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Tag: Biotech

Make Mine Bioresorbable

By KIM BELLARD

I learned a new word this week: bioresorbable.  It means pretty much what you might infer — materials that can be broken down and absorbed into the body, i.e., biodegradable.  It is not, as it turns out, a new concept for health care – physicians have been using bioresorbable stitches and even stents for several years.  But there are some new developments that further illustrate the potential of bioresorbable materials. 

It’s enough to make Green New Deal supporters smile.

Bioresorbable stents and stitches are all well and good – who wants to be stuck with them or, worse yet, to need them removed? – but they are essentially passive tools.  Not so with pacemakers, which have to monitor and respond.  Medicine has made great progress in making pacemakers ever smaller and longer lasting, but now we have a bioresorabable pacemaker. 

Researchers from Northwestern University and The George Washington University just published their success with “fully implantable and bioresorbable cardiac pacemakers without leads or batteries.”  What their title might lack in pithy is more than offset by the scope of what they’ve done.  Fully implantable!  No leads!  No batteries!  And bioresorbable! 

Most pacemakers are, of course, designed to be permanent, but there are situations where they are implanted on a temporary basis, such as after a heart attack or drug overdose.  Dr. Rishi Arora, co-leader of the study, noted: “The current standard of care involves inserting a wire, which stays in place for three to seven days. These have potential to become infected or dislodged.” 

Dr. Arora went on to explain:

Instead of using wires that can get infected and dislodged, we can implant this leadless biocompatible pacemaker. The circuitry is implanted directly on the surface of the heart, and we can activate it remotely. Over a period of weeks, this new type of pacemaker ‘dissolves’ or degrades on its own, thereby avoiding the need for physical removal of the pacemaker electrodes. This is potentially a major victory for post-operative patients.

The device is only 15 millimeters long, 250 microns thick and weighs less than a gram, yet still manages to deliver electric pulses to the heart as needed.  It is powered and controlled using near field communications (NFC); “You know when you try to charge a phone wirelessly? It’s exactly the same principle,” GW’s Igor Efimov, a co-leader of the study, told StatNews

It dissolves over a period of days or weeks, based on the specific composition and thickness of the materials.

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Health Tech, Part I: Where We Are Going, Not Just How Fast We Can Get There

By MIKE MAGEE

What will be the lasting impact of the Covid 19 pandemic?

We still don’t know the answer to that question in full. But one thing that can be said with some certainty is that it has strengthened the hand of Big Tech and all things virtual. Consider the fact that within the Biden White House administration, 13 senior aides have Big Tech resumes with time spent in firms like Google, Facebook, Twitter, Apple, Amazon, Microsoft and more.

This pandemic-induced scrape with mortality has instigated widely varied responses ranging from existential re-awakenings to explosive entrepreneurship.

In health care for example, health tech start-up’s are altering research, education, care delivery and coordination, data mining, patient privacy and financing.

As we know well from health care, intermingling profit, policy and politics can eventually lead to conflict and recrimination. The current controversy over NIH indirect funding of Shi Zengli’s Wuhan “gain-of-function” viral research through Peter Daszak’s New York based EcoHealth Alliance is a case in point.

But we’ve been there before. In the 1990s, James M. Wilson received a PhD and an MD degree from the University of Michigan, then completed an internal medicine residency at Massachusetts General Hospital and a postdoctoral fellowship at MIT. By 1997, he was one of the leading stars in the new gene-therapy movement, directing his own research institute at the University of Pennsylvania.

The institute focused on adjusting the genes of children born with a hereditary disease called ornithine transcarbamylase deficiency (OTD), which prevents the normal removal of ammonia in the body. Wilson’s experimental technique involved genetic engineering, splicing therapeutic genes into supposedly harmless viruses that, once injected into the body, could carry their payload to defective cells and repair the genetic errors.

Dr. Wilson was attempting to determine the maximum dose of genetically modified material that could be safely injected into affected youngsters. He had enlisted 18 participants, including a teenager named Jesse Gelsinger who had a version of the genetic disease in which some of his liver cells carried the genetic abnormality but other cells were entirely normal. Those who have the full-blown disorder die in early childhood. But with his mosaic, Jesse most of the time felt well, as long as he continued to take 32 pills a day.

