Compared to blood plasma and serum, Interstitial Fluid (ISF) is largely an underutilized biofluid that could provide a new source of biomarkers for routine clinical monitoring and testing. The currently available tools that provide access to ISF include suction blister, microdialysis, microfiltration, and open flow microperfusion. These techniques, however, fail to extract ISF with all its native components and produce only a small fraction of the total ISF when diluted in an aqueous or organic solution.
Capitalizing on the diagnostic and prognostic possibilities of the ISF, Kiffik Biomedical has designed a novel medical device based on years of research, development, and testing. “Our patented technologies—that can be used together or independently— allow continuous, real-time monitoring of the ISF biomarkers, offering nearly limitless potential to advance the science of medicine,” says George Cagna, President and CEO, Kiffik Biomedical.
The Kiffik Electroporator and Extractor are compact, wearable devices that offer sustained, continuous, and non-invasive access to 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 microopenings through the epidermis. Once the microopenings are created, the device uses negative pressure to extract ISF at a low-flow rate. Kiffik Biosensors then detect both systemic and localized biomarkers. Though designed to be worn within a convenient, comfortable wristband, the technology could be applied to other areas of the body.
Kiffik is working on a model where the device can be shipped to patients, who wear it and continue with their activities while the extraction is in process. Once the fluid is collected, they send it back to the lab, stored in the device. The lab can then remove the cartridge from the device and examine the ISF for diagnosis.
The science and patents that support the diagnostic device have also demonstrated potential for therapeutic applications via transdermal drug delivery. By reversing the polarity, drugs could be administered through the same epidural pores used for ISF extraction. The technology can potentially facilitate drug delivery at an intercellular level, which will bring revolutionary changes in the treatment of cancer and further oncology researches.
During extraction, the embedded biosensor takes readings and sends alerts to a patient’s phone to avoid potential emergency situations. A variation of the device is being developed for more specific sports applications. Kiffik is in discussion with Olympic committees and European professional football teams. Currently, Kiffik is preparing for FDA regulatory submission, as well as seeking regulatory approval in several other countries.
For the road ahead, Kiffik is seeking licensing partners to deliver their next-generation, continuous glucose monitoring system. The company is also engaging with the University of Texas for studies on potassium and creating biosensors that can be embedded in their devices.
Our patented technologies allow continuous, real-time monitoring of the ISF biomarkers, offering nearly limitless potential to advance the science of medicine
Kiffik is also advancing the research toward artificial kidneys. ISF will be filtered and returned back transdermally, replacing the need for dialysis. This mode of filtration can be further developed into an implantable device that can function as an artificial liver, as well.
The transdermal drug delivery system can also be extended to treatment applications in Parkinson’s and Alzheimer’s diseases. Plaque from cerebrospinal fluid that drains into the ISF can be removed through transdermal extraction. “Kiffik is not just changing the future of health monitoring—we’re accelerating the future of healthcare,” says Cagna.
KIFFIK Biomedical Secures Strategic $50 Million Capital Commitment from GEM
Thursday, October 12, 2023
KIFFIK Biomedical secures a pivotal $50 million investment from GEM Global Yield, positioning the company as a 'Unicorn-in-Waiting' and bolstering its revolutionary MedTech solutions for remote patient care and clinical diagnostics.
PROVIDENCE USA based KIFFIK Biomedical, Inc. today announced securing a strategic $50 Million investment commitment from GEM Global Yield LLC SCS ('GEM'), the $3.4 Billion, Luxembourg based, private alternative investment group with offices in Paris, Bahamas and New York. GEM manages a diverse set of investment vehicles focused on emerging markets and has completed over 550 transactions in 72 countries.
According to the agreement, GEM has committed to providing KIFFIK Biomedical Inc. with a Share Subscription Facility of up to $50 million for a duration of 36 months, commencing upon the public listing of KIFFIK Biomedical's common stock. Additionally, as of 2023, KIFFIK Biomedical's valuation has surpassed $185 million, positioning it as a prospective Unicorn with secured capital upon its NASDAQ listing.
KIFFIK Biomedical will have full control over the timing and the maximum number of drawdowns allowed under this facility, and there is no mandatory minimum drawdown requirement. In conjunction with the public listing of KIFFIK Biomedical's shares, the company will also grant warrants to GEM, enabling them to acquire up to 4.9% of its common stock.
With this funding secured, KIFFIK Biomedical's total funding commitment now amounts to $58 million, underpinned by the recent valuation of $185 million. This significant investment commitment sustains the fundraising momentum established through previous successful investor rounds in 2022.
