InCarda Therapeutics

Key People

• Dr. Myles Greenberg - President and CEO
• Dr. Luiz Belardinelli - Chief Medical Officer
• Dr. Carlos Schuler - Chief Operating and Technology Officer
• Dr. Grace Coln - Former President and CEO

Assessment

Team

Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises experienced professionals with significant backgrounds in medical technology and biopharmaceuticals.

Dr. Myles Greenberg, the current CEO, has a robust background in healthcare leadership. Dr. Luiz Belardinelli, the Chief Medical Officer, brings substantial expertise in cardiology. Dr. Carlos Schuler, serving as Chief Operating and Technology Officer, has a strong track record in technology development. The former CEO, Dr. Grace Coln, also contributed significantly to the company's growth. This collective experience positions InCarda Therapeutics favorably in the biopharmaceutical industry.

Clinical Need

Aspect: Very Strong
Summary: InCarda addresses a significant unmet need in the treatment of paroxysmal atrial fibrillation (PAF) through innovative inhalation therapy.

PAF is a common cardiac arrhythmia with substantial morbidity. Current treatments often involve invasive procedures or systemic medications with side effects. InCarda's inhaled flecainide offers a rapid, patient-administered solution, potentially transforming the management of PAF episodes.

Competition

Aspect: First mover
Summary: InCarda's inhaled therapy for PAF represents a novel approach with limited direct competition.

While there are established treatments for PAF, such as oral medications and catheter ablation, InCarda's inhaled delivery system is unique. This first-mover advantage offers market differentiation but also requires significant efforts in clinical validation and physician education to drive adoption.

Technical Challenge

Aspect: Moderate
Summary: Developing an effective inhaled formulation of flecainide presents moderate technical challenges.

Inhaled drug delivery requires precise formulation to ensure adequate pulmonary absorption and rapid onset of action. Additionally, patient factors such as inhalation technique can influence drug efficacy. InCarda's development efforts must address these variables to ensure consistent clinical outcomes.

Patent

Aspect: Very Strong
Summary: InCarda holds robust patents covering its inhaled cardiovascular therapies.

InCarda has secured patents in the U.S., Australia, and Canada, covering the pulmonary delivery of antiarrhythmic agents, including flecainide. These patents encompass unit doses, aerosols, kits, and methods for treating heart conditions via inhalation, offering a strong defense against market competitors.

Financing

Aspect: Well-funded
Summary: InCarda has successfully raised significant capital to support its development programs.

In 2018, InCarda completed an oversubscribed $42 million Series B financing led by investors such as Sofinnova and HealthCap. This funding supports ongoing clinical trials and operational activities, positioning the company to advance its therapeutic candidates through regulatory pathways.

Regulatory

Aspect: Pivotal Trial
Summary: InCarda is progressing through pivotal clinical trials for its lead product.

InCarda has conducted Phase 2 and Phase 3 trials for its inhaled flecainide product. While the Phase 3 RESTORE-1 trial was terminated early due to efficacy concerns, the company is refining its approach and plans to reinitiate safety and efficacy trials in 2025. Successfully navigating these regulatory steps is crucial for market entry.

Opportunity Rollup

Odds of Success

3.65

Peak Market Share

4.35

Segment CAGR

9.1%

Market Segment

Cardiovascular Devices

Market Sub Segment

Cardiac Rhythm Management Devices

Key Takeaway

InCarda Therapeutics is pioneering inhaled therapies for atrial fibrillation, addressing a significant clinical need with a novel approach, supported by strong leadership and intellectual property, though facing challenges in clinical validation and market adoption.