Category Archives: Health

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Tips on Optimizing Reimbursement and Staying Compliant Webinar, April 8, 2020


WCG CenterWatch

WCG CenterWatch

Billing for Clinical Trials

Tips on Optimizing Reimbursement and Staying Compliant

A CenterWatch Webinar

Wednesday, April 8, 2020, 1:30-3:00 p.m. EDT

https://www.centerwatch.com/billingforclinicaltrials

Achieving clinical billing compliance is complicated and critical to mitigating financial and legal risk. What is the best way to optimize your reimbursement to stay compliant?

Eve Brunts, Esq., a partner in Ropes & Gray LLP’s health care practice, regularly advises research sponsors and clinical sites on a variety of clinical research compliance and contracting issues. She’ll share how one can overcome the challenges of clinical trial billing compliance using applicable coverage and coding requirements and implementing appropriate policies and operational processes:


  • How to achieve efficiency in billing using key principles for clinical trial billing compliance, including necessary required documentation and format
  • How to maximize coverage of clinical trial services by third-party payers
  • Medicare coverage and coding requirements, including Medicare clinical trial policy and investigational devices
  • Federal and state laws addressing coverage of clinical trial services for other third-party payers, including comparisons of federal and state provisions
  • Common challenges and current uncertainties
  • How to ensure clinical trial compliance, with guidance on policies and procedures
  • Common clinical trial agreement contracting approaches
  • Development of a clinical trials coverage analysis
  • Tracking clinical trial services
  • Key takeaways of relevant enforcement actions by government officials

Optimize reimbursements. Get critical tips for best practices in billing, documentation and compliance. Click here to learn more or register.

Interested in registering multiple sites?

Call 888.838.5578 in the U.S. or +1 703.538.7600 globally

to learn about our special multisite discount.

Webinar Details:

Billing for Clinical Trials

Tips on Optimizing Reimbursement and Staying Compliant

A CenterWatch Webinar

Wednesday, April 8, 2020, 1:30-3:00 p.m. EDT

https://www.centerwatch.com/billingforclinicaltrials

Tuition:

$287 per site

Easy Ways to Register:

Online: https://www.centerwatch.com/billingforclinicaltrials

By phone: 888.838.5578 or 703.538.7600

About CenterWatch:

Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.

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Ixlayer Launches COVID-19 Clinical Testing Platform to Power Labs, and Health Systems for in Clinic and Remote Testing


The ixlayer COVID-19 Clinical Test can plug into any health system and lab within 48 hours – enabling labs to digitize ordering and produce real time results delivery while also streamlining healthcare so physicians can pre-screen patients, order tests, coordinate sample collection, and triage patie

ixlayer, an industry leader in technology solutions for health testing, has adapted their platform to address the need to rapidly launch and scale COVID-19 clinical testing. The ixlayer platform, already encompassing the security components that are complex and time consuming to deliver, has been adapted for COVID-19 specific content and user flows, allowing physicians/health systems, organizations, and university groups to quickly connect with partnering labs to deliver COVID-19 clinical testing.

“When the World Health Organization declared rapid and global testing was needed to address COVID-19, I knew that would present challenges. Bringing a new test online can be complicated and time consuming without technology solutions. Thankfully, the ixlayer platform has been efficiently delivering precision health testing across the US using the telehealth model for several years, so we already have the needed security and infrastructure in place,” said Pouria Sanae, CEO of ixlayer. “I am proud of my team’s swift modifications to the ixlayer platform, ensuring the additional measures needed to scale COVID-19 testing nationally are in place. “

Learning from the global responses to COVID-19, ixlayer made sure the platform addressed the issues facing US clinical labs including:

  • Scalable technology to support multiple labs and providers across all states,
  • Telemedicine infrastructure so ordering physicians can connect with patients at home,
  • Secure online (HIPAA compliant) collection of patient health screening and eligibility data,
  • 3rd party Telemedicine physician networks to support high demand, and
  • Ability to schedule COVID-19 sample collection for patient drive through.

The ixlayer platform has specific user flows and content for each type of relationship, connecting clinical laboratories to:

Organizations,

Employee groups, and

Physicians/health systems.

