Ventripoint Diagnostics assured investors that the company is inching ever closer to FDA submission of its Pulmonary Arterial Hypertension product, touting a recent $500,000 funding round.
Ventripoint had previously submitted an application for FDA consideration, and the agency asked the company to provide additional information on the PAH technology. In response the company prepared what it calls a "detailed statistical plan" to beef up submission materials for the federal watchdog agency.
The new analysis, conducted in conjunction with the Hospital for Sick Children, Toronto, and already underway, is slated to take 6 to 8 weeks to completely. Researchers will gather more data from the 75 cases studied originally to meet the FDA’s requirements.
The Seattle, Wash.-based diagnostic device company also drummed up $500,000 in a private placement sale of securities, and said in a statement that the cash will go to commercialization and clinical testing of its Ventripoint heart measurement system, and to repay debt and and other company functions.
The company recently landed a green-light from European regulators to launch its NRV 2D ultrasound imaging application on its right-heart analysis platform, which allows clinicians to assess heart imaging in patients with additional cardiac conditions.