BioControl's CEO announcement
Jun. 29, 2016
During the last six month we have been through a process of analyzing the INOVATE-HF data following study closure on Dec 15, 2015. During this process we have identified a subgroup of patients that seem to benefit from the therapy. However, the INOVATE-HF trial was not designed to demonstrate benefits in parts of the population; and additional studies will be required to confirm these possibilities.
At the ACC 2016 meeting we had presented the overall results of INOVATE-HF at the late-breaking clinical trials session, as well as the subgroup analysis at the deep-dive session. In parallel we started a dialogue with the FDA to identify the optimal way to move forward with assessing the efficacy of the CardioFit therapy in that subgroup of patients and proceed toward its approval.
However, during that process, which originated with the unexpected negative DSMB recommendation, we have run out of funds, and are not able to continue operations. Biocontrol is therefore shutting down today. Starting July 1’st, there will be no employees in the company, and all facilities will be closed.
We are still available at email@example.com for any inquiries, while we are in the process of debt settlements and orderly shutdown.
We do hope vagal stimulation will find its right place among heart failure therapies, as we have seen many patients that benefit considerably from this treatment.
During the years in BioControl I had the pleasure and honor to team with hundreds of clinicians, patients, consultants, funding partners and employees – I wish to thank you all for your contribution to the development of neuromodulation in Heart Failure, and do hope to team up again in the future.