Pulmonx Corporation | September 05, 2022
Pulmonx Corporation a global leader in minimally invasive treatments for severe lung disease, announces the presentation of interim results from the CONVERT Study at the 2022 European Respiratory Society International Conference. Data on the first 40 patients in the study demonstrated that treatment with the AeriSeal System successfully converted the collateral ventilation status in 78% of patients who were subsequently treated with Zephyr Valves.
The AeriSeal System is used to close collateral air channels in a target lung lobe of a patient with severe COPD/emphysema, making the patient eligible to then undergo Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Valves. Patients whose lungs have untreated collateral ventilation are currently ineligible for treatment with Zephyr Valves and have limited options once medical management alone does not control symptoms. Once the target lobe is converted from CV+ to CV-, patients can be treated with Zephyr Valves, which has been shown to improve lung function, quality of life, and exercise capacity for patients with severe COPD/emphysema.
The CONVERT study uses the AeriSeal System to close collateral air flow. Once the treated lobe tests negative for collateral ventilation Zephyr Valves are implanted to address hyperinflation of that target lobe to ease emphysema symptoms without major surgery. Successfully converted patients who received Zephyr Valves had clinically meaningful Target Lobe Volume Reduction with a mean reduction of greater than one (1) liter. The CONVERT trial is ongoing and full clinical outcomes of BLVR with Zephyr Valves were not reported at this time. However, results recently published from a single-center feasibility study at Macquarie University Hospital in Australia showed that the AeriSeal System successfully closed collateral air channels and allowed for successful clinical outcomes after treatment with Zephyr Valves.2 At 6 months, AeriSeal and Zephyr Valve treated CV+ patients experienced clinically meaningful improvements similar to improvements in CV- patients treated with Zephyr Valves alone.2 Improvements included
Lung function (FEV1 increase of 19.7%, Residual Volume decrease of 16.2%)
Quality of life (SGRQ score decrease of 15.1 points)
Exercise capacity (Six-Minute Walk Distance increase of 77.2 meters)
There were no serious adverse reactions experienced by patients in the Australian feasibility study; 20% of patients in the CONVERT Study experienced an inflammatory response following AeriSeal treatment - all were transient, medically managed, and resolved. The available data suggest that patients with collateral ventilation can undergo successful BLVR with Zephyr Valves following closure of the fissure gap with the AeriSeal System.
“This is very promising news for patients with advanced COPD. We know that treatment with Zephyr Valves can provide long-term improvements in lung function, breathing, and quality of life, but for patients with collateral ventilation, this minimally invasive treatment has not been available as an option,” explains Dr. Michela Bezzi, Department Head and Director Interventional Pulmonology - ASST Spedali Civili, University Hospital, Brescia, Italy. “Having a technology like the AeriSeal System to convert collateral ventilation positive patients to negative status means we can provide a treatment to patients who currently have very few options.”
“This work reflects our continued commitment to developing and testing new medical technologies to help patients with severe lung disease breathe easier and have better quality of life. These early study results are encouraging and move us closer to the goal of helping severe emphysema patients who have collateral ventilation benefit from our proven Zephyr Valve treatment.”
Glen French, President and Chief Executive Officer of Pulmonx
About the CONVERT Study
CONVERT is a prospective, open-label, multi-center, single-arm study being conducted at up to 20 investigational sites. The study plans to enroll 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System, which uses a synthetic polymer foam to occlude collateral air channels in a target lung lobe and convert the target lung lobe to having little to no collateral ventilation. Patients will then undergo Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves. Zephyr Valves are not effective if collateral ventilation (CV+) is present but once the target lobe is converted from CV+ to CV-, patients can be treated with Zephyr Valves which has been shown to improve lung function, quality of life, and exercise capacity for patients with severe COPD/emphysema.
About Zephyr Valves
The Zephyr Valve is a minimally invasive treatment option for severe COPD/emphysema. Zephyr Valves are placed via bronchoscopy to block off a diseased portion of the lung to prevent air from getting trapped and reduce hyperinflation, which allows the healthier lung tissue to expand and take in more air. This results in patients being able to breathe easier, be less short of breath, and have an improvement in their quality of life.1 National and global treatment guidelines for COPD include Endobronchial Valves like Zephyr Valves with the Global Initiative for Chronic Obstructive Lung Disease giving valves an ‘Evidence A’ rating. More than 25,000 patients have been treated with the Zephyr Valve worldwide.
