Graphwear Secures $20.5M Series B for Needle-Free Glucose Monitor

GraphWear Secures $20.5 Million to Advance Needle-Free Glucose Monitoring

GraphWear, a company dedicated to developing non-invasive glucose monitoring technologies, has successfully completed a $20.5 million Series B funding round. This investment signifies strong investor confidence in GraphWear’s innovative approach to tracking vital bodily metrics, including glucose levels, without the need for skin penetration.

Company Origins and Core Technology

Founded in 2015 by Rajatesh Gudibande and Saurabh Radhakrishnan, both graduates with master’s degrees in nanotechnology from the University of Pennsylvania, GraphWear Technologies is pioneering a new era in wearable sensor technology. The company is focused on creating a skin-surface wearable device constructed from graphene.

The sensor itself is compact, comparable in size to an Apple Watch. However, the core technological component resides on its underside – a delicate graphene layer designed to adhere to the back of the watch or a dedicated adhesive patch for application to the abdomen.

Future Plans and Funding Allocation

According to Gudibande, the funds from this Series B round will primarily support the advancement of the wearable through further validation studies. Specifically, the company intends to complete a pivotal clinical trial and subsequently submit an application for FDA clearance.

Mayfield led the investment round, with additional participation from MissionBio Capital, Builders VC, and VSC Ventures.

Addressing a Significant Need in Healthcare

Ursheet Parikh, co-leader of Mayfield’s engineering biology investment practice, highlights the long-standing challenge in the field: “The primary objective has been to accurately determine blood composition without resorting to skin pricks and blood extraction.” He believes GraphWear has made substantial progress and is poised to be among the first to introduce a product accessible to a vast population.

The Rise of Continuous Glucose Monitoring

Continuous glucose monitoring (CGM) has gained considerable traction within the diabetes community. Several CGM devices, such as the FreeStyle Libre – FDA approved in 2017 – have entered the market. However, these existing devices typically employ a subcutaneous filament inserted under the skin to measure glucose levels.

Impact on Diabetes Management

CGM offers significant benefits for individuals with Type I diabetes, a condition where the body produces little to no insulin. Approximately 1.6 million people in the U.S. are affected by this condition. The American Diabetes Association recommends that individuals regularly using insulin “should be encouraged” to utilize self-monitoring glucose technologies, including continuous glucose monitors, as outlined in their 2020 guidelines.

The utility of CGM for individuals with Type II diabetes (affecting around 34 million Americans) or those not routinely administering insulin is a subject of ongoing discussion. Some argue that frequent glucose monitoring may not be beneficial for these populations.

For instance, a 2017 study published in JAMA Internal Medicine found that routine self-monitoring of glucose did not lead to improvements in A1c levels – a crucial diabetes biomarker – after one year. It’s important to note that this study focused on traditional finger-stick tests, not non-invasive CGM systems.

Nevertheless, the American Diabetes Association acknowledges that, when implemented correctly, CGM, in conjunction with insulin therapy, can be a valuable tool for these individuals as well.

GraphWear’s Innovative Approach

GraphWear’s sensor employs a nanotechnology-based approach to continuous glucose monitoring. Unlike other CGM devices that may require a small filament or finger pricks, this device operates entirely non-invasively, according to Gudibande.

“The graphene creates an electric field that draws molecules upwards,” Gudibande explains.

“We’re dealing with approximately 200 molecules,” he continues. “The sensor then ‘analyzes’ them, converting the data into an electrical signal, which is transmitted via Bluetooth to your smartphone for continuous charting and display of glucose values.”

Measuring Interstitial Fluid Glucose

It’s important to understand that these sensors measure glucose levels in interstitial fluid, not directly in blood. However, the American Diabetes Association’s 2020 guidelines confirm that glucose measurements from interstitial fluid “correlate well with plasma glucose,” making them clinically relevant for diabetes management. Gudibande adds that GraphWear’s own clinical data supports this correlation.

Promising Feasibility Study Results

GraphWear has already completed a feasibility study involving 40 patients with both Type I and Type II diabetes. The device’s glucose monitoring performance was compared to measurements obtained from traditional venous blood draws. While the full results are pending release, Gudibande states that GraphWear’s accuracy was “comparable” to that of conventional sensors.

The Potential of Graphene

Beyond glucose monitoring, the material at the heart of GraphWear’s technology – graphene – holds significant promise. Graphene is a single-atom-thick carbon sheet, renowned for its exceptional electrical conductivity, strength, lightness, and flexibility.

Since its discovery in 2004, graphene has generated considerable excitement, initially touted as a potential successor to silicon. While that prediction hasn’t fully materialized, significant investment continues.

The U.K., China, and the EU are heavily investing in the large-scale production of graphene. Graphene-based products are already emerging in various applications, including bicycles, shoes, sensors, and tennis rackets, as highlighted in a 2019 review paper.

Maintaining Graphene Purity and Scalability

GraphWear has developed a method to maintain the “pristine” condition of the graphene used in its sensors, enhancing its sensitivity to glucose molecules. Parikh emphasizes that the company can also manufacture the material at scale and is exploring new nanotechnology applications beyond glucose sensing.

“The team has patented a method for utilizing polarized fluids as transistors,” Parikh explains.

“When glucose molecules are present on the skin, they act as a transient transistor,” says Parikh. “This represents a novel class of transistor and a fundamental innovation.”

Path to Regulatory Approval

While the focus remains on glucose monitoring, GraphWear recognizes the potential for broader applications. The company believes that a successful pivotal trial demonstrating equivalence to existing CGM devices could pave the way for FDA 510(k) clearance. Gudibande acknowledges potential challenges, including the possibility that the non-invasive approach could place GraphWear in a unique regulatory category.

“There’s a risk associated with that, regarding whether we will qualify for 510(k) clearance,” Gudibande says. “However, the process typically takes between six and fourteen months. Our primary goal is to complete the trials and submit our application to the regulatory body.”

Looking Ahead

If GraphWear successfully demonstrates its ability to measure other biomolecules using its graphene platform, it could expand its capabilities to detect a wider range of substances and continuously monitor internal bodily processes. This Series B funding round, however, is focused on achieving the initial milestone: a clinically validated, graphene-based glucose sensor.