Supersecret mitral valve startup Twelve has raised $35.2 million, bringing its total raised via equity to $70 million, according to SEC filings. It's going to need that cash to support a recently divulged clinical trial for its Twelve Transcatheter Mitral Valve Replacement System. Without a website and no press releases, the company has done its best so far to remain hush-hush.
The open-label, 10-person trial is in patients with severe, symptomatic mitral regurgitation--a condition in which the heart's mitral valve doesn't close tightly and allows blood to flow backward into the heart.
The study is being conducted at a hospital in Krakow, Poland, suggesting that the data is intended to advance Twelve toward a CE mark. The trial started in September and continues to enroll patients; final data for the primary endpoint is expected in September 2016.
Catheter-based treatment of mitral regurgitation is an attractive option, rather than open or even minimally invasive surgery, and it can be used to implant a clip or a bioprosthetic valve.
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| Twelve CEO Andrew Cleeland |
The first FDA-approved percutaneous mitral valve repair therapy was Abbott Laboratories' ($ABT) MitraClip, which was approved in October 2013, and is doing quite well with double-digit sales growth. It continues to be the only marketed minimally invasive treatment for this indication, Abbott Chairman and CEO Miles White noted on the company's April earnings call. MitraClip is specifically approved for patients who have symptomatic degenerative mitral regurgitation but are at too high a risk to have surgery.
Twelve was the twelfth company to graduate from The Foundry, a Menlo Park, CA-based medical device incubator that started in 1998. It raised its $3 million Series A in January 2010 from Morgenthaler Ventures, Split Rock Partners, and Domain Associates, which was later bumped up to $4 million. The SEC filing for Twelve's latest financing lists investors from Morgenthaler and Domain, as well as Versant Ventures and Vertex Management. Executives of The Foundry, as well as Dr. Thomas Fogarty of the medical device incubator Fogarty Institute for Innovation, are also listed.
In fact, Abbott's MitraClip came out of another Foundry company, Evalve, that was acquired by Abbott in 2009 for up to $410 million. Evalve was the first startup incubated by The Foundry more than 16 years ago.
"So, we know our way around the mitral valve!" said The Foundry Managing Director Mark Deem in an email.
Twelve's president and CEO is Andrew Cleeland, who is also vice chairman of The Foundry. He previously led renal denervation startup Ardian, which Medtronic ($MDT) said in November 2010 it would acquire for $800 million plus undisclosed commercial milestones. Ardian also came out of The Foundry.
- here is the SEC filing
- and here is the trial info from clinicaltrials.gov