About Pulmonx Corporation
Pulmonx Corporation is a global leader in minimally invasive treatments for severe lung disease. Pulmonx’s Zephyr® Endobronchial Valve, Chartis® Pulmonary Assessment System and StratX® Lung Analysis Platform are designed to assess and treat patients with severe emphysema/COPD who, despite medical management, are still profoundly symptomatic. Pulmonx received FDA premarket approval to commercialize the Zephyr Valve following its designation as a “breakthrough device.” The Zephyr Valve is commercially available in more than 25 countries, with over 100,000 valves used to treat more than 25,000 patients.
Cue Health Inc. | August 25, 2022
Cue Health Inc. a healthcare technology company announced a new collaboration with Fresenius Kidney Care to provide the most accurate* COVID-19 self-test to certain patients and clinical care teams.
People who are immunocompromised have been disproportionately affected by COVID-19 throughout the pandemic and remain highly dependent on measures that reduce the likelihood of infections, including vaccination. Cue can be used by vulnerable patient populations and their care partners to detect and treat COVID-19 early, often before complications arise and hospitalization is required. This is especially important in remote locations where timely and accurate results are critical for making clinical treatment decisions. Fresenius Kidney Care in Hawaii, Alaska, Puerto Rico, Guam, and Saipan will use the Cue Health Monitoring System and Cue COVID-19 Test to screen employees and test symptomatic immunocompromised patients in-center and at-home.
"This is a great example of how Fresenius Kidney Care is seeking out the best technologies to ensure we do everything we can to protect our vulnerable patient population from COVID-19," said Ines Dahne-Steuber, President of Spectra Laboratories, a Fresenius Medical Care company providing laboratory diagnostics to dialysis centers across the country. "This collaboration with Cue will help us provide patients with greater access to high-quality timely diagnosis and care in our effort to improve health outcomes while lowering costs."
Fresenius Kidney Care operates more than 2,600 dialysis centers in the U.S., providing more than 200,000 patients annually with services that include at-home peritoneal dialysis, at-home hemodialysis, in-center hemodialysis, and additional clinical care resources.
"By utilizing Cue's platform, Fresenius Kidney Care can continue to provide its life-saving services to immunocompromised patients with confidence they are using the most accurate COVID-19 self-test. We treat accuracy as non-negotiable so healthcare-affiliated organizations across the country can continue to trust Cue for their testing needs in high-stakes environments."
Ayub Khattak, Chairman and CEO of Cue Health
Fresenius Kidney Care is one of the growing number of healthcare-affiliated organizations and internationally-recognized hospital systems throughout the U.S working with Cue to transform how diagnostic healthcare is delivered to close gaps in the patient journey and drive improved health outcomes. Cue is used in many other point-of-care settings such as Johns Hopkins Medicine and Mayo Clinic, by world-class organizations across the country, including Google, the National Basketball Association, and Major League Baseball, and in homes.
Cue's test uses molecular nucleic acid amplification technology (NAAT) providing lab-quality results directly to connected mobile devices in 20 minutes. The test can detect all known COVID-19 variants and subvariants of concern - including Omicron, BA.4, and BA.5 - and can be used on adults and children (age 2 years and over for over-the-counter (OTC) / home use and under 2 for professional use), with or without symptoms.
About Cue Health
Cue Health is a healthcare technology company that makes it easy for individuals to access health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health's first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription and physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, regulatory approval from India's Central Drugs Standard Control Organization, and PSAR authorization from Singapore's Health Sciences Authority. Cue was founded in 2010 and is headquartered in San Diego.
CareCloud, Inc | August 30, 2022
CareCloud, Inc. a leader in healthcare technology solutions for medical practices and health systems nationwide, has begun deploying its new CareCloud Wellness offering for chronic care management to a variety of clients. Since the start of Q2 2022, clients in 12 states, including New York, Washington and Florida, and in nine different practice specialties, ranging from internal medicine, endocrinology to behavioral health have signed up for CareCloud Wellness. Clients utilize CareCloud Wellness to provide software-enabled, CCM services to patients through CareCloud’s expanding suite of digital health solutions to help providers enhance patient care and revenue streams.
“The digital health industry is on the cusp of creating the next generation of healthcare with access to real-time data, which enables provider-driven care across a broader range of patient conditions. CareCloud’s suite of technology for managing patient care helps our clients jump to this next generation of healthcare. CareCloud Wellness adoption so far in Q3 is already higher than during all of Q2, highlighting the enthusiasm we are seeing from our clients. The number of new CareCloud Wellness clients across a range of specialties is evidence of this trend.”
CareCloud CEO and President Hadi Chaudry
Ninety-two percent of healthcare providers say they want to improve patient experience through digital transformation. CareCloud Wellness is a new, elective digital health program that boosts care for high-risk patients with multiple chronic conditions. This service supports today’s value-based healthcare models, allowing practices to enhance patient care while generating additional reimbursement through participation in the government’s new CCM incentive program.
