Interview by Kym McNicholas, The Way To My Heart

As part of our ongoing Vascular Innovation Series in conjunction with The Way To My Heart, journalist Kym McNicholas interviewed DermaFlow CEO and Board Member, Irene Jaffe, Ph.D. DermaFlow develops a non-invasive proprietary technology to monitor and stimulate the peripheral blood flow. Dermiflow’s Perivasc and DermVasc are currently limited to investigative use.

U.S. Congressional Representative Donald Payne is emphasizing the importance of early detection for Peripheral Artery Disease, clogging of arteries with plaque that can lead to amputation, which will benefit companies such as DermaFlow which have screening technologies. Representative Payne introduced the Amputation Reduction and Compassion (ARC) Act in October of 2020, which would allow Medicare or Medicaid beneficiaries who are at risk for Peripheral Artery Disease (PAD) to get their PAD screening covered without any cost-sharing requirements. The theory behind this legislation is that early detection will lead to early minimally invasive treatments and ultimately prevent needless amputations, especially in the most vulnerable communities where African Americans have the highest limb loss rates. The sooner the better. That is where Dermaflow could thrive.

Dermaflow has developed a technology that could help reveal the earliest signs of PAD, which impacts 1 in 20 people over age 50. Dermaflow CEO and BOD member Irene Jaffe, Ph.D. shares the backstory behind Dermaflow, its products, their potential impact, and commercialization plans.

What is the story behind the technology? Where did it originate?

DermaFlow CEO Irene Jaffe, Ph.D.: The initial brainchild behind Dermaflow is Ilya Skoletsky, who immigrated to Israel in the early 1990’s from the former Soviet Union, together with nearly a half-million other Soviet immigrants, many of whom were scientists, engineers, mathematicians, etc.  With that movement, an age of technological incubators was born with significant funding from the government, to not only provide employment funds for this substantial immigration, but also to push innovation and invention of products in a way that was just becoming well known in the Western World.  Ilya, an Electronics Engineer and Information Specialist decided to join one of those technological incubators and start a company.

Ilya spent most of his career on electronic measuring systems in heavy industry, namely the oil industry which had been a dominant industrial player in his native Baku, Azerbaijan. But in starting a new life with his wife and son in a new country, he felt it was time for a new career direction, one with meaning and impact. So, he decided to marry his experience in electronic measuring with his fascination of medical devices, especially those which could impact chronic conditions.  His early work was mostly directed to initial prototype development and proof of concept, there was no one application focus at that time.

These developments and technological platform eventually morphed into DermaFlow , founded in 2011 in New Jersey USA, with a mandate to perfect a measuring or monitoring technology which could accurately, routinely and inexpensively monitor the peripheral blood flow, sometimes also known as skin blood flow or dermal blood flow.  This is the blood flow in capillaries, the smallest blood vessels, as part of the microcirculation in the body. 

I met Ilya during his time in the technological incubator when I was introduced by the Incubator’s director and asked to give a general evaluation of the technology. I felt that the technology had a huge potential but needed to be effectively channeled towards meaningful marketable applications.  Though I kept in contact with Ilya, I was then recruited by another medical startup company with whom I worked with for quite a number of years.

In 2011, we felt that non-invasive physiological healthcare monitoring was trending in and beginning to blossom, and Ilya, myself and a third co-founder, Jim Kleinburd, who had been an investor in the incubator company, decided to found DermaFlow.  I joined the team as CEO to drive the technology forward, selecting appropriate applications, coordinating clinical studies and partnering and working on investment with Jim Kleinburd as Chair BOD. Ilya has remained as our Chief Technology Officer to date.

What need does it address?

Peripheral blood flow is essential to healthcare and wellness, as its vital role is to provide the over trillion cells in your body with nutrients, oxygen and remove cellular wastes.  Without this, an individual could not survive, as his/her cells and organs would simply collapse and die.  When peripheral blood flow is not sufficient or impacted otherwise negatively, that is the point that health deterioration sets in.  To be able to monitor the peripheral blood flow and correlate its changes to a specific disease state or health condition provides a HUGE advantage for early detection of deterioration over a broad medical platform.

Peripheral blood flow changes can indicate a variety of chronic conditions including some cancers, organ dysfunction, wound healing, overall vascular health etc. DermaFlow’s challenge was to select an initial healthcare use case which could be readily translated into a commercializable product(s) and for which the need(s) was clear, significant, and provided a substantial market.  Timely market readiness and acceptance were key.The earlier incubator company Ilya founded, in retrospect, was ahead of its time, as changes in healthcare monitoring trends especially in the home or remote area, but also in certain clinical areas were due to occur, but not  yet readily present. That time has certainly arrived now.

About 2 years ago, DermaFlow made the decision to focus in the vascular area, specifically Peripheral Artery Disease. Together with that, our company created new and complementary Intellectual Property that developed methodology to be used together with our suite of Perichek™ devices and sensors that we had evolved which are designed to be integrated into patient monitoring equipment in hospitals and clinics as well as in home remote monitoring equipment. With the development of the Perichek devices and sensors we conceptualized the DermaVasc vision, which is a combination of non-invasive DermaFlow technology and non-invasive TENS stimulation followed by measurement of lower limb peripheral blood flow, which made it easier and more sensitive than other current methods to differentiate between insufficient blood flow in the lower limbs in a way that healthy, pre-PAD (i.e. early PAD) and PAD legs could be detected.  Insufficiencies in peripheral blood flow in the legs, could mirror early peripheral vascular deterioration which may lead to PAD. 

