What Syntheon does

Syntheon LLC is a Miami, Florida-based medical device incubator founded in 1999 that invents, develops, prototypes, and manufactures electromechanical medical devices for subsequent licensing, sale, or co-development with major medical device OEMs. The company operates from a 35,000 sq. ft. facility that includes modeling design stations, PCB assembly, 3D printing, CNC and standard machining, a fluoroscopy-equipped clinical lab, and a 5,000 sq. ft. manufacturing clean room, allowing it to take a concept from ideation through clinical-trial-ready or commercial manufacturing in-house. Its technology portfolio spans cardiology, interventional neurology, and surgical/endoscopic devices, anchored by over 200 issued patents developed by the principals and a 100-year combined product development experience base.

Syntheon's business model is a hybrid of three revenue streams: (1) outright technology licensing and acquisition sales to large OEMs such as Johnson & Johnson, Boston Scientific, Edwards Lifesciences, Olympus, Medtronic, and Covidien; (2) risk-and-reward-sharing co-development partnerships where Syntheon develops products identified as market needs by partner companies; and (3) direct manufacturing and sale of products through subsidiary entities using its in-house clean room capacity. Its most prominent commercial product to date is the Penditure Left Atrial Appendage Exclusion System, an innovative implantable cardiac surgery clip that is the only LAA clip capable of recapture, repositioning, and redeployment after deployment, which was acquired by Medtronic in August 2023 and commercially launched in the U.S. later that year. Customers served are exclusively large enterprise medical device manufacturers; end beneficiaries are patients (over 52 million cumulatively, by the company's count) treated with products developed by Syntheon principals. Pricing is not publicly disclosed and operates on a custom, quote-based B2B engagement model.

Name

Syntheon

Legal name

Syntheon LLC

Website

https://syntheon.com

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

11–50 employees

Short description

Syntheon LLC is a Miami-based medical device incubator that invents, prototypes, and manufactures electromechanical medical devices for licensing, sale, or co-development with major medical device OEMs, holding over 200 patents across cardiology and surgery.

Ownership category

akta.pro rank

Product category

Medical Device Development

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Process Development & Tech Transfer Services (CDMO) (HLAGABAL)

Keywords

• Medical device incubation
• Cardiac surgery devices
• Medical device licensing
• Electromechanical medical devices
• Medical device manufacturing

Headquarters

HQ city

Miami

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, Infrastructure, Operations, Supply Chain, Marketing or Sales

Revenue model

1. Technology Licensing and Acquisition: Syntheon develops medical device technologies and sells or licenses proprietary technologies to major medical device companies. Companies such as Johnson & Johnson, Boston Scientific, Edwards, Olympus, and others have acquired Syntheon's proprietary technologies.
2. Co-development Partnerships: Working with medical device companies that identify market needs, Syntheon develops new products from initial innovation through final manufacturing, sharing both risk and reward with partners.
3. Manufacturing Operations: Products manufactured through subsidiary entities, leveraging in-house 35,000 sq. ft facility with manufacturing clean room capabilities.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels3 records

Core offering

Syntheon is a medical device incubator that invents, develops, and manufactures innovative electro-mechanical medical devices. The company partners with major medical device companies through co-development, technology licensing, and acquisition arrangements, bringing products from initial innovation through clinical trials and final manufacturing. Products are either licensed or sold to industry partners such as Medtronic, Johnson & Johnson, Boston Scientific, Edwards Lifesciences, Olympus, and Covidien, or brought to market through subsidiary entities using its 35,000 sq. ft. Miami facility with in-house prototyping, clean room manufacturing, and clinical lab capabilities.

Product overview

Syntheon is a medical device incubator that invents and develops innovative medical devices for unmet clinical needs. The company leverages over 200 issued patents and 100 years of product development experience to create patented electro-mechanical medical devices. Their portfolio includes the Penditure™ Left Atrial Appendage Exclusion System, which was acquired by Medtronic in 2023. Syntheon operates from a 35,000 sq. ft. state-of-the-art facility in Miami, Florida with in-house capabilities including modeling design stations, PCB assembly, programming, 3D printing, CNC machining, clinical lab with fluoroscopy, and a 5,000 sq. ft. manufacturing clean room.

Differentiator

Problem solved

Functional benefit

Products and services

• Penditure Left Atrial Appendage Exclusion System An innovative implantable clip pre-loaded on a single-use delivery system for left atrial appendage management during cardiac surgery. The curved clip matches atrial anatomy, is designed without fabric for atraumatic closure and reduced inflammation, and is the only LAA clip that can be recaptured, repositioned, and redeployed after deployment. The technology was acquired by Medtronic in August 2023.
• Medical Device Development, Co-Development, and Technology Licensing Services Comprehensive medical device incubator services spanning initial innovation, rapid prototyping, testing, and final manufacturing. Syntheon partners with major medical device companies through co-development engagements that share risk and reward, licenses or sells proprietary technologies, and brings products to market through subsidiary entities. The offering leverages in-house capabilities including 3D printing, CNC machining, PCB assembly, a clinical lab with fluoroscopy, and a 5,000 sq. ft. clean room manufacturing facility.

