“At Kiffik, we have developed novel technology that allows completely non-invasive access to interstitial fluid that fits in a wearable, connected device capable of transmitting health data from nearly anywhere in the world.”
Interstitial fluid is a vital, yet often forgotten part of our anatomy. In the human body, vital fluids reside in basically three different areas. The first is inside the cells or the intercellular space, the second area is inside the circulatory system and branching blood vessels, and the third resides in the space outside of cells. In this last area, in the extracellular space, you find interstitial fluid (ISF). ISF plays a major role in delivering key nutrients and expelling cellular waste to and from the cells via the circulatory system, but gaining access to this vital part of our anatomy has been incredibly complex and challenging, until now.
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 Extractors. 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 potential for future therapeutic applications via transdermal drug delivery.
The Kiffik Electroporator and Extractor is a compact, wearable device that offers sustained, continuous, and noninvasive access to interstitial fluid (ISF). 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.
The development of this innovative technology to further explore both human and animal ISF is the “engine” behind Kiffik Biomedical’s market strategy and future success. This strategy includes exploring options to license their intellectual property to companies interested in wearable technologies and to develop new personal health monitoring platforms while speeding up the development of medical and life science solutions for various disease states.
For the first time, extraction of bio-rich ISF with all its components will be available for multiple health scenarios. 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. Biotechnologists will have the opportunity to produce antibodies, other therapeutic molecules, and therapeutic cells such as lymphocytes. Companies exploring pharmaceutical drug development in preclinical through phase-3 studies will benefit from this technology too. It has the potential to be quite the game-changer for the healthcare industry, and it’s one which the team is determined to see used for the benefit of as many people and animals as possible.
ISF can help clinicians, researchers, and biopharmaceutical developers overcome the limitations of plasma and serum monitoring. Many decisions in drug development and clinical practice are based on measuring blood concentrations of endogenous and exogenous molecules. Yet, most biochemical and pharmacological events take place in the tissues represented by the ISF. Moreover, with few notable exceptions, most drugs exert their effects not within the bloodstream, but in defined target tissues. Therefore, plasma drug profiles are frequently inappropriate for predicting pharmacodynamic and clinical outcomes. Instead, it is often the ISF in the surrounding tissue space that is most closely related to the site of action, or biophase, of the drug.
By completing the process of researching and prototyping their idea, Kiffik Biomedical has pushed open doors into a world of exciting opportunities. The next stage of commercializing Kiffik’s technology has already begun, with engineering for a final design well on its way. This phase of product development is being done in preparation for FDA regulatory submission. The US is not the only region which is likely to benefit from the work the team has done, however. Kiffik Biomedical is seeking regulatory approval in several countries around the world with research opportunities already being explored both in the US and in Europe.
The growth of new ideas for this incredible technology is only possible thanks to an approach which considers collaboration a boon. Instead of performing all their work in-house, the Kiffik team has made it a priority to hold discussions with like-minded organizations that have resources and strategic goals that align with their technologies and capacities. Finding the right leader organizations to work with is understandably a priority, as this will provide the impetus for the next several phases of development and growth. To make sure that Kiffik Biomedical remains at the forefront of what the industry has to offer, the team is focused on collaborating with and engaging highly-experienced and well-connected individuals and companies.
“One possible collaboration we foresee is in working with companies focused on diabetes and chronic kidney disease (CKD). Because our process can be sustained for extended periods and continuous testing intervals lasting up to three weeks, we have successfully analyzed the concordance of measurements between glucose concentrations in drops of extracted ISF and drops of capillary blood from fingers. Beyond monitoring, our technology can provide the foundation for the future development of a wearable artificial kidney,” George Cagna said.
The secret to Kiffik Biomedical’s future success will come from the disruptive nature and impact their technology will have on the healthcare industry. Not only will it have an enormous impact on the way the scientific industry operates, but it will open a door of opportunity that hasn’t been seen before. By partnering with organizations that will benefit from their advancements and attracting the best industry talent, the team hopes to accelerate this incredible achievement and push the boundaries into entirely new areas. 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—it’s accelerating the future of healthcare.