Acutus Announces Four Deals To Expand Its Reach Into Electrophysiology
Executive Summary
Acutus announced a deal to acquire Rhythm Xience, and new strategic partnerships with Peerbridge Health, Cardiac Designs and MedFact, to offer more electrophysiology products that complement its AcQMap multi-electrode electrophysiology mapping catheter system.
Acutus Medical Inc., which markets the AcQMap multi-electrode electrophysiology mapping system, will acquire Rhythm Xience, which makes devices to help electrophysiology catheters cross the heart’s septum, the companies announced on 9 May.
On the same day, Acutus also announced strategic partnerships with monitoring companies Peerbridge Health and Cardiac Designs, and a deal with MedFact to distribute its robot-enabled radiofrequency ablation catheter.
Terms of the deals were not disclosed.
“We've been working on these for quite a while and had discussions on each of these companies for over a year getting to know each other ... They’re great culture fits,” Acutus CEO Vince Burgess told Medtech Insight. The deals were announced on 9 May to coincide with the Heart Rhythm Society conference in San Francisco.
The AcQMap platform uses dipole density mapping to create a three-dimensional map of cardiac electrical activity of the heart in real-time. Burgess believes combining AcQMap with the technologies from Rhythm Xience, Peerbridge Health, Cardiac Designs and MedFact will make the treatment of cardiac arrhythmias more efficient and effective. (Also see "Acutus Is Trying To Fundamentally Change Understanding Of Arrhythmia With AcQMap" - Medtech Insight, 28 Mar, 2019.)
“It's been our stated strategy for quite some time here at Acutus to provide a complete solution for electrophysiologists … not just mapping, but provide a full suite of products,” Burgess said.
“It's been our stated strategy for quite some time here at Acutus to provide a complete solution for electrophysiologists." – Vince Burgess
Acutus will help push the field of electrophysiology from “EP 2.0” to “EP 3.0,” Burgess said. “EP 1.0” was the early development of the surgical Cox-Maze ablation procedure and the first 2D electrophysiology recording systems in the 80s and 90s, he explained. The advent of 3D mapping systems in the last 20 years created “EP 2.0” but, “success rates and procedure times … seem to have started to plateau. Success rates are not seeing the kind of improvements that everyone would like to see.”
To move past this plateau, Acutus is “obsessively focusing on looking at every single element of an electrophysiology procedure and every element of the continuum of care of a patient who has an arrhythmia [in order to] improve the whole diagnostic and therapeutic loop, and also simplify, streamline and improve the success rates of each individual procedure,” Burgess said.
"[Acutus is] in discussions with a number of other companies that are bringing important new improvements to the field large and small," Burgess said. "We're not done yet. We hope and expect to bring much-needed change to this field."
Rhythm Xience Brings Specific Catheter Expertise
Catheter mapping and ablation procedures require electrophysiologists to navigate the catheter across the interatrial septum of the heart, which is "one of the dodgiest parts of the procedure, especially for newer electrophysiologists," Burgess explained.
Minnesota-based Rhythm Xience markets three devices to help this process: the Lancer integrated transseptal dilator/needle, the Guider fixed-curve introducer and the Flextra steerable introducer. All three devices earned a 510(k) from the US Food And Drug Administration in 2017 and Rhythm Xience markets them in the US. Acutus expects to earn CE marks soon, which would allow it to market them in Europe.
Other competitors in this space include Baylis Medical Co. Inc.’s NRG platform, Pressure Products’ SafeSept transseptal access system, and
Abbott Laboratories Inc.’s Agilis NXT system, which was originally developed by St. Jude Medical Inc.
“Each [of these devices] offer really novel and unique features that streamline, simplify and improve the safety profile of the septal crossing and septal access part of the [electrophysiology] procedure,” Burgess said.
A “couple of key people” from Rhythm Xience, including founder and CEO Jim Hassett, will be joining Acutus, Burgess said. Hassett was also one of the primary developers of the Agilis catheter when he was the vice-president for clinical development at St. Jude Medical. “He's a great addition to our team and he's going to be a key part of our accessories development program,” Burgess said.
MedFact Enhances Robotic Capabilities
In March, Acutus and Stereotaxis Inc. announced an agreement to co-develop a version of Stereotaxis' robotic magnetic navigation system integrated with Acutus' AcQMap. (Also see "Starts & Stops: CardioFocus Studies HeartLight X3 In Persistent AF; IntraLink Spine Launches Trial Of Low-Back Device In Australia" - Medtech Insight, 17 Mar, 2019.) On 9 May, the company announced an exclusive agreement with MedFact for European distribution of MedFact’s robotically enabled point radiofrequency ablation catheter compatible with Stereotaxis’ robotic navigation system.
With the addition of the products from Rhythm Xience and MedFact, Acutus will be able offer “a full suite of products necessary to conduct a state of the art [electrophysiology] ablation as guided by a robot,” Burgess explained.
Stereotaxis’ robotic system is available in the US, but Acutus will have to obtain FDA approval for the software that integrates it with AcQMap and MedFact’s ablation catheter technology. “We'll have to do some regulatory work to gain approval on a robotically enabled ablation catheter and that is likely to include some clinical trial work,” Burgess said.
Integrating Arrhythmia Management
“We're starting to think hard about how to get a ‘bear hug’ around the clinicians in this space who are interested in arrhythmia management, [atrial fibrillation], and other arrhythmias, and around the patient,” Burgess said. Acutus wants to “foster an environment of a continuum of care as opposed to what we've historically seen in the field, which is more episodic.”
Acutus’ deals with Peerbridge Health and Cardiac Designs will help it integrate arrhythmia monitoring and treatment into an overall management approach that helps physicians and patients.
“There's probably a better way to wrap up patients, help physicians and keep closer tabs on those folks. So we're starting to be much more aggressive with our partnering with some of the diagnostic approaches,” he said.
Acutus will help Peerbridge Health market its Peerbridge Cor system for wireless multi-channel electrocardiogram monitoring. It is the only completely wireless monitor that is FDA-cleared to detect up to 26 different arrhythmias, according to Peerbridge. It records every heartbeat for up to seven days and transmits information to clinicians via the cloud to ensure accelerated arrhythmia detection. The system also analyzes the data and sends a summary of each patient’s atrial fibrillation burden to the doctor.
Acutus will market its QCheck handheld electrocardiogram and mobile app through Cardiac Designs, which markets the ECG Check handheld electrocardiogram device. QCheck can record arrhythmia data that patients can see on their mobile device and transmit to a medical professional. The QCheck app is available in the Apple App Store and Google Play by prescription or over the counter.