The U.S. Army has signed a Collaborative Research and Development Agreement with Vicor Technologies (Boca Raton, Florida) to investigate technology that could assess the severity of injury, and probability of survival, of critically injured combat casualties and critically ill civilian patients.

Vicor’s PD2i Cardiac Analyzer risk stratifies patients who are at high or low risk of suffering a fatal arrhythmic event or sudden cardiac death (SCD) within a six-month time frame. But the technology can be adapted to analyze any biological stream of data.

“Our initial application is focused on stratifying patients at risk for sudden cardiac death,” Vicor president/CEO David Fater told Medical Device Daily. “Our technology is being looked at as another vital sign that can be collected relatively easily because it’s based on a digital EKG recording. Our algorithm and software can analyze those heartbeats and can identify those patients who are in need of life-saving intervention.”

The Army and Vicor will test the PD2i algorithm in several diverse cohorts of animal data as well as in human trauma, ICU patients and combat casualties. It is expected that the effort will lead to lead to development of new comprehensive decision support tools.

SCD is a leading killer in the U.S. with more than 500,000 annual deaths. It is a fatal arrhythmic event and is different than a heart attack. A heart attack is analogous to a plumbing problem, where the blood supply to a part of the heart is choked off, leading to the death of that portion of the heart muscle. SCD is theorized to be caused by a breakdown of the normal neurological communication pattern between the heart and brain, more like an electrical problem, which can lead to a rapid heart rhythm that is usually fatal within minutes. It often has no advance warning or symptoms.

Vicor’s PD2i Cardiac Analyzer is based on an algorithm that the company intends to guard close to home.

“If FDA-approved, we intend to operate like a Quest Laboratory model,” Fater said. “Physicians send us a digital EKG file with 1,000 heartbeats. It gets processed through our software and a report comes back that says the patient is positive or negative. Right now, we’re not letting go of the software in the commercial applications because we don’t want any software piracy.”

The military application, however, may eventually include hardware loaded with the software.

Vicor’s VITAL Trial (a prospective, multicenter study of the ability of the PD2i Cardiac Analyzer to predict risk of VentrIcular TachyArrhythmic events such as sudden cardiac death, ventricuLar fibrillation or ventricular tachycardia in high-risk patients) was initiated in August 2006 and is being conducted by Harvard Clinical Research Institute (Boston).

The FDA, in pre-investigational device exemption meetings, has agreed to final PD2i protocol and study design for the pivotal VITAL study.

The Vicor product’s closest competitor is Cambridge Heart’s (Bedford, Massachusetts) HearTwave II Microvolt T-Wave Alternans test, which measures a specific and extremely subtle pattern of beat-to-beat fluctuations in a person’s electrocardiogram.

Fater said a primary difference between the two technologies is that Vicor will offer it as a service ($100 per patient analysis), rather than as a standalone product that physicians must purchase and keep in their offices.

He added that the technology could eventually be adapted to assess a vast array of conditions and diseases from burn victims to Alzheimer’s disease risk.

In other agreement news:

• Misonix (Farmingdale, New York), a developer of minimally invasive ultrasonic medical device technology for the ablation of cancer and other chronic health conditions, reported an agreement with Medline Industries (Mundelein, Illinois) for the domestic distribution of the SonicOne Ultrasonic Wound Debridement System has expired.

In a limited-release test market, Misonix and Medline have been working together to determine the best distribution model for the product. Both companies said the best opportunity for market success would be sales of the product by Misonix through a proprietary distribution network. Medline will continue to close pending SonicOne sales opportunities through March of this year.

To date, SonicOne has been used by more than 50 physicians in more than 2,500 debridement procedures.

• Applied Biosystems (Foster City, California) said that its software development community has established relationships resulting in two formal agreements intended to help scientists address sequencing bioinformatics challenges.

Geospiza and GenomeQuest will develop bioinformatics tools that are expected to advance data analysis and management for life scientists utilizing data generated by the SOLiD System, the life science industry’s highest throughput system for sequencing.

Geospiza, a provider of data management infrastructure solutions for genetic analysis, has signed an agreement expanding its relationship with Applied Biosystems to include sequencing instrumentation.

Applied Biosystems also formed an agreement with GenomeQuest, which provides an integrated sequence information platform allowing researchers to search and analyze genomic sequence data as a hosted service or as a hardware appliance.

The SOLiD System is capable of generating sequence data that exceeds 4 gigabases, which is more than the roughly 3 billion bases of the human genome.