For example, physicians order tests on the platform using their NPI number. Employee groups or researchers can access the platform through a clinical portal to order tests. Patients can also directly request testing, by logging-in to the secure Patient Portal and completing a Health Screening Eligibility Questionnaire that evaluates their current symptoms, recent travel, and community exposure to COVID-19. They then provide the contact information for their healthcare provider and the platform reaches out to the provider to review the patient’s request and determine if the test is a good-fit for their present situation.

The COVID-19 Clinical Test platform also gathers real-time data, including demographics on positive and negative tests by age, gender and geographic location – allowing the Centers for Disease Control or other researchers to identify trends in disease transmission. In addition, if a large number of inconclusive or “no-call” results are present in a given area, issues with the testing pipeline can be identified and addressed rapidly.

Finally, content throughout the platform was thoughtfully developed, using CDC and WHO guidelines, to ensure patients have accurate, up-to-date educational materials. The content is evaluated and adjusted regularly, as CDC and WHO guidelines and recommendations evolve. It can also be customized for an individual group’s specific needs, while maintaining the integrity of the message from these leading authorities.

“We can support not only the infrastructure and technology issues of the clinical labs and healthcare system, but also deliver metrics to help researchers model and learn from disease trends. Now employee groups can also order bulk testing to clear employees, so only the healthy are in essential positions,” said Pouria Sanae, CEO of ixlayer. “I hope our platform can help connect the critical pathways in the national health ecosystem working diligently to combat COVID-19.”

For more information, visit:

https://ixlayer.com/covid-19-testing-platform/

https://ixlayer.com/blog/technology-solutions-for-covid-19-testing/

About ixlayer:

ixlayer is an industry leader in the health-tech ecosystem, providing innovative solutions to power precision health testing to physicians, health systems, health-focused companies, and pharmaceutical partners. The ixlayer platform delivers end to end solutions for the technical, security, regulatory, and user experience components of complex health testing.

The ixlayer COVID-19 Clinical Test can plug into any health system and lab within 48 hours – enabling labs to digitize ordering and produce real time results delivery while also streamlining healthcare so physicians can pre-screen patients, order tests, coordinate sample collection, and triage patients to the right care… all from afar.

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SSHC, Inc. Introduces Enerjoy® Radiant Heaters for Hospital and Mobile Medical Units


Direct source-to-object radiant heat transfer which is free of contaminants is a preferred heat delivery alternative.

An anticipated large influx of COVID-19 infectious patients will require containment in hospital rooms with airborne isolation. This is an overwhelming task for the healthcare system, such as the one New York is currently experiencing. Most hospitals only have a handful of these rooms. In addition, modifying or installing ducted and other forced air systems is imperfect as conventional space ductwork can distribute contaminants throughout an area in both the delivery and return modes.

Studies state that virus aerosolization can extend up to several hours. Virus aerosols can be generated from patients as well as be stirred up from surfaces. An aerosol that encounters a solid object will adhere to that object. Direct source-to-object radiant heat transfer is free of contaminants.

Enerjoy® radiant ceiling panels, manufactured by SSHC, Inc., heat the mass of objects and floor surfaces that reradiate to warm the air. There is no noise, no dust, no allergens, no pollutants, no odors, no ductwork, no air stratification or contaminant-laden drafts. Enerjoy radiant heat panels are used in burn units or “clean” rooms to ensure the safety as well as comfort of patients.

Enerjoy radiant panels heat an entire space for a fraction of convective operating and system cost. Enerjoy electric heaters partner well with alternative energy sources such as photovoltaic and wind energy due to the low energy draw.

Lightweight aluminum panels install directly to the ceiling surface, lay in to a T-bar grid or in the case of industrial height ceilings, suspend with chains. Enerjoy panels install as easily as a light fixture. Furthermore, they are safe to touch and enable full use of all floor space.

SSHC is introducing plug-in Enerjoy Personal Heaters for mobile use. These floor models heat with only 400 to 750 watts and are safe to touch. The Enerjoy Personal Heaters provide personal comfort when, where and as needed in emergency circumstances. Low-wattage Enerjoy Personal Heaters provide the same non-draft, non-contaminant benefits as the ceiling models.

The floor models can be placed in supplied stands or mounted to a nearby wall, if permanent installation is preferred. The smooth panel surfaces allow for disinfection on an as-needed basis. The Enerjoy Personal Heaters are easily transportable for make-shift site locations.

