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Liver Roll-Ups? (Not the Deli Kind)

This article was originally published in Start Up

Executive Summary

Merchant bank The Aethena Group aims to provide a new kind of resource to emerging and middle market companies that need a boost to get to a valuation level that supports investment by traditional investors. One field in need of such support, Aethena believes, is liver disease, which represents enormous untapped markets, but product risk associated with an evolving understanding of liver biology. Aethena hopes to offer strategic options to companies in this industry.

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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.

The Heat is on for First Circle Medical

Many scientists and physicians believe in the healing power of heat, but to date, there have been no major commercial successes in hyperthermia. Hyperthermia companies suffer from the field's checkered past: a wave of commercial hyperthermia flameouts in the 1980's means that many investors won't give hyperthermia companies a second glance. First Circle Medical's challenge is to win over skeptical investors and clinicians as it pursues a new device market for hepatitis C. There it aims to offer a side effect free alternative to drugs for a deadly and prevalent disease with few therapeutic options, or, at the very least, a procedure that will potentially boost the efficacy of drugs. But as the first and only player in a new field, and in light of the prejudice against hyperthermia devices that many share, First Circle has to create a base of rigorous scientific data from scratch; indeed, it has to bear the burden of doing everything right.

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