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AI Image Analysis Shown to Predict Embryo Health

IVF microscopic image

In-vitro fertilization (Elena Kontogianni, Pixabay. https://pixabay.com/photos/ivf-fertility-infertility-1514174/)

28 June 2022. An algorithm designed to analyze microscopic images is shown to largely predict the genetic integrity of embryos from in-vitro fertilization. Findings from a study evaluating the technology developed by Presagen, an artificial intelligence health analytics company in San Francisco, appear in the 8 June issue of the journal Human Reproduction.

Presagen creates analytics based on A.I. to address women’s health. The company says it collaborates with clinics worldwide to design its algorithms, for analytics that represent a wide range of races and ethnic groups, as well as identify potential errors early in their development. For embryo health algorithms, Presagen established Life Whisperer, a subsidiary that works with in-vitro fertilization or IVF clinics to analyze images of early embryos for viability to find the healthiest candidates for implantation. Life Whisperer says it offers a cloud-based service that captures data and returns results quickly to IVF clinics worldwide.

One of the Life Whisperer algorithms analyzes a blastocyst formed a few days after fertilization for chromosome abnormalities. A healthy blastocyst has 46 chromosomes indicating normal genetic development, but those with different numbers, called an aneuploid, indicate a greater chance for developing into a genetic disorder. The current method for discovering genetic abnormality in a blastocyst is the pre-implantation genetic testing for aneuploidy or PGT-A test. That test uses a biopsy to take a tiny sample of cells from a blastocyst for genetic analysis. Presagen says PGT-A tests are invasive and risky to the developing embryo, with additional high costs for genetic testing.

Correlated algorithm to PGT-A results

A team from Presagen developed the Life Whisperer algorithm trained with blastocyst images collected from 10 IVF clinics in the U.S., Spain, India, and Malaysia. Some 5,050 microscopic blastocyst-stage embryo images at day five of development were selected from a pool of more than 15,000 images to train the algorithm. The microscopic images were also linked to PGT-A genetic test metadata. The researchers correlated analytics from the algorithm with PGT-A test results, looking for accuracy in predicting a genetically healthy blastocyst called a euploid, or an aneuploid, a genetically abnormal blastocyst.

The findings show the Life Whisperer algorithm accurately predicted euploid status 77 percent of the time in a blind-test data set, following removal of poor-quality or mislabeled images. In addition, the researchers found a high probability, from 82 to 97 percent, of an embryo with a high score from the A.I. algorithm also being a euploid, with the rank-order of algorithms scores about 26 percent higher than from random ranking. Further analysis shows results from the algorithm generalized well to patient demographics, and could also detect mosaic embryos, where mistakes in cell division occur, leading to miscarriages or birth defects.

Sonya Diakiw, Presagen’s chief medical scientist and lead author of the paper, notes in a company statement that the Life Whisperer algorithm will not likely replace the PGT-A test, but can still be a valuable tool for IVF decisions. “Because this assessment is based on images alone,” says Diakiw, “it is not as accurate as PGT-A itself, which involves actual DNA sequencing.” Diakiw adds however, “PGT-A only tests five cells from a total of around 200, so it is not always representative of the entire embryo. Life Whisperer genetics is a whole-embryo assessment of genetic integrity that does not require any invasive procedures, which can be used to prioritize embryos for use in IVF procedures.”

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Diagnostics Companies Partner on Monkeypox Test

Patient with monkey pox

Person in Democratic Republic of the Congo with monkeypox (CDC.gov)

27 June 2022. Two developers of tests for infectious diseases are collaborating on a molecular test to detect monkeypox, an emerging international public health concern. Financial terms of the agreement between Cepheid in Sunnyvale, California and BioGX Inc. in Birmingham, Alabama were not disclosed.

Monkeypox is a viral zoonotic disease, one that spreads from animals to humans, occurring initially in central and west Africa. The virus is part of the orthopoxvirus sub-family that includes smallpox, with symptoms similar to smallpox. Those symptoms typically last two to four weeks, including a rash with raised blisters, fever, headache, muscle aches, chills, fatigue, and swollen lymph nodes. Monkeypox is spread from lesions on the skin through close physical contact, such as sexual or close respiratory contact, or with infected materials like bedding. The disease is considered less contagious and deadly than smallpox, with a fatality rate of three to six percent.

