April 4 2020 | Chicago | Infographics #3 by HelmetBasedVentilation.com Thank you PrimeLabelStudios.com for design!

Vista, California 4/2/2020 As COVID-19 cases – and deaths – continue to go up in the United States, the search for needed ventilators continues to be a problem for medical facilities and makeshift hospitals. An alternative to invasive ventilators – helmet based ventilation – already being used outside of the United States, is starting to get noticed in communities who are getting hit hard by the virus, according to Mike Malone of Amron International. The company, based out of Vista, Calif., was founded in 1978, manufacturing commercial diving equipment. The Amron oxygen treatment hood (another name for a helmet) was designed in 1998 and holds two patents, Malone said. Based on recent research, Amron’s oxygen treatment hoods (helmets) could potentially be used in hospitals for COVID-19 patients. However, it was designed to be a hyperbaric product, Malone said. “A lot of the hospitals are inquiring about the product and buying smaller quantities at first,” said Malone, vice-president of marketing for the company. “I think the hospitals are going through the process of approving the hoods for this application.” The company has enough product to put out about 500 helmets within the next week or so, Malone said. The company is adding suppliers and tooling to meet the impending demand of devices over the next several weeks. It is challenging to determine how, when, and where the virus will peak to reasonably meet the demand. Due to the supply and the demand, the helmets will be shipped based on a first-come, first-served basis, Malone said. When a hospital calls and needs the helmets, Amron could potentially supply the product. Amron has supplied helmets to Australia, Italy, Germany, and Hungary, with inquiries from other countries including the Netherlands and UK. “A lot of our (worldwide) dealers are calling us,” Malone said. Malone said the company is investing a sizable sum into added tooling to manufacture helmets – he estimated that the helmets cost about $150. “We’re juggling a lot – we’re juggling customer calls, safety protocols for our production team … everything -- trying to get this thing going,” Malone said regarding the impact of the virus on the company and the country. “We’re going off the doctor’s recommendation, and people who have grabbed the hood have spoken very highly of the hood,” Malone said, talking about a video from Tom Fox. Fox is the Research Physiologist for the Hyperbaric Institute for Research and Training, a division of Island Hyperbaric Centre in Pincourt, Quebec, Canada. He used one of the Amron helmet based ventilators to show the uses of the product for COVID-19 patients. “(Fox is) very passionate about this prospective use,” Malone said. As the virus is unprecedented, Amron International hopes to be able to contribute to help patients recover from COVID-19. “We are getting a lot of inquiries from Central and South America, as well,” Malone said. “They are also calling me believing they’re going to need our hoods in the very near future.  Hospitals don’t have enough respirators … period.”

UK could benefit from success in other countries in the COVID-19 battle. Chicago 4/1/2020 As countries continue to venture into the unknown battle against COVID-19, questions arise about the best practices to eradicate the virus and save lives. The United Kingdom only recently advised residents to observe social distancing – and may have further put patients at risk by using a Continuous Positive Airway Pressure (CPAP) face mask device for treatment. Pulmonologists around the world treating COVID-19 patients warn noninvasive positive pressure ventilation (NIPPV) via face mask is not safe for patients or medical staff. Clinicians in the UK are more comfortable working with CPAP face masks as they have been using them for a long time. A better, safer option for all is helmet-based ventilation, which creates a closed system with little or no air leaks, along with an antiviral filter providing another barrier against the spread of coronavirus. This is an obvious benefit to medical personnel who are in constant contact with many patients. Helmets are common in Italy, and hospital staff has had success using them to treat COVID-19 patients. A helmet also is a better alternative for patients -- they can eat and drink without creating an air leak. It also is more comfortable and avoids the breakdown of skin experienced by wearing face masks for a long period of time. A three-year study at the University of Chicago showed patients using helmet-based ventilation improved faster, had fewer days in the ICU and hospital and were less likely to need intubation. Doctors in Italy have had 20-35% success using helmet-based ventilation among COVID-19 patients. According to international guidelines for COVID-19 patients, a helmet is preferred when applying noninvasive positive pressure ventilation (NIPPV). Pulmonologists who have worked with COVID-19 patients in respiratory distress have warned about spreading the infection using masks or high-flow nasal cannulas. Excerpt from: “International Pulmonologist’s Consensus on COVID-19” Chief editors: Dr.Tinku Joseph (India), Dr. Mohammed Ashkan Moslehi (Iran). A CPAP device was re-engineered by Formula One engine manufacturer Mercedes with University College London engineers and clinicians, CNN reported. Article: Mercedes F1 help develop coronavirus breathing device for health service use The United Kingdom is testing 100 of these redesigned devices on COVID-19 patients this week. The CNN article states CPAP devices have been used in China and Italy to treat COVID-19 patients and that roughly half of patients have avoided the need for ventilators. What the article doesn’t say is that in Italy, medical staff use helmets for NIV. A BBC Newshour interviewer asked Professor Rebecca Shipley about this concern. Shipley is director of the Institute of Healthcare Engineering at University College London, who collaborated on the new Mercedes CPAP device. “Obviously, the protection of health care workers is exceptionally important,” Shipley said. Shipley said all the indications -- both within the UK, and, for example in Italy and China – suggest that if health care workers are wearing the appropriate personal protective equipment, the chance of transmission is extremely low. Based on Shipley’s comment, every listener should ask these questions: Italy uses helmets, so health care workers are more protected. How does that factor into face masks? How do medical workers stay safe with a shortage of personal protective equipment (PPE) around the world? Based on data from Italy, patients require days of NIPPV to recover. Face masks are difficult for patients to tolerate. Why choose a face mask design? While these questions likely were asked during the development of the redesigned CPAP face mask, it looks the same and continues to present problems for patients and doctors. Increasing amounts of time, money, and effort are being expended to battle and conquer COVID-19. If we can’t adapt to new guidelines – and learn from those who already have been in the fight, we are not just losing a battle, we are losing the war.

