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Sat Sep 30 08:02:23 PDT 2023

Medgadget (Medical Technology) Daily Digest (Unofficial)


( Refillable Device for Drug Delivery Past the Blood-Brain Barrier: Interview with Mike Maglin, CEO at CraniUS
Sep 29th 2023, 16:56

( CraniUS, a medtech company based in Baltimore, has developed the NeuroPASS drug delivery system. The technology is designed to deliver drugs to the brain, and it can bypass the blood-brain barrier. This layer of specialized endothelium significantly restricts which drug molecules can enter the brain, normally greatly limiting treatment options for patients with brain-based disease.

The NeuroPASS device is implanted into the skull, where it sits under the scalp. The device inserts catheters into the brain tissue which allow for controlled infusions of drug when required. The implant can be easily refilled from outside, allowing for long-term, minimally invasive drug treatment. It is also wireless and can even be charged wirelessly. 

Here’s a quick video introducing the technology:

Medgadget had the opportunity to discuss the technology with Mike Maglin, CEO at CraniUS.

Conn Hastings, Medgadget: Please give us an overview of the blood-brain barrier, and how it affects treatment for a variety of brain-based conditions.

Mike Maglin, CraniUS: The blood-brain barrier serves as a formidable defense mechanism, protecting the brain from potential harmful substances while allowing essential nutrients to pass through. This selective barrier, composed of specialized endothelial cells, tight junctions, and astrocytes, prevents many therapeutic agents (medicine delivered systemically through pill form or via the bloodstream) from reaching the brain, posing a significant challenge for treating various brain-based conditions.  Over 95% of therapeutic drugs’ effectiveness is blocked by the blood brain barrier.

Medgadget: What existing techniques are used to bypass this barrier? How are they suboptimal?

Mike Maglin: There are several existing techniques that have been employed to bypass the blood-brain barrier but often face limitations that hinder their efficacy (I would refrain from calling out other companies here). These limitations include the following:

In-hospital administration through external catheters that can cause infection over time.  In addition, it isn’t sustainable to have patients in-hospital for months at a time seeking this type of treatment.

Inability to chronically deliver medicine through “one and done” delivery mechanisms

Inability to easily refill medicine for some implanted devices

Inability to change flow rates and monitor patient care remotely

Not MRI safe or compatible. The NeuroPass device resides in important real estate in the skull space with close proximity and access to the brain

Medgadget: What inspired you to develop a drug delivery device that could circumvent the blood-brain barrier? 

Mike Maglin: The motivation to develop a drug delivery device capable of circumventing the blood-brain barrier stems from the urgency to revolutionize brain treatment. Witnessing millions of patients struggling with limited treatment options and recognizing the potential of innovative medical technology compelled Dr. Gordon and our team to embark on this endeavor. The NeuroPass device serves as a platform that has the potential to be drug agnostic and treat several chronic brain diseases.

Medgadget: Please give us an overview of the NeuroPASS device, how it is used and what conditions it is suitable for.

Mike Maglin: The NeuroPASS device is a groundbreaking solution designed to navigate the challenges posed by the blood-brain barrier. It is the first fully implantable, wireless medical device that enables chronic and direct delivery of medicine to the brain.  It is easily refillable, rechargeable from a distance, and sits invisible under the skin in the skull space.

It is a minimally invasive implantable device that utilizes convection-enhanced delivery (CED) to precisely administer therapeutic agents to the brain. NeuroPASS is suitable for a spectrum of brain-based conditions, ranging from neurodegenerative diseases to brain tumors.

Medgadget: How does the device work? What is convection-enhanced delivery?

Mike Maglin: The device operates by inserting catheters into the brain tissue driven by a pump, allowing for the controlled infusion of therapeutic agents. Convection-enhanced delivery leverages pressure gradients to distribute these agents throughout the affected region with unparalleled precision, overcoming the limitations of passive diffusion.

Medgadget: What are the next steps for the technology, and how do you plan to achieve them?

Mike Maglin: CraniUS recently completed a breakthrough pre-clinical study successfully demonstrating convection enhanced delivery in a swine model. Our roadmap for advancing this technology entails rigorous testing, refinement, and collaboration with experts in neurology, neurosurgery, and medical engineering. We aim to optimize the device’s design for enhanced safety, reliability, and patient comfort and are targeting FDA IND submission and approval in late 2024 to conduct a Phase I first-in-human study in 2025.

The NeuroPASS device represents a significant leap forward in addressing the challenges posed by the blood-brain barrier. By harnessing the power of convection-enhanced delivery, we aspire to transform the landscape of brain treatment and offer hope to countless individuals and their families who have long awaited more effective therapeutic options.

