Comparative Ultrasound Visualization Analysis Between Ultherapy® and Ultherapy PRIME and Survey and Clinical Case Results from the Ultherapy PRIME Early Experience Program | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Comparative Ultrasound Visualization Analysis Between Ultherapy® and Ultherapy PRIME and Survey and Clinical Case Results from the Ultherapy PRIME Early Experience Program Jennifer Levine, MD, Alec D. McCarthy, PhD, Tatjana Pavicic, MD, PhD, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6229189/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Microfocused ultrasound with visualization (MFU-V) is a non-invasive treatment for skin lifting and tightening. Ultherapy ® (MFU-V 1.0) and Ultherapy PRIME (MFU-V 2.0) are both MFU-V devices, with the latter being recently developed with enhanced visualization technologies amongst other notable improvements. Thus, we sought to compare the ultrasound visualization components and visual noise reduction capabilities of MFU-V 1.0 and MFU-V 2.0 systems. We also sought to gain insights from clinicians with experience using both systems. Materials and Methods: A comparative analysis was conducted on the ultrasound imaging components of both systems. Screen size, pixel count, and ultrasound images taken with 3.0 mm and 4.5 mm transducers on water blocks were collected and analyzed and visual noise levels quantified. An early user experience survey was sent out to query clinicians on their experience 2 months after switching from MFU-V 1.0 to MFU-V 2.0. Results The ultrasound field of MFU-V 2.0 was 38.14% larger and its pixel density was 91.01% greater than MFU-V 1.0. Visual noise reduction in MFU-V 2.0 was significantly reduced by up to 72.02% using new transducers and up to 64.04% using used (at least 1400 lines) transducers. Nine clinicians having treated 68 patients with MFU-V 2.0 noted an average treatment time reduction of 19.7% and reported high degrees of satisfaction with the improved visualization, ergonomics, ease of use, and intuitiveness of MFU-V 2.0. Conclusion MFU-V 2.0 significantly enhances ultrasound visualization quality and reduces visual noise compared to MFU-V 1.0. Clinicians noted a reduction in average treatment time and broad system improvements with MFU-V 2.0. These improvements facilitate faster and more precise targeting during treatment potentially leading to enhanced clinical outcomes in skin lifting and tightening procedures. Level of Evidence Not applicable preclinical Dermatology Ultherapy Ultherapy PRIME MFU-V ultrasound visualization microfocused ultrasound skin lifting skin tightening Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Introduction Ultherapy (MFU-V 1.0) has become a widely recognized non-invasive, microfocused ultrasound with visualization (MFU-V) treatment for skin lifting and tightening.[ 1 ] It employs micro-focused ultrasound energy in distinct patterns known as thermal coagulation points (TCPs) to target the different layers of the collagen-rich tissue, specifically the superficial facial system (superficial musculoaponeurotic system [SMAS], plastysma, and frontalis in the face and neck), promoting regeneration of collagen and elastin via controlled tissue heating.[ 2 – 5 ] These changes result in tissue repositioning, changes in skin quality, and improved skin mechanical properties.[ 6 – 8 ] The precision of MFU-V 1.0 treatment is largely due to its advanced DeepSEE® (DS) visualization technology, which provides real-time imaging of the tissue layers, allowing for accurate targeting and consistent treatment outcomes.[ 9 ] Ultherapy PRIME (MFU-V 2.0) represents the latest advancement in this technology. MFU-V 2.0 was designed to enhance visualization and provider experience of the MFU-V treatment process. While maintaining the core principles and mechanism of action of micro-focused ultrasound, MFU-V 2.0 introduces several key advancements in its ultrasound imaging capabilities. These improvements provide practitioners with enhanced accuracy and control of TCP deposition during MFU-V treatment. In addition, MFU-V 2.0 was designed with improved processing power and operational ease of use. In this two-part study, we first sought to quantify the technical differences between the visualization aspects of MFU-V 1.0 and MFU-V 2.0. We have developed a novel image analysis algorithm for quantifying ultrasound noise to compare the ultrasound fields between MFU-V 1.0 and MFU-V 2.0, both with new and significantly used 3.0 mm and 4.5 mm DS transducers. The goal of using significantly used (exceeding 1400 lines) transducers in this study was to determine if MFU-V 1.0 and MFU-V 2.0 experienced similar visualization quality degradation with extended transducer use. In the second part of this study, we asked US-based healthcare providers to provide blind feedback on an early experience questionnaire about the speed, flow, ergonomics, and opinions after using MFU-V 2.0. Methods Tissue-Mimicking Material TCP Deposition and Image Acquisition A comparison of the ultrasound imaging components of both MFU-V devices was conducted. Screen size, pixel count, and ultrasound images taken with new and used (at least 1400 lines) 3.0 mm and 4.5 mm transducers on tissue-mimicking material were collected and compared. Solid blocks of tissue-mimicking material polybutadiene (Da/Pro Rubber Compound #DP3601-B-50, Broken Arrow, OK, USA) were used as model substrates for ultrasound observations of TCPs and visual noise calculation. The attenuation coefficient of the solid tissue-mimicking material was 1.18–1.30 dB/cm/MHz, which closely matches that of human epidermis and dermis which is approximately 1.8 dB cm − 1 MHz − 1 .[ 10 ] Tissue-mimicking blocks were cleaned, and ultrasound gel was applied to the imaged surface. Images were captured using the save image functionality on the control unit. They were downloaded from the system access key for exportation and analysis. Under normal operation, DeepSEE® transducers were used to deposit TCPs at the specified depth into solid tissue-mimicking blocks. Lines were delivered using both new and used transducers (at least 1400 lines) with and without the green treatment line on the solid tissue-mimicking block. After each line was delivered, the ultrasound scan was paused to capture an image of the lines. Images were captured using the image capture feature of either MFU-V 1.0 or MFU-V 2.0, and each image was exported for analysis. Noise Calculation of Ultrasound Images In order to quantify the visual noise of the obtained ultrasound images, ImageJ was used based on concepts previously reported.[ 11 , 12 ] To quantify visual noise, images were opened in ImageJ and cropped to isolate only the ultrasound field. Next, the image (mother image) was duplicated (daughter image). A 3-pixel radius Gaussian blur was applied to the daughter image. The daughter image was subtracted from the mother image and a 32-bit float image was generated. The 32-bit generated image was thresholded to highlight the high frequency visual noise. Four proportionate regions of interest were randomly sampled beneath the TCPs and the integrated density was measured. Integrated density sums highlighted pixels (the isolated visual noise) within the region of interest, reflecting the total amount of signal intensity in the chosen region. Histogram of Pixels Dispersion To observe the intensity distributions of the two ultrasound imaging modalities, images were opened and cropped to include only the ultrasound field. Images were converted to grayscale and a histogram of intensities was created. Since MFU-V 1.0 and MFU-V 2.0 have different resolutions and screen sizes, the values in the histogram were divided by the pixel density of each modality. To compare the distribution curves, Kolomogorv-Smirnov testing was used. Survey Data An online survey was conducted to gather feedback from a variety of US-based clinicians using the newly released MFU-V 