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Heartstitch

Full company profile

uuid0008cpg

Namestring
Heartstitch
Websiteurl
heartstitch.com
Company typeenum
Private
Founded yearstring
-
Short descriptiontext

Heartstitch is a small, private U.S. medical device company based in Fountain Valley, California, that develops devices for cardiovascular surgery. The firm operates with 11–50 employees, though its current commercial status is unclear given an inactive web presence.

Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersFountain Valley, United States
HQ citystring
Fountain Valley
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Keyword5 values
cardiovascular surgery devices, cardiac medical devices, structural heart devices, cardiac surgery tools, interventional cardiology devices
Industry3 codes
1Cardiac Surgery Devices (Cannulas, Clamps, Closure, Grafts)
CodeHLAHAFAHPrimaryYes
2Structural Heart Valves (TAVR/SAVR) & Valve Repair
CodeHLAHAFABPrimaryNo
3Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation)
CodeHLAHAFALPrimaryNo
NAICS code3 codes
  • Surgical and Medical Instrument Manufacturing339112
  • Surgical Appliance and Supplies Manufacturing339113
  • Electromedical and Electrotherapeutic Apparatus Manufacturing334510
SIC code2 codes
  • Surgical & Medical Instruments & Apparatus3841
  • Electromedical & Electrotherapeutic Apparatus3845
Product category
Cardiovascular Medical Devices
Social media profiles1 record
Cost components4 values
Personnel, Operations, Supply Chain, Technology or R&D
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Core offering1 text field

Heartstitch operates a manufacturing and research facility that develops medical devices for cardiovascular surgery. The company focuses on producing hardware used in cardiac surgical procedures, serving the structural heart and cardiovascular surgery device market.

Differentiator
Functional benefit
Problem solved
Product and service1 record
1Cardiovascular Surgery Medical Devices
No data
Peers10 records
1Artivion (formerly CryoLife)
TypeDirect peer
Description

Specialty cardiac and vascular surgery company offering surgical sealants, heart valve implants, and tissue processing — direct competitor in the cardiovascular surgery device niche for a company of similar size.

2Boston Scientific
TypeBroad incumbent
Description

Major cardiovascular medtech with structural heart, cardiac surgery, and electrophysiology franchises. Comparable incumbent whose Watchman and structural heart programs define the competitive ceiling.

3Occlutech
TypeEmerging player
Description

Specialist in structural heart occlusion and closure devices, with a comparable European-anchored, niche-positioning profile to a small US cardiac surgery device developer.

4Medtronic
TypeBroad incumbent
Description

Largest diversified medtech with broad cardiac surgery, structural heart, and mechanical circulatory support portfolios. Comparable as a likely acquirer and as the benchmark for the scale of evidence-generation and regulatory capability a small competitor must match.

5Abbott
TypeBroad incumbent
Description

Major player in structural heart (MitraClip, Tendyne) and broader cardiovascular surgery devices. Comparable as both a competitive incumbent and a strategic acquirer of niche cardiac surgery device developers.

6Edwards Lifesciences
TypeBroad incumbent
Description

Global leader in structural heart valves and critical care monitoring, with deep cardiovascular surgery device franchises (e.g., TAVR/surgical heart valves, cannulae). Most relevant incumbent for a cardiac surgery device developer targeting structural heart or related surgical adjuncts.

7CorMatrix Cardiovascular
TypeEmerging player
Description

Smaller, niche cardiac surgery device company developing tissue-engineered products for cardiovascular repair. Comparable as a similarly-sized peer in the cardiac surgery niche.

8AtriCure
TypeDirect peer
Description

Specialist in cardiac surgical ablation and left atrial appendage management devices, comparable in scale and category (small-cap, single-vertical cardiac surgery).

9SentreHEART
TypeEmerging player
Description

Cardiac surgery device company with left atrial appendage closure technology acquired by AtriCure; comparable as a small, niche cardiovascular surgery developer that ultimately exited to a strategic.

10LivaNova
TypeDirect peer
Description

Public medtech focused on cardiac surgery (heart-lung machines, oxygenators, cannulae) and neuromodulation. Closest publicly traded pure-play analogue to a small cardiac surgery device manufacturer.

