CLINICAL STUDIES

Numerous researches conducted in the last decade, have shown consistently how the JVR technology makes difference in various clinical trials.

We bring you a small fraction representing the most outspoken of those researches.

Kinetic energy of a liquid jet has been demonstrated to achieve clinical efficacy by injecting hyaluronic acid for skin thickening and improving facial sagging.

A pneumatically accelerated jet penetrates the epidermis leaving HA particles spherically spread in the dermis and initiating microtraumatic wound healing.

Retrospective data showed successful implementation of liquid jet injections of HA in correction of aging middle and lower facial regions.

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Needle-free jet injection implements kinetic energy of liquid jet for transcutaneous delivery of drugs into soft tissues. Combination therapy of intralesional 5-fluorouracil and triamcinolone offers efficacious treatment for keloids with a reduced adverse effect of the drug monotherapy.

This study evaluates safety and efficacy of the drug combination administered to keloid scars via intralesional jet injections.

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Jet Volumetric Remodeling (JVR) utillizes the principle of superficial soft tissue delivery of fluids, such as hyaluronic acid (HA) and other therapeutic materials. Dermal delivery of HA activates fibroblasts increasing collagen and elasting synthesis with a long-lasting dermal remodeling and thickening effect. JVR-injected HA causes immediate and diffuse skin hydration resulting in an aesthetically pleasing aspect.  JVR technology is able to target different layers during the same treatment with only minor side effects.

The article reviews JVR delivery of hyaluronan in comparison to current skin remodeling treatment modalites.

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Alternative to traditional needle injections, jet delivery of HA is needle-free and less dependent on the injector’s skills and experience, therefore associated with much lower rate of adverse events.

This paper reviews the factors optimizing clinical outputs of HA treatment administered by jet injection.

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Many cutaneous drug delivery techniques rely on passive diffusion to deliver topical compounds to the skin. When attempting to deliver drugs to thicker lesions, such as skin tumors, modalities that do not rely on diffusion may serve as a better drug‐delivery method. Needle‐free injection was investigated in 24 ex vivo porcine skin samples and one basal cell carcinoma (BCC) tissue sample. A needle‐free injection device with a nozzle size of 200 μm delivered 80 μl compound ink at low (30%), medium (50%), high (65%), and stacked pressures. Depth, width, and depth of maximum width of ink deposition were evaluated on histological slides. Conclusion: with an electronically controlled, pneumatic needle‐free injector, depth and width of a cutaneous deposition can be influenced by pressure and stacking, respectively. The pneumatic needle‐free injection can potentially serve as a viable drug‐delivery technique for cutaneous pathologies where dermal deposition is essential.

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Three females (ages 61–63) with moderately deep upper-lip wrinkles were treated with cross-linked hyaluronic acid. HA was injected with EnerJet along the upper lip border. Each patient received 3 treatments with 1-month intervals. Results were assessed at baseline, post treatments and 6 months after the last treatment. Baseline conditions of the skin and wrinkles was quantified by 3-D imaging ;  Dermal thickness in the upper lip area was measured with dermal sonography and skin elasticity in the treatment area was determined by Cutometer. All patients tolerated the treatment well, without any injection pain. Post-treatment evaluation showed: a decrease in the wrinkle severity score (LRS) from 3.7 to 2.3, which indicated a reduction in full wrinkle class after JVR therapy, an average skin roughness index lessened in the upper lip by 13.4%, dermis height measured at the follow-up revealed a mean increase by 0.4mm and mean skin elasticity increased post-treatment from 60.0 to 75.6 non-specific units. Jet Volume Rejuvenation (by EnerJet) showed promising results in the correction of upper-lip rhytidosis.

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Initial trial aiming to test the efficacy of Enerjet System was conducteded, looking for a way to provide relief  to patients with hyperhidrosis. Nowadays common practice makes use of BTX injections, commonly known to be painfull and cause future deterrence from further treatments. 11  patients took part in the study. All patients expressed satisfaction with the procedure and with the results, reporting that the injection pain was much lower compared to the control needle injections. Using Enerjet as the delivery system of BTX, replacing syringe injections, indicated improvement in symptom burden and quality of life.

