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The market for visual neuroprosthetics products has taken some interesting turns since our last article on this product category earlier this year [NBR Aug23 p1]. Prominent companies like Second Sight Medical Products and Pixium Vision SA, once pioneers in implantable vision restoration devices, now grapple with financial challenges. In 2022, Second Sight (founded entrepreneur Alfred Mann) merged with Nano Precision Medical, forming Vivani Medical, Inc.

The bioelectronic medicine market for treating overactive bladder and related disorders is likely to become more congested as new players enter the arena with new targets and new technology. Market leaders Medtronic and Axonics currently own the vast majority of the market for implanted sacral nerve stimulation systems. In recent weeks three new competitors in this space reported progress toward commercial development.

The bioelectronic medicine market for treating overactive bladder and related disorders is likely to become more congested as new players enter the arena with new targets and new technology. Market leaders Medtronic and Axonics currently own the vast majority of the market for implanted sacral nerve stimulation systems. In recent weeks three new competitors in this space reported progress toward commercial development.

The 23rd annual Neurotech Leaders Forum, which took place in San Francisco earlier this month [see conference report p15], offered an excellent opportunity for neurotech professionals to sound off—and to listen in—on pressing issues confronting the industry. One of the most productive sessions, we think, was devoted to responding to negative publications and negative decisions impacting neuromodulation firms.

Manufacturers of surgically implanted brain devices have generally had to make a compromise between the level of invasiveness and the ability to access deep brain structures. Most DBS systems on the market today are able to reach brain centers such as the subthalamic nucleus or the GPi only of cerebral cortex and other brain structures. Most BCI systems on the market or under development minimize penetration deep in the brain but only come into contact with cortical neurons on the surface of the brain.

The interface between technology and medicine has reached a milestone with the development of DART (Direct Current-Actuated Regulatory Technology), an electrogenetic interface that integrates wearable devices with gene-based therapies. This has potential in real-time medical adaptations, specifically in the management of type 1 diabetes—a condition that requires meticulous monitoring and immediate therapeutic interventions.

The U.S. Centers for Medicare & Medicaid Services recently issued draft rules for hospital price transparency, which stand to exert a profound effect on manufacturers of implanted bioelectronic medicine systems. The new rules state that beginning January 1, 2024, CMS will start enforcing the requirement that all U.S.-based hospitals and ambulatory surgical centers publicly list their standard patient charges in a machine-readable file.

Medical device industry professionals traveled to Anaheim, CA for the 2023 MedTech Conference, produced earlier this month. Neurotechnology firms played an active role in the meeting. One of the unique attributes of this conference was a series of “reverse pitches” in which large strategic medtech firms informed startups of the advantages of partnering with them. Chris Cleary, senior vice president for business development at Medtronic, was one such presenter.

Neurotechnology researchers and manufacturers are well aware that clinical trials and the collection of evidence supporting a new therapy are important elements of the commercialization process. No one in this field would argue that advanced medical products, particularly implantable devices with sophisticated electronic components should be marketed without some degree of testing to ensure that the products are safe and do what they’re supposed to do.

For seasoned professionals working with implanted neurotechnologies, the challenge has always been multi-fold: how do you achieve high resolution in neural recordings, minimize scarring, and maintain the structural integrity of brain tissue? One new development at the University of Utah is the biohybrid transition microelectrode array (TMEA). The developers of these biohybrid electrodes were motivated neural implants and the desire to ensure that an implant’s survival matches the patient’s lifespan.