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U.S. FDA Grants CytoSorb Emergency Use Authorization for Use in Patients with COVID-19 Infection

CytoSorbents Corporation, a  critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of CytoSorb® for use in patients with COVID-19 infection.

Under the EUA, CytoSorbents Corporation can make CytoSorb available, through commercial sales, to all hospitals in the United States for use in patients, 18 years of age or older, with confirmed COVID-19 infection who are admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure who have early acute lung injury or acute respiratory distress syndrome (ARDS), severe disease, or life-threatening illness resulting in respiratory failure, septic shock, and/or multiple organ dysfunction or failure, as described in FDA’s authorization and as detailed below.

Patients with COVID-19 infection often exhibit a cytokine storm with severe hyper inflammation that can contribute to worsened injury to vital organs like the lungs, heart, and kidneys.  The goal of CytoSorb therapy is to reduce cytokine storm and the deadly inflammatory response through blood purification so that this injury may be mitigated or prevented.  CytoSorb is plug-and-play compatible with the most commonly used blood purification machines or pumps in the intensive care unit used to treat COVID-19 patients, including hemoperfusion, hemodialysis, continuous renal replacement therapy (CRRT), and extracorporeal membrane oxygenation (ECMO) machines.

Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents commented, “We greatly appreciate the FDA’s recognition, through this EUA, of the potential of CytoSorb and extracorporeal blood purification to help patients stricken with this terrible illness.  It was clear in this truly collaborative process with the FDA, that the Agency was committed to urgently providing physicians and patients with new treatment options in the fight against COVID-19.  We plan to continue working with the FDA to help as many patients as possible.”

Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, “As a U.S. based company with CytoSorb device manufacturing in New Jersey, we are eager to expand the availability of CytoSorb to U.S. hospitals and patients as a treatment option to fight cytokine storm and deadly inflammation that is believed to exacerbate COVID-19 infection.  With more than 555,000 documented coronavirus infections, the U.S. leads the world with over 22,000 deaths, and emergently needs new therapies to reduce the severity of this disease.  This is important not just to reduce poor clinical outcomes and mortality, but to also alleviate the bottleneck for scarce resources such as ventilators and ECMO in the treatment of these critically ill patients.”

Dr. Chan continued, “CytoSorb has been used in critically-ill and cardiac surgery patients in more than 80,000 human treatments abroad, to help treat the same complications seen in COVID-19 patients such as lung failure, shock, and multi-organ failure.  With CRRT, and in many cases ECMO, being standard in ICUs worldwide, CytoSorb can be easily implemented with minimal training.  More than 200 COVID-19 patients have been treated with CytoSorb outside the U.S., resulting in the inclusion of CytoSorb into the COVID-19 treatment guidelines in Italy, Panama, and China.  We have now received more than 70 requests from major U.S. hospitals to use CytoSorb in COVID-19 patients.  Under the EUA, we plan to ramp the availability of CytoSorb in a controlled manner, to clinical centers that will work with us to generate data and leverage our knowledge of how to use the device most effectively.  We are pleased to collaborate with the FDA to make this possible.”

According to the EUA letter from the FDA, “There are no FDA approved, licensed, or cleared device treatments for COVID-19. Based on bench performance testing and reported clinical experience, FDA has concluded that the CytoSorb device may be effective at treating certain patients with confirmed COVID-19 by removing various pro-inflammatory cytokines from their blood.  FDA believes, based on the totality of scientific evidence available, that the removal of pro-inflammatory cytokines may ameliorate cytokine storm due to the overabundance of pro-inflammatory cytokines and, in turn, provide clinical benefit,” adding that “It is reasonable to believe that the CytoSorb device may be effective in treating patients 18 years of age or older with confirmed COVID-19 admitted to the ICU with confirmed or imminent respiratory failure when used consistently with the Scope of Authorization of this letter.”

As referenced in the EUA letter, CytoSorb can be used on patients 18 years of age or older, with confirmed COVID-19 who are admitted to the ICU with confirmed or imminent respiratory failure who have any one of the following conditions:

a)   Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
b)   Severe disease, defined as: 
         1) dyspnea, 
         2) respiratory frequency ≥ 30/min, 
         3) blood oxygen saturation ≤ 93%, 
         4) partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or 
         5) lung infiltrates > 50% within 24 to 48 hours; or
c)   Life-threatening disease, defined as: 
         1) respiratory failure, 
         2) septic shock, and/or 
         3) multiple organ dysfunction or failure.

