During the third quarter and first nine months of 2012, Cytori Therapeutics (NASDAQ: CYTX) advanced its cardiac cell therapy pipeline and achieved important strategic commercial and regulatory milestones. Additionally, Cytori reaffirmed its $9 million revenue guidance for the year. The Company accomplished the following objectives since the end of the second quarter:
- Awarded a U.S. Government contract with the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the Department of Health and Human Services. The contract is valued at up to $106 million and will be used to develop Cytori’s cell therapy for the treatment of thermal burns combined with radiation injury. Contract activities are currently underway including the initiation of key proof of concept studies in addition to accelerating development of the next generation Celution® system.
- Initiated enrollment in ATHENA, the U.S. clinical trial of Cytori’s cell therapy for refractory heart failure; the trial is on track to fully enroll by mid-2013.
- Resumed enrollment in ADVANCE, a European acute myocardial infarction trial; primary emphasis of the trial continues to be completion of country and site clearances.
Operations & Financial Performance
- Expanded Japanese market access in the third quarter by obtaining a full commercial operational license for Cytori Therapeutics K.K. and Class 1 medical device clearance for the Celution® and Puregraft® based technologies. In combination, these resulted in the highest gross quarterly product shipments to date.
- Expanded Celution® CE Mark certification to include indications-for-use in wound healing and tissue ischemia.
- Reduced net cash used in operating activities in the first nine months of 2012 compared to the first nine months of 2011, driven by reductions in sales, general and administrative expenses.
“This quarter we made significant progress on both the clinical and commercial fronts which will help drive our growth in 2013 and beyond,” said Christopher J. Calhoun, chief executive officer for Cytori Therapeutics. “Throughout the rest of the year and into 2013, we will look to continue to expand enrollment in our ongoing clinical trials, achieve additional strategic partnerships and secure more approvals that drive revenue growth.”