Non-invasive prostate cancer diagnosing and monitoring

Photo: Washington State University

Technology being developed at Washington State University provides a non-invasive approach for diagnosing prostate cancer and tracking the disease’s progression.

The innovative filter-like device isolates prostate cancer indicators from other cellular information in blood and urine. It could enable doctors to determine how cancer patients are responding to different treatments without needing to perform invasive biopsies.

Guidance for effective treatment

The WSU research team fitted a mat of tiny glass springs with specially designed biomarkers that attract the fatty droplets of proteins and RNA that tumor cells shed into body fluids. The droplets, called exosomes, contain genetic information that can be analyzed to determine a cancer’s molecular composition, even how far it has advanced.

“It may be possible to predict which drugs would be most effective in treating a patient’s cancer,” said WSU chemistry professor Clifford Berkman, who led the design of the biomarkers. “More broadly, this technology could be expanded to other types of cancers and diseases.”

Writing in Springer’s Journal of Materials Science, Berkman, Parissa Ziaei, a Ph.D. student in the interdisciplinary materials science and engineering program, and Grant Norton, professor of mechanical and materials engineering, said their capture technique is more efficient than previous approaches at isolating prostate tumor exosomes from other bits and pieces of cellular information.

The researchers are working on designs for a version of their filter-like device for use in a clinical setting.

A non-invasive alternative to biopsy

Prostate cancer can be a serious disease, but most men diagnosed with prostate cancer do not die from it. In fact, more than 2.9 million men in the United States who have been diagnosed with prostate cancer at some point are still alive today, according to the American Cancer Society.

The fact that prostate cancer can remain in a human for years before spreading to other organs makes monitoring its progression and response to treatment an important, long-term process.

A biopsy, a procedure in which small samples of the prostate are removed with a needle, is sometimes performed on a patient if blood tests reveal abnormalities that indicate the presence of prostate cancer. Biopsies are also performed to track the progression of the disease and how it is responding to treatment. The biopsy is generally safe but sometimes leads to bleeding or infection.

The WSU exosome capture technique could provide a reliable and non-invasive alternative to biopsy.

“Say you have a urine sample from a patient known to have prostate cancer. You could pass the urine through the device we are in the process of putting together and measure the number of exosomes that are specifically from prostate cancer cells,” Norton said. “The physician would propose a treatment plan and the amount of exosomes in a follow-up urine sample would indicate how effective the treatment was.”

Possibilities for detecting other cancers

In addition to helping doctors monitor the progression of prostate cancer, the WSU researchers hope their new approach can be applied to help treat patients with other forms of cancer and disease. The filter-like mat of glass nanosprings synthesized in Norton’s lab could feasibly be fitted with a wide array of biomarkers to attract cancer exosomes in urine, blood and other bodily fluids.

“It wouldn’t be a big step to imagine applying what we are doing now to breast cancer or pancreatic cancer,” Norton said. “It opens up all kinds of exciting possibilities.”

The research supports WSU’s Grand Challenges – initiatives aimed at particularly pressing societal concerns. It is particularly relevant to the challenge of sustaining health and changing the course of disease.

Source: Washington State University

Oral delivery system could make vaccinations needle-free

Photo: UC Berkeley

Patients could one day self-administer vaccines using a needleless, pill-sized technology that jet-releases a stream of vaccine inside the mouth, according to a proof-of-concept study conducted at UC Berkeley.

The study did not test vaccine delivery in people, but demonstrated that the technology, called MucoJet, is capable of delivering vaccine-sized molecules to immune cells in the mouths of animals. The technology is a step toward improved oral vaccine delivery, which holds the promise of building immunity in the mouth’s buccal region of cells, where many infections enter the body. When patients hold the MucoJet against the inside of their cheek, the device releases a jet stream that directly targets the buccal region. This region is rich in immune cells but underutilized in immunology because of the challenge of efficiently penetrating the thick mucosal layer in this part of the oral cavity with existing technologies, such as the oral spray often used for influenza vaccination.

In laboratory and animal experiments, the research team showed that the MucoJet can deliver a high-pressure stream of liquid and immune system-triggering molecules that penetrate the mucosal layer to stimulate an immune response in the buccal region. The jet is pressurized, but not uncomfortably so, and would remove the sting of needles.

“The jet is similar in pressure to a water pick that dentists use,” said Kiana Aran, who developed the technology while a postdoctoral scholar at Berkeley in the labs of Dorian Liepmann, a professor of mechanical and bioengineering, and Niren Murthy, a professor of bioengineering. Aran is now an assistant professor at the Keck Graduate Institute of Claremont University.

The portable technology, designed to be self-administered, stores vaccines in powder form and could one day enable vaccine delivery to remote locations, but years of further study are needed before the device would be commercially available.

Source: UC Berkeley

Velano Needle-Free Blood Draw Technology FDA Approved

Photo: Velano Vascular

Medical device innovator Velano Vascular announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for PIVO™, its innovative needle-free vascular access device that seeks to improve the blood draw experience for patients while reducing risk to both patients and practitioners. Based on significant usage and input from practitioners, the new, improved device is designed for ease-of-use and high volume manufacturing.

“The deliberate and thoughtful design inputs for the next generation of PIVO reflect our commitment to rapid product development cycles informed by real world experience in the country’s leading health systems,” said Velano Vascular Chief Executive Eric M. Stone. “Feedback from hundreds of practitioners already using our technology reinforced PIVO’s ability to enhance the blood draw experience for patients and clinical staff, and helped us to develop a next generation product better suited for widespread adoption.”

