Handheld blood analysis system

ChroMedX, founded by Director and Chief Science Officer James Samsoondar, went public in 2014 and develops novel medical devices for in vitro diagnostics and point-of-care testing (POCT). The company’s HemoPalm prototype system is a handheld, blood-analyzing, connected device with a suite of single-use cartridges duplicating the blood gas analysis that takes place in a central laboratory benchtop machine. It measures total hemoglobin (Hb), Oxy-Hb, Deoxy-Hb, Met-Hb, carboxy-Hb, blood gases, and electrolytes. An additional cartridge is being developed to measure bilirubin in babies as an indicator for neonatal jaundice.

For these blood analyses, medical professionals typically require an arterial blood sample taken by a physician or specially trained technician, and retrieving these samples can be painful and dangerous, especially for geriatric patients. What sets the system apart is the cartridge’s ability to take standard syringe samples or a pin-prick, to collect blood, making the device available for first responders, disaster relief situations, military operations, and Doctors Without Borders. The results of the analysis can then be sent to local hospitals before patients arrive for early diagnosis and to expedite hospital stays.

“We provide doctors with more information faster, for better patient care, and patients are out of the emergency room faster,” says Wayne Maddever, director, president, and CEO of ChroMedX. “This device will be connected to the hospital information system to link with patient records.”

Research & development

The HemoPalm system integrates full CO-oximetry using spectroscopy, or light analysis, to measure all of the hemoglobin species. Biosensors perform blood gas and electrolytes analysis.

“I call this an engineering integration project,” Maddever says. “None of these technologies that we are using are new. We’re not putting a man on the moon, we are taking existing technologies and adapting them to our use. That doesn’t mean that you don’t have to do any development, though.”

ChroMedX adapts existing technology from Boehringer Ingelheim for its microspectrometer to power the system’s spectroscopy measurements. The company does the same for its biosensor technology, working with a company that implements its sensors for other uses.

To further the HemoPalm’s development, ChroMedX has collaborated with McMaster University’s Advanced Manufacturing Research Institute in Hamilton, Ontario, Canada.

“As an early-stage company, funding is important, and public funding can be helpful,” Maddever says. “What is interesting about McMaster University is that the engineering and medical schools are literally side-by-side, so there is a lot of collaboration between those groups. As a result, we received an Engage grant with the McMaster engineering group, and they’re doing the prototyping of our cartridge through micro-machining.

“Rather than spending the money on getting an injection mold and having to make changes, we’re doing this with very fine detailed micro-machining. This allows us to make changes quickly, and keep costs down. We are all too aware that a lot of start-up companies fail due to too much overhead. This has been a way for us to collaborate with the university and access some expertise,” Maddever adds.

In addition, McMaster University’s Dr. Cynthia Balion provides the necessary laboratory space for ChroMedX to handle and treat blood samples and develop key algorithms for the HemoPalm spectroscopic analyzer.

“This is more cooperation that has helped us move forward for very little cost,” Maddever says.

The university is also helping the company develop the system’s second cartridge for bilirubin.

“Fifteen percent of newborn babies suffer from this common disease. We can use this device to take a simple heel prick and measure bilirubin and determine whether that child will develop jaundice,” Maddever explains. “If jaundice develops when the mother gets home, they have to return to the hospital. If you know that this child is going to have jaundice, then you can prepare the parents.”

Manufacturing a connected device

The HemoPalm is currently in its alpha prototype stage and is expected to reach its beta prototype next year, followed by FDA approval.

“The alpha prototype is a desktop prototype where you have all the key components: the biosensors in the cartridge, the electronics, and microspectrometer,” Maddever explains. “The beta prototype looks a lot like the final product will look like. This is called the packaging. We’ve started to make some 3D-printed models of the analyzer to be able to feel and hold the model.”

Maddever says ChroMedX will likely outsource manufacturing of the device.

“We can outsource it and there are companies that do that at the early stage especially when you don’t need that many. That is the next stage for the HemoPalm,” Maddever explains.

Though ChroMedX is leaning toward outsourcing its HemoPalm, Maddever says quality is still of utmost importance.

“There is no doubt that we will be using quality suppliers,” Maddever says. “I suspect we will stay within North America. The U.S. is obviously a bigger market [than Canada] despite the exchange rate, and we will be selling the majority of our product in the U.S. initially.”

With the HemoPalm, Maddever hopes to provide doctors with more information faster through point-of-care.

“The industry is going more toward point-of-care devices, and the HemoPalm will contribute to that move,” Maddever explains. “This has to be a connected device. This has to lock into the hospital system. When you take a sample, it will have a bar code on it and that bar code/cartridge will be linked to that patient. This cannot be a standalone device.”

About the author: Arielle Campanalie is an associate editor of TMD and can be reached at acampanalie@gie.net or 216.393.0420.

ChroMedX Corp.

www.chromedx.com

McMaster University Manufacturing Research Institute

www.mcmaster.ca