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THCB’s Bookclub, September 2020 – NEO.LIFE

By JESSICA DAMASSA & MATTHEW HOLT

The THCB Book Club is a discussion with leading health care authors, which will be released on the third Wednesday of every month.

This month we hosted Jane Metcalfe (Founder of NEO.LIFE) to talk about her 2020 book NEO.LIFE. You can get a copy of it here!

NEO.LIFE is a very unusual book. It’s over 25 very short chapters (ranging from 1 page to 78) which include interviews, concepts, art, science, science fiction, and one short story. All from different authors or groups of authors that are all edited into place by Jane Metcalfe and Brian Bergstein.

The topic is the future of humans! And the loose focus is on biotech, human engineering, and well watch along and get a copy!

You can see the video below (and the podcast version will be in our iTunes & Spotify channels very soon).

In October the THCB BookClub will feature Mike Magee’s book, Code Blue.

Detecting Heart Conditions Faster: The Case for Biomarkers-PLUS-AI | Dean Loizou, Prevencio

BY JESSICA DAMASSA

Can artificial intelligence help prevent cardiovascular diseases? Biotech startup, Prevencio, has developed a proprietary panel of biomarkers that uses blood proteins and sophisticated AI algorithms to detect cardiovascular conditions like coronary and peripheral artery disease, aerotic stenosis, risk for stroke and more. Dean Loizou, Prevencio’s VP of Business Development, breaks down the process step-by-step and explains exactly how Prevencio reports its clinically viable scores to doctors. How does the AI fit into all this? We get to that too, plus the details around this startup’s plans for raising a B-round on the heels of this work with Bayer.

Filmed at Bayer G4A Signing Day in Berlin, Germany, October 2019.

Science-Driven Innovation and Tech-Driven Innovation: A Marriage of Convenience or a Marriage Made in Heaven?

NEHI recently convened a meeting on health care innovation policy at which the Harvard economist David Cutler noted that debate over innovation has shifted greatly in the last decade. Not that long-running debates about the FDA, regulatory approvals, and drug and medical device development have gone away: far from it.

But these concerns are now matched or overshadowed by demands for proven value, proven outcomes and, increasingly, the Triple Aim, health care’s analog to the “faster, better, cheaper” goal associated with Moore’s Law.

To paraphrase Cutler, the market is demanding that cost come out of the system, that patient outcomes be held harmless if not improved, and it is demanding innovation that will do all this at once.   Innovation in U.S. health care is no longer just about meeting unmet medical need. It is about improving productivity and efficiency as well.

In this new environment it‘s the science-driven innovators (the pharma, biotech, and medtech people) who seem like the old school players, despite their immersion in truly revolutionary fields such as genomic medicine. It’s the tech-driven innovators (the healthcare IT, predictive analytics, process redesign, practice transformation and mobile health people) who are the cool kids grabbing the attention and a good deal of the new money.

To make matters worse for pharma, biotech and medtech, long-held assumptions about our national commitment to science-driven innovation seem to be dissolving. There’s little hope for reversing significant cuts to the National Institutes of Health. User fee revenues painstakingly negotiated with the FDA just last year have only barely escaped sequestration this year. Bold initiatives like the Human Genome Project seem a distant memory; indeed, President Obama’s recently announced brain mapping project seems to barely register with the public and Congress.

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Clinical Trials for Beginners

Have you ever wondered about what goes on behind the scenes—how new drugs are magically produced and brought forth? We’ll continue to take the mystery out of clinical research and drug development and to provide background information so that both patients and physicians can make more informed decisions about whether they wish to participate in clinical trials or not.

Why care?

To develop a medicine, from the time of discovery of the chemical until it reaches your drug store, takes an average of 12-15 years and the participation of thousands of volunteers in the process of clinical trials (Fig 1).

Very few people participate in clinical trials—it is even less than 5% for patients with cancer—due to lack of awareness or knowledge about the process. We’ll go into detail about how drugs are developed in later posts.

An inadequate number of volunteers is one of the major bottlenecks in drug development, delaying the product’s release and usefulness to the public. Of course, many people may suffer or even die during this wait, if they have an illness that is not yet otherwise treatable. So if you want new medicines, learn about—and decide if you wish to participate in—the process. I have, as a volunteer subject, researcher, and advocate.Continue reading…

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