Image Credit: Super Vision
Super Vision was founded in Beijing in 2018 by professors from the Peking University and Beijing University of Technology. It developed the i-NYS implantable stimulation device for the treatment of congenital nystagmus – a condition where the eyes move rapidly and uncontrollably.
Image Credit: Presidio Medical
Presidio Medical is a San Francisco-based private company founded in 2017 to develop neuromodulation devices based on the delivery of ultra-low frequency (ULF) signals.
The idea is to use very low frequency biphasic currents to achieve the same type of blocking effect that DC Direct current has on the propagation of nerve action potentials, but without damaging tissues.
A paper published in Science in 2021 on Presidio-sponsored studies conducted with ULF signals showed that a ULF waveforms produced a rapidly-developing and completely reversible conduction block in animal models. The same paper reported on a 2-week human trial that tested the analgesic effects of epidural ULF currents in 20 subjects with chronic leg and back pain. Pain ratings improved by 90% after 2 weeks and returned to 72% one week after lead explant.
In June 2023, Presidio announced that it had received $72 million Series C funding round led by Deerfield Management, existing investors Invus Opportunities and Action Potential Venture Capital, and joined by ShangBay Capital. Presidio is using these funds to expand their team, scale manufacturing, and conduct long-term, pivotal clinical studies of the ULF™ SCS system.
The 2015 “Made in China 2025” and subsequent domestic development initiatives have significantly benefited Chinese medical device manufacturers. The 2015 plan prioritized the expansion of high-tech device production with the goal of supplying 70% of China’s device market by 2025. More recently, in 2021, the Chinese government issued the 14th five-year plan (2021–25) that aims at making at least six Chinese companies reach the top 50 revenue-making medical device companies globally.
I was recently chatting with Victor Pikov at the First AIMD Workshop, and he mentioned that in the last couple of years the number of Chinese AIMD manufacturers have grown from 5 to over 10. I was really surprised about the progress that China has made in the AIMD field, so this blog expands on the list of Chinese AIMD companies that Victor compiled and kindly shared with me. Continue reading
Image Credit: Stimwave Technologies
Stimwave Technologies was founded by Laura Tyler Perryman in 2010 to develop wireless injectable neurostimulation devices.
The Freedom® stimulator is composed of a stimulating electrode array and a receiver element containing a dipole antenna and stimulation circuitry configured to receive energy from an externally-placed antenna through radiative coupling.
From: Vannemreddy, Prasad & Perryman, Laura & Janaswamy, Jyotsna & Slavin, Konstantin. (2019). Minimally Invasive Wireless Spinal Cord Stimulation: A Novel Approach for Refractory Angina in Women. Indian Journal of Cardiovascular Disease in Women WINCARS. 04. 10.1055/s-0039-3402829.
Great idea!
However, Stimwave’s problems started soon after the introduction of the StimQ peripheral nerve stimulation device. The issue was that physicians were having trouble implanting the “pink stylet” receiver component in certain patients because it was too long. This is when Laura Tyler Perryman ordered the creation of a “white stylet” “receiver” that could be cut to length by the physicians. The issue however was that the component was made of all plastic, with no circuitry inside, and misrepresented it to doctors as an alternative to the receiver component.
According to the U.S. Attorney prosecuting the case, Perryman directed Stimwave employees to vouch for the efficacy of the white stylet as a receiver and oversaw training for doctors suggesting the component was functional. Insurance companies, including Medicare, were charged $16,000 to $18,000 between 2017 through 2020 for the non-functional “receiver.”
After the fraud was exposed, Laura Tyler Perryman resigned as Stimwave’s CEO in November 2019. She was arrested in March 2023. In December, the U.S. Securities and Exchange Commission charged Perryman with defrauding investors out of about $41 million. This week (March 6, 2024), a jury unanimously found Perryman guilty of committing healthcare fraud and conspiracy to commit healthcare fraud and wire fraud. The count of healthcare fraud carries a maximum penalty of 10 years, and the count of conspiracy to commit healthcare and wire fraud carries a maximum sentence of 20 years in prison.
In July 2020 Stimwave recalled the device and in June 2022 filed for
Chapter 11 bankruptcy protection, sold most of its assets, and ceased its operations. In November 2022, Curonix of Pompano Beach, Florida completed the purchase of Stimwave Technologies’ assets and liabilities.
Image Credit: Neural Implant Podcast by Ladan Jiracek
I don’t know how I’ve missed it, but now that I found it, I’m hooked! The Neural Implant Podcast hosted by Ladan Jiracek presents engaging conversations with the people driving innovation in neuroprosthetics, brain machine interfaces, and brain implants.
Image Credit: Victor Pikov, Ph.D., Medipace Inc.
Victor Pikov, Medipace’s founder and CEO, presented the OpenNerve Project at the First Workshop on Active Implantable Medical Devices last week. As part of his excellent presentation, he discussed the current commercial landscape of bioelectronic medicine therapies. A picture (in this case, the graph above) is worth a thousand words.
The First Workshop on Active Implantable Medical Devices took place at in Punta del Este, Uruguay last Friday (March 1st 2024) as part of the LASCAS 2024 meeting.
Image Credit: CARSS
The University of Southern California, Medipace Inc., and Med-Ally LLC are the CARSS collaborative team part of NIH’s Human Open Research Neural Engineering Technologies (HORNET) initiative for open-architecture, open-source implantable neuromodulation system. This team is developing the OpenNerve implantable neuromodulation platform, which consists of an IPG with an associated charging device. The OpenNerve IPG will perform current-based neuromodulation, measure impedance, monitor electronic biosignals, and interface with chemical and physical sensors.