2.0 system as part of the Ultherapy PRIME Early Experience Program. The survey was developed and distributed using Microsoft Forms. Clinicians who used the MFU-V 2.0 system for at least two months were invited to participate via email. The survey consisted of a structured questionnaire incorporating a combination of Likert scale questions (generally following 4- or 5-point scales) and open-ended response fields. Likert scale questions were designed to assess various aspects of the clinicians' experiences with MFU-V 2.0, including system speed, ultrasound image clarity, ease of use, intuitiveness, and ergonomic design. Open-answer fields allowed participants to elaborate on their experiences and provide qualitative feedback on any additional advantages or challenges encountered while using the MFU-V 2.0 system. Responses were collected anonymously to ensure unbiased feedback and were used to gain insights into the clinical utility, efficiency, and user satisfaction associated with the MFU-V 2.0 system compared to its predecessor, MFU-V 1.0. The results were analyzed to identify common themes and patterns, which were then summarized and presented as stacked bar graphs totaling 100% of participants. For empirical data, such as number of patients treated and speed improvements, frequency distributions were used to visualize the data. Statistical Analysis Data is expressed as mean ± standard deviation. When comparing the size and resolution of MFU-V 1.0 and MFU-V 2.0 pairwise comparisons were marked as the percentage difference between the two values. To compare the absolute visual noise, a 2-way ANOVA was used with Sidak’s post hoc test applied. To compare the distribution frequencies of the ultrasound intensity, Kolmogorov-Smirnov (K-S) testing was applied, and the K-S D values and P values were computed. K-S testing is a nonparametric test used to compare sample distribution that can determine if two distribution curves significantly differ.[ 13 ] In all cases, P* < 0.05, P** < 0.01, P*** < 0.001, and P**** < 0.0001. Ordinal survey data was tabulated as a percentage of survey respondents and expressed with stacked bar graphs totaling 100%. Results Imaging Quality Significant differences between the ultrasound quality and visualization components exist between MFU-V 2.0 and MFU-V 1.0. The visualization field on MFU-V 2.0 exists on a 19-inch screen (9.13 inches height by 15.94 inches width) and is 2.68 inches in height by 9.49 inches in width, while the visualization system of MFU-V 1.0 is 1.85 inches in height by 6.42 inches by width and exists on a 15-inch screen (8.94 inches height by 11.81 inches width (Fig. 1 A). In addition to a larger screen and ultrasound viewing field, MFU-V 2.0’s resolution is 1920 x 1080 pixels, resulting in a total pixel density of 2204 pixels/cm². Conversely, MFU-V 1.0’s resolution is 1024 x 768 pixels, resulting in a total pixel density of 1,154 pixels/cm 2 (Fig. 1 B). Thus, MFU-V 2.0’s ultrasound visualization field is 113.6% larger than MFU-V 1.0’s, and its pixel density is 91.01% greater. The proportional size differences between MFU-V 1.0 and MFU-V 2.0 can be visualized in Fig. 1 C. For both new and used transducers, the latter of which was tested to determine how extended transducer use affected visualization quality, and with both the 3.0 mm and 4.5 mm transducers, ultrasound noise was significantly lower with MFU-V 2.0. When using new transducers, MFU-V 2.0 had an overall visual noise reduction of 53.35% and 72.02% using the 3.0 mm and 4.5 mm transducers, respectively (Fig. 2 A). Similarly, when using used 3.0 mm and 4.5 mm transducers, MFU-V 2.0 had overall visual noise reductions of 48.42% and 64.04%, respectively. In all cases, these values varied significantly (P < 0.001) (Fig. 2 B). Cumulative visual noise values of the ultrasound images provide overall insight on the overall noise of each device. To determine the distribution of visual noise, histograms were constructed to compare the visual noise distribution frequency. In general, a smoother peak centered around a small range of values indicates lower visual noise, while higher deviations from the moving average signify more visual noise. Similarly, higher frequencies at multiple intensities represent deviations from the target frequency. To this end, with both new and used 3.0 mm and 4.5 mm transducers, the distribution frequencies varied significantly based on the Kolmogorov-Smirnov test (K-S D = 0.2422–0.2773; P < 0.0001) (Fig. 3 A-D). The observed difference in visual noise is readily observed in ultrasound images obtained with both devices (Fig. 4 A & B ). Summary values, percent changes, K-S D values, and P values are given in Table 1 . Table 1 Summary average values for visual noise calculations and K-S D values for frequency distribution comparisons. Transducer (mm) Transducer Status MFU-V Model Visual Noise (a.u.) % Change in Visual Noise (1.0 to 2.0) P Value Kolmogorov-Smirnov D Value P Value 3.0 New 1.0 331850.6 -53.34% < 0.0001 0.2773 < 0.0001 2.0 154810.5 Used 1.0 198681.4 -48.44% 0.0003 0.2422 < 0.0001 2.0 102482.0 4.5 New 1.0 311326.7 -72.03% < 0.0001 0.2695 < 0.0001 2.0 87108.0 Used 1.0 166077.9 -64.04% 0.0001 0.2539 < 0.0001 2.0 59721.0 Treating Clinician Questionnaire Nine US-based clinicians responded to the early user experience program poll. Seven of the nine respondents are Medical Doctors (78%), 1 is a Nurse Practitioner (14%), and 1 is a Registered Nurse (14%). Survey respondents had treated an average of 7.6 ± 2.5 patients (range: 4–11; sum: 68) with MFU-V 2.0 (Fig. 5 A). The respondents noted a speed improvement of 19.7% ± 20.4% (range: 0%-70%) per patient treatment when comparing MFU-V 2.0 with MFU-V 1.0 (Fig. 5 B ) . Regarding the speed of the system, 100% of respondents were at least satisfied (56% “very satisfied”, 44% “satisfied”) with the speed of the MFU-V 2.0 system (Fig. 6 A). The improved speed is partially attributed to the improved processing speed and reactivity of MFU-V 2.0’s system. In addition, respondents indicated that the time reduction was due, in part, to the improved imaging quality of MFU-V 2.0, to which 100% thought MFU-V 2.0’s imaging system was at least better than MFU-V 1.0 (88% “much better”, 11% “better”) (Fig. 6 B ) . Similarly, 100% of respondents found MFU-V 2.0 to be “very easy” (67%) or “easy” (33%) to use, which was attributed to both its intuitive nature and improved ergonomics Fig. 6 C. Most providers (88%) found MFU-V 2.0 to at least be “very intuitive” (44% “extremely intuitive”, 44% “very intuitive”, and 11% “moderately intuitive”) with the majority (100%) finding the new design of MFU-V 2.0 to be at least a good design (67% “excellent design”, 33% “good design”, 11% “average design”) (Fig. 6 D & E ). Overall, this resulted in 78% of respondents “definitely recommending” and 22% “probably recommending” MFU-V 2.0 to their colleagues (Fig. 6 F). Clinical Case Report A 49-year-old female patient presented to JL complaining of worsening skin laxity and a tired appearance. After discussion, the patient underwent treatment with MFU-V 2.0 and received 751 total lines (320 with DS 10 − 1.5 and 431 with DS 7 − 3.0) in addition to injections of incobotulinumtoxinA in the glabella, crow’s feet, along the frontalis, and in the platysma bands. After 3 months, the patient and treating physician noticed improvements in skin quality, skin texture, and skin laxity along her jawline and upper face. Areas most affected by the treatment appeared to be the jawline and midface, where improvements in laxity were most pronounced. Manual assessment of skin firmness using the pinch test revealed improvements in skin firmness and recoil. During follow up, the patient reported looking younger and is feeling highly satisfied with the treatment outcomes. The before and after results from this 49-year-old patient treated during the early experience program are shown in Fig. 7 A-D. Discussion The findings of this study demonstrate the superior capabilities of the MFU-V 2.0 ultrasound system over the MFU-V 1.0 system in terms of both resolution and enhanced image clarity. The near doubling of pixel density provides substantially clearer ultrasound images during live imaging and MFU-V treatments. This improved resolution facilitates more precise visualization of the different tissue layers, allowing clinicians to target fibroblast-rich planes more accurately.