The CytoSorb device has been authorized by the FDA under a EUA. It has neither been cleared nor approved for the indication to treat patients with COVID-19 Infection.  The EUA will be effective until the declaration, that circumstances exist justifying the authorization of the emergency use of the CytoSorb device during the COVID-19 pandemic, is terminated under section 564(B)(2) of the Act, or the EUA is revoked under section 564(g) of the Act.

FDA: (COVID-19) Update: Daily Roundup

FDA today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • The FDA issued an immediately in effect guidance that outlines a temporary policy to help expand the availability of portable cryogenic oxygen and nitrogen containers. The demand for these critical medical gases is expected to rise during the pandemic and may result in a shortfall of portable cryogenic medical gas containers that meet regulatory requirements. The FDA does not intend to take enforcement action against firms that fill and distribute oxygen and nitrogen in portable cryogenic medical gas containers that do not comply with certain regulatory requirements, provided that  alternative, specific safeguards are in place to prevent gas mix-ups. This guidance will be in effect until the end of the public health emergency.
  • The FDA issued information and best practices for retail food stores, restaurants, and pick-up and delivery services during the pandemic to protect both workers and customers. Information shared includes smart food safety practices that employers can consider at any time. It is being issued in two convenient formats.
  • Due to the potential risk of transmission of SARS-CoV-2 through Fecal Microbiota for Transplantation (FMT), the FDA updated information on its websitepertaining to safety protections regarding the use of FMT, informing healthcare providers about screening donors for COVID-19 and exposure to and testing for SARS-CoV-2. This update follows a safety alert posted on March 23, 2020. The FDA has determined that additional protections are needed for any investigational use of FMT, whether under an investigational new drug application on file with FDA or under FDA’s enforcement discretion policy.
  • The FDA and Federal Trade Commission (FTC) issued a warning letter to one company for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The seller warned, Free Speech Systems LLC, DBA Infowars.com, offers unapproved and misbranded products for the prevention or treatment of COVID-19. There are currently no approved preventatives or treatments for COVID-19. Consumers should not purchase or take any product to prevent or treat COVID-19 unless it is prescribed by their health care provider and acquired from a legitimate source.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 270 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
    • To date, 32 emergency use authorizations have been issued for diagnostic tests.
    • The FDA has been notified that more than 150 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Additional Resources:

Fresenius Medical Care Calls for Kidney Disease Patients to Have Continued Access to Customary Care Level During the COVID-19 Crisis

Fresenius Medical Care, a provider of dialysis products and services, has released an advisory calling for clinical care principles on access to be upheld for patients with advanced chronic kidney disease if a surge in COVID-19 infections overwhelms the available supply of facilities, caregivers and ventilators.

The Global Medical Advisory on Apportioning Care outlines the company’s position on how care should be allotted during and after the pandemic and addresses the differing care standards being articulated by various healthcare systems, groups and governments. It stresses the company’s commitment to maintaining uninterrupted healthcare delivery for patients around the world who require renal replacement therapy during the pandemic.

The advisory recognizes that capacity issues may become overwhelming to healthcare systems during the pandemic. However, it calls on “all authorities to recognize the need to make critical equipment, supplies, facilities and care delivery available to patients with advanced kidney diseases that need lifesaving therapy at all times, including during this COVID-19 disease pandemic.”

Dr. Frank Maddux, Global Chief Medical Officer of Fresenius Medical Care and member of the company’s Management Board, said the company stands firmly behind the clinical principle that despite the strain on healthcare resources caused by the pandemic, patients with End-Stage Kidney Disease requiring dialysis should be able to continue with their prescribed dialysis treatment frequency. Furthermore, dialysis access surgery or interventions needed by some patients are “not elective procedures and should be delivered in a timely manner” to prevent potential complications, he added.

