Americans with diabetes have been relying on insulin injections to manage their illness for decades. Those injections can be painful, expensive and inconvenient. The daily invasive testing regimen adds to that pain and inconvenience.
But new developments from companies such as Novo Nordisk A/S NVO, Rockley Photonics Holdings Ltd RKLY, Movano Inc MOVE and Know Labs Inc. KNWN are reportedly on the verge of changing the game for those dealing with diabetes.
The U.S. Food and Drug Administration (FDA) recently approved Rybelsus, also known as oral semaglutide, which controls blood sugar in Type 2 diabetes patients. Novo, which developed Rybelsus, has not revealed what the pill would cost. Still, the company claims it is committed to working with health insurance providers and pharmacy benefit managers to increase patient access. Novo is not yet done and is awaiting more guidance from the FDA on a second Rybelsus indication — reducing the risk of cardiovascular issues in Type 2 diabetes patients.
The price of insulin products has been soaring with Novo, Eli Lilly and Co. LLY and Sanofi SA SNY controlling most of the world’s nearly $30 billion insulin market. Ninety percent of commercially insured patients with Type 2 diabetes are prescribed newer versions of insulin that are more effective and more accessible to administer than the costlier versions. Insulin prices have risen more than 15% across the board in the last 10 years.
Newer versions of insulin retail for between $175 and $300 per vial, but several moves have been made in the commercial sector to address affordability. This includes insurance company Cigna Corp.’s CI pharmacy benefit Express Scripts division announcing a new program that caps out-of-pocket costs for patients with diabetes at $25 per month.
Beyond the cost and availability of insulin is the issue of invasive or minimally invasive blood glucose diagnostics, which is also seemingly on the verge of change due to companies like Seattle-based Know Labs.
The company says its Bio-RFID™ technology uses radio-frequency spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. The technology can be integrated into various wearable, mobile or bench-top form factors. That would make it possible to effectively identify and monitor biomarkers that could only previously be performed by invasive, expensive and time-consuming lab-based tests.
Know Labs recently announced it was granted two new foundational patents for its proprietary Bio-RFID™ technology. The patents allow the company to protect its ability to create and use any database built with data captured through its noninvasive sensors. The Company believes this widens its technological gap to others pursuing non-invasive diagnostics, such as Movano and Rockley.
Know Labs believes it could become the first company to bring an FDA-cleared noninvasive glucose monitoring device to market. It is conducting a 200-person internal clinical trial of Bio-RFID, which will help refine its algorithm and confirm its Bio-RFID accuracy. This could be a significant milestone towards regulatory clearance and ultimately product commercialization, potentially changing the lives of millions worldwide.
For more information on Know Labs, Inc., visit www.knowlabs.co.
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