August 8, 2022

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FIERCE Biotech released  top 15 medical technology companies in 2020

FIERCE Biotech released  top 15 medical technology companies in 2020

 

FIERCE Biotech released  top 15 medical technology companies in 2020.  The response of the medical technology industry to COVID-19 has been enthusiastic, innovative and positive.

The world is calling for emerging technologies such as tests to track the COVID-19 epidemic and the development of treatments. For example, ventilators to help people breathe and reliable vaccines for millions of people. At the same time, many companies rearranged their R&D pipelines to respond to new threats, and all companies were forced to adapt to the adverse effects of the COVID-19 epidemic. For example, lock down or close the laboratory, turning the office into a home office.

FIERCE Biotech released  top 15 medical technology companies in 2020

All companies this year have the potential to provide treatment changes that may last longer than this pandemic.

Each of these 15 companies selected this year has stood out in a different way, but they have overcome the unforgettable obstacles of last year, which makes each of their successes more important. More importantly, their progress may lead to changes in the way of treatment.

Including the use of artificial intelligence to screen large amounts of data to find treatments that may be related to global diseases, or to perform gene editing and on-demand diagnosis as needed to quickly identify diseases when needed.

It also includes the use of technology to guide professionals, which can assist the pathologist or assist in the heartbeat. They can help us observe the health of the brain and the inner workings of cells, or ensure the safety of new mothers.

There will always be more work to be done in the future, but every advancement in the medical technology industry makes these problems easier to climb. This is a better direction for clinicians, developers of treatment methods, and especially for patients.

1. Alydia Health

CEO: Rob Binney
Established time: 2010

Alydia Health’s Jada system uses an original method to treat postpartum hemorrhage, applying a light vacuum to the inside of the uterus to pull the muscle walls together and maintain its natural shape.

In the past three decades, the maternal mortality rate in the United States has been steadily increasing. Despite the high level of medical technology and technology, many childbirth-related deaths can be prevented due to infection or excessive bleeding.

It is common that the uterine muscles become so exhausted during childbirth that they lack enough energy to fully contract, which opens up the blood vessels connected to the placenta and puts the mother in danger.

Alydia Health’s Jada system uses an original method. It applies a vacuum to the inside of the uterus, pulling the muscle walls together and maintaining its natural shape. Fundamentally, the device has a core medical technology: applying pressure to stop bleeding.

However, the way it works is actually the opposite of an intrauterine balloon, which inflates to provide pressure in an emergency-but may be contrary to what the body is ultimately trying to do. Other blood control methods include uterine massage and drugs designed to cause muscle contraction, as well as their side effects and contraindications.

“The challenge of postpartum hemorrhage is that you just don’t know-it is almost impossible to predict which patients will not respond to treatment,” said Rob Binney, CEO of Alydia.

The Jada device includes a soft silicone ring with fine holes inside to prevent the surrounding tissues from being squeezed, while providing very gentle suction-the pressure is equivalent to the force of blood at rest between two heartbeats, or it can barely lift the table Put a piece of paper on it. The vacuum device is connected to a cylinder that can measure the amount of blood collected, so that the clinician can more clearly understand the patient’s condition. In a published clinical study, the system showed that bleeding can be completely controlled in about three minutes, with a success rate of 94%.

2. Avail Medsystems

CEO: Daniel Hawkins
Established time: 2017

Avail provides consoles to hospitals and surgical centers for free, rather than charging for the time spent using the equipment.

In operations involving medical devices, patients, surgeons, and staff are not the only people in the operating room. The sales representative of the company that manufactures the product usually needs to be there.

“Procedural health care has an obligation to have external personnel enter the operating room. This is everything from medical education, training to new product launches, and continuous product support after the product launch,” Avail Medsystems CEO Daniel Hawkins said.
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The problem is that requiring them to visit in person means that the patient’s surgery may be unexpected due to a variety of reasons, such as the limited travel budget of equipment manufacturers, flight delays and cancellations, and even a global pandemic.