Market position
Customer concentration

Classification, Details

Ideal customer profile1 record

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
No
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles1 record

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Heartstitch

Cardiovascular Medical Devicesheartstitch.com

Heartstitch is a small, private U.S. medical device company based in Fountain Valley, California, that develops devices for cardiovascular surgery. The firm operates with 11–50 employees, though its current commercial status is unclear given an inactive web presence.

Heartstitch firmographics

Firmographics
Name
Heartstitch
Website
https://heartstitch.com
Company type
Private
Headcount range
11–50 employees
Short description
Heartstitch is a small, private U.S. medical device company based in Fountain Valley, California, that develops devices for cardiovascular surgery. The firm operates with 11–50 employees, though its current commercial status is unclear given an inactive web presence.
Ownership category
akta.pro rank

Heartstitch industry classification

Industry
Product category
Cardiovascular Medical Devices
NAICS
Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
SIC
Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)
akta.pro primary industry
Cardiac Surgery Devices (Cannulas, Clamps, Closure, Grafts) (HLAHAFAH)
akta.pro secondary industries
Structural Heart Valves (TAVR/SAVR) & Valve Repair (HLAHAFAB), Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation) (HLAHAFAL)

Keywords

  • Cardiovascular surgery devices
  • Cardiac medical devices
  • Structural heart devices
  • Cardiac surgery tools
  • Interventional cardiology devices

Where Heartstitch is headquartered

Location

Headquarters

HQ city
Fountain Valley
HQ country
United States
HQ region
North America

Markets served

Heartstitch business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Personnel, Operations, Supply Chain, Technology or R&D

Heartstitch product offering

Product offering

Core offering

Heartstitch operates a manufacturing and research facility that develops medical devices for cardiovascular surgery. The company focuses on producing hardware used in cardiac surgical procedures, serving the structural heart and cardiovascular surgery device market.

Differentiator

Problem solved

Functional benefit

Products and services

  • Cardiovascular Surgery Medical Devices

Companies that use Heartstitch

Customer profile

Ideal customer profiles1 record

Heartstitch technology and API

Technology

Technology focussed No

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Heartstitch competitors and assessment

Company assessment

Direct peers

  • Artivion (formerly CryoLife): Specialty cardiac and vascular surgery company offering surgical sealants, heart valve implants, and tissue processing — direct competitor in the cardiovascular surgery device niche for a company of similar size.
  • AtriCure: Specialist in cardiac surgical ablation and left atrial appendage management devices, comparable in scale and category (small-cap, single-vertical cardiac surgery).
  • LivaNova: Public medtech focused on cardiac surgery (heart-lung machines, oxygenators, cannulae) and neuromodulation. Closest publicly traded pure-play analogue to a small cardiac surgery device manufacturer.

Broad incumbents

  • Boston Scientific: Major cardiovascular medtech with structural heart, cardiac surgery, and electrophysiology franchises. Comparable incumbent whose Watchman and structural heart programs define the competitive ceiling.
  • Medtronic: Largest diversified medtech with broad cardiac surgery, structural heart, and mechanical circulatory support portfolios. Comparable as a likely acquirer and as the benchmark for the scale of evidence-generation and regulatory capability a small competitor must match.
  • Abbott: Major player in structural heart (MitraClip, Tendyne) and broader cardiovascular surgery devices. Comparable as both a competitive incumbent and a strategic acquirer of niche cardiac surgery device developers.
  • Edwards Lifesciences: Global leader in structural heart valves and critical care monitoring, with deep cardiovascular surgery device franchises (e.g., TAVR/surgical heart valves, cannulae). Most relevant incumbent for a cardiac surgery device developer targeting structural heart or related surgical adjuncts.

Emerging players

  • Occlutech: Specialist in structural heart occlusion and closure devices, with a comparable European-anchored, niche-positioning profile to a small US cardiac surgery device developer.
  • CorMatrix Cardiovascular: Smaller, niche cardiac surgery device company developing tissue-engineered products for cardiovascular repair. Comparable as a similarly-sized peer in the cardiac surgery niche.
  • SentreHEART: Cardiac surgery device company with left atrial appendage closure technology acquired by AtriCure; comparable as a small, niche cardiovascular surgery developer that ultimately exited to a strategic.

