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 present in various phospholipids, especially in phospholipids that constitute the bilayer structure of cell membranes.
PC technology is a proprietary technology platform of methacrylic acid polymers containing phosphorylcholine. These biomimetic materials are built on the body's own chemistry, yet they are entirely synthetic, allowing precise control over purity, molecular structure, and avoiding the risks associated with animal-derived ingredients. They can provide a simple and effective solution to the biosensitivity challenges faced by medical devices and can be tailored to specific application needs.

Product List
Ventruus Biomaterials offers a wide range of polymer coatings and monoliths to take advantage of the wide range of properties and benefits that PCs can offer:

Polymer	Summary	App
PC1036	Standard cross-linked PC coating, high durability drug delivery matrix	BiodivYsio® Dexamet® TriMaxx™, Endeavor® Stent
PC1059	Standard non-crosslinked PC coatings are stabilized by hydrophobic surface interactions	Guide wire, CPB system
PC2118	Cross-linked PC coating, high content PC forms self-wetting surface	Blood filtration and processing
PC1062	Cross-linked PC coating, with low positive charge content, can bind heparin to form an anti-thrombosis coating	Blood filtration and processing
PC2028	Cross-linked PC coating, high content of positive charges, 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, applied to curable materials, such as ketone silicone	Functionalized products
PC1015	Cross-linked overall PC hydrogel material, suitable for mold forming	Proclear® Contact Lenses
PC2083	Flexible monolithic PC hydrogel with high reflectivity index for mold forming	Functionalized products

· Overall PC biomaterials and coatings can be stents, guide wire flow components, oxygenators, dialysis components, intraocular lens drainage tubes, shunts, filters, dental materials, catheters , bone fixation wires and screws etc. to provide solutions.
· Approved and used by several medical device companies, such as Abbott, Medtronic, Cooper Optical Co., Ltd. and Italy Sorin Group, the three label claims allowed by the FDA demonstrate the clinical benefits of PC technology .
· This technology is also supported by a series of multifaceted 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
Ventelus stated in the FDA application: "In short-term clinical applications, PC coating is beneficial to prevent the formation of thrombus at the tip of the guide wire..."

b. Resistance to bacterial adhesion and biofilm formation
Ventruus stated in the FDA application: "This coating has been shown to resist the formation of Staphylococcus aureus and Pseudomonas aeruginosa biofilms..."

Application of PC Technology™ in Medical Field
In various 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 Fibrocystic formation
In addition, PC biomaterials have been proven to be good matrices for the controllable delivery of multiple 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 Tooth enamel and other tissues
Monolithic 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. The solution, in part, is as follows:

a. Reduce protein deposition

  Filter with PC technology         Filter without PC technology

b. Reduce blood activation

Blood filter with PC technology Blood filter without PC technology

c. Reduce biofilm formation

  Ureter with PC technology           Ureter without PC technology

Application of PC Technology™ in non-medical fields
It is clear that the non-fouling and surfactant properties of PC have potential benefits in non-medical areas.
Some applicable properties, benefits and examples of potential applications are summarized below:

Performance	Benefits	Potential application areas
Reduce protein attachment	Less fouling; easier to clean	Food and beverage processing equipment; pharmaceutical processing equipment
	Reduce the use of high-strength cleaning chemicals	Non-toxic marine antifouling
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	Intensive moisturizing and conditioning	Cosmetics; functional/reactive textiles
Transfer active substances	Active substances and benefits mentioned above	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 clearest example has always been the drug-eluting stent (DES) market, which has exploded from $1.5 billion to $5 billion in two years. PC coating has played an important role in this field. Abbott's PC dimethasone stent, Dexamet®, the second DES to market in Europe, and Medtronic's PC-coated otarolimus-eluting Endeavor® DES system, were notable in a two-year follow-up of 1,300 patients In the trial, there was no late frame thrombosis. These application examples highlight the value of PC materials to the medical device market.
The flexible chemical properties of PC polymers make it possible to modify various monomers, so that the polymers can be customized according to different active substances and the drug elution performance can be fine-tuned. Breakthrough drug-device combinations that demonstrate clinical benefits through controlled drug release, and Ventruus' 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 Exhibit precise dosing and controlled release
o Once the drug is released, it remains stable

PC coating can deliver:
o Anti-inflammatory drugs o Pain relievers
o Antimicrobials 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 Batimastat o Angiopep
o Dipyridamole

Manufacturer information
Ventruus Biomaterials' headquarters and application laboratories are located in Hampshire, UK. The division is part of Van Truust Specialty Products UK Limited in the North of England and the company's operations are accredited to an ISO9001:2008 Quality Management System (Certificate No. FM02222). Van Truus 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 the Biomaterials Division's operations. Ventrux 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.

Methone o Estradiol
o Paclitaxel o Sirolimus
o Batimastat o Angiopep
o Dipyridamole

Manufacturer information
Ventruus Biomaterials' headquarters and application laboratories are located in Hampshire, UK. The division is part of Van Truust Specialty Products UK Limited in the North of England and the company's operations are accredited to an ISO9001:2008 Quality Management System (Certificate No. FM02222). Van Truus 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 the Biomaterials Division's operations. Ventrux 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.