SATE OF PLAY

DEVICE
GOOD;
Device Works, many advantages.
Relieves Symptoms
For most patients:-
Halt progression of HF
Reverse remodelling
Expect around a 20% recovery rate in the 9 to 12 mths time frame.

EU data/feasibility trial data very good
Scientific evidence of mechanism of action.

In phase 3 trials for HF.
No competing technology.

Huge HF market and other huge markets likely.

40 sites enrolling, clinical support.

RECOVERY trial could target less sick patients. (Something I think we have all been looking for)

IFS;
NUB approval
Options HF trial discontinued new EU trial based on RECOVERY instituted, is this a much better way to structure trial? No leads for life. More exciting for doctors.

Fully implantable coming, but how soon? Expediated pathway.

Enrolment in US slow
Unexpectedly high problem/delinquent rate seen in enrolees, not seen in feasibility trial. Means more need to be enrolled to make randomised numbers.Something is always different between the feasibility trial and the Phase 3 , if the delinquent rate it probably OK.

Trial lost momentum with halt, slow response by FDA and changes to protocol which took a long time to work through hospital ethics committees. Can the trial regain momentum? (Increased clinical support with increased data and science)

FINANCE
BAD;
My guess:-Management will cost cut to get through to end of February at least.

IF's
SSH to shop EU data etc around.

Two big firms that do the more techniqual surgery, Medtronics and ST Judes.
St Judes has board observation rights. I believe they have taken them up. Just paid too much? for an LVAD company, do they have the appetite for another play? Synergies?
Medtronic, interested in barorecptors for years. Had money in a failed company looking at this? Understand the space.

While both players will understand the dynaism of the data and the evidenced mechanism of efficacy neither will be keen to show enthusiasm to alert others and start a bidding war. So the investor isn't going to know if they are interested or not.

CVRx and Medtronics validates the barorecptor space but neither of them have been successful.

GOOD
St Judes and Medtronics have a strong rivalry.
Convincing data and science.
Rumoured further problems in LVAD space, Hartware docs discouraged from talking. Seems the right time for a new approach.
Only feasible asset left in the Class 3 HF space.
Not many dollars to have a look and see.