Recap of 2015 so far
ping_pow_princess
2015 (as of 5/14/2015)
Q1 2015
* Presentation at OneMedForum, Jan 12-13
* Exhibited at the 44th Society of Critical Care Medicine Congress, Jan 17-21
* ABC Pharma Services and Biocon, “Extracorporeal Therapies in Sepsis” meeting, Sri Lanka, Feb 15
* German Society for Thoracic and Cardiovascular Surgery, Feb 8-11
* Symposium of Intensive Medicine and Intensive Care in Bremen, Germany, Feb 18-20
* Received $385,000 from the New Jersey Technology Business Tax Certificate Transfer Program
* CytoSorb Symposium at the St.Anton, Rostock, Germany, Jan 24-30
* Signed on Italian Distributor, Aferetica SRL, Jan 30
* Upgraded direct sales force, distributor support infrastructure, and customer service in Germany to help convert the considerable, positive physician awareness that is growing around the world into new CytoSorb usage and sales
* FDA approves IDE to run REFRESH study in the US, 20 patient pilot study using CytoSorb intra-operatively during cardiac surgery
* On-line International CytoSorb Registry in English and German, developed in accordance with FDA and ICH guidelines; anticipated that as many as 1,000 patients may be included by the end of 2015
* Research symposia and Users Meeting at ISICEM, Brussels, March 17-20
* Cytosorb available in 29 countries worldwide; withdrew registration process in Taiwan due to complexity
* 40+ investigator initiated studies, looking at a broad set of clinical applications that include sepsis, cardiac surgery, trauma, liver failure, and others, that have either started, or are being planned
* Working with 150+ KOLs in Germany, Austria and Switzerland; 300+ KOLs worldwide
* Used in 50+ hospitals in Germany; 200+ hospitals worldwide
* Dr Chan featured in NJ TechNews magazine
* Product sales of $704,000
* $9.4 million net proceeds of registered common stock offering
* $13.4 million cash and short term investments
Q2 2015
* Presentation at 14th Annual Needham Healthcare Conference, Apr 14-15
* Shareholder letter, Apr 24
* Appointed Dr Joerg Scheier as European Medical Director, Apr 27
* CytoSorb featured on the German NDR news show, Apr 28
* CytoSorb registered in France, Australia, New Zealand, Saudi Arabia (registered but waiting for Saudi FDA approval), working on Canada registration, final stages with Russia (expected by Q1 2016), and multiple registrations in process in other countries
* Fresenius working to complete start-up activties and training to launch CytoSorb for their terrorities: France, Poland, Sweden, Denmark, Norway, and Finland
* Bicon targeting total of 15 dedicated sales & marketing staff and a medical director for CytoSorb sales
* Biocon in planning stages for 4 investigator initiated studies
* Biocon to expand into Sri Lanka
* CytoSorb available in 29 countries worldwide, additional 5 countries in progress
* Data analysis of the Germany dosing study
* Considering one of two facilities for manufacturing expansion
* 50+ investigator initiated studies, looking at a broad set of clinical applications that include sepsis, cardiac surgery, trauma, liver failure, and others, that have either started, or are being planned
* Sharholder meeting, New York, June 2
------------------------------
Q3 2015
* Start of REFRESH cardiac surgery pilot study (CytoSorb treatment and non-intervential); expected length of study: 3-6 months
* Rodman & Renshaw Conference, Sept 8-10
* 7th Weimar Sepsis Congress of the German Sepsis Society (DSG) in Weimar, Sept 9-11
* World Sepsis Day, Sept 13
* HAI 2015 Conference, Sept 17 (four presentations about CytoSorb)
Q4 2015
* 2nd International CytoSorb User Meeting, Berlin, Oct 2
* ESICM Conference, Berlin, Oct 3-7
* Sepsis Congress, "Adjuvant Therapy in Severe Sepsis and Septic Shock- Unilastatin , Cytosorb, Pentaglobulin – Current Status", New Delhi, Nov 27-28
* Exhibitor at DIVI conference, Germany Dec 4
In progress
* Aggressively pursuing EAP designation for CytoSorb for critical illnesses
* A potential cardiac partner performing a market evaluation of CytoSorb in France, approx. 10-12 patients
* Targeting 2 more strategic partners to help broaden the reach of CytoSorb both in the European Union as well as outside the European Union in 2015
* Seeking partner to help fund/commercialize Hemodefend platform
* Planning additional sepsis studies in the US and Europe
* 32 issued US patents with multiple applications pending
* New product development (Have four/five different products under development not yet disclosed)
* Product registration and reimbursements in key markets - ongoing
* Results of Germany dosing study
* Biocon to create patient registry
* Start of European Pivotal Sepsis Trial
* US Air Force funded 30 patient human pilot study in trauma (2013) on-going
* DARPA awarded 3.8 million for 5 year contract "Diaylsis-Like Theapeutics" program (2012) on-going
* NIH/NHLBI $203,351 Phase I SBIR grant to advance HemoDefend intended to improve quality and safety of blood transfusion (2013) on-going
* CytoSorbents and University of Pennsylvania Vet School collaborate to expand CytoSorb research in cancer immunotherapy (2014) on-going
