Company Research Report: InnovHeart
Company Overview
Name and Mission
Company Name: InnovHeart
Mission: InnovHeart aims to provide patients with an innovative therapeutic system designed to replace incompetent Mitral Valves through a safe, effective, and user-friendly transcatheter technology. The company is dedicated to achieving this mission with utmost quality.
Founding Information
- Founded: 2015
- Founder: Giovanni Righini, Chief Technology Officer & Board Member
Key People
- David J. Wilson: Chief Executive Officer
- Keith D. Dawkins: Chairman of the Board
- Barbara Castellano: Board Member, Partner at Panakes SGR
- Federica Draghi: Board Member, Managing Partner at XGEN Venture
- Paolo Fundaró: Board Member, Managing Partner at XGEN Venture
- Azin Parhizgar: Board Member, Venture Partner at 415 Capital Management
- Giovanni Righini: Founder and Chief Technology Officer
Headquarters
- Locations: Milan, Italy, and Boston, Massachusetts, USA
Employees
- No information is available
Revenue
- No information is available
Known For
InnovHeart is renowned for developing transcatheter mitral valve replacement (TMVR) systems specifically designed to treat patients with mitral valve disease. The SATURN TMVR prosthesis stands out due to its compatibility with the mitral valve’s anatomy and delivery options through both Trans-apical and Trans-septal approaches.
Ethics and Certifications
InnovHeart adheres to an Organizational, Management and Control Model in accordance with Italian Legislative Decree n. 231/2001. The company's Quality Management System is ISO 13485:2016 certified.
Products
SATURN Mitral Valve Replacement System
- Description: The SATURN TMVR system is crafted to provide a therapeutic replacement for mitral valves using transcatheter technology.
- Key Features:
- Low-profile design adaptable for Trans-apical and Trans-septal delivery.
- Includes 29 French Valve Delivery System with 2 valve sizes (28 and 31mm).
- Anchoring mechanism involving a subannular ring for alignment with native mitral valve architecture.
Recent Developments
New Products and Features
- First-In-Human Trans-Septal Implantation: Successful completion of the first trans-septal clinical trial implant of the SATURN TMVR, showing excellent hemodynamic results.
- Clinical Trials: Initiation of the CASSINI-EU study for trans-septal technology following the SATURN TA clinical experiences.
Partnerships and Financial Growth
- Financing Round: InnovHeart raised $55 million in Series C financing to advance the SATURN trans-septal TMVR system.
- Exclusive License Agreement: InnovHeart partnered with Grand Pharmaceutical Group for the development and commercialization of the SATURN TMVR device in Greater China.
Key Corporate Changes
- Appointment of CEO: David J. Wilson was appointed as CEO on March 30, 2022, to spearhead the company's growth and the SATURN TMVR Program.
Conclusion
InnovHeart stands at the forefront of mitral valve disease treatment with its SATURN TMVR systems. The company’s strategic leadership, innovative technology, and clinical success mark it as a pivotal player in the field of transcatheter mitral valve replacement.
