What Ancora Heart does

Ancora Heart, Inc. is a Santa Clara, California-based private medical device company developing the AccuCinch Ventricular Restoration System, a completely transcatheter device designed to treat the enlarged left ventricle in patients with heart failure with reduced ejection fraction (HFrEF). The system consists of an AccuCinch Guide Catheter, NavCath guide wire, TracCath delivery catheter, and a series of anchors separated by spacers deployed into the left ventricular wall and cinched with a nitinol lock to reduce ventricular size, lower wall stress, and initiate reverse remodeling. The device is positioned to fill the treatment gap between guideline-directed medical therapy/pacemakers and more invasive options such as LVAD or heart transplant, targeting symptomatic HFrEF patients who have exhausted other treatments. Ancora holds FDA Breakthrough Device Designation and protects its technology with 33 U.S. issued patents, 35 foreign issued patents, and 37 pending applications.

The company is pre-revenue and commercializes only through clinical investigation. Its go-to-market motion is currently the CORCINCH-HF pivotal study, a randomized, multicenter, international trial enrolling up to 400 patients at up to 80 centers worldwide to support PMA submission. Ancora engages interventional cardiologists and heart failure specialists at cardiac centers via clinical site partnerships, scientific publications, patient and physician education portals (multilingual website content), and patient testimonials. Post-approval commercialization is planned through traditional medical device enterprise field sales to hospitals and cardiac centers, with a newly hired Chief Commercial Officer (ex-Terumo Aortic, Medtronic) tasked with building that organization. Ancora Heart has raised approximately $151 million in cumulative equity financing across rounds in 2010, 2018 (two rounds), and 2021, with the July 2021 $80 million round led by Sands Capital Ventures and Sio Capital Management to fund pivotal trial completion and FDA preparation.

Name

Ancora Heart

Legal name

Ancora Heart, Inc.

Website

https://ancoraheart.com

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

11–50 employees

Short description

Ancora Heart is a private medical device company developing the AccuCinch Ventricular Restoration System, a transcatheter implant that reduces the enlarged left ventricle in heart failure patients with reduced ejection fraction (HFrEF) who have failed medication or device therapy. The investigational device is currently in pivotal clinical trials ahead of FDA approval.

Ownership category

akta.pro rank

Product category

Structural Heart Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation) (HLAHAFAL)

akta.pro secondary industry

Heart Failure & Transplant Cardiology (HLAKABAD)

Keywords

• Transcatheter ventricular restoration
• Heart failure treatment
• Implantable cardiac devices
• Structural heart devices
• Ventricular remodeling therapy

Headquarters

HQ city

Santa Clara

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales (Future): Once FDA approval is obtained, Ancora Heart plans to commercialize the AccuCinch Ventricular Restoration System through direct hospital/health system sales. As a Class III implantable medical device, it will be sold to hospitals and cardiac centers for use in heart failure patients. The company currently operates in a pre-revenue state as the device is undergoing clinical evaluation and is not yet commercially available.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Ancora Heart develops the AccuCinch Ventricular Restoration System, a completely transcatheter device designed to treat the enlarged left ventricle in heart failure patients with reduced ejection fraction (HFrEF). The catheter-based procedure attaches a flexible implant with anchors and spacers to the inner wall of the left ventricle, which is then cinched and secured with a nitinol lock to reduce ventricular size, provide structural support, and initiate reverse remodeling to improve cardiac function. The system is currently investigational and not yet commercially available, distributed through the CORCINCH-HF clinical trial.

Product overview

Ancora Heart is a medical device company offering a single core product: the AccuCinch® Ventricular Restoration System. This is the only completely transcatheter device designed to treat the enlarged left ventricle, targeting heart failure patients with reduced ejection fraction (HFrEF) who remain symptomatic despite guideline-directed medical therapy. The system fills the treatment gap between medication/pacemaker therapy and more invasive options like LVADs or heart transplant. The AccuCinch System is currently undergoing clinical evaluation (CORCINCH-HF Study) and has received FDA Breakthrough Device Designation.

Differentiator

Problem solved

Functional benefit

Brands

• AccuCinch: The AccuCinch Ventricular Restoration System is the company's primary product — a transcatheter therapy designed to treat the enlarged left ventricle in heart failure patients with reduced ejection fraction (HFrEF).

Products and services

• AccuCinch Ventricular Restoration System A completely transcatheter ventricular restoration system designed to treat the enlarged left ventricle in heart failure patients with reduced ejection fraction (HFrEF). During a minimally invasive, catheter-based procedure, a flexible implant is attached to the inner wall of the left ventricle and then cinched to reduce ventricular size, provide structural support, and initiate reverse remodeling to improve cardiac function. The device is for use by interventional cardiologists, heart failure specialists, and cardiac surgeons at hospitals and cardiac centers.

Quantifiable outcome

• Early feasibility clinical data demonstrated potential to improve quality of life (QoL), improve functional capacity, and initiate reverse remodeling in HFrEF patients
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators4 records

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• Medtronic: Medtronic acquired HeartWare and operates a major heart failure franchise (HVAD, future VADs) plus structural heart and cardiac surgery portfolios. It is a broad incumbent in heart failure devices and a likely strategic acquirer of late-stage assets like AccuCinch.
• Edwards Lifesciences: Edwards is a structural heart giant with transcatheter heart valve franchises (TAVR/SAVR, transcatheter mitral) and heart failure programs. It operates broadly in the same patient population and specialty channels as Ancora and has the R&D and commercial scale to enter adjacent LV restoration categories.
• Abbott: Abbott markets the HeartMate 3 LVAD for advanced heart failure and operates a large structural heart and electrophysiology portfolio. It addresses the same HFrEF treatment continuum and has the commercial reach to compete with or acquire novel LV therapies.

Direct peers

• Impulse Dynamics: Impulse Dynamics markets the Optimizer Smart system delivering cardiac contractility modulation (CCM) for HFrEF patients. Comparable as an implantable device therapy targeting advanced HFrEF with limited treatment options, similar stage and target specialist audience.
• Berlin Heart: Berlin Heart develops ventricular assist devices (EXCOR for pediatric and adult applications). Comparable as a dedicated heart failure mechanical support company addressing the same advanced HFrEF patient population, with overlapping clinical and regulatory expertise.
• BioVentrix: BioVentrix develops the Revivent TC system for transcatheter/less-invasive ventricular restoration in HFrEF patients. It is the most direct competitor to Ancora's AccuCinch in the LV remodeling category, targeting the same patient population with a similar anatomical approach.
• CVRx: CVRx developed the Barostim neo system, an implantable neuromodulation device for HFrEF. It is a direct peer in the implantable heart failure device category at a similar pre-commercial/early-commercial stage, addressing the same HFrEF treatment gap.

Emerging players

• Procyrion: Procyrion is developing a catheter-deployed, partial circulatory support system (Aortix) for HFrEF and cardiogenic shock. Comparable as a small, venture-stage heart failure device company developing catheter-based LV unloading/therapy.
• ReliantHeart: ReliantHeart develops next-generation mechanical circulatory support devices (LVADs) for advanced heart failure. Comparable as a heart failure device company focused on the same advanced HFrEF patient segment served by Ancora, with overlapping specialist customers.
• CorWave: CorWave develops a next-generation implantable LVAD using a unique undulating membrane pump. Comparable as a venture-stage heart failure device company building mechanical circulatory support, addressing the same advanced HFrEF treatment gap.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/AncoraHeart
• LinkedInlinkedin.com/company/24214239

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds4 records

Investors3 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 Ancora Heart