The millions of dollars that St. Jude Medical has invested in CardioMEMS, a medical technology company in Atlanta, may in the end be all worth it.
CardioMEMS, hailed as a promising company for developing a wireless sensing and communication technology inside the human body, ran into a major roadblock in 2011 when an FDA panel voted to reject its application for an implantable device for heart failure patients.
But five days ahead of a second panel review, the draft documents released for the meeting, appear to suggest that the mood may have changed.
Two analysts who reviewed those draft documents separately published research notes stating that they believe an FDA approval of the Champion Heart Failure sensor is now more likely. The sensor, which has no batteries or leads, is implanted in the pulmonary artery and capable of wirelessly transmitting pressure readings to an external device. The device in turn sends the data a database accessible by a physician.
In a research note on Friday, RBC Capital Market's senior analyst Glenn Novarro wrote that:
Despite lingering concerns over the trial conduct, we believe the tone of these documents is more positive than the briefing documents from the 1st panel in 2011 and bode very well for a positive panel outcome."
The trial conduct refers to the fact that an FDA site review revealed emails that showed that nurses employed by CardioMEMS often provided clinical advice to physicians regarding pressure readings of patients when all physicians should have been receiving were automated alerts when the pressure threshold was exceeded.
Analyst Danielle Antalffy with healthcare investment bank Leerink Swann also echoed Novarro's comments.
To us, the likelihood of a positive panel -- and ultimate approval -- moves to over 90% from 75% previously based on: (1) The FDA's acknowledgment of the consistency and clinical efficacy seen in the totality of the data, (2) A detailed recommendation for a post-approval study upon approval, and (3) A proposed label (with a broad indication of use) -- something we usually see when the FDA wants a device to come to market.
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