|Over a week ago|
Acutus announces FDA clearance of 2nd generation AcQMap 3D catheter » 16:0709/1709/17/20
Acutus Medical announces…
Acutus Medical announces FDA 510k clearance of the second-generation AcQMap 3D imaging and mapping catheter which builds on its predecessor, improving handling and deliverability. This flagship 3D mapping and navigation catheter combines 48 ultrasound transducers responsible for creating the anatomical geometry and 48 engineered electrodes which enable electrical activation patterns to be displayed along the inner surface of the heart. Compatible with an 0.035" guidewire, the AcQMap catheter is designed to be inserted into the left and right atrium. The AcQMap catheter is the cornerstone of Acutus' innovative mapping platform. It is the world's only integrated high-resolution ultrasound-based imaging and non-contact mapping catheter capable of capturing cardiac imaging information in addition to cardiac activation mapping. This second-generation catheter carries additional benefits such as improved anatomy reconstruction, faster acquisition times and the potential for enhanced procedural efficiencies. The catheter also comes with a reusable and sterilizable cable that can be used up to 10 times, resulting in greater cost savings for health care systems. Customer feedback during development suggested that users perceived anatomy reconstruction to be faster than our generation one catheter*. Dr. Anil Rajendra from Grandview Medical Center in Birmingham, Alabama commented, "the new ergonomic handle and catheter deployment mechanism has the potential to allow me to maneuver the catheter with greater speed, ease and control."
Acutus Medical reports Q2 EPS ($32.24) vs ($45.70) last year » 16:0509/1709/17/20
Reports Q2 revenue…
Reports Q2 revenue $1.13M, consensus $1.1M. The company said, "We effected a 1-for-9.724 reverse split of our capital stock on July 28, 2020 in anticipation of our IPO. We have retrospectively adjusted outstanding shares to reflect the impact of the reverse stock split for all periods presented. Net loss was $23.2 million for the second quarter of 2020 and net loss per share was $32.24 on a weighted-average basic and diluted outstanding share count of 0.72 million, compared to $30.3 million and a net loss per share of $45.70 on a weighted-average basic and diluted outstanding share count of 0.66 million in the same period of the prior year."
Acutus Medical announces pulse field ablation program, pre-clinical results » 08:4409/0809/08/20
Acutus Medical announced…
Acutus Medical announced pre-clinical experimental results of a novel diagnostic and therapeutic workflow utilizing the AcQMap System along with tissue-selective, non-thermal pulse field ablation via a proprietary Acutus ablation catheter. While Acutus has been known for its rapid imaging and mapping platform along with access and diagnostic products, the company is now aggressively pursuing the therapeutic commercial market. Pulsed field ablation is an emerging ablation modality that distinguishes itself from traditional thermal ablation, such as radiofrequency energy ablation and cryoablation, by delivering therapeutic energy faster and more selectively with minimal collateral damage. While not fully clinically proven or approved by regulatory authorities for use in cardiac tissue in humans, recent pre-clinical and clinical studies suggest that PFA may enable rapid targeted ablation of cardiac muscle while leaving adjacent tissue, such as nerves, blood vessels and the esophagus, completely unaffected. In addition, PFA does not rely on heat or extreme cold to ablate tissue. The application time required to create a lesion takes less than a second compared to thermal ablation which may take many seconds to minutes at each location. The AcQMap cardiac mapping system, distinguishes itself from conventional contact mapping via ultra-fast ultrasound imaging of cardiac anatomy and information-rich display of actionable diagnostic maps. By coupling the AcQMap System and the potential of PFA, procedure times may be dramatically shortened while enhancing the safety profile. In a series of pre-clinical experiments, Acutus researchers employed a novel workflow that involved ultrasound imaging of whole-chamber cardiac anatomy and non-contact mapping of electrical activity, followed by delivery of 4 to 8 contiguous ablation lesions in regions of interest via a novel PFA catheter. Following creation of these lesions, non-contact mapping was utilized to assess and confirm the effectiveness of the therapy in the treated regions. In multiple experiments with multiple physician-advisors, this entire whole chamber map / ablate / re-map to confirm block workflow was completed in an average of 12 minutes. Acute ablation efficacy was further confirmed by conventional high-density contact mapping of the treated region with the AcQMap System and a contact mapping catheter. After a recovery period of 10 days, intra-cardiac re-mapping confirmed lesion durability in the treated experimental model indicating that the ablated regions were irreversibly treated via PFA. Visual observation of cardiac muscle under a microscope further confirmed that the ablated regions were clearly demarcated, spanned the entire tissue thickness and non-cardiac tissue were not affected. More importantly, blood vessels within and near the ablated regions also appeared structurally unaffected. This post study analysis indicates that durable, non-conductive lesions were created without damage to collateral structures, confirming the hypothesis that PFA may be tissue-selective. Acutus Medical with its physician-advisors are preparing to conduct clinical trials to prove the safety and efficacy of PFA in patients with a wide range of cardiac arrhythmias.
