EBR - EBR Systems Inc.

[System]

EBR Systems Inc. (EBR) is a medical device company that has developed the world's smallest inside-the-heart wireless and leadless cardiac pacing device, WiSE®. Leads are the primary cause of device failure with implanted cardiac pacing devices.

Heart failure is a significant public health problem with an estimated prevalence in 2020 of 6.9 million people in the U.S., and around 64 million people worldwide. The Company believes that WiSE® is the only way to provide heart failure patients with leadless cardiac resynchronisation therapy (CRT). CRT is the clinically proven and accepted standard of care for treating patients suffering moderate to severe heart failure due to dyssynchrony. WiSE® enables CRT to be delivered to patients who are unable to receive CRT from a traditional lead-based system or are at high risk from an upgrade procedure. Without effective CRT these patients have a very poor clinical prognosis, poor quality of life and reduced life expectancy.

WiSE® is able to deliver CRT without leads by using Ultrasonic Energy from a subcutaneous source to power the receiver electrode inside the heart. The absence of a battery allows the receiver electrode to be approximately 5-6% of the size of the other leadless pacemakers, slightly larger than a grain of rice.

The Company is currently conducting its SOLVE pivotal clinical trial that is expected to complete patient recruitment in H1 2022. This trial is expected to provide headline data in H2 2022 to support an application in H1 2023 for FDA approval of WiSE®. EBR's compelling human clinical data, CE Mark and FDA Breakthrough Device Designation status underpins our confidence in the Company's clinical and commercial pathway. Endpoints in the SOLVE pivotal trial have been achieved in three previous studies conducted by EBR.

The Company is anticipating WiSE® could receive FDA approval and launch commercially in the U.S. in H2 2023. EBR has an initial addressable market opportunity of approximately US$2.1 billion with initial adoption to be driven by sites participating in the SOLVE clinical trial for currently untreatable and high-risk patients. In the future, EBR intends to broaden its target markets by expanding the use of WiSE® into other patient groups and clinical applications. EBR estimates that the total addressable market can grow to approximately US$7.1 billion.

It is anticipated that EBR will list on the ASX on 24 November 2021.

EBR Systems, Inc

EBR aims for outstanding treatment of cardiac rhythm diseases with an innovative leadless therapy.

ebrsystemsinc.com

 

[Dona Ferentes]

Listing date	24 November 2021 11:00 AM AEDT ##
Company contact details	https://ebrsystemsinc.com/ Ph: +1 (408) 720-1906
Principal Activities	EBR Systems, Inc. (Company) is a pre-revenue, medical device company that is focused on developing and bringing to market, devices to treat patients with certain types of heart failure. The Company has patented technologies that can provide clinical advantages over technology currently available from incumbent companies.
GICS industry group	TBA
Issue Price	USD 1.08
Issue Type	CHESS Depositary Interests 1:1
Security code	EBR
Capital to be Raised	$110,000,000
Expected offer close date	5 November 2021
Underwriter	Bell Potter Securities Limited, Morgans Corporate Limited and Wilsons Corporate Finance Limited (Joint Underwriters/Lead Managers).

 

[Dona Ferentes]

EBR has opened, at A$1.06.. Bouncing around between 96c and $1.10.

Which isn't too strong, as the CDI issuance at IPO was in US$, at 1.08. (if I am reading it right)

The EBR business is backed by M.H. Carnegie & Co, Brandon Capital and big super funds AustralianSuper, Hesta and Hostplus. In October, EBR raised $110 million, with present investors chipping in more than $30 million of the funds raised.

New investors supporting the latest capital raise include TelstraSuper, private investment manager Mason Stevens and pioneer of the Australian venture capital sector, Bill Ferris.

The new funds will be used to complete the company’s pivotal Phase III clinical trial and US regulatory application, and to support the commercialisation of its WiSE technology in the US and select markets, including Australia.

 

[Garpal Gumnut]

EBR leapt today, 10%.

A medtech with a groundbreaking doofullackey for inserting in to heart chambers to make them pump more efficiently.

gg

 

[bk1]

Is that what they do? I didn't know, but i like the chart.
Thinly traded but looking good.

 

[rnr]

Is that what they do? I didn't know, but i like the chart.
Thinly traded but looking good.