All files relevant to the design and manufacture of the CARSS OpenNerve Platform are available on a Github repository. Details are posted on the project’s Wiki.
Image Credit: CARRS
Image Credit: Gimer Medical
Gimer Medical is a Taiwanese medical device manufacturer founded in 2013. It set up the first implantable electronics factory in Taiwan in 2018.
Gimer’s NeuroBlock spinal cord stimulation (SCS) system is based on technology developed at the Taiwan National University in 2008 combining pulsed radio frequency (PRF) with SCS into the so-called “+RF” technology – an ultra-high frequency of 500 kHz, which Gimer claims has a high penetration rate, no heat sensation during the treatment, no protein denature, and no action potential changes. It is expected to produce paresthesia-free and prolonged treatment effect for chronic pain patients.
On August 13, 2022, the US FDA granted conditional Investigational Device Exemption (IDE) approval to Gimer to trial the NeuroBlock SCS system.
Image Credit: Santiago Martinez, et al.
Santiago Martínez, Francisco Veirano, Timothy G. Constandinou, and Fernando Silveira presented a very interesting poster at the First Workshop on Active Implantable Medical Devices organized at LASCAS 2024.
The complete paper is available from IEEE:
S. Martínez, F. Veirano, T. G. Constandinou and F. Silveira, “Trends in Volumetric-Energy Efficiency of Implantable Neurostimulators: A Review From a Circuits and Systems Perspective,” in IEEE Transactions on Biomedical Circuits and Systems, vol. 17, no. 1, pp. 2-20, Feb. 2023, doi: 10.1109/TBCAS.2022.3228895.
I believe that this paper is especially important for developers in the AIMD Industry since it points out opportunities for improving the volumetric and energy efficiencies of neurostimulators.
Impulse Dynamics, the company where I’m CTO and Executive VP, announced yesterday that it completed a $136M financing round to accelerate its commercial growth and advancing the development of pipeline products.
From the announcement:
“Marlton, NJ, Feb. 14, 2024 (GLOBE NEWSWIRE) — Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure (HF), is proud to announce that it raised $136 million in financing to accelerate investment in global commercialization, technology, product innovation, and further development of clinical evidence. The financing was led by Perceptive Advisors, Redmile Group, Alger, and Hobart Healthcare. This substantial investment reflects investor confidence in, and commitment to, the company’s vision and expansion.
…
The funding will fuel commercialization efforts, develop future product pipelines, and support groundbreaking clinical trials such as the INTEGRA-D and AIM HIGHer clinical trials. The INTEGRA-D trial is a multicenter study evaluating the combination of CCM and ICD therapy in a single device – the Optimizer Integra CCM-D System. The AIM HIGHer clinical trial is a multicenter study with the objective to evaluate the safety and efficacy of CCM therapy in patients with symptomatic HF with an ejection fraction (EF) of 40 to 60 percent (inclusive). The trial is currently in its initial enrollment phase and has generated significant attention, feedback, and excitement among experts in HF.”
I’ll be presenting the keynote “AIMD-based Therapies of Heart Failure” at the First Workshop on Active Implantable Medical Devices dedicated to understanding the trends and challenges in bioelectronic medicine.
For the complete announcement of the workshop with some great talks by Rikky Muller (UC Berkeley), Pedro Arzuaga (Impulse Dynamics), Marcelo Barú (Biotronik), Federico De Mula (Integer), and Victor Pikov (Medipace) click here: AIMD Workshop LASCAS 2024 Program.
Image Credit: UroMems
UroMems was founded in 2011 in Grenoble, France. They are developing the UroActive™ implantable device to treat Stress Urinary Incontinence (SUI), or involuntary urinary leakage, which affects an estimated 40 million Americans and 90 million Europeans, and occurs when the pressure in the bladder exceeds that of the sphincter around the urethra.
The “MyoElectroMechanical System (MEMS)” is placed around the urethral duct and is designed to be automatically controlled based on the patient’s activity, without the need for manual adjustments.
According to UroMems, “The expected benefit of the UroActive™ device is twofold. First, the urethral pressure can be increased when the patient is engaged in a physically demanding activity, which is expected to improve continence during activity. Second, when the patient’s activities do not require increased pressure, the compression on the urethral tissue can be released, therefore potentially reducing erosion or other tissue damage.”
The first human implant of the device was performed in November of 2022, and a 6 male subject feasibility study reached its six-month endpoint last December. The Company announced today that its first female patient had reached the six-month endpoint.
Image Credit: Synchron
Brain-computer interface (BCI) developer Synchron announced the acquisition of an equity stake in ACQUANDAS, a provider specializing in high-precision nitinol components.
Synchron is developing endovascular technology to restore functionality in patients with motor impairment. Synchron’s Stentrode™ is an endovascular neural interface. It is essentially an electrode array shaped as an endovascular stent that can be implanted via the jugular vein and advanced into the brain to the motor cortex. Neural signals are detected by the electrodes on the Stentrode™ and sent to a processing and communications unit implanted subcutaneously in the chest, and then wirelessly to an external receiver. The idea is that the device can interpret signals from the brain for patients with paralysis to control a computer operating system and set of applications that interact with assistive technologies.
Image credit: Neuralink
Elon Musk posted on X that Neuralink conducted the first human implant of its brain-computer interface:
Image Capture from X
Details are scant at this time, but Neuralink announced back in September ’23 that they had started recruiting subjects with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) for their PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface), which is an IDE trial for their fully-implantable, wireless brain-computer interface (N1) and surgical robot (R1).