The U.S. Food and Drug Administration has picked up the pace on novel medical device approvals, but this year still may not hit levels seen in 2011 and 2012. During the first six months of 2014, the agency granted 17 premarket approvals, way up from 23 for the entirety of 2013.
But even if PMA approvals by the FDA set a similar pace during the second half of 2014, this year won't eclipse the number of novel med tech approvals in 2011 and 2012, which was 42 and 39, respectively. All this is according to data compiled by EP Vantage.
The average review time for PMAs during the first half of 2014 was 18.4 months, way down from 35.9 months in 2013. That figure was aided considerably by the fastest one, which was for Medtronic's ($MDT) transcatheter aortic valve CoreValve in January with an approval time of only 5.8 months. Rival Edward Lifesciences ($EW) followed with an approval for a competitive product in June, the next-generation Sapien XT aortic valve.
The slowest PMA approval during the first half was for Anika Therapeutics ($ANIK) at 49.9 months, or more than four years. It was for the company's hyaluronate-based osteoarthritis therapy Monovisc. But that timing doesn't look so bad when you consider the FDA had already rejected Monovisc twice.
Roughly two-thirds of these PMA approvals during the first half went to big med tech companies. Among the smaller public and private companies wringing out a novel approval were recent IPO company Ocular Therapeutix ($OCUL), hearing implant company Cochlear and Medtronic spinoff Inspire Medical Systems, for the first FDA-approved sleep apnea implant. (Another approval that was high-profile during the first half was for powered exoskeleton company ReWalk Robotics, but it went through the de novo approval pathway rather than a PMA. ReWalk recently filed for a $58 million IPO.)
CardioMems was perhaps the most notable small company to garner a novel FDA approval during 1H14; at the same time its implantable heart failure monitor was approved by FDA in late May, St. Jude Medical ($STJ) acquired the company. It already held 19% of the startup and paid $375 million for the remainder.
- here is the release from EP Vantage
- and the FDA monthly PMA approval data