ApiJect Systems, Corp.

Key People

• Jay Walker - Co-founder, Executive Chairman & CEO
• Marc Koska - Co-founder, Head of Product Design
• Jon Ellenthal - President
• Bo Kowalczyk - Chief Commercial Officer
• Ed Kelley, PhD - Chief Global Health Officer
• Molly Weaver - Chief Technology Officer

Assessment

Team

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

Jay Walker, the CEO, is a seasoned entrepreneur known for founding Priceline.com. Marc Koska, the Head of Product Design, is renowned for inventing the K1 auto-disable syringe, demonstrating a strong track record in medical device innovation.

Clinical Need

Aspect: Very Strong
Summary: ApiJect addresses a critical need for safe, single-dose prefilled injectors, especially in global health contexts.

Unsafe injection practices contribute to over a million deaths annually. ApiJect's technology aims to mitigate this by providing cost-effective, single-use prefilled injectors, particularly beneficial in low-resource settings.

Competition

Aspect: Somewhat crowded
Summary: The market for prefilled injectors includes several established players, but ApiJect's unique technology offers differentiation.

Companies like Becton Dickinson and Gerresheimer dominate the prefilled syringe market. However, ApiJect's Blow-Fill-Seal technology offers a novel, scalable solution that could disrupt traditional manufacturing methods.

Technical Challenge

Aspect: Predictable
Summary: The technology involves established manufacturing processes with manageable technical challenges.

Blow-Fill-Seal technology is a recognized aseptic packaging process. ApiJect's adaptation for prefilled injectors involves predictable engineering challenges, with a clear path to implementation.

Patent

Aspect: Strong
Summary: ApiJect holds several patents protecting its proprietary technology.

ApiJect's modular Blow-Fill-Seal injector system is protected by multiple U.S. patents, including 11,382,833 and 11,607,369, safeguarding its innovative design and manufacturing processes.

Financing

Aspect: Well-funded
Summary: The company has secured significant funding from reputable investors.

In May 2022, ApiJect completed a $111 million investment round led by Royalty Pharma and Jefferies Financial Group, valuing the company at approximately $300 million. This funding is earmarked for further development and deployment of its manufacturing platform.

Regulatory

Aspect: 510k/PMA
Summary: ApiJect's products are subject to standard regulatory pathways for medical devices.

The Prefilled ApiJect Injector and its manufacturing process are designed to meet FDA requirements. The company is preparing for regulatory submissions to ensure compliance and facilitate market access.

Opportunity Rollup

Odds of Success

3.7

Peak Market Share

4.7

Segment CAGR

2.4%

Market Segment

Drug Delivery Devices

Market Sub Segment

Prefilled Syringes

Key Takeaway

ApiJect's innovative prefilled injector technology addresses a critical clinical need with strong leadership and financial backing, positioning it well in a competitive market.