News
April 2022 – First patient treated in skin cancer study.
The dermatology departments at Bispebjerg and Roskilde University Hospitals in Denmark initiate pioneering treatment of Basal Cell Carcinoma, the world’s most common cancer, with the convenient, minimal-pain and easy-to-operate modality for skin oncology facilitated by the TOOsonix System ONE-M.
Basal Cell Carcinoma (BCC) is sun-induced, and is expected to increase in incidence along with the increase of the elderly population. Adding safe, effective and cost-efficient treatments will therefore be important for both patients and healthcare providers around the world.
The clinical study will include 40 patients diagnosed with superficial BCC. The focused ultrasound treatment will be administered as a single dosing of approximately 1-2 minutes of active focused ultrasound. The treatment does not require any local anesthetics and no special after-care. Study participants are monitored with regular follow-up visits over 12 months after treatment. A report with evaluation of cure rate and safety profile 3 months after treatment is planned.
See the full Press Release here.
April 2022 – Invited talk at Polish Academy of Dermatoscopy conference.
Dr. Tomasz Zawada was invited to present a review of ultrasound in Dermatology including both diagnostic and therapeutic methods.
With about 750 participants, the conference is the one of the biggest events in the EU relating specifically to the diagnosis of skin conditions, and is attended by expert doctors and medical specialists involved in the rapidly expanding fields of dermatology and dermato-oncology.
Other medical presentations included an overview of the latest results from HIFU treaments presented by our close clinical partners, Dr. Jacek Calik and Dr Bartosz Woźniak from Old Town Clinic Wroclaw Poland (link).
See Conference homepage here.
April 2022 – TOOsonix papers among top sited in journals from Wiley and Sons Inc.
Two papers from TOOsoix is among the top sited in journals from the scientific publishing house Wiley and Sons Inc.
A big thanks to the teams behind the papers, and in particular Professor Joergen Serup at Bispebjerg University Hospital, Copenhagen Denmark, who performed the treatments reported in these papers.
Links to papers:
March 2022 – Plans for coming clinical study for removal of cutaneous neurofibroma presented to Danish NF1 Patient Association.
TOOsonix and Professor Joergen Serup from University Hospital Bispebjerg Copenhagen was invited to share the plans for a coming clinical study to remove/reduce cutaneous neurofibromas in patients with Neurofibromatosis Type 1. The venue was the annual meeting in the Danish Neurofibromatosis patient association, with participation of a very active and motivated group from all over the country.
The presentation gave the details on the coming dual-center GCP study at Bispebjerg Hospital in Copenhagen Denmark and Sahlgrenska Hospital in Gothenburg Sweden. The study is aimed at using the TOOsonix System ONE-M in a non-ablative modality, where open wounds are avoided, and the regular complications of pain, infection and scarring is drastically reduced.
The study aims at demonstrating a completely new therapeutic solution for patients suffering from Neurofibromatosis Type 1, the most common single-gene inherited condition worldwide (approximately 1 in 3000 people).
January 2022 – System ONE-M installed at leading University Hospital in Sweden.
A System ONE-M is now installed at the Department of Dermatology and Venereology at Sahlgrenska University Hospital in Gothenburg. The team there is led by professor Sirkku Peltonen, who is one of the world’s leading capacities in treating patients with the genetic tumor syndrome Neurofibromatosis Type 1 (NF1).
NF1 is among the most common single-gene inherited conditions worldwide. Almost all patients with the condition suffer from various degrees of tumors in the skin, called cutaneous neurofibromas. These can number in the hundreds to thousands on a given individual, and while the tumors themselves are mostly benign, they are socially debilitating, painful and impede activities of daily living for those affected.
Despite the remarkable prevalence of skin tumors in people with NF1, and their documented negative influence on quality of life, current treatment is limited to surgical or laser removal. These both have well-known problems of pain during treatment, slow healing, potential infection, dyspigmentation and scarring.
The group in Gothenburg is therefore now all set for the coming clinical investigation on non-invasive removal/reduction of these tumors. It is our hope that the HIFU method can remove the tumors with a non-invasive and significantly less painful procedure, that at the same time effectively eliminates the regular side effects of scarring and dyspigmentation.
Read more about the coming trial here
Read more about Prof. Sirkku Peltonen and her work here.
December 2021 – Independent publication on Actinic Keratosis.
Paper on HIFU treatment of Actinic Keratosis published by the dermatology department at Inselspital Bern in Karger Dermatology, a medical journal with one of the highest impact factors (5.4) in the field of dermatology.
Actinic Keratosis (AK) is the most common precancerous condition in humans, affecting more than 100 million people in USA and EU alone. Finding safe, efficient, quick, pain-reduced and cost-effective treatment modalities are therefore becoming more and more important.
Results show and excellent 72.2% of the treated areas with full resolution of the condition after a single session lasting only about one minute, and without any pre- or post-procedure treatment. A further 14.8% and 11.1% experienced partial-to-complete or partial response respectively. An overall improvement in the condition after a single treatment session was thus observed in 98.1% of the cases. No adverse events were reported.
