Sunshine Heart (SSH) Remains Neutral-Rated at BTIG; Commencement of New Trial w/ Same Device Questioned

BTIG affirms Sunshine Heart (NASDAQ: SSH) at Neutral following Q4 results and update reported earlier Thursday.

Analyst Sean Lavin is conflicted on the COUNTER-HF trial stoppage. The analyst thinks that, while focusing on a fully-implantable device makes sense, it might not be the best use of cash.

On plans for a new trial, Lavin commented, Mgmt plans to start a shorter-term trial with the current device while working on the fully implantable. It sounds as though this would leave the patient with a driveline for 6-12 months with a goal of restoring heart function. We see two hurdles here: First, given the company’s cash, we’d prefer it all be focused on the implantable. Second, the FDA has always preferred mortality trials for implantable LVADs. We were surprised when SSH was able to get the FDA to agree to hospitalizations plus mortality as an endpoint previously. We wonder if the FDA will agree to a functional endpoint.

Lavin is positive on incomeing CEO John Erb and the swift action he took with COUNTER-HF.

For an analyst ratings summary and ratings history on Sunshine Heart click here. For more ratings news on Sunshine Heart click here.

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