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Dr. Zenker reviewing a few articles about physicians experience with JVR unique technology, in the treatment of hard-to-treat indications such as severe acne scars, red and white stretch marks and wrinkles in large or gentle areas to name a few, while demonstrating the safety and effectiveness of the treatment.  In one study, after treating 20 patients in a time frame of few months, majority of patients showed increase of skin thickness which led to significant improvement in appearance. Other study mentioned in the article found that 83% of the patients stated they will recommend the treatment to friends and family.

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A study in Korea aimed to asses the possibility of treating wrinkles of the dermis by using subdermal minimal surgery technology. 12 participants underwent up to 4 treatments at a 4 week intervals. By using photography of before and after treatments, the study showed improvement of at least 50% of wrinkling after 6 moths in more than half of the participants,  which led to the possibility of using Enerjet to effectively treat neck wrinkles.

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Evaluating the efficacy and safety of skin remodeling by using pneumatically accelerated jet of HA solution under high pressure, was conducted in a study by a group of researchers from Rabin medical center in Petach Tikva and other leading physicians with similar expertise. 34 participants underwent treatments using Enerjet technology for treatment of wrinkles and skin tightness and texture, which was applied to their face, neck, chest and dorsal hands. After treating 69 dermal areas, Photographic analysis demonstrated improvement in skin variables at all body sites treated, while face and neck treatments reduced the mean Fitzpatrick-Goldman Wrinkle Classification score by 39.4% and 30.4% respectively, showing a full wrinkle class improvement.

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In a Period of 6 months the researchers applied 105 treatments to 20 patients using Airgent (Enerjet) while measuring skin thickness using ultrasonography. Within a week after the last treatment, all patients showed increase of skin thickness. The upper lip showed substantiating increase in thickness – 1.3 mm. Six months after the last  treatment, the skin around the eyes showed an increased thickness of 0.77mm over the baseline. The study showed that using Airgent produced increase in skin thickness that correlated with substantial improvement of appearance, so reported the patients.

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This study examined application of Enerjet Technology on Non-surgical Facelift tightening procedure, in wake of an existing expectations for minimally invasive procedures in cosmetic medical treatments. 30 patients in Japan, aged 41 to 69, underwent 3 sessions of treatment at 4-week intervals. pneumatic injections were applied at 5 target sites: 4 along the temporal hairline and 1 at the malar prominence, with the aim of tightening and contracting the subcutaneous layer. As a result, more than half of the patients showed mild to moderate improvement in aging face, especially in the lower face: jawline and marionette lines. The results suggest the potential of pneumatic injection of non-cross-linked HA and hypertonic glucose solution as a novel facial rejuvenation treatment with minimal morbidity and little patient discomfort.

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A worried patient in Korea seeking a cure for a significant Herpes Zoster, was treated with monthly application of subdermal Airgent treatment, with anesthetic cream applied for 3o minutes prior to the treatment. Noticeable improvement was noted after 2 months, followed by a satisfactory patient, after 6 months of treatment. The high-velocity HA particles act as “nano-bullets” as they disturb the dermal healing process is thought to gradually replace the HA particles. This technique might be applied in various fields of dermatologic scars and surgical scars with excellent clearance in an easy and safe manner.

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Acne, a skin condition widely common (seen in almost 80% of the population) can in some cases, result in permanent scars that are difficult to treat with efficacy. 10 Korean patients underwent 3 sessions of Airgent treatments while 2 independent dermatologists evaluated clinical improvement. The results showed Airgent is both effective and safe for improving acne scars, all volunteers were satisfied with the procedure and 3 months after the last treatment session, 2 patients had improvement of greater than 75% in acne scars, 6 had 50% to 75% improvement, and 2 had 25% to 50% improvement. There were no side effects except transient spot bleeding at entry points and slight edema that resolved within 48 hours.

