The major cause of failure in pacemakers is due to lead failure. EBR's Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for wires to the left ventricle (via the coronary sinus) which provide the electrical stimulation for that chamber. WiSE differs from all existing leadless pacemakers in that the stimulating WiSE electrode does not require an internal battery and is small enough to be placed inside the left ventricle (endocardially placed) without a heightened risk of blood clots.
The Technology
The WiSE CRT System includes a subcutaneously implantable transmitter and a separate receiver-stimulator that is spaced apart from the transmitter and anchored to the cardiac tissue within the left ventricle. The transmitter can detect a pacing signal of a separate cardiac pacemaker (co-implant device), and generate acoustic energy (e.g. ultrasound pulses) that are synchronized with the pacing signal of the cardiac pacemaker. The receiver-stimulator receives the acoustic energy generated by the transmitter, and converts that acoustic energy into electrical energy based on the energy and signal information provided by the received acoustic energy. The electrical energy is then delivered to cardiac tissue in which the receiver-stimulator is implanted.
Fraction of Size of Competing Devices
The stimulating electrode implanted in the left ventricle is approximately 5-6% of the size of the other leadless devices (i.e. Medtronic's micra). Consequently, the WiSE electrode is small enough that it can be overgrown by the endocardium within weeks of placement and this is another key reason why the risk of blood clots is low.
US Launch Expected in 2024
The initial target market across these indications is estimated at US$2.1bn. The company is enrolling patients in a pivotal study being conducted in the United States (192 patients). Data from the study is expected to support a Pre Market Approval (PMA) application to the FDA in 2023 ahead of a FDA approval and US launch in 2024.
Why We Invested in EBR
– Experienced Board and Management team have built and sold multiple medical device companies.
– WiSE is the only pacemaker solution for Heart Failure and is approved and marketed in EU
– The portfolio of patents includes 53 granted U.S. patents, 44 granted non-U.S. patents, and 15 patent applications across 20 different patent families.
– The markets it is targeting are large and established (US$2.1 billion).
– The SOLVE-CRT pivotal study has >50% of patients en rolled. EBR has secured FDA Breakthrough Designation status. Once the trial is completed the FDA review process will be expedited.
– Headline data for the SOLVE-CRT pivotal trial is expected in 2H 2022.
– Six previous studies have all exceeded the current primary endpoint of the Pivotal trial.
Horizon 3 Biotech is a later stage investor and patient capital. Whilst there was some selling off in the stock in the months following the IPO, along with many other tech/growth stocks, the investment thesis has not changed for us or the company. With the current share price below the IPO price, EBR represents even better value than at the IPO price of $1.08.
