We are Half Way There

It suddenly struck me last week -- we are half way there.

Let me explain.

We have been very busy here working to deliver a device to amplify growth factor that a corporate sponsor needed by the end of April. Since we do not receive compensation from Islet Sheet, we must jump on such a lucrative project! The prototype has been delivered so we can turn our attention again to islets, sheets, and diabetes.

I had been neglecting Islet Sheet Medical. Because of Tom Bethell's article on our work in the March edition of The American Spectator I had an e-mail box full of requests for information on the company. All I had was an obsolete business plan from October, 2000; I had to update it before I would let anyone see it. We had made great strides in animal studies at Edmonton, and I was being educated on the realities of the regulatory path by Peter Hammonds, our new regulatory advisor.

Islet Sheet Medical is getting real. It had been my dream for 20 years to find a cure for diabetes, if only for myself. But mostly it was hope and dreams. Now we were testing a device that met all of our design standard at the best islet laboratory in the world!

Dreamy plans no longer cut it. I am sure that I will be talking with major New York type investors about the many millions of investment dollars I will need to get the Islet Sheet on the market. And I think that will happen within the year. No more dreams and hope: I must have a plan I can justify to flinty-eyed investors with the big money.

Peter Hammonds wrote me (in a friendly way): "Thanks for the Business Plan, I'll read it with great interest. I had a
quick look at the timelines, and I hope nobody with a regulatory background gave you the (much too short) clinical timeline!" Peter and I worked out a regulatory plan that would pass muster with someone with a regulatory background. It was going to take three years longer to get to market that I had thought. Major bummer. "Wake up and smell the coffee" time.

Back to my revised plan, and my need to put our regulatory review in context. I decided a big time line was the way to go. I would break the time line into the stages from idea to product launch, showing now much time they take and how they overlap, and mark major milestones: Our first dog implant, our patent applications etc., and projections for future milestones.

The last thing I did was put in a dotted line to show May, 2001 in this scheme. That's when it hit me. We are half way there.

Randy Dorian, my partner and our in-house genius, we go back a long way. We worked together on a microencapsulation system was was very close to a cure. (I'll tell you all about that some other time.) He had always said that a thin sheet would be better than microcapsules. I had always told him, sure, it would be, but he could never build it. In 1995 he he made some.

So we filed a patent application, and I started talking to backers. We almost had $15 million, but that went to Neocrin instead. (I'll tell you all about that too some other time.) Finally in 1998 we decided to raise a little angel money and do some animal feasibility studies. Now it is 2001 and the Edmonton group has proven that diabetes can be cured -- at a cost. They have decided to test our technology because it has the promise to cure diabetes without that cost. "If the Islet Sheet concept works without significant risk to patients, this could be an incredible advance for islet transplant." said Dr. Shapiro.

My biggest fear had always been that we would invent a cure for diabetes and never be able to prove it. That fear is now gone. We think the Islet Sheet will work. But we are sure that it will get a thorough evaluation in studies at Edmonton.

We are more than half way there.

Scott King

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