Sky Medical Technology Submits IPO Prospectus for Its Breakthrough 10g Wearable Neuromuscular Stimulator geko™

Blood is a living fluid and serves as the body’s super logistics system. Blood clots that cause embolism act like “boulders,” slowing or blocking normal blood flow, and may even detach and travel through this circulatory system to other organs. Currently, venous thromboembolism (VTE), together with myocardial infarction and stroke, is recognized as one of the three major cardiovascular diseases.

Venous thromboembolism (VTE) is known as the “silent killer.” Once symptoms manifest, deep vein thrombosis (DVT) or pulmonary embolism (PE) has already occurred. According to statistics from the International Society on Thrombosis and Haemostasis (ISTH), there are nearly 10 million cases of VTE globally each year, with 60% of these cases occurring during hospitalization or after discharge.

For instance, following transplant or orthopedic surgeries, patients are in a hypercoagulable state and have limited mobility, which increases the risk of venous thromboembolism (VTE). The treatment and care of stroke patients carry similar risks. Therefore, both inpatient postoperative care and post-discharge health monitoring require more convenient and efficient approaches to reduce the incidence of VTE.

In response, UK biotechnology company Sky Medical Technology (hereinafter referred to as Skymedtech) has developed the geko™ neuromuscular electrical stimulator, which integrates OnPulse™ muscle pump activation technology, to prevent and treat conditions such as venous thromboembolism (VTE).

Deep vein thrombosis (DVT) is a common complication following fracture surgery. In severe cases, thrombi may detach and travel upstream to the pulmonary arteries, causing pulmonary embolism—a critical condition that can lead to sudden patient death. Sky Medical Technology aims to “revitalize” the blood transport system through electrical stimulation. By mimicking muscle contraction and relaxation, it acts as a substitute for patient movement, thereby preventing blood clots from causing “blockages.”

Skymedtech was founded in 2007. According to Crunchbase data, the company has completed seven rounds of financing, reaching its Series B round, with a total amount of $59.6 million. Skymedtech was selected by the UK Department for Business and Trade as a 2023 UK Life Sciences Innovator.

According to data from the Skymedtech official website, Skymedtech has obtained FDA approval and currently holds more than 175 registered patents. The treatment duration for the latest version of the geko™ device has been increased from two 12-hour sessions in the previous version to two 24-hour sessions, allowing patients to wear the geko™ overnight without needing to replace it.

In a clinical trial conducted in collaboration between Sky Medical Technology and the Stroke Centre at Royal Stoke University Hospital, the VTE incidence rate was 1.5% among patients wearing geko™, compared with 6.6% among those not wearing it.

In addition to the prevention and treatment of VTE, geko™ has also been proven to reduce postoperative edema, heal venous and arterial leg ulcers, and treat other chronic wounds.

Among them, Sky Medical Technology published a multicenter randomized controlled trial (RCT) in the International Wound Journal. The trial results showed that patients with venous leg ulcers (VLU) treated with the geko™ device healed more than twice as fast as those receiving standard care alone.

As early as 46 AD in Rome, physicians used electric shocks from torpedo rays to alleviate patients’ gout. Today, the bioelectronic medicine market is projected to reach $60 billion by 2029 (according to CBRE Research data). Bioelectronic medicine is transforming modern healthcare delivery, with innovators in medical devices increasingly applying “electrical stimulation” technology to the treatment and care of various patient conditions.

Existing Neuromuscular Electrical Stimulation (NMES) therapies are broadly categorized into three types, with clinical outcomes primarily determined by the parameters of the therapeutic devices. Traditional NMES therapy typically stimulates only a single muscle at high intensity, which often causes physical discomfort to patients.

Electrical Stimulation Therapy

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The OnPulse™ platform, a muscle pump activation technology developed by Skymedtech, differs from other forms of NMES.OnPulse™ utilizes low-frequency neuromodulation that mimics the body’s endogenous neural signals, with motor nerves serving as the targets.

OnPulse™ stimulates the lower leg nerves by delivering low-frequency electrical currents transcutaneously via non-invasive skin electrodes (conductive hydrogel) placed over the common peroneal nerve, thereby activating the tibialis anterior, peroneus longus, and lateral gastrocnemius muscles. The contraction of these calf muscles facilitates the return of blood from the lower extremities to the heart, thus enhancing venous return circulation.

