For neuromodulation pulse generator device used in the treatment of pregnancy related nausea and vomiting

Neurowave Medical Technologies (NMT) and Alaven Pharmaceutical (Alaven) have entered into a licensing agreement. As per the deal, Alaven will commercialise NMT’s patented prescription neuromodulation pulse generator device for the treatment of pregnancy induced nausea and vomiting (NVP) in the US.

The company said that the device will be sold through prescription distribution channels and promoted to OB/GYN physicians by Alaven’s professional sales force. NMT will retain worldwide rights for the commercialisation of the technology platform for other clinical indications, and also maintain responsibility for manufacturing and regulatory compliance.

According to the agreement, Alaven will market the device under the brand name ‘PrimaBella’, with plans to launch the product in the fourth quarter of 2009.

The company claims that PrimaBella is the only product which has been cleared by the FDA for use in NVP. PrimaBella is a sophisticated neuromodulation pulse generator developed from a patented technology that utilises NMT’s nerve stimulation therapy. The device is worn on the underside of the wrist and emits a proprietary programmed intermittent gentle impulse that stimulates the median nerve.

These impulses act to positively modulate the nerves that control feedback to the higher emetic center in the brain and by restoring the stomach’s gastric rhythms back to their normal cycle, via the vagus nerve. Unlike medications, PrimaBella has no drug-like side effects or drug-drug interactions and is fully controllable by the patient such that it can be used before or after symptoms arise.

Farhan Hussain, CEO of NMT, said: “We are delighted to be working with Alaven to bring the PrimaBella anti-emetic device to market and address the very prevalent unmet need for treating NVP. This transaction is key to NMT’s strategy of becoming a recognized global leader in developing therapeutic neuromodulation medical devices for clinical indications that have traditionally required treatment by pharmaceuticals.”

Bala Venkataraman, CEO of Alaven, said: “Alaven is perfectly suited to bring this ground-breaking product to the market and we are very pleased to be working with NMT to market this revolutionary new device. PrimaBella complements our existing line of branded prenatal vitamins and other Women’s Health products.

“It allows us to further serve the needs of pregnant women as it offers physicians an innovative clinically proven, FDA cleared, non-drug therapy for the treatment of morning sickness that avoids drug induced side effects for both mother and baby.”