Healthcare Industry News: neuromodulation
News Release - December 17, 2009
Neurowave Medical Technologies LLC and Alaven(R) Pharmaceutical LLC Announce Licensing Agreement for Medical Device for the Treatment of Pregnancy Related Nausea and Vomiting (NVP)CHICAGO--(HSMN NewsFeed)--Neurowave Medical Technologies(TM) (“NMT”) and Alaven(R) Pharmaceutical (“Alaven”) have entered into an exclusive licensing agreement under which Alaven will commercialize NMT’s patented prescription neuromodulation pulse generator device for the treatment of pregnancy induced nausea and vomiting (“NVP”) in the United States.
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 commercialization of the technology platform for other clinical indications and also maintain responsibility for manufacturing and regulatory compliance.
neuromodulation is an important emerging category that represents an exciting therapeutic option for treating NVP. Alaven will market the device under the brand name “PrimaBella(TM)” with plans to launch the product in the fourth quarter of 2009. NMT’s CEO, Farhan Hussain, commented: “We are delighted to be working with Alaven to bring the PrimaBella(TM) 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.”
PrimaBella(TM) is the only product, either device or pharmaceutical, which has been cleared by the FDA for use in NVP. “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,” said Bala Venkataraman, CEO of Alaven. “PrimaBella(TM) complements our existing line of branded prenatal vitamins and other Women’s Health products. PrimaBella(TM) 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.”
About the Market:
In the United States, there are more than 6.3 million pregnancies per annum and NVP, or “morning sickness,” affects up to 80% of pregnant mothers. The effects of morning sickness are debilitating and have significant negative clinical, social and physiological impact on pregnant mothers. Currently, no medications are approved by the FDA for treatment of NVP. As such, there is a significant need for a safe and cost-effective treatment of NVP. PrimaBella(TM) will be positioned as a first line therapy alongside standard dietary and lifestyle modification recommendations.
PrimaBella(TM) is the only product, either device or pharmaceutical, which has been cleared by the FDA for use in NVP.
PrimaBella(TM) is a sophisticated neuromodulation pulse generator developed from a patented technology that utilizes NMT’s Nerve Stimulation Therapy(TM). 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(TM) 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.
Alaven Pharmaceutical is a privately held specialty pharmaceutical company located in Marietta, Georgia. We develop and market prescription and non-prescription products that treat women’s health and gastroenterological conditions. At Alaven, our mission is to build a world-class specialty pharmaceutical company by developing and marketing products of the highest quality.
Neurowave Medical Technologies(TM) (NMT) is a rapidly growing, privately held Chicago-based medical device company that develops and manufactures non-invasive neuromodulation devices for the treatment of a wide range of acute and chronic clinical conditions. Using its patented proprietary Nerve Stimulation Therapy(TM) technology platform, NMT’s mission is to offer non drug alternatives that are on par with the efficacy of “gold standard” pharmaceuticals, but superior in terms of cost-effectiveness, safety profile, and ease of use. NMT commercializes products via out–licensing and distribution to various marketing partners worldwide.
Source: Alaven Pharmaceutical
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