CytoSorbents Corporation (CTSO)

[techxen]

Trauma/myoglobin market alone is > $1B

From the recent 10K:
"Cytokine and myoglobin reduction by CytoSorb and related technologies may have benefit in trauma, potentially improving clinical outcome. The total addressable market for CytoSorb for the treatment of trauma is estimated to be $1.5 billion to $2.0 billion in the U.S. and the EU."

In general, most extracorporeal therapies are not well-suited to remove myoglobin. CytoSorb reduces myoglobin, and other polymers under development, removes myoglobin without significant losses of albumin.

If you recall they had a long running FDA approved study with the Air Force a while back but ended up closing it down due to recruiting difficulties.

"In June 2013, we announced that the U.S. Air Force was funding a 30 patient, single site, randomized controlled human pilot study of CytoSorb to evaluate patients with severe trauma and rhabdomyolysis. The primary endpoint for this study was myoglobin removal. Though we did not expect to receive material direct funding from this $3.0 million budgeted program, it was hoped that the study would generate valuable data that could be used commercially by us or in our future trauma studies. However, because of the stringency of the inclusion criteria, and because of the patient mix seen at the single clinical trial site, the study experienced difficulty in enrolling patients. In an effort to increase enrollment, in 2015 we amended the applicable study protocol to modify the key inclusion criteria and expand the number of clinical trial sites. Unfortunately, these amendments did not result in increased enrollment. In December 2016, we contacted the Contracting Officer’s representative for the study to discuss potential options and alternatives, including closing the study. Due to the continued difficulty in enrolling patients in this study and likelihood this would continue without significant modification to the protocol, we determined, together with the U.S. Air Force, to close the study."