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

Category Archives: AIMD Business

Nevro Announced 5% Workforce Layoffs As Part of Restructuring

Posted on by Posted in AIMD Business, Nevro, Pain, Spinal Cord Stimulation

Image Credit: Nevro

As part of its Q4 2023 results, Nevro announced that it plans to lay off approximately 5% of its internally-facing workforce to increase its 2024 earnings by $14 million to $15 million.

This news comes after Nevro announced at the end of November 2023 that it acquired Vyrsa Technologies for $40 million cash plus up to an additional $35 million based on milestones.  Vyrsa manufactures a spinal-fusion device for patients suffering from chronic sacroiliac joint (“SI Joint”) pain.

Nevro’s Q4 2023 worldwide $116.0 million revenue exceeded Company’s expectations (2% growth as reported and 1% constant currency compared with Q4 2022).  Its full-year 2023 worldwide revenue was approximately $425.0 million, representing 5% growth reported and 4.5% on a constant currency basis.

Boston Scientific Acquires Axonics

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

Image Credit: Axonix

Boston Scientific Corporation  announced it has entered into a definitive agreement to acquire Axonics, a company that develops implantable sacral neuromodulation devices to treat urinary and bowel dysfunction. According to the announcement, the purchase price is $71 in cash per share, reflecting an equity value of approximately $3.7 billion.

 

AngelMed Changes Name to Avertix, Prepares to Go Public Through SPAC

Posted on by Posted in Acute Coronary Syndrome, AIMD Business, Angel Medical, Avertix, ECG Monitoring

Image Credit: Angel Medical Systems

In May 2023 AngelMed changed its name to Avertix.  AngelMed developed the Guardian System, which is an FDA-approved implantable device designed to detect and warn patients of acute thrombotic coronary occlusion.

BIOS Acquisition Corporation, a special purpose acquisition company, then announced that it had entered into a definitive merger agreement with Avertix so it would become a publicly traded company on Nasdaq. The Transaction is expected to close in the second half of 2023.  According to the announcement, the combined company, which will be named Avertix Medical, Inc., will have an enterprise value of approximately $195 million.

Resonetics buys EaglePicher’s medical battery division

Posted on by Posted in AIMD Business, Eagle Pitcher, Resonetics
Resonetics implantable-grade battery

Image Credit: Resonetics

Resonetics announced  that it has acquired EaglePicher Technologies’ Medical Power business, a leading manufacturer of implantable batteries for critical medical devices based near Vancouver, British Columbia.

Resonetics was founded in 1987 as a provider of engineering and manufacturing solutions for the life sciences industry. Resonetics offers laser processing, centerless grinding, nitinol processing, thin-wall stainless steel & precious metal tubing, photochemical machining, microfluidics manufacturing, and sensor technology.  The acquisition of EaglePicher’s medical battery division expands on the components that it can provide to the AIMD industry.

From the announcement:

“EaglePicher Medical Power has been designing and manufacturing batteries for medical devices for over 25 years and produced one of the first lithium-ion cells for an implantable medical device. The Vancouver site features a modern 60,000 square foot facility with extensive application engineering resources and manufacturing expertise. Chris Huntington, President, EaglePicher Medical Power, will join Resonetics as its Chief Commercial Officer.”

Boston Scientific Results for Q4 21 and Full-Year 2021: CRM/Neuro 11.8% up (Q4), 19.7% (FY21)

Posted on by Posted in AIMD Business, Boston Scientific

Boston Scientific Logo

Boston Scientific announced its financial results for Q4 and full-year 2021, reporting a Q4 growth in Rhythm and Neuro of 11.8% reported basis, 13.2% operational, and 6.1% organic.  CRM had 14% growth, and Neuromodulation 5.2%.  For the full year, Rhythm and Neuro grew by 19.7% (reported basis), with CRM growing by 18.5% and Neuromodulation by 19.5%.

The press release mentioned the following implantable-related developments:

  • “Initiated the MODULAR ATP clinical trial to evaluate the safety, performance and effectiveness of the mCRM™ Modular Therapy System. The mCRM System consists of two cardiac rhythm management devices intended to work together to coordinate therapy: the EMBLEM™ MRI Subcutaneous Implantable Defibrillator System and the EMPOWER™ Modular Pacing System, designed to be the first leadless pacemaker capable of delivering both bradycardia pacing support and antitachycardia pacing (ATP).

  • Presented positive late-breaking clinical trial data on the COMBO randomized control trial at the 2022 North American Neuromodulation Society (NANS) meeting demonstrating the durable effectiveness of the WaveWriter™ Spinal Cord Stimulator (SCS) System, capable of delivering combination therapy for the treatment of chronic pain, designed to offer more opportunities to customize SCS therapy and optimize outcomes.”

 

Heart Failure Left-Ventricle Wireless Pacing Company EBR System Raises AU$110M in the Australian Securities Exchange

Posted on by Posted in AIMD Business, Cardiac Pacing, EBR Systems, Heart Failure (CHF), Ultrasound

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.

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Parandromics Raises $20M to Develop High Data Rate BCI

Posted on by Posted in AIMD Business, Brain-Computer Interface, EEG Monitoring, Paralysis, Parandromics

Image Credit: Parandromics

The scene has been hot for brain-computer interfacing (BCI) since Elon Musk announced its Neuralink project.  One of Neuralink’s competitors is Austin-based Paradromics Inc., founded in 2015, about a year ahead of Neuralink.  Bloomberg reported that Parandromics recently raised $20M to continue developing its high data rate implantable BCI.