Up to recently, monkeypox has been a health concern in central and west African countries. According to World Health Organization, the disease began spreading outside of Africa in 2003 through contacts with wild animal pets, then from contacts with Nigerian travelers to Israel and the U.K. starting in 2018. From 2019 to 2022, cases were reported in the U.S. and Singapore. Centers for Disease Control and Prevention says as 24 June 2022, 201 confirmed cases of monkeypox or other orthopoxvirus are reported in the U.S.

PCR needed for definitive diagnosis

Cepheid designs and develops diagnostic molecular diagnostic tests to detect genetic indicators of infectious diseases and cancer built on an automated platform. That platform, called GeneXpert, uses polymerase chain reaction or PCR, a genetic lab technique that quickly reproduces short DNA segments from small samples to amplify the DNA for genetic analysis. In the  GeneXpert system, samples for testing are captured in interchangeable cartridges. In the case of monkeypox, samples for testing are taken from skin lesions. Because many monkeypox symptoms are similar to other diseases, says Cepheid, PCR testing is needed to give a more definitive diagnosis.

BioGX also makes diagnostic tests, including PCR tests, as well as materials including chemical reagents for PCR tests. Many of the company’s testing materials are lyophilized, or freeze-dried, which removes the need for refrigeration for storage or shipping. The two companies have worked together before. In a test of the GeneXpert cartridge system to detect monkeypox in Democratic Republic the Congo, published in a research journal in 2017, Cepheid used reagents made by BioGX.

“Our flexible cartridge program gives Cepheid the ability to work with external partners to develop accurate tests quickly when the need arises,” says Cepheid chief scientist David Persing in a company statement. BioGX’s founder and chief scientist Michael Vickery adds, “Regional response teams need a PCR test that is fast and easy to implement when they suspect an outbreak due to a novel pathogen.”

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Infographic – Q1 Mental Health Tech Funds Drop

Mental health tech venture funds

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

25 June 2022. After a year of nearly constant gains in 2021, venture investments in digital mental health companies took a sharp drop in the first quarter of 2022. Technology intelligence company CB Insights issued a report this week (registration required) on these trends, which reflect the overall pattern of digital health funding so far this year.

The CB Insights data show venture funds for digital mental health technologies fell by 60 percent in the first three months of 2022 to under $800 million, from nearly $2 billion in the fourth quarter of 2021. The number of venture deals in this sector also dropped but less dramatically from 87 in Q4 2021 to 76 in Q1 2022. Throughout 2021, venture investments in digital mental health start-ups rose in three of the four quarters, almost doubling from about $1 billion in Q1 to $2 billion by the end of the year.

The decline in investments for mental health technology start-ups reflects a cooling of venture capital interest in digital health companies overall. CB Insights says digital health venture dollars dropped 36 percent from $16.2 billion in the fourth quarter of 2021 to $10.4 billion, with the number of deals falling from 709 to 653. As with venture funds for mental health technology companies, investments in digital health start-ups overall generally rose in 2021 compared to the previous year.

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FDA Issues Action Plan for Rare Neuro Diseases

Man in wheelchair

(PXHere)

24 June 2022. The Food and Drug Administration published its blueprint to encourage new treatments for rare neurodegenerative disorders, including ALS. FDA says its five-year action plan seeks to promote more innovative medical products addressing amyotrophic lateral sclerosis or ALS and other rare degenerative diseases of the nervous system, as specified in legislation enacted late last year.

The Accelerating Access to Critical Therapies for ALS, or ACT for ALS bill calls for FDA to create a five-year plan to encourage new drug and medical device development addressing rare neurodegenerative diseases, such as ALS. The law also asks FDA to increase access to investigational therapies, and provide financial support in grants or contracts to cover costs of research for prevention, diagnostics, and treatments for these diseases. In addition, the law calls for FDA to work with National Institutes of Health to establish a public-private partnership, with funding through cooperative agreements or contracts, to advance understanding and new therapies for ALS and other rare neurodegenerative disorders. The bill authorizes $100 million over five fiscal years for these measures.

