In December of 1995 FDA approved the Res-Q ACD. This was Intermedics’ first implantable defibrillator. The abdominal-implant device was a relatively late-comer, and large for the time (230 g), but it did offer the highest energy output (40 Joules). Another unique feature of the ResQ device was that it provided a connectorized sterile package which allowed complete pre-implant testing, thereby reducing the need for additional equipment.
NeuroPace of Mountain View, CA announced last month that it filed with the SEC to raise up to $75 million in an initial public offering. However, the IPO was upsized from the initial expectations, with the company offering 6 million shares of common stock at $17 per share, totaling gross proceeds of $102 million. It shares began trading on April 21, 2021 on the Nasdaq under the NPCE ticker.
On April 26 NeuroPace announced the closing of its initial public offering of 6,900,000 shares of its common stock, including the exercise in full of the underwriters’ option to purchase 900,000 additional shares of common stock, at the initial public offering price of $17.00 per share. The gross proceeds to NeuroPace, before deducting underwriting discounts and commissions and offering expenses, were approximately $117.3 million.
Shares rose above $24 after the first day of trading, and have remained steady, closing at $25.78 today.
Unlike Cyberonics’ VNS IPGs, the RNS® neurostimulator is designed to detect abnormal electrical activity in the brain and respond by delivering electrical stimulation to normalize brain activity before the patient experiences seizure symptoms. The neurostimulator is implanted in the cranium and connected to one or two leads that are implanted near the patient’s seizure focus.
Boston Scientific announced today its Q1 2021 results, showing CRM up 7.4% from $437M last year to $467M. Neuromodulation also increased 3.5% from $191M last year to $198M.
Among its accomplishments related to AIMDs, it listed:
- Launched Vercise Genus™ Deep Brain Stimulation (DBS) System in the U.S. Additionally, the system is being used with the world’s first 16-channel directional leads—Cartesia™ X and HX leads—in the eXTend 3D Study in Europe.
- Commenced U.S. launch of the WaveWriter Alpha™ portfolio of spinal cord stimulator (SCS) systems, consisting of four full-body MR conditional, Bluetooth-enabled devices, new FAST paresthesia-free therapy and all supported by Cognita™ Solutions—a suite of digital tools that helps physicians and patients navigate the pain management journey.
- Presented five-year outcomes from the EFFORTLESS study, the largest post-market registry of the Subcutaneous Implantable Defibrillator (S-ICD) System, further validating the long-term efficacy of the device. Results demonstrated 98% overall efficacy over five years, consistent with results of previous S-ICD studies and comparable to or higher than many large transvenous ICD studies.
Zoll Medical announced on April 12, 2021 that it had acquired Respicardia and its neurostimulation technology for treating sleep apnea. The financial terms of the deal were not disclosed.
Respicardia makes implantable neurostimulators to treat moderate to severe central sleep apnea (CSA). The system is FDA approved to treat severe CSA in adult patients with reduced cardiac function.
Zoll Medical Corporation, an Asahi Kasei company, develops and markets medical devices and software solutions for emergency care, and has been a significant Respicardia investor.
LivaNova and Verily announced that they have enrolled their first patient in a study to evaluate treatment effectiveness for patients living with depression. From the press release:
“The first patient has been enrolled in their collaborative UNCOVER study or “The RECOVER Sub-Study, Which Leverages Quantitative and Credible Research Tools from Verily, Will Provide Assessment Measures for Depressive Episodes.”
The UNCOVER sub-study deploys technology-enabled research tools from Verily to evaluate the real-world effectiveness of VNS Therapy as an adjunctive treatment for difficult-to-treat depression (DTD).
Participants in the UNCOVER sub-study will use two Verily-developed digital tools – a wearable, multi-sensor device (Verily Study Watch) along with an Android smartphone application (Verily Mood App). The Verily tools measure passive and active data, such as the participant’s pulse rate, activity levels and sleep quality. The Mood App also allows participants to record voice diaries to more accurately assess depressive episodes and their effect on daily living.
Quantitative data obtained from these Verily tools will supplement the clinical outcomes collected in the RECOVER study, providing clinicians a more comprehensive view of whether each patient’s depression is improving, staying the same, or worsening.”
In 1973, former Medtronic sales representative Albert Beutel founded Intermedics in Freeport, TX. The company’s first product was the C-MOS-I implantable pulse generator – a small (for the time), mercury-cell-powered pacemaker.
Mike Sklanowsky shared pictures of a C-MOS-I sample that he owns. Mike was a software consultant to Intermedics in Freeport around 1974, where he developed the first computerized pacemaker tracking and product recall software. Through his software, Intermedics tracked pacemaker locations and movement through distribution warehouse shelves, hospitals, clinics, doctors, nurses, patient notification of expiring battery charge, product recall communications, follow-ups, etc.
Before Intermedics, Mike worked for JPL, which was his first full-time job upon graduating from UCLA. At JPL he worked on problems related to celestial mechanics, spacecraft orbit determination, trajectory analysis, instrument operations, and human interfaces for real-time command and control. His first project was Mariner 9 Mars, which became the first man-made satellite to orbit another planet.
Mike, and fellow UCLA graduate Bob Patterson were the only two people from their class to get hired by JPL. Bob’s mentor, Prof. Ken Nobe involved both with Intermedics. Dr. Robert (Bob) Patterson was an expert in long-life lithium battery technology for space exploration, and his work for Intermedics led to the 1974 development of a lithium-powered version of C-MOS-I, followed in 1976 by InterLith which was hermetically sealed, and weighed just 65 grams.