The advisory asserts that patients needing renal replacement therapy during the pandemic should still be offered the appropriate treatment that has been agreed in consultation with their physicians. “These discussions may include mechanical ventilation, dialysis, continuous renal replacement therapies and any other extracorporeal support” advised by a patient’s care team, it states.

“People with advanced kidney disease come in varied degrees of health and functional status, but they all want to be productive and active members of their families and communities, and we are doing everything in our power to support their desire for individual choices on the level of care they receive,” said Dr. Maddux. “We want to avoid population-based decisions on care that may not be in the best interests of the individual person.”

Global Medical Advisory on Apportioning Care available here.

TriClip Transcatheter Tricuspid Valve Repair System Receives CE Mark

April 9, 2020

TriClip Transcatheter Tricuspid Valve Repair System has received CE Mark and is now approved for use in Europe and other countries that recognize CE Mark as a non-surgical treatment for people with a leaky tricuspid valve, a condition known as tricuspid regurgitation (TR).

With the CE Mark designation, Abbott’s TriClip device is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available in the world. Abbott is a global leader in developing transcatheter treatments for heart valve disorders and has brought to market three first-in-class therapies for structural heart disease: MitraClip for mitral valve repair, Tendyne™ for mitral valve replacement, and now TriClip to treat the tricuspid valve.

The tricuspid valve, often referred to as the “forgotten heart valve,” has three leaflets that control the flow of blood between the two chambers on the right side of the heart. When those leaflets do not close properly, blood can flow in the reverse direction – known as regurgitation – forcing the heart to work harder. When left untreated, TR can lead to conditions such as atrial fibrillation, heart failure, and ultimately, death. The condition is difficult to treat, however, and options for patients have historically been extremely limited. People with TR are typically older and suffer from multiple co-morbidities, making open-heart surgery a high-risk procedure.i

The TriClip procedure repairs the tricuspid valve without the need for open-heart surgery. The device is delivered to the heart through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood. This approach allows the heart to pump blood more efficiently, relieving symptoms of TR and improving a person’s quality of life.

“Patients suffering from severe tricuspid regurgitation are extremely ill and have very few treatment options,” said Georg Nickenig, M.D., Ph.D., professor and chief, Department of Cardiology, University Hospital, Bonn, Germany, and lead investigator of the TRILUMINATE trial, which generated strong data that helped lead to the CE Mark of TriClip. “Abbott’s TriClip could profoundly impact how physicians treat these patients. The therapy is backed by data proving safety and performance, durability, and improved patient quality of life.”

The CE Mark for TriClip Transcatheter Tricuspid Valve Repair System follows positive six-month data from Abbott’s pivotal TRILUMINATE study examining edge-to-edge repair technique using TriClip, which was published in The Lancet in November 2019. The study demonstrated that TriClip reduced severity of TR and was associated with strong improvement in functional capacity and in quality of life at six months.

“Tricuspid regurgitation is a highly prevalent, yet seldom treated disease, which is why this approval is a significant milestone for the healthcare community. TriClip has the potential to fill a treatment gap and transform how doctors are able to help people with tricuspid regurgitation,” said Michael Dale, senior vice president of Abbott’s structural heart business. “Our clip-based technology provides clinicians a life-changing, proven safe, simple, and effective option to treat people suffering from a crippling and life-threatening disease.”

TriClip builds upon the proven success of Abbott’s MitraClip device, which treats people with leaky mitral valves, or mitral regurgitation (MR). TriClip leverages the same clip-based technology as MitraClip but has a differentiated delivery system designed specifically for delivery to the tricuspid valve.  A new, steerable guiding catheter system adapts to the right side of the heart, where the tricuspid valve resides, enabling the physician to effectively grasp and clip the leaflets of the tricuspid valve. Additionally, the TriClip device is available in two different sizes (NT and XT) to accommodate different patient anatomies.

The MitraClip system is the first and only transcatheter mitral valve therapy with more than 16 years of clinical experience and proven safety, survival and durable clinical outcomes. More than 100,000 patients have been treated worldwide with the device. Abbott also recently announced CE Mark approval of its Tendyne Transcatheter Mitral Valve Implantation System, a minimally invasive valve replacement option to add to its portfolio of mitral solutions.

For U.S. important safety information on TriClip Transcatheter Tricuspid Valve Repair System visit here.

