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DaVita & RenalytixAI Partner for Early Risk Identification to Help Slow Kidney Disease Progression

Humana and REACH Kidney Care Sign Care Coordination Services Agreement

RenalytixAI, a developer of AI-enabled clinical in vitro diagnostic solutions for kidney disease, and DaVita, the largest provider of kidney care services in the U.S., announced a partner program aimed at slowing disease progression and improving health outcomes for the nation’s estimated 37 million adults with chronic kidney disease (CKD). The program is expected to improve patient outcomes and provide meaningful cost reductions for health care providers and payors by enabling earlier intervention for patients with early-stage kidney disease (stages 1, 2 and 3) through actionable risk assessments and end-to-end care management.

The collaboration is expected to launch in three major markets this year. As the program expands, DaVita and RenalytixAI intend to pursue risk-sharing arrangements with health care providers and payors to drive kidney disease patient care innovation, cost efficiencies and improve quality of life.

Kidney disease currently affects over 850 million people globally — 20 times more than cancer. As such, it is a growing concern among healthcare companies, medical providers and the government, and researchers, who are now investigating its connection to COVID-19. In July 2019, the Trump administration announced the Advancing American Kidney Health (AAKH) initiative. And, now organizations, administrations, and companies are calling on the Biden-Harris administration to expand on that initiative and prioritize kidney disease in the first 100 days.

Early Risk Identification at Core of Innovative Kidney Care

The program utilizes the KidneyIntelX in vitro diagnostic platform from RenalytixAI, which uses a machine-learning algorithm to assess a combination of biomarkers from a simple blood draw with features from the electronic health record to generate a patient-specific risk score. The initial version of the KidneyIntelX risk score identifies Type 2 diabetic patients with early-stage CKD as low-, intermediate- or high-risk for progressive decline in kidney function or kidney failure. The integrated program may also help reduce kidney disease misclassification, which leaves some higher-risk patients without recommended treatment. The expected outcome of the collaboration will also be used to expand indicated use claims for KidneyIntelX.

After risk stratification, program patients identified as intermediate- and high-risk will receive care management support through DaVita’s integrated kidney care program, for which Renalytix will compensate DaVita in lieu of providing those services itself. DaVita’s integrated kidney care program is comprised of a coordinated care team, practical digital health tools, award-winning patient education and other offerings. Focused on the patient experience, these services are designed to empower patients to be active in their care, delay disease progression, improve outcomes and lower costs. DaVita’s team also closely collaborates with the treating nephrologist, who leads the care team, to create a seamless care experience.

For patients whose kidney disease does progress, earlier intervention can provide the patient and treating nephrologist more time to make an informed decision about the treatment option that is best for them, including pre-emptive transplantation, home dialysis or in-center dialysis. For those patients who choose to begin dialysis, the extra time increases their chance for an out-patient dialysis starts, which can help them to avoid starting dialysis with a costly hospitalization.

Withings, Redox Partner to Make Remote Patient Monitoring Devices Integrated With All EHRs

Withings, Redox Partner to Make Remote Patient Monitoring Devices Integrated With All EHRs

Withings, early pioneers of the connected health revolution, announced it has partnered with Redox, a single, secure API endpoint that connects and integrates provider EHRs with healthcare products and services. The partnership makes MED·PRO CARE, the unique Withings remote patient monitoring solution, compatible with nearly all EHRs used by physicians, hospitals, and medical institutions.

Withings launched MED·PRO CARE, its remote patient monitoring platform, to allow caregivers, medical institutions, and private organizations to manage multiple patients’ physiological data through the company’s portfolio of connected health devices and data analytical capabilities.

Patients benefit from beautifully designed devices that require little to no set up to fit effortlessly into their daily lives. In fact, thanks to the Withings Data HUB, a plug and play cellular gateway created specifically for Withings MED·PRO solutions, health providers can even deliver devices to patients that require no set up or daily management at all.

Clinically Validated Health Devices Now Compatible with EHRs

Through the partnership, physicians can now order and ship Withings clinically-validated connected health devices directly to their patients through their EHR in just a few simple steps. Patients can use their Withings devices to monitor and track their health in their traditional home environments while their physicians access and analyze their data seamlessly through Redox. The solution is HIPAA compliant and uses HL7 international standards.

