VERTELLUS drug-eluting stent coating drug-delivery stent coating

Introduction to PC Technology
PC is the abbreviation of phosphorylcholine, which is the chemical name of the polar head group that exists in a variety of phospholipids, especially in the phospholipids that constitute the double-layer structure of cell membranes.
PC Technology is a proprietary technology platform for methacrylic acid polymers containing phosphorylcholine. These biomimetic materials are built on the body's own chemistry, but they are entirely synthetic, allowing precise control of purity, molecular structure, and avoiding the risks associated with animal-derived ingredients. They can provide a simple and effective solution to the biochemistry challenges faced by medical devices and can be tailored to specific application needs.

Product List
Ventrus Biomaterials offers a variety of polymer coatings and monolithic materials to take advantage of the various properties and benefits that PC can offer:

Polymer	Brief description	Application
PC1036	Standard cross-linked PC coating, highly durable drug delivery matrix	BiodivYsio® Dexamet® TriMaxx™, Endeavor® Stent
PC1059	Standard non-cross-linked PC coatings are stabilized by hydrophobic surface interactions	Guidewire, CPB system
PC2118	Cross-linked PC coating, high content of PC forms a self-wetting surface	Blood filtration and processing
PC1062	Cross-linked PC coating, with low positive charge content, can bind heparin to form an anti-thrombotic coating	Blood filtration and processing
PC2028	Cross-linked PC coating, with high positive charge content, can be used as a matrix for high molecular weight drug delivery	BiodivYsio Matrix Hi bracket
PC1071	In-mold PC coating with vinyl functional groups for curable materials such as ketone silicone	Functional products
PC1015	Cross-linked monolithic PC hydrogel material, suitable for mold molding	Proclear® Contact Lenses
PC2083	Flexible monolithic PC hydrogel with high reflectivity index, suitable for mold molding	Functional products

· Integral PC biomaterials and coatings can be used for stents, guide wire flow path components, oxygenators, dialysis components, intraocular lens drain tubes, shunts, filters, dental materials, and catheters , bone fixation wires and screws, etc. provide solutions.
· Recognition and use by multiple medical device companies, such as Abbott Laboratories, Medtronic, Cooper Optical Co., Ltd. and Italy's Solin Group, the three label statements allowed by the FDA prove the clinical advantages of PC technology .
· This technology is also supported by a series of multi-faceted patents and FDA Master files.

PC Technology™ improves clinical performance
There are numerous reports detailing the results of clinical and in vitro studies, some of which are as follows:

a. Hematocrit
Ventrus stated in the FDA application: "In short-term clinical applications, PC coating is beneficial in preventing the formation of guidewire tip thrombosis..."

b. Resists bacterial adhesion and biofilm formation
Ventrus states in its FDA application: "This coating has been shown to resist the formation of Staphylococcus aureus and Pseudomonas aeruginosa biofilms..."

Application of PC Technology™ in the Medical Field
Across a variety of applications, PC materials have been proven to improve the biocompatibility and performance of medical devices and materials by reducing:
o Protein deposition/activation o Biology�Deposition
o Blood activation/thrombosis o Inflammatory response
o Bacterial adhesion o Fibrous capsule formation
​ ​ In addition, PC biomaterials have been proven to be a good matrix for the controlled delivery of a variety of active ingredients.

PC biomaterials have been successfully used to coat the following substrates:
o Metals, including stainless steel, nitinol, titanium, gold, platinum
o Plastics, including polyolefin, polyvinyl chloride, PMMA, PET, polyurethane, polycarbonate, polyamide, polyimide, polystyrene, polytetrafluoroethylene
o Rubber, including silicone, latex, PIB
o Glass and Ceramics
o Enamel and other tissues
Integral PC biomaterials and coatings can be provided for stents, guide wires, blood flow components, oxygenators, dialysis components, intraocular lenses, excretory tubes, shunts, filters, dental materials, catheters, bone fixation wires and screws, etc. Some of the solutions are as follows:

a. Reduce protein deposition

Filters with PC technology Filters without PC technology

b. Reduce blood activation

Blood filter with PC technology Blood filter without PC technology

c. Reduce the formation of biofilm

Ureter with PC technology Ureter without PC technology

Application of PC Technology™ in Non-Medical Fields
It is clear that PC’s non-scaling and surfactant properties have potential benefits in non-medical applications.
The following summarizes some examples of applicable features, benefits, and potential applications:

