Tag Archives: medical devices

Germany’s Largest Authorized Health Insurance Company Approves MyoPro | Business | Instant News

BOSTON – (BUSINESS WIRE) – February 16, 2021–

Myomo, Inc. (NYSE American: MYO) (“Myomo” or “Company”), a wearable medical robotics company offering enhanced functionality for those with neurological disorders and upper limb paralysis, today announced Techniker Krankenkasse (TK), Germany’s largest Statutory Health Insurance (SHI) company. , now approves MyoPro replacement on a case by case basis. TK covers more than 10 Million lives insured and joins the ranks of other major German health insurance providers including BARMER, IKK Classic, regional AOK insurance and several BKK insurances which collectively cover 28 million German lives and have now approved funding for MyoPro.

About 90% of the German population is covered by SHI providers.

In addition, one of the largest private health insurance companies in Germany, Allianz, has now authorized MyoPro. Private insurance covers about 9% of the population.

Myomo’s Managing Director for Europe, John Frijters, stated, “Many users who have received MyoPro through German insurance experience loss of hand and arm function due to stroke, brachial plexus injury or spinal cord injury. Receiving MyoPro as a result of this insurance decision changed their life. “

In Germany, MyoPro is administered through a growing network of Orthotic and Prosthetic (O&P) clinics across the country. Currently, these 35 facilities serve and support MyoPro users.

Paul R. Gudonis, CEO of Myomo, said, “Our progress in Germany, although now limited by the COVID-19 lockdown, shows us that there is strong and wide-ranging demand for MyoPro. Coupled with the joint venture we recently announced in China, we are working to become the global standard of care for those with paralyzed or weak arms. “

This announcement coincides with the introduction of the new Myomo website in German. These can be found on www.myomo.de.

Myomo, Inc. is a medical robotics company that offers enhanced arm and hand function to those with neurological disorders and upper limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper limb orthosis designed to support the arm and restore the function of a weakened or paralyzed arm of a patient who has had a CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS or other neuromuscular disease or injury. It is currently the only device on the market that, by sensing a patient’s own EMG signal via a non-invasive sensor in the arm, can restore an individual’s ability to perform daily activities, including self-feeding, carrying objects and performing household tasks. Many are able to return to work, live independently, and reduce maintenance costs. Myomo is headquartered in Cambridge, Massachusetts, with sales and clinical professionals throughout the US and international representatives. For more information, please visit www.myomo.com.

Forward-looking Statements

This press release contains forward-looking statements regarding the Company’s future business expectations, including the benefits expected from insurance coverage in Germany and our activities in Germany, Australia and China, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forwards are only predictions and may differ materially from actual results due to various factors.

These factors include:

  • our sales and commercialization efforts;
  • our ability to obtain reimbursements from third party payers for our products;
  • our reliance on external sources to finance our operations, to the extent that we do not break even in cash flows;
  • our ability to effectively execute our business plans and improve our operations;
  • our expectations for our development program; and
  • general market, economic, environmental and social factors, including the ongoing COVID-19 pandemic, which may affect the evaluation, installation, delivery and sale of our products to patients.

Further information on these and other factors that could potentially affect our financial results including in Myomo’s filings with the Securities and Exchange Commission, including those contained in the risk factors section of the Company’s annual report on Form 10-K, quarterly reports on Form 10 -Q and other submissions with the Commission. The company warns readers not to rely too much on forward-looking statements, which only take effect on the date they are made. Although the forward-looking statements in this release of financial information are based on our beliefs, assumptions and expectations, taking into account all the information currently available to us, we cannot guarantee future transactions, results, performance, achievements or results. No guarantee can be made for any investor by anyone that the expectations reflected in our forward-looking statements will be achieved, or that deviations from them will be material and detrimental. The Company disclaims any further obligation to revise forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of events that were anticipated or unexpected.

