Industry Sector:
Structural Hear Disease;Implantable Devices for Heart Valve Repair
Type of Organization: Private (Venture and Private Equity Financed)
Year of Incorporation: 2004
Summary:
MiCardia has developed a new-to-world technology platform to dynamically optimize mitral valve repair, during and after surgery, to achieve the proper shape and size necessary to produce superior clinical outcomes for each patient.
Key Milestones
- 65 chronic and acute animals completed
- 600 million cycle fatigue testing completed flawlessly
- 2 GLP animal studies completed
- US 510(k) clearance on first generation static device, Sept. 08
- DYANA I (35 patients) Study completed in 2009
- 40 Human implants successfully completed
- CE Mark awarded for enCor™, October 2010
- Commercialization in Europe planned for Q4, 2010
- IDE submission for sub-cutaneous device Q2, 2011
| Intellectual Property: | 11 US patents issued; 2 European patents; 40 patents filed/pending | |
| Law Firm: | Knobbe Martens Olsen & Bear LLP | |
| Key Executives: | Mike Henson | Co-founder and Chairman of the Board |
| Samuel Shaolian | Co-Founder, Chief Technology Officer | |
| Don Rohrbaugh | Chief Executive Officer | |
| John McIntyre | Director of RA, QA and Compliance | |
| Ross Tsukashima | Director of Engineering and R&D | |
| Bart Navarro | Director of Operations | |
| Robin Gibbs | Director Clinical Marketing | |
| Contacts: | Investors: Don Rohrbaugh, drohrbaugh@micardia.com | |
