PHC Unveils Prototype of LiCellGrow, New Cell Expansion System to Support Development of Cell and Gene Therapy Products Manufacturing Process

August 30, 2024

PHC Corporation Biomedical Division (Headquarters: Chiyoda-ku, Tokyo; President: Nobuaki Nakamura, hereinafter referred to as “Biomedical Division”) will showcase a prototype of its new cell expansion system LiCellGrow at the ISCT (International Society for Cell & Gene Therapy) Europe 2024 Regional Meeting held in Gothenburg, Sweden on September 4-6. LiCellGrow, currently under development, is designed to allow pharmaceutical companies to visualize continuous metabolic changes in cells in real-time and adjust the cell culture automatically to optimize conditions for cell growth. The system seeks to expand availability of cell and gene therapy (CGT) products by accelerating the manufacturing of specific cells needed for these therapies.

CGT, in which a patient’s cells are removed, modified, and reintroduced to the body to fight disease, has emerged as a promising therapeutic field for difficult-to-treat conditions such as cancers and hematologic disorders. Since the patient’s own cells are used as raw materials, it is essential to maintain stable cell quality when producing new cells, to counteract natural variations in cell characteristics and ensure consistency throughout the therapy manufacturing process. The current method of evaluating cell quality by sampling the final product may lower both manufacturing efficiency and yield, increasing production cost.

LiCellGrow seeks to enable more efficient and stable manufacture of high-quality CGT products by enabling researchers to monitor and control the cell culture environment in real time, optimizing cell quality while minimizing interruption to the therapy manufacturing process.

The system under development uses proprietary In-Line monitoring technology, which continuously measures cell metabolites in the culture medium without the need for repeated sampling by immersing sensors in the medium at all times. LiCellGrow then continuously and accurately measures concentrations of two critical indicators of cell metabolism, glucose and lactate, to offer a visualization of actual changes in the culture environment and cell status. Based on real-time measurement data, the system then automatically exchanges the culture medium to maintain the culture environment in an optimal state. This technology is designed to improve and homogenize cell quality while increasing cell culture efficiency and reducing costs through loss reduction. The system will also feature easy-to-install single-use culture bags with In-Line sensors, enabling closed-system cell culturing to maintain a sterile environment, and can be installed in existing CO₂ incubators, enabling researchers to conduct studies using their preferred equipment.

LiCellGrow is an example of synergy between the Biomedical Division and IVD Division (hereinafter referred to as “IVD”) of PHC Corporation. The In-Line monitoring technology featured in this cell expansion system is newly developed proprietary technology building on the core technology of blood glucose sensor, the main product developed by IVD. By combining this sensor technology from IVD with advanced cell culture environment control technology from the Biomedical Division, PHC seeks to offer researchers and pharmaceutical companies greater value.

The Biomedical Division plans to launch LiCellGrow to support the development of manufacturing processes for CGT products globally in the short term, and aims to accelerate development of this system to ultimately support commercialized production of CGT products.

LiCellGrow builds on the Biomedical Division’s 20-year history of pioneering solutions in the field of cell therapy, including the Cell Processing Center^*1in 2000 and the Cell Processing Isolator^*2in 2007. Moving forward, we will continue to accelerate the creation of innovative solutions addressing QCD (Quality, Cost, Delivery) challenges in the therapeutic manufacturing process for early adoption of CGT, aiming to contribute to advancing modalities (therapy methods.)

ISCT Europe 2024
Event period:		Sept. 4 to 6, 2024
Location:		Gothenburg, Sweden
Venue:		Swedish Exhibition & Congress Center
(PHC Europe B.V. Booth No. F03.12)
Website:		Home – ISCT EU 2024 (isctglobal.org)

*1 Strictly controlled cell processing facilities for aseptic processing of cell culture, processing, among others.
^*2 Device that combines a closed space sterilized with hydrogen peroxide inside the isolator, detachable culture modules, centrifuge modules, and other components, allowing a series of cell processing steps to be performed while retaining a sterile environment.

New Opportunities for Aspiring Nurses in Idaho with Joyce University Expansion

August 30, 2024

Aspiring nurses in Idaho can now prepare for RN licensure in as few as 20 months. Joyce University of Nursing and Health Sciences is broadening its hybrid pre- and post-licensure nursing programs to include Idaho.

Since 2022, Joyce University has expanded beyond Utah to include locations such as Arizona, Colorado, Missouri, New Mexico, Nevada, and now Idaho.

“This expansion is part of Joyce University’s ongoing commitment to make accelerated, high-quality nursing education available to communities across the US,” said Dr. John Smith-Coppes, President and CEO of Joyce University. “By eliminating barriers to entry such as prerequisites and waitlists plus offering online coursework with rich experiential focus, Joyce University is creating a flexible pathway for students at all stages of life while prioritizing excellence in quality, safety, and outcomes.”

