EBR Systems (ASX:EBR) anticipates FDA approval for its Wise wireless cardiac pacing system by April 13, paving the way for a potential commercial launch in the second half of the year. This follows a successful pre-marketing inspection of EBR’s US manufacturing facilities, with no outstanding concerns raised by the FDA.
Wireless Pacing Technology
The Wise system is designed to eliminate the need for coronary sinus leads, which are often prone to failure, in heart failure patients requiring cardiac resynchronization therapy (CRT). This innovative approach offers a potential solution to the limitations of traditional pacemaker leads. Future applications may include wireless endocardial stimulation for bradycardia and other non-cardiac indications.
"We are very pleased with the successful conclusion of the FDA’s pre-approval inspection audit," said EBR chief John McCutcheon. "These audits are very rigorous, and the result is a clear indication of our team’s commitment to following good manufacturing practices."
Expedited Reimbursement Pathway
EBR Systems also announced that Wise has been accepted into a US program that provides a faster route to national reimbursement coverage for medical devices with FDA breakthrough device designation status. This program, under the Centers for Medicare and Medicaid Services, is crucial for ensuring access to the technology upon approval.
Cogstate Benefits from Clinical Trial Funding
Cogstate (ASX:CGS), a brain monitoring group, reported a 19% increase in revenue, reaching US$23.9 million in the second half of the year. This growth is attributed to improved funding conditions for US biotech and an increase in neurological clinical trials. A significant portion of Cogstate's revenue, US$22.7 million, is derived from its involvement in these trials, particularly in Alzheimer’s disease studies, which contributed US$14.2 million (up 112%).
Percheron Therapeutics Reassesses Strategy
Percheron Therapeutics (ASX:PER) is currently analyzing further data from its Phase IIb Duchenne muscular dystrophy (DMD) trial of avicursen (ATL1102), which failed to meet its secondary endpoints. Despite the setback, the company is exploring other clinical programs to restore shareholder value. As of September 2024, Percheron had $8 million in cash reserves and has initiated discussions with potential partners.
"Companies in our position must have the courage to recognise futility when it occurs, and our assumption at this stage is that the drug will not move forward in DMD," said CEO Dr. James Garner. "However, we owe it to all those who have invested their time, money, energy and hope in avicursen for DMD to make sure that we do not abandon it prematurely."