The TriClip Transcatheter Tricuspid Valve Repair System is an investigational device only in the U.S.

The Tendyne Transcatheter Mitral Valve Implantation System is an investigational device only in the U.S.

 

FDA Grants Vapotherm Oxygen Assist Module (OAM™) Breakthrough Device Designation

Vapotherm, Inc. is a company that is focused on the development and commercialization of its proprietary Hi-VNI® Technology products that are used to treat patients of all ages suffering from respiratory distress, today announced that the U.S. Food and Drug Administration (FDA) recently granted Breakthrough Device Designation for the Company’s Oxygen Assist Module (OAM).

FDA’s Breakthrough Device Program is intended to help patients and healthcare providers receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program creates an expedited pathway for prioritized FDA review of the OAM. Separately, Vapotherm submitted an Investigational Device Exemption (IDE) for pediatric use of OAM to FDA.

“We are delighted that the FDA granted OAM Breakthrough Device Designation status and look forward to working closely with them to provide clinicians with a solution to more effectively keep their patients within the physician-prescribed target oxygen saturation range with significantly fewer manual adjustments to the equipment,” said Joe Army, President and CEO of Vapotherm.

Vapotherm OAM is a module for use with most versions of Vapotherm’s Precision Flow® systems. The Precision Flow system incorporates Hi-VNI® Technology, a mask-free and seal-free clinically validated alternative to nasal continuous positive airway pressure (nCPAP) as well as noninvasive positive pressure ventilation (NiPPV) in pediatrics and adults. When used with the Precision Flow system, the Vapotherm OAM assists staff in maintaining a targeted SpO2 (amount of oxygen in the blood) range.

The effectiveness of the Vapotherm OAM algorithm was evaluated in a 2018 study published by Reynolds and colleagues in the Archives of Disease in Childhood: Fetal and Neonatal Edition. The data show that trained staff using manual controls alone were able to maintain premature infants’ oxygen saturation in the physician-prescribed target range 49% of the time. When using the OAM device, the staff were able to maintain the target oxygen saturation range 80% of the time, while at the same time requiring significantly fewer manual adjustments to the oxygen delivered by the equipment. The study refers to the algorithm in the OAM by its prototype name of IntellO2.

 

Dutch Ministry of Health Also Opts for Evone®by Ventinova from Eindhoven

Ventinova Medical, a company based in Eindhoven, recently received good news concerning a substantial order for the delivery of Evone®, an innovative ventilation device, equipped with the FCV® technology patented by Ventinova, which controls both the supply and the exhaust of air during mechanical ventilation. The company states that this is a global first!

New Technology

The guiding principle for the design of Evone was to develop a device that is as effective as possible and that prioritizes the health and recovery of the patients. The company worked on this aspect for many years. Evone is based on Ventinova’s FCV ventilation technology. The significant clinical benefits of FCV have been demonstrated in several international clinical trials in recent years. Simply put, this device results in a strongly improved oxygen transfer, because the lungs remain open more effectively during the so-called expiratory phase (‘exhalation phase’). This minimizes lung damage as a result of ventilation and allows for a faster recovery. Evone can be life-saving, particularly for patients in a critical condition.

Superior Ventilation

Ventinova CEO Dirk van Asseldonk: ‘The market for ventilation equipment is incredibly dynamic at the moment. It is important not to lose sight of the crux of this application; at the moment, the crux is the ventilation of corona patients in ICUs, in critical condition. Due to the specific mechanism of the patented FCV technology, Evone allows us to offer superior ventilation for patients.”

He added, “We need to remain cautious about the conclusions, but initial experiences gained in the ventilation of COVID-19 patients appear to confirm that these patients recover more quickly than with conventional ventilation.”

In addition, van Asseldonk said, “Just last night we received a report of a very impressive case: the patient was initially so ill that he normally would not even be able to receive ventilation and instead he would have required a cardiopulmonary bypass machine. In this patient, the ventilation could already be phased out after six days of ventilation by Evone!” “An additional benefit is that ICU beds could be freed up more quickly. And the less time a patient spends on a ventilator, the better for the patient. This is an exceptionally positive development,” he concluded.