This is not a problem that only affects individual patients. This requirement can delay the procedures required to complete the clinical trials required for FDA approval, thereby increasing the time to use new or improved equipment for patient care.

Avail provides a solution: to virtualize this state. It builds a portable console that can connect doctors in the operating room with industry experts who may be anywhere. With the help of multiple remote-controlled high-resolution cameras, external experts can see and hear the process as if they are there, and can advise doctors in real time.

3. Babson Diagnostics

CEO: David Stein
Established time: 2017

With the support of Siemens and BD, Babson’s goal is to collect laboratory-quality blood samples in pharmacies and other places without any training.

With more convenient locations, shorter waiting times and lower prices, blood testing becomes easier, and Babson Diagnostics removes the barriers that prevent people from getting the tests they need.

Babson’s CEO David Stein took over the position from the company’s supporter Siemens in September last year, where he served as the head of global strategy and innovation and the head of immediate medical services for the medical technology giant.

Stein said that Babson was initially incubated at Siemens, and Siemens Medical is still a “very strong and supportive partner.” “When I left Siemens Medical Group, I never expected to join Babson, but I started to help Babson as a consultant and board member, and fell in love with the company’s mission, the company’s employees, and the permanent Influence,” he said. “I fell in love with the mission of the company because I saw that Babson has the potential to really help improve people’s lives.”

But just a few months after his tenure, the world was hit by the global pandemic. Although COVID-19 has disrupted many biopharmaceutical trials and work, it has had the opposite impact on medical technology and blood testing companies.

4. BenevolentAI

CEO: Joanna Shields
Founded: 2013

For many years, people have been encouraging and developing artificial intelligence in drug discovery as the future of drug discovery, but BenevolentAI is committed to turning this dream into reality.

For many life science companies, the coronavirus pandemic has been hit particularly hard, especially in traditional clinical trials, which have severely damaged clinical trial centers due to shutdowns. This pushed down the R&D work for months or even years.

However, for BenevolentAI, COVID has become a testing ground for its rapid AI-based drug discovery method, and the Anglo-American company urged Eli Lilly to conduct trials for its moderate arthritis drug (baricitinib) during COVID-19.

Unlike many other drugs used for disease detection, Olumiant is not blind: In a study published in The Lancet early last year, the BenevolentAI team suggested that Eli Lilly’s drugs can not only reduce inflammation, but also stop the virus. Enter infects lung cells by inhibiting a protein called AAK1.

This prompted Eli Lilly to launch a phase 3 trial in the summer. By October, the drug was used in combination with Gilead’s re-typed Ebola virus drug remdesivir, showing that it can shorten patients infected with COVID-19 compared to remdesivir. Recovery time and improve clinical outcome. In its own. The FDA quickly granted emergency authorization for the drug combination to certain hospitalized patients.

5. C2N Diagnostics

CEO: Joel Braunstein, MD, MBA
Established time: 2007

Last year, C2N launched the blood test PrecivityAD in the United States, and recently received the CE mark in the European Union.

C2N Diagnostics hopes to make the diagnosis of Alzheimer’s disease easier through its non-invasive blood tests.

Alzheimer’s disease is one of the cruelest diseases of mankind: it deprives people of memory and may make grandparents forget their grandchildren and even children. Some situations can drastically change a person’s behavior and character, causing their family members to lose someone they know.

What makes this situation even more cruel is that there are few drugs to treat this disease. According to data from the Centers for Disease Control and Prevention (CDC), in the past 20 years, the disease killed 121,404 Americans in 2017, making it the sixth most common cause of death that year.

The amyloid hypothesis is one of the theories used to treat the disease in experiments. This hypothesis believes that the accumulation of β-amyloid peptides is the main cause of the disease.

The idea is that when beta amyloid gathers together to form deposits in the brain, it triggers the neurodegenerative process, which leads to the loss of memory and cognitive abilities, which is observed in Alzheimer’s disease.

