Industry Sector:
Structural Heart Disease. Implantable Devices for Dynamic Repair of Heart Valves and Interruption of Progression to Heart Failure
Type of Organization: Private, VC-financed
Year of Incorporation: 2004
Summary:
MiCardia has developed a new-to-world technology platform to dynamically optimize mitral valve and tricuspid valve repair, during and after surgery, to achieve the proper shape and size necessary to produce superior clinical outcomes for each patient as the disease continues to evolve, particularly with the onset of heart failure.
- 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 NiTi device, Sept. 08
- DYANA I (30 patients) Study initiated in Q4/08
- 9 Human implants successfully completed since Q4/08
- Company will complete DYANA study in Q2/09 and file for CE mark subsequently
- Company will append its US 510(k) clearance to include dynamic devices in Q2/09
- Commercialization in US and Europe in the next 18 months
| Intellectual Property: | Six patents issued; 40 patents filed/pending | |
| Law Firm: | Knobbe Martens Olsen & Bear LLP | |
| Financial Summaries: | Series A (2004) — $5.2 million | |
| Series B (2006) — $9.0 million | ||
| Convertible Debt Financing (2008) — $5.0 million | ||
| 35,345,980 fully diluted shares outstanding | ||
| Key Executives: | Paul Molloy | Chief Executive Officer, Board Member |
| Samuel Shaolian | Co-Founder, Chief Technology Officer | |
| Jeff DuMontelle | Director of RA, QA and Compliance | |
| Ross Tsukashima | Director of Engineering and R&D | |
| Al Diaz | Director of Operations | |
| Jody Errandi | Director of Clinical Affairs | |
| Contacts: | Investors: LizBeth Lane, llane@micardia.com | |