Launch of The Resolution Medical Lattice Swab, Crafted with Carbon™ Technology

Resolution Medical, an FDA registered, in vitro diagnostic and medical device manufacturer reports to help increase COVID-19 testing capacity, they have announced the launch of The Resolution Medical Lattice Swab, Crafted with Carbon™ Technology. Resolution Medical has already sent the new 3D printed nasopharyngeal swabs for COVID-19 testing to healthcare organizations and is able to provide swabs to others in the United States who order on its website.

Manufactured using Carbon Digital Light Synthesis™ (DLS™) technology and KeySplint Soft® Clear material for Carbon printers from Keystone® Industries, the Lattice Swab is classified by the FDA as a Class I 510(k) Exempt in vitro diagnostic medical device.

Patient testing swabs are among the most critical medical supplies needed by healthcare providers for COVID-19 testing. Expanding the availability of testing supplies, and thus testing frequency, is a vital part of the timely identification of COVID-19 patients and helping to curb the pandemic’s spread. The new Resolution Medical Lattice Swab exhibits a conformal lattice design made with Carbon’s Lattice Engine software. The hollow structure of the lattice is designed for specimen collection efficiency, with a geometry that is also flexible to promote functionality and comfort for patients. The product is now undergoing clinical evaluation by clinicians at multiple institutions, including Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital affiliated with Harvard Medical School, and Stanford Medicine.

“We are proud to be collaborating with digital manufacturing company, Carbon, to produce the Lattice Swab,” said Shawn Patterson, Founder and President of Resolution Medical. “We have worked together urgently to get this product into the hands of healthcare workers to help address immediate needs for increased COVID-19 testing. At scale, we plan to supply over 1 million swabs per week.”

To produce the Lattice Swab, Resolution Medical works with Carbon’s network of dental labs and production partners, as well as its internal printing team, who use Carbon M2 printers and Keystone Industries’ KeySplint Soft® Clear material, indicated for the fabrication of orthodontic and dental appliances such as mouthguards, night guards, and snoring appliances in the US, Canada, EU, Australia, and New Zealand. The swabs, which are biocompatible and autoclavable, are currently printed hundreds at a time with a unique serialization present on each strip to facilitate traceability.

“Triggered by the COVID-19 pandemic, Carbon’s engineers and material scientists quickly sprung to action to identify the KeySplint Soft® Clear material as having the right balance of properties to make a soft, flexible swab with appropriate strength that could be printed with precision using the Carbon M2 at 75-micron pixels,” said Dr. Joseph DeSimone, Co-Founder and Executive Chairman at Carbon. “Resolution Medical, our production partner since 2018, has been amazing in leading the effort to launch the product.”

In developing, testing, and refining the Lattice Swabs, the team collaborated with a coalition of researchers led by clinical pathologist Ramy Arnaout, MD, Ph.D., associate director of the clinical microbiology laboratories at BIDMC and assistant professor of pathology at Harvard Medical School. His group performed clinical assessments of the swabs based on design, materials testing, usability, and a variety of human factors; collection sufficiency of biological samples; and PCR compatibility using their in-house commercial COVID-19 test. Leading an open and public process, Dr. Arnaout’s group tested and provided feedback on over 160 designs, materials, and prototypes from over a dozen manufacturers, resulting in a decision to launch an ongoing clinical trial of the Lattice Swabs.

“Resolving the national shortage of nasopharyngeal testing swabs is critical to the global fight against COVID-19,” Dr. Arnaout said. “We have brought together a multi-disciplinary team of scientists, academics, and industry partners in a shared effort to resolve this crisis and have begun a clinical trial of Lattice Swabs and other prototypes here at Beth Israel Deaconess Medical Center.”

Carbon and Resolution Medical also collaborated with Kit Parker, Ph.D., a lieutenant colonel in the United States Army Reserve and a professor of bioengineering and applied physics at Harvard University, who played a key role in convening and coordinating efforts, as well as assessing the mechanical properties of various swabs submitted by several providers.

