CircuLite has locked down a CE mark for its tiny blood pump device. With that in hand, the startup now has big plans on two continents: a controlled commercial launch in Europe, starting in Germany, and the hoped-for start of a U.S. clinical trial by the 2013 first quarter.
In the U.S., CircuLite is waiting for the FDA's sign off to start testing its Synergy micro-pump under an investigational device exemption, a designation that will allow it to collect data on safety and effectiveness in a 20-patient trial (A larger trial will follow before an eventual PMA application.). CircuLite president and CEO Paul Southworth told FierceMedicalDevices that all signs suggest the company can proceed as scheduled with what the company has said is the world's smallest implantable blood pump, which is about the size of an AA battery.
"At this point, it's in the FDA's hands. But we have been making good progress and are on track with that time frame," Southworth said to FMD. "With the CE mark under our belts and the European launch in the immediate future, development in the U.S. is our next major priority."
Synergy is implanted superficially, the company explains, in a pacemaker-like pocket under the right collarbone. Designed to stop the advance of heart failure, the product is about 90% lighter than ventricular assist devices on the market and doesn't require major surgery for implant, unlike VADs. CircuLite's CE mark covers Class IIIb and early Class IV heart failure patients who continue to have symptoms despite other medical treatment. Other LVAD products focus on later-stage patients, according to CircuLite. Competitors in the space will include Abiomed and Berlin Heart.
Luckily, CircuLite and its 41 employees don't need to worry about fundraising to support its European commercial launch or U.S. clinical development plans. The company pulled in a $30 million Series D financing in November 2011 from the likes of new investors MacAndrews & Forbes Holdings and Forbion Capital Partners. Crédit Agricole Private Equity, Saints Capital, Foundation Medical Partners and SB Life Science Ventures were among the CircuLite's existing investors who also participated in the round. Including this round, CircuLite has raised $98.1 million to date.
Looking ahead, Southworth said CircuLite is contemplating "another, potentially final" funding round of between $30 million and $40 million that would help it become cash flow positive and also support additional clinical studies and development for other products in the company's pipeline.
Launched in 2004, CircuLite has offices in Saddle Brook, NJ and Aachen, Germany.
- read the release