CIO Bulletin

QuLab Medical Ltd — Realizing Personalized Metabolic Profiling

Diabetes is a severe and life-threatening disease. Over time it affects multiple organs, causing kidey and nerve damage, leading to amputations and blindness, among many other serious co-morbidities. For the case of Type II diabetes, most people who are pre-diabetic aren’t aware of disease development and progression and don’t monitor their blood sugar levels regularly. QuLab Medical has leveraged a proprietary silicon nano-sensing platform technology, coupled with MEMS (Micro Electro Mechanical Systems) and data science from the worlds of predictive analytics to provide a holistic monitoring solution helping both diabetic and pre-diabetic. We interviewed Idan Tamir, the CEO of QuLab Medical, to learn more about the company’s vision and the products and services it offers. Here are a few excerpts of the interview:

Q. Tell us what inspired you to start QuLab Medical.

As an entrepreneur with a Ph.D. degree in immunology, I have been involved in the field of diagnostics for over a decade, developing multiple platforms and products for the point-of-care in-vitro diagnostics market. It became evident to me that these platforms require improved test usability by the patients and their healthcare provider and direct and immediate communication of digitized and interpreted test results to both.

In my role as co-founder and CEO of Immunarray I was inspired by the ability of machine learning (ML) to identify unique patterns among data derived from seemingly unrelated biomarkers, generating classifiers that could be used to stratify and diagnose patients suffering from autoimmune diseases, such as multiple sclerosis (MS) and systemic lupus erythematosus (SLE). These classifiers could then be used to better understand chronic disease dynamics and predict disease progression, severity, remission, and relapse phases, thereby promoting improved disease management by the patients themselves.

I was looking for technologies that could take such interactive diagnostic tools to the next level that would not require a lab for their operation but rather be automatically and continuously performed at home. This has led me to identify the core technology that was the basis for creating QuLab Medical. The original concept was developed at the Tel-Aviv University in Israel, where the idea of placing multiple miniature sensors within the dermal tissue was initially speculated.

‘Our vision is to revolutionize diabetes prevention, early diagnosis, and management by delivering a complete solution which will be deeply rooted in users’ individual needs.’ Would you like to elaborate on this a bit more

Absolutely. The current state-of-the-art technology for helping people with diabetes better manage their condition is Continuous Glucose Monitors (CGM). These devices have revolutionized the field of diabetes by providing real-time actionable data for people with Type-I diabetes (TID), allowing the timely administration of insulin to counter increasing glucose levels, helping reduce the time a patient is hypo or hyper-glycemic.

However, we have realized that controlling glucose levels is only part of the challenge for people with TIID, since most of these people concurrently suffer from hyper-insulinemia. This latter condition is caused by increased insulin tolerance, leading to increased pancreatic insulin production and secretion into the bloodstream. We realized that the best solution to help people with TIID cope with their condition would be reducing their insulin and glucose levels in tandem. However, no simple technological solution for continuously monitoring insulin levels was available.

Fortunately, hyper-insulinemia is manifested by its effect on additional metabolites, including ketone bodies. We hypothesized that the use of continuous ketone monitors (CKM) could help people with TIID improve their condition by shifting to a fat-based diet (AKA ketogenic diet) that would increase their circulating ketone body levels. Such a shift is expected to cause insulin levels to drop, thereby preventing hyper-insulinemia. This, in turn, will lead to a more balanced metabolism between sugar and fat – the main energy sources of our bodies.

Interestingly, commercial CKMs are not yet available, and people with TIID rely on fingerstick blood draws to determine their BHB (beta-hydroxybutyrate – the main ketone body in blood) levels, much like blood glucose levels were previously determined. Our vision is to integrate the continuous monitoring of glucose, BHB, and additional metabolites into one chip-based patch platform we have termed Continuous Metabolic Monitoring (CMM), allowing the simultaneous and continuous monitoring of multiple metabolites. Almost anyone can benefit from continuously monitoring their metabolism using a single miniature patch. It would almost certainly help pre-diabetics avoid the slippery slope of TIID progression and may even assist people with TIID reverse their condition, or at least better mitigate its major risks and side-effects.

Q. How does QuLab Medical enable access to continuous metabolic data more effectively?

We are developing the FirstQ™ - a microprobe-based minimally-invasive CMM patch. As a starter, FirstQ will improve patient compliance by avoiding those long needles employed by current CGM for introducing their sensing elements through the skin. Secondly, our FirstQ patch will include all mechanical components required for microprobe insertion, thereby avoiding the cumbersome sensor introducers used by other manufacturers. Moreover, the FirstQ patch will also include the electronics, data transmission, and power modules, averting the need for replacing, disposing of, or reusing different patch elements.

Finally, and most importantly, we will be able to continuously monitor multiple metabolites employing a single patch, leading to an unprecedented amount of data that will be collected, analyzed, and made available to the patient in real-time, along with specific health, exercise, nutritional and medical recommendations. Our strong belief is that our CMM patch will help people manage their health more effectively, delaying or even reversing chronic diseases.

Q. Nanotechnology is an astonishing field. How’s QuLab Medical reinventing proprietary silicon nano-sensing technology?

We think that the future of medicine lies, at least partially, in wearable devices that would continuously monitor multiple physiological parameters and signals, analyze them, and send this analysis to the patient and healthcare provider. This will expand remote patient monitoring capabilities, shifting patients away from hospitals and clinics to their homes for ongoing/chronic healthcare administration and management. A significant enabler for realizing this much-awaited shift in healthcare provision is the biochip – a marriage between miniaturized electronic and biological components and systems. The ability to manufacture such biochips relies heavily on recent advances in nanotechnology, especially regarding the design and scaling-up of seemingly contradicting methodologies while overcoming material incompatibilities. QuLab Medical has filed for several patents in this area and has partnered with leading chip fabs to ensure the manufacturing scalability of its proprietary technology.

Q. Will your company be expanding, bringing on any new products or services that we should be aware of?

There are many different healthcare applications we are looking to expand into once our product platform has matured. Furthermore, we believe that the wellness market is also ripe to benefit from our FirstQ patch. There is still a long way ahead of us to fully realize our vision. We are in the process of raising our Series A round to help us move forward quickly.

Q. Where do you stand as a company in the current market landscape? And what are you doing to stay ahead of the curve?

This is probably our biggest challenge since there are already several mammoth companies dominating the CGM field that share at least part of our vision. Our strategy for moving forward is by carefully selecting and collaborating with strong industrial partners to complement our in-house technological development efforts while securing our proprietary core technological advantage.

We believe that this will provide us with both the required complementary know-how and infrastructure to scale up our fabrication processes into affordable industrial manufacturing. The next step will be identifying and contracting the right commercial partners having a global market reach for thecommercialization of our products and solutions.

About the CEO

Idan Tamir is the Founder and CEO of QuLab Medical Ltd. In this role he has identified and patented a novel electrochemical sensor platform based on a unique field-effect-transistor (FET) technology. He has also championed chip fabrication scale-up from basic research to a fab process. As the CEO of RAD Biomed, he has founded multiple start-up companies and helped entrepreneurs start others, leading to several notable exits and successful IPOs. Tamir has received his Ph.D. in Chemical Immunology from the Weizmann Institute of Science and held managerial and founder positions at BMT Diagnostics, Virginia Life Science Investments, Immunarray, Xenolith Medical, and other medical device and healthcare companies. He has been a Senior MBA course Lecturer at the Faculty of Industrial Engineering and Management, Technion – Haifa, and is also an author of fifteen peer-reviewed papers and several patents.