 

Wolters Kluwer Health Announces Integration of its Clinical Interface Terminology Solutions with Henry Schein MicroMD’s EMR Platform

 Wolters Kluwer Health Announces Integration of its Clinical Interface Terminology Solutions with Henry Schein MicroMD's EMR Platform

Wolters Kluwer Health announced that Henry Schein MicroMD, a practice management and electronic medical record (EMR) solution, will be using Health Language Clinical Interface Terminology (CIT) to quickly map over a million medical abbreviations, typos, incomplete terms, and acronyms to standardized terminology. As a result, clinicians using MicroMD can easily search for diagnoses and procedure codes using their own day-to-day jargon with Wolters Kluwer Health Language Provider-Friendly Terminology (PFT).

“Unspecified diagnosis codes can have a significant financial impact for a medical practice. To avoid revenue loss, it’s critical that patient encounters be documented correctly at the point of care,” said Kristen Heffernan, General Manager at MicroMD, a Henry Schein company. “The integration of Wolters Kluwer’s provider-friendly terminology solutions can help enable clinicians to document more quickly and accurately, help reduce rejected claims, and help increase patient time with their providers.”
Kristen Heffernan

Health Language PFT is built upon tools that deliver a computer-processable collection of medical terms providing codes, terms, synonyms and definitions used in clinical documentation and reporting, such as ICD-10-CM, ICD-9-CM, and SNOMED CT®. Sophisticated search algorithms convert a clinician’s problem or diagnosis search into a standard, compliant code using a continually updated array of related terms, including synonyms, misspellings, word order variants and partial words. For example, clinicians using MicroMD can search familiar clinical shorthand or jargon such as AFib, A-Fib, atrial fib, or AF and PFT will consistently provide the corresponding ICD or SNOMED CT codes for atrial fibrillation.

“Our technology solution uses more than 300,000 attributes to help clinicians navigate the complexities of ICD-10 and pinpoint appropriate codes,” said Karen Kobelski, Vice President and General Manager, Clinical Surveillance, Compliance & Data Solutions at Wolters Kluwer Health. “With just a few clicks, clinicians are able to narrow 1,000 ICD-10 codes down to the one they need using their own terms. This significantly improves the physician documentation experience and the accuracy of the revenue cycle.”
Karen Kobelski

For medical practices, PFT can improve clinical documentation, increase clinicians’ satisfaction with their EHR, support clinician productivity and reduce revenue losses associated with inaccurate or incomplete clinical documentation.

CareSource, Healthify Partner to Address Social Determinants of Health in Ohio

COVID-19 Causes Healthcare To Adopt More Touchless Payments

CareSource, a nonprofit multi-state managed care plan has partnered with Healthify to build a statewide network of community-based organizations in Ohio. The new network will provide social services to CareSource’s members throughout the state with referrals to address Social Determinants of Health (SDoH). This new collaboration will expand upon the existing CareSource Life Services program and Healthify OH social services network.

The network will be made up of community organizations that provide a range of services that address SDOH such as food insecurity, lack of transportation, unemployment, inadequate housing, and financial instability. CareSource will also use Healthify’s population analysis modeling to identify social risk across OH and target hard-to-reach members to ensure they are connected to critical services.

Identifying Social Risk Across OH to Target Hard-to-Reach Members

In addition to the statewide network, CareSource will use Healthify’s population analysis modeling to identify social risk across OH and target hard-to-reach members to ensure they are connected to critical services. By layering this on top of clinical and cost data, CareSource can meaningfully improve member engagement among membership while tracking their long-term outcomes. Please visit the following link to learn more and join the statewide network to better coordinate care between healthcare and social services.

Philips and GSK partner to better inform parents about child vaccination

RSPH calls for quick measures to keep child vaccine decline in check

Virtually every parent looks for the best way to care for and nurture their kids to give them the best start in life. But with so much misinformation, or conflicting information, coming from multiple sources, mostly online and via social media, there is a real need for reliable and credible information to aid their decision making. Vaccination is one of the topics around which there continues to be a lot of discussion.

Few would deny that vaccines have been one of medicine’s greatest triumphs in protecting people’s health and wellbeing, helping to largely eradicate diseases such as polio, measles, mumps, rubella and diphtheria. However, that might give the impression that these diseases are no longer a threat. So where can you find information about vaccination that is both reliable and evidence-based so you can make informed decisions?

Helping parents make the right choices
In the belief that parents should be able to make decisions based on the best possible evidence, Philips and GSK have teamed up to equip Philips’ Pregnancy+ and Baby+ apps with comprehensive and reliable information about vaccine preventable diseases and the vaccines that are available. This includes articles and videos about the importance of vaccination, together with a vaccination hub that helps parents access comprehensive and reliable information to support conversations with their healthcare professionals, such as which vaccines are relevant and when they need to be administered. Parents are also invited to participate in on-line research that will help to better understand their views on different vaccinations.

