January 7, 2020

Proximo Medical Named Commercialization Partner for CeloNova BioSciences in Select United States Markets

January 8, 2020—Proximo Medical, LLC, announced a partnership in select United States markets with CeloNova Biosciences, Inc.

Proximo Medical is a fractional commercial organization for start-up medical device technologies and established medical device companies looking to expand adoption in the United States.

CeloNova, a global medical device company, offers products based on its Polyzene-F (PzF) nanocoating technology, including the Cobra PzF nanocoated coronary stent (NCS) that is specifically designed to treat percutaneous coronary intervention patients at high risk for bleeding complications. CeloNova stated that it seeks to leverage Proximo’s expertise, experience, and scale to accelerate the overall market impact of the CeloNova product portfolio.

According to the press release, the Cobra PzF NCS allows physicians to safely and effectively treat patients who may benefit from short (1 month) dual antiplatelet therapy (DAPT). In the PzF SHIELD investigational device exemption trial, Cobra PzF NCS with 1-month DAPT demonstrated 0% stent thrombosis and 4.6% total lesion revascularization at 9-month follow-up. Low total lesion revascularization and low stent thrombosis with short DAPT is consistently demonstrated across CeloNova’s comprehensive clinical trial program.

Aloke Finn, MD, Medical Director and Chief of Research at the CVPath Institute Inc. in Gaithersburg, Maryland, commented in the announcement, “High bleeding-risk patients who cannot tolerate prolonged 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.”

Dr. Finn, who is also Associate Professor of Medicine at the University of Maryland in Baltimore, Maryland, continued, “Additionally, Cobra PzF NCS’s powerful thromboresistant effects and significantly faster, higher quality healing compared to market-leading drug-eluting stents as seen in preclinical studies, further suggests that it is a suitable treatment option for patients requiring short DAPT.”


January 9, 2020

JenaValve Pericardial TAVR System Receives FDA Breakthrough Device Designation

January 7, 2020

EACTS Seeks to Collaborate With EXCEL Investigators to Resolve Trial Data Concerns