On November 24, 2021, EBR Systems went public in the Australian stock exchange. According to the press release, the IPO raised AU$110M (around $78.5M). EBR pland to use these funds to complete its pivotal study, targeting FDA submission for approval in 2023 followed by rapid U.S. commercial launch.
Image Credit: Neuspera Medical
Neuspera Medical is a startup company located in San Jose, CA. They are developing miniaturized neuromodulation implants that are externally powered from a wearable device.
In December 2019, Neuspera announced that it had received FDA’s approval to implant their systems under IDE. Neuspera now announced that they closed a $65M series C equity financing round to fund their trial on the use of their device in patients with Urinary Urgency Incontinence (UUI), a symptom of overactive bladder. The Series C round was co-led by Vertex Ventures HC and Treo Ventures.
Neuspera’s website: http://neuspera.com
Image Credit: iota Biosciences
iota Biosciences was established in 2017, building up on the concept of “neural dust” technology invented at the University of California, Berkeley by iota co-founders and co-CEOs Jose Carmena, Ph.D. and Michel Maharbiz, Ph.D.
iota’s “neural dust” consists of a small implantable device (a few mm long) that is powered from an external ultrasound generator. According to iota, their devices can record electrical information, stimulate nerves and communicate with other machines through ultrasound. Iota claims that “neural dust” devices can modulate the information transmitted through nerves, enabling doctors to better treat conditions from arthritis to cardiovascular disease
In 2018 iota completed a $15 million series A funding round aimed at developing a sensing platform. In September 2019, iota entered into a joint R&D agreement with Japanese Astellas Pharma to “design detailed specifications of implantable medical devices and conduct preclinical studies for several diseases with high unmet medical needs.”
Astellas today announced that it would acquire Iota in a deal that includes an initial payment of about $127.5M, covering the equity that Astellas did not acquire in 2018. An additional $176.5M are development-related milestone payments. Iota will be an independent subsidiary under Astellas’ U.S. umbrella.
Eventually, iota hopes to shrink the device to the size of grain of sand that can simultaneously sense neural activity and stimulate nerves to enable highly-targeted closed-loop therapies.
iota Biosciences’ website is at: https://iota.bio/
Image Credit: Neuspera Medical
Neuspera is a startup company located in San Jose, CA. They are developing miniaturized neuromodulation implants that are externally powered from a wearable device.
According to Neuspera, their “Mid-Field Powering” technology uses evanescent and propagating electromagnetic waves to power implanted medical devices to beyond 10cm of depth. Their technology is claimed to use the body as a natural waveguide to focus power ensuring energy is delivered to where it is needed.
In December 2019, Neuspera announced that it had received FDA’s approval to implant their systems under IDE. Neuspera now announced that it had performed the first human implants as part of their SANS-UUI two-stage seamless pivotal clinical trial to support FDA approval for patients with Urinary Urgency Incontinence (UUI), a symptom of overactive bladder.
Neuspera’s website: http://neuspera.com
Image Credit: Neuspera Medical
Image Credit: iota Biosciences
iota Biosciences was established in 2017, building up on the concept of “neural dust” technology invented at the University of California, Berkeley by iota co-founders and co-CEOs Jose Carmena, Ph.D. and Michel Maharbiz, Ph.D.
iota’s “neural dust” consists of a small implantable device (a few mm long) that is powered from an external ultrasound generator. According to iota, their devices can record electrical information, stimulate nerves and communicate with other machines through ultrasound. Iota claims that “neural dust” devices can modulate the information transmitted through nerves, enabling doctors to better treat conditions from arthritis to cardiovascular disease
In 2018 iota completed a $15 million series A funding round aimed at developing a sensing platform. In September 2019, iota entered into a joint R&D agreement with Japanese Astellas Pharma to “design detailed specifications of implantable medical devices and conduct preclinical studies for several diseases with high unmet medical needs.”
Eventually, iota hopes to shrink the device to the size of grain of sand that can simultaneously sense neural activity and stimulate nerves to enable highly-targeted closed-loop therapies.
iota Biosciences’ website is at: https://iota.bio/
Image Credit: Composite of images by Leviticus Cardio
Leviticus Cardio, a company based in Petach Tikva, Israel, has been developing a wireless power transfer technology that they call “Coplanar Energy Transfer” (CET). The system supports high-efficiency (up to 75%) power transfer levels of up to 30 Watts, making it suitable for powering ventricular-assist devices.