With this expansion, students in Idaho can access a range of pre-licensure programs, such as the Associate of Science in Nursing (ASN), the Bachelor of Science in Nursing (BSN) and the Accelerated Bachelor of Science in Nursing (ABSN). Joyce University offers two post-licensure programs for those looking to further their nursing careers: the 4-semester online RN to BSN program and the 3-semester online MSN in Leadership program.

“Our programs are designed to meet the rising demand for well-trained nurses,” said Dr. Kelly McCullough, Dean of Nursing at Joyce University. “Our blended education model combines online lectures with hands-on labs and simulations and clinical experiences in their community, ensuring students have the flexibility they need while getting a high-quality education.”

Students participate in online lectures and attend scheduled skill immersions at the Joyce Johnson Center of Simulation at Joyce University’s Draper, UT campus. To build connections in their local communities and reduce travel, students complete clinical and practice experiences in their state of residence.

Enrollment for Idaho students is now open, with the next cohort starting in the Spring Semester on January 6, 2025.

WuXi Biologics Successfully Completes First Scale-Up of High-Productivity Bioprocessing Platform WuXiUI™ in 2,000L GMP Manufacturing

August 30, 2024

WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that it has successfully accomplished 2,000L drug substance (DS) GMP manufacturing by utilizing its proprietary ultra-intensified fed-batch bioprocessing platform WuXiUI™. The platform achieved a titer of 18 g/L, a 4-fold increase compared to conventional fed-batch process, demonstrating the high efficiency of WuXiUI™ in improving productivity.

In addition, the company’s enhanced downstream technology platform enabled doubled purification processing capacity and similar impurity removal, which resulted in a 50% reduction in downstream processing time and a final DS yield of 70% with comparable product qualities. Moreover, WuXiUI™ downstream platform also enabled 30-50% reduction in the utilization of materials and consumables and therefore downsized waste generation. The improvement in total DS production contributed to significant reduction in manufacturing COGS, a substantial economic efficiency improvement in biologics production.

The WuXiUI™ platform, launched in 2023, enhances the productivity of multiple different CHO or other mammalian cell lines that express diverse product modalities, while maintaining desirable product qualities. It provides an effective solution for global clients to meet the growing demand for therapeutic proteins and antibodies with lower COGS. At the same time, it allows for a lower carbon footprint due to its more efficient media consumption, lower waste generation, and reduced demand for building space in the production line. The successful scale-up of the WuXiUI™ platform from bench scales to 2,000L GMP manufacturing confirms the robustness of the technology and its readiness for larger-scale production.

WuXiUI™’s strong performance was boosted through the application of MagniCHO™, WuXi Biologics’ proprietary platform cell culture media enriched with nutrients for intensified processes. Furthermore, operation efficiency and production robustness were improved by integrating the Raman Process Analytical Technology (PAT) tool into the scale-up manufacturing, not only for process monitoring, but also – for the first time under GMP settings – to provide real-time automated process control.

Dr. Chris Chen, CEO of WuXi Biologics, commented, “The successful application and achievement of WuXiUI™ is a result of our relentless pursuit of technology innovation to speed up biologics development while achieving cost efficiency for global clients. With this milestone, we have enhanced our capabilities to enable clients to bring more affordable, high-quality biologics to market, benefiting patients worldwide.”

Advancing Fully Implanted Hearing Systems | By Brent Lucas, CEO of Envoy Medical

August 30, 2024

Brent Lucas, CEO of Envoy Medical

“What do you do for a living?”

“I work for a company that makes hearing implants for people with hearing loss.”

“What?”

“I work for …”

“(laughter)”

I have fallen for this joke hundreds, if not thousands, of times. The fact of the matter is that hearing loss is a punchline to most people until they or someone close to them is affected.

After working in the hearing industry for the last 17 years, I can say with confidence that most people take their hearing for granted. We seem to assume our ability to hear will always be there until it begins to deteriorate, and then we struggle to come to terms with the oversized impact hearing loss can have on our lives. As Joni Mitchell famously sang: “You don’t know what you’ve got ‘til it’s gone.”

Hearing loss is common and impacts a large portion of our population. The World Health Organization (WHO) believes that more than 1.5 billion people may have some form of hearing loss during their lifetime, with 430 million of those people having “disabling hearing loss” that requires intervention.[1]

It has been said that “hearing loss is the third most common chronic physical condition in the United States and twice as prevalent as diabetes or cancer.”[2] According to the National Institute of Deafness and Other Communication Disorders, approximately 15% of adults – 37.5 million people – in the U.S. ages 18 and older report some trouble hearing.[3] Older Americans have a greater incidence of hearing loss with one estimate suggesting that 68% of people in their 70s and 90% of people 80 or older experience hearing loss.[4]

Unfortunately, hearing loss also tends to be an underdiagnosed or undertreated problem. It is well documented that a majority of people who could benefit from hearing aids have never used them.[5] Even more concerning is the estimate that less than 5% of the adults in the U.S. who could benefit from a cochlear implant choose to get one. Sadly, these low adoptions rates for hearing interventions seem to suggest that we, as a society, are ignoring the fact that untreated hearing loss is closely tied to other health conditions such as social isolation, dementia, balance, risk of falls, and even diabetes and cardiovascular disease.[6]

Envoy Medical: Offering Different Solutions

Traditional hearing devices of one form or another have been available for many decades. Most of these hearing solutions – whether they are OTC hearing aids, prescription hearing aids, bone conduction hearing devices, middle ear implants, or cochlear implants – have some key features in common. First, the traditional hearing devices have an external component that is placed in the ear, on the ear, or behind the ear. Second, they rely on one or more microphones to pick up the sound that the device uses as the signal.

