Move toward decentralized trials means sponsors may be working with naïve clinical investigators who lack experience, Greenleaf’s Cynthia Schnedar says; DoJ’s Gustav Eyler urges drug sponsors to look for oddities in clinical trial data and to voluntarily report potential misconduct.

Synchron has high hopes that after successfully implanting the first minimally invasive neural brain-computer interface device in a human, it will eventually be able to give a "voice" to patients, including paralyzed individuals, who are unable to communicate. The company is conducting clinical trials and is hoping to use the data to apply for US FDA approval of the Stentrode device.

In this month's issue of Start-Up, we profile 4Tech, Advanced Cooling Therapy, Enumeral Biomedical Holdings, MiNDERA, PeptiMimesis and Synchron.

Synchron Inc. is developing what it believes is the first minimally invasive implantable brain device that could help paralyzed patients: its neural interface, Stentrode, consists of an electrode array built onto a self-expanding stent that is implanted in a cerebral blood vessel. Once the stent is implanted, the array is designed to record local neuronal activity, then translate that activity into a signal that could be used to manipulate mobility-assist devices and return movement to the paralyzed user.