“CareCloud Wellness enables proactive care and participation in government initiatives that benefit every practice’s bottom line,” said Dr. Iram Fatima, M.B.B.S, CareCloud COO of EHR and Telehealth. “Our track record delivering high quality services to practices for over 20 years and our dedicated team of care managers will allow us to provide value to our customers and their patients.”
CareCloud brings disciplined innovation to the business of healthcare. Our suite of technology-enabled solutions helps clients increase financial and operational performance, streamline clinical workflows and improve the patient experience. More than 40,000 providers count on CareCloud to help them improve patient care while reducing administrative burdens and operating costs.
Softheon | July 01, 2022
Softheon, a leading cloud-based eligibility, enrollment, and billing provider for health plans and government agencies, has acquired NextHealth Technologies, an AI-powered SaaS-based healthcare analytics platform. With the acquisition, Softheon will be better able to help health plans sell and deliver efficient, high-quality care through synergies in the companies' respective products and solutions. Health plans cans save tens or even hundreds of millions of dollars on medical and operational costs through Softheon's growing suite of solutions.
The acquisition significantly enhances Softheon's talent density, enhancing go-to-market strategies, engineering processes, and leadership. The overall speed and capability of NextHealth's AI solutions will increase through Softheon's propriety technology.
Softheon CEO, Eugene Sayan, will continue to lead the company. Eric Grossman, NextHealth's founder, has become the combined organization's Chief Commercial Officer, supporting Sayan's vision and the company's growth objectives.
Sayan shared, "Artificial Intelligence in healthcare is here, and we are seeing the incredible impact it can have on both members and carriers. Our goal has been to make healthcare more affordable, accessible, and plentiful, and we see AI as a clear path forward to bring efficiencies to our carrier partners. This acquisition is a testament to Softheon's commitment to helping health plans tackle some of their biggest challenges, such as population health and the movement toward consumerism in healthcare."
NextHealth Technologies, founded in 2013, offers a cloud-based platform that utilizes rigorous methodologies and standardized processes to enable health plan customers to identify impactable populations, measure which clinical initiatives work best for whom, and integrate data-driven decisions into the workflow in real-time to derive the highest ROI from their analytics investments.
"We are thrilled to be part of Softheon's continued growth and expansion. This is an incredible opportunity for our respective teams. NextHealth's technical and service staff will continue to build and support cutting-edge applications of AI for carrier member populations with the support and resources of a larger company. We see a bright future for our health plan partners as we bring those tools to bear to deliver significant value and reduced costs."
Softheon's purchase of NextHealth is expected to bring economies of scale and operating leverage to the combined company. NextHealth investors, Norwest Venture Partners and TT Capital Partners, will become investors in Softheon and expressed excitement on the prospects of the transaction.
"Together, NextHealth and Softheon can provide better care at lower medical and administrative costs while advancing the application of AI in healthcare." said Casper de Clercq, General Partner at Norwest Venture Partners.
"The acquisition of NextHealth will enhance Softheon's AI capabilities for health plans," said Ryan Engle, partner at TT Capital Partners, "Member data spanning shopping and enrollment through claims creates opportunities for proprietary methodologies to shape member behavior and create value for plans."
Softheon has continued its growth and expansion, having completed more than 20 million enrollments since the inception of the Affordable Care Act, through public and private exchange technology. The acquisition comes after the company introduced its first foray into AI by creating a machine learning algorithm that predicts which members are at risk of letting their insurance coverage lapse, as featured in Bloomberg Law.
Founded in 2000, Softheon's Software-as-a-Service (SaaS) and Business Process-as-a-Service (BPaaS) solutions solve complex challenges for health plans and government health agencies. Currently, Softheon's solutions serve 8 State agencies and over 90 health plans. Issuers and consumers utilizing Medicaid, Medicare, and the ACA Marketplace benefit from Softheon's innovative technology that reduces administrative overhead and enhances user-experiences. Softheon is an Agent, Broker, and Merchant of Record that facilitates health insurance enrollment, administration, and renewal.
About NextHealth Technologies
NextHealth Technologies, based in Denver, is an AI-powered analytics platform that rapidly optimizes the effectiveness of health plans' cost, quality, and service enhancement initiatives resulting in significantly reduced costs and improved outcomes. Its cloud-based solution utilizes scientifically rigorous methodologies and standardized processes, enabling and promoting a culture of measurement. The platform is HITRUST-certified, scalable, and is deployed with expert services to ensure client adoption and success. Know what works™ and make it better.