Medical Professionals
Our flagship product, Vertica, represents groundbreaking advancement in the field of non-invasive, user-friendly home treatments for erectile dysfunction. Developed by experts in advanced technologies, Vertica embodies a clinically-oriented approach to medical device innovation.
We continue our commitment to medical excellence and maintain active partnerships with leading urologists to conduct ongoing clinical trials aimed at broadening Vertica's applications and enhancing its efficacy. The proven Vertica technology provides a platform for the development of treatment solutions for a growing range of urological indications such as Peyronie and post-radical prostatectomy,
Our dedication to innovation aligns closely with the stringent standards expected of medical devices.
Clinical Investigation
Prior to public release, our company conducted a pilot study to evaluate the feasibility, effectiveness, and safety profile of Vertica®. Led by Principal Investigator Prof. Ilan Gruenwald, this pilot clinical study took place at the Neuro-urology unit, Rambam Healthcare Campus, Israel.
Detailed findings of the study are accessible here.
Pilot Study Results
Twenty-eight men with a minimum six-month history of erectile dysfunction participated in the study, revealing that 85% experienced improved erectile function. A subsequent six-month follow-up study demonstrated the sustained efficacy of Vertica treatment.
Participants underwent a regimen of 12 treatments with the Vertica® device, comprising two treatments per week over four weeks (eight sessions in total), followed by one treatment per week for an additional four weeks (four sessions in total). Treatment administration was self-managed by participants according to provided instructions.
The study concluded with positive changes observed in both subjective and objective measures of erectile function, without any reported adverse events.
Continued Clinical Research
Ohh-Med is presently engaged in an IRB-approved randomized controlled trial (RCT) clinical study across several sites in the USA to assess the effectiveness of Vertica for the treatment of Erectile Dysfunction. The stringent protocol was designed together with the FDA to enable submission at the end of the study.
The site currently active is: UCI (University of California - Irvine), under the guidance of Dr. Faysal Yafi.
Additionally, we are collaborating with leading international urologists to expand our clinical research efforts, exploring further indications for Vertica treatment, including Peyronie’s disease, penile rehabilitation after radical prostatectomy, and beyond.
Clinical Information
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Vertica and RelatedBistritzky Dr. Sergiu, Appel Dr. Boaz, Shechter Dr. Arik, Gruenwald Prof. Ilan, (267) Erectile Dysfunction Treatment with Radiofrequency energy-based device RF Vertica®, 6-month follow-up, The Journal of Sexual Medicine, Volume 20, Issue Supplement_4, July 2023, qdad062.014, https://doi.org/10.1093/jsxmed/qdad062.014 Gruenwald I, Spector A, Shultz T, Lischinsky D, Kimmel E. The beginning of a new era: treatment of erectile dysfunction by use of physical energies as an alternative to pharmaceuticals. Int J Impot Res 2019;31:155–61. https://doi.org/10.1038/s41443-019-0142-y. Gruenwald, I., Appel, B., Shechter, A. et al. Radiofrequency energy in the treatment of erectile dysfunction—a novel cohort pilot study on safety, applicability, and short-term efficacy. Int J Impot Res (2023). https://doi.org/10.1038/s41443-023-00733-1 Perugia G, Liberti M, Vicini P, Colistro F, Gentile V. Use of local hyperthermia as prophylaxis of fibrosis and modification in penile length following radical retropubic prostatectomy. Int J Hyperthermia. 2005 Jun;21(4):359-65. doi:10.1080/02656730500133827. PMID: 16019861.