See the paper here.
November 2021 – Two Clinical Studies announched.
Two multicenter studies have been announced publicly on Clinicaltrials.gov.
See details on our BCC study with Bispebjerg and Roskilde University Hospital here.
See details on our Neurofibroma Study with Bispebjerg and Salgrenska University hospitals here.
August 2021 – Clinical Study on Removal of BCC Approved
The Danish Medicines Agency and National Committee on Health Research Ethics approved the start of a clinical investigation on single-session removal of basal cell carcinoma (BCC).
BCC is the most common type of cancer in the world, and treatments are counted in several tens of millions every year. Existing therapies have shortcomings in the form of varying efficacies, high treatment pain, scar formation, burn/freeze damages, pigmentary changes, radiation damages, nerve damages, hair-loss, and pharmaceutical side-effects.
With the new HIFU treatment we believe we can improve this situation.
The study will be conducted as a dual-center GCP investigation following all requirements from the new European Medical Device Regulation. It will be performed at the dermatological departments of Bispebjerg and Roskilde University Hospitals. The teams will recruit participants over the following months, and thereby start treatments in the autumn.
The full follow-up period will be 12 months as in most other cancer studies, but the protocol includes interim reports and updates during the study.
Please wish the medical teams good luck, and keep looking out for the updates on this unique new treatment that can change the lives of millions!
July 2021 – TOOsonix Installs System at Harvard Medical School
We are very happy to have completed a new installation of a research HIFU system at the Wellman Center for Photomedicine at Massachusetts General Hospital / Harvard Medical School.
The world-leading team there will use the system to test new non-invasive treatment modalities, and in particular therapy solutions for cutaneous neurofibromas in people living with Neurofibromatosis Type 1 (also known as von Recklinghausen’s disease). The work forms a part of the activities coordinated by the Neurofibromatosis Therapeutic Acceleration Program at Johns Hopkins University School of Medicine.
For TOOsonix, this is what it is all about. Using our technology to help people with symptomatic tumors that often result in significant disfigurement and pain, and where surgery is the only standard of care, is definitely a worthy cause by any measure.
We wish the research teams at Harvard and Johns Hopkins the best of luck with their research work, and will support them as much as we possibly can.
June 2021 – Invited talk at Polish Academy of Dermatoscopy conference.
Dr. Tomasz Zawada was invited to present the latest results on Dermatology HIFU at the annual Dermoscopy conference in Wroclaw Poland (link).
With almost 600 participants, the conference is the one of the biggest events in the EU relating specifically to the diagnosis of skin conditions, and is attended by expert doctors and medical specialists involved in the rapidly expanding fields of dermatology and dermato-oncology.
Other medical presentations included very positive clinical results from HIFU treatments of Seborrheic Keratosis from Dr. Monika Migdal and Dr. Jacek Calik from Old Town Clinic Wroclaw Poland (link), and early results on combined HIFU and pharmaceutical treatment of hyperpigmentation by Dr. Boguslaw Pilarski from Cerko Lab (link).
TOOsonix had a System ONE-M from Old Town Clinic Wroclaw in the exhibition area, so Dr. Migdal and Dr. Calik had the opportunity to demonstrate the device, and make several treatments on interested attendees.
March 2021 – TOOsonix installs system at leading private hospital in Denmark.
We are very proud to have our System ONE-M installed at the leading private hospital in Denmark, Skin Centre Molholm.
At Skin Centre Molholm, highly skilled dermatologists and nurses handle a large number of treatments, ranging from skin cancer and pre-cancers over general skin diseases and pigmentary disorders to cosmetic treatments. The expertise within the center furthermore comprise advanced diagnosis and analytics to secure that patients get thorough guidance on the impressive range of available treatment modalities.
In parallel with the internal activities, the Skin Centre Molholm participates and coordinates state-of-the-art medical research in cooperation with university hospitals in Denmark through the recently formed Knowledge Center for Skin Cancer.
The TOOsonix System ONE-M will gradually be included in the daily work on skin diseases and cosmetic treatments in the clinics of Skin Centre Molholm. In TOOsonix we fully support this work, and wish the staff all the best of luck with the coming period, where experience and routine will be build.
We very much hope that the equipment will become the preferred general dermatological tool and workhorse that we designed it to be. This way it will generate happy clients for the center, and help fulfill our vision of offering a quick, effective and less painful dermatological treatment modality for every dermatology clinic.
November 2020 – Presentation at the 7th International Symposium of the Focused Ultrasound Foundation.
TOOsonix presented its latest clinical results at the world’s leading forum for the latest translational and clinical advances in focused ultrasound.
The conference was attended by more than 1800 medical experts from all over the world in a fully virtual event. Key-note speakers included a highly impressive range of world leading medical professors and industrial leaders, including Nobel Laureate and Chair of Immunology at MD Anderson Cancer Center, James P Allison.
September 2020 – Invited talk at Polish Academy of Dermatoscopy.