Envoy Medical has taken a different approach with its fully implanted hearing devices, and it looks to turn the industry on its… ear.

We believe that the status quo of traditional hearing devices is not enough for everyone, and our investment thesis is that a large portion of the hearing loss population wants different hearing solutions to choose from.

Envoy Medical currently has two products: the FDA-approved Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI) and the investigational Fully Implanted Acclaim® Cochlear Implant.

Both of our products leverage the actual ear, not microphones, to pick up sound. We operate from the point of view that the human ear is the way it is for many reasons, and that there are likely benefits from leveraging that anatomy. There is no traditional microphone in either of our products. We use the anatomy of the outer and middle ear to pick up sound as you would if you were hearing without any hearing device.

Designed to leverage the natural ear to pick up sound, both of our products are fully implanted with no external components, allowing for several potential benefits. For example, people with our devices can be discrete, if they choose, about their hearing loss and not be forced to share that they are hearing impaired. We believe many people do not treat their hearing loss because they are uncomfortable with the visible nature of existing traditional technologies.

In addition, patients with our devices can leave their devices on all day, every day. Traditional hearing devices such as hearing aids and partially-implanted cochlear implants are taken off at night, for example, leaving the user without hearing during potentially vulnerable times. As a person’s hearing loss is with them all day, every day, their device used to treat that hearing loss should be as well.

Hearing Device Coverage Clarification Act

In addition to our two products, we are a strong supporter of the two Hearing Device Coverage Clarification Acts working their way through the House of Representatives and the Senate. Both of these bipartisan bills seek to clarify that fully implanted active middle ear hearing devices should not be classified as hearing aids and therefore not be subject to the Medicare hearing aid coverage exclusion. These devices should be properly classified and considered hearing prosthetics, which would allow Medicare and Medicare beneficiaries access to these important technologies.

Final Thoughts

Hearing is critical to our experience as human beings as it keeps us connected to the world around us. Hearing loss is common and impacts the lives of so many people around us. Unfortunately, as an “invisible disability,” it is not given the attention it deserves, and we are paying unnecessary costs as a result.

Envoy Medical is passionate about helping people on their hearing health journey and creating solutions that will positively impact society. We are just getting started and look forward to continuing to innovate in this space.

[1] World report on hearing. Geneva: World Health Organization; 2021. License: CC BY-NC-SA 3.0 IGO.

[2] CDC citing Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for US adults: National Health Interview Survey, 2012. Vital Health Stat 10. 2014; 260:1-161.

[3] https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing

[4] Goman, Adele M. and Lin, Frank R. Prevalence of Hearing Loss by Severity in the United States. American Journal of Public Health. 2016. Found on the internet at

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024365/

[5] https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing

[6] https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-minute-how-untreated-hearing-loss-can-result-in-a-negative-health-spiral

Anavex Tackles Cognitive Aging and Related Disease Pathologies

August 29, 2024

“Successful cognitive aging” refers to maintaining cognitive function and avoiding significant decline as one ages. Recent studies have highlighted several factors contributing to successful cognitive aging, such as physical activity, social engagement, mental stimulation and a healthy diet. As part of its research in developing therapeutics to treat neurodegenerative and neurodevelopmental disorders, Anavex Life Sciences focuses on better understanding cognitive aging, superagers and how disease pathologies relate to cognitive aging.

Lifestyle plays a key role in this area. For example, research shows that regular exercise can enhance brain plasticity and delay cognitive decline. Social interactions and maintaining a strong social network are linked to better cognitive function and reduced risk of dementia. Additionally, engaging in mentally stimulating activities, such as reading or learning new skills, can bolster cognitive reserve.

These findings suggest that interventions promoting physical activity, social connections, and mental engagement may enhance cognitive aging. Experts believe that public health policies focusing on these areas could mitigate the societal impact of age-related cognitive disorders, potentially reducing healthcare costs and improving quality of life for older adults.

“Superagers” and Relevance to Studies

Superagers are described as people 80 and older who exhibit cognitive abilities comparable to those of much younger people. This concept emerged from studies aiming to understand why some elderly people maintain exceptional mental acuity. Superagers typically display higher levels of memory, attention and problem-solving skills than their peers, aligning more closely with middle-aged adults in cognitive performance.

Research suggests that superagers possess certain biological and lifestyle characteristics contributing to their cognitive resilience. Brain scans reveal that their brains — particularly the cerebral cortex — tend to have greater thickness and fewer signs of age-related deterioration. Superagers also tend to lead active lifestyles, both physically and socially, which is believed to play a crucial role in maintaining mental sharpness.

