By Ritu Jha-
In an exclusive interview with indica, Sarvajna Dwivedi, president, CEO, and co-founder of AngioSafe Inc., shared his 30 years of experience developing pharmaceuticals and devices, the regulatory challenges and his pro bono work to avoid the next pandemic.
Dwivedi previously co-founded Pearl Therapeutics in 2007 and built it to a $1.15 billion exit in 2013, despite the global economic meltdown. Before that, he was associated with AstraZeneca, Glaxo, Glaxo Wellcome, Dura, Alkermes, and Nektar.
Q: What is AngioSafe, and how does it aim to revolutionize treatment for blocked arteries?
A: “Our science is very strong, and we certainly will help millions of patients worldwide. Physicians will help patients worldwide, and the entire insurance and reimbursement system will benefit.”
Dwivedi explained that many patients today are not adequately treated for blocked arteries, often enduring prolonged symptoms, relying solely on medication, or facing surgeries.
“We want to change that in favor of restoring blood flow through totally blocked arteries, and that’s the opportunity we’re creating. Things are going very, very well scientifically. Now it’s a matter of releasing the company from stealth mode and turning it into a commercial company.”
Q: What role does artificial intelligence (AI) play in AngioSafe’s work?
A: “Our company has very little use of AI. We are actually working with classical material sciences and mechanical engineering. While AI is often used to analyze and differentiate diseases among patients, Dwivedi emphasized that AngioSafe’s focus is on a breakthrough medical device that can safely and rapidly open totally blocked arteries without surgery.
“The problem of blocked arteries has existed for nearly 60–70 years. Plaques inside blood vessel walls are compressible, meaning they can be dilated and blood flow can be restored. However, the industry has taken a paradigm that creates more damage while opening totally blocked arteries. We are going to take away from that entire paradigm safely, rapidly open up the blood vessels, and restore blood flow while going through total blockages.”
Q: What are the challenges in treating cardiovascular diseases among South Asians, particularly Indians?
A: “There are more than 100 million diabetics in India. Patients in India are showing up with totally blocked arteries 10 years earlier than their counterparts in the Western world. There are multiple reasons for this – a sedentary lifestyle, opulence, rich food, poor diet, and lack of exercise.”
Q: What are some of the biggest regulatory challenges in bringing new medical devices to market in the U.S.?
A: “The biggest challenge when it comes to the system is that in the field of breakthrough medical devices, it takes an average of 5.7 years to get some sort of reimbursement under the current rules.”
He cited research from Stanford University that revealed only 44% of such devices receive reimbursement after the 5.7-year period.
“President Trump had a rule called Medicare Coverage for Innovative Technologies in his first term. That was a swift-acting rule, but it was taken away by President Biden’s administration. Now, a new one is being implemented, but the process is very slow.”
Dwivedi called for a faster bureaucratic process to ensure patients benefit quickly.
“The fundamental challenge in the U.S. health system is that physicians are not completely free to exercise their clinical judgment. They have to follow guidelines and some pay-for-performance metrics driven by population-based data. This should be reversed in favor of physicians exercising their clinical judgment.”
Q: What are your thoughts on the politics surrounding COVID-19 vaccines?
A: “It’s very difficult for me to get into anything that has to do with politics associated with vaccines. I’m science-driven, and I think a vaccine is a well-known concept where you introduce an infectious agent into the body so that the immune system can train itself to handle the actual virus. From that point of view, vaccines help. However, extrapolating that a vaccine will prevent infection entirely was not well-proven during the pandemic. Nobody should have made that claim, and that’s where all the politics comes in.”
He defended the emergency use authorization of vaccines during the COVID-19 crisis.
“You can only do so much when hospitals are full of patients, many of whom are dying. At that point, everyone was in emergency mode. Scientific committees, virologists, vaccine experts, and immunologists all voted in favor of these vaccines. I don’t think it’s wise to turn that decision-making process into a political battle. But politicians will do what they wish to do. As a scientist, I just have to look at the evidence.”
Q: What is your involvement with the Antiviral Drug Discovery (AViDD) Centers?
A: Dwivedi is working with a team at Stanford University on preparing medicines and vaccines for future pandemics.
“The Department of Health and Human Services under Dr. Anthony Fauci’s leadership in 2021 or 2022 started nine major antiviral drug discovery centers throughout the country called Antiviral Drug Discovery (AViDD) Centers. The primary purpose of these centers is to develop sufficiently advanced medicines and have them ready for any new medical emergency like a pandemic.”
According to Dwivedi, the goal is to ensure the world has pharmaceutical interventions available when needed.
“If you’ve got multiple well-researched therapies, then the probability that one will work for a given virus increases. Just as mRNA research for vaccine development was available, other vaccines could have been developed.”
He highlighted the potential of alternative vaccine technologies.
“A yeast-based COVID-19 vaccine, which is very cheap, could still be developed. There are various different technologies that have been on the shelf for the last 50 years, which actually helped in developing COVID-19 vaccines. The AViDD Centers at Stanford and many other universities in the country are going to prepare for future interventional efforts—not just vaccines, but pharmaceutical treatments that alleviate symptoms, reduce viral infection, and potentially decrease infectivity.”
Q: What is your hope for the future of healthcare innovation?
A: “We need to speed up regulatory processes so patients benefit quickly. Physicians should have more freedom to exercise their clinical judgment. And as a global community, we need to be better prepared for the next pandemic. My hope is that through innovation, collaboration, and smarter policies, we can improve healthcare for millions worldwide.”
