Proximo Medical Named Commercialization Partner for CeloNova BioSciences, Inc. in Select U.S. Markets

CeloNova BioSciences’ COBRA PzF NCS is world’s first and only non drug-eluting, nanocoated coronary stent; specifically designed to treat PCI patients at high risk for bleeding complications

 

CASTLE PINES, COLO. (Jan. 13, 2020)   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.1, 2 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.3

 

“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 studies4, 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 improved patient care.”

 

About Proximo Medical
Proximo Medical, LLC is a business acceleration solution that effectively and efficiently overcomes medical device commercialization challenges by providing start-ups and international medical device companies entering the U.S. market with market analysis, economic insights and a world-class national sales team. We help bring innovative solutions to market, providing patients the best care in a cost-effective model.  Proximo Medical also provides insights to venture capital and private equity groups on medical device technology. Visit ProximoMedical.com

 

About CeloNova Biosciences, Inc. 
CeloNova BioSciences, Inc., is a global medical device company that develops, manufactures and markets a family of products based upon its novel Polyzene-F nanocoating technology. This next generation nano- thin surface coating is the result of years of rigorous scientific research and engineering and has been extensively published in numerous academic articles to date. For additional information about CeloNova, visit www.celonova.com.

 

1.       Cutlip D, Garrat K, Novack V, et al. 9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System. JACC Cardiovasc Interv. 2017;10(2):160-167.

2.       Levine G, et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients with Coronary Artery Disease. Circulation. 2016;134(10): e123-55.

3.       ATLANTA FIM (n=55) TLR 3.6%, LST 0%; ATLANTA 2 Registry (n=300) TLR 6.5%, LST 0%; REVEAL OCT (n=34) Strut Coverage: PzF-97%, DES-90%, BMS-96%; ATLANTA FME Registry (n=500) TLR 4.3%, LST 0%; MAILLARD IIT (n=100) TLR 5%, ST 0%; UMEÅ IIT (n=103) TLR 3.9%, ST 0%

4.       Jinnouchi H Mori H, et al. Thromboresistance and Functional Healing in the COBRA PzF Stent versus Competitor DES: Implications for Dual Anti-Platelet Therapy.EuroIntervention. 2018; Jaa-468 2018.