Medical Device Daily National Editor

Medical device improvement, as the industry well knows, is clearly different than drug development. While a pill or tablet is what it is, individual devices constantly move through a series of iterations and improvements.

And developmental firm CeloNova (Newnan, Georgia) is pursuing this strategy in two different pathways for itself and for other device companies, medical and otherwise.

Besides developing its own device systems in particular, a new breed of cardiovascular stents CeloNova wants to be the "Intel inside" for a range of medical device companies, Thomas Gordy told Medical Device Daily.

President/CEO of CeloNova, Gordy uses the phrase "very lucky" more than once or twice in describing the company's funding, its opportunities for its platform chemistry that could have a broad variety of applications, and its potential for making a large impact in those applications.

That platform chemistry is Polyzene-F, a material developed by a researcher at the University of Heidelberg (Heidelberg, Germany) and now owned by CeloNova.

Polyzene-F is a synthesized inorganic polymer, with a variety of properties, according to the company, highly useful for both medical and industrial applications, by itself or in combination with other materials.

It is, the company says, "lubricious, anti-thrombotic, anti-inflammatory, and bacterial-resistant," all characteristics that are likely to produce considerable buzz among device developers who have their antennae fine-tuned to device improvements of a major sort.

The company recently received FDA clearance for microspheres used in treating hypervascularized tumors (Medical Device Daily, Dec. 18, 2008). And it recently marked an important milestone with publication, in the Journal of the American College of Cardiology, of highly positive data for its Catania Coronary Stent System.

The Catania, Gordy says, essentially creates a new species of coronary stent, because solving the major problems of bare-metal stents (BMS) and drug-eluting stent (DES) on the one hand, the high restenosis associated with BMS use, on the other, the occurrence of thrombosis and the need for the difficult and expensive regimen of anti-platelet use following DES implant.

But besides developing its own branded products, CeloNova will offer its Polyzene-F polymer for coating on a wide variety of devices thus Gordy's "Intel inside" reference and the company is likely to have a 50/50 split between its own branded products and Polyzene-F use with the products of other companies.

Gordy said the company currently holds 150 patents, is developing the materials for 100 more, and is ramping up the near-term roll-out of seven new products under its own brand and as a coating for other branded products. It will unveil at least two of these products this year, Gordy told MDD.

An obvious blockbuster opportunity is offered by the Catania stent which, in the publication of the ATLANTA trial data in JACC, is showing less restenosis than BMS devices and less thrombogenicity than DES. Importantly, the ATLANTA enrollees were able to discontinue, 30 days post-implant, anti-platelet therapy, the huge costs and difficult compliance with the anti-platelet regimen being the primary difficulty for DES devices.

ATLANTA is a first-in-man trial of 55 patients, with obstructive lesions of their coronary arteries producing ischemic heart disease, at a single center. The CATANI provided sustained benefit in the treatment of de novo coronary lesions and maximized endothelialization, while reducing restenosis. The Catania achieves these results by means of a coating with an ultra-thin version of Polyzene-F.

Professor Corrado Tamburino, MD, PhD, professor of cardiology, chief of the Cardiovascular Department, Ferrarotto Hospital (Catania, Italy), and lead ATLANTA investigator, told MDD that he is using the Catania stent "exclusively" instead of BMS devices and he specifically praised its lack of thrombogenicity.

CeloNova hasn't been seeking big waves of publicity, but it isn't in stealth mode either.

Gordy says the company's main goal is to be "prudent" and "strategic about what we do" in its developmental efforts, and is in "active discussions" with those interested in licensing opportunities.

The company says that Polyzene-F has a variety of applications, able to be used on "a multitude of substrates, including other polymers, metals and ceramics. It can be applied as a surface coating of less than 50 nanometers as well as up to 150-200 nanometers (and beyond)." It can be used by coating, extrusion, weaving or electro-spinning and "tailor-made to suit" the desired application.

Given the broad opportunities these features provide, the company's discussions with other firms include contacts with potential acquirers, Gordy acknowledges. But he describes these simply as "overtures," adding, "We're happy to talk to anybody."

He says that the company is "very lucky" to have strong support from investors and that it may seek in the future a C-round funding of up to $25 million.

While not being in stealth mode, CeloNova says that Polyzene-F does its job in its main cardiovascular application with a good bit of stealth, the coating on the Catania stent being so thin that it isn't recognized by the body.

This provides the basis for the company's name: Celo meaning "hidden, cloaked or stealthy" Nova, or "new," underlining what the company considers its breakthrough potential.

"CeloNova has started a scientific revolution involving the way physicians think about BMS and DES," says Tamburino. "I can definitely assert that Polyzene-F is innovative, effective in several aspects, unique and striking. The polymer is why I chose the Catania stent to implant in my very best friend."

Gordy says that as CeloNova moves forward with further trials of the Catania, it is still deciding on which stent it will designate in seeking FDA approval.

Meanwhile, it is pursuing commercialization of its first FDA-cleared product, its Embozene color-advanced microspheres used in treating hypervascularized tumors (tumors with a large number of blood vessels in many locations) and arteriovenous malformations (defects in the circulatory system).

The microspheres consist of a hydrogel core and an exterior shell made from Polyzene-F, the company calling this product the first and only microspheres to be color-enhanced with a different color for each size for increased procedural safety, efficiency and visibility.

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