Additionally, Carbon and Resolution Medical have been working with a team of faculty and laboratory and nursing staff at Stanford Medicine, including Ryan Van Wert, MD, clinical assistant professor of medicine; Christina Kong, MD, medical director of the Pathology and Clinical Laboratory; and Jennifer Fralick, administrative director of Laboratory Services. The 3D Printing for COVID-19 Taskforce at Stanford Medicine has been led by Sridhar Seshadri, Ph.D., Chief Administrative Officer, Destination Service Lines.

David Long Named CFO of Cynosure

David Long has been named Chief Financial Officer of Cynosure effective immediately. With more than 25 years of global finance experience and a proven track record of success, the Cynosure reports David Long will help accelerate the company’s business transformation and growth plans under the new leadership of Chief Executive Officer and former Hershey and Unilever executive, Todd Tillemans.

Mr. Tillemans said, “This is an exciting time as we look to position Cynosure for long-term sustainable growth and we’re thrilled to have David join the team. He is a highly respected finance leader who will be invaluable as we prioritize investments in new innovation to drive our customers’ businesses, and ultimately provide patients around the globe with best-in-class technology and service.”

Until recently, David Long served as CFO at Corindus Vascular Robotics, Inc. where he led numerous commercial and operational improvements, successfully brought the company public and, ultimately, navigated its strategic sale to Siemens. Prior to his time at Corindus, Long spent nearly a decade at Thermo Fisher Scientific, where he held the position of Vice President of Finance of the Laboratory Equipment Division. Long also served as an adjunct professor in the Department of Accountancy at Bentley University.

“I’m excited to join such a strong team of leaders,” Long said. “I’m eager to get to work and make an impact alongside the leadership team to ensure we remain positioned for continued success and deliver the market-leading technology clinicians and consumers rely on from Cynosure.”

David Long holds a Master of Public Administration from the University of Pennsylvania and a Bachelor of Science in Finance from the University of Massachusetts.

New Clinical Study Results Demonstrate Rezūm is Proven to Give Men Suffering with BPH Sustained Symptom Relief and Quality of Life Improvements for 5 years

Results of a five-year clinical trial confirming the long-term durability of Rezūm™ Water Vapor Therapy for treatment of benign prostatic hyperplasia (BPH) was published in the Journal of Urology.

The supplement, available online now, includes standard and late-breaking abstracts for the American Urological Association (AUA) Annual Meeting.

The abstract notes that the study found the Rezūm System provided significant, sustained improvement of lower urinary tract symptoms (LUTS) and quality of life for patients suffering from BPH out to five years post-procedure. More detailed results will be released later this year.

Why:  BPH is a common condition that affects roughly half of all men by the age of 60, and up to 90 percent of men by the age of 85.(1) BPH can cause symptoms like frequent or urgent urination, a weak or interrupted urine stream, and the need to get up several times a night to urinate. Medications to treat BPH may not work for many or may have undesirable side effects.(2) And some minimally invasive procedures may only treat BPH symptoms, not the underlying condition.

At the end of the five-year trial, the medication and surgical retreatment rates were:

  • 4.4 percent of the Rezūm System patients required surgical retreatment through 5 years
  • 11.1 percent of the Rezūm System patients required medications through five years

The study also solidified the therapy’s International Prostate Symptom Score (IPSS), Qmax (peak urinary flow rate) and quality of life improvements at 48 percent, 49 percent and 49 percent respectively, all significantly improved from baseline.

From Spain: GPAINNOVA’s RESPIRA Emergency Ventilation Device Receives Approval from the Agencia Española de Medicamentos y Productos Sanitarios to Carry Out a Clinical Trial

GPAINNOVA, located in Barcelona Spain is leading the way in what they define as the RESPIRA project, focusing all their equipment and resources on the design of their medical ventilator in record time. The company reports that Siemens Digital Industries is its main partner and also has the support of SMC, TEG, and MAM.

GPAINNOVA reports the RESPIRA device prototype automates manual resuscitators type AMBU, assisting them automatically and monitored.

The clinical trial will now be carried out with patients affected by COVID-19, which is the last step before homologation by Agencia Española del Medicamento y Productos Sanitarios (AEMPS) of the Ministry of Health. The validation tests have been carried out following the guidelines of the AEMP and under the supervision of the Institut Català de la Salut (ICS) of the Catalonian Government, and are being performed at the Hospital Clínic of Barcelona and at Centre de Medicina Comparativa I Bioimatge del Institut de Recerca Germans Trias i Pujol – Can Ruti in Badalona, and also has the participation of medical experts from the Hospital de Sant Joan de Déu in Barcelona.