Stimulated Muscle/Muscle Stimulation

Image source: Sky Medical Technology official website

NMES based on the OnPulse™ platform increases blood circulation by inducing muscle contractions, effectively draining blood from the deep veins of the lower leg.The increased blood flow velocity under OnPulse™ stimulation is equivalent to 60% of the patient’s blood flow velocity during walking.Furthermore, OnPulse™ electrical stimulation does not alter heart rate or blood pressure. These findings have been published in The International Journal of Angiology.

OnPulse™ Muscle Pump Activation Technology, as a clinically validated technology platform, is capable of addressing unmet patient needs across multiple care pathways. The two neuromuscular electrical stimulation devices developed by Sky Medical Technology based on the OnPulse™ platform each offer distinct advantages.

geko™ is a non-invasive, wearable, single-use medical device with a total weight of approximately 10 g,It provides painless neural electrical stimulation at 1 Hz. Powered by batteries and watch-like in appearance, the geko™ device is simply applied to the lower leg during use. It delivers gentle, low-frequency electrical stimulation to the common peroneal nerve, activating the calf and foot muscle pump. This passive muscle contraction increases blood flow in the deep veins of the lower leg, allowing patients to engage in normal activities without interference while wearing the geko™.

Currently, there are two geko™ products available. The hospital-grade device is primarily used for the prevention of venous thrombosis and the treatment of edema, featuring 11 stimulation modes to accommodate varying patient responses to stimulation. The wound care device mainly prevents and treats edema by promoting blood circulation and facilitating wound healing, with a total of 10 stimulation modes.

geko™, for hospital-based thrombosis prevention (see image above)

geko™, for wound care (see figure below)

Image source: Skymedtech official website

According to the clinical trial results published on the Sky Medical Technology website, geko™ stimulation increased volumetric flow in the superficial femoral vein by 100% (Int J Angiol 2010), increased volumetric flow in the femoral artery by 75% (Phlebology. 2015 June), and increased microcirculatory volumetric flow in the skin of the dorsum of the foot and the posterior thigh by 400% (2014 Journal Vasc Surg).

Comparison Chart of Arterial and Venous Blood Flow (Figure Above)

Comparison Chart of Microcirculatory Blood Flow (Figure Below)

Image source: Sky Medical Technology official website

Sky Medical Technology has now integrated the geko™ device into the UK’s National Health Service (NHS). The device is currently in use at six NHS trusts, with an additional 28 NHS hospitals planning to incorporate geko™ into their prevention and care protocols for post-stroke venous thromboembolism (VTE).

geko™ has also obtained regulatory approvals from the U.S. FDA, the EU CE, Australia’s TGA, and Canada’s MDL. To date, 95% of Sky Medical Technology’s sales revenue has come from exports, with its products sold to hospitals in more than 60 countries, including China, the United States, Canada, and Costa Rica.

Unlike the single-use geko™ device, the portable, multifunctional rehabilitation device firefly™ is reusable. firefly™ operates on the same principle as geko™, delivering small electrical pulses to stimulate the peroneal nerve and induce a gentle foot “flutter,” thereby increasing blood flow. The enhanced blood flow delivers more oxygen and nutrients to the muscles, reducing lactate accumulation and pain.

firefly™

Image source: firefly™ official website

Clinical research data indicate that,firefly™ can triple the recovery speed of professional athletes after exerciseThese findings were published in the 2014 issue of Science and Medicine in Sport. The portable, multifunctional rehabilitation device firefly™ can also alleviate leg discomfort among passengers during long-distance travel by enhancing lower-limb venous return and reducing peripheral vascular resistance. These results were published in the 2010 issue of the International Journal of Vascular Medicine.

The firefly™ device is currently available for purchase on its official website, where consumers can choose to buy the firefly™ device bundled with a fixed knee strap or purchase either product individually.The Firefly™ main unit is priced at $45 per pair.

Firefly™ Sales Page

Image source: firefly™ official website

As a portable rehabilitation device, firefly™ can be used in any setting, including airplanes and buses. The product has currently gained the favor and adoption of multiple Olympic gold medalists and other professional athletes. Notably, earlier this year, firefly™ secured $1 million in investment from five professional athletes.