Melodi

What Melodi does

Melodi Health is a pre-revenue, clinical-stage medical device company developing the Melodi Matrix™, an absorbable mesh that elutes antibiotics and degrades via hydrolysis to provide temporary soft tissue support during immediate, two-stage post-mastectomy alloplastic prepectoral breast reconstruction. The device is designed to address high complication and infection rates in breast reconstruction, where approximately 1 in 4 procedures experience complications and 1 in 10 require re-operation or experience infection-related complications. The platform combines four differentiated design elements: antibiotic elution for infection prevention, a bioabsorbable macroporous scaffold that promotes tissue ingrowth, hydrolytic absorption eliminating the need for surgical removal, and an expandable architecture that accommodates tissue expansion during reconstruction.

The company is currently running the ARIA IDE pivotal clinical trial — the first FDA-approved study evaluating an antibacterial soft tissue support device for breast reconstruction — with University of Utah Health as the first enrollment site. Melodi is pursuing a Class III combination-device regulatory pathway and has no commercial revenue to date. Its go-to-market, post-approval, will be enterprise field sales directly to hospitals and board-certified plastic surgeons performing breast reconstruction, supplemented by conference presence and direct physician outreach during the clinical phase.

Melodi is headquartered in Minneapolis, Minnesota, operates with 1–10 employees, and is led by co-founder and CEO Sarah Worrell, CSO Michele Hilmer (infection control and reconstructive surgery), CMO Hunter Moyer, MD (breast reconstruction surgeon), and VP Operations Kaitlyn Roth (implantable combination devices). The company has raised $10.75 million in a Series A led by HM Venture Partners (August 2024), with prior seed participation from Engage Venture Partners. Customer-facing activity is currently limited to clinical trial recruitment rather than commercial sales.

Name

Melodi

Legal name

Melodi Health

Website

https://melodihealth.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

1–10 employees

Short description

Melodi Health is a pre-revenue, clinical-stage medical device company developing the Melodi Matrix™, an antibiotic-eluting absorbable mesh for soft tissue support in post-mastectomy breast reconstruction. It targets plastic surgeons and hospitals via the FDA pathway through the ARIA IDE trial.

Ownership category

akta.pro rank

Headquarters

HQ city

Minneapolis

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

Revenue model

1. Medical Device Sales: Once FDA approved, the company will generate revenue through the sale of the Melodi Matrix device to hospitals and surgeons performing breast reconstruction procedures. Currently pre-revenue as the product is in clinical trial stage.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

Melodi Health is developing the Melodi Matrix, a clinical-stage soft tissue support device that combines an absorbable mesh with antibiotic elution for use in immediate, two-stage post-mastectomy alloplastic prepectoral breast reconstruction. The device provides temporary scaffolding that promotes tissue ingrowth, allows for tissue expansion, and gradually releases antibiotics to reduce post-surgical infection, then absorbs harmlessly into the body. The company is currently advancing the product through the ARIA IDE clinical trial to obtain FDA approval.

Product overview

Melodi Health is a single-product medical device company focused on breast reconstruction technology. The company offers the Melodi Matrix™, an antibiotic-eluting absorbable mesh device designed for soft tissue support in post-mastectomy breast reconstruction. The product is currently in clinical trials (ARIA IDE study) seeking FDA approval.

Differentiator

Problem solved

Functional benefit

Brands

• Melodi Matrix: Clinical stage soft tissue support device that elutes antibiotics and absorbs into the body. Intended to provide soft tissue support in immediate, two-stage post-mastectomy alloplastic prepectoral breast reconstruction.

Products and services

• Melodi Matrix A clinical-stage soft tissue support device that elutes antibiotics and absorbs into the body via hydrolysis. Designed as a synthetic scaffold to provide soft tissue support in immediate, two-stage post-mastectomy alloplastic prepectoral breast reconstruction, with the aim of reducing post-surgical infection and re-operation rates.

Quantifiable outcome

• Reduces post-surgical infection rates in breast reconstruction patients
• +1 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• University of Utah HealthcoreStrategic or Co-development PartnerUniversity of Utah Health served as the first enrollment site for the ARIA IDE clinical trial evaluating the Melodi Matrix device. This partnership is critical for generating clinical data to support FDA approval.

Scale indicators4 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• TELA Bio: TELA Bio markets resorbable surgical mesh products (OviTex) for hernia and breast reconstruction — directly comparable absorbable soft-tissue support technology targeted at the same breast reconstruction use case as the Melodi Matrix.
• Integra LifeSciences: Integra manufactures acellular dermal matrices and regenerative tissue technologies used in breast reconstruction (e.g., SurgiMend, DermACELL) — a primary competitive product set that Melodi Matrix must displace.
• MTF Biologics: MTF Biologics produces AlloDerm, the dominant acellular dermal matrix in breast reconstruction — the entrenched incumbent against which Melodi Matrix will compete for surgeon adoption.
• Sientra: Sientra is a breast-focused aesthetics company offering breast implants and tissue expanders used in reconstruction — a comparable single-vertical surgical device company targeting the same plastic surgeon customer base.
• Establishment Labs: Establishment Labs develops advanced breast implant technology (Motiva) for aesthetic and reconstructive procedures — a focused breast-device competitor with overlapping surgeon customers and reconstructive positioning.
• Tepha Inc. Tepha develops resorbable polymer (PHA) technologies used in implantable medical devices and surgical meshes — a direct technology-platform peer to Melodi's absorbable mesh approach.
• Galatea Surgical (Tepha subsidiary): Galatea Surgical developed absorbable surgical scaffolds using Tepha's PHA polymers for soft tissue reinforcement, including breast reconstruction — a near-direct comparable product and technology.

Broad incumbents

• AbbVie (Allergan Aesthetics): Allergan Aesthetics, owned by AbbVie, sells breast implants (Natrelle) used widely in reconstruction — a large incumbent whose sales force and surgeon relationships Melodi will need to navigate.
• Johnson & Johnson (Mentor Worldwide): Mentor, a J&J MedTech company, is one of the largest breast implant and tissue expander manufacturers globally — represents the broad incumbent benchmark for breast reconstruction device commercialization.
• Stryker: Stryker is a diversified surgical and medical device company with relevant soft tissue, biologics, and surgical implant capabilities — represents a potential strategic acquirer with overlapping hospital channels.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/melodi-health

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds3 records

Investors5 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 Melodi