March 31 2020 | Chicago | Infographics #1 by HelmetBasedVentilation.com Thank you PrimeLabelStudios.com for design.

March 31 2020 | Chicago | Infographics #2 by HelmetBasedVentilation.com Thank you PrimeLabelStudios.com for design.

3/29/2020 Chicago US hospitals are beginning to order helmets to use for noninvasive ventilation for COVID-19 patients, although supplies remain limited. According to an article in The Wall Street Journal, Massachusetts General Hospital, the University of Chicago Medical Center, the Hospitals at the University of Pennsylvania and others are ordering helmets. So far (3/29/2020), only Sea-Long Medical Systems Inc and Amron International Inc. are the only producers of helmets in the US. The Sea-Long company is ramping up production to meet the greater demand but is limiting the number of helmets shipped so “everybody gets some,” owner Chris Austin told The Wall Street Journal. Amron International Inc., a maker of hyperbaric helmets, tested its product for COVID-19 treatment and believes it is safe, according to Mike Malone, vice president of sales. He told The Wall Street Journal that Amron is starting to take orders. Massachusetts General Hospital ordered 20 of the Sea-Long helmets but will only receive five, according to the article. The University of Pennsylvania hospital has received 50 helmets and ordered another 200. Maurizio Cereda, a University of Pennsylvania intensive-care doctor who trained in Italy where helmet use is common, told The Wall Street Journal, “It’s very convenient, something a nurse can manage and can be done on the general floor of the hospital.” The Food and Drug Administration has granted emergency approval for positive-pressure breathing devices to be used in the US during the COVID-19 pandemic, which incorporates helmets for noninvasive ventilation as an alternative device according to a Fact Sheet for Healthcare Providers issued March 24, 2020 Noninvasive ventilation via helmet was studied successfully at the University of Chicago. Researchers found patients using helmets improved faster, were less likely to be intubated and had a lower morbidity rate than those using face masks. Dr. Bhakti Patel, the study’s main author and a pulmonologist at the University of Chicago, said her hospital ordered 100 helmets “for the reality of the time when we don’t have ventilators. We want to preserve ventilators for those who fail the helmet.” They expect 20 helmets this week, according to The Wall Street Journal article. Helmets used for COVID-19 patients in Europe are made in Italy, but they aren’t exporting them to the US because of the great need there. The Lombardy region in northern Italy has been hit hard by the coronavirus, with many patients requiring hospitalization and treatment. HelmetBasedVentilation.com provides updates about helmet suppliers on a daily basis. Please contact us to add a manufacturer name and contact information to the website. Aurika Savickaite explained the project, HelmetBasedVentilation.com, and its mission to Wall Street Journal reporter Mark Maremont. The site was created to organize information about NIV via helmet and help health care professionals learn the benefits for patients with COVID-19. Helmets can be used without a ventilator, attached to hospital wall air and oxygen gas flow. They have been successful for 20% to 35% of patients in Italy during this crisis. We will see these patients on helmet-based ventilation in the US soon. Hopefully, hospitals will receive helmets on time and use them for patients in respiratory distress.

