Helios Cardio

What Helios Cardio does

Helios Cardio is a privately held, commercial-stage cardiac repair and regeneration company founded in 2015 and headquartered in Weston, Massachusetts, with research, development, and manufacturing operations in Natick, Massachusetts. The company is built around a proprietary platform technology called Fetal Engineered Biologic Matrix (f-EBM), a decellularized fetal bovine dermis collagen matrix that is high in Type III collagen, delivers mechanical strength without chemical crosslinking, and is designed to remodel into native cardiac tissue. Its lead commercial product, CardiaMend Pericardial and Epicardial Reconstruction Matrix, received FDA 510(k) clearance in January 2022 and is indicated for pericardial repair and reconstruction and epicardial support and repair during cardiac surgery.

The company sells to U.S. cardiac surgeons and hospitals through a hybrid model: direct enterprise field sales to cardiac surgery departments, an exclusive distribution agreement with Shamrock Surgical covering states west of the Mississippi, and government contract placement on FSS, DAPA, ECAT, and GSA Advantage via Lovell Government Services for VA and DoD facilities. Beyond the cleared device, Helios Cardio is investing in an IND-stage clinical program combining CardiaMend with amiodarone for postoperative atrial fibrillation prophylaxis (first patient enrolled January 2025, NCT06730828), and has stated R&D direction toward stem-cell and local drug-delivery combination products for heart failure and other cardiovascular indications.

Helios Cardio is founder-led by Yiannis Monovoukas, PhD, MBA, who previously led TEI Biosciences and TEI Medical through their acquisition by Integra LifeSciences for more than $300 million. The company operates with 1-10 employees, has not disclosed any external funding rounds, and is targeting the U.S. cardiovascular disease market, where more than 6.2 million Americans live with heart failure and coronary heart disease drives more than 350,000 U.S. deaths annually at an economic cost above $30 billion per year.

Name

Helios Cardio

Legal name

Helios Cardio Inc.

Website

https://helioscardio.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

Helios Cardio is a privately held cardiac repair and regeneration company that develops and commercializes the FDA-cleared CardiaMend matrix, built on its proprietary fetal engineered biologic matrix platform, selling to U.S. cardiac surgeons, hospitals, and federal healthcare channels.

Ownership category

akta.pro rank

Product category

Cardiac Surgery Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Cardiac Surgery Devices (Cannulas, Clamps, Closure, Grafts) (HLAHAFAH)

akta.pro secondary industry

Cardiovascular & Vascular Regeneration (vascular grafts, angiogenesis) (HLAAAGAJ)

Keywords

• Cardiac tissue repair
• Biologic matrix devices
• Pericardial reconstruction
• Regenerative biomaterials
• Fetal engineered matrix

Headquarters

HQ city

Weston

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Medical Device Sales: Sale of FDA-cleared CardiaMend Pericardial and Epicardial Reconstruction Matrix to cardiac surgeons and hospitals
2. Product Distribution: Revenue generated through distribution partnerships with Shamrock Surgical for states west of the Mississippi

Go-to-market motion3 records

Distribution channels3 records

Marketing channels4 records

Core offering

Helios Cardio develops and manufactures biologic medical devices for cardiac repair and reconstruction, with its commercial lead being the FDA 510(k)-cleared CardiaMend™ Pericardial and Epicardial Reconstruction Matrix. The company is built on a proprietary Fetal Engineered Biologic Matrix (f-EBM) platform technology derived from fetal bovine dermis, designed for use in cardiac surgery and as a scaffold for combination drug and stem cell therapies.

Product overview

Helios Cardio is a cardiac repair and regeneration company that has developed a platform technology called Fetal Engineered Biologic Matrix (f-EBM), derived from fetal bovine dermis. The company's lead commercial product is CardiaMend™ Pericardial and Epicardial Reconstruction Matrix, an FDA-cleared device for pericardial and epicardial repair during cardiac surgery. f-EBM serves as the foundational technology that enables both the CardiaMend™ product line and future therapeutic combinations with stem cells or drug therapies for cardiac tissue regeneration.

