What InnovHeart does

InnovHeart S.r.l. is an Italy-based, privately held medical device company founded in 2015 by Giovanni Righini, a 30-year veteran of the implantable cardiac device industry, with continuous backing from Genextra S.p.A. The company is developing the Saturn Transcatheter Mitral Valve Replacement (TMVR) system to treat patients suffering from mitral regurgitation, a condition affecting an estimated 4 million people in the US and EU and for which approximately 98% of cases remain untreated due to the invasiveness of conventional surgery. The Saturn platform combines a low-profile bioprosthetic valve with a proprietary annular remodeling structure that anchors through a subannular ring at the base of the left ventricle, intended to eliminate mitral regurgitation while minimizing valve migration, paravalvular leak, LVOT obstruction, and Systolic Anterior Motion.

The core technology supports two delivery approaches — an initial trans-apical pathway, which achieved first-in-human status in August 2020, and a trans-septal delivery system using a 29 French delivery catheter with two valve sizes (28mm and 31mm), which achieved first-in-human implantation in May 2024 as part of the CASSINI-EU Early Feasibility Study. InnovHeart has built ISO 13485:2016 certified quality systems (issued by ACCREDIA) and maintains an intellectual property portfolio anchored by more than 30 patent applications from its founder in transcatheter heart valve replacement, plus 10 medical device patents held by CEO David Wilson.

Commercially, InnovHeart is pre-revenue and investigational-only. Its revenue model, once approvals are obtained, envisions direct hardware sales of the Saturn TMVR system to tertiary and quaternary cardiac centers, complemented by an exclusive licensing agreement with Grand Pharmaceutical Group Limited (closed January 2022) covering development, manufacturing, and commercialization in Greater China, which provides milestone payments and structured royalties alongside the equity financing. Go-to-market relies on enterprise field sales, physician education, key opinion leader engagement at major structural heart conferences (EuroPCR, TCT, NY Valves, TVT, CSI Frankfurt, PCR London Valve), and peer-reviewed publications (JACC Case Reports, Annals of Thoracic Surgery Short Reports, Eurointervention). The company operates from Milan (legal headquarters) and Colleretto Giacosa, Italy, with a US subsidiary (InnovHeart US Inc.) in Newton, Massachusetts.

Name

InnovHeart

Legal name

InnovHeart S.r.l.

Website

https://innovheart.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

InnovHeart is an Italy-based, privately held medical device company developing the Saturn Transcatheter Mitral Valve Replacement (TMVR) system to treat mitral regurgitation in high-risk patients unsuitable for conventional surgery. The investigational platform combines a bioprosthetic valve with proprietary annular remodeling architecture, delivered via trans-apical or trans-septal approaches, with commercialization pending regulatory approval.

Ownership category

akta.pro rank

Product category

Transcatheter Mitral Valve Replacement (Structural Heart Devices)

NAICS

Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

Structural Heart Valves (TAVR/SAVR) & Valve Repair (HLAHAFAB)

akta.pro secondary industry

Interventional Radiology & Image-Guided Therapy Systems (HLAHABAG)

Keywords

• Transcatheter mitral valve
• Structural heart devices
• Mitral valve replacement
• Cardiac medical devices
• Transseptal delivery systems

Headquarters

HQ city

Milano

HQ country

Italy

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Product Sales (Future): Once commercially approved, InnovHeart plans to generate revenue through direct sales of its Saturn TMVR system to hospitals and cardiac surgery centers. The company currently has an exclusive licensing agreement with Grand Pharmaceutical for Greater China.
2. Licensing Royalties: InnovHeart receives milestone payments and structured royalties from Grand Pharmaceutical Group Limited under the exclusive licensing agreement for Saturn device development and commercialization in Greater China (Mainland China, Hong Kong, Macau, Taiwan).

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

InnovHeart develops the Saturn Transcatheter Mitral Valve Replacement (TMVR) System, a novel low-profile prosthetic mitral valve designed for both trans-apical and trans-septal delivery to treat patients with mitral regurgitation. The device features an annular remodeling structure with a subannular ring and a 29 French delivery system, offered in two valve sizes (28mm and 31mm). The product is currently limited to investigational use in clinical trials (CASSINI-EU study) and is not commercially available.

Product overview

InnovHeart develops a single unified product line centered on the Saturn Transcatheter Mitral Valve Replacement (TMVR) System. The core Saturn platform is a low-profile prosthetic valve designed for both trans-apical and trans-septal delivery approaches, addressing the treatment of mitral regurgitation. The trans-apical version was the first to undergo clinical testing, followed by the trans-septal version which uses the same Saturn valve technology with an updated delivery system. All Saturn products are investigational devices limited to clinical trial use and are not commercially available.