“With misinformation and often conflicting information from multiple sources, mostly found online and via social media, there is a great need for reliable and credible information,” said Deeptha Khanna, Chief Business Leader Personal Health at Philips. “With our Pregnancy+ and Baby+ apps we are in direct contact with millions of parents and parents to be. We want to support them with trustworthy and reliable information and create greater awareness of vaccination programs and vaccine preventable diseases.”

Commenting on the partnership for GSK, Dr. Francesca Ceddia, Vice President, Head of Global Medical Affairs at GSK Vaccines said: “Pregnancy and bringing home a new baby are exciting experiences for parents – experiences that have them asking many questions about their child’s health and searching for clear, accurate answers. While multiple digital resources are now available and access to information has never been quicker, the spread of misinformation on social media can make it difficult to know where to turn. For this reason, we have partnered with Philips to offer parents access to scientifically accurate, easy-to-understand information on vaccine-preventable diseases, which can help them protect their child.”
Delivering on the quadruple aim

With the Philips Pregnancy+ and Baby+ apps reaching a combined total of almost 2 million parents across the globe every day, the Philips/GSK vaccine partnership represents a huge step forwards in providing parents with factual, scientifically accurate information. By facilitating preventative care, offering easy digital access to information, and eliminating much of the cost and heartbreak of treating preventable childhood diseases, it further cements Philips’ commitment to the quadruple aim of healthcare – improved outcomes, better patient and staff experiences, and lower cost of care.

The Philips/GSK partnership offering is already live in Brazil, Canada, Switzerland, Poland, Spain, Germany, Italy, Australia, Russia and Mexico, where it has proved highly successful in reassuring parents who have been unable to have face-to-face contact with their child care teams due to the COVID-19 pandemic.

SurgCenter Development Announces Development of Advanced Surgical Care of Maryland

SurgCenter Development (SCD), a leading developer of ambulatory surgical centers (ASCs) throughout the United States, today announced its latest partnership in Maryland, Advanced Surgical Care of Maryland.

SCD is actively scouting locations for the center and expects to open its doors to patients in late 2021. Advanced Surgical Care of Maryland will feature two operating rooms featuring state-of-the-art equipment and a trained team that includes surgeons who specialize in general orthopedics, sports medicine, outpatient total joint replacement surgery, and pain management.

“SCD has developed hundreds of outpatient surgery centers in partnership with physicians from across the country for decades, and we continue to see a growing demand as patients seek a safe and convenient option for their surgical needs,” said Chris Urban, MD, SCD Principal and Chief Development Officer. “We provide the industry experience and expertise to develop highly successful centers that support the physicians’ and the patients’ needs. We look forward to working with top tier surgeons in opening Advanced Surgical Care of Maryland.”

SCD currently has 21 operational centers in Maryland and one additional center in development in Bethesda, MD.

RefleXion and HealthMyne Collaborate to Use Patients Tumor Data to Guide Cancer Therapy

RefleXion and HealthMyne Collaborate to Use Patients Tumor Data to Guide Cancer Therapy

RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) as a new modality for treating all stages of cancer, and HealthMyne Inc., an innovative developer of applied radiomic solutions, announced a strategic partnership to bring together the companies’ technologies to quantify and improve the inherently complex decisions surrounding cancer therapy and develop a more individualized approach to patient treatment.

“Our novel BgRT technology produces data-rich CT and PET images at each patient treatment session,” said Thorsten Melcher, Ph.D., chief business officer at RefleXion. “Applying HealthMyne’s unique radiomic insights and AI-enabled algorithms holds the promise of decoding these data so clinicians can use the tumor’s characteristics and its response to radiotherapy to inform and guide the entire patient journey. Instead of delivering standardized treatment protocols, we can now think about the best care plan for each patient and use our biological guidance to deliver it confidently, even one day, to metastatic patients.”

HealthMyne’s solutions enable clinicians to access image data not discoverable with the naked eye and translate it into groundbreaking disease insights. The core of HealthMyne’s solutions enables precise extraction of quantitative imaging or structural information, known as radiomic data, to improve and automate decision making in cancer research, screening, treatment planning, and clinical management. This includes over 1,500 multi-dimensional measurements and novel radiomic data capable of powering predictive algorithms and precision medicine initiatives.