Like other transcutaneous energy transfer systems, Leviticus is used on inductive power transfer between an external primary coil and an implanted secondary coil. However, instead of the traditional pancake coil subcutaneous implant, the CET coil is placed around the lung. The unique engineering of the coplanar energy transfer system is characterized by two large rings utilizing a coil-within-the-coil topology, ensuring robust resonance energy transfer Continue reading
Bioness is a Valencia, California medical device/rehabilitation company founded by the late Alfred Mann some 15 years ago. He had previously acquired a miniature stimulator called the BION, and a company called NESS who had a footdrop stimulator. The combination of the two is where the name Bioness came from.
One of its products is the “StimRouter”, which is an externally-powered implantable peripheral nerve stimulator designed to reduce chronic pain. It gained FDA approval in 2015 and was launched in mid-2016.
Unlike most externally-powered neurostimulators however, the StimRouter is not powered by RF received from the external transmitter. Instead, the external pulse transmitter is more like a TENS unit with gelled electrodes applied to the skin. The implant has no electronic components. It is just a lead that has a coil electrode that intercepts part of the current between the TENS electrodes, and routes the captured current to small electrodes in contact with the target nerve at the distal end of the lead.
Neuspera’s Mid-Field Powering technology. Image credit: Neuspera
Neuspera is a startup company located in San Jose, CA. They are developing miniaturized neuromodulation implants that are externally powered from a wearable device.
According to Neuspera, their “Mid-Field Powering” technology uses evanescent and propagating electromagnetic waves to power implanted medical devices to beyond 10cm of depth. Their technology is claimed to use the body as a natural waveguide to focus power ensuring energy is delivered to where it is needed.
In addition to coming up with their own neuromodulation system, Neuspera hopes to license its Mid-Field Powering technology to recharge or power other types of implantable devices. According to their technical publications and patent, they use a phased array microwave transmitter operating at a 1.6GHz local minimum in tissue absorption to maximize power transfer. Per the patent, if the power coupled into tissue is allowed to meet the maximum permitted level of exposure, up to 2.2 mW can be transferred by their system.
Neuspera Medical announced that it has raised a new total of $26 million in equity financing, following the closing of the second tranche of its series B round, to help fund clinical testing programs for its neuromodulation implants.
A vide explaining Neuspera’s technology is available at:
Neuspera Medical from Tiffany Wise on Vimeo.
Neuspera’s website is: http://neuspera.com
Yesterday I visited the Udvar-Hazy Center of the Smithsonian Air & Space Museum in Chantilly, VA. There I found this demo rechargeable pacemaker being displayed as a spinoff of NASA’s technology with the following explanation:
I can’t remember exactly where I found the picture of a Pacesetter model BD102 VVI, but the story behind it is documented by Kirk Jeffrey in “Machines in our Hearts”:
“In 1968, Robert Fischell, of the Applied Physics LOaboratory at Johns Hopkins University, and cardiologist Kenneth B. Lewis had begun a collaboration that led in 1973 to a new kind of Ni-Cad battery able to function more effectively at body temperature and hermetically sealable. Alfred E. Mann, a California entrepreneur with background in the aerospace industry, had provided some financial support to the Hopkins group. Eventually Mann founded a small company to develop a pacemaker for the rechargeable battery; this was the origin of Pacesetter Systems. The rechargeable pacemaker reached the market in the summer of 1973, just as CPI introduced its lithium pacer.”
Active Implantable Medical Devices generate heat as a result of resistive losses in their circuitry, exothermic reaction in their batteries, eddy-current heating due to inductive recharge, friction between mechanical components, etc. The European Standard which regulates AIMDs limits the heating of the outer surface of an AIMD to 2ºC above normal body temperature. Despite the rapid growth in the use of AIMDs, the relationship between AIMD endogenous heat generation and tissue temperature has not been quantified. In the attached paper we aimed at determining the limit of endogenous heat that can be dissipated in-vivo by the surface area of an AIMD to remain compliant with the 2ºC temperature increase limit. In our study, four Sinclair mini-pigs underwent implantation of AIMD simulants instrumented to dissipate heat and measure temperature internally, as well as the device/tissue interface temperature.
We found that for a device with the surface area and geometry that we used, approximately 1W can be dissipated before reaching the 2ºC temperature increase limit.
