Earnings 11/10
SAN CARLOS, Calif.--(BUSINESS WIRE)--BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and provided a corporate update for the third quarter ended September 30, 2017.
“These financial results demonstrate BioCardia’s efficiency in its use of capital while conducting the CardiAMP HF Trial. The trial has received Investigational Device Exemption (IDE) Category B reimbursement designation from the Centers for Medicare and Medicaid Services. This significantly reduces the overall development cost of the program.”
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BioCardia reported a net loss of $3.0 million for the third quarter of 2017, which compares to a net loss of $3.3 million for the third quarter of 2016. Research and development expenses were $1.7 million for the third quarter of 2017, compared to $684,000 in the third quarter of 2016, primarily due to expenses incurred for the pivotal CardiAMP Heart Failure Trial (CardiAMP HF Trial). Selling, general and administrative expenses were $1.3 million for the third quarter of 2017, compared to $919,000 in the third quarter of 2016, primarily due to additional costs for the organizational structure needed to support the CardiAMP HF Trial and operations as a public company.
BioCardia CEO Peter Altman, PhD, stated, “These financial results demonstrate BioCardia’s efficiency in its use of capital while conducting the CardiAMP HF Trial. The trial has received Investigational Device Exemption (IDE) Category B reimbursement designation from the Centers for Medicare and Medicaid Services. This significantly reduces the overall development cost of the program.”
Recent accomplishments include:
Successful data safety monitoring board review of the roll-in cohort in the CardiAMP HF Trial,
Activation of five world-class cardiovascular centers enrolling patients in the trial today,
Launch of the patient recruitment website, www.CardiAMP.com,
Appointment of Ian McNiece, PhD, as Chief Scientific Officer,
Publication of the positive Phase II results from our co-sponsored TRIDENT trial evaluating allogeneic mesenchymal stem cells in heart failure in Circulation Research, and
Issuance of US Patent No. 9,301,975 relating to a method of producing mesenchymal stem cells from bone marrow cells, and US Patent No. 9,775,963 related to steerable devices.
BioCardia Chief Medical Officer Dr. Eric Duckers, MD, PhD, said, “The ongoing CardiAMP pivotal trial in ischemic heart failure and the anticipated submission of CardiAMP in the related indication of chronic myocardial ischemia are supported by our CardiAMP Phase I open-label TABMMI ischemic heart failure trial and the Phase 2 randomized placebo-controlled TACHFT-BMC ischemic heart failure trial. In both trials, patients who received cells experienced clinically meaningful and statistically significant improvements in established endpoints of exercise tolerance, while also demonstrating positive changes to their heart geometries. These results are also supported by a recent meta-analysis of 21 randomized controlled trials of bone marrow-derived cells for treating ischemic heart disease, which showed a significant reduction in mortality at long term follow-up in patients who received cells when compared to those who did not receive cells.”
Looking forward, the Company anticipates submitting an IDE supplement to enable an interim analysis on efficacy at the end of 2018, and having top line data available at the end of 2019. The Company also anticipates filing a second IDE with the FDA for a CardiAMP Chronic Myocardial Ischemia Trial in 2017.
September 30,
2017
December 31,
2016
Assets:
Cash, cash equivalents and short-term investments $ 15,125 $ 21,352
