A Medical Device Daily

Embla Systems (Denver) a company that develops sleep diagnostic software and equipment reported the signing of an exclusive agreement with the Beth Israel Deaconess Medical Center (BIDMC; Boston) for the distribution of the Cardio Pulmonary Coupling (CPC) technology developed by Robert Thomas, MD, Ary Goldberger MD, C-K. Peng, MD, and Joseph Mietus MD.

CPC technology presents a picture of sleep oscillations and interactions instead of manual sleep stage scoring and counting of respiratory events that has been the standard for the last 40 years. The analysis has been validated using more than 10,000 sleep studies.

"The CPC technology is not a sleep-stage or respiratory event detector but [it] does provide a dynamic measure of sleep state-modulated cardio-pulmonary interactions," says Robert Thomas MD. "As the technique is automated, inter-scorer reliability is eliminated as a problem. The technique can track dynamic sleep physiology, and provide a unique ambulatory measure of sleep quality."

"With the anticipated introduction of reimbursement for home testing, the integration of this technology into Embla's existing product line confirms our dominant position in this market place," said David Baker, president/CEO of Embla.

"In addition, the technology will allow us to develop very low cost and reliable diagnostic tools to assist clinicians in diagnosing the presence of sleep apnea among the huge population of undiagnosed people who suffer from this condition, while allowing an unprecedented method to monitor treatment effects on sleep quality and respiratory dynamics in the 13 million or so users of CPAP machines in the U.S. alone".

The CPC technology will give physicians the "Sleep Health" of a patient and to evaluate if the patient has Obstructive, Central or Complex Sleep Apnea. The clinical significance of such a simple and low cost test is that it will accelerate necessary medical assistance to those patients in need of diagnosis for sleep disorder breathing at a fraction of today's current cost. Moreover, clinicians will benefit from the phenotyping capabilities of the technology to enhance diagnostic accuracy of non-obstructive forms of sleep disorder breathing (including heart failure patients), recommend appropriate treatment, and evaluate treatment efficacy. Over the next 12 to 18 months Embla will be developing the technology into their existing laboratory based Polysomnography (PSG) equipment and their portable home monitoring equipment.

In other agreements:

  • Allarae Healthcare, (Irving, Califorina) reported that it has signed a distribution agreement with Intellect, to sell their entire product line on a non-exclusive basis, worldwide. Intellect has developed a broad range of personal health testing kits, several already FDA approved and personal tracking software for home use. The test kits are ready for market but have not yet been commercialized. The company added that tests for strep, influenza, cholesterol, and glucose levels are the first to be packaged for immediate sale. Tests for certain other conditions including certain forms of cancer and hepatitis are near completion and will be ready for the market in 2008. Allarae's President, Phil Matteis, said that the company's goal is to become the premier provider of personal health management products. The vision for the company is to provide a complete toolkit that will allow individuals to manage their health more effectively.
  • TrialStat (Ottawa), which calls itself the industry's first clinical data solutions on-demand company, reported that Notal Vision (Tel Aviv, Israel), a medical device company specializing in the early detection of advanced macular degeneration (AMD), has selected its ClinicalAnalytics (CA) system for a Phase II device trial in Israel and the U.S. Notal Vision's flagship product is The Foresee Preferential Hyperacuity Perimeter (Foresee PHP), a non-invasive diagnostic tool for the detection and monitoring of wet AMD, the most severe form of AMD, affecting about 50 million people worldwide. Notal Vision selected TrialStat for its on demand flexibility, the ability to attach images to eCRFs and import data from Notal Vision's medical devices. A key part of the trial requires independent ophthalmologists to review Foresee PHP's ability to evaluate the progression of wet AMD in study participants. CA 4.0 allows the study's researchers to attach images of participant eyes to an eCRF to enable ophthalmologists to view them and enter data for analysis in one step, speeding the collection and management of study data. In addition, patient data from Foresee PHP can be imported to CA 4.0 in XML format for review, allowing for optimal flexibility in capturing trial data. TrialStat provides clinical data solutions that optimize the collection and management of research to accelerate the commercialization of new life science products.
  • Digital Angel (St. Paul, Minnesota), a company developing rapid identification, location tracking and condition monitoring of high-value assets, and VeriChip (Delray Beach, Florida), a provider of RFID systems for healthcare, reported its manufacturing partner, Raytheon Microelectronics Espana will participate in the production development of a self-contained implantable RFID glucose-sensing microchip being developed by Digital Angel and its project partners VeriChip and Receptors (Chaska, Minnesota). Receptors' technology originates from its Cara Affinity by Design discovery platform, which allows the company to optimize artificial receptors to any application. Its product suite focuses on the development of an integrated proteomics "toolkit", with an emphasis on high-performance protein isolation and biomarker discovery.