[ 14 ] Precise targeting is critical for enhancing the efficacy of regenerative treatments by promoting robust collagen and elastin synthesis and improving aesthetic outcomes. In addition to enhanced resolution, the MFU-V 2.0 system exhibits significantly reduced ultrasound noise, a common issue in imaging that can obscure critical anatomical details and make it challenging to differentiate between tissue planes. Lower visual noise levels contribute to clearer images, crucial for avoiding the deposition of TCPs across unintended tissue layers. This is particularly important for preventing complications such as inadvertent energy deposition into deeper structure, like sweat glands, which could lead to unwanted outcomes like anhidrosis.[ 15 ] Compared to other energy-based devices, including systems that use bulk heating that may inadvertently fuse tissue planes, MFU-V offers a significant advantage with the ability to visualize the treatment depth. The real-time imaging capability of MFU-V enables precise identification of the target tissue layer, helping to individualize the treatment and ensure that TCPs are deposited only where intended. This minimizes the risk of tissue fusion and helps to preserve the natural anatomical tissue plane separations. These advancements clinically translated to high satisfaction among clinicians using the MFU-V 2.0 system. Clinicians in the early experience program reported significant improvements in treatment speed, ergonomics, and ease of use, which they attributed to enhanced visualization and reduced visual noise levels of MFU-V 2.0. The average treatment time was reduced by nearly 20%, and clinicians expressed a high level of satisfaction with the system's performance, with 100% of respondents noting that the imaging quality was better or much better compared to MFU-V 1.0. The improved user experience and treatment outcomes underscore the clinical relevance of the advancements in MFU-V 2.0, further supporting its adoption in clinical practice. Overall, the MFU-V 2.0’s advancements in ultrasound visualization quality and visual noise reduction translate to improved targeting accuracy and treatment precision, which are critical for achieving better clinical outcomes in skin lifting and tightening procedures. Further research on human skin is necessary to confirm these findings, and clinical studies should be conducted to assess the long-term effects of MFU-V 2.0. Follow-up surveys involving a broader range of clinicians over a longer period may also be warranted to gather more comprehensive feedback on its performance in clinical practice. Conclusion This study demonstrates that MFU-V 2.0’s ultrasound visualization system significantly outperforms the MFU-V 1.0 system in both visualization and visual noise reduction. These two components, aside from enhancing the treating providers workflow, may enhance TCP deposition accuracy, which is critical for targeting proper tissue layers and preventing accidental deposition of TCPs across multiple tissue layers. In addition to improved visualization, survey respondents noted improved speed of approximately 20%, saw improved ultrasound clarity, and found MFU-V 2.0 easy to use, intuitive, and ergonomic. Declarations Funding: This research supported by Merz Aesthetics. However, not specific funding was received by any of the authors for this research. Conflicts of Interest : JL is a consultant for Merz Aesthetics, Galderma, Allergan, BTL, and Benev Inc. AD and JA and employed by Merz Aesthetics. JG discloses that he performs clinical trials and is a speaker/on the advisory board for Allergan, Brickell Biotech (San Diego, CA), Croma (Leobendorf, Austria), Cutera (Brisbane, CA), Endo Aesthetics, Galderma, Merz, Pulse Biosciences (Hayward, CA), and Revance; and holds stock/ownership in Candesant (San Francisco, CA) and Illustris (Irvine, CA). TP is a consultant, investigator, and lecturer for Merz Aesthetics. Human and Animal Rights : This research does not contain any human or animal subjects. The clinical case presented was treated through standard care and after obtaining informed consent. Informed Consent : Informed written consent for treatment and participation in the publication of case details and images was obtained from the patient. Author Contributions JL : Conceptualization, validation, formal analysis, investigation, resources, data curation, writing – original draft, writing – review & editing, visualization, software. AM : Conceptualization, validation, formal analysis, investigation, resources, data curation, writing – original draft, writing – review & editing, visualization, project administration, supervision, software, methodology. TP : Validation, formal analysis, investigation, resources, data curation, writing – review & editing. JG : Validation, formal analysis, investigation, resources, data curation, writing – review & editing. JA : Conceptualization, formal analysis, investigation, resources, writing – review & editing. References Fabi SG, Joseph J, Sevi J et al (2019) Optimizing Patient Outcomes by Customizing Treatment With Microfocused Ultrasound With Visualization: Gold Standard Consensus Guidelines from an Expert Panel. J Drugs Dermatol 18:7 White WM, Makin IRS, Barthe PG et al (2007) Selective Creation of Thermal Injury Zones in the Superficial Musculoaponeurotic System Using Intense Ultrasound Therapy. Arch Facial Plast Surg 9:22–29 White WM, Makin IRS, Slayton MH et al (2008) Selective transcutaneous delivery of energy to porcine soft tissues using intense ultrasound (IUS). Lasers Surg Med 40:67–75 Suh DH, Shin MK, Lee SJ et al (2011) Intense Focused Ultrasound Tightening in Asian Skin: Clinical and Pathologic Results. Dermatol Surg 37:1–8 Vachiramon V, Pavicic T, Casabona G et al (2024) Microfocused Ultrasound in Regenerative Aesthetics: A Narrative Review on Mechanisms of Action and Clinical Outcomes. J Cosmet Dermatol epub ahead of print. Fabi SG, Massaki A, Eimpunth S et al (2013) Evaluation of microfocused ultrasound with visualization for lifting, tightening, and wrinkle reduction of the décolletage. J Am Acad Dermatol 69:965–971 Araco A (2020) Prospective Study on Clinical Efficacy and Safety of a Single Session of Microfocused Ultrasound With Visualization for Collagen Regeneration. Aesthet Surg J 40:1124–1132 Kerscher M, Nurrisyanti AT, Eiben-Nielson C et al (2019) Skin physiology and safety of microfocused ultrasound with visualization for improving skin laxity. Clin Cosmet Investig Dermatol 12:71–79 Pavicic T, Ballard JR, Bykovskaya T et al (2022) Microfocused ultrasound with visualization: Consensus on safety and review of energy-based devices. J Cosmet Dermatol 21:636–647 Guittet C, Ossant F, Remenieras J-P et al (1999) High-frequency estimation of the ultrasonic attenuation coefficient slope obtained in human skin: simulation and in vivo results. Ultrasound Med Biol 25:421–429 Sayed IS (2018) Multi-frequency ultrasound imaging: Phantom study. Int J Allied Health Sci 2:304–309 Kratzer W, Güthle M, Dobler F et al (2022) Comparison of superb microvascular imaging (SMI) quantified with ImageJ to quantified contrast-enhanced ultrasound (qCEUS) in liver metastases—a pilot study. Quant Imaging Med Surg 12:1762–1774 Berger VW, Zhou Y (2014) Kolmogorov–Smirnov Test: Overview. Wiley StatsRef: Statistics Reference Online. John Wiley & Sons, Ltd Zuo Y, Yu X, Lu S (2016) Dermal Fibroblasts from Different Layers of Pig Skin Exhibit Different Profibrotic and Morphological Characteristics. Anat Rec 299:1585–1599 Nestor MS, Park H (2014) Safety and Efficacy of Micro-focused Ultrasound Plus Visualization for the Treatment of Axillary Hyperhidrosis. J Clin Aesthetic Dermatol 7:14–21 Additional Declarations The authors declare potential competing interests as follows: Dr. Levine is a consultant for Merz Aesthetics, Galderma, Allergan, BTL, and Benev Inc. Dr. McCarthy and Dr. Akers are both employed by Merz Aesthetics. Dr. Green discloses that he performs clinical trials and is a speaker/on the advisory board for Allergan, Brickell Biotech (San Diego, CA), Croma (Leobendorf, Austria), Cutera (Brisbane, CA), Endo Aesthetics, Galderma, Merz, Pulse Biosciences (Hayward, CA), and Revance; and holds stock/ownership in Candesant (San Francisco, CA) and Illustris (Irvine, CA). Dr. Pavicic is a consultant, investigator, and lecturer for Merz Aesthetics. