A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: AIMD Business

GLP-1 drugs competing with implantable devices

Posted on by Posted in AIMD Business, Inspire Medical, Sleep Apnea

Image Credit: Inspire Medical

This week Inspire’s shares dropped by 32% after it cut its full-year sales outlook by $42.5M below the outlook Inspire issued three months ago.  Inspire also expected income to be in the range of 40 to 50 cents a share, well below its previous guidance for $2.20 to $2.30 per share.

Inspire blamed the slower-than-expected rollout of Inspire’s new Inspire V system and the disclosure that patients may be delaying implant of the Inspire device as they first try GLP-1 weight-loss drugs, some of which are now approved by FDA to treat obstructive sleep apnea.

Obesity is a cause of a number of diseases that are now treated with implantable medical devices. It is no surprise that GLP-1 drugs, which have gained enormous popularity for their effectiveness in weight loss, would be seen by patients and medical providers alike as a first alternative to using invasive devices.

I believe that this trend will impact the AIMD industry as GLP-1 drugs (which are not without major downsides) take precedence ahead of implantable devices in the treatment of hypertension, cardiovascular diseases, neurological diseases, and autoimmune diseases.

 

The AIMD Workshop: A Growing Independent Forum for Innovation

Posted on by Posted in ADCORPUS, AIMD Business, Pompeu Fabra University

AIMD 2025 Podium

The Second AIMD Workshop was held in Barcelona on June 5–6, 2025, bringing together a global community of experts to explore cutting-edge topics in the field of Active Implantable Medical Devices (AIMDs). This year’s event was expertly organized by Antoni Ivorra (Universitat Pompeu Fabra) and Nicolas Barabino (ADCORPUS), and featured a compelling program of presentations focused on the latest challenges, breakthroughs, and opportunities in our industry.

Although I wasn’t able to attend in person, Nicolas generously shared the final program along with a summary of key highlights captured in LinkedIn posts from the attendees.

Building on the momentum of last year’s inaugural workshop in Punta del Este, Uruguay, the AIMD Workshop has rapidly become a vibrant, independent forum for exchanging forward-looking ideas. What makes this initiative especially valuable is that it isn’t dominated by the industry’s giants—it fosters open, collaborative dialogue among innovators of all sizes, encouraging fresh perspectives and real technical depth.

I look forward to continued growth of this important forum and hope to join in person in next year’s event.

 

 

Medtronic and Boston Scientific Settle Axonics IP Dispute

Posted on by Posted in AIMD Business, Axonics, Incontinence, Sacral Root Stimulation

Image Credit: Axonix

Medtronic and Boston Scientific have reached a confidential settlement over the IP dispute between Medtronic and Axonics (now part of Boston Scientific). The settlement, which includes a payment from Boston Scientific to Medtronic resolves all outstanding litigation between Medtronic and Axonics.

 

 

DOJ Investigating Inspire Medical for Medicare/Medicaid False Claims

Posted on by Posted in AIMD Business, Inspire Medical, Sleep Apnea

Image Credit: Inspire Medical

Inspire Medical disclosed that it is being investigated by the Department of Justice for allegations of false Medicare and Medicaid reimbursement claims.

Their latest SEC 10k filing explains:

“On January 17, 2025, we received a civil investigative demand (“CID”) from the Department of Justice U.S. Attorney’s Office for the District of Minnesota pursuant to the False Claims Act in the course of the government’s investigation concerning allegations of false claims, including false claims arising from violations of the Anti-Kickback Statute, submitted to government payors in connection with our implant. The CID requests information relating to the marketing, promotion and reimbursement practices associated with our products. We are cooperating with the investigation”

 

Axonics Prevails in Patent Infringement Lawsuit with Medtronic

Posted on by Posted in AIMD Business, Axonics, Bowel Discfunction, Incontinence, Medtronic, Sacral Root Stimulation, Wireless Power Transmission
Axonix rechargeable stimulator

Image Credit: Axonix

Axonix announced that a jury in the U.S. District Court for the Central District of California returned a unanimous verdict in the patent infringement lawsuit brought by Medtronic against Axonics in Axonix favor.

The jury ruled unanimously for Axonics, on claims related to three separate patents.  One relates to transcutaneous recharging, and the other two two  to the implantation of electrodes for stimulating the sacral nerve to help support urinary and bowel control.