Click here for a preprint of this paper
This month’s Medical Device and Diagnostic Industry (MD+DI) magazine carried an interesting article by David Schatz – WiTricity’s VP Sales – on their efforts to develop highly resonant wireless power transfer technology for use in AIMDs. The article is available online at http://www.mddionline.com/article/wireless-power-medical-devices.
The article mentions the work that WiTricity has been doing with Thoratec to wirelessly power a HeartMate II® LVAD, and which was announced back in May 2011. David told me that for this project, WiTricity has been able to transfer 20 Watts over 20 cm, with SAR and temperature-rise compliance, and without the use of resonant repeaters.
If these levels scale well to small receiver units, I believe that this technology would enable not only the development of deep-implant AIMDs that are currently outside the range of classical resonant-inductive TET, but would also allow the development of more patient-friendly rechargeable AIMDs that don’t require dedicated recharge sessions, but rather receive their charge from a WiTricity transmitter under the patient’s bed while the patient sleeps. From the MD+DI article:
“A circulatory assist device like an LVAD is just one example of a medical device that can harness the benefits of highly resonant wireless power transfer. There is also promise for other implanted devices, including neurostimulators, implantable defibrillators and pacemakers, implantable drug-delivery pumps, electronic ophthalmic and cochlear implants, and rechargeable hearing aids.
In this broad range of implanted medical devices, high-resonance wireless power transfer can enable higher charge rates than would be possible with traditional magnetic induction. Higher charge rates allow for device implantation deeper within the body and enable more flexible charger configurations outside of the body.
For example, the wireless charger for ophthalmic or cochlear implants could be deployed in a pair of eyeglasses or a pillow. The wireless charger for a neurostimulator implanted in the lower back could be deployed in a chair or bed. Hearing aids could be recharged by simply placing them in a charging box on one’s nightstand, without requiring precise fixturing or galvanic contacts as do today’s rechargeable hearing aids.”
I have been honored with an invitation to present at the Fourth IEEE CASS Summer School on Wearable and Implantable Biomedical Circuits and Systems in Bogotá, Colombia (July 9 – 12, 2013).
I will be giving two 1 hour and 20 minute talks on “A Practical Perspective on Developing Novel Commercial Active Implantable Medical Devices”. Unlike other commercial devices, developing medical implantable devices takes place in a heavily regulated environment which requires decisive proof of the devices’ safety and efficacy. Costs, schedules, and clinical strategies must be planned accordingly to achieve a successful exit. This two-part lecture will focus on the practical technical and business-oriented aspects of planning and executing the development of implantable medical devices intended for a commercial application.
Image Credit: Fraunhofer Institute for Ceramic Technologies and Systems
Scientists at the Fraunhofer Institute for Ceramic Technologies and Systems developed a magnetically-coupled motor/generator system that they claim is able to transcutaneously transfer 100 mW to an implant up to 50 cm away.
In the external power-transfer module, a rotating magnet driven by an EC motor generates a magnetic rotary field. A magnetic pellet in the implanted receiver connects to the alternating exterior magnetic field and as a result, is set in rotation itself. The rotational movement is transformed into electricity, thus the power is produced right in the generator module. “With magnetic coupling, power can be transported through all non-magnetic materials, such as biological tissue, bones, organs, water, plastic or even a variety of metals. Moreover, the magnetic field produced has no harmful side effects on humans. It doesn‘t even heat up tissue,” says Dr. Holger Lausch, highlighting the advantages of the system. Continue reading
Image Credit: Stanford University
Stanford Engineering assistant professor Ada Poon demonstrated a tiny, wirelessly powered, self-propelled medical device capable of controlled motion through blood. The device drives electrical current directly through the fluid, which in the presence of an external magnetic field creates a directional force that pushes the device forward. This type of device is capable of moving at just over half-a-centimeter per second.
That was the news picked up by bloggers from Poon’s presentation at the International Solid-State Circuits Conference (ISSCC). However, what caught my attention is her work on inductive transcutaneous energy transmission. From Stanford’s press release: Continue reading
Image Credit: Purdue University
A group of researchers at Purdue University led by Prof. Babak Ziaie developed a vibrating cantilever that is excited by an external bass source from 200-500 Hz. The excitation causes the cantilever to vibrate, generating electricity and storing a charge in a capacitor.
Although playing tones within a certain frequency range would be ideal, the group concentrated on the use of music as an excitation source. According to the researchers, “a plain tone is a very annoying sound. We thought it would be novel and also more aesthetically pleasing to use music.” Continue reading