CeloNova BioSciences Announces Financing Arrangement With Two Entities

CeloNova BioSciences Inc. (CeloNova), a medical device firm that develops, manufactures, and markets a family of cardiovascular products based upon its Polyzene-F nanocoating technology, has completed a four-year joint financing arrangement with Congruent Investment Partners and SWK Holdings Corporation. The proceeds of this transaction will provide growth capital for CeloNova to continue its trajectory in new product initiatives and focus on enrollment in its ongoing clinical trials.
 
Earlier this year, CeloNova initiated the U.S. commercial launch of its first-in-class COBRA PzF NanoCoated Coronary Stent (NCS). Approved by the U.S. Food and Drug Administration (FDA) to treat patients with symptomatic ischemic heart disease, including those with diabetes mellitus, the COBRA PzF NCS requires a minimum one-month dual antiplatelet therapy (DAPT) regimen following intervention.¹
 
“We are pleased to partner with CeloNova. CeloNova has proven to be an innovator in developing high quality biocompatible products using its proprietary Polyzene-F nano-thin polymer,” said Travis Baldwin, co-founder of Congruent. “We are confident that CeloNova is well positioned to gain market share within the interventional cardiology industry.”
 
“We are impressed with the quality and depth of CeloNova’s management team and its latest innovative product,” said Winston Black, CEO of SWK. “The COBRA PzF NCS is an important addition to the interventional cardiology marketplace and should provide physicians a clear choice for treating patients with coronary artery disease.”
 
The COBRA PzF NCS combines a highly deliverable cobalt chromium platform design with a proprietary Polyzene-F nano-thin polymer. Polyzene-F nanocoating is designed to be durable, elastic and biocompatible, acting as a barrier between metal, blood and circulating elements. The ultra-pure, nano-thin characteristics of Polyzene-F have shown thrombo-resistance, reduced inflammation and rapid and complete strut coverage when tested in pre-clinical studies.^{2 3 4 5 6 7}
 
“Following FDA approval of the COBRA PzF NCS in February 2017, we are continuing to move forward with our national commercialization efforts. This financial agreement provides us with the necessary capital to bolster our overall growth and expansion in the U.S. marketplace,” said Jason Cone, CEO of CeloNova. “It’s an exciting time for CeloNova and we thank both Congruent Investment Partners and SWK Holdings for their steadfast support.”
 
CeloNova is continuing to study the COBRA PzF NCS in the COBRA REDUCE trial, which began enrollment in February 2016. The trial will evaluate whether the stent can help reduce bleeding as compared to drug-eluting stents, by shortening the duration of DAPT to 14 days in patients who are at high-risk for bleeding and require treatment for coronary artery disease.
 
The COBRA PzF NCS was awarded FDA approval in 2017 and CE Mark approval in 2012.
 
The COBRA PzF NanoCoated Coronary Stent combines a unique highly deliverable cobalt chromium platform with a Polyzene-F nano-thin polymer. Polyzene-F nanocoating is a proprietary, ultra-thin polymer that is designed to be durable, elastic and biocompatible, acting as a barrier between metal, blood and circulating elements. The COBRA PzF NanoCoated Coronary Stent is approved for use in the United States, Europe and the Middle East.
 
CeloNova BioSciences Inc. develops, manufactures, and markets a family of products based upon its Polyzene-F nanocoating technology. The next-generation nanocoating is the result of years of rigorous scientific research and German-engineering, and has been extensively published in numerous academic articles to date.
 
Congruent manages investment funds with long term capital that make lower middle market mezzanine and equity investments of $5 million to $40 million across a broad range of industries. Congruent is a partner for banks, operators, and sponsors that need flexible and creative capital solutions.
 
SWK Holdings Corporation is a specialized finance company with a focus on the global healthcare sector.

References
1. Levine G, Bates E, Bittl J, 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. doi: 0.1161/CIR.0000000000000404.
2. Koppara T, Sakakura K, Pacheco E, et al. Preclinical evaluation of a novel polyphosphazene surface modified stent. International Journal of Cardiology. 2016; 222: 217-225. doi: 10.1016/j.ijcard.2016.07.181.
3. Mrowietz C, Franke R, Seyfert U, et al. Haemocompatibility of polymer-coated stainless steel stents as compared to uncoated stents. Clinical Hemorheology and Microcirculation. 2005; 32:89–103.
4. Richter G, Stampfl U, Stampfl S, et al. A New Polymer Concept for Coating of Vascular Stents Using PTFEP (poly(bis(trifluoroethoxy)phosphazene) to Reduce Thrombogenicity and Late In-Stent Stenosis. Investigative Radiology. 2005; 40(4):210-218.
5. Adapted from Claudia R. Gries, Univ. of Heidelberg. Doctoral dissertation, 2001 (Data on File)
6. Radeleff B, Thierjung H, Stampfl U, et al. Restenosis of the CYPER-Select, TAXUS-Express, and Polyzene-F NanoCoated Cobalt-Chromium Stents in the Minipig Coronary Artery Model. Cardiovasc Intervent Radiol. 2007. doi: 10.1007/s00270-007-9243-y.
7. DATA ON FILE (TRD 0007).