3/27/2020 Chicago An Italian patient Fausto Russo, 38 who is recovering from pneumonia from COVID-19 has shared his experience of using helmet-based ventilation with the media. Video Transcript: I don’t really know what is happening outside my room. Doctors are in and out to check on you. They try to limit contact to a minimum. It’s really lonely. You can’t have your family close by, nobody to support you. The time I’ve spent in hospital has been truly unique. You have to be patient, that’s the most important thing. You must wait and wait. This experience has changed my life. I spent six days and six nights wearing a breathing helmet. It is something difficult to imagine and understand. Time never passes, you can’t find a position to sleep. After six days they took the helmet off because my breathing was improving. They gave me an oxygen mask to wear. Coronavirus walks on the legs of people without symptoms. I didn’t have any contact with people who officially had the virus. Now we just need to stop the pandemic and try to return to normal life as soon as possible. “I spent six days and six nights wearing a breathing helmet. It is something difficult to imagine and understand,” Russo said. “After six days they took the helmet off because my breathing was improving. They gave me an oxygen mask to wear.” Fausto Russo, 38, told journalists from the Foreign Press Club via videolink that coronavirus changed his life. He spoke from the Santa Maria Goretti hospital after being released from an intensive care unit. The video is posted by Guardian News on YouTube. Helmet-based ventilation is common in Europe but not in the US. The goal of our website, HelmetBasedVentilation.com, is to organize information about noninvasive ventilation (NIV) via helmet and help health care professionals learn the benefits of its use for patients with COVID-19. “Italians are lucky to have this option before patients are intubated. In the US, hospitals were not using helmets until this coronavirus pandemic. The University of Chicago Hospital has used NIV via helmet for its patients during a three-year study.” said Aurika Savickaite, the HelmetBasedVentilation.com team leader. Helmet-based ventilation is a safer alternative for COVID-19 patients and their caregivers because it creates a closed system with little or no leaks and filters the air to keep the virus from spreading. NIV via helmet prevents intubation for 20% to 35% of patients.

3/25/2020 Chicago Italy is in the midst of a “tsunami,” according to Prof. Antonio Pesenti, head of Lombardy intensive-care crisis unit. Pesenti is a professor of Anesthesiology and Intensive Care Medicine at the University of Milan, Italy. Yesterday, Prof. Pesenti spoke to John P. Kress, MD, about the helmet ventilation use during the COVID-19 crisis in Italy. Pesenti had predicted high numbers of patients would require intensive care in hospitals, more than they could handle. He told Dr. Kress that about 20% - 35% of patients improve on noninvasive ventilation (NIV) via the helmet. Prof. Pesenti said that when you apply the helmet, you will see results in one to two hours of helmet ventilation. Physicians will see if a patient needs intubation or is recovering from respiratory distress. According to the International Pulmonologist’s Consensus on COVID-19 guidelines we should not use noninvasive positive pressure for COVID-19 patients to prevent the spread of the virus. However, by using NIV via helmet with an antiviral filter creates a closed system to prevent the virus from passing from the patient to the medical staff. Successful use of helmets in Italy shows they are safe and can be used by US hospitals. Excerpt from: “International Pulmonologist’s Consensus on COVID-19” Chief editors: Dr.Tinku Joseph (India), Dr. Mohammed Ashkan Moslehi (Iran). NIV via helmet regularly is used in Italy but is not common in the US. Helmets were used in one hospital during a three-year study. Dr. Kress co-authored a report of that study of helmet-based ventilation at the University of Chicago Medical Center that found patients recovered faster and were less likely to be intubated compared to those using NIV face masks. The Lombardy region in northern Italy experienced the first cases of COVID-19 in the country and has been the hardest hit in Italy. Dr. Kress is a professor of medicine, specializing in pulmonary medicine and critical care medicine. He is the director of the Medical Intensive Care Unit at the University of Chicago Medicine. He is an advisor for HelmetBasedVentilation.com.

