Aurora Sterilisation

Founded in 2019 by two entrepreneurs following to take over the results of 5 years of academic research, Aurora is a French DeepTech/MedTech startup that specializes in developing a breakthrough low temperature sterilization technology for medical devices. Based in Rouen (headquarters and production) and Reims (R&D and regulatory affairs), the company employs 24 people, including 7 PhDs. It has raised €12.5 million in funding, with a significant €2.5 million grant from the European Innovation Council (EIC) in November 2023. Through the EIC program, the EBI is committed to investing up to €10 million in equity in the next rounds.

Aurora's proprietary technology utilizes low temperarure plasma from gases from the air to sterilize complex and heat-sensitive medical devices [endoscopes, robotic arms, implants, biomaterials,…] , which are otherwise challenging to sterilize using existing methods. The company has developed two primary solutions:

1. Aqsaniit: Designed for healthcare centers, it sterilizes devices like gastrointestinal (GI) endoscopes in about one hour.
2. Silanaq: Tailored for medical device manufacturers, it allows batch sterilization, processing up to 10 pallets in around 10 hours.

The significance of Aurora's technology lies in addressing two critical market needs. First, the reprocessing of long and flexible GI endoscopes has been a persistent regulatory challenge. These devices constitute 60% of all endoscopic procedures but cannot be reliably sterilized using conventional methods. Health concerns have been exacerbated by incidents involving contaminated endoscopes, leading to serious patient infections and regulatory scrutiny. The FDA, for instance, has issued warnings and may introduce stricter regulations. Second, Aurora's technology provides a non-toxic alternative to Ethylene Oxide (EtO), a common but hazardous sterilization method associated with severe environmental and health risks. The demand for alternatives has grown as regulatory bodies increase pressure on manufacturers to phase out EtO.

Aurora's natural plasma sterilization technology boasts several advantages:

• It operates at low temperatures (30-40°C), making it suitable for sensitive materials.
• It uses only oxygen as a sterilizing agent, avoiding toxic chemicals and reducing environmental impact.
• It ensures a high sterilization standard, achieving a 10^-6 risk of contamination.
• The process is efficient, with hospital sterilization taking only about an hour.

Aurora's market potential is substantial, with a total addressable market (TAM) of approximately $9 billion by 2030. This includes the GI endoscope sterilization market, expected to grow from $5 billion in 2023 to $6.4 billion by 2030, and the sterilization market for single-use devices, projected to rise from $1.6 billion to $2.5 billion in the same period. The company's solutions could significantly disrupt these markets, given the increasing global emphasis on safe, efficient, and environmentally friendly sterilization methods.

Aurora's development roadmap highlights key milestones leading to market entry. Regulatory submissions for CE marking and FDA approval are scheduled for 2024, with approvals expected in late 2025. Aqsaniit machines will be installed at key hospitals for testing and demonstration, supporting the technology's adoption. The company plans a €7.5 million Series B fundraising round to finance production and regulatory efforts, leveraging EIC's equity investment commitment. If no strategic exit occurs, Aurora envisions a Series C round in 2027 to expand into the U.S. and broader European markets, aiming for €74 million in revenue by 2028.

Aurora's leadership team brings extensive experience in general management, scientific research, and medical device regulation. The founders, Jan Laarman and Thomas Parias, bring expertise in business administration and large-scale industrial projects, respectively. They are supported by a robust executive team, including specialists in microbiology, regulatory affairs, and medical device sales.

Aurora's vision is to revolutionize sterilization practices, offering a safer and more sustainable solution for the medical community while addressing critical regulatory and environmental challenges.