Quantifiable outcome

• 52+ million patients improved through Syntheon-developed products
• +2 more outcomes

Named customers1 record

Segments2 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

Partnerships

Six partnerships are on record, tiered core.

• MedtroniccoreOEM/ Whitelabel/ Licensing Partner · 1 August 2023Medtronic completed the acquisition of the Penditure Left Atrial Appendage Exclusion System technology from Syntheon LLC in August 2023. The acquisition expands Medtronic's Cardiac Surgery portfolio to include left atrial appendage management. The first cases were performed by Drs. Gorav Ailawadi and Basel Ramlawi at the University of Michigan Frankel Cardiovascular Center and Lankenau Heart Institute.
• Johnson & JohnsoncoreOEM/ Whitelabel/ Licensing PartnerJohnson & Johnson (including subsidiary Ethicon) has acquired proprietary technologies from Syntheon, representing a long-term partnership in medical device development.
• Boston ScientificcoreOEM/ Whitelabel/ Licensing PartnerBoston Scientific has acquired Syntheon proprietary technologies, representing a significant partnership in the interventional medical device space.
• Edwards LifesciencescoreOEM/ Whitelabel/ Licensing PartnerEdwards Lifesciences has acquired proprietary technologies from Syntheon, indicating a partnership in cardiac device innovation.
• OlympuscoreOEM/ Whitelabel/ Licensing PartnerOlympus has acquired Syntheon proprietary technologies, representing a partnership in endoscopic and surgical device development.
• CovidiencoreOEM/ Whitelabel/ Licensing PartnerCovidien (now part of Medtronic) has acquired proprietary technologies from Syntheon, indicating a historical partnership in medical device development.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Conformal Medical: Conformal Medical develops next-generation left atrial appendage (LAA) closure devices — directly competitive with Syntheon's Penditure clip in the same cardiac surgery procedure category. Comparable as an early-to-mid-stage medical device innovator targeting strategic acquisition by major medtech acquirers.
• Corvia Medical: Corvia Medical developed the InterAtrial Shunt Device (IASD) for heart failure with preserved ejection fraction. Comparable as a clinical-stage structural heart device innovator pursuing partner-driven commercialization.
• JenaValve Technology: JenaValve develops transcatheter aortic valve replacement (TAVR) systems and operates as a clinical-stage medical device innovator partnering with major cardiac medtech players. Comparable through its structural heart focus, IP-driven differentiation, and reliance on strategic partners for commercialization.
• Cardiac Dimensions: Cardiac Dimensions develops the Carillon mitral contour system for functional mitral regurgitation, operating as a structural heart device innovator. Comparable to Syntheon through its focus on cardiac surgery innovation and partner-driven commercialization pathway.
• Intact Vascular (acquired by Philips): Intact Vascular developed the Tack Endovascular System for peripheral arterial disease and was ultimately acquired by Philips. Closely comparable exit pathway to Syntheon's model of building specialized vascular devices for strategic acquisition by larger medtech.
• Svelte Medical Systems: Svelte Medical Systems developed a low-profile drug-eluting stent delivery system acquired by Integer Holdings. Comparable as a small-team medical device innovator whose proprietary technology was ultimately licensed/divested to a larger medtech partner.
• Foundry Medical Innovations: Foundry Medical Innovations operates as a medical device incubator developing innovations across cardiovascular and other specialties for licensing to strategic partners. Directly comparable business model to Syntheon's incubator approach.
• SentreHEART: SentreHEART developed LAA closure technology acquired by AtriCure, mirroring Syntheon's exit path of licensing/divesting novel structural heart technology to a larger cardiac medtech player. Operates in the same clinical procedure category (left atrial appendage management).

Emerging players

• REVA Medical: REVA Medical developed bioresorbable polymer scaffolds for vascular applications. Comparable through its small-team medical device innovator profile targeting cardiovascular procedure markets through strategic partner channels.
• Aria CV: Aria CV is developing an implantable pulmonary artery sensor system for pulmonary hypertension, operating as an early-stage structural heart/pulmonary device innovator. Comparable through its pursuit of strategic partnership/acquisition pathways in the cardiology space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/syntheon-llc

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds2 records

Investors

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

M&A

Investments3 records

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

Frequently asked questions about Syntheon