Innovative Cardiovascular Solutions, a Kalamazoo, Mich.-based clinical stage company developing the Emblok™ Embolic Protection System, completed a Series C round of financing, raising a total of $8M. The company intends to use the funds to conduct clinical trials in the U.S. and Europe as well as manufacturing and operational activities. Led by R. Kevin Plemmons, co-founder and CEO, Innovative Cardiovascular Solutions provides the Emblok system, which is designed for use in Transcatheter Aortic Valve Replacement (TAVR) and other structural heart procedures where embolic protection is required. The Emblok system is an 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 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 – the embolic filter and pigtail catheter – to be deployed through a single femoral puncture site. Emblok is available for investigational use only and is not approved for sale. FinSMEs

Innovative Cardiovascular Solutions Raises $8M in Series C

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Innovative Cardiovascular Solutions closes $8m Series C
December 18, 2018
Innovative Cardiovascular Solutions said today that it closed an $8 million Series C round of financing to support clinical trials of its Emblok embolic protection system as well as manufacturing and operational activities. The Kalamazoo, Mich.-based company’s Emblok system is an embolic protection device designed for full circumferential aortic collection while protecting the cerebral, abdominal and peripheral vasculature from embolic debris. The system is designed for use in transcatheter aortic valve replacement and structural heart procedures and includes an integrated 4 French radiopaque pigtail catheter to provide constant visualization and eliminate the need for dye injections to confirm positioning, Innovative Cardiovascular Solutions said. “We are pleased with the continued support from our current investors as we advance the clinical evaluation of the Emblok system. Our team has made significant progress refining the system’s design and preparing for the U.S. pivotal trial. We are in discussions with the U.S. Food and Drug Administration to finalize the pivotal trial design and look forward to demonstrating the Emblok system’s clinical impact during structural heart procedures,” co-founder & CEO R. Plemmons said in a press release. KCI has launched its V.A.C.RX4 Therapy System in the U.S. for civilian healthcare professionals. The system was originally designed for the U.S. Air Force and the U.S. Department of Defense to help military personnel treat multiple wounds on the battlefield with a single negative pressure wound therapy device. “In trauma centers and burn units, physicians… […]
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Innovative Cardiovascular Solutions closes $8m Series C

Innovative Cardiovascular Solutions Raises $5.0 Million in Series B Financing for Advanced Device Development and Initiation of U.S. Clinical Activities
KALAMAZOO, Mich., July 11, 2017-- 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. Forward-Looking Statements
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. Contact:

Innovative Cardiovascular Solutions Raises $5.0 Million in Series B Financing for Advanced Device Development and Initiation of U.S. Clinical Activities

By FinSMEs
Innovative Cardiovascular Solutions (ICS), a Kalamazoo, MI-based clinical stage company, completed a $5M Series B funding. The proceeds will be used for device development and initiation of a 510(k) clinical study in the U.S. Led by R. Kevin Plemmons, co-founder and CEO, Innovative Cardiovascular Solutions 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. The EMBLOK system is an 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 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. FinSMEs

Innovative Cardiovascular Solutions Raises $5.0M in Series B Financing

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Innovative Cardiovascular Solutions raises $5m in oversubscribed Series B

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Innovative Cardiovascular Solutions is a privately-held clinical stage company. The company's Emblok Embolic Protection Catheter that has been designed to be utilized in Trans Aortic Valve Replacement (TAVR) procedures as well as several other left heart interventional procedures where embolic protection would be required.

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