Comphya

We are excited to announce that the interim results of our CaverSTIM clinical trials were presented at the World Meeting on Sexual Medicine 2024 in Rio de Janeiro! The findings were shared by our esteemed lead investigators: -       Dr. Phil Dundee presented the post-prostatectomy trial results conducted at the Australian Prostate Centre and Royal Melbourne Hospital, Australia. -       Dr. Sidney Glina presented the spinal cord injury trial results conducted at the Faculty of Medicine ABC and Hospital Mario Covas, São Paulo, Brazil. Both presentations showcased encouraging outcomes, with CaverSTIM demonstrating excellent safety profile and promising improvements in erectile function. We are incredibly grateful for the enthusiastic reception from the urology community and want to extend our sincere thanks to Dr. Dundee, Dr. Glina, and their respective teams for their dedication and outstanding work. These results mark a significant milestone in our journey to alleviate the burden of erectile dysfunction, offering hope to patients and their partners. At Comphya, we stay committed to providing a unique solution to improve the life for millions of patients worldwide. #CaverSTIM #neurostimulator #neuromodulation #erectiledysfunction #postprostatectomy #spinalcordInjury #sexualmedicine #clinicaltrials #urology #menshealth

Showcasing Our Clinical Breakthroughs at the World Meeting on Sexual Medicine We are excited to announce that the results from our ongoing clinical trials with CaverSTIM will be presented at the prestigious World Meeting on Sexual Medicine 2024 in Rio de Janeiro from September 26-29. This premier global congress is a key platform in urology and sexual medicine, gathering leading experts and pioneers to explore cutting-edge advancements and innovations in the field. Our two ongoing clinical studies will be presented: -    Dr. Phillip Dundee, urology surgeon at Royal Melbourne Hospital in Melbourne, will present data from 7 prostatectomy patients implanted with CaverSTIM in the study conducted in Melbourne, Australia. -    Dr. Sidney Glina, professor of urology at FMABC São Paulo, will present the outcomes of 6 spinal cord injury patients implanted with CaverSTIM in the study conducted in São Paulo, Brazil. These trials focus on evaluating the safety and effectiveness of our device in restoring erectile function after prostate surgery and spinal cord injury. The early results from both studies are highly encouraging and mark a significant milestone in our mission to transform the lives of men with erectile dysfunction. This event offers a valuable opportunity for professionals in the field to learn about our technology and review this promising data. We are excited about the future of our technology and the difference it can make for patients worldwide. We will share more updates after the meeting - stay tuned! #ProstateCancer #Prostatectomy #ErectileDysfunction #MedicalDevice #Neuromodulator #Neurostimulator #MensHealth #WorldMeetingonSexualMedicine

Comphya SA Receives Approval to Launch Clinical Study for CaverSTIM in Prostatectomy Patients in Brazil. Lausanne, Switzerland, August 23rd, 2024 – Comphya SA, a pioneering medical technology company and the developer of CaverSTIM, the first implantable neuromodulator designed to treat erectile dysfunction, is pleased to announce that it has received approval from the Brazilian National Research Ethics Committees (CEP and CONEP) and the federal regulatory authority ANVISA to initiate a pilot clinical trial in patients undergoing prostatectomy. This new study will significantly bolster the ongoing clinical trials in prostatectomy patients in Australia and serves as a key component of Comphya’s global clinical development program, which also includes clinical studies in the United States. The procedures will be conducted using minimally invasive laparoscopic surgery at the renowned Mario Covas Hospital, Faculdade de Medicina do ABC, in Sao Paulo. The study will focus on assessing the effectiveness and safety of the CaverSTIM system. Recruitment has already begun, marking the launch of this highly anticipated clinical trial that holds significant promise for advancing patient care in erectile dysfunction. "We are excited to initiate this pivotal study in Brazil, which represents a critical milestone in our mission to deliver groundbreaking solutions for erectile dysfunction," stated Dr. Rodrigo Fraga-Silva, Ph.D., CEO of Comphya SA. "This approval not only reflects the progress of our clinical program but also underscores the growing global recognition of CaverSTIM’s potential to transform treatment outcomes for patients." “We are thrilled to be expanding our clinical research with this new study in prostatectomy patients. The first study we initiated last year in spinal cord injury patients has shown promising results so far, giving us strong confidence as we now extend our investigation to patients undergoing prostatectomy," stated Dr. Sidney Glina, Principal Investigator at FMABC. "With CaverSTIM, if we continue with those exciting results, we may offer a groundbreaking therapeutic option that can significantly improve the quality of life for patients suffering from erectile dysfunction. We are eager to assess its effectiveness and safety in this new patient population and are optimistic about the potential outcomes". https://lnkd.in/e2N7pU98 #ErectileDysfunction #Neuromodulation #Neurostimulator #Prostatectomy #ProstateHealth #MensHealth #MedicalDevices

