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Safety Reports Analyzed with A.I. to Reduce Medical Errors

Data and person graphic

(Gerd Altmann, Pixabay)

13 Nov. 2019. Research is underway to write algorithms for analyzing free text and other unstructured data in safety report databases to reduce medical errors. The new project joining researchers at a university and hospital system is funded by a three-year, $815,000 award from National Library of Medicine, part of National Institutes of Health.

A team led by statistics professor Srijan Sengupta at Virginia Tech in Blacksburg, with colleagues from the MedStar Health National Center for Human Factors in Healthcare in Washington, D.C., aims to fill a gap in analyzing patient safety event reports. These reports, residing in a number of databases, usually have both structured data — predefined fields with predictable types of information — but also unstructured data, usually free text narratives. Structured data lend themselves to quantitative analysis, but the free text narratives are not easily processed. As a result, this rich source of information on medical errors is often ignored.

The unstructured data often describe in detail an entry in a structured data code or category. Thus, when put together they offer a richer and more detailed story. Sengupta and colleagues plan to mine patient safety event reports with natural language processing and statistical models to identify where near-misses occur, and quantify further deterioration and severity of errors. The end deliverable is a set of algorithms offering statistical tools to identify these factors for faster and more accurate identification of conditions contributing to medical errors.

Identifying timing factors and patterns in unstructured data is a key objective of the project. “What may seem like an infrequent hazard at a hospital,” says Sengupta in a Virginia Tech statement, “may be part of a broader national trend when viewed across health care systems. Using our algorithms to effectively analyze documents from reporting systems has the potential to dramatically improve the safety and quality of care by exposing possible weaknesses in the care process.”

MedStar Health’s Human Factors Center is providing its expertise on patient safety, natural language processing, and machine learning for the project. Raj Ratwani, director of the Human Factors Center and co-investigator on the project, says tens of thousands of safety issues are reported to FDA, but the data are not adequately analyzed, allowing potentially unsafe products to continue on the market that could threaten patients’ well-being.

“This research,” notes Ratwani, “is critical to identifying patterns in the reported data and turning data into knowledge that the health care provider can then use to assess the safety of their technologies and processes and develop actions and interventions to prevent patients from being harmed by recognized hazards.”

The team plans to issue open-source software as one of its deliverables. “Releasing open-source software that will enable other practitioners in public and private health care systems to implement our methods on their own proprietary data sets,” adds Sengupta, “will be one of the most important outcomes of our research.”

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Spray Fiber Process Designed for Wound Bandages

EStAD device drawing

EStAD device drawing (L.G. Huson and E.A. Kooistra-Manning, Montana Tech)

13 Nov. 2019. An engineering team created a portable device that in lab tests sprays bio-compatible fibers on simulated wound surfaces to promote healing. Researchers from Montana Technological University in Butte describe the device and process in yesterday’s issue of the Journal of Vacuum Science & Technology B, published by American Institute of Physics.

A team led by Montana Tech mechanical engineering student Lane Huston is seeking to apply electrospinning, a technique that sprays electrically-charged polymer micro- and nano-scale fibers toward a surface, where the fibers form a mat-like structure. Electrospinning can also be used to create dressings and even engineered tissue to heal wounds. Most of today’s electrospinning systems, including those in health care, are large, table-top systems with high-voltage power supplies.

Huston and colleagues aim to develop a portable electrospinning device needing far less power than current systems, for use at the point of care in clinics. Their solution combines an electrospinning unit with electrodes and an air blower to propel the fibers on a target surface, but is powered by a battery enclosed in a portable, self-contained device, called an electrostatic and air driven or EStAD system. The system produces electrospun bandages with two types of polymer fibers used in biomedical applications — polyethylene oxide and cellulose diacetate — at a lower volume than table-top systems.

“In spray painting, pressurized gas forces direct particles toward a surface, creating a sort of deposited material,” says Huston in an American Institute of Physics statement. “Like spray painting, the EStAD device is used by directing its nozzle at the desired surface during operation, causing a fiber mat to be deposited onto that surface.”