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General Research and Current Treatments for Erectile DysfunctionMcCabe MP, Sharlip ID, Atalla E, Balon R, Fisher AD, Laumann E, et al. Definitions of sexual dysfunctions in women and men: a consensus statement from the fourth international consultation on sexual medicine 2015. J Sex Med. 2016;13:135–43. Kessler A, Sollie S, Challacombe B, Briggs K, Van, Hemelrijck M. The global prevalence of erectile dysfunction: a review. BJU Int 2019;124:587–99. Debasis B, Ann SP, Bhimrao FS, Sonia M. Erectile Dysfunction: A Review on Prevalence, Perceptions, Diagnosis and Management in India. J Assoc Physicians India. 2020;68:57–61. Islam MM, et al, The Race to Replace PDE5i: Recent Advances and Interventions to Treat or Manage Erectile Dysfunction: Evidence from Patent Landscape (2016-2021). J Clin Med. 2022 May 31;11(11):3140. doi: 10.3390/jcm11113140. PMID: 35683526; PMCID: PMC9181403. Pang K, et al, Advances in physical diagnosis and treatment of male erectile dysfunction. Front Physiol. 2023 Jan 9;13:1096741. doi: 10.3389/fphys.2022.1096741. PMID: 36699684; PMCID: PMC9868413. Pang K, et al, Advances in physical diagnosis and treatment of male erectile dysfunction. Front Physiol. 2023 Jan 9;13:1096741. doi: 10.3389/fphys.2022.1096741. PMID: 36699684; PMCID: PMC9868413. Olsen AB, Persiani M, Boie S, Hanna M, Lund L. Can low-intensity extracorporeal shockwave therapy improve erectile dysfunction? A prospective, randomized, double-blind, placebo-controlled study. Scand J Urol. 2015;49:329–33. Ilangovan G, Venkatakrishnan CD, Bratasz A, Osinbowale S, Cardounel AJ, Zweier JL, et al. Heat shock-induced attenuation of hydroxyl radical generation and mitochondrial aconitase activity in cardiac H9c2 cells. Am J Physiol Cell Physiol. 2006;290:C313-24. https://doi.org/10.1152/ajpcell.00362.2005. Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997;49:822–30. Mulhall JP, Goldstein I, Bushmakin AG, Cappelleri JC, Hvidsten K. Validation of the erection hardness score. J Sex Med. 2007;4:1626–34. Cappelleri JC, Tseng LJ, Stecher VJ, Althof SE. Clinically important difference on the erectile dysfunction inventory of treatment satisfaction questionnaire in patients with erectile dysfunction. Int J Clin Pract. 2018;72:e13073. Dean RC, Lue TF. Physiology of penile erection and pathophysiology of erectile dysfunction. Urol Clin North Am. 2005;32:379–95. Raviv G, Kiss R, Vanegas JP, Petein M, Danguy A, Schulman C, et al. Objective measurement of the different collagen types in the corpus cavernosum of potent and impotent men: an immunohistochemical staining with computerized-image analysis. World J Urol. 1997;15:50–5. Luangkhot R, Rutchik S, Agarwal V, Puglia K, Bhargava G, Melman A. Collagen alterations in the corpus cavernosum of men with sexual dysfunction. J Urol. 1992;148:467–71. Goldstein AMB, Meehan JP, Morrow JW, Buckley PA, Rogers FA. The fibrous skeleton of the corpora cavernosa and its probable function in the mechanism of erection. Br J Urol. 1985;57:574–8. Pozzi A, Yurchenco PD, Iozzo RV. The nature and biology of basement membranes. Matrix Biol. 2017;57, 58:1–11. Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010;58:243–8. Capogrosso P, Frey A, Jensen CFS, Rastrelli G, Russo GI, Torremade J, et al. Low-Intensity Shock Wave Therapy in Sexual Medicine—Clinical Recommendations from the European Society of Sexual Medicine (ESSM). J Sex Med 2019;16:1490–505. https://doi.org/10.1016/j.jsxm.2019.07.016. Ciampa AR, De Prati AC, Amelio E, Cavalieri E, Persichini T, Colasanti M, et al. Nitric oxide mediates anti-inflammatory action of extracorporeal shock waves. FEBS Lett. 2005;579:6839–45. Kim N, Vardi Y, Padma-Nathan H, Daley J, Goldstein I, De Tejada IS. Oxygen tension regulates the nitric oxide pathway. Physiological role in penile erection. J Clin Invest. 1993;91:437–42. Harris MB, Blackstone MA, Ju H, Venema VJ, Venema RC. Heat-induced increases in endothelial NO synthase expression and activity and endothelial NO release. Am J Physiol Heart Circ Physiol. 2003;285:H333-40. https://doi.org/10.1152/ajpheart.00726.2002 Mamede C1, Quibervile A1, Sodré P1, et al., Clinical, Abstract - 525, On Demand Rehabilitation, Scientific Open Discussion, Session 34, Male Sexual Dysfunction : https://www.ics.org/2021/abstract/525 Moreland RB. Pathophysiology of erectile dysfunction: the contributions of trabecular structure to function and the role of functional antagonism. Int J Impot Res. 2000 Oct;12 Suppl 4:S39-46. doi: 10.1038/sj.ijir.3900576. PMID: 11035385.