"KIFFIK Biomedical is proud to announce a revolutionary technology that promises to transform the clinical diagnostic space and remote patient management," says KIFFIK Biomedical President & CEO George Cagna. "The global healthcare landscape is evolving rapidly, and our innovative solutions are poised to address critical challenges such as reducing healthcare disparities, enhancing medical compliance and improving the overall quality of patient care. The result of which has the potential to significantly reduce healthcare costs and help drive equality initiatives worldwide."
KIFFIK's patented platform will disrupt current MedTech markets by offering real-time insights and personalized care in a way that was previously unimaginable while allowing healthcare professionals to fully diagnose, monitor, and more extensively treat patients remotely. Mr. Cagna further adds, "This breakthrough comes after years of research and development, and we remain committed to pushing the boundaries of what's possible in remote patient care and clinical research."
KIFFIK Biomedical is actively partnering with healthcare institutions, research organizations, biosensor developers and global MedTech companies interested in further developing and deploying KIFFIK's breakthrough technology.
For inquiries and collaborations, please contact: deanna.dammers@kiffik.com
This strategic investment round was led by Jawad Farooq, Chief Investment Officer for KIFFIK Biomedical. Speaking on this historic occasion Jawad stated "This is a momentous milestone for KIFFIK Biomedical and its visionary team. By securing this strategic investment commitment of $50m from GEM Group, KIFFIK Biomedical secures its slot as a "Unicorn in Waiting" with certainty of capital upon listing on NASDAQ. This is a quantum leap for KIFFIK in its journey to become a MedTech leader and lights the path for a new wave of inventions in this fast-developing ISF industry." Jawad is a serial entrepreneur with number of successful startups with potential to become unicorns. He has raised over $150m in institutional funding and is widely published in global press including Forbes, Bloomberg, Yahoo, Business Insider, Associated Press.
Deep Dive
Biomarker Access Depends on Repeatable Biological Sampling
Biomarker measurement has advanced faster than access to some of the biological material researchers want to study. Interstitial fluid, which surrounds cells throughout the body, can contain molecular information that complements blood, yet obtaining it repeatedly has remained difficult. For executives assessing biomarker access technology, the procurement tension sits here. A method may expose useful biology, but its research value narrows if collection is invasive, technically demanding or difficult to repeat at the frequency a study requires.
Collection practicality deserves close scrutiny because longitudinal research changes the demands placed on sampling. Suction blisters, microdialysis and microneedle-based approaches have contributed to ISF research, but historical methods can involve tradeoffs in invasiveness, collection time, technical complexity and sample volume. A prospective technology should be examined for how the collection fits into repeated study protocols, including the burden placed on participants and research staff. Repeatability is not just a convenience when the scientific objective is to observe biological change across hours, days, weeks or longer periods.
Biological relevance is equally important. ISF and blood are physiologically connected but distinct, which makes substitution a poor basis for evaluation. The stronger question is whether access to ISF adds useful visibility for the biomarkers and applications under study. Signals originating in tissue can change before they are ultimately measured in blood because dilution, degradation and other biological processes may affect concentration or timing. Executives should examine which analytes can be accessed and how reliably samples support downstream measurement. They should also determine whether the resulting information complements existing specimens rather than duplicating them.
Study design also depends on whether an access method can move beyond isolated sampling. Many biomedical datasets still capture biology at discrete moments, even though disease progression and therapeutic response unfold over time. More frequent molecular measurement can give researchers a different view of change between conventional collection points. Procurement teams should assess whether a technology supports the sampling cadence required by the intended protocol and whether that cadence can be sustained without introducing collection procedures that undermine participation or study execution.
“KIFFIK Biomedical’s K-EXP platform is designed to enable repeat, non-invasive access to ISF, creating a practical route to longitudinal molecular information without relying on episodic collection alone.”
The downstream use of collected material matters just as much as access itself. Biomarker discovery, drug development, therapeutic monitoring and precision medicine can place different demands on collection frequency and molecular analysis. Data intended for computational models adds another constraint because useful longitudinal datasets depend on consistent access over time. Buyers should connect the sampling method to the scientific question before judging the breadth of application.
KIFFIK Biomedical’s K-EXP platform is designed to provide non-invasive access to interstitial fluid for research and clinical applications. The platform is designed to enable repeat, non-invasive access to ISF, creating a practical route to longitudinal molecular information without relying on episodic collection alone. Its development path also advances toward continuous ISF access and monitoring. That approach addresses the central procurement constraints around collection burden and repeatability while opening access to a biologically distinct fluid that can complement blood-based measurement. Select clinical partner programs are planned around the platform, with clinical devices slated for the second half of 2026. For organizations whose studies depend on repeated ISF collection and longitudinal biomarker data, KIFFIK merits consideration as a biomarker access technology provider.
This device is not FDA approved. For investigational use only.
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