Understanding the factors that contribute to becoming a superager can provide valuable insights into promoting cognitive health and longevity in the broader population. Currently, The Albert Einstein College of Medicine is recruiting a group of superagers and their adult children in order to conduct a comprehensive study on this subject.

Disease Pathologies and Their Relationship to Cognitive Aging

Disease pathologies can significantly influence cognitive aging, impacting how the brain functions over time. Conditions such as Alzheimer’s disease, cerebrovascular disease and Parkinson’s disease are primary contributors to cognitive decline in older adults.

Alzheimer’s disease, characterized by amyloid plaques and neurofibrillary tangles, leads to significant memory loss and impairments in other cognitive functions like language and problem-solving. These pathological changes disrupt neuronal communication and eventually cause neuron death.

Anavex is a clinical-stage biopharmaceutical company that is currently developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system disorders. As such, the company’s research encompasses the study of successful cognitive aging, superagers and how disease pathologies relate to cognitive aging.

Cerebrovascular disease, which includes strokes and other vascular problems, affects cognitive aging by reducing blood flow to the brain. This deprivation can result in both acute and chronic cognitive impairments, ranging from sudden, severe deficits following a stroke to gradual declines associated with chronic small vessel disease. Vascular contributions to cognitive impairment and dementia highlight the critical role of vascular health in maintaining cognitive functions.

Parkinson’s disease, marked by the degeneration of dopamine-producing neurons, primarily affects motor functions but also has substantial cognitive repercussions. Patients often experience executive dysfunction, slowed thinking, and memory issues as the disease progresses.

In addition to these specific diseases, comorbidities such as diabetes, hypertension and chronic inflammation exacerbate cognitive aging. These conditions contribute to neuroinflammation, oxidative stress, and metabolic dysregulation, further accelerating cognitive decline.

Understanding the interplay between disease pathologies and cognitive aging is essential for companies like Anavex in developing interventions to maintain cognitive health in older adults.

Advancements in Research Relating to Diseases Impacting Cognitive Aging

Research on disease pathologies impacting cognitive aging, especially Alzheimer’s disease and Parkinson’s disease, have made significant strides in recent years, and Anavex remains at the forefront of these advancements. These neurodegenerative disorders, which primarily affect older adults, are characterized by progressive cognitive decline and motor dysfunction, respectively. Understanding their underlying mechanisms is crucial for developing effective treatments and preventive strategies.

In Alzheimer’s disease, significant advancements have been made in elucidating the roles of amyloid beta plaques and tau tangles. These protein accumulations disrupt neural communication and lead to cell death. Recent research has focused on targeting these proteins to slow or halt disease progression. For instance, immunotherapies that clear amyloid beta plaques have shown promise in clinical trials, with drugs like aducanumab receiving conditional approval. Moreover, tau-targeting therapies, including small molecules and antibodies, are being actively explored.

Anavex’s recent Phase 2b/3 Trial of Anavex 2-73 (blarcamesine) in patients with Alzheimer’s disease showed a high level of clinical efficacy and slowed neurodegeneration.

Genetic research has also shed light on Alzheimer’s pathology. The identification of risk genes such as APOE4 has improved understanding of genetic predispositions and led to personalized medicine approaches. Additionally, advances in biomarker development, such as cerebrospinal fluid analysis and PET imaging, enable early detection and more accurate diagnosis, crucial for timely intervention.

In Parkinson’s disease, research has focused on the role of alpha-synuclein aggregates, which form Lewy bodies, disrupting normal neuronal function. Therapies aimed at reducing alpha-synuclein aggregation are in development, with several compounds currently in clinical trials. Deep brain stimulation, a surgical intervention, has shown effectiveness in alleviating motor symptoms, and advancements in DBS technology have improved patient outcomes.

The gut-brain axis has also emerged as a critical area of research in Parkinson’s disease. Studies suggest that gut microbiota may influence neuroinflammation and disease progression, leading to potential probiotic or dietary interventions.

An earlier study conducted by Anavex reported that blarcamesine significantly improved cognitive function, memory and REM sleep in patients with Parkinson’s disease dementia. This included improvements in complex cognitive tasks that impact quality of life — such as making a choice between similar objects and remembering daily personal experiences — which are often impaired in Parkinson’s disease.

Advancements in genetic, molecular, and imaging technologies have significantly enhanced the understanding of Alzheimer’s and Parkinson’s disease pathologies. These developments hold promise for more effective treatments and preventive strategies, ultimately aiming to improve the quality of life for individuals affected by these debilitating disorders.

Novel Investigational Therapies, Techniques, and Anavex in the News

Recent advancements in novel investigational therapies and techniques for cognitive aging are garnering significant attention in the medical field. One such promising area is the development of targeted therapies aimed at amyloid beta plaques and tau tangles, hallmark pathologies of Alzheimer’s disease. Researchers are investigating monoclonal antibodies like aducanumab, which aim to reduce amyloid beta plaques in the brain, potentially slowing cognitive decline.