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Radiofrequency Energy in Medical ApplicationsFu L, Long S, et al, The efficacy and safety of temperature controlled dual-mode radiofrequency in women with vaginal laxity. BMC Womens Health. 2023 Mar 23;23(1):121. doi: 10.1186/s12905-023-02261-y. PMID: 36959573; PMCID: PMC10035145. Meyer PF, de Oliveira P, Silva FKBA, da Costa ACS, Pereira CRA, Casenave S, et al. Radiofrequency treatment induces fibroblast growth factor 2 expression and subsequently promotes neocollagenesis and neoangiogenesis in the skin tissue. Lasers Med Sci. 2017;32:1727–36. https://doi.org/10.1007/s10103-017-2238-2. Bonjorno AR, Gomes TB, Pereira MC, de Carvalho CM, Gabardo MCL, Kaizer MR, et al. Radiofrequency therapy in esthetic dermatology: A review of clinical evidences. J Cosmet Dermatol. 2020;19:278–81. https://doi.org/10.1111/jocd.13206. El-Domyati M, El-Ammawi TS, Medhat W, Moawad O, Brennan D, Mahoney MG, et al. Radiofrequency facial rejuvenation: evidence- based effect. J Am Acad Dermatol. 2011;64:524–35. Beasley KL, Weiss RA. Radiofrequency in cosmetic dermatology. Dermatol Clin. 2014;32:79–90. Lolis MS, Goldberg DJ. Radiofrequency in cosmetic dermatology: a review. Dermatologic Surg. 2012;38:1765–76. de Araújo AR, Soares VPC, da Silva FS, da Silva Moreira T. Radiofrequency for the treatment of skin laxity: myth or truth. Bras Dermatol. 2015;90:707–21. Zelickson BD, Kist D, Bernstein E, Brown DB, Ksenzenko S, Burns J, et al. Histological and ultrastructural evaluation of the effects of a radiofrequency- based nonablative dermal remodeling device: a pilot study. Arch Dermatol. 2004;140:204–9. Leibaschoff G, Izasa PG, Cardona JL, Miklos JR, Moore RD. Transcutaneous temperature controlled radiofrequency (TTCRF) for the treatment of menopausal vaginal/genitourinary symptoms. SurgTechnol Int. 2016;29:149–59. Longo C, Galimberti M, De Pace B, Pellacani G, Bencini PL. Laser skin rejuvenation: epidermal changes and collagen remodeling evaluated by in vivo confocal microscopy. Lasers Med Sci. 2013;28:769–76. Mamede c, Quibervile a S p. Non-ablative radiofrequency improves hemodynamic parameters in patients with erectile dysfunction: preliminary data. www.ics.org/2021/abstract/525. Mobley DF, Khera M, Baum N. Recent advances in the treatment of erectile dysfunction. Postgrad Med J. 2017 Nov;93(1105):679-685. doi:10.1136/postgradmedj-2016-134073. Epub 2017 Jul 27. PMID: 28751439.
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Professor Ilan Gruenwald has been leading the Neurourology unit, Rambam Medical Center for over 10 years. He has been intimately involved in the development of Vertica and was the PI of the first pilot study.
Please feel free to contact Prof Gruenwald if you have clinical questions for your patients.