ALS, also known as Lou Gehrig’s disease, is a progressive disorder where neurons in muscles start wasting away, and no longer send or receive signals from the brain or spinal cord. As these nerve cells stop working, muscles in the limbs, followed by speech and breathing muscles, begin weakening and eventually stop functioning. Most people with ALS die of respiratory failure. According to Johns Hopkins University, ALS affects some 30,000 people in the U.S., with 5,000 new cases reported each year.

Fewer biomarker targets and and preclinical models

“We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” says FDA commissioner Robert Califf in an agency statement. “To face that challenge and to accelerate drug development, we need innovative approaches to better understand these diseases while also building on current scientific and research capabilities.”

FDA’s action plan notes that ALS and other rare neurodegenerative diseases are difficult to study because of their small numbers of occurrences, and thus have few new therapies in current pipelines. Molecular drivers and mechanisms of these disorders, says the agency, are less understood, with fewer biomarker targets and and preclinical models, resulting in fewer new diagnostics or drugs, and lower success rates in clinical trials for new product candidates.

FDA’s plan includes a science strategy to address these knowledge gaps for ALS. The agency says it plans to support research that better defines and quantifies the progression of ALS in the body and reveals more biomarkers for predicting disease progression. The science strategy also proposes more flexibility in clinical trial design, including decentralized studies and digital data gathering, and improved access for patients to reduce their time and cost. Better access to clinical trials, says FDA, can also provide greater access to therapies in development. Similar science strategies are planned for other rare neurodegenerative disorders.

For the immediate future, FDA is establishing with NIH a public-private partnership for rare degenerative diseases to encourage new treatments and better tools for drug development. And FDA is setting up an internal rare disease taskforce to coordinate actions related to new therapies among its drug, biologics, and orphan products offices. In May, the agency began a program to accelerate development of treatments for rare diseases, which will establish a working group for neurodegenerative disorders.

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An Ultimate Guide to Engineering Consulting Firms

Post removed at request of sponsor.

Trial Underway of Nasal Spray Flu Vaccine

3-D print of influenza virus

3-D print of influenza virus (National Institute of Allergy and Infectious Diseases, NIH)

23 June 2022. A clinical trial has begun testing an influenza vaccine given as a nasal spray with a conventional syringe-delivered vaccine among older U.S. adults. The study is conducted by the vaccine developer FluGen Inc., a biotechnology company in Madison, Wisconsin, and funded by a grant from the U.S. Department of Defense.

While the Covid-19 pandemic captured much of the public’s attention in the past three years, influenza or flu remains a public health concern, particularly for older populations. The flu virus has two main types, influenza A and B, with influenza A made up of combinations of 18 hemagglutinin proteins and 11 neuraminidase proteins, abbreviated to H and N. Because flu viruses mutate continually, called viral drift, the precise targets of H and N proteins are difficult to predict from year to year. And, vaccines need a long lead time for production, requiring those targets to be decided months in advance.

FluGen says it creates an influenza vaccine that addresses these issues. The FluGen technology uses a live engineered influenza virus with a part of a key gene called M2 removed. The full M2 gene is reconstructed only during production of the vaccine, which the company says limits the virus’s replication to just one time. FluGen says the M2 deleted, single-replication or M2SR live viruses, infect cells when given as a vaccine, but do not spread, yet still generate immune responses against the full range of influenza RNA and proteins. In addition, says the company, M2SR viruses generate immune responses in mucus membranes, antibodies, and cells.

Combinations of nasal spray, injection, or placebo

The early-stage clinical trial is enrolling 300 healthy participants, age 65 to 85, considered a vulnerable population to influenza, at four sites in the U.S., with the first of those individuals enrolled. Participants are randomly assigned to one of four groups receiving combinations of a FluGen nasal spray vaccine designed for the H3N2 flu virus that emerged in 2020 and conventional high-dose quadrivalent flu vaccine, or nasal spray and vaccine placebos.

The study team is looking primarily for signs of adverse effects in the first seven days after receiving vaccines and/or placebos, then for the next three weeks, particularly serious adverse effects. The company says participants are also assessed for their immune responses during this time, including production of anti-viral T-cells.

