Medical Ingenuities Receives FDA 510(k) Clearance for PH Band

HOLLAND, Mich., Dec. 9, 2020 /PRNewswire/ -- Genesis Innovation Group's cultivate(MD) Capital Fund II LP, a fund focused on investments into early stage healthcare companies with innovative technologies, announces that one of their portfolio companies, Wheaton, IL-based Medical Ingenuities, a medical device company that has developed a novel radial artery occlusion device, PH Band, has received its 510(k) clearance from the US Food and Drug Administration.

There are approximately 6 million Cardiac Catheterization procedures performed annually in the United States, with more than half of those done via the radial artery. There has been a persistent complication of Radial Artery Occlusion (RAO) of ~10% over the last 15 years worldwide, driving the need to achieve rapid and patent hemostasis at radial closure, to help prevent RAOs.

PH Band's innovative design sets it apart from competitors in its ability to provide real time feedback to medical personnel monitoring radial artery patency to prevent radial artery occlusion.  The first-of-its-kind device is designed to be used in conjunction with a micro Doppler Probe to achieve patent hemostasis after a minimally invasive cardiac or vascular procedure and it aids in reducing nurse workload and occlusion-related complications. 

This innovation meets the key recommendations of the Society for Cardiovascular Angiography and Interventions (SCAI) that: "Patent Hemostasis techniques be used for Radial Closure."  Paul  J. Grunenwald, M.D., Chairman of Cardiology at AMITA Alexian Brothers Medical Center in Elk Grove, Illinois explained, "The paradigm shift from default femoral access to radial access over the last decade has truly been a win-win in terms of both improved safety outcomes and patient comfort. However, as with many steps forward, there is a small price to be paid, and radial access is no exception. The not so uncommon complication of radial artery occlusion is probably best mitigated by a combination of pharmacotherapy and patent hemostasis. The PH Band is uniquely poised to deliver on all fronts with the potential to methodically reduce occlusion rates; reduce bleeding, eliminate variability, and minimize valuable nursing resources." The PH Band system provides real time audible and visual feedback to clinicians, to assist them in achieving patent hemostasis.  This feedback will confirm the proper application of pressure to attain hemostasis, while ensuring the patency of the radial artery.

Chip Corrigan, Founder and CEO of Medical Ingenuities, stated, "Worldwide, interventional cardiologists have been looking for a quick and simple way to achieve patent hemostasis in an effort to reduce complication rates and standardize patient recovery after accessing the radial artery.  The PH Band will provide the interventional cardiologist new and vital information to properly complete a more effective radial artery closure. This outcome will, in turn, support their goal to reduce overall complications and healthcare costs and in turn increase patient satisfaction."

Don Running, Managing Director and Vice President of Research & Development for Genesis Innovation Group said, "We at cultivate(MD) are thrilled that Medical Ingenuities has received their recent FDA clearance.  From the beginning, we have been excited about the technology contained within the PH Band to quickly and efficiently confirm patent hemostasis and this news validates our initial thoughts.  We look forward to continuing to support the team in commercializing this product and clinically documenting its efficacy with significant key interventional cardiology centers around the country."

The PH Band's ability to ensure Patent Hemostasis has the potential to become the standard of care in radial closure. The company will begin marketing the PH Band in early January to some prominent hospitals across the country.

About cultivate(MD) Capital Funds

As a medical device venture capital fund, cultivate(MD) is dedicated to bringing emerging health care innovations to market, with a special focus on medical device and orthopedic technologies. cultivate(MD) is focused on investing in early stage healthcare companies with innovative technologies that have demonstrated evidence of effectiveness.

This press release does not constitute an offer to sell or solicitation of an offer to buy any securities in any offering of securities. There will not be any sale of any 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.

For more information, visit: https://genesisinnovationgroup.com/

SOURCE cultivate(MD)

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