Another innovative approach involves gene therapy. Scientists are exploring the use of CRISPR-Cas9 technology to correct genetic mutations linked to neurodegenerative diseases, addressing the root cause of cognitive impairments. Additionally, researchers are studying neurotrophic factors, which support growth and survival of neurons, for their potential to rejuvenate aging brain cells.

Advancements in neuroimaging techniques, such as functional MRI and PET scans, enhance understanding of brain aging by providing detailed insights into brain activity and pathology progression. These imaging techniques are crucial for early diagnosis and monitoring the effectiveness of new treatments.

Lifestyle interventions, including dietary modifications and physical exercise, are being integrated with pharmacological treatments to create comprehensive therapeutic strategies. Studies suggest these combined approaches may offer synergistic benefits, potentially improving outcomes for individuals with cognitive decline.

These cutting-edge therapies and techniques hold promise for significantly altering the landscape of cognitive aging, offering hope for improved management and treatment of related diseases. Anavex’s Phase 2 studies with Anavex 2-73 in Alzheimer’s and Parkinson’s patients showed progress in slowing cognitive decline.

Another investigational gene therapy, AB-1005, is being considered for Parkinson’s disease, while verapamil has been used to ease symptoms in a mouse model of myotonic dystrophy type 1. Studies are also exploring the use of macrophages tagged with gadolinium-loaded anisotropic micropatches to identify animals exposed to traumatic brain injury.

The COVID-19 Effect and Neuropsychiatric Pathologies

Current research by Anavex into the neuropsychiatric symptoms following acute COVID-19 infection, particularly in older adults, is revealing significant insights into the pandemic’s long-term impact on mental health. Studies indicate that older adults recovering from COVID-19 often experience a range of neuropsychiatric symptoms, including anxiety, depression, cognitive impairment, and psychosis. These symptoms can persist for months after the acute phase of the infection, a condition often referred to as “long COVID.”

Recent findings suggest that these symptoms may be due to several factors, including direct viral invasion of the central nervous system, inflammatory responses, and the psychological stress associated with severe illness and isolation. Neuroimaging studies have shown structural and functional changes in the brains of affected individuals, including alterations in gray matter volume and white matter integrity. Additionally, biomarkers of inflammation and neuronal injury are being investigated to understand their role in the persistence of these symptoms.

Particularly concerning in older adults is the potential exacerbation of preexisting cognitive decline and the increased risk of developing dementia. Ongoing research aims to identify specific risk factors, mechanisms, and potential therapeutic interventions to mitigate these long-term effects. Understanding these neuropsychiatric sequelae is crucial for developing targeted treatments and providing comprehensive care for older adults recovering from COVID-19.

The Importance of Research Into Successful Cognitive Aging

The investigation into successful cognitive aging by Anavex and other researchers represents an exhilarating field of study. This research holds the promise of fundamentally transforming the current understanding of the aging process and the various cognitive disorders that can accompany it. As scientists delve deeper into the mechanisms that support cognitive health in older adults, there is hope that their findings will lead to development of more effective therapies and interventions. These advancements could significantly enhance the quality of life for individuals experiencing cognitive impairments and neurological disorders, offering new ways to maintain mental acuity and overall brain health.

One particularly intriguing aspect of this research is the potential to identify and study superagers. By understanding the factors that contribute to their cognitive resilience, researchers can uncover valuable insights into the biological, environmental, and lifestyle influences that promote cognitive health in the aging population. This knowledge could inform strategies to help others achieve similar levels of cognitive preservation, potentially delaying or even preventing the onset of cognitive decline and related conditions such as Alzheimer’s disease and other dementias.

The study of successful cognitive aging not only aims to improve individual outcomes, but also address broader public health challenges associated with an aging society. Through continuous research and discovery, researchers appear to be on the brink of breakthroughs that could revolutionize how we approach aging and cognitive wellness, leading to a future where advanced age does not necessarily equate to cognitive

Kidney Donors | Risk of Death at All-Time Low

August 28, 2024

The risk of death for people who donate a kidney for transplantation — already small a decade ago — has dropped by more than half since then, a new study shows.

Each year, roughly 6,000 Americans volunteer to donate a kidney, according to the Organ Procurement and Transplantation Network. Before undergoing the procedure, donors are informed of the potential risks, including death. Based on data from 1995 through 2009, experts had originally predicted that about three of every 10,000 donors were likely to die within three months of the procedure. The authors of the new study argue that advances in surgical techniques, donor selection, and postoperative care have since rendered that estimate out of date.

Analyzing three decades of medical records representing 164,593 kidney donors from across the country, a team led by researchers at NYU Langone Health found that by 2022, fewer than one death occurred for every 10,000 donations. That translates into 36 deaths in total over 30 years.

