Mr. Stephen Kilmer reports
JOHNS HOPKINS MEDICINE TREATS FIRST COMMERCIAL TULSA-PRO® CASE
The Johns Hopkins Hospital has treated its first non-clinical-trial prostate cancer patient using Profound Medical Corp.'s Tulsa-Pro
system. The milestone marks the official launch of Tulsa-Pro at one of the world's most influential centres for prostate cancer innovation and coincides with the opening of Johns Hopkins Medicine's new interventional MRI (iMRI) suite -- signalling the continued evolution of MRI from diagnostic imaging -- only to a real-time therapeutic platform.
The Tulsa procedure represents a major advancement in prostate care, and is used by physicians to treat prostate cancer and benign prostatic hyperplasia (BPH, also known as an enlarged prostate). Robotically controlled directional ultrasound is delivered from inside the urethra to precisely and gently heat prostate tissue to "kill temperature" (55 to 57 degrees Celsius) with directional ultrasound, while protecting surrounding nerves and anatomy. Real-time MRI thermography enables continuous visualization and autonomous temperature adjustment throughout the procedure. This level of precision allows physicians to tailor therapy to each patient, resulting in no procedural blood loss, no overnight hospital stay and a quicker return to everyday life, while minimizing side effects typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.
"The implementation of Tulsa-Pro in a newly built interventional MR suite specifically designed for surgical procedures that benefit from the precision of real-time MRI to deliver superior clinical outcomes is a growing movement. Accordingly, it is not surprising that a leading institution such as Johns Hopkins Medicine is at the forefront of this trend. John Hopkins University was an early participant in the clinical development of Tulsa-Pro through participation in the TACT pivotal clinical trial that led to the technology's FDA clearance, and then in the more recent randomized prospective postmarket Captain trial. We are thrilled to see them now offer Tulsa-Pro to their patients as an option to treat prostate cancer or symptoms of BPH," said Arun Menawat, chief executive officer and chairman of Profound Medical.
About Profound Medical Corp.
Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue.
Profound is commercializing Tulsa-Pro, a technology that combines real-time MRI, AI-enhanced planning, robotically driven transurethral ultrasound and closed-loop temperature feedback control. The Tulsa procedure, performed using the Tulsa-Pro system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate- or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (BPH); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. The Tulsa procedure employs real-time MR guidance for precision to preserve patients' urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55 to 57 degrees Celsius. Tulsa is an incision- and radiation-free one-and-done procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively and efficiently treated with Tulsa. There is no bleeding associated with the procedure; no hospital stay is required; and most Tulsa patients report quick recovery to their normal routine. Tulsa-Pro is CE marked, Health Canada approved and 510(k) cleared by the U.S. Food and Drug Administration (FDA).
Profound is also commercializing Sonalleve, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumours and osteoid osteoma. Sonalleve has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a humanitarian device exemption for the treatment of osteoid osteoma. Profound is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.
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