CAUTION – The NeuroPASS device is an investigational device limited by Federal (or United States) law to investigational use and is not available for commercial distribution

Link: ( CraniUS homepage…

( Optical Strain Sensors for Rehab
Sep 29th 2023, 16:43

Researchers at Pohang University of Science & Technology in South Korea have developed a durable strain sensor that can detect complex body movements. The technology will be useful for patients undergoing physical rehabilitation, allowing physical therapists to assess their movements in significant detail and measure progress. Conventional strain sensors are often affected by heat and humidity, making them less durable as a wearable, and they typically detect only biaxial strain, providing less detail than these new sensors. The new technology uses computer vision, whereby an algorithm reviews digital images of the sensor deformation and calculates the movements of the sensor wearer.    

Physical rehabilitation allows patients to regain mobility after an injury, disease or medical procedure. Physical therapists and clinicians are interested in characterizing the movements of such patients, such as determining their range of motion, gait, etc. This not only allows them to quantify a patient’s mobility, but monitor progress over time.

To date, researchers have developed plenty of new technologies that can help in this arena, from motion sensors to wearables. Strain sensors attached to the skin are a useful way to assess movement in specific regions of the body, but existing sensors have some limitations. This includes a complicated manufacturing process, and vulnerability to temperature and humidity, which is a drawback for an object expected to reside in close contact with the skin. They can also only typically measure strain in two axes. 

To develop a better sensor, these researchers turned to optical sensors that employ computer vision to measure strain. This involves a miniature camera within the sensor that views a micropatterned silicon film that moves with the skin. The camera can view the film as it is deformed by the wearer’s physical movements, and then the system can use computer vision techniques to interpret these movements.

The researchers have called their technology computer vision-based optical strain (CVOS) sensors, and so far have shown that the sensors can detect rotational movements in three axes and can provide multiaxial strain mapping in real time. The system also incorporates an AI algorithm that works to reduce artifacts and errors in the data, and the sensors are robust, maintaining their performance over 10,000 cycles of use.

“The CVOS sensors excel in distinguishing body movements across diverse direction and angles, thereby optimizing effective rehabilitative interventions,” said Sung-Min Park, a researcher involved in the study. “By tailoring design indicators and algorithms to align with specific objectives, CVOS sensors have boundless potential for applications spanning industries.”     

Study in journal npj Flexible Electronics: ( Real-time multiaxial strain mapping using computer vision integrated optical sensors

Via: ( Pohang University of Science & Technology

( Droplet Battery Harnesses Ionic Gradients for Bioelectronic Implants
Sep 29th 2023, 12:23

Researchers at Oxford University have developed a tiny battery that can power small implantable devices, such as drug delivery technologies. The new battery is inspired by the ionic gradients that electric eels use to generate electricity. It involves tiny droplets of a conductive hydrogel that are placed near each other. Each droplet has a different ionic concentration, meaning that ions will flow from high concentration droplets to low concentration droplets. When the researchers connect electrodes to this chain of droplets they can harness the energy generated by this ion gradient in the form of electricity. The researchers can print large arrays of these nanodroplets, allowing them to customize the technology to suit a range of implantable devices with different space restrictions and power needs.

Tiny medical implants could find use in a wide variety of applications, from drug delivery to neural stimulation. However, there is a constant challenge inherent to creating such devices, which is creating safe and effective power sources. Traditional batteries are often too bulky for use in tiny bioelectronic devices, and also pose safety concerns if they leaked or were damaged in the body.

To address this, these researchers took inspiration from the electric eel, which uses ion gradients to create electricity. The Oxford team used a chain of hydrogel droplets with a differing ion concentration in each drop to create a similar ion gradient. When the ions flow across the drops they generate energy, and simply attaching electrodes to each end of the chain is enough to harness this in the form of electric current.

“The miniaturized soft power source represents a breakthrough in bio-integrated devices,” said Yujia Zhang, a researcher involved in the study. “By harnessing ion gradients, we have developed a miniature, biocompatible system for regulating cells and tissues on the microscale, which opens up a wide range of potential applications in biology and medicine.”

One of the key strengths of the system is its modular nature, whereby the researchers can print different arrays and arrangements of droplets to power different devices. For instance, by combining 20 sets of five droplets together in series, the researchers could power an LED light which requires 2 Volts.

‘This work addresses the important question of how stimulation produced by soft, biocompatible devices can be coupled with living cells,” said Hagan Bayley, another researcher involved in the study. “The potential impact on devices including bio-hybrid interfaces, implants, and microrobots is substantial.’

Study in journal Nature: ( A microscale soft ionic power source modulates neuronal network activity

Via: ( Oxford

Forwarded by:
Michael Reeder LCPC
Baltimore, MD

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