20 MHz HIFU applications in dermatology and oncology. Dr. Tomasz Zawada.
See Conference homepage here.
September 2020 – TOOsonix launches research cooperation on treatment of BCC and other medical skin indications with leading oncologist in Poland.
TOOsonix has supplied a System ONE-M to the renowned oncologist and expert in dermoscopy diagnosis, Dr. Jacek Calik (http://oldtownclinic.pl/en/). The system will be used in his private practices for treatments within the indicated use as well as experimental treatments, after appropriate approvals. We give Dr. Calik full support and look forward to publishing the results of treatments as soon as possible.
August 2020 – Success story published by Medical PC supplier Cybernet.
Cybernet, a pioneer in all-in-one computing technology for the healthcare sector, published the TOOsonix System ONE as a success story on their internet page and newsfeeds. See case-story here.
August 2020 – Newsletter and Industrial profile on Focused Ultrasound Foundation.
The Focused Ultrasound Foundation is an entrepreneurial service organization recognized as one of America’s 10 best medical research organizations. It coordinates, funds, and supports the world’s leading experts in HIFU treatments through venture philanthropy and social entrepreneurship movements, and has become a model of how donor funding can be used to bridge the gap between laboratory research and widespread patient treatment.
Read the foundation’s story on Dermatology HIFU here. and their profile on TOOsonix here.
July 2020 – Two clinical papers on medical treatment and tattoo removal receives a top 98% rating among 15 million papers published by Wiley & Sons Inc.
Altmetric, a scoring algorithm used measure of the quality and quantity of online attention among more than 15 million publications made by Wiley & Sons Inc, quickly rose to almost 90 for both papers released earlier in July. This brings both papers with the 98% fractile of all articles measured by this site.
See the Altmetric Attention Score here.
July 2020 – CE marking and publication of clinical papers picked up by several media feeds and professional sites
The press release and publications regarding System ONE-M and its highly positive clinical results had a very positive reception, and was picked up by several news sites both within the Dermatology and Business sectors.
See for example stories from Dermatology Times, Practical Dermatology or Morning Star.
June 2020 – RELEASE OF MEDICAL PRODUCT: TOOsonix System ONE-M.
June 22nd 2020: TOOsonix proudly announces the release of its first medical product. The device provides highly diverse non-invasive treatments, and will, as a starting point, address unmet clinical needs for several conditions within the aesthetic field. The system provides unprecedented accurate thermal lesion points confined to the very outer layer of the human dermis and epidermis, and thereby mobilizes the humans own immune system of regeneration to replace cells with unwanted content of pigments and/or structure.
Read the press release here.
February 2020 – ISO 13485 Certification
TOOsonix received ISO 13485:2016 certification from TÜV SÜD. The certification was expanded to include the full scope from design and development to production and sales of medical devices. for full scope.
Download the certifiate here.
June 2019 – Poster at 19th International symposium of ISTU/EUFUS
High Frequency (20 MHz) focused ultrasound – A novel method for dermal intervention. Torsten Bove1 and Tomasz Zawada1, Jørgen Serup2
1TOOsonix A/S, Denmark. 2Department of Dermatology, Bispebjerg University Hospital, Denmark.
Download Abstract here. (Please contact us for a pdf-copy of the poster). Link to conference site here. Link to organizer sites: International Society for Therapeutic Ultrasound (ISTU) and European Focused Ultrasound Charitable Society (EUFUS).
May 2019 – Invited talk at Polish Society of Dermoscopy
Novel non-invasive method using therapeutic focused ultrasound and its applications in dermatology. Dr. Tomasz Zawada, TOOsonix A/S, Denmark.
(Polish title: Nowatorska metoda nieinwazyjnej terapii skoncentrowana wiazka ultradzwiekowa i jej zastosowania w dermatologii).
Link to conference site here.
April 2019 – Invited talk at the spring meeting of the Danish Dermatologic Society, Bispebjerg Hospital, Copenhagen Denmark
20 MHz focused ultrasound (HIFU) for dermatologic therapy, a novel Danish method with a wide spectrum of potential applications in clinical therapy. Prof Jorgen Serup, Department of Dermatology, Bispebjerg University Hospital, Denmark.
(Danish Title: 20MHz fokuseret ultralyd (HIFU) til dermatologisk terapi, en ny dansk metode med et spektrum af potentielle applikationer i klinisk dermatologi)
Link to conference site: here. Link to the Danish Dermatologic Society (DDS) site here.
March 2019 – Invited talk at the 4th European Congress on Tattoo and Pigment Research
High Frequency (20 MHz) focused ultrasound (HIFU), A novel method for tattoo removal: Preclinical experience and first experience in man. Prof. Jorgen Serup, Department of Dermatology, Bispebjerg University Hospital.
Download Abstract here. Link to conference site here. Link to the European Society of Tattoo and Pigment Research (ESTP) here.
January 2019 – ISO 13485 certification
TOOsonix received ISO 13485:2016 certification from TÜV SÜD. The certification comprise the necessary scope for design and development of medical devices.