Innovation and indigenous R&D are crucial to MedTech Sanjeev Bhatt

Innovation and indigenous R&D are crucial to MedTech: Sanjeev Bhatt In order to move the technological needle we innovated in the direction of bioresorbable scaffolds.

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Shahid Akhter • ETHealthWorld • Updated: August 19, 2019, 21:02 IST

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Shahid Akhter, editor, ETHealthworld spoke to Sanjeev Bhatt, Vice President, Meril Life Sciences, Mumbai, to know more about the growth and the need for development in medical technology in India.

Med-Tech Market These are interesting days for MedTech, not just in India but worldwide. I'd like to reflect on how the world is changing in order to improve healthcare. Never before has so much technology been available to treat myriad disease conditions. Today, we are able to treat infectious diseases, lifestyle related diseases, and we are able to treat diseases that come with age. So today is

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the best time from the MedTech point of view, as healthcare is becoming more and more available to the worldwide population.

The global MedTech market is now sized in excess of $400 billion and is growing at a good pace of more than about 10%. Indian MedTech is now slotted at close to about $50 to 60 billion, and is expected to grow at a rate of about 20% over the next five to six years.

Meril Life Sciences Journey so far Meril Life Sciences is an Indian MedTech company present in more than hundred countries worldwide. The company was founded in 2007. And we are spread across four business verticals. We have a range of products in vascular interventional technologies. We work in orthopedics and we have products and technologies in endo-surgical range of products. And we also do in-vitro diagnostics. Currently, the company has more than 4000 people associated with it. And we are present in close to 145 countries worldwide with a robust portfolio of more than 100 unique technological platforms.

Innovation and R&D are intrinsic to Meril Life Sciences The company is founded on the basis of innovation and R&D. We realized that from the Indian MedTech point of view, unless we innovate, and unless we bring in this whole culture of indigenous R&D in medical device technology, we will not be able to stand out in terms of the developmental work that is going on elsewhere in the world. Also, more pertinently, in all these past years, the country has been dependent on technologies which have been imported either from USA or from Europe or elsewhere. Here at Meril, our R&D has the characteristics of a person who has a childlike, thrifty, curious and innovative nature. The way we work is that we identify an unmet clinical need. And we build products and technologies to solve that unmet clinical need.

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One of the crucial things that we've done over the last seven years is we worked quite a bit on a next generation drug eluting stent. In order to move the technological needle, we innovated in the direction of bioresorbable scaffolds.

MeRes100 is one such unique example of a polylactic acid based vascular scaffold, which has an ability to degrade in two to three years.

MeRes100TM: Pioneer in Next-Gen BRS technology with thinner struts MeRes100 is a bioresorbable vascular scaffold. The strut thickness of MeRes100 is 100 micron. It is in fact the next generation bioresorbable scaffold. The drug eluted from the surface of the scaffold is Sirolimus and this is meant for treatment of patients who present with coronary artery disease and require angioplasty and stenting. The bioresorbable nature of MeRes100 allows it to fully degrade in a period of two to three years. So, this is a unique advantage over the metal based drug eluting stents that we have currently.

The product has been approved by the CDSCO in India and the product is also now approved by the European Union. So, it is a CE Mark product and very shortly, Meril will decide on the launch of MeRes100.

MeRes100 launch and awareness Currently, coronary artery disease and occlusive coronary artery disease has been treated using metal based stents, more commonly drug eluting stents with a metal-based platform. These patients who receive a metal-based stent will have a prosthetic device permanently implanted in their coronary arteries.

It is very intuitive - especially if the patient is younger in age - to have a scaffold which will degrade over a period of time. This is done with the intention that as age progresses, the patient will have progression of the disease and thus it is ideal to not have anything left behind. So the quest for a fully degradable bioresorbable scaffold has been around and in that several technologies have been trying to establish clinical safety and efficacy.

MeRes100 was developed with an intention to address this unmet clinical need. It's a true 100 micron scaffold, which has Sirolimus eluted from the surface of the scaffold, and it’s timed to degrade over a period of two to three years.

Now, over three years of clinical follow up in a large clinical trial, we know that MeRes100 has a lower rate of target lesion revascularization which is just

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under 2%. Whereas with a metal-based platform, the target lesion revascularization rates are usually in the range of 5% to 6% and sometimes it might be up to 10%. One of the problems with stents has been stent thrombosis. In MeRes100, we've seen zero scaffold thrombosis in all these patients over three years. So the device has not just established its efficacy, but it has also established its uniqueness in terms of being extremely safe.

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