The Silicon Review
KIFFIK Biomedical is a fast-moving MedTech company that has developed the next breakthrough technology in medicine. One that will have far-reaching implications for all sorts of diseases, drug development, and diagnostics.
“Through our patented technology, we can provide patients with an exact measurement of the molecules found in interstitial fluid (a bio-rich fluid found in the extracellular spaces of the body), which is nearly identical to blood,” said George Cagna, who’s the President and CEO of KIFFIK Biomedical.
Based on years of research, development, and testing, KIFFIK Biomedical, Inc. has developed a novel medical device, which incorporates two patented, distinct technologies: the KIFFIK Electroporator and Extractor. Used together or independently, these technologies offer transformative diagnostic advantages that can accelerate the understanding of chronic disease and the discovery of biopharmaceutical solutions. Additionally, the science and patents that support the diagnostic device have demonstrated the potential for future therapeutic applications via transdermal drug delivery.
The KIFFIK Electroporator and Extractor is a compact, wearable device that offers sustained, continuous, and non-invasive access to the interstitial fluid (IF). The process is painless, non-heat generating, and reversible at the end of the process of extraction, thus leaving no permanent changes to the epidermis of the wearer. The technology works by forming stable micro-openings through the epidermis. Once the micro-openings have been created, the device uses negative pressure to extract interstitial fluid at a low-flow rate. Once extracted, Kiffik Biosensors will be able to detect both systemic and localized biomarkers. The system is designed to be worn within a convenient, comfortable wristband, but could also be applied to other areas of the body.
For the first time, extraction of bio-rich interstitial fluid (IF) with all its components will be available for multiple health applications. This addition to the medical professional’s toolkit opens the door to a range of opportunities. For scientists,physicians, veterinarians, and hospital professionals, there is the chance to perform continuous or periodic monitoring of critical biomarkers that are prevalent in diseases. The information learned from this fluid can help clinicians, researchers, and biopharmaceutical developers overcome the limitations of plasma and serum monitoring.
The challenge to improve remote-patient care starts with identifying tools that can provide real-time remote diagnostics, which can deliver medical-grade results. Physicians rely on verifiable clinical data to make prescription and therapy decisions. To make remote patient management (RPM) work, you need a tool that does not require a healthcare professional to administer and is easy to use. Vitals, such as heart rate, respiration, and temperature aren’t enough, providers need continuous, real-time biological data for accurate decision-making.
The KIFFIK Biomedical Electroporator and Extractor will completely disrupt the remote monitoring industry by eliminating the need for in-person laboratory testing and providing the supporting data physicians must have for clinical decision-making. The device will be small, adheres to any place on the upper or lower extremity, and will comfortably provide access to the body’s bio-rich interstitial fluid which, according to an article published in the National Library of Medicine (https://www.ncbi.nlm.nih.gov/pmc/articles /PMC7871333/) there are over 10,000 biomarkers that were found to be present in the interstitial fluid, 1200 more biomarkers than found in the blood. This bio-rich environment has been virtually inaccessible until now.
KIFFIK Biomedical is on task to deliver a platform that can be embedded with specific biosensors to detect biomarkers present in diabetes, sepsis, or HAIs (hospital-acquired infections), renal and cardiac diseases, the detection of male and female hormones, allergy assessment, cancer, and neurocognitive detection. Over the next 18 to 24 months, KIFFIK will enter a variety of studies including GLP and Non-GLP trials in Q1 and Q2 of 2023. KIFFIK plans on its first regulatory submission for clearance with the FDA, CE, and MHRA governing regulatory bodies for Continuous Glucose Monitoring (CGM), lactate detection, and drug detection devices.
“Our interstitial extraction device can be fitted with hundreds of sensors that can detect and continuously monitor a multitude of disease states. Our goal is to identify different vertical markets that a specific sensor setup will benefit from and then identify those stakeholders interested in owning those offerings. That said, we plan to deliver to the market, three to five vertical opportunities per year over the next 10 years.”
Starting with continuous monitoring for glucose, KIFFIK is working to identify those companies who want to offer their customers a state-of-the-art CGM, one which isn’t invasive, doesn’t require insertion of a needle probe into the skin, or deteriorate in accuracy over time it is implanted. KIFFIK Biomedical has solved the problem with wired penetrating sensors currently offered on the market.
“By pulling the interstitial fluid out of the body before it is measured, we eliminate the potential of ‘bio-fouling’, the buildup of proteins induced by the body’s defensive immune system, which can and does affect accuracy over time. Because there is no insertion of a needle or wires, we eliminate the risk of hitting vessels which can cause ongoing bleeding or injuring nerves due to insertion errors.”
“We, at KIFFIK, will provide the most accurate glucose readings of any remote CGM because we are measuring and calibrating the same fluid. We do not have to perform a blood glucose reading to then calibrate that to the interstitial fluid (IF), the fluid we pull is the fluid we measure. Finally, because there is no deterioration in readings due to bio-fouling, patients get the same quality reading on the first day as they do the last day of device usage (+21days).”
The secret of KIFFIK Biomedical’s future success will come from the disruptive nature and impact its technology will have on the healthcare industry. This is being driven by patient, physician, and industry demand for remote patient monitoring. Not only will it have an enormous impact on the way the scientific industry now has access to a bio-rich bodily fluid, but it will open a door of opportunity that hasn’t been seen before. The world of interstitial fluid opens a greater understanding of how humans can reach better health through continuous monitoring and better diagnostics. It will rapidly expand the understanding of diseases, expand possibilities in preventive medicine, accelerate the discovery and development of new therapeutics, and empower patients to proactively manage their health. These benefits cannot be simply calculated. The possibilities that come with studying interstitial fluid are limitless. Kiffik Biomedical is set to become a major player in the world of life sciences, due in no small part to the team’s ability to offer a product that is unlike anything else on the market.
“The potential applications for our technology are expansive and offer an opportunity to advance many fields of medicine. KIFFIK Biomedical is not just changing the future of health monitoring—we’re accelerating the future of healthcare. Through strategic partnerships and offering a platform that can address multiple vertical markets, we will rapidly expand the understanding of diseases, expand possibilities in preventive medicine, accelerate the discovery and development of new therapeutics, and empower patients to proactively manage their health.”