First indigenously developed animal-derived tissue engineering scaffold gets CDSCO nod for wound healing

In 2017, the technology was transferred to Alicorn Medical, a start-up biopharmaceutical firm in the technology incubation facility of the institute namely TIMed.

“Considering the stringency of the compliance requirements for Class D Medical Devices as per the 2017-Medical Device Rules of India and the general belief among stakeholders that development of animal-derived Class-D Medical Devices is not practical in India, this is a milestone achievement for the Institute, especially the research team as well as Alicorn Medical,” said Dr. Harikrishna Varma, the Head Biomedical Technology Wing of the institute.

In a recent research paper accepted for publication in Comparative Medicine, the team showed that the scaffold has the ability to mitigate fibrotic scarring in rats suffering an experimental myocardial infarction.

It is expected that with the introduction of Cholederm to the Indian market, the treatment cost can be reduced from Rs 10,000/- to Rs 2,000/- making it more affordable to the common man. Moreover, the technology for recovering extracellular matrix from the gall bladder is not available to others and it gives a fair chance for competition in the international market. In addition, the above findings made gall bladder of pigs, normally a slaughterhouse waste without any monetary value, a highly value-added raw material for biopharmaceutical industry thereby creating an additional income-generating opportunity for pig farmers.

However, the application of membrane forms of the scaffold for treating cardiac injury was cumbersome. Therefore, the team is developing injectable gel formulations of the scaffold that permits transvenous on-site delivery of the scaffold and for surface modification of polymeric medical devices. “Further investigations in multiple species of animals are necessary to confirm the claim. If true, these observations are likely to revolutionaries the contemporary modalities of managing patients suffering from myocardial infarction,” said Prof. T. V. Anilkumar