Seems like there are plenty of reasons to get in soon...
[from the CTSO release]
More recently, there have been a number of developments and near term catalysts that should begin to accelerate growth in the second half of this year. These include:
-- Expansion of the direct sales team in early Q3 to 7 people, including 2
new full-time sales people and a contract sales representative. With the
planned addition of 2 more sales people and a medical science liaison
before the end of the year, we believe we will be well-positioned to meet
the interest and demand for CytoSorb(R) in our direct sales territories
-- Recent approval of CytoSorb(R) in Saudi Arabia and signing of TekMed in
Australia and New Zealand, which immediately opened markets representing
57 million people
-- Nearing initial marketing with partner Fresenius Medical Care in France,
Poland, Denmark, Norway, Finland and Sweden, which would unlock
additional markets covering more than 127 million people
-- Completion of, and near-term availability of clinical data from two
randomized, controlled investigator-initiated studies from University of
Hamburg-Eppendorf and Medical University of Vienna, evaluating the safety
and ability of CytoSorb(R), when used intra-operatively during cardiac
surgery, to reduce cytokines and post-operative inflammation
-- The planned completion of an evaluation of CytoSorb(R) when used
intra-operatively during cardiac surgery by one of the leading global
cardiac surgery companies. CytoSorb(R) has now been used safely, without
complications, intra-operatively in more than 300 cardiac surgeries
to-date in Germany and Austria
-- Hosting the 2nd International CytoSorb(R) Users Meeting in Berlin,
Germany on October 2, 2015, just before our major presence at the 28th
European Society of Intensive Care Medicine Congress in Berlin (ESICM,
Oct 3-7) and the 29th European Association for Cardio-Thoracic Surgery
Meeting in Amsterdam, Netherlands (EACTS, October 3-7). These events
represent great exposure for the Company and CytoSorb(R), and put us
directly in the mindshare of our current and future customers."
Dr. Chan continued, "In addition to our commercialization efforts abroad, we are heavily focused on bringing CytoSorb(R) to the U.S. market through two main paths.
-- Cardiac Surgery: We are seeking approval to use CytoSorb(R)
intra-operatively during complex cardiac surgery and extended
cardiopulmonary bypass. These open heart surgeries are very common and
can result in the production of large amounts of toxic plasma free
hemoglobin, cytokines, activated complement and other factors that can
lead to post-operative complications such as kidney and respiratory
failure.
-- The FDA has approved an amendment to our REFRESH (REduction in
FREe Hemoglobin) trial, to convert it into a 40-patient, 8-center,
randomized controlled feasibility study. In doing so, we have
consolidated the original 20 patient, single arm, 3 center study
together with the larger non-interventional study that we had
previously discussed. Led by our Chief Medical Officer, Dr. Robert
Bartlett, MD, we are in the final contract negotiation and
Institutional Review Board (IRB) approval stage at 8 major U.S.
heart centers and are on schedule to begin the study in
September.
-- We welcome Steven Sisk, Director of Clinical Operations, from
Medtronic, who will oversee the day-to-day operations of this
trial and our other U.S. trials. He replaces Dr. Greg Di Russo,
who stepped down for personal reasons.
-- Sepsis and Critical Care: Sepsis is the overzealous immune response to a
severe infection and a top ten cause of death worldwide for which there
is no effective therapy. We are preparing an Expedited Access Pathway
(EAP) application, and look to submit the application to the FDA in the
coming weeks to seek EAP Designation, similar to "Breakthrough
Designation" for drugs and biologics. The EAP pathway was developed by
the FDA to help expedite market approval of safe medical devices that
address major unmet medical needs. We believe that CytoSorb(R) is
well-suited for the EAP program."
AI
