NH001 promotes consciousness and improves the functional outcome in patients in a post-traumatic coma, vegetative state or minimally conscious state. The faster the patient recovers consciousness, the better the chances for recovery of functionality.

As a result of trauma, portions of the brain die. During the recovery process, the remaining functional structures of the brain reorganize and take control of functions formerly controlled by the now dead structures. This natural healing is mediated by a process that is referred to as neural plasticity. NH001 aims to provide the right conditions in order to accelerate the neural plasticity process.

NeuroHealing has designed two clinical trials to study the safety and efficacy of NH001 in accelerating the recovery and improving the functional outcome of post TBI vegetative state and minimally conscious state patients. The first clinical trial, a pilot open-label study, treated patients at two clinical sites with dramatic responses. NeuroHealing initiated a Phase II, 76-patient, double blind, placebo controlled trial (http://clinicaltrials.gov/ct2/show/NCT00761228). NH001 targets a US market of $0.5 – 1 billion in peak revenues.

NeuroHealing is developing a novel treatment for sialorrhea (drooling or un-controlled salivation), a major non-motor complaint of Parkinson’s Disease patients and often described as the major debilitating social problem in many neurological conditions including Cerebral Palsy, ALS, TBI and stroke. Current treatments, which include surgery, Botox injections and oral anticholinergic drugs, are unsatisfactory. NeuroHealing’s approach is based on a novel formulation of a safer anticholinergic compound that down-regulates salivary glands. NH004 has shown activity in a clinical study. It has a favorable safety profile, a rapid onset and duration of action best to manage the problem, and a convenient product form for use on an “as needed” basis for sialorrhea control.

Premature ejaculation (PE) is the most prevalent male sexual disorder affecting 20-30% of sexually active men and is even more prevalent than erectile dysfunction. Currently, there are no clinically proven products available for the treatment of PE in the United States or Europe. NH02D is an orally administered drug that is being developed for on-demand treatment of premature ejaculation (PE). As reported during human studies for another indication and subsequently confirmed in pre-clinical models, NH02D increases the time to ejaculation in males with rapid or early ejaculation. NeuroHealing is currently establishing a pilot study to confirm human activity and then advance clinical development under a 505(b)2 strategy, resulting in an accelerated timeline.

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