Recardio

What Recardio does

Recardio is a late clinical-stage life science company developing drug-based regenerative therapeutic modalities for cardiovascular diseases. Its lead drug candidate, dutogliptin, is a second-generation DPP-IV inhibitor co-administered with G-CSF (filgrastim) to enable endogenous cardiac regeneration. The mechanism works by inhibiting DPP-IV, which normally neutralizes SDF-1 (stromal cell-derived factor-1), thereby preserving SDF-1 levels to promote stem cell homing to damaged cardiac tissue and activating the body's paracrine repair pathways. Unlike ex-vivo stem cell therapies, Recardio's approach is delivered as subcutaneous injections (14 days for dutogliptin, 5 days for G-CSF), avoiding the need for cell collection, processing, and intracoronary reinfusion.

The company targets two primary patient segments: adults with acute myocardial infarction (STEMI patients who have undergone PCI and stenting, addressed in the global pivotal Phase 3 HEAL-AMI trial with FDA- and EMA-approved design and enrollment intended starting in 2026), and patients with congestive heart failure with reduced ejection fraction (HFrEF <40%, NYHA Class II–III, addressed in the planned Phase 2B REC-DUT-004 study targeted for 2027). Recardio's clinical history includes a Phase 1 study completed in Vienna in September 2017 and a Phase 2B REC-DUT-002 AMI study whose enrollment was completed in January 2021 but which was closed out early in Q2 2021. The company is headquartered at 201 Mission Street, San Francisco, with operational footprint across the USA and Europe, and operates with an 11–50 employee headcount.

Commercially, Recardio is pre-revenue and operates a partnership- and licensing-oriented business model, pursuing enterprise-level co-development and commercialization relationships with global pharmaceutical leaders rather than building its own commercial salesforce. Go-to-market is event-driven, anchored by participation in BIO International Convention, ChinaBIO Partnering Forum, and the J.P. Morgan Healthcare Conference. Revenue generation is contingent on successful Phase 3 completion, regulatory approval, and subsequent licensing or partnership economics. The company is currently funded via venture capital, having expanded its Series C and closed an initial tranche of a Series C+ round in May 2026 with existing shareholders and new undisclosed investors, with proceeds earmarked for pipeline expansion into additional cardiometabolic assets.

Name

Recardio

Legal name

Recardio Inc.

Website

https://recardio.eu

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

Recardio is a late clinical-stage biotechnology company developing dutogliptin, a DPP-IV inhibitor combined with G-CSF, to enable cardiac regeneration in acute myocardial infarction and heart failure patients via subcutaneous injection. The company is pre-revenue, pursuing pharmaceutical licensing partnerships.

Ownership category

akta.pro rank

Product category

Regenerative Cardiovascular Medicine

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

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

akta.pro secondary industry

Stem Cell–Based Regenerative Therapies (HLAAAGAA)

Keywords

• Cardiovascular drug development
• DPP-IV inhibitor therapy
• Regenerative cardiac medicine
• Stem cell homing therapy
• Myocardial infarction treatment

Headquarters

HQ city

San Francisco

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Drug Development and Commercialization: Recardio is a late clinical-stage biotechnology company developing novel regenerative cardiovascular therapies. The company is raising capital to fund patient enrollment in clinical trial programs and support business development activities with global pharmaceutical leaders. As a pre-revenue company in clinical development, revenue generation is contingent on successful Phase 3 completion and regulatory approval for commercialization.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

Recardio develops dutogliptin, a second-generation DPP-IV inhibitor administered in combination with G-CSF (filgrastim) as a regenerative therapy for cardiovascular diseases, specifically Acute Myocardial Infarction and Congestive Heart Failure. The therapy works by inhibiting DPP-IV to preserve SDF-1, enabling endogenous stem cell homing to damaged cardiac tissue and activating the body's own repair mechanisms through the paracrine effect. The lead candidate is currently advancing through the FDA- and EMA-approved global pivotal Phase 3 HEAL-AMI clinical trial.

