|Angel Medical Systems' Guardian System heart monitor--courtesy of Angel Medical Systems|
Angel Medical Systems' Guardian System heart monitor is actively being sold in Europe and Brazil. But $27.5 million in new financing will help the company reach the long-awaited regulatory finish line in the U.S.
The Shrewsbury, NJ, company says the new money will help it complete a U.S. pivotal trial involving 660 patients. Assuming all goes well and the trial meets all of the required endpoints, expect a PMA submission in 2013.
Angel's regulatory pathway reflects a broader strategy increasingly used by smaller medical device companies to seek regulatory approval and commercial sales outside of the U.S. first. They often turn to Europe, South America or elsewhere, because they can gain approval with shorter time and expense. That data gathered from international use often informs subsequent U.S. trials, or an eventual U.S. regulatory submission.
In Angel Medical's case, the company's Guardian monitor is already CE marked in Europe, and doctors are actively implanting the device in Germany and selling it in Europe and Brazil. (Interestingly, St. Jude Medical ($STJ) licensed some of the technology for its own implantable cardioverter defibrillators, which are available in Europe and being tested in the United States.) The device is designed to give "continuous intracardiac ischemia monitoring" and alerts, and comes in both implantable and external versions, according to its website.
The new funding, termed "aggregate financing," will help support continued commercialization of the product in Europe and Brazil, and also work on a next-generation ischemia monitoring device.
Angel's investment round drew new investor SOAM Angel Partners, plus existing, venture capital, strategic partner and angel investors, according to the company.
- read the release
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