The case has been one of several intellectual property disputes between Medtronic and Axonics, which is expected to become a Boston Scientific subsidiary in a $3.7 billion deal.

 

FTC scrutinizing Boston Scientific’s $3.7B bid to acquire Axonix

Posted on by Posted in AIMD Business, Axonics, Boston Scientific, Incontinence, Sacral Root Stimulation
Axonix rechargeable stimulator

Image Credit: Axonix

In January of this year Boston Scientific announced it had entered into a definitive agreement to acquire Axonics a publicly-traded developer of devices to treat urinary and bowel dysfunction. The purchase price was set at  $3.7B.     However, the proposed deal is facing scrutiny by the FTC, most probably because the companies are dominant providers of some treatments for incontinence.

The Axonics product portfolio includes the Axonics R20 and the Axonics F15 Systems used to deliver sacral neuromodulation (SNM) therapy. In clinical studies, Axonics Therapy has demonstrated meaningful improvement in patients’ quality of life in follow-up out to two years, with no serious device-related adverse events reported.

China’s Evolving Domestic AIMD Industry

Posted on by Posted in Aerospace Taixin Technology, AIMD Business, Bradycardia, Brain Stimulation, Cardiac Contractility Modulation, Cardiac Pacing, Cardioversion/Defibrillation, CH Biomedical (Tongxin Medical Equipment), Circulatory Support, Cochlear Stimulation, Core Medical Technology, CoreRhythm, General Stim, Genlight, Hearing Impairment, Heart Failure (CHF), Leadinno Medical Valley, Lepu Medical, Lifetech Scientific, Microport, Nerve Blocking, Nurotron, Nystagmus, Pain, Parkinson's Disease, PINS Medical, PNS, Qinming Medical, Rectus Muscle Stimulation, Rishena Medical, Rocor Medical Technology, Sacral Root Stimulation, Sceneray, Seeneuro, Singular Medical, Sneuro, Spinal Cord Stimulation, Super Vision, Tachycardia, Vagus Nerve Stimulation, Yongrenxin

AIMDs made in China www.implantable-device.com

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→

Former Stimwave CEO Found Guilty of Selling Non-Functional Neurostimulators

Posted on by Posted in AIMD Business, Curonix, News, Pain, PNS, Spinal Cord Stimulation, Stimwave Technologies
Stimwave injectable neurostimulator system

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.

Stimwave receiver

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.

 

Impulse Dynamics Completes $136M Financing Round

Posted on by Posted in AIMD Business, Cardiac Contractility Modulation, Cardiac Pacing, Cardioversion/Defibrillation, David Prutchi's Portfolio, Heart Failure (CHF), Impulse Dynamics

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.”

Presenting Keynote “AIMD-based Therapies of Heart Failure” at LASCAS 2024

Posted on by Posted in AIMD Business, Cardiac Contractility Modulation, Cardiac Neuromodulation, Cardiac Pacing, Cardiac Stimulation (other), Cardioversion/Defibrillation, Circulatory Support, David Prutchi's Portfolio, Heart Failure (CHF), Hypertension, My Portfolio, Vagus Nerve Stimulation

LASCAS Keynote

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.

 

BCI Developer Synchron Acquires Equity Stake in Nitinol Part Maker ACQUANDAS

Posted on by Posted in AIMD Business, ALS, Brain-Computer Interface, EEG Monitoring, Paralysis, Synchron
Synchron stent electrode

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.

Motif Neurotech Raises $18.75M to Fund R&D and Clinical Study of Device to Treat Depression

Posted on by Posted in AIMD Business, Brain Stimulation, Depression, Motif Neurotech
Motif brain stimulator for depression

Image Credit: Motif

Rice University announced that Motif Neurotech, which was formed through the Rice Biotech Launch Pad, closed a Series A financing round of $18.75 million.  According to the press release:

“Proceeds from the Series A financing will be used to advance the development of Motif’s lead product, the DOT microstimulator, a miniature brain pacemaker that is designed to precisely stimulate the brain to restore healthy circuit activity to treat mental health disorders. The initial indication Motif is pursuing for the device is treatment-resistant depression (TRD), a form of major depressive disorder (MDD).”