The Montana Tech team tested the EStAD system with two applications. The researchers first used the system to create direct bandages on simulated wounds, spraying the fibers on a gloved hand from a distance of up to 16 centimeters. In a second test, the team created transitional bandages, sprayed on parchment paper for later application. The team also added the antibiotic vancomycin to electrospun bandages, which when tested with live Staphylococcus aureus bacteria. In addition, the researchers created fiber bandages with gold nanoparticles, used for drug delivery.

Results of the tests show the EStAD system created both direct and transitional bandages on various surfaces, including a simulated wound in pig skin. The system’s bandages, both direct and transitional, with the antibiotic vancomycin killed staph bacteria in a petri dish. And tests of EStAD system bandages seeded with gold nanoparticles showed the bandages release the gold particles on simulated surfaces.

The authors expect their device can help clinics, particularly those in rural areas, can benefit from the EStAD system. “The bandage material, as well as the drug used,” adds Huston, “can be chosen on demand as the situation warrants, making modular and adaptable drug delivery accessible in remote locations.”

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Digital Meds Boost Hepatitis C Drug Adherence

Proteus Discover system

Proteus Discover system — pill with sensor, patch, mobile app (Proteus Digital Health)

12 Nov. 2019. A system with electronic sensors added to pills helps people known to skip taking medications stick with their drugs prescribed for hepatitis C. Findings from a clinical trial evaluating the DigiMeds system made by Proteus Digital Health in Redwood City, California, among patients with a history of non-adherence to drugs, were presented on Sunday, 10 November at a meeting of American Association for the Study of Liver Diseases in Boston.

Hepatitis C is a viral infection affecting the liver, with some 2.4 million living with the virus in the U.S., according to Centers for Disease Control and Prevention. The disease is transmitted through contact with infected blood, with intravenous drug users sharing needles among those at the highest risk of contracting the disease. The virus causes inflammation of the liver and can lead to cirrhosis or scarring and poor liver function over many years.

Because there are no symptoms early on, many people with hepatitis C infections do not get treatment until more serious complications occur. And even when treatment is started, many individuals with the virus are often at high risk of not adhering to their therapies, often due to difficult life circumstances associated with substance abuse, such as psychiatric disorders or alcoholism.

Proteus Digital Health offers what the company calls its digital medicines or DigiMeds program that adds a tiny electronic sensor to medications in a capsule to track adherence. The system, formerly called Discover, also has an electronic patch worn on the torso that reads signals from the sensor, a mobile app that reads data from the patch to record the individual’s taking of medications, and a web portal used by health care providers and caregivers to track patients’ adherence to treatments.

The clinical trial, led by Mark Sulkowski, a Johns Hopkins University medical school professor that studies management of viral hepatitis, recruited 288 individuals with hepatitis C at 18 clinics in the U.S. The study team was particularly interested in enrolling people with a history of medication non-adherence, and the trial’s sample reflected that profile: 52 percent of participants reported alcohol or substance abuse, while 23 percent had a serious psychiatric disorder. About one in five participants (19%) also had HIV infections. Most trial participants reported that their families earned less than $25,000 per year and nearly 1 in 10 participants said they were homeless.

In the trial, the Proteus DigiMeds sensor was added to direct acting antiviral medications, combinations of drugs taken daily to reduce hepatitis C viral loads. Participants were asked to report back to the clinics after 4 and 12 weeks to assess their sustained virologic responses, indicating the treatments were clearing their blood of hepatitis C, while the DigiMeds system tracked medication adherence.

Among the initial participants, 205 reported for the 4-week check and 217 for the 12-week check. The study team says drop-outs occurred for a variety of reasons, including 30 participants who did not respond to follow-ups and 6 individuals reporting adverse effects, of which 3 rash cases were attributed to the treatments. Of those reporting after 4 weeks, all were found with sustained virologic responses, and after 12 weeks nearly all — 216 of 217 — likewise had sustained virologic responses. At both points, adherence to prescribed medications averaged 93 percent among participants.