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PUB: 02/16/2021 08:30 AM / DISC: 02/16/2021 08:30

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Changes taking place in the UK and the United States related to COVID-19 | Instant News

With the Coronavirus pandemic hitting the world in early 2020, there are some significant changes that must be adapted by the world community and government. Since there is no cure for the virus, the Government has implemented special rules that must be followed in public so that people will be safe, reducing their chances of catching the virus. As the number of cases of people with Corona virus increases, the UK will push for a nationwide lockdown to keep people safe. Since the start of the pandemic, they have implemented several significant changes and restrictions related to border closings, along with strict travel restrictions.

The lockdown means people are not allowed to leave their homes and can only leave for essential services.

The United States also has restrictions on moving from one place to another, and companies and businesses are allowed to stay open. Public eateries and restaurants, for the most part, should stay closed, while open spaces entertain only small groups of people. There are rules about the number of people you can meet in a given area and the types of jobs and companies you can run. They also added rules on whether people can meet at work, with US states implementing them at varying levels. Likewise, when Britain entered its second lockdown, it imposed the six rule, so no more than six people could meet in public.

Working as a medical practitioner or doctor in the UK is usually seen as a significant achievement, for various reasons including, India and England have the same medical roots, the same textbooks in most medical colleges, similar references, and knowledge transfer, making the system very easy to adapt. In addition, the NHS or National Health Service that currently exists to care for people in the EU is seen as one of the best health care systems for work in the world.

With so many people catching COVID-19, the health care systems in the US and UK are quite overwhelmed. They are unsure whether their hospital can support such a large number of patients and whether they have enough doctors to help them all. The government is pushing for more people into the medical field, but they have to follow a lot of rules and regulations if they plan to join as medical practitioners. In addition, since the start of the pandemic, doctors, along with people helping the medical profession, have been working longer hours and passing busy work schedules because they are understaffed and there are lives at stake.

Until the start of the pandemic, people all over the world weren’t sure how they would get through. There is no cure for the virus, and doctors don’t have enough information about it to know how to treat it. There are changes and challenges that they continue to adapt and convey the details to the public.

Fortunately for all, there is a drug being distributed throughout the US with doctors and medical professionals being the first to receive it. They have started distributing the same to the public and finished giving most of the population, the first dose.

However, having the right team to help with the whole process is one of the most important requirements when going through a pandemic. When selecting a team of medical practitioners or doctors in the UK, their employer must ensure that they provide Background

check. They want proof that the people they work with have no criminal records. Apart from that, there are special requirements they have to go through since they are working in the medical field where they interact and relate to people of all ages. In addition to past criminal records, background checks provide information on whether a person is on good terms with other age groups, whether from youngest to oldest or if they have had it in the past which means they shouldn’t interact with them.

There are many challenges that doctors face during the pandemic, the most significant of which is that there is no specialization in dealing with the Coronavirus. With the one who catches

virus and lacking a doctor to help with the process, other people in the medical field have to pull up their socks and help in any way they can. Many doctors have complained that they are unhappy with the changes that are taking place, but they are making peace with it because they are doing their part to help the pandemic. Another challenging part of the process

The point is that most doctors are unsure about how to treat the virus and are focused on treating the symptoms that will arise. The idea is to end up in a place where they solve the problems they face.

About 2,500 new emergency drugs doctors enter the world of work every year in the United States. However, with the pandemic, they are ironically struggling to find jobs. The US desperately needs as many doctors, paramedics and medical practitioners as possible, but is not sure what changes they will have to go through or whether they will be lining up for a job once it passes and the market opens the following year. In a strange event, doctors began applying for additional courses, learning new streams and other information they could use to get through this difficult and challenging time. The Coronavirus pandemic is not only making changes in the job market for doctors but also overall and most people are struggling to find jobs, with a large number of businesses and companies closing down even if they are not connected to the medical field. .


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Swiss startups are betting on nanotechnology to speed up cancer diagnosis | Instant News

A Swiss startup is testing devices that rely on nanotechnology to speed up cancer diagnosis, a goal shared by many researchers and entrepreneurs around the world.

