Affera, Inc.

Key People

• Doron Harlev - Founder and CEO

Assessment

Team

Aspect: Multiple successful MedTech entrepreneurs
Summary: Affera's leadership includes experienced MedTech entrepreneurs.

Doron Harlev, Affera's founder and CEO, previously co-founded Rhythmia Medical, which was acquired by Boston Scientific in 2012. This background indicates a strong track record in MedTech entrepreneurship.

Clinical Need

Aspect: Very Strong
Summary: High demand for innovative cardiac arrhythmia treatments.

With nearly 60 million people affected by atrial fibrillation worldwide, there is a significant need for advanced treatment options. Affera's technologies aim to address this growing demand.

Competition

Aspect: Very crowded + Strategics
Summary: Highly competitive market with major players.

The cardiac ablation market is highly competitive, featuring major companies like Medtronic, Boston Scientific, and Abbott. Affera's acquisition by Medtronic positions it within a leading strategic player.

Technical Challenge

Aspect: Complex
Summary: Developing advanced cardiac mapping and ablation systems is complex.

Creating integrated systems for cardiac mapping and ablation involves significant technical challenges, including ensuring precision, safety, and efficacy in treating arrhythmias.

Patent

Aspect: Strong
Summary: Affera holds strong patents in cardiac ablation technology.

Affera's proprietary technologies, such as the Prism-1 mapping platform and Sphere-9 catheter, are protected by strong patents, providing a competitive edge in the market.

Financing

Aspect: Strategics
Summary: Well-funded through strategic investments and acquisition.

Affera secured significant funding, including a $75 million Series C round led by Bain Capital Life Sciences, and was later acquired by Medtronic for approximately $925 million, ensuring robust financial backing.

Regulatory

Aspect: Pivotal Trial
Summary: Engaged in pivotal trials for regulatory approval.

Affera initiated the SPHERE Per-AF Trial, a pivotal randomized trial approved by the FDA to evaluate the safety and effectiveness of its system for treating persistent atrial fibrillation.

Opportunity Rollup

Odds of Success

3.5

Peak Market Share

4.3

Segment CAGR

4.5%

Market Segment

Cardiac Ablation Devices

Market Sub Segment

Electrophysiology Devices

Key Takeaway

Affera's acquisition by Medtronic positions it strongly in the competitive cardiac ablation market, leveraging innovative technologies to address the growing need for advanced arrhythmia treatments.