Describe your device and how it will benefit healthcare.
Acutus Medical is developing the AcQMap High Resolution Imaging and Mapping System. This technology is able to create a real-time, 3-D map of the heart chamber to truly visualize the source of atrial fibrillation (AFIB).
AFIB is extremely difficult to treat due to antiquated mapping technologies. Currently, the rate of successful procedures (ablations) is around 50%.
AcQMap solves this by creating a more precise map of the heart that will inform more accurate treatment decisions on behalf of the physician. This has the potential to lead to better patient outcomes and reduced costs associated with repeat ablation procedures.
In the last three decades, diabetes incidence has more than tripled. Meanwhile, techniques for controlling glucose levels in hospitalized patients have remained unchanged, relying on a nurse to a perform a repeating cycle of imprecise, labor-intensive, error-prone tasks. High glucose levels prevent healing, increase complications, and lengthen hospital stays, driving up care costs. Low glucose levels risk seizures, coma, and even death. Precision is necessary for high-quality outcomes. Repeatability at scale is needed for cost control.
Admetsys has developed the first artificial pancreas system specifically for the needs of hospital and surgical care. The system attaches to a patient's intravenous line, and automatically measures blood glucose concentration in real time and with no blood loss. From this, it creates an adaptive, computational model of each patient's metabolism, evolving as patient condition does, and delivers precisely-optimized, treatment - insulin to reduce high glycemic levels and glucose to raise and support falling levels.
How does your product differ from the competition?
AcQMap differs from other imaging and mapping systems like Topera, Carto, and NavX primarily due to its ability to accurately visualize the source of an arrhythmia. Presently, electrophysiologists (EPs) can only map the inside of the heart chamber with existing technologies by actually touching the heart wall with a catheter one location at a time. This limitation prevents them 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. The key differentiator of the AcQMap System is its ability to truly map AFIB and other complex arrhythmias, identify the mechanism of those arrhythmias and provide a guide for ablation therapy. In addition, AcQMap can show the EP the effectiveness of the therapy in real-time. After the ablation has been delivered and upon the next heartbeat, a new complete map is rendered to confirm how the therapy changed the electrical pattern inside the heart. This real-time feedback loop can continue until the EP is satisfied that the therapy and the procedure have been successful.
Admetsys' system is the first fully- automated glucose control device designed for hospital care; no competitive closed-loop systems presently exist. Moreover, it is the only technology that provides an active safeguard against hypoglycemia in hospital patients.
Do you have customers yet?
AcQMap received a CE Mark in May of 2016 and is currently being evaluated in the UNCOVER-AF trial, a multi center clinical study evaluating its efficacy in patients with persistent AFIB.
Admetsys has conducted three FDA approved clinical trials using fully-engineered prototype devices, demonstrating 97% target glucose control (80-125 mg/dL) and 100% prevention of hypoglycemia (<70 mg/dL). Pivotal trials to support market clearance will begin in 2017.
How much money have you raised?
Acutus has raised approximately $100M to date.
Admetsys has raised a $1.5M convertible debt round led by Blue Cross & Blue Shield and Baptist Health System to accelerate its production engineering and support its European clinical trials. A subsequent series A raise of $12 million will be required to achieve market clearance both in the Europe and the United States, with commercial launch in select European markets. These objectives would position the company strongly to raise future growth capital, as well as make the company highly attractive to potential acquirers.
Who are your investors?
Advent Life Sciences, Deerfield, GE Ventures, Index Ventures, OrbiMed, Undisclosed investor
Blue Cross & Blue Shield, Baptist Health System, Dreamit Ventures, University of Michigan Zell Early-Stage Fund
What is the next milestone for your device?
Acutus is seeking FDA clearance of AcQMap in the second half of 2017. In addition, the UNCOVER-AF trial in Europe is underway and will be concluding in the second half of 2017.
ISO 13485 and CE certification to support a market launch in the European Union is expected in Q4 2017.