Grove Instruments is developing a pocket-sized device so diabetes patients can measure their glucose levels without taking their own blood. If clinical trials go well in 2013, its CEO expects to initiate the process of seeking Food and Drug Administration (FDA) approval for the device in 2014. And if that goes well, Worcester, Mass.-based Grove Instruments' product could become available for use by the 25.8 million U.S. children and adults with diabetes by 2015 or 2016.
In a July 24 interview with CEO, Arthur Combs, I learned that his previous experience makes him a very strong leader for Grove Instruments. Combs was a critical care physician in the intensive care unit during a very invasive phase of medicine - e.g., cutting open peoples' chests to do heart surgery - before joining Mallinckrodt where he rose to Executive VP, R&D. He then led three medical device start-ups before joining Grove Instruments in 2007.
By the time Combs joined, Grove Instruments had been around for 16 years. "Grove's Chief Scientist, Dr. Hannu Harjunmaa of Finland and now-retired Worcester Polytechnic Institute professor, Robert A. Peura, independently identified the importance of the Optical Bridge approach to noninvasive glucose determination. Peura has a personal passion for this because two of his children have Type 1 diabetes and lance their fingers to test their blood sugar 10 to 12 times daily. But the company was run more like a science project until the early 2000s," explained Combs.
By the time Combs joined the company, it was much closer to commercialization. "Grove had developed two devices - for the earlobe and fingertip. It was getting good clinical results even though they were not up to FDA or international standards. But they had done enough to convince me that the technology could be commercialized. The first thing I did when I joined was to build Grove Instruments' organization. I built the team from four people to 14 plus consultants and five full-time interns and we now have 5,000 square feet of office space," said Combs.
It was the optical bridge technology that makes Grove Instruments' product so much better than the competition. According to Combs, "Many companies are using a laser to send out light with a specific wavelength to detect glucose in the blood. The laser generates a specific wavelength of light that is absorbed in a stoichiometric fashion by glucose molecules - the more glucose molecules; the more photons are absorbed. The problem is that people are at least 50 percent water which absorbs the light and is not useful for detecting glucose. But our Optical Bridge technology - which has nine issued patents and four pending - negates that background water and increases the signal to noise ratio by a factor of 1,500."
Grove Instruments' product is therefore much more effective than competitors'. But Grove Instruments' product is not yet ready to be sold to the public. As Combs explained, "We have completed a trial at U Mass Medical Center and are starting another trial at Yale University. We will do more trials at Yale, U Mass and other places in 2013."
This would set the stage for FDA approval efforts. "If those trials go well, we should be in a position to begin FDA testing starting in 2014. The FDA has very specific requirements including making sure that we test the exact product we will be selling - instead of a prototype; that we follow Good Manufacturing Practice standards; that we test the product under FDA clinical practice standards; and that we follow FDA design standards. Depending on whether we form a partnership to do this testing, we could complete the FDA approval process in 2015 or 2016," said Combs.
Grove Instruments is burning through cash and needs to raise more. According to Combs, "Throughout the company's history it has raised about $25 million to $30 million. This includes grants from the National Institute of Health and a prize from the Massachusetts Life Sciences Collaborative. I am raising funds now from private equity investors that should last us through June 2014. Wealthy individuals in 12 states are willing to invest because they have a personal connection with diabetes - regardless of the general economic climate."
If Grove Instruments succeeds, the number of daily finger lances by the U.S.'s diabetes patients would plunge below its current 310 million. And that would be a big step in the right direction for non-invasive medicine.
Published on : Thursday, July 25, 2013
Category : Diabetes
Post URL : http://internal-med.blogspot.com/2013/07/258-million-diabetes-patients-need-what.html
No comment to "25.8 Million Diabetes Patients Need What Grove Instruments Is Developing"
Post a Comment