Hi bk1,
Just out of interest a few "firsts" are listed below which were all recorded on the same date (29th May 2023).
Highest High $1.35
Highest Open $1.2150
Highest Close $1.20

N.B. The Close & High on last Tuesday (June 4th 2024) was $1.20

Cheers, Rob

 

[Knobby22]

My pick for the month of August.
Pacemakers surely are a growth market,

Chart good. Volume increasing. Confidence growing. Big investor Backing. Haven't got any spare cash but this looks like a winner.

Bell Potter have a $1.43 price on it.
"In the June quarterly update, EBR reaffirmed that it expects to submit the 5th and final module of its Pre-Market Approval (PMA) application to the US FDA by September 2024, in line with previous stated expectations. This is the second reaffirmation of the expectation this month following statements made at a recent investor conference. Once the submission is made the FDA has 180 days to review the application and deliver its decision, which is currently expected by March 2025. EBR has also stated that the FDA’s breakthrough device designation automatically qualifies WiSE to benefit from two reimbursement programs (New Technology Add-On Payment – NTAP, and Transition Pass-Through – TPT), enabling unit pricing to be lifted to c.US$45k, from the current base price of c.US$35k, upon which BPe are set"

 

[Dona Ferentes]

Heartbeats, no strings attached: EBR’s big step toward FDA approval​

By Adrian Tan | More Articles by Adrian Tan

EBR Systems (ASX:EBR) has announced that the US Food and Drug Administration will conduct a Pre-Approval Inspection of its manufacturing facility during the week commencing 6 January 2025.

The inspection is part of the FDA’s review of EBR’s Pre-Market Approval submission for its WiSE Cardiac Resynchronisation Therapy System, a wireless cardiac pacing device. The FDA began its substantive review of the submission in September 2024, with a Day-100 Meeting scheduled for 20 December 2024.

So, what does it do?
EBR's product is a "CRT device". It's like a pacemaker, but has additional benefits. For instance, a pacemaker is standard treatment for someone with a slow or irregular heart rhythm. CRT devices, in contrast, resynchronise the heart when the left and right ventricles beat out of sync.

Current CRT devices use leads (thin insulated wires) to deliver electrical impulses to the heart. One of these leads is threaded through veins and positioned on the outer surface of the heart's left ventricle. The process can be technically challenging and prone to complications, like infection, dislodgement or breakage.
EBR’s WiSE technology is the only wireless CRT system in development. It stimulates the heart’s left ventricle directly from the inside using a small implant roughly the size of a grain of rice. This approach is safer — it reduces the risk of complications, device failure and repeat surgeries — and it also could offer better heart function.

Regulatory approval
Devices follow different approval pathways from drugs: the pre-approval inspection is one of the final stages of review.
EBR's technology has already undergone clinical trials to assess safety and efficacy, and received "Breakthrough Device Designation". This designation is only given to technologies that offer major clinical benefits over existing treatments and allows faster review.
As part of the PAI, FDA inspectors will visit their facility and audit the entire production environment to ensure it can produce compliant devices reliably and at scale. The visit will assess manufacturing, quality control, training and documentation, supplier control.

Next steps
FDA inspection announcements are often seen as a signal that a company is near the finish line. Many device developers stay silent about inspections unless they believe their facility is well-prepared and issues will be minimal.
If successful, EBR’s system could replace lead-based systems, with no direct competitors, and Cardiac Resynchronization Therapy is a multi-billion-dollar global market.
After any issues are addressed from the PAI and the Day-100 Meeting, the FDA then performs a final review, and issues an approval if everything is in order.
The timeline from a PAI to approval can vary significantly. Most approvals occur within three to six months post-PAI. If there are critical issues identified, then the process could take six to 12 months, or up to two years in the worst cases.
.
around $1.00

 

[Country Lad]

Another of the biotechs I am holding. No likely mews of not until March when they gain full FDA approval. From the charts it looks like it is starting to drift down till then.

 

[Country Lad]

Still holding even though it has dropped quite (ignored my stops). This one probably holds the most promise of all the early stage biotechs I hold/have held. Imminent FDA decision may account for price movement

 

[Bourseboy]

Learned today (reading wife's Hesta update) that Hesta Super fund holds EBR. Is this a good sign for EBR?
EBR raised capital recently (Institutional) and via a Security Purchase Plan, thus funded to Q1 of 2027. I understand a Security Purchase Plan is just another name for Share Purchase plan/Share Participation Plan.
Putting EBR on my watch list. Tradingview has EBR as a buy.
Don't hold at present.