RESCUE is a prototype of vascular prosthesis engineered with bioactive molecules, such as antioxidants with anti-inflammatory activity and proteins with chemoattractant and cellular trans-differentiation activities which, respectively, will be able to modulate the post-implant inflammatory process and induce endothelialization of the implanted prosthesis. RESCUE, with a diameter of less than 6 mm, is produced by using the electrospinning technique and is biocompatible, biodegradable, and bioabsorbable.

Patent Status

PENDING

Priority Number

102019000014985

Priority Date

23/08/2019

Licence

INTERNATIONAL

Market

To date, RESCUE has no equal in the world of vascular prostheses and its economic impact, considering that peripheral arterial disease represents one of the most important health problems in the world, could be considerable. The improvements in surgical practice that would be obtained by applying RESCUE as a vascular prosthesis will also include a significant reduction of costs for national health systems due to the decrease in the number of replacement interventions compared to commercial prostheses that usually have to be changed after few years.

Problem

In Western countries, diseases affecting the cardiovascular system are the most common cause of morbidity and mortality with important effects on national health systems. In the presence of vascular obstruction, in order to restore the blood flow, preserving all the functions of the downstream tissues, it is necessary to introduce an arterial bypass or completely replace the obstructed vessel. During the last decades, different types of vascular substitutes have been used to obtain bypasses or to replace damaged vessels. Non-biodegradable prostheses have been successfully used as vascular substitutes but only for vessels with a diameter greater than 6.0 mm. However, these cannot be used when the affected vessel has a smaller caliber as it could lead to events of thrombotic nature, intimal hyperplasia, possible calcification, and possible inflammatory response, as well as infections that derive from the implanted prosthesis. To date, different laboratory-scale approaches have been developed to obtain small-caliber, biocompatible, biodegradable, and bioresorbable prostheses, made of polymers processed by 3D printing, electrospinning or from decellularized animal tissues, but without success. RESCUE is produced by the electrospinning technique and could be a highly innovative vascular prosthesis that could have important socio-economic implications.

Current technology limitations

In the presence of vascular obstruction, in order to restore the blood flow, while preserving all the biological functions of the organs supplied with blood, it is necessary to introduce an arterial bypass or completely replace the obstructed vessel. The limitations that the commercial prostheses posses are:

  • not be biodegradable and not bioabsorbable;
  • can be thrombogenic for small diameters (less than 6 mm);
  • they frquently have to be replaced over time by subjecting the patient, usually elderly and with comorbidities, to a second intervention;
  • cannot be easily engineered with bioactive molecules;
  • they do not induce a process of regeneration of the vessel wall.

RESCUE is proposed as an innovative prototype capable of overcoming all these limitations, paving the way for a new era of vascular surgery.

Killer Application

RESCUE can find application in vascular surgery such as:

  • prosthesis that actively guides and modulates vessel regeneration;
  • prostheses with cell recruitment activity;
  • prostheses with cellular trans-differentiation activity;
  • prosthesis that modulates the post-implant inflammatory process;
  • prosthesis as a biocompatible, biodegradable, and bioabsorbable substitute for small-caliber vessels.

Our technology and solutions

RESCUE is a highly innovative vascular prosthesis as it is functionalized and engineered with biomolecules that will actively guide the regeneration process of the new vessel. These characteristics make it possible to recruit, support, and induce the differentiation of the cells which, as the prosthesis degrades, will give rise to the new vessel. RESCUE is biocompatible, biodegradable, bioabsorbable and it is produced by the electrospinning technique in order to have a small caliber (less than 6 mm).

The properties of RESCUE can be summarized as follows:

  • it is available in different calibers depending on the collector used to collect the electrospun fibers (all of them in any case less than 6.0 mm);
  • it is structurally adequate for its application and its polymeric structure is gradually replaced by the extracellular matrix;
  • has a characteristic pleating;
  • can be easily sterilized with gamma rays without compromising the structure;
  • it is suitable for suturing and maintains its mechanical properties even when sutured;
  • has mechanical properties similar to those of healthy arteries;
  • it is not very permeable to blood due to the presence of a superficial layer of gelatin;
  • is not thrombogenic;
  • it is biocompatible;
  • it is biodegradable;
  • it is bioabsorbable;
  • it can be functionalized on the surface with hydroxyl and carboxyl groups through chemical modifications or plasma treatment;
  • can be engineered with bioactive molecules.

Advantages

RESCUE could be considered as an innovative vascular prosthesis to be used in surgical practice, revolutionizing it, as it has important advantages including:

  • it is a biologically active vascular prosthesis;
  • it is a small-caliber biocompatible, biodegradable, and bioabsorbable vascular prosthesis;
  • it is a vascular prosthesis with a reduced risk of early post-implant thrombosis;
  • it is a vascular prosthesis that reduces the risk of subjecting the patient to repeated surgical interventions.

Roadmap

The validation of RESCUE will require further investments that will be essential to implement the following steps:

  • production and engineering of RESCUE in full compliance with good manufacturing practices and in sterile conditions;
  • animal experimentation in mini pigs;
  • obtaining certifications as a biomaterial;
  • human clinical trial;
  • involvement of a company for the production of RESCUE (raw material, production, engineering, and packaging);
  • product marketing and distribution.
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