CorInnova, Inc.

JLABS @ TMC

2450 Holcombe Blvd. Suite J

Houston, Texas 77021

Phone: (346) 772-0345

Email: info@corinnova.com

© 2018 CorInnova. All Rights Reserved.

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Preclinical Results

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Bench testing and acute/chronic animals studies have been implemented to support the first-in-human study.​ Large animal studies in an ovine acute cardiogenic shock model and in a chronic heart failure model demonstrate that the CorInnova device:

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1. be implanted minimally invasively through a sub-xiphoid incision in a sheep (equivalent to a mini-thoracotomy [through left ribcage] in human by being deployed through a tube approximately 1-inch in diameter)

Minimally invasive delivery using the deployment tube.

As the inner passive component bladder is filled with saline via a subcutaneous injection port it conforms to the shape of the heart.

2. Stays on the heart via intrinsic pneumatic attachment and does not need to be sutured to the heart or aorta​

3. Exhibits non-obligatory operation (when not being operated, does not significantly inhibit heart function)

Pressure-volume loops of left ventricle before and after device deployment.  Stroke work and cardiac output were not significantly affected.  Therefore, user should be able to turn device on and off safely.  LVAD operation is obligatory, lest thrombosis and stroke follow re-starting device.

4. Increases the heart's stroke work by as much as 100% (stroke work = stroke volume multipled by mean aortic pressure)

Improved stroke work from assist is evident in the increase in area of PV loops of left ventricle of sheep.

5. Increases cardiac output up to 50% or more

Comparison of the healthy, esmolol failure, and assisted failure cases in sheep (ovine) model of cardiogenic shock. Note the 100% increase in stroke work (SW, right) and 50% increase in cardiac output (CO, left) when active assist of 20 mmHg is applied (Note that Esmolol failure model reduces blood pressure significantly, so doubling of SW is not accompanied by doubling of CO, as pressure increases as well as output to increase SW). 

6.  Improves diastolic function by enhancing filling by increasing end diastolic volume and increasing total stroke volume

7.  Maintains natural curvature of the heart while operating, promoting normal heart motion

Minimally invasive delivery using the deployment tube.

As the inner passive component bladder is filled with saline via a subcutaneous injection port it conforms to the shape of the heart.

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