Many of the diseases that afflict people today are fundamentally addressable through neuromodulation, a process by which nervous activity is regulated by way of controlling the physiological levels of several classes of neurotransmitters. Neuromodulators are a subset of neurotransmitter.

Unfortunately, many challenges confront clinicians in the study of the nervous system and hinder the discovery of new treatments, said Jose M. Carmena, co-chief executive officer and founder at iota, a precision medicine technology startup.

THE PROBLEM

“From a patient’s perspective, these challenges mean that many therapies that could affect the course of a disease are currently not translatable into the clinic due to limitations in existing technologies,” Carmena explained.

“These limitations include lack of access to deep structures of the body in a clinically relevant way, access to small nerves or brain structures and devices that are both very small and have very long lifetimes in the body,” he said.

For example, a complication in the treatment of certain neurological diseases are the limitations in monitoring and reporting on specific nerve clusters. Targeting smaller clusters yields more accurate diagnostics, but implanted electrodes must be small enough and placed deeply enough to be in direct contact with nerves to detect and record activity, Carmena explained.

“Foreign objects in the human body typically trigger a negative response from the immune system, so it becomes necessary to develop implantables that are scalable and made of biocompatible materials,” he added.

"Implantable electronic devices should ideally function over a lifetime with minimal negative impact to an individual."

Jose M. Carmena, iota

Another barrier to treating neurological diseases is the unsustainable nature of traditional implantable devices.

“They often are powered by batteries and rely on wires to interface with peripheral nerves and muscles,” he said. “The dependence on wires and batteries, which can degrade within one to two years, becomes a health risk. Implantable electronic devices should ideally function over a lifetime with minimal negative impact to an individual.”

PROPOSAL

The neural dust platform from iota is powered by ultrasound, enabling the company to produce devices the size of a grain of sand that avoid the dangers associated with wire- and battery-powered implantables.

Because they are smaller and can be implanted deeper into the human body than traditional technologies, neural dust can interface directly with specific nerve clusters, enabling more precise diagnostics and treatments.

The company’s devices can simultaneously record information and stimulate nerves, offering near instantaneous closed-loop therapies that could better treat complex disease from the inside out, said Michel M. Maharbiz, co-CEO and founder at iota.

“Neural dust technology is part of the growing field of bioelectronic medicine that aims to monitor nerves accurately and stimulate them safely,” he explained. “Neural dust devices are the size of a grain of sand and can be inserted closer to nerve clusters for more precise readings. This leads to better, more targeted treatments. The miniature size of these devices also reduces impact on surrounding tissue at the time of insertion.”

Neural dust devices do not require wires or batteries. Instead, they are powered by and communicate digitally and securely through ultrasound. As a powerful tool, the application of ultrasound sets neural dust technology apart because it is a safe alternative to conventional, wireless implantable devices that use electromagnetic waves, Maharbiz stated.

“Whereas long-term exposure to electromagnetic waves could lead to negative health effects, the limits for ultrasound are already well-defined and widely used in current clinical therapies and diagnostics,” he said. “Compared to radio waves, approximately 72 times more power is allowable in the human body when using ultrasound.”

MEETING THE CHALLENGE

Neural dust presents opportunities in both therapeutics and diagnostics. With ultrasound powering neural dust, researchers can study the nervous system more precisely. Innovations in bioelectronic medicine are building on the neural dust platform to create powerful implantable electrodes that are wirelessly charged by ultrasound and can communicate with the central and peripheral nervous system, Carmena said.

“This is an emerging and exciting new area in medicine,” he added.

"Early pre-clinical results of the technology and the therapeutic hypothesis are very encouraging and we look forward to submitting an application to the FDA next year."

Michel M. Maharbiz, iota

In addition, a family of diagnostic devices are enabled by neural dust: sensors embedded in the neural dust implants could provide valuable insight on the body’s pressure, temperature and oxygen levels leading to implanted wearables that instantly report on an individual’s health,” he said.

RESULTS

Vendor iota’s initial product is a neuromodulation device, currently in contract manufacturing.

“Early pre-clinical results of the technology and the therapeutic hypothesis are very encouraging and we look forward to submitting an application to the FDA next year,” Maharbiz reported. “Academically, publications in high-impact journals and conferences have demonstrated prototypes that record peripheral nerve and muscle signals, stimulate nerves and record certain diagnostic data; these papers continue to be published with our academic partners as new results are available.”

ADVICE FOR OTHERS

“Although our journey began with a technological innovation, our company is entirely focused on bringing new clinical solutions to patients,” Carmena said. “Our core drive is to develop new therapies and diagnostics to improve human lives. We believe we are the beginning of a new revolution in how the human body can be modulated to treat and prevent disease and we are always looking for new application areas where our platform can make a big difference in people’s lives.”

As a result, iota asks that providers reach out to the company, he concluded.

Twitter: @SiwickiHealthIT
Email the writer: bill.siwicki@himssmedia.com