“This is encouraging data showing how DigiMeds can make a significant impact on curing patients at high risk of non-adherence,” says  Andrew Thompson, CEO of Proteus Digital Health in a company statement. “As we pursue the use of DigiMeds across therapeutic areas, we believe we will continue to see improved patient outcomes.”

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Liquid Injectable Electrodes Designed for Nerve Stimulation

Kip Ludwig with syringe

Kip Ludwig holds a syringe with the injectable electrode material (Renee Meiller, University of Wisconsin – Madison)

12 Nov. 2019. In lab animal tests, an injectable silicon-metal material performs as well as conventional electrodes for electrical nerve stimulation, an emerging therapy for pain. Researchers at University of Wisconsin in Madison and Case Western Reserve University in Cleveland describe the material and test results in the 7 November issue of the journal Advanced Healthcare Materials (paid subscription required).

Stimulating nerve pathways with implanted electrodes is used increasingly as a non-drug alternative treatment for pain and other neurological conditions. Implanting electrodes, however, is an invasive procedure, usually requiring surgery, which adds cost and complexity to the treatments. Researchers led by Wisconsin biomedical engineering professor Kip Ludwig and Case Western Reserve adjunct professor Andrew Shoffstall are seeking a simpler and less expensive method for inserting electrodes into the body for electrical nerve stimulation.

The solution devised by Ludwig, Shoffstall, and colleagues is a material they call an “injectrode,” a material injected as a liquid that coats the nerves being stimulated. The team’s injectrode is a liquid, uncured bio-compatible silicon plastic, mixed with enough metallic particles, silver in this case, to attract and conduct an electric current.

The injectrode material is injected to the nerve requiring stimulation, where the silicon cures in the body and forms a conductive contact with the nerve. “Typical implants are really stiff, and so as the body moves, they wear and tear and break down,” says Ludwig in a University of Wisconsin statement. “Our liquid cures, and the result is much closer to the normal elasticity of tissue. You can actually stretch it and increase its size 150 percent to 200 percent without losing its conductivity.”

The researchers first bench-tested the material’s conductivity in the lab, and found the material performs as well as pure silver wire and commercially-available nerve stimulation electrodes. Then, to prove the concept, the team tested the injectrode with rats and pigs. For the animal tests, the team injected the material around the target nerve and retracted the syringe leaving a thin, wire-like residue that reached to a small well of injectrode under the skin’s surface. The tests used a low voltage current similar to today’s transcutaneous electrical nerve stimulation with implanted electrodes.

In the tests with pigs, animals with organs similar in size and function as humans, the researchers injected the material around the vagus nerve. The vagus nerve pathway extends from the brain stem to the abdomen, connecting other major organs including the heart, esophagus, and lungs. Results show the injectrode enables stimulation of the pig’s vagus nerve that induces changes in the animal’s heart rate.

In September, the Ludwig-Shoffstall team received a three-year, $2 million grant from National Institute of Neurological Disorders and Stroke, part of National Institutes of Health, to develop an injectrode system to stimulate the dorsal root ganglion, a complex of sensory nerve cells in the spinal cord, as a less expensive and more widely available non-opioid treatment for pain. Collaborating on the project is the company Neuronoff Inc., in Valencia, California, founded by Ludwig and Shoffstall in 2017, to commercialize the injectrode technology.

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New Company Using A.I. to Discover Mental Health Drugs

Artificial intelligence graphic

(Gerd Altmann, Pixabay)

11 Nov. 2019. A new enterprise combining resources from biotechnology and artificial intelligence aims to find safer and more effective treatments for psychiatric disorders. The company called Entheogenix Biosciences Inc., incorporated in the U.S., is a joint venture of ATAI Life Sciences AG in Berlin and Cyclica Inc. in Toronto, but no funding nor personnel were disclosed for the company.