What is the potential for patient impact? 

With the early clinical demonstration of the utility of the DermaVasc concept for PAD, we realized that we could impact two major areas for patients:

a)      Routine Clinical screening outside of the vascular clinic, i.e. GP or podiatrist offices/clinics;

b)      Home/remote patient monitoring.

In the burgeoning remote patient monitoring field, we realized DermaVasc and Perichek™ could give PAD patients and non-diagnosed but susceptible individuals a tool that would allow them to be more responsible and more cognizant of their vascular health status and how implementing lifestyle changes may affect that.  In addition, PAD patients that have undergone interventions such as stents placed in their legs, may then continue to monitor themselves at home. DermaFlow also notes implications of their monitoring technology for critical limb ischemia, namely the diabetic foot inclusive of ulcer formation and overall compromised foot and leg circulation.  Namely, the possibility of having quantitative comparative measurements versus qualitative clinical observation.

The story of impact has become personal for our entire team as Ilya’s wife, Ina, was diagnosed with Peripheral Artery Disease during this journey. When we developed DermaVasc, Ina had recently been diagnosed with PAD in her right leg.  That led her to be our first PAD subject in our internal proof of concept clinical study.  At the time she had been told that while her right leg was diseased, her left leg was healthy.  We were able to prove otherwise. We applied DermaVasc, and showed that while her left leg was “healthier” than her right PAD leg, it nevertheless was NOT healthy, and fell in the category we call “pre-PAD”.

Where is the technology in development and what is next for the company?

DermaFlow, though still an early stage, pre-revenue company, nonetheless has already developed a product line, Perichek™, which includes sensors both disposable and reusable, and devices with one sensor which can be modules for embedding into other devices or a handheld form, or a portable table-top version, Perichek Multi™ with multiple sensors for simultaneous monitoring.  We are working on a patch type of wearable, Perichek Patch™ which will be Blue-Tooth-enabled, and have appropriate software for smart devices (i.e. cell phones) but also for PCs.  These are yet to be commercialized but we believe the home monitoring product can be launched in a very timely fashion.

DermaFlow has created Intellectual Property including patents both regarding its technology and use cases. DermaFlow also has a host of early clinical work and trials under our belts in a variety of different application areas including, of course, our current focus area, the vascular space.

What is next for DermaFlow? We have many plans. First, we will augment and continue our vascular clinical studies which will be used to submit to the FDA/CE Mark for approval. Upon sufficient data accumulation of our own, and complementary data from other vital signs, biomarkers and correlative ABI, CVD measured values we plan to work with Machine Learning Algorithms and AI to develop sophisticated software to heighten capabilities towards early early disease prediction and prevention. Second, we will engage further partners (i.e. TENS or other appropriate MedDev companies) especially those with whom we can launch to the home markets as early as possible. Third, we will continue to work with advocacy partners and collaborators, i.e. Vascular Cures, to ensure our innovation is reaching patients and physicians, which will facilitate market entry. Lastly, and importantly, to make all our efforts scale, DermaFlow is currently raising equity funding in order to allow our future plans to proceed and become a reality; market presence and patient benefit being primary goals. 

How can patients or advocates get involved?

We have already started on the road to increased advocacy with our recent ties to Vascular Cures, dialogues with Vascular Clinics, and Key Opinion Leaders in the vascular space, i.e. Dr. David Armstrong from Keck School of Medicine, University of Southern California (USC), has just recently joined our Medical and Scientific Advisory Board.  We plan to continue down that path and onboard other key advisors and partners.

We always welcome patient dialogues, as they keep us on a desirable and necessary learning curve.  Serving their needs is of utmost interest to us.  Even today, patients can contact us via our website, and I am hoping for more of that as time goes by.  I absolutely love the surprise calls from patients who have found our website and as I field the calls, I get to learn more about their needs. This constantly serves to affirm our goals and truly inspires me to know we are on a journey towards significant impact on REAL people. However, we also plan outreach programs through traditional media and social media channels as well as through grassroots affiliations to allow us ‘meet and greets’ with patients for continued productive discussions that could influence future products. We are currently working with the non-profit, “The Way to My Heart”, on some of these aspects to obtain direct patient  feedback and allow them to fuel our efforts going forward. We believe strongly that in order to have impact at-scale we need to host a team effort that necessitates inclusion of patient engagement.

Anything else we should know?

DermaFlow was founded by three passionate innovators and entrepreneurs, myself, Ilya Skoletsky and Jim Kleinburd, who all bring different skillsets to the company, spanning biomed innovation, engineering and innovation and financing strategy.  All three founders have “skin in the game” and invested our own financial resources to arrive at where we are today. Again, DermaFlow is currently raising equity funding in order to allow our future plans to proceed and become a reality; market presence and patient benefit being primary goals. 

We and the rest of the DermaFlow team are passionate about bringing our innovations to PAD patients, ultimately helping to save lives and limbs, and working with others to elevate the field of vascular medicine to the next patient-centric dimension and thus contributing to the reduction of the vast annual expenditure in the vascular field which now tops $21 Billion in the US alone. We feel this is not only possible, but is very timely.

Important Note: Health-related information on this page, including text, graphics, images and other material is for educational purposes only and is not intended to be a substitute for professional medical advice, diagnosis or treatment. All opinions discussed in the PAD Facebook Group and Online Community are solely at the discretion of the administrators and community members and participants.  

To learn more about Vascular Cures’ Patients as Partners Program, please visit: https://vascularcures.org/patients-as-partners/ 

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