PIVO is a single-use, disposable device that enables consistent, high quality blood samples from indwelling peripheral IV lines, allowing hospitals to reduce reliance on repeated needle sticks and central line access for blood collection. In addition to seeking a more compassionate care experience for patients, a safer environment for practitioners, and a more financially responsible alternative for health systems, PIVO aims to equip hospitals to better serve the increasing population of DVA (Difficult Venous Access) patients.

“Our experience with PIVO illuminates that blood draws can be a painless, lower risk experience for patients and practitioners,” explained Sutter Health Chief Nurse Officer Anna Kiger, DNP, D.Sc., MBA, R.N. “By further improving the usability and accessibility of this innovation, the potential exists for a global standard of more compassionate care.”

PIVO is currently in use at multiple health systems nationwide and will be available more broadly in 2017 following this FDA-clearance for the second generation PIVO solution. Frost & Sullivan awarded PIVO its New Product Innovation Award for Vascular Access in 2016.

Source: Velano Vascular

Study establishes link between coronary artery disease and voice

Beyond Verbal announced the results of a new study on Coronary Artery Disease (CAD) patients, conducted together with the Mayo Clinic. The research shows that voice analysis can be used to identify the presence of CAD by establishing a strong correlation between certain voice characteristics and CAD. The study represents a significant breakthrough in this field, proving that there is a connection between distinct voice features and health conditions, which can significantly improve continuous monitoring and reduce remote healthcare costs.

Continue reading “Study establishes link between coronary artery disease and voice”

Study: Non-invasive Vagus Nerve Stimulation (nVNS) as mini-prophylaxis for menstrual related migraine

The Journal of Headache and Pain published an open label study – Non-invasive Vagus Nerve Stimulation (nVNS) as mini-prophylaxis for menstrual/menstrually related migraine.

Abstract

Background

Menstrual migraine and menstrually related migraine attacks are typically longer, more disabling, and less responsive to medications than non-menstrual attacks. The aim of this study was to evaluate the efficacy, safety, and tolerability of non-invasive vagus nerve stimulation for the prophylactic treatment of menstrual migraine/menstrually related migraine.

Methods

Fifty-six enrolled subjects (menstrual migraine, 9 %; menstrually related migraine, 91 %), 33 (59 %) of whom were receiving other prophylactic therapies, entered a 12-week baseline period. Fifty-one subjects subsequently entered a 12-week treatment period to receive open-label prophylactic non-invasive vagus nerve stimulation adjunctively (31/51; 61 %) or as monotherapy (20/51; 39 %) on day −3 before estimated onset of menses through day +3 after the end of menses.

Results

The number of menstrual migraine/menstrually related migraine days per month was significantly reduced from baseline (mean ± standard error, 7.2 ± 0.7 days) to the end of treatment (mean ± standard error, 4.7 ± 0.5 days; P < 0.001) (primary end point). Of all subjects, 39 % (95 % confidence interval: 26 %, 54 %) (20/51) had a ≥ 50 % reduction (secondary end point). For the other secondary end points, clinically meaningful reductions in analgesic use (mean change ± standard error, −3.3 ± 0.6 times per month; P < 0.001), 6-item Headache Impact Test score (mean change ± standard error, −3.1 ± 0.7; P < 0.001), and Migraine Disability Assessment score (mean change ± standard error, −11.9 ± 3.4; P < 0.001) were observed, along with a modest reduction in pain intensity (mean change ± standard error, −0.5 ± 0.2; P = 0.002). There were no safety/tolerability concerns.

Conclusions

These findings suggest that non-invasive vagus nerve stimulation is an effective treatment that reduces the number of menstrual migraine/menstrually related migraine days and analgesic use without safety/tolerability concerns in subjects with menstrual migraine/menstrually related migraine. Randomised controlled studies are warranted.

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Siemens and INSIGHTEC sign agreement to expand access to Exablate Neuro technology

INSIGHTEC announced the signing of a strategic agreement with the global leader in Magnetic Resonance Imaging, Siemens Healthineers. The strategic collaboration will involve the development of compatibility between Exablate Neuro and Siemens leading 1.5T and 3T clinical MRI systems, MAGNETOM Aera and Skyra. With this agreement, Siemens Healthineers follows its strategy of broadening and complementing its diagnostic imaging portfolio with advanced therapy solutions. Both parties will work towards providing access to Exablate Neuro for installed base, as well as new product installation customers.

Exablate Neuro is the world’s first and only CE and FDA-approved device for the non-invasive application of MR guided focused ultrasound to treat essential tremor and other conditions. Clinical research, development and regulatory approvals are ongoing for additional neurosurgical applications and markets.

“Our agreement with Siemens Healthineers will allow us to significantly expand Exablate Neuro’s market presence. Siemens has embraced our technology and together we will bring our therapy to significantly more patients and providers,” said Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board. “INSIGHTEC is committed to continue investing in research and development of MRgFUS technology. The strategic collaboration with Siemens Heathineers will allow more patients and researchers globally to benefit from the unique MRgFUS technology,” he concluded.

Christoph Zindel, MD, Senior Vice President and General Manager of SIEMENS Healthineers’ Magnetic Resonance business further highlights the importance of the agreement: “This strategic partnership of two leading organizations is exciting and further underlines Siemens Healthineers’ strategy of enabling better patient outcomes by broadening its diagnostic imaging portfolio into advanced therapies in the area of neurological and other disorders. Together with INSIGHTEC and its innovative technology, we will jointly drive healthcare further together with our strong research and clinical customer network worldwide.”

Exablate Neuro uses focused ultrasound waves to precisely target and accurately ablate tissue deep within the brain with no incisions, and while minimizing damage to adjacent healthy tissue. Siemens MR imaging plans to provide patient-specific treatment planning and continuous temperature monitoring for assessing treatment outcome in real-time during Exablate Neuro procedures.

A press release is available from Siemens website.