KALAMAZOO, Michigan, July 11, 2017 /PRNewswire/ -- Innovative Cardiovascular Solutions, LLC (ICS), a privately-held clinical stage company headquartered in Kalamazoo, MI, announced today completion of an oversubscribed Series B round of financing totaling $5M USD. The company is currently developing the EMBLOK™ Embolic Protection System which is designed for use in Transcatheter Aortic Valve Replacement (TAVR) and other structural heart procedures where embolic protection is required. Proceeds will be used for device development and initiation of a 510(k) clinical study in the U.S.
"ICS has made tremendous progress in the past 12 months with the initiation of human clinical cases in Milan, Italy. At the halfway mark of study enrollment, initial results look promising," said R. Kevin Plemmons, ICS's co-founder and CEO. "We are pleased by the strong vote of confidence from our investors supporting the pursuit of this innovative and comprehensive approach to embolic protection."
"The EMBLOK system is intuitive and easy to use," said Dr. Azeem Latib, San Raffaele Hospital in Milan, Italy. "It is the only system to provide full capture and protection from embolic material released during TAVR and has become a necessary addition in my left heart interventions."
The EMBLOK system is the world's first and only embolic protection device designed to offer complete circumferential aortic collection while protecting the cerebral, abdominal and peripheral vasculature from liberated embolic debris. In addition, the EMBLOK system features an integrated 4 Fr radiopaque pigtail catheter which provides the physician constant visualization, while eliminating the need for unnecessary dye injections to verify positioning. The entire system is 11 Fr and allows two devices (i.e., embolic filter and pigtail catheter) to be deployed through a single femoral puncture site.
About Innovative Cardiovascular Solutions (ICS)
ICS strives to develop novel solutions that offer full capture and protection from embolic material released during left-sided heart procedures. With the first product, the EMBLOK Embolic Protection System, the goal is to improve patient quality of life and lower overall healthcare costs that are associated with embolic risks.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities in this offering. There will not be any sale of these securities in any state or jurisdiction in which such offering, sale or solicitation would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
This press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. Information in this press release, which is not historical, is forward-looking and involves a number of risks and uncertainties. Investors are cautioned not to put any undue reliance on any forward-looking statement. ICS's actual results may differ materially from ICS's historical results of operations and those discussed in the forward-looking statements for various reasons, including, but not limited to ICS's ability to carry out its business plan, successful development and commercial acceptance of its products, ability to fund development necessary for its products and for the pursuit of new product opportunities, ability to hire required personnel, the risk of whether products result from development activities, protection of ICS's intellectual property portfolio, the risk associated with obtaining the necessary regulatory approvals, the ability to obtain foreign regulatory approvals for products and to establish marketing arrangements in countries where approval is obtained, and other potential factors.
R. Kevin Plemmons
SOURCE Innovative Cardiovascular Solutions, LLC