Genetesis, Inc. - Company Market Research Report

Company Overview

• Name: Genetesis, Inc.

• Mission: Delivering the world’s most cost-effective and patient-centric solution for cardiovascular disease.

• Founded: In 2013

• Founders: Peeyush Shrivastava (CEO), Vineet Erasala (COO), Emmanuel Setegn (CTO)

• Headquarters: Based in Mason, Ohio, USA

• Number of Employees: No information is available.

• Revenue: No information is available.

• Notable For: Innovating the field of magnetocardiography (MCG), specifically through its flagship product, CardioFlux, which provides non-invasive cardiac imaging without the use of radiation or injected agents.

Products

CardioFlux

• Description: CardioFlux is a magnetocardiography (MCG) system designed to non-invasively measure and display the magnetic signals produced by the electrical activity of the heart. It provides a rapid diagnostic pathway for the detection of myocardial ischemia.

Key Features:

• Non-Invasive Measurement: Utilizes Earth Magnetic Field gradients for non-invasive imaging.

• Speed: Capable of completing a scan in 90 seconds and delivering results in 5 minutes.

• Zero Patient Burden: No need for stress testing, injections, or radiation.

• Simple Operation: Requires minimal operator training, with a setup needing only a standard wall outlet and simple narrative interpretation methods.

• Portable: No need for extensive infrastructure, making it adaptable for various clinical settings.

Recent Developments

Regulatory Approvals and Designations

• Health Canada Approval (September 2024): Genetesis received approval for CardioFlux for the diagnosis of myocardial ischemia, marking the first approval of an MCG device by Health Canada.

• FDA 510(k) Clearance (2019): CardioFlux is cleared in the United States for non-invasive measurement and display of cardiac magnetic signals.

Clinical Trials & Research

• MICRO Trial: Examined CardioFlux’s efficacy in detecting myocardial ischemia in ANOCA patients. Demonstrated diagnostic potential for coronary microvascular dysfunction.

• MAGNETO Trial: Evaluated CardioFlux's diagnostic performance against standard noninvasive stress tests for myocardial ischemia in acute coronary syndrome contexts.

Partnerships and Expansion

• Canadian Expansion: Since the 2024 approval by Health Canada, Genetesis has been seeking Canadian partners for early adoption to enhance patient outcomes and experience in Canada.

• Ongoing Collaborations with U.S. Institutions: Significant clinical trials in collaboration with institutions such as The Cleveland Clinic, Ascension St. John Hospital, and The Christ Hospital.

Key Personnel

• Board of Directors:

• John Rice, PhD - Chairman

• Sajid Malhotra - Chairman

• Peeyush Shrivastava - Co-Founder & CEO

• Scientific Advisory Board:

• Mort Kern, MD

• Amir Lerman, MD

• Viviany Taqueti, MD, MPH, FACC

• Leadership Team:

• Peeyush Shrivastava - Co-Founder & CEO

• Vineet Erasala - Co-Founder & COO

• Emmanuel Setegn - Co-Founder & CTO

• John Emanuel - Chief Financial Officer

• Robert Takla - Chief Medical Officer

• Rhea Malhotra - VP of Product

Conclusion

Genetesis, Inc. continues to break ground in the biomedical imaging industry with its advanced MCG technology through CardioFlux. With recent approvals and ongoing trials, they are poised to redefine methodologies for diagnosing ischemic heart disease in the clinical landscape.