Enerjoy radiant panels, US DOE Energy Related Invention Program #34, are manufactured in Westbrook, Connecticut, in standard and custom sizes, voltages, and wattages. The joint D.O.E NAHB Enerjoy case study found a 32% energy savings over the heat pump and 52% over baseboard, with superior occupant thermal comfort – all with 50% lower BTU sizing.

About the SSHC, Inc.and the Founder

SSHC,Inc. has been a leader in the radiant industry for over 30 years, providing innovative solutions for heating using far infrared technology. Richard Watson, President and Founder of SSHC, Inc. co-authored McGraw-Hill’s 900 page book THE HANDBOOK OF RADIANT HEATING & COOLING. Mr Watson is an ASHRAE member and previous committee chair, and has published many white papers on the subject of radiant heat. Enerjoy radiant panels, flagship product of SSHC, Inc., are used worldwide for residential, commercial, industrial and personal heating applications.

For more information, visit http://www.sshcinc.com or email info@sshcinc

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Dentistry at East Piedmont Offers Free Virtual Dental Appointments to All


Dentistry at East Piedmont, a cosmetic dentistry practice and dental spa, is offering free online dental appointments for both patients and members of the community in efforts to promote social distancing without having to sacrifice oral health. These teledental appointments will take place via phone or video call, with either Dr. Ashish Patel or Dr. Dahlia Levine administering the consultation.

Teledentistry allows people to receive dental advice from trusted professionals while in the safety of their own homes, preventing unnecessary physical contact in the wake of the Coronavirus. The Marietta dental spa is offering this complimentary service to everyone, regardless of whether they are a current patient.

On Dentistry at East Piedmont’s new, free service and efforts to reduce the virus from spreading, practice founder Dr. Patel said, “In this tough time it’s really important that we pull together as a community. We want to try to help as much as possible.”

About Dentistry at East Piedmont: Dentistry at East Piedmont is a dental spa located in Marietta, GA that provides both cosmetic and general dentistry services. Founded in 2001, Dentistry at East Piedmont focuses on offering premium oral care while keeping patient comfort top of mind. Practice founder Dr. Patel was named as one of the Top Dentists in Atlanta by Atlanta Magazine in 2018 and 2019.

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Mytonomy Launches Patient Experience Cloud™ for COVID-19 to Enable Virtual Care


“Mytonomy has an urgent responsibility to deliver virtual care tools that can help the entire healthcare industry prepare for and respond to the needs of their communities during this challenging time,” said Anjali Kataria, CEO, and co-founder.

Mytonomy, an enterprise SaaS company and film studio specializing in virtual care, announced today a novel configuration of its Patient Experience Cloud™ (PEC) platform to respond to the unique challenges presented by COVID-19, which include digitally educating, engaging and triaging large numbers of people outside the hospital to keep workers safe and reduce costs.

As providers turn to virtual care in the form of phone calls and video visits to meet the demand for healthcare, the need to triage the inbound phone calls and potential visits to the ED and Urgent Care takes top priority. Routing visits to telehealth is a common strategy, but not all patients need a telehealth visit right away.

The PEC gives health systems a fast, easy-to-deploy custom publishing platform with built-in surveys, SMS, and email capabilities, which can be rapidly configured to each health system forming the basis for virtual care delivery.

Building on a strong foundation of consumer tech combined with enterprise software, Mytonomy’s PEC for COVID-19 requires no login for patients, complements existing telehealth offerings found both inside and outside patient portals, and eliminates multiple points of friction in digital engagement.

The PEC for COVID-19 builds on Mytonomy’s past success for enabling similar types of virtual engagement across multiple health interactions spanning cardiology, oncology, diabetes and hypertension.

“Mytonomy has demonstrated that we can deliver consumer-internet-like user engagement by delivering hospital-approved and branded video education to patients across multiple condition areas. Our user-experience is designed for a training use case, unlike merely linking out to 3rd party videos. We can deliver this consumer attention to health systems looking to grow patient portal adoption, leading the public to rapidly sign-up for their telehealth offerings and absorb important information quickly,” said Vinay Bhargava, President, and co-founder of Mytonomy.