Biogen’s aducanumab treatment is currently undergoing FDA review, trying to remove these deposits as a treatment route. At the same time, C2N also believes that amyloid levels are a viable biomarker for assessing whether someone has the disease.

For the longest time, there has not been a simple and reliable test method for diagnosing Alzheimer’s disease. Currently, the diagnosis comes from tests by experts on the patient’s memory or intelligence, or from brain scans, which are usually done in the later stages of the disease process. Although the disease is irreversible, early treatment may help maintain its daily functions.

6. Canary Medical

CEO: William Hunter, MD
Established time: 2012

CEO Bill Hunter said: “I don’t respect wearables, but what happened on my left wrist can only tell me a lot about my right knee.” Walking knee: “smart” the implant for real-time Feedback.

Canary Medical is bringing the Internet of Things to medical equipment starting with an artificial knee. Its smart implants are designed to provide real-time feedback on how it works and the patient’s recovery.

Eventually, when the company collects enough data from enough patients, it plans to use machine learning to identify patterns that can help doctors find problems, such as infections or loose joints, before they get worse.

Canary’s method provides data from the implant itself, rather than through second-hand methods. Today, doctors collect data from imaging (MRI, CT scan, or X-ray) as well as postoperative visits and patient reports, and the latter are often unreliable.

At the same time, skeptics asked Canary CEO Bill Hunter why they couldn’t get the same type of data from wearable devices like Fitbit. Hunter said: “I don’t respect wearable devices, but what happened on my left wrist can only tell me a lot about my right knee.” “Data from my right knee provides details and understanding that are otherwise difficult to achieve. Level.”

 

7. Caption Health

CEO: Charles Cadieu
Established time: 2013

Cardiac ultrasound usually requires years of training and practice, coupled with skilled hand-eye coordination to correctly obtain a clear image, which may reveal signs of a heart attack or other serious conditions.

Caption Health is pursuing one of the great dreams of science fiction: smart enough hardware can provide advanced medical services anywhere and help providers quickly understand the hidden dangers of patients.

Its artificial intelligence driver can guide technicians, regardless of their previous experience, to gradually collect ultrasound images of the heart to observe the anatomy of the muscles and the force of the pump each time it beats.

Complex tasks usually require specialized training, years of practice, and skilled hand-eye coordination to properly operate the probe and obtain clear enough images to assess whether there are signs of a heart attack or other serious conditions.

But Caption’s AI knows what to look for, and can guide any professional’s actions in real time by prompting the professional to rotate and move the transducer slowly, for example, until the picture is viewable. The program then automatically records the best scan results and calculates important cardiac measurements, such as ejection fraction.

The device can be used in hospital emergency rooms as well as smaller clinics and doctors’ offices, making cardiac ultrasound a widely used skill and service.

Caption co-founder and CEO Charles Cadieu said: “This is one of the things I just thought about, because how AI will become a lever to improve the level of medical care in the entire medical environment.” said in an interview.

Ultrasound has become a particularly necessary diagnostic technique for COVID-19, because the new coronavirus can not only attack the lungs, but also the heart muscle. Cardieu said that Caption’s AI can allow hospital staff who are already in the room of a COVID patient to perform inspections without having to call for each procedure and possibly call for an expert.

 

8. Cue Health

CEO: Ayub Khattak
Established time: 2010

In order to provide fast turnaround time, Cue’s Instant Medical Center COVID-19 test is similar to the antigen test used for immediate care decision-making and virus control, and has become the NBA’s screening program.

In order to provide fast turnaround time, Cue’s Instant Medical Center COVID-19 test is similar to the antigen test used for immediate care decision-making and virus control, and has become the NBA’s screening program.

Cue Health has been focusing on new tests for influenza, but the pandemic has created new opportunities for him. Its instant medical COVID-19 test is designed to provide a fast turnaround time similar to that of an antigen test, and has become the first choice for the NBA and its protective players.

