|Acutus' proprietary "basket" catheter--Courtesy of Acutus|
Acutus Medical has raised a $75 million Series C round to get its 3-D, real-time cardiac surgical imaging system through regulators in U.S. and Europe. It also expects to develop a suite of products specifically for catheter-based procedures. The San Diego-based startup has already got at least a couple of strategic investors--GE Ventures, who is an existing investor, and a mystery undisclosed strategic investor who joined with this latest financing.
The company hopes to tap into several converging cardiac market trends including imaging during surgical procedures, minimally invasive surgery, 3-D and real-time imaging, as well as the expansion of tools for electrocardiologists (EPs). Actus is aiming to get a CE mark and a 510(k) clearance for its AcQMap.
In fact, CE mark submissions have already been made. The catheter has won a CE mark, with a pending approval for the console. A 510(k) submission is expected during the first half of 2017.
"The Acutus Medical AcQMap technology has the potential to play an important role in the detection and treatment of atrial fibrillation," said Deerfield Management Partner Steve Hochberg said in a statement. Deerfield joined the financing as a new investor. "Presently, EPs are only able to map the inside of the heart chamber by actually touching the heart wall with a catheter one location at a time."
He continued, "This limitation prevents the EP from truly seeing the AFib in a complete, full chamber, high-resolution view, leading them to treat the patient via an empirically-based approach versus an evidence-based approach. AcQMap allows EPs, for the first time, to see a three dimensional, high-definition view of the heart chamber and its electrical activity in real-time, helping them to make critical treatment decisions based on clear evidence of the abnormality causing the arrhythmia."
|AcQMap console that displays the map of the atrium--Courtesy of Acutus|
The imaging system is expected to map atrial fibrillation (AFib or AF) and other arrhythmias, identify the mechanism of them and offer a guide for ablation therapy that adapts over time during surgery as treatment is applied. As ablation is delivered, with the next heartbeat AcQMap is able to identify how each application has changed the electrical pattern inside the heart. Therefore, ablation can be adjusted and applied until the procedure is deemed successful.
In November, a clinical assessment of AcQMap was published in the European Heart Journal. It discussed the imaging of three patient's hearts with the AcQMap, as well as with a conventional 3D system. Abbott ($ABT), Medtronic ($MDT) and St. Jude ($STJ) all market cardiac imaging systems. The small study found that AcQMap was a 4x improvement over voltage maps, which it said was a "clinically significant improvement in mapping performance."
"We have completed one small proof-pf-concept study and one mid-sized for all left-atrial procedures, including atrial fibrillation," Acutus President and CEO Randy Werneth told FierceMedicalDevices via email. "These studies will be published when follow-up reaches 12 months in all patients. We are also just starting a multi-center, multi-national persistent AF study, it's across 15-20 centers in Europe, Canada and Australia. In 2017, we will apply for an IDE for our ablation catheter in the U.S."
New investor Xeraya Capital joined with this latest round alongside existing investor Advent Life Sciences, which has been an investor since Acutus' 2011 inception, and OrbiMed, which joined in the Series B round. The startup has already raised a total of $125 million in venture capital.
"The rapid pace of progress in the past few years has brought Acutus from an early stage startup to a company on the verge of a commercial launch," said Werneth. "That progress has energized our existing syndicate of top-tier investors and financial partners, while attracting the participation of new, world-class investors to participate in the next critical stages of the company."
- here is the release