FluGen is spun-off from research labs at University of Wisconsin veterinary medicine school in Madison, founded in 2007. In Sept. 2018, Science & Enterprise reported on an earlier clinical trial of the company’s technology with children and teens, sponsored by National Institute of Allergy and Infectious Diseases.

“We have seen numerous approaches to solving the challenge of influenza vaccine efficacy over the past decade,” says Yoshihiro Kawaoka, professor of virology at UW-Madison and a co-founder of FluGen in a company statement, “but despite these efforts, none have achieved the efficacy needed to improve health outcomes. This study is important, as it is the first of its kind to combine intranasal vaccine delivery with intramuscular shots to determine the potential for boosting vaccine efficacy and reducing transmission and virus shedding.”

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Biotech in $1.5B Gene-Editing Tech License Deal

Sickle cell illustration

Sickle cell illustration (National Heart, Lung, and Blood Institute)

22 June 2022. A biotechnology company is licensing a gene-editing enzyme to Novartis to create treatments for inherited blood disorders such as sickle cell disease. Precision BioSciences Inc. in Durham, North Carolina says the deal with global drug maker Novartis could earn the company as much as $1.475 billion if all terms of the agreement are fulfilled.

Precision BioSciences is a developer of a genome editing process applied first to engineered crops and now to therapies for cancer, as well as infectious and inherited diseases. That technology, called Arcus, uses the company’s own synthetic enzymes known as homing endonucleases that target specific DNA sequences, often longer sequences that occur infrequently in the genome. The company says its homing endonucleases also perform editing tasks. Precision Bio says the synthetic enzymes are compact in size, which makes them suitable for precise genome edits, and reduces the risk for off-target damage.

The company is developing treatments for blood-related cancers that edit genes in T-cells from healthy donors to add chimeric antigen receptor or CAR proteins. These off-the-shelf CAR T-cells are then able to find and attack cancer cells, says Precision Bio, while sparing non-cancerous tissue, thus reducing adverse effects. Three of the four cancer treatment candidates are in clinical trials. Precision Bio is also developing genome-edited therapies that work in vivo, or inside the body, for several infectious and inherited diseases, all of which are in research, discovery, or preclinical stages.

Edit the disease-producing genes

Under their agreement, Novartis and Precision Bio are collaborating on an in vivo genome editing therapy for the inherited blood disorders sickle cell disease and beta thalassemia. In sickle cell disease, the protein hemoglobin that normally delivers oxygen to cells in the body, also causes blood cells to become crescent or sickle shaped instead of their normal round form. The abnormal shape causes blood cells to break down, become less flexible, and accumulate in tiny blood vessels, leading to anemia and periodic painful episodes. People with beta thalassemia produce lower levels of hemoglobin in their blood.

The deal calls for Precision Bio to develop a nuclease enzyme with Arcus that can be safely inserted into the genome for transfer in vivo to patients with sickle cell disease or beta thalassemia. The enzyme would be designed to edit the disease-producing genes in patients with these inherited blood disorders. Novartis would then receive an exclusive license to the nuclease to further develop into a one-time treatment for sickle cell disease and beta thalassemia. Precision Bio is responsible for initial preclinical testing of the nuclease, while Novartis will conduct further R&D, manufacturing, and commercialization work.

The agreement calls for Precision Bio to receive an upfront payment from Novartis of $75 million, and is eligible for further milestone payments totaling $1.4 billion. In addition, Precision Bio is eligible for research support from Novartis, as well as royalties on sales once any products reach commercialization.

Michael Amoroso, CEO of Precision Biosciences, says in a company statement, “This collaboration will build on the unique gene insertion capabilities of Arcus and illustrates its utility as a premium genome editing platform for potential in vivo drug development.” Jay Bradner, president of the Novartis Institutes for Biomedical Research, calls the partnership an opportunity to create, “a potential one-time treatment administered directly to the patient that would overcome many of the hurdles present today with other therapeutic technologies.”

