Innovative use of silk in medical devices

Unlike many who go to the US to study and build a career there, Anuya Nisal returned to India after her Master’s degree in Material Science from the University of Delaware, USA.

“I wanted to contribute to the science ecosystem in India,” she said. She joined GE Plastics as a scientist where she could explore and gain practical experience in polymer applications. The job deepened her understanding of the potential that lies in materials science and how it could be harnessed to better human life.

Meanwhile, she decided to pursue her PhD and as part of the course she was looking into publications on silk, which is also a material. She said, “Silk was used since the 1880s as sutures and since 2000 there has been a lot of interest in this material. As part of my PhD, I spoke to a lot of doctors and surgeons to understand how silk could be used to help the medical field. While silk is commonly associated with luxury fabrics, Anuya’s research opened up the varied potential this ‘luxury’ fabric material held. Her research with the medical fraternity showed that there was a huge need in the medical device sector.”

Injuries can be sustained on account of an accident or a disease condition like diabetes or cancer. Different injuries require different treatment methods. For example, a synthetic ceramic material is typically used to fill and repair a cavity in the bone or advanced wound care bandages made of polymeric materials are used to treat diabetic or non-healing wounds.

But Anuya’s studies discovered the magic held in silk. She said, “Silk as a biomaterial is biocompatible, biodegradable, and can be configured for tissue repair. Also, India is the world’s second-largest sericulture industry. Dr Lele, my PhD advisor, envisioned connecting this abundant resource to India’s rapidly growing medical device sector to cater to the diverse unmet clinical needs of patients worldwide.”

Initial research on silk by Anuya and her colleagues at CSIR-NCL (Council of Scientific and Industrial Research-National Chemical Laboratory), Pune, revealed the potential of silk in medical applications. This meant the team had to now work on harnessing this potential to create medical devices that could heal wounds and fill bone voids, to begin with. As a first step, Anuya verified the potential of silk for tissue regeneration at the CSIR-NCL, together with seasoned researcher-inventor Dr Premnath Venugopalan.

In 2015, Serigen Mediproducts was established along with co-founders Dr Swati Shukla and Dr Premnath Venugopalan. Serigen was created as a spin-off company of CSIR-NCL and incubated at Pune’s Venture Centre, which is India’s largest science and technology business incubator. Venture Centre was instrumental in nurturing this deep-science innovative startup. At Serigen, Anuya and her co-founders, built a team of biomedical technology experts and researchers to develop next-gen silk-based tissue regeneration products engineered to solve specific clinical problems in orthopaedics, advanced wound care and breast cancer.

Meeting the ‘need’

The team filed an initial patent for the innovative technique to convert silk into medical devices (tissue regeneration products) in 2014. Over the years, Serigen has filed further patents to strengthen its intellectual property portfolio. Their innovation has not only been granted international patents and published in reputed international peer-reviewed journals but has also been awarded by the Orthopaedic Research Society, USA.

“Medical devices, unlike drugs, require clinical trials in two phases – pilot and pivotal. For our bone void filler product Serioss, we are in the final stage of our pivotal clinical trial where we implant our bone filler in the body and compare the performance of our product with other global alternatives. This pivotal clinical trial is being conducted by partnering with several premier Hospitals in India” said Dr Shukla, co-founder and COO of Serigen.

Anuya explains how Serioss works.

“If a doctor has to remove a cancerous bone that void must be filled. Our product Serioss is used to fill the cavities in the bone. Serioss serves as a porous scaffold and allows cells from the neighbouring healthy bone to migrate into the scaffold. These cells start depositing the new bone. Serioss dissolves over time and the cavity is filled by the patient’s new bone tissue”.

For wounds, Serigen has innovated a non-adherent and absorbent wound dressing called Seriderm.

“Seriderm has helped over 300 patients by accelerating wound healing. For wounds to heal, it is vital that the right amount of moisture is maintained in the wound bed. The wound area should not be too dry as this will prevent tissue cells from regenerating, and it should not be too moist as that can cause infections. In addition to this, the dressing should not stick to the wound as that can also impact healing. More importantly, Seriderm reduces inflammation, which is vital to healing.

In addition to these two products, Serigen is also working on developing Serimat which will help doctors in breast reconstruction surgery for breast cancer patients.

Swati said, “Post-mastectomy, the breast is reconstructed using a silicone implant. However, this needs mechanical support at the bottom pole of the breast to support the weight of the implant. Serimat can be used to form a pocket in which a silicone implant can be kept during breast reconstruction.”

Funding

Deep science innovation is necessarily resource-intensive, especially in the medical industry.

“We raised funds through angel investments, promoter investments and grant funding. We are the proud recipient of competitive and prestigious government grants (BIRAC BIG, SBIRI, BIPP and IIGP 2.0) to the tune of ₹2.6 crore plus that have been very important for the initial stages of product development. We are grateful to our angel investors and venture capital funds for believing in our vision” said Anuya.

In 2022, Serigen set up a manufacturing and R&D plant at an industrial centre in Pune.

“This setup caters to the manufacturing of Seriderm, our wound care product. It is an ISO 13485 certified facility that meets global quality standards” said Swati.

Market Dynamics

Given the resistance to accept newer products by the medical fraternity, Anuya feels that it is the opinion makers who will be vital to achieve faster market penetration. Serigen plans to establish research collaborations with KOLs (key opinion leaders) to report the patient/ clinical performance data in scholarly and professional meetings and conferences, improving the acceptability of the innovative products.

Further, Serigen has a national sales team of 10 members, focusing on multi-speciality and super-speciality hospitals in Tier 1 cities. “We have only just started full-time sales a few months back, but our initial results are encouraging.”

Encouraging enough for Anuya to see global sales. “Several wound dressing products exist for the treatment of chronic wounds. They can help with non-adherence and moist wound healing. However, silk additionally helps in controlling the inflammation in the wound bed. This is specifically because of silk and how we process it in our patented formulation. To the best of our knowledge, we are the first company to show clinical evidence of silk-reducing inflammation in wound beds.

My interactions with the medical fraternity showed that there was a huge need in the medical device sector. The research on silk has further evolved to show that the silk thread can be dissolved, and the protein can be extracted to form a solution. At Serigen, we have developed a process that can convert this liquid silk into shapes and structures that can be used for hard or soft tissue in the body, using different shapes and forms. This is a unique versatile biomaterial. No other synthetic or natural material has the versatility like silk that can cater to both hard and soft tissue regeneration.”

Indeed, the fascination has been translated into innovative solutions that provide faster wound healing, efficient bone repair and superior soft tissue regeneration. Serigen’s products provide the appropriate environments for cells to multiply and function, resulting in the regeneration of damaged tissues. We hope this fascination continues.