Radiomic data forms the basis for imaging biomarkers, defined by the Radiological Society of North America as objective tumor characteristics derived from an image, which indicate normal or disease processes, or response to a therapeutic intervention. These markers, which provide clinical signatures as unique as each patient, complement the more widely known genomic or molecular biomarkers. Together, these two different biomarkers could dramatically alter the clinical decision-making landscape for cancer care.

BgRT uses emissions from a patient’s cancer cells created by injecting a small amount of a targeting molecule carrying a positron-emitting radioisotope, known as a PET tracer, to guide external beam radiotherapy. As the tracer binds to the tumor cells, groups of emissions form partial PET images that signal the cancer’s location and immediately guide delivery of a partial dose of radiation. By the end of the treatment session, delivery of the full radiation dose is complete, and full CT and PET images containing thousands of tumor characteristics are available for radiomic analysis.

“RefleXion’s use of PET emissions to prescriptively determine where to attack the cancer combined with HealthMyne’s ability to objectively measure tumor characteristics and quantify treatment response creates a powerful technological foundation from which to improve patient care,” said Rose Higgins, CEO at HealthMyne. “In the future, clinicians may have the ability to determine much earlier and with a high degree of accuracy, whether changes to the individual patient’s treatment plan are warranted and the predicted outcomes.”

About HealthMyne
HealthMyne, a pioneer in applied radiomics, the cutting-edge field of extracting novel data and biomarkers from medical images, believes that every cancer patient’s story begins with an image. The company’s FDA-approved and CE marked, AI-enabled solutions allow organizations to easily access and translate groundbreaking radiomic insights into use in research, clinical outcomes, and treatment pathways. By leveraging radiomics, HealthMyne’s clients and partners can accelerate the development and delivery of the best possible treatments.

About RefleXion
RefleXion is a privately held therapeutic oncology company developing the first biology-guided radiotherapy (BgRT) machine, with the potential to move beyond single tumor therapy to one day treat multiple metastatic tumors throughout the body in the same treatment session. Currently, the RefleXion™ X1 is cleared for the delivery of stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT). The company is also developing BgRT, which incorporates positron-emission tomography (PET) data to enable tumors to continuously signal their location. The BgRT technology will synchronize these data with the linear accelerator to direct radiotherapy to tumors with sub-second latency.RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) as a new modality for treating all stages of cancer, and HealthMyne Inc., an innovative developer of applied radiomic solutions, today announced a strategic partnership to bring together the companies’ technologies to quantify and improve the inherently complex decisions surrounding cancer therapy and develop a more individualized approach to patient treatment.

“Our novel BgRT technology produces data-rich CT and PET images at each patient treatment session,” said Thorsten Melcher, Ph.D., chief business officer at RefleXion. “Applying HealthMyne’s unique radiomic insights and AI-enabled algorithms holds the promise of decoding these data so clinicians can use the tumor’s characteristics and its response to radiotherapy to inform and guide the entire patient journey. Instead of delivering standardized treatment protocols, we can now think about the best care plan for each patient and use our biological guidance to deliver it confidently, even one day, to metastatic patients.”

HealthMyne’s solutions enable clinicians to access image data not discoverable with the naked eye and translate it into groundbreaking disease insights. The core of HealthMyne’s solutions enables precise extraction of quantitative imaging or structural information, known as radiomic data, to improve and automate decision making in cancer research, screening, treatment planning, and clinical management. This includes over 1,500 multi-dimensional measurements and novel radiomic data capable of powering predictive algorithms and precision medicine initiatives.

Radiomic data forms the basis for imaging biomarkers, defined by the Radiological Society of North America as objective tumor characteristics derived from an image, which indicate normal or disease processes, or response to a therapeutic intervention. These markers, which provide clinical signatures as unique as each patient, complement the more widely known genomic or molecular biomarkers. Together, these two different biomarkers could dramatically alter the clinical decision-making landscape for cancer care.

BgRT uses emissions from a patient’s cancer cells created by injecting a small amount of a targeting molecule carrying a positron-emitting radioisotope, known as a PET tracer, to guide external beam radiotherapy. As the tracer binds to the tumor cells, groups of emissions form partial PET images that signal the cancer’s location and immediately guide delivery of a partial dose of radiation. By the end of the treatment session, delivery of the full radiation dose is complete, and full CT and PET images containing thousands of tumor characteristics are available for radiomic analysis.