Product overview

Recardio is a late clinical-stage life science company developing novel regenerative cardiovascular therapies. The company's lead drug candidate Dutogliptin (a DPP-IV inhibitor) works in combination with G-CSF/Filgrastim to enable cardiac regeneration by preserving SDF-1 and promoting stem cell homing to damaged heart tissue. The therapeutic platform encompasses multiple clinical trial programs: the pivotal Phase 3 HEAL-AMI trial for Acute Myocardial Infarction (with FDA and EMA approval), completed Phase 2B REC-DUT-002 study, and planned Phase 2B REC-DUT-004 for Congestive Heart Failure. The company also has earlier-stage cardiometabolic programs in clinical and preclinical development.

Differentiator

Problem solved

Functional benefit

Products and services

• Dutogliptin

Quantifiable outcome

• Combination of G-CSF with dutogliptin significantly enhanced survival and reduced infarct size in pre-clinical model
• +2 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Capricor Therapeutics: Capricor is a late clinical-stage biotech developing CAP-1002 (allogeneic cardiosphere-derived cells) for Duchenne muscular dystrophy cardiomyopathy and other cardiac indications. It is a direct regenerative cardiac medicine peer, using a cell-based approach to address post-infarction cardiac damage and heart failure.
• Mesoblast: Mesoblast develops mesenchymal stem cell therapies including rexlemestrocel-L for chronic heart failure with reduced ejection fraction (HFrEF). It is a direct peer in regenerative cardiovascular medicine, targeting similar post-AMI and heart failure indications via cell therapy mechanisms.
• BioCardia: BioCardia is a clinical-stage cell therapy company developing autologous and allogeneic cell therapies for heart failure, delivered via its proprietary Helix catheter system. It is directly comparable to Recardio as a cardiac regenerative medicine peer with overlapping indications.
• Vericel Corporation: Vericel commercializes cell therapy products (MACI, Epicel) and is developing cardiac regenerative programs. As a peer in advanced cell-based cardiac therapeutics, Vericel shares Recardio's regenerative medicine orientation and target indications in cardiovascular disease.

Broad incumbents

• Boehringer Ingelheim: Boehringer Ingelheim markets linagliptin (Trajenta/Jentadueto), a leading DPP-IV inhibitor, and has a major cardiovascular franchise (including empagliflozin/Jardiance). As the originator of the DPP-IV class competitor and a major CV player, it is a broad incumbent peer whose diabetes and cardiovascular assets frame Recardio's competitive landscape.
• Merck & Co. Merck markets sitagliptin (Januvia), the first and largest-selling DPP-IV inhibitor, and has extensive cardiovascular outcomes data through the TECOS trial. As a DPP-IV originator and broad CV-metabolic incumbent, Merck is a relevant incumbent peer with overlap on the underlying pharmacology class Recardio is repurposing.
• AstraZeneca: AstraZeneca co-markets saxagliptin (Onglyza, with BMS) and has a major cardiovascular franchise including Brilinta (ticagrelor) and a robust heart failure portfolio (Farxiga, dapagliflozin). It is a broad incumbent with overlapping DPP-IV and post-AMI/cardiovascular presence comparable to Recardio's positioning.
• Takeda Pharmaceutical: Takeda markets alogliptin (Nesina) and has a significant cardiovascular and rare disease franchise. As a DPP-IV competitor and broader CV-metabolic incumbent, Takeda is comparable as both a class competitor and potential strategic partner/acquirer for Recardio's technology.

Emerging players

• Tenaya Therapeutics: Tenaya Therapeutics is a clinical-stage gene therapy company developing TN-201 for genetic hypertrophic cardiomyopathy and TN-401 for genetic HFrEF/arrhythmias. It is an emerging player in cardiac regenerative/curative medicine, addressing overlapping cardiovascular indications via a different (gene therapy) modality.
• Lexeo Therapeutics: Lexeo Therapeutics is a clinical-stage gene therapy company with cardiac programs including LX2000 for Friedreich's ataxia cardiomyopathy and other CV assets. It is an emerging player in cardiac regenerative medicine, with thematic overlap to Recardio's goal of restoring cardiac function in cardiovascular disease.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/recardio-gmbh

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Funding overview

Funding rounds1 record

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 Recardio