Thanks for posting this link, Warren. Hope you're dealing with Charlie's loss OK
I think your namesake would snap EBR up if it were NASDAQ listed. And it ought to be, IMO. Not now, but after FDA approval I reckon it should qualify. The market potential is sensational. My notes and paraphrasing the speech-
EBR is a California based ASX listed company. [Why? Probably doesn't qualify for NASDAQ listing as it's too small]. They make the first and only leadless pacemaker for heart failure. [ for a particular subset of heart failure patients which will be explained].
Thedevice addresses an unmet clinical need: the failure of cardiac pacing leads.
There are NO direct competitors, and the company is de-risked due to having met/exceeded the required endpoints for formal clinical trials. There is a clear path to FDA approval, having already received
Breakthrough Device Designation. This affords direct channels of communication with the agency, which has enabled EBR to submit its application in a modular fashion, having successfully completed 4 out of 5 submissions, with the 5th due in Q3, and FDA approval estimated to occur in Q1 2025. Another benefit of Breakthrough Device Designation is that the
product qualifies for two reimbursement schemes, which has allowed the company to upwardly revise their average sales price in the US [from $35000] to $45,000.
EBR has $US 73 m in cash reserves. [In a conversation with the CEO I understood their financing partner is VERY supportive and enthusiastic.]
The company operates in the Cardiac Resynchronisation Managment space, where biventricular pacing remedies ventricular desynchrony. When traditional pacemakers pace the right side of the heart, it induces this desynchrony, or pacing induced heart failure. Non -EBR companies use leads for the left side of the heart, and these leads fail in about 30% of cases (lead fractures, lead migration etc). EBR's solution is to implant a tiny device in the left ventricle (1/20th the size of Abbott's or Medtronic's) which easily becomes grown over by heart tissue, preventing the risk of blood clots that could travel toward the brain and lead to a stroke. EBR's device is the only device that addresses this life-threatening problem.
Andrew Shute pointed out that last November, Abbott introduced a leadless pacemaker for the right ventricle and right atrium, which creates 5 x additional sales opportunities not previously realised.
It is estimated Abbott will sell 1 million such devices over the next 5 years. Of those, 30% will result in pacing induced heart failure. EBR therefore has a
captive market, addressing these failures with the only known (and unique) solution available. That's 300,000 patients x $US 45,000 just for fixing problems caused by Abbott's device. This amount contributes to a market size of $US 9.6 billion in 5 years.
EBR's management is experienced in scaling and manufacturing new medtech products to market. The market is tightly concentrated, as 50% of it is in 250 hospitals. This makes the sales force's job relatively easy, but it will first concentrate on an initial addressable market of $US 2.6 billion, beginning with hospitals that previously used the device in EBR's trials. Meanwhile EBR is already planning to expand their in-house manufacturing, [as well as continuing to invest in R&D.]
End of presentation. I note that over 60% of EBR's shareholders are institutional investors. IMO the current SP does not reflect the true value of EBR. This presents a great opportunity to accumulate, especially if this thinly traded stock's SP is manipulated (?) further down. This of course is just my opinion. I would also venture to opine that any takeover offer probably wouldn't be entertained if it were less than $4 per share. But why can't EBR eventually list on the NASDAQ? Especially as the company is California based, right inside their most lucrative market, the USA. Hence, I ain't selling this stock anytime soon!
DYOR and all that.
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(20min delay)