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Innovative biological biomaterial for surgical applications

Country of Origin: Italy
Reference Number: TOIT20180410001
Publication Date: 10 April 2018

Summary

The company is an Italian startup, founded in 2014 by an academic research group. It offers innovative biological substitutes for surgical applications, with high biocompatibility, for soft tissue repair and regeneration. Technical and research cooperation agreements with EU companies and research institutions active in the field of medical devices and new materials are being sought .

Description

The idea behind this Italian startup located in northern Italy  was developed in autumn 2013 by a University research group. One year later, in November 2014, the company was set up as an academic spin-off by a chemist, a biologist and two medical biotechnologists. 
The company develops innovative biological substitutes for surgical applications, with high biocompatibility, aimed at soft tissue repair and regeneration, in particular vascular substitution. The proposed products involve the use of biological matrices appropriately decellularized, in order to eliminate the risk of immunogenic reaction in the implant site. The biological matrices can be activated and subsequently enriched with bioactive substances (eg. Antibiotics, peptides, growth factors, etc.) in order to optimize their use in surgical clinical need.

The main characteristics of biological patches are:
• Sterility
• Biocompatibility
• Adequate mechanical properties in different surgical areas
• Elasticity
• Possibility to functionalize the matrix for a driven biological response after the implantation.
• Optimized tissue regeneration

The company is looking for technical and research cooperation agreements with companies and/or research institutions located in the EU. The company offers services for the development of new medical devices from the idea conception to the market production. In particular, the following services are provided:
- Assessing biocompatibility, haemocompatibilty and mechanical properties of materials for tissue engineering and regenerative medicine.
- Improving existing products of companies involved in regenerative medicine, through innovative processes.
- Developing new products in collaboration with companies interested in regenerative medicine market.

The company's business strategy consists in developing products until the preclinical phase, through in vivo animal tests, and finding companies interested in purchasing the prototype.

Advantages and Innovations

Current clinical approaches show poor efficiency in the replacement of small-caliber arteries. The use of autologous saphenous vein or mammary artery is currently the best solution. However, this approach is not always feasible, since most of the vessels are affected by widespread atherosclerotic abnormalities. Another option is the use of synthetic grafts, which leads to implant failure for small-caliber systems. The  innovative scaffold proposed by the company is obtained from decellularization of porcine or bovine medium caliber blood vessels. Subsequently, the vessels are enriched with a non-toxic cross-linker, to strengthen the decellularized matrix structure. The reinforced vascular substitutes will be used for replacement of damaged small-diameter vessels and obtainment of artero-venous access. 

The competitive advantage of the company lies in its proprietary technology, through an innovative process aimed at enriching the decellularized tissue with bioactive molecole, able to improve the reinforcement of decellularized matrix, the resistance to infections and the reduction of the regeneration period of the damaged tissue.
This technology is unique in the world and represents a new application field. The functionalization of the biological matrix is an highly innovative technique, which is still absent in the biomedical market, but offers significant potential for the development and production of highly innovative biological substitutes, able to drive properly tissue regeneration and better control outcomes immediately after surgery.

Stage Of Development

Already on the market

Requested partner

Partner search is restricted to EU countries, due to regulatory reasons. 

The company is interested in getting in touch with companies or research institutes active in the field of medical devices and new materials, willing to set up a cooperation on existing, developed materials or on new joint products. The royalties and the other retributions will be distributed according with the product potential and the partner company / research institute support on the certification phase. The requirements for the vascular prosthesis production (such as ISO and other certifications) will be a responsibility of partner companies / research institutes.

Cooperation offer is closed for requests