What makes Cue Health so hot: Cue has achieved tremendous growth in the past 12 months. The diagnostic company has grown from a staff of only 100 to more than 600, and it continues to grow. Once in full production, this will include actively recruiting its manufacturing operations and other company functions.

Last summer, the company also received an important $100 million in funding, based on a $13 million contract awarded by the U.S. Biomedical Advanced Research and Development Administration (also known as BARDA) in March. Cue has been working with BARDA since 2018 and previously signed a $30 million contract to develop tests for influenza A and B for use in the field or at home through online services. The test is currently undergoing clinical testing.

Then there is a major contract: In October 2020, the U.S. Department of Health and Human Services and the Department of Defense awarded Cue $481 million, which allowed the company to expand its industrial base and American production capacity. The contract between BARDA and HHS/DOD, plus a separate round of $100 million in financing, stems from its rapid response to the influenza pandemic in the form of a Cue COVID-19 test.

Cue was authorized by the FDA in June to use a nasal swab and reader to send the results to a connected smartphone app in about 20 minutes. As a highly sensitive and specific nucleic acid amplification test, it aims to provide a more accurate supplement to the first-line screening provided by rapid antigen testing.

The test box is a one-time-use independent device that can apply the reagents and related materials required for molecular detection of the SARS-CoV-2 virus that causes COVID-19.

In the second half of last year, the diagnostic test was used by the NBA to screen players and shipped to five states through a government pilot program under HHS. The company was not surprised by this.

Cue told Fierce Medtech that its goal is to provide the US government with 6 million COVID-19 tests and 30,000 cassette readers this year to support the ongoing pandemic response. The company said: “In addition to signing 6 million test contracts with the federal government, Cue is also committed to developing business with healthcare and corporate customers.” “Cue is expanding its facilities to enable it to manufacture 100,000 tests per day.”

 

9. CVRx

CEO: Nadim Yared
Established time: 2001

The CVRx device is implanted under the clavicle and attached to the carotid artery, and sends electrical pulses to the pressure-sensitive receptor to trick the brain into thinking that it is not getting enough oxygen.

Most treatments for heart failure focus on reducing the workload of the heart or directly reducing cardiovascular symptoms. They are traditionally divided into two main categories: drugs designed to make it easier for the heart to pump blood around the body, and devices that use electricity to control its rhythm.

CVRx takes a different angle. The Minneapolis-based device manufacturer did not create a device that interacts with the heart (which brings various risks), but instead treats heart failure by sending a separate message to the brain.

Its Barostim device was approved by the FDA in 2019 for the treatment of symptoms of heart failure. In the future, CVRx hopes to prove that it can change the course of the disease and reverse the condition.

 

10. Ellume

CEO: Sean Parsons
Founded: 2010

To return to work or enter public places, people often need to show their COVID-19 certificate, with constant updates and the latest results. The growing demand for coronavirus testing has put pressure on central laboratories to require other diagnostic methods.

Enter Ellume. The Australian company developed the first home COVID-19 test, which can be sold over the counter in the United States without a doctor’s prescription. It is funded by the National Institutes of Health’s “Rapid Diagnosis Acceleration Program”, which aims to accelerate the development and manufacturing of COVID tests.

Before Ellume conducts COVID home testing, there are other tests that allow patients to take samples at home and mail them to a central laboratory for analysis. But people have to wait a few days to get results. The FDA also authorized Abbott’s BinaxNOW and Lucira kits for rapid COVID testing at home, but people need a prescription to get them.

In contrast, consumers can immediately purchase Ellume’s test. Once the device has acquired a valid sample, it can produce results in about 15 minutes. And it is also accurate. In a simulated clinical study, the test showed that the positive results of symptomatic people were 96% consistent, while the more complex standard of care RT-PCR test had a negative rate of 100%. The prevalence of asymptomatic patients was 91% and 96%, respectively.