Entheogenix Biosciences plans to discover new small-molecule, or low molecular weight, therapies for complex psychiatric diseases such as depression, bipolar disorder, and schizophrenia, including drugs based on psychedelic compounds. The company’s founders in ATAI Life Sciences and Cyclica say current therapies with individual drugs are inconsistent or do not adequately treat the disorder, often leaving physicians to prescribe multiple drugs, which can lead to adverse effects or low medication adherence.

ATAI Life Sciences offers a biotechnology platform that the company says addresses the complexity of treating mental health. Founded last year, ATAI acts as a framework company for individual enterprises developing new therapies addressing specific mental health targets. Among the company’s proposed solutions are psychedelic drugs, many of which are considered dangerous or controlled substances by law enforcement authorities, yet are beginning to receive serious consideration as a basis for psychiatric therapies. While only about a year old, ATAI Life Sciences so far raised $68 million in two full venture funding rounds, according to Crunchbase.

Cyclica applies computational biology and biophysics to drug discovery to assess the total effects of proposed treatments on the body, not just the prime targets. The company’s Ligand Design service starts with what the company calls seed molecules, then designs more complex molecules with artificial intelligence to achieve specific chemical interactions in the body, as well as reflect desired ADMET — for absorption, distribution, metabolism, excretion, and toxicity — properties.  Cyclica’s Ligand Express is a complementary cloud-based service that screens small molecule compounds against a large simulated protein repository with artificial intelligence routines to visualize and predict multiple interactions in the body.

Entheogenix Biosciences expects to apply Cyclica’s technology to discover new treatments for psychiatric disorders. The new company plans to start with a number of seed molecules from existing small molecule compounds, as well as psychedelic drugs such as psilocybin and mescaline. The aim is to synthesize new compounds that work faster to address debilitating psychiatric diseases, but without hallucinogenic side effects associated with psychedelic drugs.

“Entheogenix will use state-of-the-art technology to identify the most promising candidates for drug development quickly and precisely,” says ATAI Life Sciences CEO Florian Brand in a joint statement. “We are especially passionate,” adds Naheed Kurji, CEO of Cyclica, “about advancing health outcomes for patients suffering with the most complex and prevalent disorders like depression, which is the leading cause of disability worldwide.”

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Opioids Provide Few Pain Benefits, Yet Abuse Growing

Dispensing pills


11 Nov. 2019. Opioids appear to provide little benefit for patients with pain from osteoarthritis, yet opioid use disorder rates among patients with painful conditions continue to rise. These conclusions are reported in two separate papers presented at this week’s annual American College of Rheumatology meeting in Atlanta.

A team led by Raveendhara Bannuru, a professor specializing in comparative effectiveness research at Tufts University medical school in Boston, is seeking to better define benefits from opioid pain relievers. These drugs are often prescribed to osteoarthritis patients for pain relief, and while their addictive properties are well documented, evidence of actual benefits are sketchy, according to the authors.

Osteoarthritis is a degenerative disorder affecting cartilage in joints. Over time, the wear and tear of joints, mainly in hands, feet, knees, and back gradually hardens and deteriorates cartilage causing pain and inflammation.

Bannuru and colleagues from Tufts and Lund University in Sweden searched the Medline and Cochrane databases to April 2019 for randomized clinical trials testing the efficacy and safety of opioid pain relievers against a placebo, among patients with knee or hip osteoarthritis. Their search yielded 23 studies, both published and unpublished, enrolling some 11,400 participants. The researchers looked for evidence of opioid safety and benefits at 2, 4, 8, and 12 weeks after the initial prescription, as well as differences between strong versus weak opioid drugs.

The researchers found small yet statistically reliable improvements in pain relief and function at 2, 4, and 12 weeks and more sleep among patients. However, the team found no difference in benefits in the occurrence of depression among patients nor improvements in overall quality of life. In addition, the authors found dosage level made no difference in benefits to patients. Moreover, patients generally fared better with weaker rather than stronger opioids, although stronger opioids were associated with more safety problems, including withdrawal symptoms and other adverse effects.