Differentiator

Problem solved

Functional benefit

Products and services

• Saturn TMVR System A novel transcatheter mitral valve replacement (TMVR) system designed for the treatment of mitral regurgitation. The Saturn is a low-profile prosthetic designed for both trans-apical and trans-septal delivery approaches, featuring a bioprosthetic valve with an annular structure that remodels the native annulus and seals the perimeter of the implant. Currently limited to investigational use in clinical trials and not commercially available.
• Saturn Trans-Septal TMVR System The trans-septal version of the Saturn valve using a 29 French Valve Delivery System with two valve sizes (28 and 31mm). It anchors to the native mitral valve through a subannular ring at the base of the left ventricle, providing mechanical continuity between the bioprosthesis and annular segments. Designed to minimize screen-outs due to unsupported annulus size/shape and left ventricle size, and to minimize risks of valve migration, paravalvular leaks, LVOT obstruction and Systolic Anterior Motion. Currently investigational.

Quantifiable outcome

• Patient showed reduction from NYHA Class III to NYHA Class II within 30 days post-implant with improved six-minute walk test and KCCQ Quality of Life survey scores
• +2 more outcomes

Named customers3 records

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered core and minor.

• ENEA Tech e BiomedicalcoreStrategic or Co-development Partner · 1 October 2025ENEA Tech e Biomedical supports clinical development of Saturn TMVR system. Video collaboration showcasing company vision and technology development highlights partnership in driving clinical validation.
• Grand Pharmaceutical Group LimitedcoreOEM/ Whitelabel/ Licensing Partner · 27 January 2022Exclusive licensing agreement for Saturn TMVR device in Greater China (Mainland China, Hong Kong, Macau, Taiwan). Grand Pharma received rights to develop, manufacture, and commercialize the device. Transaction included equity investment, upfront licensing fees, milestone payments and structured royalties totaling over $55 million.
• Dr. Azin Parhizgar, Ph.D.minorOthers · 12 January 2021Independent Board Member with extensive medical device executive experience. Previously President/CEO of Claret Medical (acquired by Boston Scientific) and held positions at Conor Medsystems (J&J) and AVE (Medtronic).

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• HighLife SAS: HighLife is a European transcatheter mitral valve replacement company developing a trans-septal TMVR system. It is directly comparable to InnovHeart in size, stage, technology category, and target indication (mitral regurgitation via transcatheter replacement).
• JenaValve Technology: JenaValve is a privately held transcatheter heart valve company focused on TAVR and emerging aortic/mitral applications. It is closely comparable to InnovHeart as a similarly-sized, clinical-stage, venture-backed transcatheter valve developer targeting structural heart indications.
• Medtronic: Medtronic has historically led TMVR development through its Intrepid program and remains a structural heart incumbent with extensive TMVR/surgical mitral valve offerings. Its scale and physician relationships make it the central incumbent InnovHeart must compete with for KOL engagement and eventual market share.
• 4C Medical Technologies: 4C Medical is an emerging transcatheter mitral valve company developing the AltaValve TMVR system. It is closely comparable to InnovHeart as a clinical-stage, VC-backed company pursuing TMVR with a differentiated anchoring approach for mitral regurgitation patients.
• Edwards Lifesciences: Edwards Lifesciences is the dominant structural heart company and the most advanced competitor in TMVR with its PASCAL Precision and SAPIEN M3 programs. Both target the same mitral regurgitation patient population as InnovHeart's Saturn and represent the primary competitive benchmark for clinical and commercial success.
• LivaNova: LivaNova (formed from the merger of Sorin and Cyberonics) is a direct Italian heritage peer: founder Giovanni Righini previously served as R&D Director at Sorin Group. LivaNova continues to develop heart valve products and provides a useful comparator for an Italian-rooted, valve-focused business expanding into transcatheter technologies.
• Abbott: Abbott developed the Tendyne TMVR system and continues to operate broadly in structural heart through MitraClip and related transcatheter mitral technologies. Its positioning in both repair (MitraClip) and replacement makes it a key benchmark for the TMVR opportunity InnovHeart is pursuing.

Emerging players

• Cardiac Dimensions: Cardiac Dimensions develops the Carillon System, a transcatheter mitral annuloplasty device for functional mitral regurgitation. While focused on repair rather than replacement, it is a relevant peer addressing the same mitral regurgitation patient population with a transcatheter approach.
• Neovasc: Neovasc develops transcatheter mitral valve therapies including the Tiara TMVR system and the Neovasc Reducer for refractory angina. It is comparable to InnovHeart as a structural heart specialist pursuing transcatheter mitral replacement with a similar regulatory and clinical pathway.

Broad incumbents

• Boston Scientific: Boston Scientific is a major structural heart incumbent (Watchman, ACURATE) with deep relationships with the KOLs that InnovHeart engages (Dr. Keith Dawkins, the InnovHeart Chairman, was formerly EVP/CMO at Boston Scientific). Its commercial scale and acquisition appetite make it both a competitor and a potential strategic acquirer of InnovHeart.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

Funding overview

Funding rounds2 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 InnovHeart