 

11. Foldax

CEO: Frank Maguire
Founded: 2013

Foldax’s Tria valve combines new biopolymers and location-specific designs, designed to last a lifetime without relying on anticoagulants.

Foldax is studying the next generation of heart valves along with a new manufacturing process, tap water robot technology, to make the process more efficient and pandemic proof.

Heart valves made of animal tissues have limited durability, are at risk of disease, and require complicated manual manufacturing. At the same time, mechanical heart valves can be durable, but because they need to rely on blood thinners for life, they will impair the quality of life of patients.

To overcome this problem, Foldax is developing three so-called Tria valves, whose purpose is to reimagine heart valves by combining new biopolymers and location-specific valve designs that are designed to be independent of anticoagulants. Understand for a lifetime.

Ken Charhut, Executive Chairman of Foldax, explained: “The new biopolymers used in the Tria valve are specially constructed at the molecular level, can withstand greater pressure than the human heart, and are biocompatible and biocompatible in any valve position. Biological stability.”

The company’s first product is the aortic surgery heart valve, which is currently undergoing clinical studies in the United States. Prior to this, the FDA approved an expanded study in October last year. The FDA approved its second device, the green certification of the mitral valve surgical valve, at the end of 2020, and conducted a clinical trial in the United States, while the third product is a replacement for the transcatheter aortic valve, which is in preclinical status. Testing phase.

Not only the technology itself, but also the continuous development of the manufacturing process has made this company stronger. Charhut said that global tissue valve manufacturing is the standard method for many heart valves. “It requires hundreds of thousands of square feet and thousands of people to manually manufacture tissue valves-this is an extremely complex and inefficient process.”

 

12. Hyperfine Research

Chairman and Founder: Jonathan Rothberg
Established time: 2014

Hyperfine’s scanner is the world’s first small and lightweight device, which can be installed in an elevator, and its design can be pushed to the patient’s bedside to scan the head and brain.

For about $5,000 a month, you can use a real, real electric MRI (provided by Hyperfine Research), Hyperfine Research aims to disrupt the market and plans to use its portable portable scanner to innovate imaging technology wheels.

The company brought its Swoop system to the market, not only as a reimagining of the typical scanner over 20,000 pounds in hospitals, but also as a brand new diagnostic method designed to compete with relatively more flexible and versatile X-ray and CT machines. .

Hyperfine’s scanner is the world’s first MRI. It is small in size and light in weight. It can be installed in an elevator and can be rolled to the patient’s bedside to scan the head and brain. It can be plugged into a daily power outlet and controlled by a dedicated iPad.

It may be particularly useful for patients in the intensive care unit or at high risk of stroke. By allowing the scanner to be brought to them instead of being transferred to the radiology room in the basement through the hospital, patients can be treated and still be placed in the presence of life-sustaining machines and their staff.

The company received the first FDA approval in February 2020, and six months later (49 days after it was submitted to the agency) a new green light was given to the second-generation device, allowing people of all ages to use it .

Since then, Hyperfine has also obtained a license for artificial intelligence software that can warn of signs of trauma, including the midline deviation of the midbrain hemisphere separation and the measurement of cerebrospinal fluid-filled cavities.

“I think our device is a workflow solution,” Hyperfine’s chief medical and chief strategy officer Khan Siddiqui said in an interview. “At the end of the day, imaging is a way to make faster decisions based on the person you are treating.”

This includes future plans to scan button protocols for cerebral hemorrhages and strokes. Siddiqui said: “If you just generate images, it actually doesn’t help the decision-making process-it doesn’t actually do a lot of things.” “Our focus is actually how we can help clinicians and patients at the point of care faster and more accurately. To make these decisions.”

 

13. IsoPlexis

CEO: Sean Mackay
Founded: 2013

IsoPlexis’ hardware can help discover hidden cell types that may be overactive factors that cause specific diseases.

