FDA Breakthrough Designation and Medicare Reimbursement
The CardiAMP cell therapy for heart failure has been granted FDA breakthrough designation and is reimbursed by Medicare, highlighting its potential impact and recognition in the medical community.
Significant Decrease in Expenses
Total expenses decreased by 41% quarter-over-quarter to $1.8 million in Q3 2024, compared to $3.0 million in Q3 2023.
Positive Enrollment and Trial Developments
The CardiAMP Heart Failure II trial has a protocol amendment approved by the FDA expected to significantly increase patient eligibility and enrollment.
Successful Public Offering
Closed a $7.2 million public offering in September, ensuring compliance with NASDAQ’s listing requirements.
FDA Approval for Morph DNA Product Family
Received FDA approval for the Morph DNA Steerable Introducer platform, covering an array of 16 products, preparing for commercial release.