Pune firm launches silk protein bone void filler Serios, opens ISO 13485 manufacturing unit

Pune-based medical technology company Serigen Mediproducts has launched 'Serios', a product made using silk proteins for bone regeneration, for commercial use. The company claims it is the world's first silk protein-based bone void filler to have completed extensive clinical trials and obtained the required regulatory approvals.

Along with the launch, the company inaugurated a new ISO 13485 certified manufacturing facility in Pune. Silk protein-based medical devices will be made at the facility to international quality and safety standards.

The technology originated in research led by Dr Anuya Nisal at the CSIR-National Chemical Laboratory (CSIR-NCL) in Pune. Serigen Mediproducts was founded in 2015 to convert that research into medical devices. Dr Swati Shukla and Dr Premnath Venugopalan later joined the company as co-founders.

The company was incubated at the Venture Center. Early support from the Biotechnology Industry Research Assistance Council (BIRAC) sped up research, pre-clinical testing and the regulatory approval process. According to the co-founders, the journey of this silk protein-based technology from research to actual clinical use is now complete. The product has reached the market after more than a decade of research and trials.

'Serios' has been developed as an alternative to conventional bone fillers. It is easy to use, and it seeks to apply the biological properties of silk proteins to bone regeneration.

According to the company, patients were followed up at Sancheti Hospital in Pune after initial clinical trials, and positive findings on bone regeneration were recorded during that period. Multicentre trials were then held at various major medical centres in India. The company claims that in comparative studies, Serios showed better results than leading synthetic bone fillers in the formation of new bone and the reconstruction of bone structure.

Silk is known mainly for textiles, but the special structure of its proteins means it can also be used in medicine. Serigen is focusing on using India's silk production capacity to make high-technology medical products.

The company's products also include Seriderm, a silk protein-based dressing used to treat wounds, including acute wounds and those that do not heal for a long time. The company is also developing technology for reconstructing breast tissue after cancer surgery. The company said Serios is an important step towards making world-class medical products in India by combining indigenous research, natural resources and modern technology.