The PEC for COVID-19 can be deployed without any IT resources, in less than 72 hours and comes with 21 microlearning videos in English and Spanish along with CDC or WHO content. The Mytonomy content is clinically vetted, follows CDC guidelines, and can easily be tailored to support the local practice and messaging.

Mytonomy’s content publishing system allows health systems to rapidly upload any content of their choice to deliver to patients, providing a powerful initial engagement point for patients, followed by dynamic surveys for symptom checking, assignment into risk-based cohorts and delivery of tailored communication plans to patients while at home. This virtual engagement helps keep call volume down, prevents unnecessary flooding of access points, and allows staff to interact with patients most in need of a call or appointment.

Mytonomy microlearning video content for COVID-19 covers timely topics such as Practicing Self-Quarantine and Self-isolation, Reducing Coronavirus Stress, and Applying Social Distancing to Your Life. EMR integration is available with Epic MyChart, and the PEC can be used to mass email patients helping them sign up for MyChart if they don’t already have an account.

“As a leader in patient engagement, education, and experience cloud solutions, Mytonomy has an urgent responsibility to deliver virtual care tools that can help the entire healthcare industry prepare for and respond to the needs of their communities during this challenging time,” said Anjali Kataria, CEO, and co-founder.

To access the complete list of up-to-date Coronavirus content, visit Mytonomy’s COVID-19 response page at https://www.mytonomy.com/covid-19-patient-education-videos.html

About Mytonomy

Mytonomy has a singular mission: empower people to become confident and active participants in their health. Being diagnosed with a health condition and navigating the health system is stressful and confusing, driving people to piece things together through a web search, friends, and social media. Mytonomy’s Patient Experience Cloud™ enables health systems to build trusted, loyal, online relationships using award-winning, microlearning video content delivered through an easy-to-use digital platform. With people spending an average of 30-40 minutes viewing Mytonomy’s short-form video content, on any device, at any time, they learn how to care for themselves and take charge of their health achieving better outcomes. Providers save valuable time and generate better financial results across multiple patient encounters. Mytonomy is like a “Netflix for healthcare”, enabling healthcare’s digital front door. Learn more at http://www.mytonomy.com.

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Share your thoughts and support on COVID-19 Community Wall


The onset of COVID-19 has had a tremendous impact on all aspects of life in the past few weeks. Here at Beyond the Dash, we want to help where we can. Therefore we are announcing the launch of a COVID-19 Community Wall: a digital space to share and connect with others as we face this pandemic together.

All messages will be moderated for appropriateness and added to the wall as quickly as we can. Beyond the Dash makes no money from the wall—we see this as a place for us to get together as a community in a positive and supportive way.

Please visit the Community Wall to pay tribute to those who have died, offer condolences to their loved ones, and share positive messages of support to those on the front lines.

For those who are having difficulty with the times and are looking for resources to help them with grieving in isolation during this time, Beyond the Dash has several resources that may help. For thoughts on grieving in isolation, try https://beyondthedash.com/blog/funeral-planning/funerals-grief-and-condolences-during-covid-19/7404.

For help with understanding grief in general, here are a few helpful articles:

https://beyondthedash.com/blog/grief/grief-theory-the-dual-process-model-of-coping/7327

https://beyondthedash.com/blog/grief/how-to-support-a-friend-who-has-lost-a-loved-one/7273

https://beyondthedash.com/blog/grief/what-does-healthy-grief-look-like/6202

Link to Community Wall:

https://beyondthedash.com/obituary/covid-19-community-wall-1078889081

About Beyond the Dash

The life of a loved one is more than just a dash, bookended by two dates. That dash is their life story. Beyond the Dash helps users share, remember and celebrate life stories. We offer simple, elegant and affordable online obituaries to grieving families, giving them the tools they need to publish meaningful, detailed and memorable tributes to their loved ones.

For media enquiries contact Brigitte Ganger, press@beyondthedash.com.

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LSS Life Safety Services Delivers Critical Fire Protection and Disinfecting Services During COVID-19 Pandemic


Our clients have turned to us now during this serious issue because they know we have the experience and the training credentials to deliver the work that is so essential to public health and safety.

LSS Life Safety Services® (LSS), a nationwide fire protection company based out of Louisville, Kentucky, announced today their pledge to offer continued nationwide operations of vital fire safety inspections, products, and life safety services across the country in response to the escalating COVID-19 pandemic.