“While we had always understood that kidney donation is safe, our findings suggest that mortality among donors is extremely rare, and the procedure is safer than ever before,” said study lead author Allan Massie, PhD. Massie is director of the Center for Surgical and Transplant Applied Research (C-STAR) Quantitative Core at NYU Grossman School of Medicine, where he is also a faculty member in the Departments of Surgery and Population Health.

The results further showed that while their overall risk remained small, kidney donors who were male and those with a history of high blood pressure were more likely to die within 90 days of surgery than other donors. Meanwhile, age, race, and ethnicity had no bearing on mortality.

Massie notes that surgical methods have changed dramatically since the 1990s, with open donor nephrectomy, in which surgeons make a 6-inch to 8-inch incision to remove the kidney, being almost entirely replaced by laparoscopic nephrectomy. In this less-invasive option, the organ is removed through a much smaller incision, with the procedure aided by a camera inserted through a thin tube.

The new report, publishing online Aug. 28 in the Journal of the American Medical Association (JAMA), is the first since 2009 to examine trends in mortality risk among living kidney donors. As a result, it better reflects the reality of organ donation in a time when laparoscopic nephrectomy is standard practice, the authors say.

For the study, the team analyzed information from the Scientific Registry of Transplant Recipients, a database of transplantation centers that is overseen by the U.S. Department of Health and Human Services. Death records were sourced from the Organ Procurement and Transplantation Network, the nonprofit organization that administers the nation’s only transplantation network authorized by the U.S. Congress.

The researchers calculated mortality rates within 90 days of donation, separated out into three time periods: 1993 through 2002, 2003 through 2012, and 2013 through 2022. Then, they compared deaths across the periods and considered different demographic and health factors, such as sex, body mass index (a measure of obesity), and whether the donors had an open or laparoscopic surgery.

Researchers found that about half of deaths occurred within the first week after donation, most commonly due to blood loss linked to surgery. In addition, mortality was similar from 1993 through 2012. Specifically, a total of 13 deaths occurred before 2003, with another 18 happening between 2003 and 2012. Meanwhile, there have been far fewer deaths since 2013, with five donors dying within 90 days of their procedure.

“These results demonstrate that the current guidelines used to inform potential kidney donors of their risks need to be updated to reflect nearly a decade of safety improvements,” said study senior author Dorry Segev, MD, PhD. Segev is a professor and vice chair in the Department of Surgery at NYU Grossman School of Medicine and director of C-STAR.

“As a kidney donor and research scientist in the field, it is reassuring to see the progress we have made,” said study co-author Macey Levan, JD, PhD, an associate professor in the Departments of Surgery and Population Health at NYU Grossman School of Medicine. and director of the C-STAR Qualitative Core. Levan is also the vice president of patient and donor affairs for the Organ Procurement and Transplantation Network and had donated her kidney to her cousin in 2009.

Funding for the study was provided by National Institutes of Health grants R01DK132395 and K24AI144954.

Segev has served as a consultant for pharmaceutical companies AstraZeneca, CareDx, Moderna Therapeutics, Novavax, and Regeneron, and has received speaker fees and honoraria from Springer Publishing, AstraZeneca, CareDx, Houston Methodist, Northwell Health, Optum Health Education, Sanofi, and WebMD. Study co-author Levan has received personal fees from the health-management platform PatientsLikeMe and from the pharmaceutical company Takeda. None of these groups were involved in the current study. The terms and conditions of all of these relationships are being managed in accordance with the policies and procedures with NYU Langone Health.

In addition to Massie, Segev, and Levan, another NYU Langone researcher involved in the study is Jennifer Motter, MHS. Jon Snyder, PhD, at the Hennepin Healthcare Research Institute in Minneapolis, Minn., also served as a study co-investigator.

Abhisek Swaika, MD to Lead Northwell Cancer Institute at Rego Park

August 27, 2024

Northwell Health has appointed Abhisek Swaika, MD, as medical director of the Northwell Health Cancer Institute at Rego Park and chief of hematology/oncology at Long Island Jewish Forest Hills Hospital.

Northwell Health Cancer Institute at Rego Park, formerly Queens Medical Associates, is known for its culturally sensitive, state-of-the-art care and is committed to working with patients in their own languages. It’s cancer specialists and staff speak more than 30 languages and dialects. Dr. Swaika’s fluency in Hindi and Bengali exemplifies the practice’s diverse, patient-centered care.

“Dr. Abhisek Swaika is deeply committed to ensuring the delivery of the highest quality, state-of-the art cancer care,” said Richard Carvajal, MD, deputy physician-in-chief and director of medical oncology at Northwell Health Cancer Institute. “His leadership and experience will continue to drive our mission to care for the diverse patient population we have the privilege to see at our cancer center in Queens.”

Prior to joining Northwell, Dr. Abhisek Swaika worked for three years at Queens Medical Associates, which integrated with Northwell in 2020. He is board-certified in internal medicine, hematology and medical oncology.

“I’m excited to be part of an extraordinary team committed to providing comprehensive cancer care in the heart of the Queen’s community,” said Dr. Swaika. “My vision is to further expand accessibility and participation of our patients in our growing clinical trial research program.”

