Ventripoint Diagnostics (TSX-V:VPT, StockForum), a Seattle-based developer of diagnostic tools utilized to monitor patients with heart disease, announced the company had formally responded to the FDA's denial letter received mid-November regarding Ventripoint's VMS(TM) heart analysis system intended for use in Pulmonary Arterial Tension (PAH).
VMS(TM) is already sold in both Canada and Europe, but had yet to receive the Substantially Equivalent (SE) letter from the FDA that would allow the company enter the US market and rid the product of its present 'investigational use only' classification.
Major efforts were made by Ventripoint in order to position themselves financially and operationally for this undertaking including an array of offerings that climbed well into the seven-figure range.
After receiving notice of their failure to attain 501(k) clearance, Ventripoint market value plummeted 70% on the day from $0.15 per share to $0.045 per share and then the next day shares fell another 40% to $0.025 per share. This made for an 83% market value tumble in two days of trading. It wasn't long after that the TSX called a trading halt.
In the mean time, Ventripoint has been re-examining their approach to an American release of the VMS(TM) system and through numerous meetings with FDA officials, the company has formed a new strategy.
In this version, VMS(TM) will be released to the US market as a software-only Class II device addressing all points raised in the Non-Substantially Equivalent (NSE) letter the company received from the FDA.
Ventripoint needs to shore up their bottom line in order to successfully navigate a new 510(k) clearance submission.
According to the news release, the company intends to do this through development staff reduction and shuffling others into manufacturing and quality control. Installation staff will be directed to maintain operations by offering user support.
Executives are expected to accrue their salaries where possible and the company will continue cementing relationships with European distributors and search out new territories in other regions, all while reducing direct sales staff located in Europe.
All present sales involving VMS(TM) devices with expired evaluation periods should be completed with any customers wishing to purchase their VMS(TM).
Jim Bodkte, Vice President, Clinical Affairs, Ventripoint, commented on the process, “The FDA has been encouraging and specific in their advice to streamline the process to seek approval.”
Company CEO, Dr. George Adams, reaffirmed the importance of Ventripoint's FDA re-submission strategy, “I think our greatest opportunity for success is to reach the U.S. market and so we have identified ways to economize to ensure that we have the resources to complete the new 510(k) process.”
Dr. Adams summed up, “We owe it to ourselves, as well as to our shareholders, to reach this endpoint without further dilution.”
Ventripoint made headlines recently when the company announced they would appeal the FDA notification.
Market value gained 83% on the news to $0.055 per share.
Outstanding share count and market cap were not available at time of writing.