I attended the meeting also. I had a chance to speak with Dr. Mussivand, as well as Rod Bryden.
My comments that follow are combined from those two conversations, and are conveyed as well as I can from memory. As I have said before, I am not a physician nor an engineer, so if I get anything "technically" wrong I apologize.
First, some information on the "dark horse" competitor - the DeBakeyVAD. As participants in this thread know, the DeBakeyVAD is a non-pulsatile device. If these can ever be commercialized, they have a significant advantage in size, weight, simplicity and cost.
The DeBakeyVAD human trials that are underway in Europe are for bridge to transplant only, not permanent implant. So they will have to enter new clinical trials if they want to commercialize the device as a permanent implant. The HeartSaverVAD actually contains something called the "energy converter" which is essentially the same as the non-pulsatile impeller, and the HeartSaver could be converted to a non-pulsatile device should they ever prove to be safe and effective. However, the big difference right now is that the energy converter in the HeartSaver does not come into contact with the blood at all, whereas it does with the DeBakeyVAD. Therefore, concerns about cell damage and blood clotting are more significant with the DeBakeyVAD. Another advantage of the HeartSaver is that it can respond to the body's chemical triggers and vary the flow rate during exertion. The non-pulsatile devices can not do this effectively, without increasing its size to that of the pulsatile devices. Then, what's the point.
A big issue with non-pulsatile devices is the concern over organ damage from long term use, because you don't have a pulse. Now, I think another poster here (Mindshare?) suggested that's not an issue, since you are not replacing the heart, only aiding it. However, with Class IV heart failure (which all these devices are initially targeting), the heart is so badly failing that is not pumping nearly well enough for the patient to survive. The only alternative is heart transplantation, without it the 5 year mortality rate is 90%.
Finally, World Heart believes (correctly, I think) that even if non-pulsatile devices eventually pass trials for permanent implant, many physicians and their patients will opt for a device that gives them a pulse over one that doesn't. I did a scientific survey of one - I asked my wife what she thought. She was aghast at the thought of not having a pulse.
So, I now better understand why World Heart does not view the DeBakey device as a competitor - realistically they won't be for many years to come.
Incidentally, Dr. Mussivand is leaving today for the American Society of Cardiologists annual meeting in Puerto Rico. He is presenting a paper there, as are the proponents of the DeBakey device.
Some other points:
Mr. Bryden feels that they have enough financing to carry them through the trials, even if there is a delay due to unforseen difficulties. This is a big advantage, because they will want to next seek funds on there terms, not the markets. Therefore, he wouldn't rule out going for more equity financing if the share price has risen significantly from where it is now.
After this most recent share offering, the "insider" holdings are:
Rod Bryden: 21.3%, Michael Cowpland: 9.3%, Ottawa Heart Institute: 9.8%, and Directors and Senior Officers: 36.2%. A total of 76.6%. Add the institutions who likely will not sell for a couple of years, and it amounts to a very small public float.
It's also very unlikely a hostile takeover could occur, because of the significant insider holdings. Bottom line, if Rod Bryden and Tofy Mussivand don't agree with a buyout, it won't happen. And the thing I really respect about Rod Bryden is that, while he is a very astute businessman, he is also a staunch Canadian. (He's the only powerful business leader that I heard publicly criticize the proposed bank mergers in Canada, because he didn't think it would be good for Canadian SME's). So if anyone (Medtronic?) wants to take this company over, they will pay, and pay dearly.
That's it for now. If I think of other points, I'll add them later. |