Berlin Heals just published the results of its first-in-human study of its C-MIC device, which was conducted in 10 NYHA Class III heart failure patients with LVEF<35%. The C-MIC is an implantable electroceutical device intended to readjust the disturbed myocardial electrical gradient that, according to Berlin Heals, occurs in heart failure patients.
In the study follow‐ups, a rapid and significant signal of efficacy (P < 0.005) was present with improvements in LVEF, left ventricular end‐diastolic diameter, left ventricular end‐systolic diameter, and distance walked. For eight patients, NYHA classification improved from Class III to Class I (for seven, as early as 14 days post‐operatively); for one, to Class II; and for one, to Class II/III. 36‐Item Short‐Form Health Survey questionnaire scores also improved highly significantly.
Berlin Heals has now initiated a randomized, controlled trial in 100 DCM patients, which will take place in Germany, Austria, Serbia, and Poland.
In addition, the FDA has granted Breakthrough Device designation for the C-MIC system
Berlin Heals website: http://berlinheals.de/
Corvion is a pre-clinical stage company based in Webster, Texas. They are developing a fully-implantable LVAD that incorporates a highly efficient implantable rotary blood pump (Corvion claims 3X more efficient than competitors) coupled with a thin battery that gives 3 hours of free operation, and a robust transcutaneous energy transmission system.
Onward is a company dedicated to the development of spinal cord stimulation therapies to improve function after spinal cord injury. Onward was formed in 2014 by researchers at the Swiss Federal Institute of Technology (EPFL). They are now headquartered at the High Tech Campus in Eindhoven, the Netherlands and the EPFL Innovation Park in Lausanne, Switzerland. Onward also has a growing team based in Boston, MA.
Medgadget carried today an interesting interview with Onward’s CEO regarding their technology (the ARC devices).
Onward’s website: onwd.com
Back in March of 2020, Second Sight Medical announced that it was winding down its operations. Second Sight developed implantable devices intended to create an artificial form of useful vision for blind individuals. However, because of the impact of COVID-19 on its ability to secure financing, it laid off the majority of its employees as a first step to an orderly wind-down of its operations.
The company had developed the Orion implant, which is placed directly onto the visual cortex of the patient’s brain. Signals received from a miniature camera integrated within a pair of glasses are fed to the implant and interpreted as “vision” by the brain. At the time of the closure announcement, the company was conducting a feasibility study with the Orion device implanted in six blind patients. Second Sight had been working towards a larger “pivotal” trial of the Orion implant, while all of the patients taking part in the small-scale study had reached the 12-month mark.
On January 6, 2021, Second Sight and France’s Pixium Vision announced that they have entered into a definitive business combination agreement pursuant to which Pixium Vision will, following the contribution to Second Sight of all of its assets and liabilities in relation to its neuromodulation technology used in the treatment of blindness, become the controlling shareholder of the new combined company, owning 60% of the total equity before the capital raise. The combined company will focus on retinal stimulation through Pixium’s Prima System. As part of the transaction, a new subsidiary will be created to focus on cortical stimulation through Orion. The new combined company will own 40% of the new subsidiary and will also have a first option to exclusive global marketing rights for Orion.
Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval of its fourth-generation Vercise Genus™ Deep Brain Stimulation (DBS) System. According to the announcement, The portfolio consists of a family of Bluetooth-enabled, rechargeable and non-rechargeable, MR-conditional, implantable pulse generators (IPGs) that power Cartesia™ Directional Leads.
Impulse Dynamics – the company for which I am CTO and Executive VP – received MR-conditional approval (1.5 T head/limbs with peripheral coils) from both FDA and the European Union.
From the press release:
IMPULSE DYNAMICS ANNOUNCES FDA APPROVAL FOR MAGNETIC RESONANCE IMAGING FDA
Clears Potential Hurdle for Many Heart Failure Patients
MARLTON, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has approved the conditional use of Magnetic Resonance Imaging (MRI) for Optimizer® CCM® delivery systems. This approval represents a significant advance because the population that benefits most from cardiac contractility modulation therapy (patients with moderate to severe HF) often requires advanced diagnostic imaging procedures.
FDA has cleared Biotronik’s Vital Data Sensor to identify body temperature increases potentially associated with fever as part of its new Biomonitor IIIm injectable cardiac monitor (ICM).
The device has shown to achieve a 72 percent reduction in false positives while maintaining 100 percent of AF-related sensitivity. It removes single ectopic beats out of the AF detection algorithm, enhancing diagnostic accuracy.
According to Biotronik, “BIOMONITOR IIIm is the industry leader in battery longevity with 5.5 years of continuous service, providing long-term post-ablation or cryptogenic stroke monitoring. It is also backed by the Patient App, which allows patients to include vital symptom data, providing physicians with symptom-rhythm correlation which strengthens diagnostic precision.”
Impulse Dynamics, Inc., a company dedicated to improving the lives of people with heart failure, today announced its innovative CCM® therapy delivered by the Optimizer® system received an award from the R&D 100 Awards, a prestigious program honoring research and development pioneers and their revolutionary ideas in science and technology.
“Winning this award is a tremendous accomplishment for our company as it represents the recognition by fellow scientists and engineers for the enormous effort that has gone into developing this breakthrough technology. The therapy serves a huge unmet need for a very large group of heart failure patients who suffer every day with their symptoms, so it’s great for the technology to receive recognition at this level,” said David Prutchi, Ph.D., Chief Technology Officer and Executive Vice President at Impulse Dynamics. “I am pleased to congratulate all my colleagues that helped evolve what was initially an intriguing electrophysiological discovery into the transformational therapy that it is today.”
Impulse Dynamics’ website: www.impulse-dynamics.com