“With hospitals filled to maximum capacity with patients and staff due to the coronavirus pandemic, it’s never been more important that hospitals and nursing homes’ fire protection systems are working,” said Craig Rutledge, President and CEO of LSS. “Our service teams have been working around the clock to do our part in keeping patients and staff safe during these crucial times.”

LSS has provided mission critical fire protection inspections and repairs to facilities across the country for decades and vows to continue to deliver front-line fire protection and safety services during this crisis. Additionally, they are offering UVC Light Disinfection products and installation services in an effort to assist healthcare and other facilities disinfect work spaces and critical care spaces during the pandemic. UVC disinfection systems utilize the maximum amount of UV rays to sterilize mold, bacteria, and viruses, including COVID-1, with no harmful chemicals.

“We’ve seen a huge spike in our UVC Lighting Products, as our clients around the country look for effective solutions that kill COVID-19, especially solutions that don’t utilize chemicals that work to kill the virus in the airstream,” said Rutledge. “We’ve been deploying teams throughout the country to rapidly assist with the Coronavirus pandemic. Our clients have turned to us now during this serious issue because they know we have the experience and the training credentials to deliver the work that is so essential to public health and safety.”

LSS technicians are highly skilled in the area of fire protection and hold multiple OSHA, HAZMAT and FEMA certifications. Additionally, they have numerous ACAC Council Certified Indoor Environmentalists and Hazardous Waste Operations & Emergency Response technicians on staff.

About LSS Life Safety Services®

LSS Life Safety Services® specializes in fire and smoke damper inspections and repairs, fire door inspections, firestopping and complete fire barrier management programs. As a leader in the fire safety industry, LSS Life Safety Services®’ has made a commitment to commercial facilities to provide specialized fire protection inspections of the highest quality to ensure compliance with NFPA’s critical Life Safety Code®.

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Mobile App That Keeps Family and Friends in Touch


Porchlight – Being There

I love what Steve and his team at Porchlight are doing

Porchlight – Being There, a private social network that keeps family and close friends connected, is now 100% free to everyone in response to the global pandemic crisis of 2020. The latest version of the app, available on both iTunes and Google Play, no longer charges $9.99/month but is instead 100% free. It will remain free throughout the 2020 Global Pandemic Crisis related to COVID-19, at least through June 2020 and possibly beyond. Learn more about the app and download it for free here: Porchlight App.

The Porchlight App was originally created to address isolation and loneliness which can arise when family and close friends live far apart. The mandatory social distancing as a result of COVID-19 has created unprecedented isolation and loneliness for individuals, threatening to create a new social crisis. Porchlight is something we can all do, for ourselves and the people we love, to prevent the social crisis. Unlike traditional social media, Porchlight is quick and 100% private. It is designed for the busy modern life by offering a quick 5-second check-in and check-up, and the ability for one-on-one follow up on the things that matter with the people that matter. As a private network, Porchlight App does typically cost money ($9.99/month) in order to keep the platform Ad-free and 100% private. However, Porchlight’s founder Steve Peterschmidt believes that helping as many people as possible get through this crisis is more important than short-term profits.

“Our mission at Porchlight is simple, help people stay connected. In this time of crisis, it is even more important to be connected to close friends and family. That is why we’ve decided to let everyone use the Porchlight private network for free throughout the crisis,” said Steve Peterschmidt, founder and CEO of Support Tribe Inc, makers of Porchlight.

Connection is a human need, but one that needs some help in the modern world. As Stanford Behavior Scientist, Dr. BJ Fogg, put it “I love what Steve and his team at Porchlight are doing in the design of their app. They are helping people do something they already want to do–find a more meaningful and efficient way to connect in a busy world–which is one of my maxims for creating a new and lasting habit.” Now, with COVID-19, the need to stay connected is a global need, and Porchlight is doing our best to help.

About the Porchlight App

The Porchlight App is a private social network and related applications for Apple and Android that helps keep family and close friends connected. Unlike other social media, Porchlight App lets you know how someone is doing, not what. Porchlight also reminds you to stay in touch, and lets you know when to reach out when someone in your tribe is in need. Porchlight is available for download in the iTunes and Google Play app stores.

About Support Tribe, Inc.

