Companies / HeartPoint Global

Medical device company profile

HeartPoint Global

Cardiovascular device developer advancing IntelliStent, an investigational transcatheter system for adjustable pulmonary blood-flow restriction.

Medical Device DeveloperCardiovascular & VascularHeart Failure & Circulatory SupportStructural Heart

Headquarters🇺🇸Coral Gables, Florida, United States

Founded2014

Commercial statusIn developmentIntelliStent is investigational and not available for commercial sale.

Employees11–50 ^[2]LinkedIn company-size range · Checked 2026-10-31

Estimated revenueNot confirmed

Disclosed fundingUS$1,771,084 ^[4]Award 1R44HL182590-01; project period September 2025–August 2027. Award amount, not a cumulative funding total or confirmation of disbursement.

Official websiteheartpointglobal.com ↗

Company overview

HeartPoint Global is developing catheter-based cardiovascular technology for pulmonary blood-flow modulation. Its IntelliStent system is designed as a minimally invasive alternative to surgical pulmonary artery banding for selected congenital heart disease and heart-failure applications.

The company’s current website and NIH SBIR award identify a Coral Gables, Florida address. Its LinkedIn page also lists Irish operations and dates the company’s founding to 2014. Seth Bogner is chairman and CEO.

IntelliStent remains investigational. A 2025 NIH Phase II SBIR award supports pediatric device development, including work toward smaller sizes for neonates and infants.

^[1][2][4]

Leadership

1 people

Seth BognerChairman & Chief Executive Officer ^[3]

Products & regulatory status How does MedTechIndex get this information?

Summary

HeartPoint states that IntelliStent remains investigational, has not been cleared or approved by FDA and is not available for commercial sale. Its development program addresses pulmonary blood-flow modulation in congenital cardiovascular disease and heart failure. ^[1]

The 2025 NIH Phase II SBIR award supports downsizing the device for neonates and infants, biocompatibility testing and manufacturing preparation for first-in-human evaluation. These are funded development objectives, rather than established clinical outcomes or marketing authorization. ^[4]

Regulatory snapshot How to read this snapshot

U.S. FDA

—
510(k) clearances: —
De Novo grants: —
PMA approvals: —
Recall events

Latest recorded source review: 2026-10-31.

Scope: selected product families.

Commercial portfolio snapshot

No commercially marketed product portfolio has been established in the reviewed material.

Commercial development

Investigational pulmonary blood-flow modulation

IntelliStent ↗

Multi-lumen transcatheter implant and delivery system designed for adjustable pulmonary blood-flow restriction. Its self-expanding nitinol frame, nested configuration and balloon adjustment are intended to support minimally invasive flow modulation. ^[1][4]

Investigational · not FDA cleared or approved · not commercially available

Activity & Milestones

2 events

2025-09-01 · Funding

NIH Phase II SBIR award begins

SBIR records a US$1,771,084 award for IntelliStent development, with a project period through August 31, 2027. ^[4]

2014 · Company

Company founded

The company’s LinkedIn page lists a 2014 founding. ^[2]

4 Cited Sources

Accessed 10/31/2026

Last substantive review: 10/31/2026

[1] HeartPoint Global — IntelliStent development program ↗HeartPoint Global · manufacturer

[2] HeartPoint Global company page ↗HeartPoint Global / LinkedIn · company profile

[3] Seth Bogner — company role ↗Seth Bogner / LinkedIn · company profile

[4] SBIR — 2025 NIH Phase II award 1R44HL182590-01 ↗U.S. Small Business Administration · government