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Gene Therapy Start-Up Gains $38M in Early Funds

Gene therapy graphic

(Genome Research Limited, Flickr)

21 June 2022. A new company developing genetic treatments with a high-capacity engineered virus to deliver its therapeutic payloads is raising $38 million in venture funds. Carbon Biosciences in Lexington, Massachusetts is based on research at University of Iowa and University of Massachusetts medical schools, and founded last year by Longwood Fund in Boston.

Carbon Biosciences is creating gene therapies using paroviruses to deliver genetic materials to target cells and tissue. One form of parovirus can infect humans causing a mild rash called fifth disease that mainly affects children, while other forms affect household pets. Robert Kotin, a microbiologist at UMass medical school in Worcester and one of Carbon Bio’s scientific founders, studies paroviruses and reported on their potential for delivering larger and more complex gene therapies than adeno-associated viruses used in many of today’s gene therapies. Kotin is also Carbon Bio’s chief scientist.

Another of Carbon Bio’s scientific founders is John Englehardt, a cell biologist at University of Iowa in Iowa City and director of the school’s gene therapy center. Englehardt and associates study gene therapies to treat cystic fibrosis, a disease of glands producing mucus in the lungs and airways. In its normal state, mucus keeps lungs and airways moist, and also helps prevent infections, but in some cases genetic mutations passed from parents to children can create thick and sticky mucus that builds up in lungs and airways. Because of this accumulated mucus, bacterial infections are easier to form in the lungs, making cystic fibrosis a debilitating disease.

Deliver a full-length gene

In a paper published last year, Englehardt and a colleague outlined the limits of adeno-associated viruses in delivering gene therapies for cystic fibrosis, particularly their inability to transfer the full cystic fibrosis transmembrane conductance regulator or CFTR gene needed to replace mutated genes in people with the disease. That transfer vehicle, noted the authors, needs to deliver a treatment with high tropism or payload capacity to deliver the full healthy gene and avoid multiple doses of partial gene segments.

Carbon Bio’s first gene therapy candidate, code-named CGT-001, is a genetic treatment for cystic fibrosis using an engineered parovirus as the delivery vector. Because of the parovirus’s larger capacity, the company believes its technology can address limitations of adeno-associated viruses with gene therapies for this disease. “Our lead program,” says Englehardt in a company statement released through BusinessWire, “is the first gene therapy program demonstrating tissue tropism to the lung with the capacity to deliver the full length CFTR gene and an appropriate promotor.” Englehardt, an advisor to Carbon Bio, adds that “pre-clinical data as well as studies on human populations suggest wide applicability of our lead clinical candidate ….”

Longwood Fund founded Carbon Biosciences last year, and is taking part in the company’s first venture round raising $38 million. Leading the round is Agent Capital, a health care venture investor in Waltham, Mass. Also taking part in the financing are Cystic Fibrosis Foundation, Solasta Ventures, University of Tokyo Innovation Platform, Astellas Venture Management, and Camford Capital. Cystic Fibrosis Foundation supports start-ups developing treatments both with venture investments and, as reported by Science & Enterprise in April 2022, a challenge competition for new genetic therapies.

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Measuring Machines And Why They Matter

– Contributed content –

Industrial laser

(Opt Lasers, Unsplash. https://unsplash.com/photos/-3heA4-yTlQ)

20 June 2022. Coordinate measuring machines are devices that are used to measure the dimensions of objects. There are a variety of different types of coordinate measuring machines, each with its own advantages and disadvantages.

What Is A CMM?

A coordinate measuring machine is a tool used to measure the physical characteristics of an object. Coordinate measuring machines are used in a variety of industries, including automotive, aerospace, and medical device manufacturing.

How Does It Work?

Coordinate measuring machines use a variety of sensors to measure the dimensions of an object. The most common type of sensor is a laser interferometer. Laser interferometers use a laser beam to measure the distance between two points.

Other types of sensors include capacitive sensors, which measure the change in capacitance between two electrodes; optical sensors, which measure the reflection of light off an object; and ultrasonic sensors, which measure the time it takes for sound waves to bounce off an object. These parts are available at Metrology Parts.

Where Are They Used?

Coordinate measuring machines can be used to measure a variety of objects, including engine parts, medical implants, and electronic components. Coordinate measuring machines are also used to inspect objects for quality control purposes.

What Are Vision Systems?