“RefleXion’s use of PET emissions to prescriptively determine where to attack the cancer combined with HealthMyne’s ability to objectively measure tumor characteristics and quantify treatment response creates a powerful technological foundation from which to improve patient care,” said Rose Higgins, CEO at HealthMyne. “In the future, clinicians may have the ability to determine much earlier and with a high degree of accuracy, whether changes to the individual patient’s treatment plan are warranted and the predicted outcomes.”

About HealthMyne
HealthMyne, a pioneer in applied radiomics, the cutting-edge field of extracting novel data and biomarkers from medical images, believes that every cancer patient’s story begins with an image. The company’s FDA-approved and CE marked, AI-enabled solutions allow organizations to easily access and translate groundbreaking radiomic insights into use in research, clinical outcomes, and treatment pathways. By leveraging radiomics, HealthMyne’s clients and partners can accelerate the development and delivery of the best possible treatments.

About RefleXion
RefleXion is a privately held therapeutic oncology company developing the first biology-guided radiotherapy (BgRT) machine, with the potential to move beyond single tumor therapy to one day treat multiple metastatic tumors throughout the body in the same treatment session. Currently, the RefleXion™ X1 is cleared for the delivery of stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT). The company is also developing BgRT, which incorporates positron-emission tomography (PET) data to enable tumors to continuously signal their location. The BgRT technology will synchronize these data with the linear accelerator to direct radiotherapy to tumors with sub-second latency.

England hospital awarded top global digital healthcare award

Summit BHC acquires West Virginias Highland Hospital

A hospital in the north of England has been named as one of the most digitally advanced organisations in the whole of the UK’s National Health Service (NHS).

Sunderland Royal Hospital is the only hospital in the north of England to be awarded Level 7 status from the Healthcare Information Management and Systems Society (HIMSS). In doing so it joins the group of around 50 hospitals in the world to have achieved the accreditation.

The award was given following a two-day virtual assessment in December 2020, during which HIMSS assessors observed clinical and operational teams in action.

The hospital is part of the South Tyneside and Sunderland NHS Foundation Trust, one of the most digitally advanced organisations in the NHS. In September 2016, Sunderland Royal Hospital became one of the first Trusts in the country to be confirmed onto the national Global Digital Exemplar (GDE) programme, helping to share its digital expertise across the NHS.

Since then, South Tyneside District Hospital is now also part of the GDE fast follower programme and is already a year ahead of schedule for ‘paper-free’ HIMSS accreditation after adopting the Meditech electronic patient record in October 2019.

The hospital actually began its digital journey almost 30 years ago by making its first tentative steps towards a fully integrated electronic patient record.

Today the Meditech electronic patient record is used across the hospital, giving clinical teams access to live patient information in all departments, including the emergency department, inpatient wards, a diagnostic area or operating theatre.

The advanced Meditech solution allows staff to update patient information in real time, prescribe medication, as well as integrate to monitors and record vital signs from the bedside using scanning technology and digital patient wristbands. The system also integrates with the Great North Care Record (Health Information Exchange), meaning the information gathered in the Meditech solution is available to other healthcare settings across the north of England.

Commenting on the achievement, Dr Kevin Joisce, Consultant in Emergency Medicine and Chief Clinical Information Officer at South Tyneside and Sunderland NHS Foundation Trust, said: “This is fantastic news for our patients and testament to the hard work and dedication of all clinical colleagues who have truly embraced our digital ambitions to make them a reality in Sunderland.

“Using the most up-to-date and advanced digital systems is part and parcel of our ethos and how we want to deliver patient care, and to achieve Level 7 accreditation reflects the digital maturity of our Trust. Technology is embedded in everything we do, in all clinical processes and our nursing workflows to an extent where we have successfully eliminated our reliance on historic paper-based systems.

“Our Board have long championed the use of technology with a clear and ongoing commitment to improve patient safety and the overall quality of clinical care through the effective use and deployment of digital solutions. This is an important milestone for the organisation, and one that we will continue to build upon in the years ahead” he added.

 

 

MED-EL USA Launches SAMBA 2 Audio Processor for the BONEBRIDGE Bone Conduction System

 MED-EL USA Launches SAMBA 2 Audio Processor for the BONEBRIDGE Bone Conduction System

MED-EL USA, a leader in implantable hearing solutions, announced the launch of the SAMBA 2, a next-generation audio processor for the BONEBRIDGE Bone Conduction System, which includes the recently launched BCI 602. BCI 602 is an active transcutaneous bone conduction implant that leaves skin intact. The BONEBRIDGE System is indicated for individuals age 12 years and older with conductive hearing loss, mixed hearing loss, or single-sided deafness.