Fly Intel: Top five analyst initiations » 10:1608/3108/31/20
SPCE, TMUS, AFIB, INFU, CHEF
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Virgin Galactic (SPCE) initiated with an Outperform at Cowen. 2. T-Mobile (TMUS) initiated with an Outperform at Scotiabank. 3. Acutus Medical (AFIB) was initiated with an Overweight at JPMorgan, an Outperform at William Blair, a Buy at BTIG and BofA, and a Hold at Canaccord. 4. InfuSystem (INFU) initiated with a Buy at Craig-Hallum. .5 Chefs' Warehouse (CHEF) initiated with a Hold at Loop Capital. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
Acutus Medical initiated with an Overweight at JPMorgan » 09:0708/3108/31/20
JPMorgan analyst Robbie…
JPMorgan analyst Robbie Marcus initiated coverage of Acutus Medical with an Overweight rating and $39 price target. The global electrophysiology arrhythmia ablation market is a nearly $6B market with sustained double-digit growth, one of the largest and fastest growing markets in MedTech, Marcus tells investors in a research note. The analyst sees "significant opportunity" for Acutus' non-contact mapping technology, which he says allows for more robust and faster mapping of arrhythmias than the incumbent technology.
Acutus Medical initiated with an Outperform at William Blair » 07:4408/3108/31/20
William Blair analyst…
William Blair analyst Margaret Kaczor initiated coverage of Acutus Medical with an Outperform rating.
Acutus Medical initiated with a Buy at BTIG » 07:0408/3108/31/20
BTIG analyst Marie…
BTIG analyst Marie Thibault initiated coverage of Acutus Medical with a Buy rating and $40 price target. The analyst is positive on the company's AcQMap platform for "rapid, high-resolution" cardiac imaging and mapping, along with its "unique" non-contact charge density catheter and the flexibility of its multiple mapping modes. Thibault adds that the clinician response to the product has been "enthusiastic", indicating that the platform allows electrophysiologists to have more information about "complex arrhythmia cases" and supports "more successful" ablation treatments.
Acutus Medical initiated with a Buy at BofA » 06:1508/3108/31/20
BofA analyst Bob Hopkins…
BofA analyst Bob Hopkins initiated coverage of Acutus Medical with a Buy rating and $38 price target. The analyst is positive on the company's non-contact arrhythmia-mapping technology becoming a "critical" new tool in the "attractive" medtech market of electrophysiology, which is estimated at over $5B and growing about 10% annually.
Acutus Medical initiated with a Hold at Canaccord » 06:1208/3108/31/20
Canaccord analyst William…
Canaccord analyst William Plovanic initiated coverage of Acutus Medical with a Hold rating and $30 price target.
|Over a month ago|
James Flynn reports 17.14% stake in Acutus Medical » 16:2808/2008/20/20
This stake was reported…
This stake was reported in a 13D filing, which allows for activism.