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Biotech / Medical : ATIS is on the move! -- Ignore unavailable to you. Want to Upgrade?

To: nonzeroa who wrote (1348)	1/30/1998 6:41:00 AM
From: Rick Strange	Respond to of 2205

Gail Naughton, President and Chief Operating Officer of ATIS, told me today that they are conducting animal studies of the cartilage product to determine the optimum metabolic product that works prior to startup of human trials. But, she said that they will start human trials this year.

To: nonzeroa who wrote (1348)	1/30/1998 8:34:00 AM
From: Tom Kozma	Read Replies (1) \| Respond to of 2205

The approval was for frozen dermagraft with a therapeutic range of metabolic activity. ATIS measures the metabolic activity (MTT) of their product and began the pivitol trial using a broad range of MTT values. After enrolling more than 50 patients, they relized that product outside a tighter "therapeutic range" did not work well, so they continued the study with the "therapeutic product" and didn't include patients receiving product outside the therapeutic range. Then, they began a new study with 50 patients using only "therapeutic range" product but did not enroll any CONTROL patients. This really bothered the panel and that's why they recommended a conditional approval requiring post market surveillance. Essentially, the panel wants ATIS to repeat the second 50 patient trial with proper controls. Additionally, the panel recommended that ATIS provide training, either a video or possibly clinics, to ensure that the product is used properly. The training was recommended because ten of the twenty study centers had much better results. It was thought that the 10 best centers used better techniques for debridement of the wound and everyone using the product should be trained to use the best techniques. I'm sure the company was planning on providing training, anyway. The additional clinical trial will cost them, but they can sell product while it's being conducted. Personnally, I think the panel should have recommended it unconditionally since most members thought that the product was safe and efficacious despite their concerns with the statistical methods used by the comapny. Let the market decide if it really works since it is safe. Post market studies are a pain and cost $$$. Keep in mind that yesterday's decission is just a recommendation by a panel. The FDA still has to approve or not approve Dermagraft. I think that if FDA approves it, ATIS should try to negotiate for getting out of post market trials. Historically, post market surveillance was only required for life sustaining devices such as pacemakers and coronary stents, etc, but I'm not sure if they can get out of conducting post market studies. PS. I have no financial ties to ATIS, and I hope that Dermagraft is beneficial for the majority of chronic wound patients.