Nanotechnology is a promising approach, according to the National Cancer Institute. Apart from diagnosing cancer earlier and sooner, this has the potential to assist in making treatment decisions. The hope for a nano-oncology application is that it is also less toxic than chemotherapy.

Founded in 2017, Artidist hopes his device can do both, starting with breast, lung and pancreatic cancer, according to Marija Plodinec, co-founder and CEO of the company. Artidis employs 22 people in Switzerland and the US

The Artidis device relies on proprietary nanomechanical biomarkers and clinical data analytics to diagnose cancer in biopsied tissue.

The device – also known as Artidis – relies on proprietary nanomechanical biomarkers and clinical data analytics to diagnose cancer in biopsied tissue. Biomarkers can also measure cancer aggressiveness, allowing for customized treatment.

Results were available in less than three hours, beating the days it took after a traditional biopsy, Plodinec wrote in an emailed response to questions forwarded by a spokesperson. A cancer biophysicist, Plodinec began researching the technology used by Artidis in 2008 when he was a graduate student at the University of Basel in Switzerland.

“Breast cancer is the most common form of cancer in women and I wanted to find a device that would reduce the stressful period of uncertainty before you receive a cancer diagnosis,” wrote Plodinec.

Since its founding three years ago, Artidis has raised $ 15.1 million in seed money from investors including Bernina Bioinvest and SMD MedicalTrade AGboth based in Switzerland.

With a view to expanding in the US, Artidis hopes to raise another $ 20 million in Series A funding by the end of 2020. The company aims to enter the market by 2022 and is currently finalizing pre-submission files for submission to US Food. and Drug Administration, says Plodinec. Hospitals and health systems will be able to buy or lease accompanying devices and software, he said.

In a study involving 545 patients in Switzerland from 2016 to 2019, Artidis proved effective in detecting breast cancer in routine clinical settings. Presented at the June meeting of the American Association for Cancer Research, this study also demonstrates the potential of a tool for assessing future tumor growth.

“Secondary analysis suggests that this new technology will be able to subclassify breast cancer subtypes into more or less aggressive subgroups, which can define a patient’s treatment plan and thereby reduce over-treatment and under-treatment,” Dr. Rosemarie Burian, lead investigator of the study and a gynecologist at the Breast Center at Basel University Hospital, said in a statement announcing the results this summer.

Artidis plans to launch a multi-center study for breast cancer in the US later this year and a similar study in Europe in early 2021, Plodinec wrote. A proof-of-concept study on lung and pancreatic cancer is also scheduled to begin in early 2021.

In the US, Artidis has collaborated with MD Anderson Cancer Center at Texas Medical Center in Houston, Plodinec said, adding that the company is in talks with other US cancer centers.

“Artidis can be used to analyze any living tissue, so the potential for growth is enormous,” he wrote.

Photos: CGToolbox, Getty Images and Artidis


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CanSino Biologics can begin clinical development of the Covid-19 vaccine in Canada | Instant News

The road is nearly empty in Wuhan, China, at the height of the Covid-19 outbreak in the country in February. CanSino Biologics is conducting a phase II clinical trial of a vaccine against SARS-CoV-2 in a city of 11 million, where the virus was initially detected.

A company developing a vaccine against the virus that caused Covid-19 in China will soon bring its development program to Canada.

Canadian National Research Council the word Tuesday that they had made a deal with Tianjin, based in China CanSino Biologics to advance the development of bioprocesses and clinical adenovirus vector-based vaccines against SARS-CoV2 in Canada. The vaccine, known as Ad5-nCoV, is a Type 5 adenovirus vector-based vaccine currently under Phase II development in Wuhan, China. CanSinoBIO and NRC have had a relationship since 2013, and the Ad5-nCoV vaccine was developed using cell lines developed at NRC, a federal research and development organization headquartered in Ottawa.

