A Medical Device Daily
Vicor Technologies (Boca Raton, Florida) President/CEO David Fater issued a letter to shareholders last week, discussing Vicor's progress toward commercializing its PD2i technology.
PD2i is a proprietary algorithm now awaiting FDA 510(k) clearance for its first product, the PD2i Analyzer, which measures heart rate variability. It also is in clinical trials for 510(k) clearance for use of the algorithm in 1) risk stratifying combat and civilian trauma victims (PD2i VS) and 2) identifying patients at risk of suffering sudden cardiac death (PD2i CA).
Fater noted in the letter:
"In spite of all that transpired in the financial markets, Vicor has made immense strides. During 2008, we successfully executed an FDA strategy which we believe will both increase shareholder value and reduce time-to-market. As a result, we now expect FDA clearance for our first product, the Vicor PD2i Analyzer, by year-end.
"The PD2i Analyzer displays and analyzes electrocardiographic information and measures heart rate variability (HRV). FDA clearance will enable Vicor to market the PD2i Analyzer while its other products undergo clinical trials and proceed through the FDA regulatory process."
He added, "Our second product is expected to be the Vicor PD2i VS (Vital Sign). Developed in collaboration with the U.S. Army, the PD2i VS assesses the severity and survivability of traumatic injuries to determine if a life-saving intervention is required. In head-to-head competitive tests, the Army determined that Vicor's PD2i was the only technology that correctly identified soldiers needing immediate life-saving intervention."
Fater said, "In conjunction with our scientists and physicians, Army personnel are also testing Vicor's technology in civilian trauma and ICU patients. The ability of the PD2i VS to predict outcomes in trauma and hemorrhage as demonstrated in these trials indicates that the PD2i VS is likely to succeed in the very significant paramedic, ER and ICU markets."
He said progress in that segment "has been rapid," adding that the company "anticipate[s] completing our collaboration with the Army by year-end, commencing the regulatory process in the first quarter of 2009, and receiving marketing clearance for the PD2i VS in the third quarter of 2009."
Fater said Vicor's third product, the PD2i Cardiac Analyzer, is the subject of the large-scale VITAL clinical trial, now under way, for risk stratification of patients in jeopardy of sudden cardiac death.
He said the company expects to supplement the VITAL dataset with 651 cases from the Merte Subita en Insufficiencia Cardiaca (MUSIC) congestive heart failure trial. "This additional clinical data may result in FDA clearance of the Cardiac Analyzer in 2009, a year sooner than expected," Fater said.
Noting that the company has signed a development agreement with an unnamed manufacturer of medical diagnostic devices for the military, Fater said the agreement calls for the inclusion of the PD2i software in that company's portable monitoring devices to relay injured soldiers' PD2i values and vital signs to doctors as the soldiers are being evacuated for emergency care.
He said the devices being developed "are less than half the size and weight of comparable units" and added that it is anticipated that those devices "will also be used in the civilian market, where they will give emergency first responders a powerful new tool to monitor accident patients' conditions."
Further clinical testing of the devices and the PD2i will take place in the coming months, Fater said, with the expectation that the PD2i would be incorporated into these devices under a licensing agreement, creating a revenue stream for Vicor in the future.
He also noted that the company has developed a private-label Vicor Cardiac Analyzer EKG that includes the PD2i software through an agreement with a manufacturer. "We are negotiating an OEM agreement to be executed in the fourth quarter," Fater said, "[and] we anticipate launching this product in the first quarter of 2009 to our national cardiac pnel and having the manufacturer market a general-use EKG to other physicians through the OEM agreement."