Market position

Customer concentration

Heartstitch social profiles

Digital presence

Heartstitch financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Heartstitch leadership team

Management profile

Number of profiles

Profiles1 record

Heartstitch funding detail

Funding detail

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Heartstitch M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Heartstitch

What does Heartstitch do?

Heartstitch operates a manufacturing and research facility that develops medical devices for cardiovascular surgery. The company focuses on producing hardware used in cardiac surgical procedures, serving the structural heart and cardiovascular surgery device market.

When was Heartstitch founded?

Heartstitch was founded in -1. It employs 11 to 50 people.

Where is Heartstitch based?

Heartstitch is headquartered in Fountain Valley, United States, in the North America region.

Who are Heartstitch's main competitors?

Direct peers on record are Artivion (formerly CryoLife), AtriCure and LivaNova. Broad incumbents are Boston Scientific, Medtronic, Abbott and Edwards Lifesciences. Emerging players are Occlutech, CorMatrix Cardiovascular and SentreHEART.

Does Heartstitch have an API?

No public API is recorded for Heartstitch.

What industry is Heartstitch in?

Heartstitch's product category is Cardiovascular Medical Devices. Its primary akta.pro industry code is HLAHAFAH, Cardiac Surgery Devices (Cannulas, Clamps, Closure, Grafts), with a secondary code of HLAHAFAB, Structural Heart Valves (TAVR/SAVR) & Valve Repair. Its NAICS code is 339112 and its SIC code is 3841.