Support Tribe, Inc. was founded in 2018 to help people have meaningful connections to the important people and resources that create health and happiness. In addition to the Porchlight App for consumers, Support Tribe also offers apps and tools for the healthcare industry that create industry changing engagement between the health system and their members. Contact steve@porchlightapp.io about our B2B products.

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iFirst Begins Rapid Development of COVID-19 Nasal Swab Test


iFirst Analyzer

iFirst Analyzer

“COVID-19 poses a grave danger to public health here in the U.S. and around the globe,” said Luke Joseph, CEO of iFirst. “We at iFirst are compelled to act. Broad-based testing and on-the-spot results promise to slow the spread and save human lives.”

iFirst Medical Technologies, Inc., a leader in handheld diagnostic devices, announced today that it has begun rapid development of COVID-19 nasal swab test.

“COVID-19 poses a grave danger to public health here in the U.S. and around the globe,” said Luke Joseph, CEO of iFirst. “We at iFirst are compelled to act. Broad-based testing and on-the-spot results promise to slow the spread and save human lives.”

iFirst has begun rapid development of a nasal swab test for use with the handheld iFirst Analyzer™ to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19.

Upon successful validation of its COVID-19 Test, iFirst plans to seek Emergency Use Authorization from the U.S. Food and Drug Administration.

The iFirst Analyzer is a handheld diagnostic device, with onboard chemistry and optical analytics. It also has integrated GPS and wireless transmission of results to the iFirst Cloud™, enabling effective public health surveillance. This takes the form of real-time, automated reporting and mapping of outbreak hotspots, informing authorities and enabling better containment of the spread of an epidemic or a pandemic.

Critical use cases include ports of entry and enabling health care workers to evaluate and test quarantined patients in their homes. Mobile, in-home testing would ease the burden on clinics and hospitals as well as lessen the risk of social spread of disease.

iFirst has engaged Underwriters Laboratories and expects to complete UL testing and CE mark certification of the iFirst Analyzer during the second quarter of 2020. The CE mark indicates that a product may be sold freely in any part of the European Economic Area, irrespective of its country of origin.

Prior to COVID-19, the world has experienced threats from coronaviruses including SARS in 2003 and MERS in 2012. The underlying science used in the development of the test to detect SARS-CoV-2 (which causes COVID-19) enables rapid development of tests for the unfortunate reality of future coronaviruses.

Honolulu-based iFirst is collaborating with researchers at the University of Hawai’i John A. Burns School of Medicine (JABSOM). The company’s iFirst Analyzer technology has been bench tested at JABSOM as well as Cedars-Sinai Medical Center in Los Angeles, California.

In 2017, the iFirst Analyzer was recognized by NASA iTech as one of the Top 10 technologies that are solving problems on Earth and have the potential to address existing challenges to enable NASA missions.

“iFirst is on the forefront of diagnostic technology, with research and development that saves lives and advances humanity,” said Kevin Lye, M.D., the company’s Chief Medical Officer. “With our Coronavirus Detection Initiative, we aim to work with governments and healthcare providers to slow the spread of COVID-19 and future coronaviruses.”

iFirst is a privately held company, with backing from two Honolulu-based institutional investors, Markowitz Trust and Blue Startups. Funding for the early prototype iFirst Analyzer came from a roughly $1 million grant from the U.S. Army.

To accelerate test development, iFirst is seeking grants from governments, non-governmental organizations (NGOs) and private foundations. The company also invites collaboration with like-minded, innovative businesses. Find more info at https://www.ifirstmedtech.com/covid-19

About iFirst

iFirst Medical Technologies, Inc. is a leading developer of handheld diagnostic devices. The company’s critically acclaimed iFirst Analyzer™ employs onboard chemistry, optical analytics, GPS and wireless transmission of patient data to the iFirst Cloud™. iFirst has been recognized by NASA iTech (2017) as one of the Top 10 technologies solving problems on Earth with potential for future space missions. Headquartered in Honolulu, the company is privately held and backed by local institutional investors. Early prototyping was funded by a roughly $1 million grant from the U.S. Army.