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Human skin tissue was harvested in this ex vevo study, in which Airgent anti-aging effects were tested. After applying UV radiation to the skin in order to induce alterations in middle and profound dermis, a single Airgent treatment was applied .The results showed a staggering 48% increase in collagen synthesis, among other measurable results. The researchers concluded that Airgent is in fact effective for treatment of aged skin.

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EnerJet2.0 utilizes a liquid jet technology for needle-less delivery of various therapeutic materials into soft tissues. Conclusion: Administration of external HA through the pressure jet injection represents a beneficial therapy for improving of post-acne scarring. The therapy raises the skin depression through subcision of the scar and provides additional volume due to the hydrating, filling and lifting effect on the depressed scar tissue.

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EnerJet2.0 utilizes a high-pressure liquid-jet technology. It provides kinetic energy-based administration of various therapeutic materials through spherical intra dermal dispersion.The high-velocity jet injection of EnerJet delivers a short penetration momentum which contributes to a significant pain reduction compared to the manual needle injection.The high-pressure jet injection of EnerJet allows amore controlled and deep penetration through the full thickness of the scar.TheEnerJet-generated jet of liquid therapeutic material forcefully penetrates the scar causing instant blanching of the injected area.

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Patients demand for cosmetic improvement is constantly increasing, with equal concern for efficacy and safety of the treatment.  Safety of EnerJet treatments is determined by two components: safety profile of the injected substance and the safety related to the injection process.

For the last 10 years of active practical use, EnerJet device demonstrated its safety profile. Overall, the safety of the EnerJet treatment injections is determined by the jet’s physical impact on the tissue or is affected by the safety profile of the injected material. This has been verified clinically and histologically with different kinds of injectable therapeutic materials and for various clinical indications. The high tolerability of the treatments adds a further confidence to its incapability of causing damage whatsoever.

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CASE STUDIES

This case report covers six cases which demonstrate the ability of the EnerJet procedure to provide a safe and effective alternative to the treatment of keloids in various anatomical locations. Evaluation was based on visual improvements, palpable improvements, and frequency and level of needle-like pain or itch of ten associated with keloids. Finally a clinical rationalization for the results is presented.

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This report describes the use of jet volumetric remodeling (JVR)technology to treat acne scars in two patients. It performs by pneumatically accelerating a carrier fluid jet containing high-mass molecules of HA into the tissue.

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This report describes the use of jet volumetric remodeling (JVR)technology for non-surgical décolleté rejuvenation. The needle-free system pneumatically accelerates a carrier fluid jet containing high-mass HA molecules into the tissue. The particles spread laterally within the dermis, and simulate fibroblasts to promote the formation of new collagen fibers by accelerating the wound-healing process as well as increasing skin thickness. This technology has developed into a novel therapeutic modality for dermal remodeling procedures involving neck wrinkles, keloids, and scars due to acne or herpes zoster.

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JVR Technology by the EnerJet appears to be safe and effective for both immediate as well as long term skin augmentation and collagen remodeling. It provides significant, measurable increase in skin elasticity with no downtime. It may be applied on patients of all skin types desiring rejuvenation of aging skin on all body sites, particularly on the face, neck, chest and hands.

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This report describes the use of jet volumetric remodeling (JVR)technology for non-surgical facial rejuvenation.The needle-free system pneumatically accelerates a carrier fluid jet containing high-mass HA molecules into the tissue. The particles spread laterally within the dermis, and simulate fibroblasts to promote the formation of new collagen fibers by accelerating the wound-healing process as well as increasing skin thickness.

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JVR treatment using the EnerJet system is a safe and effective modality for treating striae distensae, resulting in a diminished appearance, even after a single session. The treatment is associated with minimal downtime, pain, or side effects. Additional controlled trials including multiple patients, longer follow-up, and different parameters will be necessary to determine the optimal settings for achieving the best clinical effects.

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