Proximo Medical, LLC, a fractional commercial organization for start-up medical device technologies and established medical device companies looking to expand adoption in the U.S., announced a partnership in select U.S. markets with CeloNova Biosciences, Inc., a global medical device company that offers innovative products based upon its proprietary Polyzene-F NanoCoating technology such as the novel COBRA PzF NanoCoated Coronary Stent (NCS).
COBRA PzF NCS allows physicians to safely and effectively treat patients who may benefit from short, 1-month DAPT. In the PzF SHIELD IDE trial, COBRA PzF NCS with 1-month DAPT demonstrated 0% stent thrombosis, 4.6% total lesion revascularization at 9 month follow up. Low TLR and low ST with short DAPT is consistently demonstrated across CeloNova’s comprehensive clinical trial program.
“High bleeding risk patients who cannot tolerate prolonged dual antiplatelet therapy (DAPT) have traditionally received bare metal stents followed by 1-month DAPT despite a higher restenosis risk compared to drug eluting stents. However, an increasing number of physicians are turning to COBRA PzF NCS due to its proven low restenosis and low stent thrombosis rates with a minimum of 1-month DAPT,” states Aloke Finn, MD, Medical Director and Chief of Research, CVPath Institute Inc. and Associate Professor of Medicine at the University of Maryland. “Additionally, COBRA PzF NCS’ powerful thrombo-resistant effects and significantly faster, higher quality healing compared to market-leading DES as seen in preclinical studies, further suggests that it is a suitable treatment option for patients requiring short DAPT.”
“COBRA PzF is a new class of coronary stent that provides superior patient safety for high-bleeding risk PCI patients without sacrificing the anti-restonotic effect of contemporary DES. The ability to reliably minimize DAPT regimens for these challenging patients from months down to weeks of therapy is priority in cath labs all over the world. COBRA PzF can deliver this critical level of safety without sacrificing stent performance,” states Carl St. Bernard, CEO, CeloNova Biosciences. “By partnering with Proximo Medical, CeloNova can leverage their tremendous expertise, experience, and scale to accelerate the overall market impact of breakthrough technologies like the COBRA PzF NanoCoated coronary stent.”
“The life saving potential of CeloNova’s COBRA PzF NCS is unprecedented, especially among patients with a high risk of bleeding. Partnering with medical device innovators who so clearly advance the current standard of care is a win for both physicians and their patients,” states Brett Martin, CEO, Proximo Medical. “We are pleased to be partnering with CeloNova, a company that is revolutionizing medicine and rethinking the bounds of improve patient care.”