Dr. Swaika earned his medical degree from Kasturba Medical College in India. He completed his residency at the State University of New York at Buffalo, followed by a fellowship at Mayo Clinic in Jacksonville, where he remained as an attending physician until 2017.

His research has been published in several journals, including Blood, American Journal of Hematology and Annals of Hematology. Dr. Swaika was nominated in 2023 for the Truly Award, a recognition of physicians by Northwell who go above and beyond to raise the standard of health care. He is actively involved in the Lead NEXT Development Program, which supports emerging leaders across the health care system. Additionally, Dr. Swaika serves on the Protocol Review and Monitoring Committee of the Northwell Health Cancer Institute.

Northwell, which cares for more New Yorkers with cancer than anyone else, is dedicated to providing the highest quality and safest medical care for optimal outcomes. In his new positions as medical director and chief of hematology/oncology, Dr. Swaika will continue his commitment to exceptional leadership at Northwell Cancer Institute at Rego Park and advance Northwell’s medical oncology and hematology services at LIJ Forest Hills.

For more information or to book an appointment, go to: https://www.northwell.edu/find-care/find-a-doctor/dr-abhisek-swaika-md-11379294.

Delcath Systems Reports Positive Outcomes from Independent Study on Hepatic Perfusion for Uveal Melanoma Patients

August 27, 2024

Delcath Systems, Inc. (Nasdaq: DCTH) (the “Company” or “Delcath”), an interventional oncology company specializing in the treatment of primary and metastatic liver cancers, today announced the publication of a retrospective study by independent investigators in the Annals of Surgical Oncology. The study, titled “Hepatic and Overall Progression-Free Survival After Percutaneous Hepatic Perfusion (PHP) as First-Line or Second-Line Therapy for Metastatic Uveal Melanoma,” was conducted by researchers at Moffitt Cancer Center in Tampa, Florida. The 30-patient study reported that Delcath’s HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) provided better disease control in the liver and improved progression-free survival in patients with hepatic metastases from uveal melanoma, compared to both immunotherapy and other liver-directed therapies.

Key Findings from the Study:

Overall Survival (OS): The study reported median OS of 22.4 months for patients treated with HEPZATO KIT as a first-line therapy (N=17) and 18.4 months as a second-line therapy (N=6).
Hepatic Progression-Free Survival (hPFS): Patients receiving HEPZATO KIT as first-line therapy had a median hPFS of 17.6 months (N=17), compared to 8.8 months (N=6) for immunotherapy and 9.2 months (N=7) for other liver-directed therapies. When used as a second-line therapy, HEPZATO KIT resulted in a median hPFS that was not reached (N=6), showing better outcomes than immunotherapy (14.7 months, N=5) and other liver-directed therapies (7.5 months, N=3) in this patient cohort.
Progression-Free Survival (PFS): The median overall PFS was 15.4 months (N=17) for patients receiving HEPZATO KIT as first-line therapy, compared to 8.8 months (N=6) for immunotherapy and 9.2 months (N=7) for other liver-directed therapies. In the second-line setting, HEPZATO KIT resulted in a median PFS of 22.2 months (N=6), compared to 14.7 months (N=5) for immunotherapy and 7.5 months (N=3) for other liver-directed therapies, reflecting longer disease control in this group.

Jonathan Zager, MD Chief Academic Officer and Director of Regional Therapies at Moffitt Cancer Center, remarked, “The findings from this study reaffirm the critical role of melphalan/HDS in managing liver-dominant metastatic uveal melanoma. These results highlight the potential benefits melphalan/HDS offers to patients, particularly in the context of first- and second-line treatments. My team is committed to further exploring the potential of combining melphalan/HDS with systemic therapies to continue improving patient outcomes.”

PaceMate Acquires Medtronic Paceart Optima™ System, Bringing Complementary Capabilities to Cardiac Data Management

August 27, 2024

PaceMate, a pioneer in cardiac data management and remote monitoring, announced today the acquisition of the Paceart Optima™ system, an on-premises cardiac workflow solution from Medtronic (NYSE: MDT.) This strategic move significantly expands PaceMate’s reach globally, adding nearly 1,000 clinic locations worldwide. This further enhances PaceMate’s ability to provide the leading and most comprehensive cardiac remote monitoring solution, continuing its position as the preferred partner in advanced cardiac data management.

“After a comprehensive evaluation, we are confident PaceMate is the best organization to service Paceart customers and their future cardiac data workflow needs,” said Kweli P. Thompson, M.D., M.P.H., senior vice president and president, Medtronic Cardiac Rhythm Management. “PaceMate offers best-in-class cardiac data management solutions and will provide excellent ongoing support to Paceart customers.”

Medtronic Cardiac Rhythm Management and PaceMate will collaborate closely to ensure a seamless transition and maintain exceptional service for Paceart customers. “Our shared values, dedication to customer experience, and commitment to exceptional patient-centric cardiac solutions make this agreement a perfect fit,” said Tripp Higgins, CEO of PaceMate. “Paceart customers will benefit from the continued support of Paceart employees transitioning to PaceMate, as well as enhanced service delivery and innovation. We are excited to set a new standard in the market by combining the strengths of both technologies for unparalleled support and advancement.”

