CeloNova Announces Appointment of New President and CEO

Company positions itself for expected near-term commercial growth within coronary stent market treating high bleeding risk patients undergoing PCI

SAN ANTONIO, Texas, Aug. 6, 2019 /PRNewswire/ -- CeloNova BioSciences, Inc. (CeloNova), a global medical device company and manufacturer of the proprietary Polyzene^™-F nanocoating technology, currently used to surface coat its novel COBRA PzF NanoCoated Coronary Stent (NCS), today announced appointment of seasoned medical device executive Carl J. St. Bernard as President and Chief Executive Officer to support the company's expected near-term commercial growth.

St. Bernard joins the company from Tryton Medical where he held the role of President and CEO, leading the company's commercialization efforts in the highly competitive coronary stent market. St. Bernard also has an extensive track record growing businesses across a variety of fields including pharmaceuticals, consumer health products and diagnostic markets. St. Bernard's prior experience includes Vice President at Johnson & Johnson Vision (formerly Abbott Medical Optics), Vice President of North American Marketing & Sales for LifeCell and Vice President at Cordis where he led the commercial operations for the cardiovascular and endovascular businesses in the U.S.

Jason Cone, who successfully served as CeloNova's interim CEO for the past 2 years, will assume a position on the company's Board of Directors. Under his leadership the company accomplished key commercial milestones and reached over 25,000 patients treated worldwide.

"Carl's strong track record of commercial success and deep understanding of our customer's needs is a huge asset as we broaden clinical adoption of COBRA PzF NCS across practices treating high-risk patients unable to tolerate long-term DAPT," stated Mark Bates, MD, DSC, FACC, FSCAI, Director of the CAMC Cardiovascular Medicine Fellowship and Senior Scientist for Cardiovascular Research and Chairman of the Board at CeloNova. "We look forward to working with Carl to bring innovative cardiovascular treatments to patients around the world."

The appointment of St. Bernard precedes the highly anticipated conclusion of the company's COBRA REDUCE study, the world's first and only randomized global trial evaluating ultra-short, 14-day dual-antiplatelet therapy (DAPT) compared to market-leading drug-eluting stents with 3 or 6 months DAPT in patients at high risk of bleeding.^{§^}

Today, 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.^1,2 Low TLR and low ST with short DAPT has been consistently demonstrated across CeloNova's comprehensive clinical trial program.³

"PCI patients at high risk for bleeding complications have long been a challenge for the interventional cardiology community," stated St. Bernard. "COBRA PzF NCS is an innovative solution, unlike any other in the coronary stent market, that offers a safe and effective option for these patients. I look forward to leading CeloNova into its next phase of commercial growth."

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. The next generation nanocoating 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, please visit our website at www.celonova.com.

About COBRA PzF NCS

COBRA PzF NCS is the world's first non drug-eluting, nanocoated coronary stent designed to help physicians safely and effectively treat patients who may benefit from short, 1-month minimum dual antiplatelet therapy (DAPT).^1,2 DAPT has been shown to increase bleeding and mortality risks, which is of greater concern for non-compliant patients or those who are at increased risk of bleeding.⁴

The COBRA PzF NanoCoated Coronary Stent System is indicated for improving coronary luminal diameter in patients, including patients with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries. The COBRA PzF NanoCoated stent is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with reference vessel diameter (RVD) of 2.5-4.0mm and lesion length of ≤24mm. Click here for IMPORTANT SAFETY INFORMATION. Rx only.

+ AS DEMONSTRATED IN PRECLINICAL STUDIES. Correlation between bench testing, animal studies and humans have not been determined.
§For more information about the COBRA REDUCE IDE trial, please visit: clinicaltrials.gov/ct2/show/NCT02594501
^ DAPT + OAC

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. Généreux P, Giustino G, Witzenbichler B, et al. Incidence, Predictors, and Impact of Post-Discharge Bleeding After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2015;66:1036-45.

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SOURCE CeloNova BioSciences, Inc.