NRC said CanSinoBIO was in the process of applying for permission from Health Canada to conduct clinical trials there.

“This is the right time to utilize advanced technology and resources from both parties that are crucial for the development of Ad5-nCoV,” CanSinoBIO CEO Xuefeng Yu said in a statement. “We are in a state of global public health emergencies together, and collaborative involvement can be a shortcut to help win this race against new coronaviruses.”

CanSinoBIO said in filing an April 10 regulation with the Hong Kong Stock Exchange that they plan to move Ad5-nCoV into Phase II development, and entry for 500 participants. learn at ClinicalTrials.gov shows that it is open for recruitment on April 13. On April 20, the page was updated again to say that the study was active, but no longer recruited participants.

It is not clear whether the latest update indicates the study has been fully registered or stopped registering participants for other reasons. The company did not respond to requests for comment.

Vaccine progress into Phase II testing places it at the forefront of developing the next most sophisticated vaccine, Moderna mRNA-1273. The company recently received permission from the Food and Drug Administration to transfer vaccines, currently in a Phase I study sponsored by the National Institute of Allergy and Infectious Diseases, into the development of Phase II, and Phase III studies are expected to begin at the start of the season it’s hot. The Moderna vaccine uses a different mechanism, being an RNA-based messenger rather than using an adenoviral vector.

Photo: Getty Images


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The federal government’s APD stock is almost gone | Instant News

The federal government ‘s supply of much – needed personal protective equipment is running out when the coronavirus outbreak continues to increase in the United States.

About 90 percent of the equipment – N95 masks, surgical masks, face shields, gowns and gloves – in the National Strategic Stockpile has been sent to countries that are fighting the coronavirus pandemic, according to documents released by the House Oversight Committee on Wednesday.

The remaining 10 percent of equipment will be stored for federal response work, said a spokesman for the Department of Health and Human Services.

Even with tapped resources, the state only receives a small amount of equipment that according to local health officials is needed.

The federal government has sent 7,920 ventilators – including 2,000 to New York City, the epicenter of the COVID-19 earthquake in the country – and 11.7 million other respirator masks.

Governor Andrew Cuomo has requested 30,000 ventilators in New York, for example, while federal officials estimate that 3.5 billion masks will be needed to fight a pandemic.

“Now that the national inventory has been drained from critical equipment, it appears that the Administration is leaving the country to look after themselves, to explore the open market for this scarce supply, and to compete with one another and federal agents in chaos, free of cost. for all bidding wars, “Rep. said. Carolyn B. Maloney (D-NY), chair of the committee, in a statement.

President Trump told a news conference on Monday that his administration still had around 9,000 ventilators, but most of them inherited stockpiles with “empty cabinets.”

“We are taking over the inventory where the cabinet is open and where the testing system is broken and old. And we tidied it up, “he said.

With the outbreak expected to peak, Admiraal Brett Giroir, a medical doctor and member of the White House coronavirus task force, assured that “everyone who needs a ventilator will get a ventilator” at the briefing.

“Now you see … out of the right American spirit that when a country like Washington or California does not need that ventilator, they do the right thing by moving them all over the country,” Giroir said.

Meanwhile, the federal government is moving to replenish its inventory.

HHS made the first mass order of the N95 mask on March 12, followed by a larger order on March 21 – but shipments will not reach national inventory until the end of April, according to federal contract records.

When supplies were running low, Trump began pressuring private industry to increase production of much-needed supplies under the Korean War-era Defense Production Law.

The White House and General Motors reach an agreement to produce 30,000 ventilators for $ 489.4 million on Wednesday after Trump first asked for that action two weeks ago.

“With contracts ranked below DPA, HHS is helping manufacturers like GM get the supplies they need to produce ventilators as quickly as possible, while also ensuring that these ventilators are diverted through the National National Stockpile to where they need the most,” and Human Services Secretary Alex Azar said in a statement.

With Post cable


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