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6229189","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":429025934,"identity":"06fbedde-3175-4493-90ec-9746b1ed2137","order_by":0,"name":"Jennifer Levine, MD","email":"","orcid":"","institution":"Lenox Hill Hospital and Manhattan Eye, Ear, and Throat Hospital","correspondingAuthor":false,"prefix":"","firstName":"Jennifer","middleName":"","lastName":"Levine","suffix":"MD"},{"id":429025935,"identity":"0df933d5-033a-4ed5-ab7a-8bf42d1d9510","order_by":1,"name":"Alec D. McCarthy, PhD","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA6ElEQVRIie3PMQrCMBSA4TwDcWnpGlGaK1gKunmWSlcP4CBYKLi6VhTv4JK5EtCl6AEyieDkUBdxtAZBF9O6CeZfXgj5CA8hk+kXq7+OBKFhFYJfp4JkXxOYVBBOjNc5DHrMme83R3vJ3e40hfwy+EyoICEFHnrJLqz7Npd+K01xY8Y13wirg4CnAcowaRakn0BEsK0hTDhXRZgiCzlOMNKTtrCIIm1FIhlQUkI8QXzaL3ZZZbjTWGykl1gQa3dxt/Ehv/AeczM40fNIMuqIdXGjWf9R8Jw1Sw2ISt6/Bbfqb00mk+mPugNzXkb8Lg6oYAAAAABJRU5ErkJggg==","orcid":"","institution":"Merz Aesthetics","correspondingAuthor":true,"prefix":"","firstName":"Alec","middleName":"D.","lastName":"McCarthy","suffix":"PhD"},{"id":429025936,"identity":"d948d2ee-9662-4b89-99dd-493ef98eb3d0","order_by":2,"name":"Tatjana Pavicic, MD, PhD","email":"","orcid":"","institution":"Private Practice for Dermatology \u0026 Aesthetics Dr. Tatjana Pavicic","correspondingAuthor":false,"prefix":"","firstName":"","middleName":"MD Tatjana","lastName":"Pavicic","suffix":"MD"},{"id":429025937,"identity":"4bbd4beb-bf4a-495d-a324-c3ae4a859c41","order_by":3,"name":"Jeremy Green, MD","email":"","orcid":"","institution":"Skin Research Institute \u0026 Skin Associates of South Florida","correspondingAuthor":false,"prefix":"","firstName":"Jeremy","middleName":"","lastName":"Green","suffix":"MD"},{"id":429025938,"identity":"55cdcf04-cb54-436e-8ad8-b588b0452611","order_by":4,"name":"John Akers","email":"","orcid":"","institution":"Merz Aesthetics","correspondingAuthor":false,"prefix":"","firstName":"John","middleName":"","lastName":"Akers","suffix":""}],"badges":[],"createdAt":"2025-03-14 21:18:28","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":true,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":true,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-6229189/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6229189/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":80104369,"identity":"5698332c-8509-4fce-92ac-2ebf7fd77480","added_by":"auto","created_at":"2025-04-08 02:52:44","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":91497,"visible":true,"origin":"","legend":"\u003cp\u003eDifferences in size and resolution between MFU-V 1.0 and MFU-V 2.0. (A) Ultrasound visualization field and (B) pixel density differences between the two systems. (C) Relative differences in ultrasound visualization field (not drawn to scale; proportionately scaled relative to one another).\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-6229189/v1/914a712ead80924fb69b6171.png"},{"id":80104372,"identity":"680e3fa6-82ac-49b1-9c55-8192537e2eb0","added_by":"auto","created_at":"2025-04-08 02:52:44","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":81025,"visible":true,"origin":"","legend":"\u003cp\u003eCumulative visual noise intensity with either (A) new or (B) used 3.0- and 4.5-mm transducers using either MFU-V 1.0 and MFU-V 2.0. (P*** \u0026lt; 0.001, and P**** \u0026lt; 0.0001)\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-6229189/v1/4e6a8f3eeb4db3bcae365af7.png"},{"id":80104373,"identity":"408f8655-844b-4b13-8700-284c637a522a","added_by":"auto","created_at":"2025-04-08 02:52:44","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":182655,"visible":true,"origin":"","legend":"\u003cp\u003eDistribution frequencies of intensity for (A) new and (B) used 3.0 mm transducers and (C) new and (D) used 4.5 mm transducers.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-6229189/v1/9dd585ebc9b50e8358e9bf83.png"},{"id":80105328,"identity":"86c7219e-e655-4467-9513-8ca19938c1d8","added_by":"auto","created_at":"2025-04-08 03:08:44","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":199943,"visible":true,"origin":"","legend":"\u003cp\u003eComparisons between the ultrasound image quality with new and used 3.0 mm transducers with (A) MFU-V 1.0 and (B) MFU-V 2.0.\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-6229189/v1/ea81ab15953ae8a5e020eab1.png"},{"id":80104843,"identity":"f5f83050-3a7e-4f90-8fec-a634f2525be5","added_by":"auto","created_at":"2025-04-08 03:00:44","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":66746,"visible":true,"origin":"","legend":"\u003cp\u003eResults from early experience program surveys. (A) Frequency distribution showing the number of patients treated by the survey respondents and (B) the estimated speed increase when treating with MFU-V 2.0 compared to MFU-V 1.0.\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-6229189/v1/ca311f98f36dc61a501566be.png"},{"id":80105818,"identity":"6a49d00f-833d-46e0-b4eb-dda3b001f9f4","added_by":"auto","created_at":"2025-04-08 03:16:44","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":223768,"visible":true,"origin":"","legend":"\u003cp\u003eResults from the early experience survey taken after 2 months of using MFU-V 2.0 in clinical practice. (A) Satisfaction with system speed and responsiveness, (B) ultrasound image clarity, (C) ease of use, (D) intuitiveness, and (E) ergonomic design. (F) Likeliness to recommend to peers.\u003c/p\u003e","description":"","filename":"6.png","url":"https://assets-eu.researchsquare.com/files/rs-6229189/v1/a2542ce992ec5543718fcfd9.png"},{"id":80104850,"identity":"e01b5487-7df8-4e0d-82b6-30cbd6491cb5","added_by":"auto","created_at":"2025-04-08 03:00:44","extension":"png","order_by":7,"title":"Figure 7","display":"","copyAsset":false,"role":"figure","size":832021,"visible":true,"origin":"","legend":"\u003cp\u003eFront-facing images of a 49-year-old female patient (A) before and (B) 3 months after treatment with MFU-V 2.0. Angled images of the same 49-year-old patient (C) before and (D) 3 months after treatment. This patient received 751 total lines (320 with DS 10-1.5 and 431 with DS 7-3.0).\u003c/p\u003e","description":"","filename":"7.png","url":"https://assets-eu.researchsquare.com/files/rs-6229189/v1/a5120ded39c048352cfe8ea7.png"},{"id":80106362,"identity":"b68e3664-6563-4acd-86a2-b3b5caec18cf","added_by":"auto","created_at":"2025-04-08 03:24:45","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2597887,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6229189/v1/38d16679-cd48-41de-8a77-d1d1bf3875f3.pdf"}],"financialInterests":"The authors declare potential competing interests as follows: Dr. Levine is a consultant for Merz Aesthetics, Galderma, Allergan, BTL, and Benev Inc. Dr. McCarthy and Dr. Akers are both employed by Merz Aesthetics. Dr. Green discloses that he performs clinical trials and is a speaker/on the advisory board for Allergan, Brickell Biotech (San Diego, CA), Croma (Leobendorf, Austria), Cutera (Brisbane, CA), Endo Aesthetics, Galderma, Merz, Pulse Biosciences (Hayward, CA), and Revance; and holds stock/ownership in Candesant (San Francisco, CA) and Illustris (Irvine, CA). Dr. Pavicic is a consultant, investigator, and lecturer for Merz Aesthetics. ","formattedTitle":"\u003cp\u003e\u003cstrong\u003eComparative Ultrasound Visualization Analysis Between Ultherapy® and Ultherapy PRIME and Survey and Clinical Case Results from the Ultherapy PRIME Early Experience Program\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eUltherapy (MFU-V 1.0) has become a widely recognized non-invasive, microfocused ultrasound with visualization (MFU-V) treatment for skin lifting and tightening.