
• Johnson & Johnson (Cerenovus): Cerenovus (J&J MedTech) offers neurovascular coils, including the Galaxy and Orbits, for aneurysm and AVM embolization. It is a broad incumbent in neurovascular embolization where TrelliX competes, and the CEO's prior Micrus Endovascular background is a J&J-acquired franchise.

Emerging players

• Kaneka: Kaneka offers the iED coil and other neurovascular embolization products in select markets, including Japan. It is an emerging player with partial overlap in the peripheral and neurovascular embolization space where Shape Memory Medical's Cosmotec partnership operates in Japan.
• ArtVentive Medical: ArtVentive Medical develops endoluminal occlusion devices (EOS) for peripheral embolization. It is a smaller emerging player with a narrower portfolio that partially overlaps with Shape Memory Medical's peripheral embolization focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/shape-memory-therapeutics-inc.
• Xx.com/ShapeMemMedical

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds11 records

Investors10 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 Shape Memory Medical