InVera Medical Company Profile

Background

InVera Medical, established in 2018 and headquartered in Galway, Ireland, is a pioneering medical device company dedicated to developing innovative, patient-centered solutions for vascular diseases. The company's mission is to enhance the quality of life for individuals suffering from chronic venous disease (CVD) by offering less invasive and more effective treatment options.

Key Strategic Focus

InVera Medical's strategic focus centers on the development of the InVera™ device, a minimally invasive, non-thermal medical device designed to treat varicose veins and venous ulcers without harmful side effects. The device utilizes the body's natural healing response to address symptoms, enabling treatment for all CVD sufferers. The company targets the substantial market of chronic venous disease, which affects up to 30% of adults globally and imposes a significant burden on healthcare systems.

Financials and Funding

In October 2020, InVera Medical secured $5.3 million (€4.5 million) in seed equity funding to accelerate the development of its InVera™ device. The investment round was led by Nipro Corporation, a leading medical product manufacturer based in Osaka, Japan, with additional contributions from the Western Development Commission, Enterprise Ireland, and international medical device experts and vascular surgeons. In August 2022, the company announced plans for a €17 million funding round to support the rollout of its device, aiming to bring the total funds raised over three years to more than €20 million.

Pipeline Development

The InVera™ device is currently undergoing clinical validation. InVera Medical initiated an in-human clinical trial in 2020 as part of its plan to obtain regulatory approval in the United States and Europe by 2025. The company anticipates that the device will be ready for market approval and registration in both regions in 2024.

Technological Platform and Innovation

InVera Medical's proprietary InVera™ device represents a significant advancement in the treatment of chronic venous disease. Unlike existing thermal ablation devices, the InVera™ device employs a purely mechanical endovascular approach, utilizing the body's natural healing mechanisms to treat varicose veins and venous ulcers without leaving behind implants, chemicals, or causing thermal injury to surrounding tissues. This innovative approach aims to provide a less invasive, pain-free, and faster treatment option for CVD patients.

Leadership Team

Stephen Cox, MBA: Co-Founder and Chief Executive Officer. Stephen brings extensive experience in medical device innovation and commercialization, leading InVera Medical's strategic direction and growth.

Sean Cummins: Co-Founder and Chief Technology Officer. Sean oversees the technological development of the InVera™ device, ensuring its efficacy and safety.

Dr. Nigel Phelan: Co-Founder and Chief Medical Officer. Dr. Phelan provides medical expertise, guiding the clinical aspects of the device's development and validation.

Aisling O’Sullivan, PhD: Vice President for Quality Assurance and Regulatory Affairs. Aisling has over 20 years of experience in regulatory affairs and quality assurance, leading the company's efforts in maintaining high standards and compliance.

Leadership Changes

In 2023, Aisling O’Sullivan was promoted to Vice President for Quality Assurance and Regulatory Affairs, reflecting her significant contributions to the company's quality management systems and regulatory compliance.

Competitor Profile

Market Insights and Dynamics

Chronic venous disease affects a substantial portion of the adult population, leading to significant healthcare expenditures. The market for CVD treatment is valued at over $2 billion annually in the US and EU, with potential growth as new treatments emerge.

Competitor Analysis

Key competitors in the CVD treatment space include:

Theraclion: A French company specializing in non-invasive ultrasound therapy for varicose veins.

Venclose: A US-based firm offering radiofrequency ablation solutions for venous reflux disease.

F Care Systems: A Belgian company providing medical devices for the treatment of varicose veins and other vascular conditions.

AngioDynamics: A US company offering a range of medical devices, including those for vascular access and peripheral vascular disease.

Medtronic: A global leader in medical technology, offering various solutions for vascular diseases.

Strategic Collaborations and Partnerships

InVera Medical has established significant partnerships to advance its mission:

Nipro Corporation: Led the 2020 seed funding round, providing financial support and industry expertise.

Enterprise Ireland: Supported the company's development through funding and resources.

Western Development Commission: Invested in the company, recognizing its potential impact on healthcare and the regional economy.

Operational Insights

InVera Medical's strategic positioning focuses on offering a less invasive, non-thermal treatment option for chronic venous disease, differentiating itself from competitors that utilize thermal ablation methods. The company's emphasis on patient safety, efficacy, and improved quality of life positions it favorably in the market.