Performance	Advantages	Potential application areas
Reduce protein attachment	Reduces scaling; easier to clean	Food and beverage processing equipment; pharmaceutical processing equipment
	Reduce the use of high-intensity cleaning chemicals	Non-toxic marine anti-fouling
Reduce bacterial adhesion and biofilm formation	Same as above, while reducing the risk of infection/contamination/spoilage	Used in hospitals to maintain clean/easy-to-clean surfaces; water filtration systems; latex
Hydrophilic and moisturizing	Enhance moisturizing and conditioning	Cosmetics; functional/active textiles
Transfer active substances	Active substances and the above advantages	Cosmetics; health products

Application of PC Technology™ in Drug Delivery
In recent years, the development of drug-device combination products has brought about significant changes in some parts of the medical device field. Perhaps the most obvious example has always been the drug-eluting stents (DES) market, which has experienced explosive growth from $1.5 billion to $5 billion in two years. PC coating plays an important role in this field. Abbott's PC dexamethasone stent, Dexamet®, the second DES to be marketed in Europe, and Medtronic's PC-coated otralimus-eluting Endeavor® DES system, were notable in a two-year follow-up of 1,300 patients. During the trial, there was no case of late frame thrombosis. These application examples highlight the value of PC materials to the medical device market.
The flexible chemistry of PC polymers makes it possible to modify a variety of monomers, allowing the polymer to be tailored to different active substances and fine-tuning drug elution properties. Breakthrough drug-device combinations that demonstrate clinical benefits through controlled drug release, Ventrus' expertise is well suited to serve the development and commercialization of combination products.

PC coating can:
o Adsorption of high molecular weight compounds
o Absorption of low molecular weight drugs
o Demonstrate precise drug content and controlled release
o Once the drug is released, it remains stable

PC coating can transport:
o Anti-inflammatories o Analgesics
o Antibacterial drugs o Hormones
o DNA fragments used in gene therapy

Specific examples of active substances that have been studied:
o Dexamethasone o Estradiol
o Paclitaxel o Sirolimus
o Bamastat o Angiopep
o Dipyridamole

Manufacturer Information
Ventruth Biomaterials’ headquarters and application laboratories are located in Hampshire, UK. The division is part of Vertruth Specialty Products UK Ltd., based in the north of England, and the company operates under an ISO9001:2008 quality management system certification (certificate number FM02222). Vertex Specialty Products UK Ltd has facilities to produce multi-tonne PC materials and has recently opened a new polymer chemistry R&D laboratory to support its biomaterials division operations. Ventrus is ideally suited to assist medical supply companies in applying the benefits of PC technology to address unmet clinical needs and provide value-added, differentiated products.

Metasone o Estradiol
o Paclitaxel o Sirolimus
o Bamastat o Angiopep
o Dipyridamole

Manufacturer Information
Ventruth Biomaterials’ headquarters and application laboratories are located in Hampshire, UK. The division is part of Vertruth Specialty Products UK Ltd., based in the north of England, and the company operates under an ISO9001:2008 quality management system certification (certificate number FM02222). Vertex Specialty Products UK Ltd has facilities to produce multi-tonne PC materials and has recently opened a new polymer chemistry R&D laboratory to support its biomaterials division operations. Ventrus is ideally suited to assist medical supply companies in applying the benefits of PC technology to address unmet clinical needs and provide value-added, differentiated products.