Opioid abuse hospitalizations continue to rise

Another team led by Jasvinder Singh, a rheumatology and immunology professor at University of Alabama in Birmingham, reviewed hospitalizations for opioid use disorder among people with common musculoskeletal diseases. Singh and colleagues looked specifically at patients with five disorders: gout, osteoarthritis, lower back pain, rheumatoid arthritis, and fibromyalgia, a chronic condition marked by pain throughout the body.

The researchers searched and reviewed data from the National Inpatient Sample, a collection of databases on hospitalizations maintained by the Healthcare Cost and Utilization Project in the U.S. Department of Health and Human Services. The team took data from 1998 through 2016, looking for opioid use disorder hospitalizations reflected in insurance claims among patients with these conditions.

The authors found low initial rates of opioid use disorder among pain patients, but then the rates began climbing, and quickly. For the first three years, through 2000, hospitalizations for opioid use disorder were low. Beginning in 2001, however, hospitalization rates started rising and by 2016 the rates increased from 3.5 times higher for lower back pain to 24 times higher for gout. After 2011, hospitalizations for opioid use disorder or OUD plateaued for lower back pain and gout, but continued rising for osteoarthritis, rheumatoid arthritis, and fibromyalgia.

“This study’s findings should alert the patients and providers regarding the chronic opioid use in people with rheumatic diseases and should encourage them to have an open dialogue regarding the risk/benefit ratio at the time of starting or deciding to continue opioids,” says Singh in an American College of Rheumatology statement. “The dramatic increase in OUD hospitalizations in these five common rheumatic conditions should highlight these diseases for policy initiatives.”

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Infographic – Q3 A.I. Health Investments Set Record

A.I. health care investments

Click on image for full-size view (CB Insights)

9 Nov. 2019. Venture capital funding for companies worldwide building artificial intelligence solutions in health care set new highs in the third quarter of 2019. These findings for our weekend infographic are part of a new report on global health care venture financing from technology intelligence company CB Insights (registration required).

The CB Insights report shows start-up companies developing A.I. systems for health care raised nearly $1.6 billion in venture investments in 103 separate deals from July through September 2019. Those numbers are sharp increases from the $926 million raised in 79 deals in the previous quarter, and the $749 million in 63 deals a year ago. However, about one-third of the $1.6 million raised in the last quarter can be traced to one deal: $550 million raised by mobile telemedicine company Babylon Health in London, led by Saudi Arabia’s public investment fund.

Other highlights from the report …

Health care start-ups raised about $12.5 billion in 1,090 deals in the third quarter of 2019, about the same levels as the first two quarters of the year, but declines from the $16.6 billion raised in 1,173 deals in the third quarter of 2018.

European health care companies received much more venture financing in the third quarter, raising $2.9 billion compared to $1.3 billion in the second quarter. North American companies received $7.6 billion in the third quarter, while Asian start-ups gained about $2 billion, both down somewhat from the second quarter.

While companies working in A.I. received record levels of venture funding, digital health start-ups overall did not fare as well. Companies developing digital health solutions raised $3.2 billion in 328 deals during the third quarter, down from $4.1 billion in 372 deals during the second quarter, and $5.3 billion in 389 deals a year ago.

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Phone-Based Infectious Disease Diagnostics Being Developed

Aedes albopictus mosquito

Aedes albopictus mosquito, one of those responsible for spreading West Nile and chikungunya viruses (

8 Nov. 2019. An engineering lab is building a system for diagnosing viral infectious diseases with blood samples analyzed by a smartphone add-on. The project by the micro- and nanotechnology lab at University of Illinois in Urbana, is funded by a four-year award from National Institute of Allergy and Infectious Diseases, part of National Institutes of Health, with $448,000 funded for the first year.

A team led by electrical and bio-engineering professor Brian Cunningham aims to create a hand-held system that can analyze a drop of blood in 30 minutes, and report the presence of disease-causing viruses, such as Zika, dengue, or chikungunya from the blood sample. The system will use a smartphone’s rear-facing camera and Internet connectivity, supplemented by a clip-on microfluidic cartridge.