We are delighted to announce that CaverSTIM was successfully implanted in the 13th patient yesterday in Brazil as part of our ongoing clinical trials. The clinical development of CaverSTIM is progressing well, with very promising results already obtained. Comphya is conducting two clinical trials: one in Melbourne, Australia, involving prostatectomy patients, and another in São Paulo, Brazil, involving spinal cord injury patients. We are also enthusiastic about the growing interest from additional clinical centers eager to join our efforts and participate in the clinical studies. This achievement marks another significant step towards advancing our innovative solutions, which will benefit many men worldwide and their partners. Stay tuned for more updates! #erectiledysfunction #prostatectomy #spinalcordinjury #neurostimulation #neuromodulation

Today, CaverSTIM technology has been featured on G1, one of Brazil’s most reputable news portals and part of Grupo Globo. In an excellent article written by Poliana Casemiro, the current challenges faced by erectile dysfunction patients who do not respond to oral drugs and resort to problematic therapies are thoroughly explained. The article highlights Comphya's technology and our commitment to addressing this critical clinical issue and better serving patients in need. Importantly, it also highlights our promising initial clinical results, indicating a positive direction for our technology to transform the lives of many men with erectile dysfunction. Thank you, G1, for spotlighting our efforts to provide a better alternative for men with erectile dysfunction. Check out the full article to learn more! https://lnkd.in/dUEhT6Aw

We are pleased to share a fantastic article by Valéria Maniero at RFI and G1 about Comphya and our innovative solution, CaverSTIM. We are excited about the promising results from our trials in Brazil and Australia. Thank you, RFI and G1, for highlighting our efforts to provide a better alternative for men with erectile dysfunction. Check out the full article to learn more! https://lnkd.in/eTWdDBDc https://lnkd.in/eQDh9TBS

Exciting news from the #AUA Congress in San Antonio, Texas. Yesterday, Dr. Phil Dundee presented the promising results from our pilot clinical trial in Melbourne, Australia. In his presentation, Dr. Dundee showcased the potential of CaverSTIM in restoring erectile function post-prostatectomy. The initial data from the first 3 cases reveal complete recovery of erectile function, as measured by the IIEF-15 score. Interestingly, patients implanted with CaverSTIM also showed preserved nocturnal erections, contrasting with the very common substantial reduction in nocturnal erections experienced by post-prostatectomy patients. This preservation of nocturnal erections by CaverSTIM is essential for preventing remodeling/tissue fibrosis and maintaining sexual function. As stated by Dr. Dundee, these initial outcomes are very encouraging, suggesting that CaverSTIM could be a game-changer in alleviating erectile dysfunction post-prostatectomy. Stay tuned for more updates! #Comphya #CaverSTIM #prostatecancer #prostatectomy #erectiledysfunction #neurostimulation #neuromodulation #menshealth

Comphya is delighted to announce that our latest clinical data will be presented at the prestigious American Urological Association's (AUA) Annual Meeting on May 3rd in San Antonio, TX, United States. Recognized as a premier scientific congress in urology, this event marks our commitment to bringing better treatment to patients suffering from erectile dysfunction. Dr. Phil Dundee, our esteemed principal investigator based in Melbourne, Australia, will be presenting the clinical results.  Stay tuned for more updates. https://lnkd.in/ewvysgZs

We are excited to share that our technology has been featured on Reporter Brazil from TV Brasil EBC. The reportage highlighted our ongoing clinical trial in São Paulo, Brazil, focused on spinal cord injury patients, led by Dr. Sidney Glina. Our innovative technology and the remarkable preliminary results have been spotlighted, showcasing the potential to positively impact countless lives. Additionally to this groundbreaking work in Brazil, Comphya is also conducting another clinical trial in Australia, focusing on prostatectomy patients, with outstanding preliminary results. Stay tuned for more updates as we continue our clinical development to make strides in medical innovation and benefit many lives. Watch the insightful coverage here: https://lnkd.in/eT-k5VaM #erectiledysfunction #spinalcordinjury #prostatectomy #prostatecancer #neuromodulation #neurostimulation #innovation

Progress Update on Our Clinical Trial in Prostatectomy Patients We are excited to announce the latest milestone in our pilot clinical trial focusing on neurostimulation therapy for erectile dysfunction post-prostatectomy. The fourth patient has been successfully implanted on March 21st, Thursday, marking another significant step forward in our mission to improve patient outcomes. Under the expert guidance of Dr. Phil Dundee, Principal Investigator, we are proud to report not only the success of the fourth implantation but also the promising results from our previous cases. As Dr. Dundee remarks, "The success of the fourth implantation shows the good progress of our study. Additionally, the functional data recently obtained from the third case underscores the remarkable preservation of erectile function post-prostatectomy with the CaverSTIM device, aligning with the excellent outcomes observed in our initial cases. Although further data is needed to draw definitive conclusions, I believe the clinical study is confidently progressing towards success". These achievements underscore our commitment to advancing innovative therapies and providing hope for patients facing erectile dysfunction following prostatectomy. Stay tuned for further updates as we continue to make strides in our clinical trial journey. Photo: Dr. Phill Dundee in the center, Fiona Joseph on the right, and Rodrigo Fraga on the left.