The U.S. Food and Drug Administration (FDA)-cleared SAMBA 2 Audio Processor features enhancements for ease of listening and handling. Intelligent Sound Adapter 2.0 automatically adjusts settings to match different environments that are particularly challenging to people with hearing loss. This includes an automatic setting for listening in cars which uses Speech Tracking to identify the optimal microphone mode for the user to understand conversation coming from the side or behind.

SAMBA 2 is also designed for easier listening in complex environments such as restaurants, effectively reducing the impact of noise, for example interfering background conversations and the clattering of plates and silverware, while adaptive directional microphones and directional speech enhancement allow the user to focus on their conversation.

“SAMBA 2 is a great example of the ongoing collaboration that MED-EL has with our recipients, even after they receive a hearing implant,” said Raymond Gamble, President & CEO, MED-EL North America. “We listened closely to feedback and worked diligently with our engineers to make the listening experience even more effortless for our BONEBRIDGE recipients.”

SAMBA 2 provides the longest lasting battery life of any active transcutaneous audio processor on the market, with approximately 8 to 10 days from one standard 675 hearing aid battery. When the time comes, battery changes are fast and easy thanks to SAMBA 2’s intuitive design.

SAMBA 2 GO connects wirelessly to Bluetooth devices and via a cable to non-Bluetooth devices to allow streaming from mobile phones, televisions and electronic devices. It can also be used with FM systems and remote microphones for better hearing in noisy environments. And, while the Intelligent Sound Adapter 2.0 adjusts settings automatically, recipients still have control over their settings with the SAMBA 2 Remote, an app available for iPhone and Android that enables users to switch between settings without a separate remote control. The Intelligent Sound Adapter 2.0 then “learns” which settings the user most often changes manually and adapts.

Thin and lightweight, SAMBA 2 offers recipients a wide array of easily interchangeable covers so the audio processor may be worn discreetly under the hair, or worn to stand out with colorful designs. The audio processor is dust, sweat and splashproof, and can be completely submersed in water with the optional WaterWear waterproof cover.

Consistent with MED-EL’s industry-leading legacy support, SAMBA 2 is compatible with both versions of the BONEBRIDGE Bone Conduction Implant, the BCI 601 and BCI 602. BONEBRIDGE bone conduction implants are also engineered to be compatible with future generations of audio processors, allowing recipients to access the latest hearing technology, no matter when they received their implant.

Neuros Medical Announces Key Milestones in the QUEST Pivotal Clinical Study for Chronic Post-Amputation Pain

Neuros Medical Announces Key Milestones in the QUEST Pivotal Clinical Study for Chronic Post-Amputation Pain

Neuros Medical, Inc., a medical device company developing innovative high-frequency nerve block technology for patients with intractable post-amputation pain, announced the achievement of two milestones in its pivotal QUEST (High-FreQUEncy Nerve Block for PoST-Amputation Pain) study. QUEST is a 180-subject, randomized, double blinded, active sham controlled clinical trial that is being conducted under an Investigational Device Exemption (IDE). QUEST is designed to assess the safety & effectiveness of the Company’s Altius® High-Frequency Nerve Block system to treat intractable post-amputation pain. Post-amputation pain is a significant unmet medical need, as existing treatment options are limited, and consist primarily of opioids and gabapentinoids.

In December 2020, an independent Data Monitoring Committee successfully completed the final planned interim safety and futility analysis of 80 subjects at the 90-day primary endpoints. In addition, despite the ongoing COVID-19 pandemic, QUEST enrollment now exceeds 100 subjects, and the study is on track for completion of enrollment by the Fall of 2021.

“I wish to thank the QUEST investigators and their clinical research teams for a remarkable collective effort during this extremely challenging year,” said Leonardo Kapural MD PhD, Carolinas Pain Institute and National Principal Investigator of the QUEST study. “I believe that the Altius therapy, with its unique mechanism of action achieved with High-Frequency Nerve Block (HFNB), has great potential to become an important treatment option for post-amputation phantom and stump pain.”

“We join Dr. Kapural in expressing gratitude to the QUEST site clinical research teams for their commitment to both the study as well as to the amputee subjects whom they enrolled,” said David Veino, Neuros Chief Operating Officer. “We look forward to completing enrollment this year, a key milestone in our efforts to develop a promising treatment option for this significant unmet medical need.”

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