Vista Partners Coverage of CTSO:
In addition to its European Union regulatory approval, commercial
viability of CytoSorb® in the U.S. is also a major goal for the Company.
The FDA has not approved the device for use in the U.S. That said the
Company has begun an FDA approved, US Air Force funded 30 patient
randomized controlled pilot study using CytoSorb® to treat trauma in
San Antonio, TX, and plans to initiate a pivotal trial in the U.S. this year
in another major clinical indication, with the goal of achieving approval
in the U.S.
Another key factor that will determine the success of the Company is
finding sources of funding to continue its development. The Company is
seeking multiple sources of capital to fund growth that may include:
• Product sales of CytoSorb® – high gross margins and increasing
sales will drive CTSO closer to cash flow breakeven
• Grant income and other non-dilutive funding – CytoSorbents
has secured more than $7M in such funding over the past 5
years from DARPA, the US Army, NIH, the Department of Health
and Human Services (that oversees the FDA), and others, that
continue to help to offset operating costs
• Potential strategic partnerships
• Raising capital through traditional equity and convertible notes
The Company has developed an intellectual property portfolio, including
32 issued U.S. patents, and multiple pending patents, covering
materials, methods of production, systems incorporating the technology
and multiple medical uses. The Company plans to add to its intellectual
property portfolio in 2014.
The Company has more than 30 investigator-initiated studies being
planned, with many currently enrolling patients, up from 18 in the
second quarter of 2013. Initial data from some of these trials,
particularly those focused on cardiac surgery, is expected in the first half
of 2014. These studies are investigating the specific use of CytoSorb® in
the treatment of trauma, sepsis, ARDS, pancreatitis, cardiac surgery as
well as kidney & liver failure. If successful, these studies may further
validate the use of CytoSorb® to treat these life-threatening conditions
which have otherwise no effective treatments. In addition, positive
treatment successes may increase broader awareness and usage in the
medical community, helping to drive revenues and strategic partner
interest.
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