[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] It employs micro-focused ultrasound energy in distinct patterns known as thermal coagulation points (TCPs) to target the different layers of the collagen-rich tissue, specifically the superficial facial system (superficial musculoaponeurotic system [SMAS], plastysma, and frontalis in the face and neck), promoting regeneration of collagen and elastin via controlled tissue heating.[\u003cspan additionalcitationids=\"CR3 CR4\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] These changes result in tissue repositioning, changes in skin quality, and improved skin mechanical properties.[\u003cspan additionalcitationids=\"CR7\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] The precision of MFU-V 1.0 treatment is largely due to its advanced DeepSEE\u0026reg; (DS) visualization technology, which provides real-time imaging of the tissue layers, allowing for accurate targeting and consistent treatment outcomes.[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eUltherapy PRIME (MFU-V 2.0) represents the latest advancement in this technology. MFU-V 2.0 was designed to enhance visualization and provider experience of the MFU-V treatment process. While maintaining the core principles and mechanism of action of micro-focused ultrasound, MFU-V 2.0 introduces several key advancements in its ultrasound imaging capabilities. These improvements provide practitioners with enhanced accuracy and control of TCP deposition during MFU-V treatment. In addition, MFU-V 2.0 was designed with improved processing power and operational ease of use.\u003c/p\u003e \u003cp\u003eIn this two-part study, we first sought to quantify the technical differences between the visualization aspects of MFU-V 1.0 and MFU-V 2.0. We have developed a novel image analysis algorithm for quantifying ultrasound noise to compare the ultrasound fields between MFU-V 1.0 and MFU-V 2.0, both with new and significantly used 3.0 mm and 4.5 mm DS transducers. The goal of using significantly used (exceeding 1400 lines) transducers in this study was to determine if MFU-V 1.0 and MFU-V 2.0 experienced similar visualization quality degradation with extended transducer use. In the second part of this study, we asked US-based healthcare providers to provide blind feedback on an early experience questionnaire about the speed, flow, ergonomics, and opinions after using MFU-V 2.0.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eTissue-Mimicking Material TCP Deposition and Image Acquisition\u003c/h2\u003e \u003cp\u003eA comparison of the ultrasound imaging components of both MFU-V devices was conducted. Screen size, pixel count, and ultrasound images taken with new and used (at least 1400 lines) 3.0 mm and 4.5 mm transducers on tissue-mimicking material were collected and compared. Solid blocks of tissue-mimicking material polybutadiene (Da/Pro Rubber Compound #DP3601-B-50, Broken Arrow, OK, USA) were used as model substrates for ultrasound observations of TCPs and visual noise calculation. The attenuation coefficient of the solid tissue-mimicking material was 1.18\u0026ndash;1.30 dB/cm/MHz, which closely matches that of human epidermis and dermis which is approximately 1.8 dB cm\u003csup\u003e\u0026minus;\u0026thinsp;1\u003c/sup\u003e MHz\u003csup\u003e\u0026minus;\u0026thinsp;1\u003c/sup\u003e.[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] Tissue-mimicking blocks were cleaned, and ultrasound gel was applied to the imaged surface. Images were captured using the save image functionality on the control unit. They were downloaded from the system access key for exportation and analysis.\u003c/p\u003e \u003cp\u003eUnder normal operation, DeepSEE\u0026reg; transducers were used to deposit TCPs at the specified depth into solid tissue-mimicking blocks. Lines were delivered using both new and used transducers (at least 1400 lines) with and without the green treatment line on the solid tissue-mimicking block. After each line was delivered, the ultrasound scan was paused to capture an image of the lines. Images were captured using the image capture feature of either MFU-V 1.0 or MFU-V 2.0, and each image was exported for analysis.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eNoise Calculation of Ultrasound Images\u003c/h3\u003e\n\u003cp\u003eIn order to quantify the visual noise of the obtained ultrasound images, ImageJ was used based on concepts previously reported.[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e] To quantify visual noise, images were opened in ImageJ and cropped to isolate only the ultrasound field. Next, the image (mother image) was duplicated (daughter image). A 3-pixel radius Gaussian blur was applied to the daughter image. The daughter image was subtracted from the mother image and a 32-bit float image was generated. The 32-bit generated image was thresholded to highlight the high frequency visual noise. Four proportionate regions of interest were randomly sampled beneath the TCPs and the integrated density was measured. Integrated density sums highlighted pixels (the isolated visual noise) within the region of interest, reflecting the total amount of signal intensity in the chosen region.\u003c/p\u003e\n\u003ch3\u003eHistogram of Pixels Dispersion\u003c/h3\u003e\n\u003cp\u003eTo observe the intensity distributions of the two ultrasound imaging modalities, images were opened and cropped to include only the ultrasound field. Images were converted to grayscale and a histogram of intensities was created. Since MFU-V 1.0 and MFU-V 2.0 have different resolutions and screen sizes, the values in the histogram were divided by the pixel density of each modality. To compare the distribution curves, Kolomogorv-Smirnov testing was used.\u003c/p\u003e\n\u003ch3\u003eSurvey Data\u003c/h3\u003e\n\u003cp\u003eAn online survey was conducted to gather feedback from a variety of US-based clinicians using the newly released MFU-V 2.0 system as part of the Ultherapy PRIME Early Experience Program. The survey was developed and distributed using Microsoft Forms. Clinicians who used the MFU-V 2.0 system for at least two months were invited to participate via email. The survey consisted of a structured questionnaire incorporating a combination of Likert scale questions (generally following 4- or 5-point scales) and open-ended response fields. Likert scale questions were designed to assess various aspects of the clinicians' experiences with MFU-V 2.0, including system speed, ultrasound image clarity, ease of use, intuitiveness, and ergonomic design. Open-answer fields allowed participants to elaborate on their experiences and provide qualitative feedback on any additional advantages or challenges encountered while using the MFU-V 2.0 system. Responses were collected anonymously to ensure unbiased feedback and were used to gain insights into the clinical utility, efficiency, and user satisfaction associated with the MFU-V 2.0 system compared to its predecessor, MFU-V 1.0. The results were analyzed to identify common themes and patterns, which were then summarized and presented as stacked bar graphs totaling 100% of participants. For empirical data, such as number of patients treated and speed improvements, frequency distributions were used to visualize the data.