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Statement Of Support By The PAP Foundation, Inc. For FDA Approval Of GM-CSF Treatment For aPAP


News Image

The PAP Foundation, Inc. (“PAPF”) is the primary patient advocacy organization for Pulmonary Alveolar Proteinosis (“PAP”) in the United States and consists of clinicians, scientists, PAP patients and their family members. With foundational goals of finding a cure and improving the lives of those affected by PAP, we have received numerous testimonials from patients whose lives have significantly improved through the use of inhaled GM-CSF. Outcomes have included improvement in exercise tolerance and quality of life, decreased need for whole lung lavage, and decreased need for oxygen therapy. Moreover, we have witnessed patients who have discontinued GM-CSF therapy after seeing significant improvement only to suffer disease recurrence necessitating the resumption of GM-CSF treatment.

PAPF commends both the PAGE (sponsored by Niigata University Medical & Dental Hospital) (shortened link: https://bit.ly/2WGi07F) and the IMPALA (sponsored by Savara Inc.) (shortened link: https://bit.ly/2y28XDC) investigators for conducting the first two multicenter randomized clinical trials using inhaled GM-CSF in patients with autoimmune Pulmonary Alveolar Proteinosis (“aPAP”). The results of the two studies differed in some regards, yet in aggregate PAPF interprets this data as further evidence inhaled GM-CSF can improve a number of outcomes including quality of life, pulmonary function testing parameters, the oxygenation of the blood as measured by “A-a gradient”, and the amount of surfactant seen on images of the lungs.

Based on the above trials and on the experiences of numerous PAPF patients, it is our continued reasoned position that inhaled GM-CSF treatment is not only an effective therapy for many patients, but the best medical option currently available to improve the overall health and quality of life for most aPAP patients. In contrast, the current standard of care for aPAP treatment is Whole Lung Lavage (“WLL”); a highly invasive, time-consuming and dangerous surgical procedure that is often needed throughout a PAP patient’s life whenever their symptoms become life-threatening or otherwise too much to bear.

Of particular note to the PAP patient and clinician communities, we believe the most efficacious results for aPAP patients on inhaled GM-CSF treatment take into consideration drug duration and dosage. The experiences shared among our patient and physician community suggest that the full impact of GM-CSF therapy can take multiple months, and treatment that does not allow for this requisite time will likely show suboptimal results. As to dosage, some in our community’s experience suggests that GM-CSF treatment is only effective once the dosage is high enough (presumably, to overcome the barrier of elevated anti-GM-CSF autoantibodies in each individual aPAP patient’s lungs). Using a number of patients in our community as case examples, 250 ug of GM-CSF daily failed to show improvement, however, when dosage was increased to 500ug daily, these patients no longer required additional whole lung lavages, some for multiple years. This represents a drastic improvement in this subset of patients compared to the year prior to initiating this increased dosage of GM-CSF.

Although the science as to PAP has come a long way in the recent past, since the revitalization of our patient foundation over 3 years ago, we have witnessed a number of patients in our PAP community tragically deteriorate; some requiring lung transplantation and others who are being kept alive on oxygen therapy or life support in a hospital setting. We believe that if these patients were properly diagnosed with PAP earlier and GM-CSF treatment was available to them, their lives and outcomes could have been dramatically improved.

The PAP Foundation remains steadfast in our mission to support the development of efficacious therapies and ultimately a cure for this devastating disease and is committed to its advocacy for FDA approval of inhaled GM-CSF therapy as a primary treatment option for aPAP patients.

In furtherance of the above, the PAP Foundation attended the FDA Rare Disease Day held at the FDA in Maryland on February 24, 2020, where we shared these sentiments during the Open Public Comment period and will be submitting this written statement together with our comments made at the FDA event to Federal Register Docket No. FDA-2019-N-5646.

This statement of support is provided by the leadership of the PAP Foundation, Inc., comprised entirely of doctors, clinicians, and PAP experts and/or patients, as such leadership is listed below:

President

Christopher Hameetman

Los Angeles, CA

Vice President & Clinical Director

Tisha Wang, M.D.

Los Angeles, CA

Second Vice President

Steven Park

Lakewood, CO

Secretary / Treasurer

Brenna Carey, M.S, Ph.D.

Cincinnati, Ohio

Scientific Director

Bruce Trapnell, M.D.

Cincinnati, Ohio

If you would like further information on this topic, please contact Brenna Carey, PAP Foundation Media Liaison, at 513-636-8916 or by email to brennac@papfoundation.org.

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