Parandromics announced back in January 2020 that it had developed an implantable, low-power, high data rate neural sensor to enable massively parallel neural recordings for next-generation therapeutic applications.  From the press release:

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Neuspera Medical Closes $65M Round to Fund Urinary Urgency Incontinence Trial

Posted on by Posted in AIMD Business, Incontinence, Neuspera, Neuspera Mid Field Powering, Sacral Root Stimulation

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

Nevro Receives FDA Approval for for High-Frequency SCS Treatment of Chronic Pain Associated with Painful Diabetic Neuropathy (PDN)

Posted on by Posted in AIMD Business, Nevro, Pain, Spinal Cord Stimulation
Nevro Senza Implantable Spinal Cord Stimulator for Back and Leg Pain

Image Source: Nevro’s Website

FDA has approved an additional indication of Nevro’s Senza® System for the treatment of chronic pain associated with Painful Diabetic Neuropathy (PDN).  According to the announcement, “this approval is specific to Nevro’s unique 10 kHz stimulation, and Nevro now has the only spinal cord stimulation system approved by the FDA with a specific indication to treat PDN.  The company will immediately initiate commercial launch activities in the U.S. under its recently launched HFX™ branding, as HFX™ for PDN.”

Nevro also announced its Q1 2021 revenue to be around $102.3 million, an increase of 81% compared to $56.4 million in the prior year period and an increase of 9% compared to $93.6 million in the second quarter of 2019.  Nevro expects Q2 2021 revenue to be $85.0 million, an increase of 67% compared to $51.0 million in the prior year period and an increase of 9% compared to $78.1 in the second quarter of 2019.

CVRx Files Intention to IPO with SEC

Posted on by Posted in AIMD Business, Baroreceptor Stimulation, CVRx, Heart Failure (CHF)

Image Credit: CVRx

Back in August of 2019, Minneapolis-based CVRx received a no-panel FDA approval for its BAROSTIM NEO™ device to treat Heart Failure.  CVRx has now filed documents with the SEC with plans to offer 6.25 million shares of common stock priced between $15 and $17 per share, expecting to yield approximately $91.5 million in the offering.

The BAROSTIM NEO™ implantable pulse generator is implanted below the collar bone and is connected to a lead that attaches to the carotid artery in the neck, targeting its baroreceptors.  The proposed mechanism of action is that the activation of baroreceptors cause the brain to relax the blood vessels and inhibit the production of stress-related hormones to reduce heart failure symptoms.

CVRx’s system  is indicated for the improvement of symptoms in patients with advanced heart failure (EF≤35%) who are not suited for treatment with other heart failure devices.

CVRx website:  www.cvrx.com

UPDATE: June 30, 2021, 2:49 pm

Yesterday CVRx upsized its IPO of 7M shares of its common stock at a public offering price of $18 per share.  Trading started today and share price was $27 mid-afternoon.

UPDATE: July 9, 2021, 2:09 pm

A week after IPO CVRx’s stock has lost all of its initial gains.  It is now trading around the original offering price of $18.

 

 

Update December 13, 2021

And CVRx stock keeps on tanking…

Bivacor Raises $22M to Start Human Trials of its Total Artificial Heart

Posted on by Posted in AIMD Business, Bivacor, Circulatory Support, Heart Failure (CHF)

Image Credit: Bivacor

Houston-based Bivacor, which was founded in 2008, has raised a total of $22M through a $19M series B funding round (co-led by Cormorant Asset Management and OneVentures) and a $3M NIH small-business grant from the National Heart, Lung and Blood Institute.  This money will be used to continue testing Bivacor’s Total Artificial Heart and expand the company’s workforce, as it prepares to begin its first human trials.

The device is unique in that it features a single moving part.  Two centrifugal impellers placed on a single rotor provide perfusion to the left and right sides of the body.  According to the company, active magnetic levitation provides precise, stable operation with no mechanical wear, while the device’s patented left-right flow-balancing system allows dynamic adaptation to changes in the patient’s physiology.

The centrifugal pump is powered by an external battery and controller connected via a transcutaneous cable. According to Bivacor, the device is small enough for a child but also powerful enough for a physically active adult.

Bivacor website: www.bivacor.com

FDA Publishes Guidance on Testing and Labeling Medical Devices for MRI Safety

Posted on by Posted in AIMD Business, MRI-safe

FDA published yesterday a final guidance document which provides recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling.

This new guidance supersedes FDA’s 2014 guidance “Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.”  The new guidance applies to all medical devices that might be used in the MR environment. This includes all implanted medical devices, medical devices that are fastened to or carried by a patient (e.g., external insulin pump, pulse oximeter), medical devices that would reasonably be anticipated to enter the MR environment during clinical care, and all medical devices that are intended to enter the MR environment.

For active implantable medical device (AIMDs), the guidance makes reference to ISO/TS 10974 “Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.”

NeuroPace IPO

Posted on by Posted in AIMD Business, Brain Stimulation, Epilepsy, NeuroPace

Image Credit: NeuroPace

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’s Q1 2021 Results: CRM up 7.4%, Neuromodulation up 3.5%

Posted on by Posted in AIMD Business, Boston Scientific

Boston Scientific Logo

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.

Second Sight and Pixium Vision Combine Businesses

Posted on by Posted in AIMD Business, Blindness, Brain Stimulation, Pixium Vision, Retinal Stimulation, Second Sight

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.

Pixium Vision’s Prima System. Image Credit: Images by Pixium Vision