\u003c/p\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eData is expressed as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation. When comparing the size and resolution of MFU-V 1.0 and MFU-V 2.0 pairwise comparisons were marked as the percentage difference between the two values. To compare the absolute visual noise, a 2-way ANOVA was used with Sidak\u0026rsquo;s post hoc test applied. To compare the distribution frequencies of the ultrasound intensity, Kolmogorov-Smirnov (K-S) testing was applied, and the K-S D values and P values were computed. K-S testing is a nonparametric test used to compare sample distribution that can determine if two distribution curves significantly differ.[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] In all cases, P* \u0026lt; 0.05, P** \u0026lt; 0.01, P*** \u0026lt; 0.001, and P**** \u0026lt; 0.0001. Ordinal survey data was tabulated as a percentage of survey respondents and expressed with stacked bar graphs totaling 100%.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eImaging Quality\u003c/h2\u003e \u003cp\u003eSignificant differences between the ultrasound quality and visualization components exist between MFU-V 2.0 and MFU-V 1.0. The visualization field on MFU-V 2.0 exists on a 19-inch screen (9.13 inches height by 15.94 inches width) and is 2.68 inches in height by 9.49 inches in width, while the visualization system of MFU-V 1.0 is 1.85 inches in height by 6.42 inches by width and exists on a 15-inch screen (8.94 inches height by 11.81 inches width (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eA). In addition to a larger screen and ultrasound viewing field, MFU-V 2.0\u0026rsquo;s resolution is 1920 x 1080 pixels, resulting in a total pixel density of 2204 pixels/cm\u0026sup2;. Conversely, MFU-V 1.0\u0026rsquo;s resolution is 1024 x 768 pixels, resulting in a total pixel density of 1,154 pixels/cm\u003csup\u003e2\u003c/sup\u003e (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eB). Thus, MFU-V 2.0\u0026rsquo;s ultrasound visualization field is 113.6% larger than MFU-V 1.0\u0026rsquo;s, and its pixel density is 91.01% greater. The proportional size differences between MFU-V 1.0 and MFU-V 2.0 can be visualized in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eC.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eFor both new and used transducers, the latter of which was tested to determine how extended transducer use affected visualization quality, and with both the 3.0 mm and 4.5 mm transducers, ultrasound noise was significantly lower with MFU-V 2.0. When using new transducers, MFU-V 2.0 had an overall visual noise reduction of 53.35% and 72.02% using the 3.0 mm and 4.5 mm transducers, respectively (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eA). Similarly, when using used 3.0 mm and 4.5 mm transducers, MFU-V 2.0 had overall visual noise reductions of 48.42% and 64.04%, respectively. In all cases, these values varied significantly (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001) (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eB).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eCumulative visual noise values of the ultrasound images provide overall insight on the overall noise of each device. To determine the distribution of visual noise, histograms were constructed to compare the visual noise distribution frequency. In general, a smoother peak centered around a small range of values indicates lower visual noise, while higher deviations from the moving average signify more visual noise. Similarly, higher frequencies at multiple intensities represent deviations from the target frequency. To this end, with both new and used 3.0 mm and 4.5 mm transducers, the distribution frequencies varied significantly based on the Kolmogorov-Smirnov test (K-S D\u0026thinsp;=\u0026thinsp;0.2422\u0026ndash;0.2773; P\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eA-D). The observed difference in visual noise is readily observed in ultrasound images obtained with both devices (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003eA \u003cb\u003e\u0026amp; B\u003c/b\u003e). Summary values, percent changes, K-S D values, and P values are given in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003eSummary average values for\u003c/b\u003e visual \u003cb\u003enoise calculations and K-S D values for frequency distribution comparisons.\u003c/b\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTransducer (mm)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTransducer Status\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMFU-V Model\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eVisual Noise (a.u.)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e% Change in Visual Noise (1.0 to 2.0)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eP Value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eKolmogorov-Smirnov D Value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eP Value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e3.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eNew\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e331850.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e-53.34%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.2773\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e154810.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eUsed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e198681.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e-48.44%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.0003\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.2422\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e102482.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e4.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eNew\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e311326.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e-72.03%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.2695\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e87108.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eUsed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e166077.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e-64.04%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.2539\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e59721.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eTreating Clinician Questionnaire\u003c/h3\u003e\n\u003cp\u003eNine US-based clinicians responded to the early user experience program poll. Seven of the nine respondents are Medical Doctors (78%), 1 is a Nurse Practitioner (14%), and 1 is a Registered Nurse (14%).\u003c/p\u003e \u003cp\u003eSurvey respondents had treated an average of 7.6\u0026thinsp;\u0026plusmn;\u0026thinsp;2.5 patients (range: 4\u0026ndash;11; sum: 68) with MFU-V 2.0 (Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003eA). The respondents noted a speed improvement of 19.7% \u0026plusmn; 20.4% (range: 0%-70%) per patient treatment when comparing MFU-V 2.0 with MFU-V 1.0 (Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003eB\u003cb\u003e)\u003c/b\u003e. Regarding the speed of the system, 100% of respondents were at least satisfied (56% \u0026ldquo;very satisfied\u0026rdquo;, 44% \u0026ldquo;satisfied\u0026rdquo;) with the speed of the MFU-V 2.0 system (Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003eA). The improved speed is partially attributed to the improved processing speed and reactivity of MFU-V 2.0\u0026rsquo;s system. In addition, respondents indicated that the time reduction was due, in part, to the improved imaging quality of MFU-V 2.0, to which 100% thought MFU-V 2.0\u0026rsquo;s imaging system was at least better than MFU-V 1.0 (88% \u0026ldquo;much better\u0026rdquo;, 11% \u0026ldquo;better\u0026rdquo;) (Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003eB\u003cb\u003e)\u003c/b\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eSimilarly, 100% of respondents found MFU-V 2.0 to be \u0026ldquo;very easy\u0026rdquo; (67%) or \u0026ldquo;easy\u0026rdquo; (33%) to use, which was attributed to both its intuitive nature and improved ergonomics Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003eC. Most providers (88%) found MFU-V 2.0 to at least be \u0026ldquo;very intuitive\u0026rdquo; (44% \u0026ldquo;extremely intuitive\u0026rdquo;, 44% \u0026ldquo;very intuitive\u0026rdquo;, and 11% \u0026ldquo;moderately intuitive\u0026rdquo;) with the majority (100%) finding the new design of MFU-V 2.0 to be at least a good design (67% \u0026ldquo;excellent design\u0026rdquo;, 33% \u0026ldquo;good design\u0026rdquo;, 11% \u0026ldquo;average design\u0026rdquo;) (Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003eD \u003cb\u003e\u0026amp; E\u003c/b\u003e). Overall, this resulted in 78% of respondents \u0026ldquo;definitely recommending\u0026rdquo; and 22% \u0026ldquo;probably recommending\u0026rdquo; MFU-V 2.0 to their colleagues (Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003eF).