3/25/2020 Chicago In the midst of the COVID-19 pandemic, the United States is manufacturing ventilators at a high rate – and with that, comes the need for specially trained staff to care for the intubated patients who are on the ventilators. It is expected that about 2% of those contracting COVID-19 will develop respiratory issues severe enough to require them to be put on ventilators, according to a report on National Public Radio. An alternative to mechanical ventilation is noninvasive ventilation (NIV) via the helmet. This treatment can prove to be a better method on many levels, especially if used early in the treatment. Helmet-based ventilation will cost less, shorten hospital stays and lower mortality rates, according to a study featured in the Journal of Hospital Medicine. The same study also found that the use of NIV resulted in lower mortality rates. Researchers found that for optimum results and best outcomes early intervention with NIV is key, as evidence suggests that delayed use of NIV may lead to severe respiratory acidosis and increased mortality. As opposed to invasive ventilation – intubation – helmet ventilation requires less staffing and puts less stress on the patient. The patient is able to be more independent during their admission, requiring less staff assistance than invasive ventilation. Noninvasive ventilation can be used in non-ICU hospital settings and emergency departments, whereas invasive ventilation should be used in intensive care units only. With proper training and early implementation, noninvasive ventilation can result in higher success rates and quicker recoveries at a lower cost. We recommend hospitals create NIV teams with experts in the field, as suggested in BTS/ICS guidelines.

Our team at helmetbasedventilation.com is not alone in seeking alternatives to help medical workers in the COVID-19 health care crisis. Others are innovating and producing devices to support noninvasive ventilation (NIV) techniques. Engineers at Isinnova, an Italian engineering, and creative firm, have developed a valve to convert a snorkeling mask into a full-face mask for NIV. Dr. Renato Favero, former head physician at Gardone Valtrompia Hospital in Brescia, Italy, reached out to Isinnova with “an idea to fix the possible shortage of hospital C-PAP masks for sub-intensive therapy, which is a concrete problem linked to the spread of COVID-19,” according to the website. Decathlon, the producer of the snorkeling Easybreath mask, provided the CAD drawing of the mask. Isinnova dismantled it, studied it, and evaluated changes. They designed a new component to connect the mask to a ventilator, dubbed the “Charlotte valve.” It can be made using 3-D printing. The prototype was tested successfully on a colleague and on a patient. It’s intended to help in a full-blown emergency situation in which it’s not possible to find official healthcare supplies, the website warns. Neither the mask nor the link valve is certified, and patients would need to sign an acceptance of the use of an uncertified biomedical device. Isinnova states the patent will remain free so all hospitals in need can use it. The file is freely shared, and it’s easy for 3-D printers to use. Hospitals can purchase the mask from Decathlon and connect with a 3-D printer to make the link valves. Isinnova is a team of engineers, designers and communication experts who collect ideas and transform them into concrete objects, according to its website. They help companies and individuals who have an idea to turn it into a finished product. Isinnova also develops internal projects. The company is based in Brescia, Italy. Our team supports the use of NIV via helmet for patients with acute respiratory distress from COVID-19 to help prevent intubation, which is more costly and can cause other health problems. NIV via face mask is another way to support patients in need.

We are a grassroots initiative by expert volunteers to CURATE, CONSOLIDATE & SHARE: WHAT: highly focused & niche expertise on Helmet-based non-invasive ventilation FROM & WITH clinicians, ICU professionals, healthcare decision-makers, manufacturers, suppliers, hospitals, governmental agencies, funders, DYI initiatives ABOUT: most relevant clinical, manufacturing, demand, supply, resources, bottlenecks, solutions, applications, funding needs & sources information WHY: to help saving more lives and contain COVID-19 pandemic. UPDATING 24/7 at www.helmetbasedventilation.com . SUBSCRIBE and choose an area of your INTEREST for curated expertise ​ How YOU CAN HELP: ALERT relevant experts and decision makers about this info source – SHARE a link to our web www.helmetbasedventilation.com SUGGEST tips & solutions to uplift our own grassroots capacity, i.e. tools to augment and automate with a laser focus on this particular niche, donate to help us hire more technical help SUBMIT INFO & contact/capacity/shortage/resource DATA (helmet ventilation related ONLY) on worldwide Clinicians, ICU staff and hospital leaders existing manufacturers, their capacities & needs for supplies or funding to expand output potential pivoting manufacturers, their capacities & needs for expertise, supplies or funding to create new capacity public, private and charity funding sources for hospitals and helmet suppliers hospital demand any other relevant ideas and suggestions ​#StopTheSpread #SharingIsCaring #Ventilator #BiPAP #CPAP #Helmet #NIV #ICU #noninvasive #ventilation #BubbleHelmet #StarMed #SeaLong #CaStar In more simple words: If there are only 1 ICU bed and 10 patients in critical condition, doctors perform brutal triage and chose 1 for hope, leaving 9 to somehow survive or die. Helmet ventilators can save more lives.

