Name of Company: NexGen Medical Systems Inc.
Industry: Medical devices (surgery)
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Location: Reno, Nevada, and Melbourne, Florida
Solution/Product: The company’s current focus is commercializing a catheter-based product line for removal of blood clots in vessels in the head and neck of patients with deep vein thrombosis and stroke. The drug warfarin, which is often given to DVT patients, can cause blood clots to fragment and migrate to the lungs, heart or brain, CEO John Kucharczyk said. NexGen’s thrombectomy product line, used under X-ray guidance, is intended to encapsulate the blood clot and remove it without the use of any drugs.
The company also thinks its device can overcome a major hurdle in the treatment of stroke by extending the window of time after onset that it can be treated. Kucharczyk said NexGen’s device could be used 10 to 15 hours after the onset of stroke, whereas the clot-busting drug tPA is recommended for use up to only 3 hours after onset.
Money Raised: Kucharczyk said the company is in the process of raising a series B round with a target of $10 million. Combined with a series A in 2008, NexGen has a total of about $7.2 million in equity capital, he said. It’s also received more than $480,000 in grants from the State of Nevada.
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How will it be used: The company’s next big milestone is starting patient registries at the University of Washington in Seattle and St. Joseph Hospital in Irvine, California, where the X-COIL system will be used to remove blood clots in patients with DVT, Kucharczyk said. Then the company will proceed with a conventional sales and marketing plan for its system.
Investors: unknown; LifeTech Developments Fund was a Series A investor
Management team: Kucharczyk was formerly CSO at CytoGenesis Inc. and director of neuroradiology research at the University of California, San Francisco. He also fo-founded Image-Guided Neurologics, which Medtronic acquired in 2005.
Market size: NexGen started with a focus in stroke but decided that the regulatory hurdles were too expensive and complicated, so the company turned its focus to DVT – which affects 300,000 to 600,000 Americans each year – for an initial launch. The U.S. clot management device market generated $570 million in sales in 2010, according to Millennium Research Group.
Competitors: Penumbra, Concentric Medical (Stryker), Possis Medical (Bayer AG). Kucharczyk emphasized that NexGen’s device does not require the use of an accompanying thrombolytic drug and effectively removes not only soft clots but also hard clots.
[Photo from NexGen Medical]