\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eClinical Case Report\u003c/h2\u003e \u003cp\u003eA 49-year-old female patient presented to JL complaining of worsening skin laxity and a tired appearance. After discussion, the patient underwent treatment with MFU-V 2.0 and received 751 total lines (320 with DS 10\u0026thinsp;\u0026minus;\u0026thinsp;1.5 and 431 with DS 7\u0026thinsp;\u0026minus;\u0026thinsp;3.0) in addition to injections of incobotulinumtoxinA in the glabella, crow\u0026rsquo;s feet, along the frontalis, and in the platysma bands. After 3 months, the patient and treating physician noticed improvements in skin quality, skin texture, and skin laxity along her jawline and upper face. Areas most affected by the treatment appeared to be the jawline and midface, where improvements in laxity were most pronounced. Manual assessment of skin firmness using the pinch test revealed improvements in skin firmness and recoil. During follow up, the patient reported looking younger and is feeling highly satisfied with the treatment outcomes. The before and after results from this 49-year-old patient treated during the early experience program are shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig7\" class=\"InternalRef\"\u003e7\u003c/span\u003eA-D.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe findings of this study demonstrate the superior capabilities of the MFU-V 2.0 ultrasound system over the MFU-V 1.0 system in terms of both resolution and enhanced image clarity. The near doubling of pixel density provides substantially clearer ultrasound images during live imaging and MFU-V treatments. This improved resolution facilitates more precise visualization of the different tissue layers, allowing clinicians to target fibroblast-rich planes more accurately.[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e] Precise targeting is critical for enhancing the efficacy of regenerative treatments by promoting robust collagen and elastin synthesis and improving aesthetic outcomes.\u003c/p\u003e \u003cp\u003eIn addition to enhanced resolution, the MFU-V 2.0 system exhibits significantly reduced ultrasound noise, a common issue in imaging that can obscure critical anatomical details and make it challenging to differentiate between tissue planes. Lower visual noise levels contribute to clearer images, crucial for avoiding the deposition of TCPs across unintended tissue layers. This is particularly important for preventing complications such as inadvertent energy deposition into deeper structure, like sweat glands, which could lead to unwanted outcomes like anhidrosis.[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eCompared to other energy-based devices, including systems that use bulk heating that may inadvertently fuse tissue planes, MFU-V offers a significant advantage with the ability to visualize the treatment depth. The real-time imaging capability of MFU-V enables precise identification of the target tissue layer, helping to individualize the treatment and ensure that TCPs are deposited only where intended. This minimizes the risk of tissue fusion and helps to preserve the natural anatomical tissue plane separations.\u003c/p\u003e \u003cp\u003eThese advancements clinically translated to high satisfaction among clinicians using the MFU-V 2.0 system. Clinicians in the early experience program reported significant improvements in treatment speed, ergonomics, and ease of use, which they attributed to enhanced visualization and reduced visual noise levels of MFU-V 2.0. The average treatment time was reduced by nearly 20%, and clinicians expressed a high level of satisfaction with the system's performance, with 100% of respondents noting that the imaging quality was better or much better compared to MFU-V 1.0. The improved user experience and treatment outcomes underscore the clinical relevance of the advancements in MFU-V 2.0, further supporting its adoption in clinical practice.\u003c/p\u003e \u003cp\u003eOverall, the MFU-V 2.0\u0026rsquo;s advancements in ultrasound visualization quality and visual noise reduction translate to improved targeting accuracy and treatment precision, which are critical for achieving better clinical outcomes in skin lifting and tightening procedures. Further research on human skin is necessary to confirm these findings, and clinical studies should be conducted to assess the long-term effects of MFU-V 2.0. Follow-up surveys involving a broader range of clinicians over a longer period may also be warranted to gather more comprehensive feedback on its performance in clinical practice.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study demonstrates that MFU-V 2.0\u0026rsquo;s ultrasound visualization system significantly outperforms the MFU-V 1.0 system in both visualization and visual noise reduction. These two components, aside from enhancing the treating providers workflow, may enhance TCP deposition accuracy, which is critical for targeting proper tissue layers and preventing accidental deposition of TCPs across multiple tissue layers. In addition to improved visualization, survey respondents noted improved speed of approximately 20%, saw improved ultrasound clarity, and found MFU-V 2.0 easy to use, intuitive, and ergonomic.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eFunding:\u003c/h2\u003e \u003cp\u003eThis research supported by Merz Aesthetics. However, not specific funding was received by any of the authors for this research.\u003c/p\u003e \u003cp\u003e\u003cb\u003eConflicts of Interest\u003c/b\u003e: JL is a consultant for Merz Aesthetics, Galderma, Allergan, BTL, and Benev Inc. AD and JA and employed by Merz Aesthetics. JG discloses that he performs clinical trials and is a speaker/on the advisory board for Allergan, Brickell Biotech (San Diego, CA), Croma (Leobendorf, Austria), Cutera (Brisbane, CA), Endo Aesthetics, Galderma, Merz, Pulse Biosciences (Hayward, CA), and Revance; and holds stock/ownership in Candesant (San Francisco, CA) and Illustris (Irvine, CA). TP is a consultant, investigator, and lecturer for Merz Aesthetics.\u003c/p\u003e \u003cp\u003e \u003cb\u003eHuman and Animal Rights\u003c/b\u003e: This research does not contain any human or animal subjects. The clinical case presented was treated through standard care and after obtaining informed consent.\u003c/p\u003e \u003cp\u003e \u003cb\u003eInformed Consent\u003c/b\u003e: Informed written consent for treatment and participation in the publication of case details and images was obtained from the patient.