The cartridge is expected to carry out a reverse-transcription loop-mediated isothermal amplification, or RT-LAMP, that analyzes RNA from the pathogen in real time. That analysis traces the RNA chemistry in the pathogen to its DNA source for identifying the responsible virus. The blood sample first interacts with paper test strips with dried pathogen primers made of short nucleic acid sequences, then the smartphone’s camera captures a video sequence of fluorescence images as the RT-LAMP analysis proceeds. The lab says preliminary data show its smartphone system returns results equivalent to conventional DNA analytical instruments, only the phone-based platform is expected to cost about $500.

“This device can substantially reduce the time, cost, and inconvenience of doing a standard lab test, while still incorporating all the controls that make the test valid,” says Cunningham in a university statement. “The information can then be shared immediately with an online health care provider who can make decisions about treatment.”

The researchers also need to create robust algorithms for analyzing the raw data that work under far from perfect conditions. “We will have to model the signal and noise,” adds Illinois electrical and computer engineering professor Minh Do, “due to many non-ideal conditions in the field, to come up with an optimal processing algorithm.” Do is a co-investigator on the project with Cunningham.

The team plans to build a prototype system for lab testing, then test the platform under real-world conditions in Brazil. The researchers are collaborating with colleagues at an infectious disease institute in Brazil for that part of the project.

Science & Enterprise reported in August 2017 on an earlier version of a smartphone-based diagnostics system from Cunningham’s lab called the TriAnalyzer. That device acts as a high-resolution spectrometer, a common piece of lab equipment that measures changes in light waves through a sample to determine its composition.

At the time of our story, Cunningham and the university received a patent on the technology but were still seeking an industry partner for licensing. Since then, the company Reliant Immune Diagnostics, now known as MDBox, in Austin, Texas licensed the TriAnalyzer technology and is developing it into smartphone-based telemedicine device.

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Artificial Kidney Component Passes Preclinical Test

Kidney illustration

(Sheldahl, Wikimedia Commons)

8 Nov. 2019. A miniaturized bio-electronic device implanted in a pig can process filtered blood like a real kidney without triggering an immune response or blood clots. Developers of the device from University of California in San Francisco and partner institutions reported on the advance yesterday at the Kidney Week meeting in Washington, D.C., sponsored by American Society of Nephrology.

The tested device is a bio-reactor, part of an implanted artificial kidney in development by the Kidney Project, an initiative of UC San Francisco and Vanderbilt University in Nashville. The artificial kidney aims to help people with end-stage renal disease, a life-threatening condition where the kidneys almost completely fail, and the only treatment options are frequent dialysis sessions to clean impurities from the blood, or a transplanted kidney with donors in short supply. According to the Kidney Project, some 750,000 people in the U.S. and 2 million people worldwide have end-stage renal disease.

The Kidney Project’s device has a filter to capture impurities in blood and a bio-reactor to perform metabolic functions. The filter has silicon membranes with pores less than 10 nanometers in size, where 1 nanometer equals 1 billionth of a meter. The bio-reactor has tubule cells from human kidneys that process the filtered blood plasma into urine, maintain healthy pH and potassium levels in the blood, as well as produce essential hormones. The silicon filtering membranes also seal off the tubule cells in the bio-reactor to prevent an immune-system reaction.

The researchers first bench-tested the artificial kidney to evaluate the system’s performance in simulated conditions. The simulated lab tests show the bio-reactor enables filtered plasma to flow through, with more than 90 percent of the human tubule cells remaining viable. When implanted into a pig for three days, an animal with organs about the same size and functionality of humans, more than 90 percent of the tubule cells also remain viable, and with no blood clotting. In addition, the device does not cause an immune reaction in the pig, which suggests it may not need drugs to suppress these reactions in humans.