Hospitals will need helmets for COVID-19 but they don’t know it. We’ve collaborated with a team from Oregon to help ramp up the production of helmets for ventilation in the US to meet a supply that hospitals don’t even know they will need because of COVID-19. Frank Selker, his brother John Selker, who is a professor at the University of Oregon, along with a couple of other people form the Oregon team. They reached out to the sole US manufacturer of helmets, Sea-Long Medical Systems Inc. Christopher Austin, an owner of the Texas-based medical manufacturer, would like to increase production, but he needs a big order. On a regular basis, Sea-Long can produce 250 helmets per week. John Selker said his group has secured $50,000 from a private firm to cover startup expenses, and the firm has committed another $1 million to order 6,000 helmets in advance from Sea-Long. This should lead the company to reach a 5,000-helmet-per-week production level in one month. The Selker brothers’ team connected with our team as we both looked for alternatives to utilize other noninvasive ventilation options for COVID-19 patients in times when ventilator and ICU bed shortages will hit the US. Hospitals in other countries, such as Italy, have been inundated with patients in respiratory distress, filling ICU beds beyond capacity. Those who are hospitalized with acute respiratory distress need ventilation to help them breathe and recover. Hospitals in Europe often use helmets for ventilation, including Italy, Lithuania and Germany. Helmets especially are helpful with COVID-19 because when used with an antiviral/antibacterial filter they reduce the likelihood of transmission of coronavirus to others. Helmets are produced mostly in Italy for the European market. Hospital staff in the US aren’t as familiar with helmets. Helmets have been tested successfully in the US, but they haven’t been widely used. Their team and ours are not-for-profit groups looking to help clinicians prepare for and deal with the medical crisis that coronavirus presents. We are collaborating to get information to clinicians, connect hospitals with resources and increase production to meet a growing need. Hospital staff members may not know about the helmets, but they are interested when they learn about them. “They do see the problem coming,” Frank Selker said. Now it’s necessary to stimulate demand among others who don’t know about the helmets, Frank Selker said. “If hospitals have some understanding,” Frank Selker said about using helmets and finding alternatives to traditional ventilation, they would be interested. “There’s nothing more persuasive than running out of ventilators. (Hospital staff are) going to be quite interested,” he said. “There’s nothing more persuasive than running out of ventilators. (Hospital staff are) going to be quite interested,” Sea-Long wasn’t in a position to increase production 100 times or even 10 times to meet the anticipated demand by hospitals for helmets, Frank Selker said. “(Christopher Austin) could double production, but it won’t be what’s needed,” Frank Selker said. “In order to scale production to 10 times or 100 times, he needs a big order.” That’s where the private firm money comes in. The Selkers’ team can help prepare Sea-Long to ramp up production and provide a buffer for the small business in the busy time ahead. Additionally, they are making advances in the helmets to improve performance prior to production. The Selkers and their team are looking for other manufacturers who can begin the production of helmets. This is what Selkers team from Oregon achieved in the last 4 days : A private firm has given $50,000 to cover startup expenses and also committed $1 million to order paid-in-advance 6,000 helmets from Sea-Long. This should lead them to 5,000- helmet-per-week production level in one month. An MBA mechanical engineering person is visiting Sea-Long today to fulfill due diligence and give us a green light to fulfill the order. Six videos are shot to support outreach. They are being reviewed by the team before they are released. Helped Aurika Savickaite and her team in Chicago to create content about helmet based ventilation for clinicians, manufacturers, and suppliers We have a survey of demand out to the medical staff to show a need. Today we have over 1,000 orders from medical professionals. We’ve made two significant advances in updating Sea-Long helmets with improved performance. Testing it today! Videos here We have a parallel track to develop a molding machine to reach 100,000 units per week level.