HeartHero, Inc. Company Profile

Background

HeartHero, Inc., founded in 2016 and headquartered in Denver, Colorado, is a medical device company dedicated to combating sudden cardiac arrest (SCA) through innovative technology. The company's mission is to empower individuals to save lives by providing accessible, portable, and user-friendly automated external defibrillators (AEDs).

Key Strategic Focus

HeartHero's strategic focus centers on developing and distributing a next-generation AED named "Elliot." This device is designed to be ultra-portable, affordable, and easy to use, aiming to increase survival rates from SCA by making AEDs more accessible, particularly in home settings where the majority of SCAs occur.

Financials and Funding

Since its inception, HeartHero has secured multiple funding rounds:

• May 2018: Received a $250,000 grant from the Colorado Office of Economic Development and International Trade (OEDIT).

• July 2018: Closed a $1.5 million seed round, surpassing initial funding goals.

• September 2018: Raised $2.67 million in a Series AA funding round.

• August 2019: Secured additional funding in a Series A round.

• August 2023: Obtained $2.08 million in a later-stage venture capital round.

Notable investors include PIC Investment Group, AngelMD, COPIC Companies, and OEDIT. The capital has been utilized to advance product development, regulatory approvals, and market penetration strategies.

Pipeline Development

HeartHero's flagship product, the "Elliot" AED, has achieved significant milestones:

• ISO 13485 Certification: In September 2020, HeartHero received ISO 13485 certification, an international standard for medical device quality management systems, marking a crucial step toward regulatory approvals.

• American College of Cardiology Collaboration: In February 2020, HeartHero partnered with the American College of Cardiology to enhance out-of-hospital cardiac arrest treatment through innovative AED technology.

• Innovation Challenge Winner: In April 2019, HeartHero's AED won the Innovation Challenge at the American College of Cardiology's Annual Scientific Session, recognizing its potential impact on SCA survival rates.

Technological Platform and Innovation

HeartHero's "Elliot" AED stands out due to its:

• Portability: Weighing just over 1 pound, it is designed for easy transport and storage.

• User-Friendly Interface: Equipped with auditory and visual guides, along with CPR prompts, to assist users during emergencies.

• Advanced Technology: Incorporates machine learning, data collection, and IoT capabilities to enhance patient treatment and provide real-time data to rescuers.

• ECG Software Integration: Licensed VivaQuant's ECG technology to improve arrhythmia detection and device performance.

Leadership Team

• Gary Montague: Founder and Executive Chairman. A medical professional with extensive experience, Montague has been instrumental in guiding HeartHero's strategic direction and product development.

• William Quirk, MD: Chief Medical Officer. Dr. Quirk brings a wealth of medical expertise to the team, ensuring the clinical efficacy and safety of HeartHero's products.

• Jonathan Rogers: Controller. Rogers oversees the company's financial operations, contributing to its fiscal health and strategic financial planning.

Competitor Profile

Market Insights and Dynamics

The global AED market is experiencing growth due to increasing awareness of SCA and the importance of timely defibrillation. The demand for portable and user-friendly AEDs is rising, particularly in non-traditional settings such as homes and public spaces.

Competitor Analysis

Key competitors include:

• AliveCor: Specializes in personal ECG devices and mobile applications, focusing on heart rhythm monitoring.

• Bardy Diagnostics: Develops cardiac monitoring solutions, emphasizing arrhythmia detection and patient data analysis.

• Element Science: Focuses on wearable defibrillators designed for patients at risk of SCA.

Strategic Collaborations and Partnerships

• American College of Cardiology (ACC): In February 2020, HeartHero partnered with the ACC to advance out-of-hospital cardiac arrest treatment through innovative AED technology.

• VivaQuant: In November 2018, HeartHero licensed VivaQuant's ECG software to enhance the arrhythmia detection capabilities of its AED.

Operational Insights

HeartHero's strategic positioning focuses on:

• Market Penetration: Targeting the home market to address the high incidence of SCAs occurring in residential settings.

• Product Differentiation: Offering a lightweight, affordable, and technologically advanced AED to stand out in the competitive landscape.

• Regulatory Compliance: Achieving ISO 13485 certification and pursuing FDA approval to ensure product quality and market readiness.

Strategic Opportunities and Future Directions

HeartHero aims to:

• Expand Market Reach: Increase accessibility of AEDs in homes and underserved areas.

• Enhance Product Features: Integrate advanced technologies such as AI and IoT to improve device functionality and user experience.

• Strengthen Partnerships: Collaborate with medical institutions and organizations to promote awareness and adoption of AEDs.

Contact Information

• Website: www.hearthero.com

• Social Media:

• Twitter: @HeartHeroAED

• Facebook: HeartHero

• LinkedIn: HeartHero