Shuvo Roy, a bio-engineering professor at UC San Francisco and technical director of the Kidney Project says in a university statement released through EurekAlert, “We couldn’t use the standard blood-friendly coatings that have been developed for heart valves, catheters, and other devices because they are so thick that they would completely block the pores of our silicon membranes. One of our accomplishments has been to engineer a suitable surface chemistry on our silicon membranes that makes them look biologically friendly to blood.”

The project’s goal is a device that can be powered by electrical signals from the heart, while still remaining small and friendly to the immune system, without the need for extra drugs. The team now plans to scale up the bio-reactor to include more tubule cells and test the device in animals with induced kidney failure, with the eventual goal of human clinical trials.

Roy and Kidney Project medical director William Fissell at Vanderbilt University are founders of the company Silicon Kidney LLC in San Francisco, commercializing the project’s technology. Silicon Kidney is the recipient of several Small Business Innovation Research grants, the latest in 2018 from National Institutes of Health for an implantable dialysis system to treat people with end-stage renal disease.

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Engineered Organ Transplant Company Raises New Funds

Two piglets

(Skeeze, Pixabay)

7 Nov. 2019. An enterprise that applies gene editing to create replacement organs from pigs for human transplant is raising $100 million in new venture financing. The biotechnology company eGenesis Inc. in Cambridge, Massachusetts is spun-off from genetics research at Harvard Medical School.

eGenesis aims to fill a critical gap in organ donations where the need for new organs far outstrips the supply. According, more than 113,000 people in the U.S. are on the waiting list for donated organs, with another person added to the list every 10 minutes. And despite more than 36,500 organ transplants performed in 2018, some 20 people die each day waiting for a transplant.

The company’s technology uses the gene-editing technology Crispr to enable transplanting organs from pigs, which have organs much the same size and functioning as humans, a process called xenotransplantion. Crispr, for clustered regularly interspaced short palindromic repeats, is derived from bacterial defense systems that use RNA to guide genome-cutting enzymes to precise locations to make the desired edits.

In this case, eGenesis uses Crispr to remove serious obstacles preventing xenotransplantion. One obstacle is the presence of the porcine endogenous retrovirus in pigs, a virus that infects and spreads through human cells. As reported in Science & Enterprise in August 2017, researchers from eGenesis and Harvard edited the genomes in pigs to deactivate the gene responsible for the virus, and enable the deactivated virus to be passed on to future generations. The company also employs Crispr to remove other genetic-based incompatibilities from pig organs that provoke a damaging immune-system response.

eGenesis is a four year-old company co-founded by Luhan Yang, a postdoctoral researcher at Harvard, working in the lab of geneticist and company co-founder George Church. Yang is eGenesis’s chief scientist, while Church is a scientific adviser. eGenesis’s lead program is producing replacement kidneys from pigs, but is also advancing islet cells for insulin production in the pancreas. Both programs are in preclinical testing. In 2017, Yang founded another company, Qihan Biotech in Hangzhou, China, that develops Crispr gene editing techniques for regenerative medicine and collaborates with eGenesis on xenotransplantation.

The new $100 million funding is the company’s second venture financing round. The round is led by the venture capital arm of Fresenius Medical Care based in Bad Homburg, Germany, a developer of products and services for people with chronic kidney disease. Joining the funding are previous investors ARCH Venture Partners, Biomatics Capital, Alta Partners, and Khosla Ventures, as well as new investors Wellington Partners and Leaps by Bayer, the pharma/chemical company’s venture arm. In its first venture round in March 2017, eGenesis raised $38 million.

“The concept of cross-species organ replacement, known as xenotransplantation,” says eGenesis president and CEO Paul Sekhri in a company statement, “has re-emerged due to recent advancements in gene editing led by eGenesis, and will become a safe and effective solution for the hundreds of thousands of patients currently on the organ transplant waitlist globally.”

As noted as recently as this week in Science & Enterprise, Church is a serial entrepreneur, founding or licensing discoveries from his labs to dozens of start-up and spin-off enterprises, including eGenesis.

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