Differentiator

Problem solved

Functional benefit

Products and services

• CardiaMend™ Pericardial and Epicardial Reconstruction Matrix FDA-cleared biologic matrix device for the repair and reconstruction of the pericardium and for the support and repair of the epicardium during cardiac surgery. Based on the Fetal Engineered Biologic Matrix (f-EBM) platform, it combines mechanical strength and high biocompatibility for cardiac surgery use cases including adjuncts to CABG and valvular surgery. Sold to cardiac surgeons and hospitals in the U.S.
• Fetal Engineered Biologic Matrix (f-EBM) platform technology Proprietary decellularized fetal bovine dermis collagen matrix containing abundant Type III collagen, providing mechanical strength without chemical crosslinking and serving as the foundational scaffold technology for CardiaMend and future combination therapies (drugs and stem cells) for cardiac tissue regeneration.

Quantifiable outcome

• Over 1 million patients treated with EBM technology since 2003
• +2 more outcomes

Named customers3 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

Feature8 records

Partnerships

Two partnerships are on record, tiered core.

• Shamrock SurgicalcoreChannel Partner/ Reseller/ Distributor · 11 April 2023Exclusive distribution agreement where Shamrock Surgical distributes CardiaMend Pericardial and Epicardial Reconstruction Matrix to cardiac surgeons in states west of the Mississippi. Shamrock supports cardiac operating rooms with best-in-class technologies and provides exceptional customer support.
• Lovell Government ServicescoreChannel Partner/ Reseller/ Distributor · 30 August 2022Partnership enabled Helios Cardio's inclusion on Defense Logistics Agency's ECAT, DoD's DAPA, Department of Veterans Affairs' FSS, and GSA Advantage contract vehicles. Lovell is a Service-Disabled Veteran-Owned Small Business (SDVOSB) that helps medical companies serve VA and military patient populations.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• CorMatrix Cardiovascular: Direct competitor developing extracellular matrix (ECM) products for cardiac tissue repair and pericardial reconstruction. Most comparable peer in terms of product category (biologic matrix for cardiac surgery) and target customers (cardiac surgeons).
• Aziyo Biologics: Regenerative medicine company commercializing biologic matrices including cardiac patches and ECM products for soft tissue repair. Direct competitor in the biologic matrix space targeting similar cardiac and surgical indications.
• LeMaitre Vascular: Specialty medical device company selling vascular and cardiac surgical patches, grafts and biologic devices. Comparable niche surgical device peer with similar hospital sales motion and cardiac surgery customer overlap.

Broad incumbents

• Artivion (formerly CryoLife): Established cardiac and vascular surgery company offering heart valves, surgical adhesives, and tissue-preserved cardiac patches. Overlaps with Helios Cardio in the cardiac surgery materials market but is a broader portfolio incumbent.
• Integra LifeSciences: Acquired Helios Cardio's predecessor companies (TEI Biosciences/TEI Medical) for $300M+ and sells regenerative tissue products including DuraGen and other ECM-based devices. Strategic incumbent with deep knowledge of the underlying EBM technology.
• Edwards Lifesciences: Major cardiac surgery and structural heart device company with heart valves and surgical products. Competes for cardiac surgery hospital budgets but at a much larger scale across a broad cardiac portfolio.
• Medtronic: Global medical device incumbent with extensive cardiac surgery portfolio (valves, surgical ablation, perfusion). Indirect competitor and large hospital-channel incumbent for cardiac surgery materials.
• Abbott: Diversified medical device major with structural heart, cardiac surgery, and vascular businesses. A broad incumbent in the cardiac surgery space with comparable hospital relationships.
• Baxter International: Medical products company with surgical solutions including hemostats, sealants and biologic surgical materials. Competes more broadly for operating room budgets rather than as a direct cardiac patch competitor.

Emerging players

• TELA Bio: Commercial-stage regenerative medicine company with biologic matrix products (OviTex, Ovitex PRS) for hernia and plastic surgery. Uses similar biologic scaffold approaches to f-EBM and is a comparable emerging peer in ECM-based devices.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/CardioHelios

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

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 Helios Cardio