Two companies are waking up European markets for sleep disorders as they explore the potential of at-home monitoring devices that detect sleep disturbances.
SPO Medical (Simi Valley, California) said its has upgraded to its PulseOx 7500, a blood oxygen saturation and heart rate monitor that uses reflectance pulse oximetry, to speak French, Italian, German and Spanish for the graphic user interface and data downloads.
The enhancements were made in response to increased demand from the company's distributors across European markets and the Spanish speaking markets of the Americas.
A diagnosis of sleep disorder symptoms are typically conducted during overnight monitoring sessions at a specialized sleep clinic.
SPO's chief executive, Michael Braunold, said the PulseOx device is positioned as a pre-screening device for detecting sleep disorders in the comfort of a patient's home.
Data is collected and stored overnight by the wrist-watch device while the user sleeps and data is downloaded the following morning to the general practitioner using SPO-supplied reporting software.
"People caring for sleep apnea sufferers recognize the value proposition of the PulseOx 7500" as a cost-effective alternative, said Braunold, adding that report generation in multiple languages make this alternative "available to a wider multi-language community and extends our technological applications to meet the needs of a worldwide customer base."
SPO's Reflective Pulse Oximetry technology is based on placing a detector on a single side of the skin using a light emitter that picks up the intensity of blood flow from a reflection just a few millimeters deep.
Power demand on the battery is one-50th of standard readers, resulting in a battery life of up to 1,000 hours, compared to 18 to 24 hours for other professional models for oxygen saturation and heart rate used routinely by caregivers monitoring patients with, for example, chronic asthma, chronic obstructive pulmonary disease or heart disease.
SPO devices are currently sold in 40 countries and include both a homecare spot check monitor and models for use by professional caregivers in institutional settings.
The company recently announced its entry in to the homecare baby monitoring market with its first product due in 2009.
The SPO baby monitor is a wireless monitoring device but like the other company products based on the RPO patent platform, the sensor needs to be physically attached to the infant using an ankle bracelet.
BiancaMed (Dublin) is building sleep disorder monitors and a baby monitor on another technology that remotely detect changes in breathing patterns and heart rate with a non-contact motion sensor up to a distance of two meters.
A spin-out from University College Dublin's School of Electrical, Electronic and Mechanical Engineering, BiancaMed's non-invasive sensor combines electrocardiogram (ECG) and oximetry (SpO2) measures and can be integrated into a cell phone handset.
BiancaBaby, which sells for $200 and hovers over the crib, monitors sound, movement and sleep patterns of an infant and is sensitive enough to detect the movement caused by a baby breathing, which is displayed on the remote parental monitor's interface as a blue light indicator that modulates according to the intensity of the baby's breathing activity, according to CEO Dr. Conor Hanley.
The sensor can detect breathing through most materials, including bedding and wood, and if no movement is detected for 20 seconds, an audio and visual alarm is activated, he said.
The push to capture a share of the baby monitor market with more advanced features than currently offered is driven by sheer size of the market.
SPO estimates the opportunity saying there are roughly 4.1 million births in the U.S. alone each year, of which over half are births to "first time" parents. Statistics are similar for Western Europe.
"First-time parents are particularly apprehensive about their new experiences and responsibilities with newborns," said Braunold.
At an investment conference in Paris in April, BiancaMed's Hanley told D&IW that in a reversal of the typical go-to-market strategy for European companies who exploit early CE approval before seeking FDA approval, the U.S. is the first market for his company's non-medical device that feature medical quality technology at a retail price.
Professor Conor Heneghan, BiancaMed's chief scientific officer, said, "A trend in parenting these days is the concept of sleep training and a novel feature of the monitor is that it can be used to keep a record of a child's sleep pattern.
"When the baby has a nap, you press a button, and when you come back two hours later, it tells you that, for example, the baby actually slept for one hour 45 minutes," he said.
He added that BiancaMed plans to adapt its non-contact technology for neonatal care so that premature babies can be monitored without infection risks.
Hanley is currently seeking investors for a strategy to challenge the market for sleep labs with an overnight sleep disorder monitor that is undergoing clinical tests.
BiancaMed estimates the current market for sleep apnea diagnostic and screening technology at more than $100 million worldwide with 20 million sleep apnea sufferers in the U.S. and a similar number in Europe.
Obstructive sleep apnea is a medical condition in which the breathing of an individual is interrupted while he/she is asleep, which can lead to daytime sleepiness, fatigue, and which also is a risk factor for heart disease. Apnea has been shown to be a co-morbidity of congestive heart failure.
BiancaMed licensed its algorithms to Del Mar Reynolds Medical (Irvine, California) for ECG-based detection of sleep apnea through a Holter monitor that received FDA approval in 2005.
But Hanley told investors at the Paris meeting that he expects to go further in challenging sleep lab monitoring using the non-contact sensor platform.
With increased cost pressures on medical payment systems, overnight monitoring of a patient's cardiac signals recorded in the individual's home can greatly reduce the cost and time involved in diagnosing related conditions, he said.
Targeting cardiologists and general practitioners, BiancaMed challenges the prescription of a sleep lab, which often have waiting lists due to a limited capacity, with preliminary at-home monitoring.
Combining the sensor platform with software, Hanley said the objective is to place enough intelligence in the event recorder to detect and reliably identify a data event of interest and then to trigger an alert.
Australian launch for DxS kit
DxS (Manchester, UK), a personalized medicine company and developer of companion diagnostics, reported the launch of its K-RAS cancer mutation detection kit in Australia.
The TheraScreen K-RAS kit allows clinicians to screen patients for mutations in the K-RAS gene, which correlates with poor prognosis if patients are treated with a class of drugs called EGFR inhibitors. The gene is mutated in 35% to 45% of metastatic colorectal cancer as well as a variety of other cancers.
The company said that by using TheraScreen, clinicians will be able to determine which patients will not respond to targeted cancer therapies such as Amgen's (Thousand Oaks, California) Vectibix and ImClone Systems' (New York) Erbitux.
Dr. Stephen Little, company CEO, said, "The TheraScreen kit will serve as an invaluable tool in deciding on correct treatment regimes for cancer patients."