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Algenix Inc.

www.algenix.com

Latest From Algenix Inc.

Start-Up Previews (4/02)

A preview of the emerging health care companies profiled in the current issue of Start-Up. This month's profile group, The New Wave in Gastroenterology, features profiles of Algenix Inc., IntraPace Inc., MediGus Ltd. and Semorex Inc. Plus these Selected Start-Ups across Health Care: Isogenica Ltd., Opt-e-scrip Inc., Renovis Inc. and Time-Concepts.com LLC.

The New Wave in Gastroenterology

Gastroenterology, once a market comprised of large, reusable pieces of equipment like endoscopes, ushers in a new era of minimally invasive surgical disposables. Indeed, minimally invasive procedures make it possible for surgical devices to encroach upon drug franchises in several multi-billion dollar markets, including gastroesophageal reflux disease and obesity.
BioPharmaceutical Medical Device

Algenix Inc.

Hoping to succeed where other liver assist devices have failed, Algenix Inc. aims to create, in an extracorporeal device, a microenvironment where hepatocytes retain a high degree of multifunctionality.
BioPharmaceutical Medical Device

Liver Assist Devices: Proof of Life

Apart from transplantation, until very recently, there have been no life-saving therapies available for liver failure. Now, one first-generation liver assist device is on the market and others are progressing through both biologic and device clinical trials. Companies with liver assist devices sort into two main groups: companies with dialysis and ultrafiltration systems that improve upon kidney dialysis and fall squarely on the device side of the divide for regulatory purposes, and those that incorporate living cells in a device-biologic combination, which require drug-like approvals. Regardless of the approval process, all companies need compelling efficacy data to convince clinicians and payers of the benefits of a brand new therapy. But the large numbers of variables and unknowns concerning liver function and liver disease have posed considerable obstacles to designing prospective, randomized, controlled clinical trials-a problem highlighted by Circe Biomedical's halting of its large Phase II/III clinical trial for lack of efficacy. There is no question that there is a tremendous need for liver support. What is tantalizing for both companies and investors in this area is that they feel liver assist devices do work-the liver can recover, physiological functions improve, patients with a prognosis of death have survived. But they just haven't been able to prove it yet, not in terms of the only endpoint that really counts at this early stage in the field, improvements in 30-day survival rates.
Medical Device Clinical Trials
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