EBR Analyst Reports and Valuation Thread Post FDA approval.

SOURCE AFR: EBR Systems, the heart device hopeful heavily backed by high-profile investors including, private equity veteran Mark Carnegie and big superannuation funds, has secured approval from authorities in the United States to begin selling its technology within months.

The Food and Drug Administration approval means the company can begin generating revenues. Its wireless pacing system prevents heart failure, for which the market for treatments could be worth as much as $6 billion.

EBR was founded in 2003 and is backed by venture capital fund Brandon Capital, M.H. Carnegie, Hostplus and HESTA. Its chief executive, John McCutcheon, said it marked the transition from “clinical development to commercialisation”.

Investing in healthcare and medical device hopefuls is fraught for shareholders because of the trials and approvals required before sales are allowed. Last month, big investors, including Regal Partners, lost hundreds of millions of dollars backing Opthea, an optical treatment company, after the failure of late-stage trials of its product.

EBR shares have doubled over the past year on expectations of FDA approval. However, the stock fell on Monday following the FDA confirmation as some investors chose to cash out. The stock was trading 16 per cent lower at $1.42 on Monday afternoon, giving it a market capitalisation of $528 million.

Wilson’s advisory analyst Shane Storey has a $3.50 per-share price target on the stock. He said there were potentially 39,000 patients in the US who could benefit from the technology. He said they could not be treated using conventional approaches or were at high risk from upgrading to biventricular pacing, which stimulated both the right and left ventricles.

EBR’s technology uses an electrode the size of a cooked grain of rice, which is placed inside the left ventricle of the heart and powered by a small ultrasound transmitter on the chest. It is an alternative to traditional systems that use wires or leads to deliver electrical pulses to the heart.

Chris Nave, the chief executive of venture capital firm Brandon Capital, a key backer, said the company could potentially be the “next Cochlear”, referring to the Australian hearing implant giant.

‘Potential to join the greats’

“There is a large group of patients who have failed traditional cardiac resynchronisation therapy and have no other treatment options,” he said.

“It’s relatively rare for Australian healthtech companies to achieve FDA approval. EBR Systems is part of a new generation of healthtech companies, and I believe it has the potential to join the greats such as Cochlear and ResMed, which, like EBR, were built off a paradigm-shifting technology.”

EBR said a limited release of its products was planned for this year, with a broader launch in 2026.

Nave said the company was not worried about the threat of US tariffs because it would manufacture in California.

“It’s hard to predict where the global economic outlook will go. What we can say is that Americans are going to continue to want access the very best drugs and medical technologies being developed. I don’t see this changing,” he said.

“Investing in biotech and healthtech companies requires patience and a long-term outlook, so it’s not for every investor. There is a lot more investor interest in life science companies than there was 20 years ago, driven by the many successes we have seen in recent years,” he said.

Monique Neu, an Australian heart failure patient and one of the early recipients of the technology, said that after a 10-year history of being housebound due to debilitating heart failure symptoms, she now goes jogging regularly and has started working as a personal care assistant in a hospital.

Neu, 27, received an EBR leadless pacemaker in 2020 at Monash Heart Hospital in Melbourne