\u003c/p\u003e\u003ch2\u003eAuthor Contributions\u003c/h2\u003e \u003cp\u003e \u003cb\u003eJL\u003c/b\u003e: Conceptualization, validation, formal analysis, investigation, resources, data curation, writing \u0026ndash; original draft, writing \u0026ndash; review \u0026amp; editing, visualization, software. \u003cb\u003eAM\u003c/b\u003e: Conceptualization, validation, formal analysis, investigation, resources, data curation, writing \u0026ndash; original draft, writing \u0026ndash; review \u0026amp; editing, visualization, project administration, supervision, software, methodology. \u003cb\u003eTP\u003c/b\u003e: Validation, formal analysis, investigation, resources, data curation, writing \u0026ndash; review \u0026amp; editing. \u003cb\u003eJG\u003c/b\u003e: Validation, formal analysis, investigation, resources, data curation, writing \u0026ndash; review \u0026amp; editing. \u003cb\u003eJA\u003c/b\u003e: Conceptualization, formal analysis, investigation, resources, writing \u0026ndash; review \u0026amp; editing.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eFabi SG, Joseph J, Sevi J et al (2019) Optimizing Patient Outcomes by Customizing Treatment With Microfocused Ultrasound With Visualization: Gold Standard Consensus Guidelines from an Expert Panel. J Drugs Dermatol 18:7\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWhite WM, Makin IRS, Barthe PG et al (2007) Selective Creation of Thermal Injury Zones in the Superficial Musculoaponeurotic System Using Intense Ultrasound Therapy. Arch Facial Plast Surg 9:22\u0026ndash;29\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWhite WM, Makin IRS, Slayton MH et al (2008) Selective transcutaneous delivery of energy to porcine soft tissues using intense ultrasound (IUS). Lasers Surg Med 40:67\u0026ndash;75\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSuh DH, Shin MK, Lee SJ et al (2011) Intense Focused Ultrasound Tightening in Asian Skin: Clinical and Pathologic Results. Dermatol Surg 37:1\u0026ndash;8\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVachiramon V, Pavicic T, Casabona G et al (2024) Microfocused Ultrasound in Regenerative Aesthetics: A Narrative Review on Mechanisms of Action and Clinical Outcomes. J Cosmet Dermatol epub ahead of print.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFabi SG, Massaki A, Eimpunth S et al (2013) Evaluation of microfocused ultrasound with visualization for lifting, tightening, and wrinkle reduction of the d\u0026eacute;colletage. J Am Acad Dermatol 69:965\u0026ndash;971\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAraco A (2020) Prospective Study on Clinical Efficacy and Safety of a Single Session of Microfocused Ultrasound With Visualization for Collagen Regeneration. Aesthet Surg J 40:1124\u0026ndash;1132\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKerscher M, Nurrisyanti AT, Eiben-Nielson C et al (2019) Skin physiology and safety of microfocused ultrasound with visualization for improving skin laxity. Clin Cosmet Investig Dermatol 12:71\u0026ndash;79\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePavicic T, Ballard JR, Bykovskaya T et al (2022) Microfocused ultrasound with visualization: Consensus on safety and review of energy-based devices. J Cosmet Dermatol 21:636\u0026ndash;647\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuittet C, Ossant F, Remenieras J-P et al (1999) High-frequency estimation of the ultrasonic attenuation coefficient slope obtained in human skin: simulation and \u003cem\u003ein vivo\u003c/em\u003e results. Ultrasound Med Biol 25:421\u0026ndash;429\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSayed IS (2018) Multi-frequency ultrasound imaging: Phantom study. Int J Allied Health Sci 2:304\u0026ndash;309\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKratzer W, G\u0026uuml;thle M, Dobler F et al (2022) Comparison of superb microvascular imaging (SMI) quantified with ImageJ to quantified contrast-enhanced ultrasound (qCEUS) in liver metastases\u0026mdash;a pilot study. Quant Imaging Med Surg 12:1762\u0026ndash;1774\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBerger VW, Zhou Y (2014) Kolmogorov\u0026ndash;Smirnov Test: Overview. Wiley StatsRef: Statistics Reference Online. John Wiley \u0026amp; Sons, Ltd\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZuo Y, Yu X, Lu S (2016) Dermal Fibroblasts from Different Layers of Pig Skin Exhibit Different Profibrotic and Morphological Characteristics. Anat Rec 299:1585\u0026ndash;1599\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNestor MS, Park H (2014) Safety and Efficacy of Micro-focused Ultrasound Plus Visualization for the Treatment of Axillary Hyperhidrosis. J Clin Aesthetic Dermatol 7:14\u0026ndash;21\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Ultherapy, Ultherapy PRIME, MFU-V, ultrasound visualization, microfocused ultrasound, skin lifting, skin tightening","lastPublishedDoi":"10.21203/rs.3.rs-6229189/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6229189/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground:\u003c/h2\u003e \u003cp\u003eMicrofocused ultrasound with visualization (MFU-V) is a non-invasive treatment for skin lifting and tightening. Ultherapy\u003csup\u003e\u0026reg;\u003c/sup\u003e (MFU-V 1.0) and Ultherapy PRIME (MFU-V 2.0) are both MFU-V devices, with the latter being recently developed with enhanced visualization technologies amongst other notable improvements. Thus, we sought to compare the ultrasound visualization components and visual noise reduction capabilities of MFU-V 1.0 and MFU-V 2.0 systems. We also sought to gain insights from clinicians with experience using both systems.\u003c/p\u003e\u003ch2\u003eMaterials and Methods:\u003c/h2\u003e \u003cp\u003eA comparative analysis was conducted on the ultrasound imaging components of both systems. Screen size, pixel count, and ultrasound images taken with 3.0 mm and 4.5 mm transducers on water blocks were collected and analyzed and visual noise levels quantified. An early user experience survey was sent out to query clinicians on their experience 2 months after switching from MFU-V 1.0 to MFU-V 2.0.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe ultrasound field of MFU-V 2.0 was 38.14% larger and its pixel density was 91.01% greater than MFU-V 1.0. Visual noise reduction in MFU-V 2.0 was significantly reduced by up to 72.02% using new transducers and up to 64.04% using used (at least 1400 lines) transducers. Nine clinicians having treated 68 patients with MFU-V 2.0 noted an average treatment time reduction of 19.7% and reported high degrees of satisfaction with the improved visualization, ergonomics, ease of use, and intuitiveness of MFU-V 2.0.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eMFU-V 2.0 significantly enhances ultrasound visualization quality and reduces visual noise compared to MFU-V 1.0. Clinicians noted a reduction in average treatment time and broad system improvements with MFU-V 2.0. These improvements facilitate faster and more precise targeting during treatment potentially leading to enhanced clinical outcomes in skin lifting and tightening procedures.\u003c/p\u003e\u003ch2\u003eLevel of Evidence\u003c/h2\u003e \u003cp\u003eNot applicable preclinical\u003c/p\u003e","manuscriptTitle":"Comparative Ultrasound Visualization Analysis Between Ultherapy® and Ultherapy PRIME and Survey and Clinical Case Results from the Ultherapy PRIME Early Experience Program","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-08 02:52:39","doi":"10.21203/rs.3.rs-6229189/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"
[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"ea4ff345-dd37-4a5d-bba2-4b5ef426e416","owner":[],"postedDate":"April 8th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":45708472,"name":"Dermatology"}],"tags":[],"updatedAt":"2025-04-08T02:52:39+00:00","versionOfRecord":[],"versionCreatedAt":"2025-04-08 02:52:39","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6229189","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6229189","identity":"rs-6229189","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}
Text is read by the "Ask this paper" AI Q&A widget below.
Extraction quality varies by source — PMC NXML preserves structure
cleanly, OA-HTML may include some navigation residue, and OA-PDF can
have broken hyphenation. The publisher copy
(via DOI)
is the canonical version.