Heartpoint Global Inc.

Miami, FL

UEI
PA71QLU96QM6
CAGE
13RQ1
Primary NAICS
339112 Surgical and Medical Instrument Manufacturing
SAM.gov registration
Active through

Company facts

Self-certified in SAM.gov
  • For Profit Organization
  • Manufacturer of Goods
Entity structure
Corporate Entity (Not Tax Exempt)
SAM.gov registration date
Physical address
1 Alhambra Plaza, Miami, FL 33134, USA
Founded
2014
Employees
11-50
Estimated annual revenue
$1M-$10M
Industry
  1. Health Care
  2. Pharmaceuticals, Biotechnology & Life Sciences
  3. Pharmaceuticals
SIC code
80 Health Services
Profiles

Registration and certifications come from SAM.gov and the SBA; company details from public web sources. Updated .

Grant awards

Grant subawards

Prime recipient Prime award Amount Awarded
Research Institute At Nationwide Children's Hospital Midwest Pediatric Device Consortium (MPDC) P50FD007961 $75,000
The Regents Of The University Of California. San Francisco 3. Deliverables • FDA Q-Submission package • FDA Pre-Submission meeting conducted • FDA written feedback • Regulatory strategy summary and IDE readiness roadmap P50FD007967 $50,000
The Regents Of The University Of California. San Francisco Project description HPG is preparing and filing our FDA pre-submission file for June 2024. Simultaneously, we are planning and will be delivering documents,… P50FD007967 $25,000

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About the company

Heartpoint Global Inc., a for-profit medical device manufacturer based in Miami, Florida, is a federal grant recipient developing a minimally invasive pulmonary flow restrictor for pediatric and congenital heart disease treatment, operating primarily in a subcontractor role (75% of recent awards) across federal health research programs. The company holds one prime grant award and three sub-grants from the National Institutes of Health and its subordinate institutes, with combined obligated dollars of $1.9 million across four awards dating from June 2024 through March 2026.

Heartpoint's federal footprint centers on a single prime grant vehicle: a $1.77 million Project Grant from the National Heart, Lung, and Blood Institute (NHLBI) under the Cardiovascular Diseases Research program (CFDA 93.837), awarded September 1, 2025, running through August 31, 2027. The grant funds development and first-in-human clinical trial preparation for the INTELLISTENT system, a minimally invasive, adjustable pulmonary flow restrictor designed to treat neonatal and pediatric heart disease patients. Deliverables include downsizing the device from its current pediatric formulation (age 12+) to neonatal and infant sizes suitable from birth, completing biocompatibility testing required for FDA regulatory submission, and optimizing manufacturing processes for clinical and commercial production. Work is performed at Heartpoint's Coral Gables, Florida facility. As a sub-recipient, Heartpoint participates in the Midwest Pediatric Device Consortium (MPDC) administered by Nationwide Children's Hospital's Research Institute (sub-award dated March 31, 2026) and receives regulatory strategy and FDA pre-submission support from the University of California, San Francisco (sub-awards dated February 9, 2026 and June 24, 2024). The June 2024 sub-award specifically supported FDA pre-submission filing, first-in-human trial protocol development, and Breakthrough Device Program designation pursuit, with budgeted clinical research organization and regulatory consulting costs. One award faces ultimate completion inside the next twenty-four months and enters recompete window.

Quick answers

Is Heartpoint Global Inc. registered in SAM.gov?

Yes. Heartpoint Global Inc.'s SAM.gov registration is active through July 27, 2027.

What is Heartpoint Global Inc.'s CAGE code?

Heartpoint Global Inc.'s CAGE code is 13RQ1, and its Unique Entity ID (UEI) is PA71QLU96QM6.

What is Heartpoint Global Inc.'s most recent federal award?

Heartpoint Global Inc.'s most recent federal grant award is Intellistent: a minimally invasive, adjustable pulmonary flow restrictor system for congenital and acquired heart… (R44HL182590), from National Heart Lung and Blood Institute (NIH), on September 1, 2025.

On GovTribe

See Heartpoint Global Inc.'s full federal record

  • Federal grant awards
  • Funding analysis by agency, NAICS and set-aside
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