The underwriters for the offering are Cantor Fitzgerald, Roth Capital Partners, and Maxim Group.
This is a clinical-stage regenerative medicine company that develops novel therapeutics for cardiovascular diseases with large unmet medical needs. Its lead therapeutic candidate is the CardiAMP Cell Therapy System (CardiAMP).
The company anticipates enrolling the first patient in its phase 3 pivotal trial for CardiAMP in ischemic systolic heart failure in 2015, then obtaining top-line data in the second half of 2017. If the phase 3 pivotal trial is successful, BioCardia believes it will be the first company to reach the market with a cell-based therapy to treat heart failure.
The second therapeutic candidate is the CardiALLO Cell Therapy System (CardiALLO). The company anticipates acceptance of an Investigational New Drug (IND) application by the FDA in 2016 for a phase 2 trial for CardiALLO in ischemic systolic heart failure.
The proceeds from this offering are expected to be put towards the phase 3 trial of CardiAMP cell therapy system, and the remainder of funds will be used for working capital, research and development of additional future products or therapies, and general corporate purposes.
In the filing the company described its market opportunity as:
Heart failure is a clinical condition in which the output of blood from the heart is insufficient to meet the metabolic demands of the body. In 2015, the American Heart Association, or AHA, report on heart disease statistics estimated that there are 5.7 million Americans over the age of 20 that have heart failure. Heart failure is increasingly prevalent due to the aging population and the increase in major cardiovascular risk factors, including obesity and diabetes. The AHA also estimates that one in five adults will develop heart failure after the age of 40.
The #1 Thing to Do Before You Claim Social Security (Sponsor)
Choosing the right (or wrong) time to claim Social Security can dramatically change your retirement. So, before making one of the biggest decisions of your financial life, it’s a smart idea to get an extra set of eyes on your complete financial situation.
A financial advisor can help you decide the right Social Security option for you and your family. Finding a qualified financial advisor doesn’t have to be hard. SmartAsset’s free tool matches you with up to three financial advisors who serve your area, and you can interview your advisor matches at no cost to decide which one is right for you.
Click here to match with up to 3 financial pros who would be excited to help you optimize your Social Security outcomes.
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.
Latest from 24/7