PaceMate delivers the industry’s leading comprehensive end-to-end platform, supporting the full spectrum of cardiac device types, including implantables, ambulatory monitors, heart failure devices, and remote patient monitors. This is paired with a complete suite of flexible solutions, including software, patient communications, and clinical service support.

PaceMate’s flagship product, PaceMateLIVE™, is recognized as the best-in-class remote cardiac monitoring software, leveraging powerful EHR integrations for seamless implementation, intuitive use, and intelligent patient prioritization. With the leading robust, research-grade data set, healthcare organizations have access to the most advanced tools for optimizing clinic operations and leveraging patient-centric data to conduct ground-breaking research. This acquisition complements PaceMate and brings it to the forefront of global cardiac care, enabling better patient outcomes and global innovation.

FDA Approves Illumina Cancer Biomarker Test with 2 Companion Diagnostics to Rapidly Match Patients to Targeted Therapies

August 27, 2024

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced Food and Drug Administration (FDA) approval of its in vitro diagnostic (IVD) TruSight™ Oncology (TSO) Comprehensive test and its first two companion diagnostic (CDx) indications.

This single test interrogates over 500 genes to profile a patient’s solid tumor, helping to increase the likelihood of identifying an immuno-oncology biomarker or clinically actionable biomarkers that enable targeted therapy options or clinical trial enrollment. TSO Comprehensive is FDA approved as a CDx to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions that may benefit from treatment with Bayer’s VITRAKVI® (larotrectinib). The test is also approved to identify adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) that may benefit from treatment with Lilly’s RETEVMO® (selpercatinib).

“FDA approval for TruSight Oncology Comprehensive with accompanying companion diagnostics marks an awaited milestone for our oncology customers and community,” said Everett Cunningham, chief commercial officer of Illumina. “We are committed to partnering with industry leaders like Bayer and Lilly to advance cancer diagnostics and help broaden access to precision oncology for more patients.”

A CDx test may identify whether a patient’s tumor has a specific gene change or biomarker that can be targeted by a therapy, helping to determine if a patient should receive the therapy. Most CDx tests are specific to one type of cancer, but TSO Comprehensive is approved for use across solid tumor indications for the NTRK CDx, helping to maximize the chances of finding actionable information from each patient’s biopsy.

NTRK gene fusions are rare across most solid cancer tumor types (~0.1%–0.3%), and can be challenging to detect, given that these genes can fuse with different partners, many of which were previously unknown. TSO Comprehensive also interrogates RNA and thus can identify a broad range of known and novel gene fusion partners across all three NTRK gene fusions, NTRK1, NTRK2, and NTRK3. Bayer’s VITRAKVI (larotrectinib) is a highly selective TRK inhibitor approved for use in patients with TRK fusion cancer, in accordance with therapeutic labeling.

NSCLC is one of the most common types of lung cancer and the leading cause of cancer-related deaths globally. The expansive actionable biomarker landscape in NSCLC has driven the need for broad molecular profiling to enable a complete view of a patient’s disease to better guide clinical management. The oncogenic activation of RET fusion-positive NSCLC by gene fusions is a primary driver in NSCLC, occurring in up to 2% of cases. Lilly’s RETEVMO (selpercatinib) is a highly selective and potent RET kinase inhibitor in locally advanced or metastatic NSCLC. TSO Comprehensive enables broad characterization and simultaneous detection of multiple prognostic and predictive biomarkers such as RET, genomic signatures such as tumor mutational burden, and emerging biomarkers within NSCLC in a single test.

“Through research conducted globally, there is a significant body of evidence demonstrating the clinical utility of comprehensive genomic profiling for patients with advanced cancer,” said Vivek Subbiah, MD, chief, Early-Phase Drug Development at Sarah Cannon Research Institute. “Illumina’s newest distributable IVD kit for comprehensive genomic profiling and accompanying CDx enable another valuable clinical tool for the oncology community to match patients with targeted therapies that can vastly improve their journey and outcomes.”

TSO Comprehensive will begin shipping to customers this year. Comprehensive genomic profiling assays with CDx claims for solid tumors, like TSO Comprehensive, are reimbursable under a Centers for Medicare & Medicaid Service national coverage determination.

Illumina has a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive following appropriate regulatory approvals. These CDx claims will help unlock groundbreaking targeted therapies and immunotherapies to make a difference in the lives of patients with cancer.

A separate CE-marked version of TSO Comprehensive is already available in Europe, launched in 2022. To learn more about TruSight Oncology Comprehensive, click here.

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Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced Food and Drug Administration (FDA) approval of its in vitro diagnostic (IVD) TruSight™ Oncology (TSO) Comprehensive test and its first two companion diagnostic (CDx) indications.

Medical Device News Magazine