A vision system is a type of coordinate measuring machine that uses a camera to take pictures of an object. The images taken by the camera are then processed by a computer to extract measurements from the image.

How Do They Work?

Vision systems work by taking multiple pictures of an object from different angles. The computer then uses algorithms to process the images and extract measurements from the images.

What Are Their Benefits?

Vision systems have a number of benefits over other types of coordinate measuring machines. Vision systems are faster, more flexible, and more accurate than other types of coordinate measuring machines. Additionally, vision systems can measure objects that are difficult or impossible to measure with other types of coordinate measuring machines.

What Is A CNC Machine?

A CNC machine is a type of coordinate measuring machine that uses computer-controlled motors to move its sensors across an object. CNC machines are used in a variety of industries, including automotive, aerospace, and medical device manufacturing.

How Do They Work?

CNC machines work by moving their sensors across an object in a pre-programmed path. The sensors take measurements as they move across the object. The measurements are then used to control the machine’s motors, which adjust the position of the sensors.

What Are Their Benefits?

CNC machines have a number of benefits over other types of coordinate measuring machines. CNC machines are more accurate and more precise than other types of coordinate measuring machines. Additionally, CNC machines can be used to measure objects that are difficult or impossible to measure with other types of coordinate measuring machines.

In Conclusion

Coordinate measuring machines are a vital tool in a variety of industries, and their use is expected to become more widespread in the future. CNC machines are the most accurate and precise type of coordinate measuring machine, and their use is expected to grow as they become more affordable. Vision systems are also becoming more popular due to their speed, accuracy, and flexibility.

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Trial Underway of AI Depression Guidance System

Depression

(Ulrike Mai, Pixabay. https://pixabay.com/photos/woman-desperate-sad-tears-cry-1006100/)

20 June 2022. A clinical trial has begun testing a system based on artificial intelligence to help clinicians prescribe personalized care for depression in patients. The trial is evaluating technology developed by Aifred Health Inc., a digital health company in Montreal, Quebec, Canada, the sponsor of the study.

Aifred Health is a five year-old enterprise that seeks to improve care for people with depression, a common mental health condition affecting five percent of the global adult population, or about 280 million people, according to World Health Organization. And Centers for Disease Control and Prevention says one in six Americans will experience depression during their lifetimes. The company cites data showing the current trial-and-error approach to prescribing therapy or medications for depression is often ineffective, with 70 percent of patients not responding to initial treatments, and as many as 30 percent still not responding to a fourth prescribed treatment.

Aifred Health says its technology analyzes behavioral health data directly from the patient, either in-person or using telehealth. The company says its system, based on best-evidence clinical guidelines, use artificial intelligence algorithms to process the data from patients. Outputs from the system, says Aifred Health, help clinicians identify the stage of a patient’s depression, and guide next steps for therapy, such as psychotherapy or medications.

Looking for adverse effects and reductions in symptoms

The clinical trial is enrolling 350 participants diagnosed with major depression rated moderate to severe, at 12 sites in the U.S. and Canada, including Veterans Affairs hospitals. All trial participants provide data on their conditions to the Aifred Health system, but only some randomly selected clinicians receive reports from the system to guide decisions about further therapy for their patients. The company says the trial’s first participant began receiving treatment.

Participants in the trial are followed for three months, with the study team looking primarily for signs of adverse effects and reductions in depression symptoms. The team is also tracking time needed for patients to reach remission, response rate to treatments, and extent of disability as measured by a standard WHO rating scale. The company hypothesizes that trial participants treated by clinicians receiving reports from the Aifred Health system will reach remission sooner, respond more readily to treatments, and score lower on the disability scale than participants with clinicians not receiving reports. (Science & Enterprise asked the company for more details on measuring effects of interventions in the trial.)

“We have been collaborating with clinicians and clinical centers for more than three years,” says David Benrimoh, Aifred Health’s chief scientist in a company statement released through Cision, “to inform and guide our development of a decision support tool that will integrate into clinical workflow and be used by treating physicians to positively impact care. If the clinical trial validates our hypothesis, I expect the rapid adoption of Aifred’s technology across North America, as the advantages for the patients, doctors, and hospitals are crystal clear.”

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