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Live signals
PR NewswireNobleStitch™ Suture-Mediated PFO Closure Demonstrates Superior Long-Term Safety and Outcomes in Largest Cohort to DateHeartStitch, Inc. announced robust long-term clinical results for its NobleStitch™ suture-mediated PFO closure system, with a study of 703 patients over a median of 4 years representing the largest cohort ever reported for PFO closure, approximately 40% larger than the pivotal Gore and Amplatzer trials. The study documented zero recurrent strokes or TIAs, zero device-related complications, and zero device-related atrial fibrillation episodes, despite 11.7% of patients having residual right-to-left shunts. The findings suggest that modifying atrial septal anatomy to restore physiological flow patterns, rather than achieving full anatomical closure, provides durable protection against embolic events.PR NewswireHeartStitch® Appoints Benjamin S. Carson Sr. To Its Board Of DirectorsHeartStitch® Inc. announced the appointment of Dr. Benjamin S. Carson Sr., a renowned neurosurgeon and former U.S. Secretary of Housing and Urban Development, to its Board of Directors, replacing retired Founder and President Benjamin Brosch. Dr. Carson brings expertise in medicine, governmental policy, and strategic development to the medical device company focused on structural heart disease treatments. HeartStitch® manufactures suture-based systems including NovaStitch™, JadeStitch™, RoseStitch™, and NobleStitch™ EL, which hold FDA clearance in the United States and CE Mark approval in the European Union.PR NewswireNobleStitch™ EL PFO Closure Performed Live For TVT/ PFO 2018 CongressProf. Dr. Achille Gaspardone and Prof. Dr. Horst Sievert performed a live PFO closure procedure using the NobleStitch™ EL device, broadcast via satellite from Frankfurt, Germany to the TVT Congress in Chicago, marking the first real-time demonstration of this technology for a US audience. Prof. Gaspardone, who has performed over 200 cases with the device, highlighted its clinical benefits including reduced fluoroscopy time and contrast usage, calling it "the first new technology in PFO closure in 20 years." Professor Anthony Nobles, inventor of the NobleStitch™ EL and Chairman/CEO of HeartStitch®, noted that the two physicians presenting the case have collectively performed over 300 procedures using the system.PR NewswireHeartStitch® Inc. Announces CE Mark For CoAp Pro Mitral Valve RepairHeartStitch® Inc. has received CE Mark approval in the European Union for its CoAp Pro device, enabling physicians to perform mitral valve repair through a less invasive suture-based percutaneous procedure. The approval expands HeartStitch's cardiovascular product portfolio and allows the company to market the device across EU member states. The company states it will leverage this approval to strengthen its position as a global leader in suture-based cardiovascular solutions.PR NewswireHeartStitch® Announces Appointment Of New PresidentHeartStitch, Inc.'s Board of Directors and Executive Management Team have approved the appointment of Dru Dobbs as the company's new President, effective immediately. Dobbs, previously Vice President of Manufacturing and Operations, succeeds Richard Bjorkman, who stepped down to spend more time with family but will remain with the company as a CFO contractor. Bjorkman and board members expressed confidence in Dobbs' ability to lead HeartStitch's continued expansion in the structural heart device market.PR NewswireHeartStitch® Inc. has received CE Mark for Its Suture Based Trans-Apical Access and ClosureHeartStitch® Inc. has received CE Mark approval for its suture-based Trans-Apical Access and Closure device, which provides percutaneous access to the heart for structural heart procedures without requiring open heart surgery. The NobleStitch Italian clinical study, published in the peer-reviewed EuroIntervention journal, demonstrated the safety and effectiveness of the suture-based technique. The company plans to launch the product in Europe in fall 2018, followed by the United States.PR NewswireDr. Achille Gaspardone Performs 150th NobleStitch™ EL PFO Closure in Rome, ItalyProf. Dr. Achille Gaspardone at Ospedale St Eugenio in Rome has completed 150 successful PFO closures using the NobleStitch™ EL suture-based closure system, becoming the first physician to achieve this milestone. The device, manufactured by HeartStitch® and distributed on behalf of Nobles Medical Technologies II, demonstrated equivalent closure rates to umbrella devices with a greater safety profile in a peer-reviewed study published in EuroIntervention. The growing adoption has generated a patient waiting list across Italy, prompting the companies to scale manufacturing to meet worldwide demand.PR NewswireHeartStitch® Leading the growth of PFO Closure in ItalyKardia announced expansion plans for HeartStitch®'s NobleStitch™ EL device for PFO closure at a meeting in Rome organized by Professor Francesco Romeo, where Prof. Achille Gaspardone performed a successful live case demonstration on a 37-year-old female patient. The device has achieved strong market uptake in Italy over 18 months, reaching 17 centers, training 24 cardiologists, and completing more than 220 procedures, with physicians and patients increasingly preferring it over traditional umbrella devices. HeartStitch® plans to expand coverage across Italy in 2018 and replicate this success throughout Europe before entering the US market.PR NewswireHeartStitch® GmbH Announces NobleStitch™ EL Closure Data Compared to Published PFO Clinical Trials "RESPECT" and "CLOSURE" in New England Journal of MedicineProf. Dr. Achille Gaspardone presented clinical registry data for HeartStitch® Inc.'s NobleStitch™ EL suture-based PFO closure system at the CSI-UCSF meeting in San Francisco, collected from 10 centers in Italy and one in Sweden across 190+ patients from January 2016 to August 2017. The data demonstrated a zero residual shunt rate at 12 months and zero complications, compared favorably to published results from the RESPECT trial (4.2% complication rate) and CLOSURE trial (12.8% complication rate) using umbrella-based devices. HeartStitch® indicated it is expanding its NobleStitch™ EL customer base across Europe and Central Asia while developing products for mitral and tricuspid valve procedures.PR NewswireHeartStitch® GmbH compare des données sur l'occlusion de FOP à l'aide du système NobleStitch™ EL avec celles des études cliniques sur le FOP « RESPECT » et « CLOSURE » récemment publiées dans le New EHeartStitch® GmbH presented clinical registry data from 10 Italian centers and one Swedish center covering 190+ patients treated between January 2016 and August 2017, showing its NobleStitch™ EL system achieved superior PFO closure rates with zero residual shunt at 12-month follow-up compared to umbrella-based devices Gore Helix® and AGA Amplatzer™ evaluated in the RESPECT and CLOSURE trials published in the New England Journal of Medicine. The NobleStitch™ EL system recorded zero complications versus complication rates of 4.2% for RESPECT, 12.8% for CLOSURE, 16.9% for CLOSURE 1, and 21% for PC Trial, despite being used by multiple first-time operators across the registry. HeartStitch® CEO Professor Anthony Nobles described the presentation as a significant milestone positioning the suture-based closure technology for expanded adoption across Europe and Central Asia ahead of a broader product pipeline targeting mitral, tricuspid, and transapical solutions.