AdenoPaint LLC: Company Profile

Background

Overview

AdenoPaint LLC is a seed-stage medical device company based in Atlanta, Georgia, specializing in the development of innovative adenosine-based technologies aimed at treating cardiovascular disorders. Founded in 2010, the company focuses on enhancing patient outcomes during percutaneous coronary interventions (PCI) through its proprietary adenosine-releasing guidewire, known as Adenowire™.

Mission and Vision

AdenoPaint's mission is to improve the safety and efficacy of PCI procedures by delivering adenosine directly to at-risk myocardial tissue, thereby preventing and treating microvascular obstruction (MVO) and reducing heart muscle damage. The company's vision is to revolutionize cardiac care by integrating therapeutic drug delivery into standard interventional devices, leading to better patient outcomes and shorter procedure times.

Primary Area of Focus

The company's primary focus is on the development of adenosine-releasing guidewires for vascular interventional procedures, particularly PCI. By incorporating adenosine into guidewires, AdenoPaint aims to provide continuous, localized drug delivery during procedures, addressing challenges such as MVO and the no-reflow phenomenon.

Industry Significance

AdenoPaint operates within the medical device industry, specifically targeting the cardiovascular sector. The company's innovative approach to integrating drug delivery with interventional devices positions it as a potential leader in improving outcomes for patients undergoing PCI, a procedure performed on approximately 900,000 individuals annually in the United States.

Key Strategic Focus

Core Objectives

• Innovative Device Development: Design and manufacture guidewires that release adenosine during PCI to prevent and treat MVO.

• Clinical Validation: Conduct pre-clinical and clinical studies to demonstrate the safety and efficacy of Adenowire™.

• Regulatory Approval: Navigate the regulatory pathways to achieve FDA clearance for clinical use.

Specific Areas of Specialization

• Cardiovascular Interventions: Specializing in devices used during PCI procedures to enhance myocardial protection.

• Drug-Eluting Technologies: Developing devices that deliver therapeutic agents directly to target tissues.

Key Technologies Utilized

• Adenosine Coating: Utilizing adenosine, a vasodilator, antiplatelet, and anti-inflammatory agent, to coat guidewires for localized drug delivery.

• Guidewire Design: Innovative design of guidewires to facilitate the controlled release of adenosine during PCI.

Primary Markets Targeted

• Cardiologists and Interventionalists: Medical professionals performing PCI procedures.

• Hospitals and Cardiac Centers: Healthcare facilities conducting interventional cardiology procedures.

Financials and Funding

Funding History

AdenoPaint has secured funding through various channels, including Small Business Innovation Research (SBIR) grants and private investments.

Total Funds Raised

The company has raised a total of $1,251,099 through SBIR grants, with $1,251,098 allocated to Phase II awards.

Recent Funding Rounds

• 2023: Received a Phase II SBIR grant of $1,751,096 from the National Institutes of Health (NIH) to support the development of novel adenosine polymers for coating medical devices.

Notable Investors

Specific details about private investors are not publicly disclosed.

Intended Utilization of Capital

The funds are primarily allocated towards research and development activities, including pre-clinical and clinical studies, device manufacturing, and regulatory processes to advance Adenowire™ towards commercialization.

Pipeline Development

Key Pipeline Candidates

• Adenowire™: A novel adenosine-releasing guidewire designed to improve outcomes in patients undergoing PCI by preventing and treating MVO.

Stages of Development

• Pre-Clinical Studies: Conducted to assess the safety and efficacy of Adenowire™ in animal models.

• Clinical Trials: Plans to initiate human clinical trials pending successful pre-clinical outcomes and regulatory approvals.

Target Conditions

• Microvascular Obstruction (MVO): A condition where small blood vessels in the heart become blocked during PCI, leading to poor outcomes.

• No-Reflow Phenomenon: A situation where blood flow does not return to the heart muscle after PCI, causing tissue damage.

Anticipated Milestones

• 2023: Completion of pre-clinical studies and submission of an Investigational Device Exemption (IDE) application to the FDA.

• 2024: Initiation of Phase I clinical trials.

• 2025: Completion of Phase I trials and preparation for Phase II studies.

Technological Platform and Innovation

Proprietary Technologies

• Adenosine-Coated Guidewire: A guidewire coated with adenosine to provide continuous, localized drug delivery during PCI procedures.

Significant Scientific Methods

• Controlled Drug Release: Utilizing adenosine's properties to achieve targeted and sustained release during interventional procedures.

• Pre-Clinical and Clinical Study Designs: Employing rigorous methodologies to evaluate device safety and efficacy.

Leadership Team

Thomas White – CEO

• Professional Background: PharmD, BCPS; over a decade of experience in medical affairs, including roles in drug development, clinical trials, and regulatory approvals.

Dr. Mervyn B. Forman – CMO

• Professional Background: MD, PhD; practicing cardiologist with extensive experience in pre-clinical drug development and clinical trial design; principal investigator on multiple NIH-sponsored grants; over 200 publications.

Dr. Edwin K. Jackson – CSO

• Professional Background: PhD; expert in adenosine and purines; holder of 17 patents; over 800 scientific publications; full professor at the University of Pittsburgh.

Dr. Anthony M. Lowman – CTO

• Professional Background: PhD; Provost and Senior Vice President at Rowan University; co-founder of Regeltec, Inc.; over 100 refereed journal articles and book chapters; more than 20 issued patents.

Dr. Erik Brewer – Head of Product Development

• Professional Background: Scientist with expertise in drug delivery, formulation science, and medical device development; lecturer and Chair of Innovations at Rowan University; former Associate Scientist at Merck Research Labs.

Dr. Bernard De Bruyne – Clinical Consultant

• Professional Background: MD, PhD; co-director of the Cardiovascular Center Aalst, Belgium; Professor of Cardiology at the University of Lausanne; pioneer in diagnostic standards for coronary artery stenosis; recognized among the top 1% most cited scientists.

Competitor Profile

Market Insights and Dynamics

• Market Size: The global market for PCI devices is substantial, with millions of procedures performed annually worldwide.

• Growth Potential: Advancements in interventional cardiology and increasing prevalence of cardiovascular diseases contribute to market growth.

• Industry Trends: There is a growing emphasis on integrating therapeutic drug delivery with interventional devices to improve patient outcomes.

Competitor Analysis

• Boston Scientific Corporation: Offers a range of PCI devices, including drug-eluting stents and guidewires.

• Medtronic plc: Provides comprehensive PCI solutions, including guidewires and balloon catheters.

• Abbott Laboratories: Develops PCI devices such as guidewires and stents.

Strategic Collaborations and Partnerships

• LSU Health New Orleans: Collaborated on research funded by an SBIR Phase II grant to study the efficacy of Adenowire™ in reducing cardiac injury during PCI.

Operational Insights

• Strategic Considerations: AdenoPaint's focus on integrating adenosine delivery into guidewires differentiates it from competitors who primarily offer standalone devices.

• Competitive Advantages: The company's innovative approach addresses specific challenges in PCI procedures, such as MVO and the no-reflow phenomenon, potentially leading to improved patient outcomes.