The Catalan multinational company GPAINNOVA is leading the RESPIRA project to respond to the global health emergency with the creation of a new prototype of a medical ventilator that is in high demand and which is essential to save lives of those most seriously affected by COVID-19 virus.

In the last two weeks, GPA has yielded all its equipment and resources to the RESPIRA project to create a prototype that allows the manual resuscitation devices (BVM or AMBU) to be activated automatically, giving a more adequate response to patients in front of the lack of approved automatic ventilators.

RESPIRA device, unlike other prototypes that are being developed, has extra features that allow monitoring of patient’s variables in a personalized way and can be controlled remotely providing easier management in hospitals. The devices are portable and have a robust design.

The device includes the necessary electronics to remotely control and monitor variables such as the frequency and volume of air and oxygen supplied to the patient with technology provided by SIEMENS and through a high-performance drive device manufactured by SMC. The use of a control station allows managing up to 16 devices simultaneously through its own Wi-Fi network.

On Tuesday, March 31st, validation tests ended at Hospital Clínic of Barcelona with a simulator and on April 1st they were tested in animals, at Centre de Medicina Comparativa I Bioimatge (CMCiB) del Institut de Recerca Germans Trias I Pujol – Can Ruti in Badalona. At the same time, as established by the guidelines of the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) of the Ministry of Health, electromagnetic compatibility tests have been carried out to ensure that the device does not interfere with other devices and medical equipment. Finally, yesterday the authorization of AEMPS has been received for the clinical trial with patients affected by Covi-19, which is the last step before the homologation.

RESPIRA project has been developed together with Hospital Clínic and Hospital Germans Trias I Pujol – Can Ruti and under the supervision of Dr. Josep M. Nicolás, a specialist in intensive care medicine at Hospital Clínic and professor at Universitat de Barcelona (UB); Dr. Ramón Farré, professor of Physiology at UB and head of the IDIBAPS Biophysics, Respiratory and Bioengineering group; and Dr. Manel Puig, from Instituto de Investigación Hospital Germans Trias i Pujol – Can Ruti. The project also counts on the participation of Joan Grasas, an entrepreneur in health technology and an innovation consultant linked to Institut Català de la Salut (ICS) of Catalonian Government and doctors Jaume Pérez Payarols, Martí Pons, Maria Cols and Arnau Valls from Hospital de Sant Joan de Déu of Barcelona for the definition of the requirements, the development of the device and validations. GPAINNOVA team is in contact with AEMPS to ensure the accomplishment of all standards and product homologation as a matter of urgency.

The entire production team is ready to start manufacturing once the device is approved by AEMPS. GPAINNOVA calculates that initially, they will be able to produce between 150 and 200 units per day, up to 1,000 units per week and progressively will increase production up to 300 units per day. To make this possible, production tests have already been carried out on the assembly line to manufacture the devices used in the clinical study with patients affected by COVID-19. RESPIRA device was created by GPAINNOVA with the support of partners as SIEMENS for electronics, SMC for electrical actuators, electrical assembly and wiring is done by TEG and manufacturing of cases and final assembly, and calibration is done by MAM. From the first moment, the project has had the support of Secretaría General de Industria y Pyme del Ministerio de Industria, Comercio y Turismo, which has constantly monitored its development, accompanying and advising GPAINNOVA, as well as Agencia Española del Medicamento y Productos Sanitarios del Ministerio de Sanidad, which has processed the authorization in record time.

Once RESPIRA device is released, GPAINNOVA will offer training and assistance services to facilitate its use by healthcare professionals in hospitals that require it.

RESPIRA device automates manual resuscitation devices (BVM or AMBU), currently widely available in medical centers, and can automatically and continuously assist the patient. Thus, RESPIRA device expands the number of respirators that can function without the need for continuous and manual actuation by medical staff. This complements the respirators commonly used by medical teams. It is a machine that saves lives by controlling and monitoring the parameters necessary to assist human respiration.

Additional details, contact information can be found here.

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