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Prostate Cancer Treatment Idea Proposal (EDAP, PROF)

Prostate Cancer Treatment Idea Proposal (EDAP, PROF)

Will EDAP’s and PROF’s minimally invasive prostate cancer treatments significantly challenge the standard of care of surgery and radiation?

Report Available: March 25, 2021


Blueshift’s initial research found that high intensity focused ultrasound (HIFU), a prostate cancer treatment that uses the energy of highly focused ultrasound to pinpoint, heat, and kill prostate cancer cells, is gaining traction with physicians and patients. It offers significant advantages over the standard of care of radiation and/or surgery. HIFU treatment is minimally invasive with no incision, has a short recovery time, targets diseased tissue only, and reduces the risk of urinary incontinence and erectile dysfunction. EDAP and PROF each offer HIFU devices and supporting equipment which are vying for a larger portion of the prostate cancer and BPH treatment market. However, challenging the standard of care in medicine is difficult, and limited reimbursement delays adoption, making it an open question whether either or both companies will gain meaningful share.



  1. EDAP’s Focal One device has been in use in Europe since receiving CE Mark approval in June 2013 and in the U.S. since FDA approval in June 2018. EDAP now offers a second-generation Focal One combined with the ExactVu Micro-Ultrasound device, making EDAP the only company offering a complete solution from diagnostics to focal treatment of prostate cancer. Focal One uses HIFU, meaning the energy must pass through the rectal wall to reach the intended treatment location in the prostate.
  2. PROF commercialized its TULSA-PRO device in Europe in April 2016 and in the U.S. in August 2019. TULSA stands for Transurethral, ULtraSound, Ablation of the Prostate. It is unique because it offers directional high-intensity ultrasound which is delivered through the urethra. The energy does not come through the rectum, meaning the rectum is not damaged. In addition, TULSA has both rectal cooling and urethral cooling throughout the treatment to further protect the rectum from any unintended heat.
  3. The recent financial performance for both companies has been strong and each company is optimistic about continued growth.
  • EDAP preannounced record Q4 results with a 28% YY increase in revenue to $18.3 million. During the quarter, HIFU revenue was up 50%, driven by the sale of eight HIFU devices including a bundled sale of Focal One and Exact Vu to the University of California, San Francisco (UCSF) Medical Center and a Focal One sale to the Cleveland Clinic. However, full year 2020 revenue declined 7% to $47.8 million vs. $50.2 for full year 2019 due to COVID-19 related restrictions. EDAP reports Q4 and full year 2020 results in March.
  • PROF preannounced Q4 revenue of approximately $3.7 million, representing growth of 32% YY and 24% sequentially. Full year 2020 total revenues are expected to be approximately $9.7 million, which compares to $5.5 million in 2019. PROF is scheduled to report Q4 and full year 2020 on March 2.
  1. A study published in The Journal of Urology found that the use of HIFU has shown adequate control of prostate cancer while avoiding major side effects of surgery or radiation therapy. The study’s authors said, “Focal HIFU ablation is safe and provides excellent potency and continence preservation with adequate short-term cancer control.” Positive study results should help both EDAP and PROF in their effort to increase adoption and usage of their devices.
  2. Despite positive study results and FDA approval of the first HIFU device for the treatment of prostate cancer in 2015, reimbursement has been slow to materialize. The first reimbursement code to be issued by the Centers for Medicare & Medicaid Services (CMS) did not come until the summer of 2017 and that only covered reimbursement for the facility where HIFU is delivered. At the time and well into 2018, commercial insurance was not covering any HIFU treatments for patients that were not covered by CMS. According to information on EDAP’s website, reimbursement is improving in 2021. A Dec. 9, 2020, press release indicated that as of Jan. 1, 2021, facilities performing HIFU would receive $4,500, a 6% increase over 2020 reimbursement. In addition, for the first time ever, physicians would receive reimbursement of $943, which puts it in-line with other minimally invasive therapies for prostate cancer like cryotherapy which receives a physician reimbursement of $736. These new reimbursements should help with establishing HIFU as a legitimate prostate cancer treatment option.


Will EDAP and/or PROF take share from standard of care prostate cancer treatments? How big is the market opportunity for each company’s prostate cancer treatment device? Is one device superior to the other? What are the competitive dynamics? Is one company’s financial model more attractive than the other? What is the TAM for HIFU? What percentage of that TAM can each company get over the next 12 to 24 months? To answer these and other questions, Blueshift will gather data and issue a market research report from independent sources in the following areas: Urologists and members of their teams, Surgical device sales channel, Hospitals and GPOs, and Industry specialists. 


Companies: EDAP TMS S.A. (EDAP), Profound Medical Corp. (PROF)


Research Begins: March 8, 2021


To see other ideas Blueshift Research is currently working on, please click here.


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