More researchers and biopharmaceutical companies are looking for those who promise to provide visualizations to analyze their interactions with individual proteins and other cells to identify core driving technologies for diseases and potential therapies.

IsoPlexis aims to make single-cell analysis more accessible through the latest debut of its benchtop IsoSpark instrument, which is designed for large and small laboratories. The company’s hardware can use antibody-based barcodes to simultaneously label hundreds of individual cells and classify them according to the full range of proteins they secrete.

This work can help discover previously hidden cell types that may be the cause of overactive specific diseases, or may change the way the body interacts with specific drugs.

Sean Mackay, CEO of IsoPlexis, said: “We did not pay attention to the level of RNA or DNA, but directly focused on the wide range of these dynamic and functional proteins at the single-cell level.”

“I think our platform opens up new models to answer key questions about truly networked intracellular biology and its combined interactions with targeted inhibitors and similar drugs,” Mackay said.

This includes research on cancer immunotherapies and CAR-T treatments that may play a role in solid tumors, as well as the immune system’s response to vaccines and infectious diseases.

“When the question is how the immune cells persist or how to achieve persistence for therapeutic drugs that require the immune system, it comes down to a subset of highly active cells,” Mackay said. “They coordinate many broader immune responses, and we have shown that You can detect them very early on our platform.”

 

14. Mammoth Biosciences

CEO: Trevor Martin
Established time: 2017

Mammoth and Agilent’s automated CRISPR test system.

Equipped with technology from the laboratory of co-founder, CRISPR pioneer and Nobel laureate Jennifer Doudna, Mammoth Biosciences aims to use editing methods not only for splicing and splicing the genetic code: the company is building customizable biological search for clinicians and The researcher’s engine.

The application built into the diagnostic program is relatively simple: when the CRISPR enzyme programmed for a specific genetic code string matches its target, letter matching (for example, DNA or RNA after a virus or bacterial infection), it will act and release A signal that shows a positive result in a test.

This is expected to provide accurate results comparable to PCR tests, while ultimately requiring less hardware and fewer laboratory resources.

“For decades, people have been making this classic choice in diagnosis: Do you want gold-standard molecular results, or do you want simple and fast products?” Co-founder and CEO Trevor Martin in an interview Said. “I think the promise we are building is breaking this trade-off-why we can’t get molecular, high-precision things, but with the many advantages of rapid testing.”

 

15. Paige

CEO: Leo Grady
Established time: 2017

The collaboration with genome testing company Agendia aims to integrate Paige’s digital pathology program with DNA sequencing to create new cancer biomarkers derived from AI.

“There are many patterns in the organization,” said Leo Grady, CEO of Paige, the Memorial Branch of the Memorial Sloan-Kettering Cancer Center, which is dedicated to artificial intelligence to assist in the diagnosis of cancer.

Paige’s procedure is based on years of slides digitized by the cancer center, plus millions of slides extracted from its archive, and then searching for these patterns and tracing them to genes that may affect the patient’s prognosis or treatment.

For years, pathologists have been saying:’I can look at the tissue, and I can see that there is a BRCA mutation here. I can see that the patient is HER-2 positive or EGFR mutation,'” Grady said in an interview.

He said: “Although pathologists say so, they can see it, but they can’t fully describe what they see.” “They can’t quantify, can’t standardize, can’t measure.” Grady said: “So patients still accept it. Immunohistochemical testing, or genomic profiling-but the phenotypic expression of this potential molecular change still exists in the tissue.”

The company’s software scans the entire breast and prostate tissue samples for suspicious features, and is approved in Europe as a breakthrough designation for clinical diagnostic procedures and the FDA, and flags them in real time for key review.

“Using modern AI technology with large databases, computers can browse these slides to measure those patterns, recognize them, quantify them, and then show them to pathologists-they may not think they are in medicine. We have learned from the hospital, but we can still prove and verify it like other diagnostic tests.”

 

 

(source:internet, reference only)


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