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Profound Medical Receives Health Canada Approval for TULSA-PRO

02 Dec Profound Medical Receives Health Canada Approval for TULSA-PRO

Profound Medical Corp (NASDAQ: PROF), a medical technology Company that offers magnetic resonance guided ablation procedures, announced the approval of its TULSA-PRO® system for the ablation of low to intermediate risk organ-confined prostate cancer by Heath Canada.

The Company develops innovative, customizable, incision-free and radiation free ablation therapies that offer the perfect amalgamation of Magnetic Resonance Imaging, thermal ultrasound and closed-loop temperature feedback control for treatment of diseased tissue.

TULSA-PRO system combines real-time MRI, robotically-driven transurethral thermal ultrasound and closed-loop temperature feedback control to provide a surgeon defined prostate volume, along with protecting the urethra and rectum by avoiding exposure to radiation. This is especially useful in cases where patients are diagnosed with organ confined disease as TULSRA–PRO has demonstrated a favorable safety profile and improved clinical effectiveness in these cases.

Goldy Singh, Profound’s VP, Regulatory Affairs & Product Management, commented

“The positive Health Canada decision is key to our global expansion strategy for TULSA-PRO®, as many major market jurisdictions, such as China, have a ‘country of origin’ approval requirement for medical devices.”

In April 2019, Profound entered into a distribution, license and supply agreement with Knight Therapeutics (GUD.TO) to act as an exclusive distributor for TULSA-PRO® in Canada. The Company foresees modest commercial potential for TULSA-PRO until government reimbursement is established.

The Company received a 510(k) clearance from the U.S. Food and Drug Administration to market TULSA-PRO for ablation of prostate tissue in August 2019. The approval was based on its TACT Clinical Trials in 115 patients across the United States, Canada and Europe with biopsy-proven, organ-confined prostate cancer. The Study met all of its primary and secondary efficacy and safety endpoints, with TULSA – PRO demonstrating safe and effective prostate tissue ablation, with minimal adverse events, significant prostate volume and PSA reduction, and low rates of residual prostate disease as per a Company statement.

Profound Medical Corp (NASDAQ: PROF)

Market Cap: $92.13M; Current Share Price: 7.85 USDChart
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Prostate Cancer is the second leading cause of death in men in the U.S, with over 1 in 41 men likely to succumb to the disease. According to an estimate by the American Cancer Society there would be 174,650 new cases of prostate cancer and 31,620 deaths from prostate cancer in 2019.

The current treatment options for the disease, which primarily affects the prostate gland, is removal of the gland surgically (Radical prostatectomy), Brachy Therapy (Implanting Radioactive Seeds into the prostate) and Conformal Radiation therapy in combination with hormonal therapy. In addition Chemotherapy and Androgen Suppression Therapy are used in cases of advanced cases of prostate cancer. The stage and grade of the disease along with the state of the patient with respect to age, existing illnesses and certain genetic factors determine the course of treatment.

A report by Datamonitor Healthcare estimates that the Total prostate cancer drug market will reach $13.5bn in 2024, growing at a CAGR of 8.6% from $6.4bn in 2015. The introduction of novel therapeutics and treatment methodologies, a rise in geriatric population and increased awareness will drive the growth in the market. However prohibitive treatment costs, adverse side-effects that include infertility may act as a deterrent for growth.

The prostate cancer market is a subject of extensive research and development that aim at treating the disease without causing adverse affects. 

Profound Medicals also offer women health solutions such as Sonalleve, which provides an incision-free alternative to traditional surgical treatments of uterine fibroids and enables incision-free, non-ionizing radiation palliative pain treatment of bone metastases. The system works by coagulating tissue deep inside the body using High Intensity Focused Ultrasound (HIFU) through the intact skin. The use of Sonalleve can offer women suffering from symptomatic uterine fibroids or adenomyotic tissue a hope for future pregnancy. In addition the application of the system can be extended for the treatment of cancer patients, allowing procedures such as incision-free, non-ionizing radiation palliative pain treatment of bone metastases. It helps reduce costs associated with hospital stays and is non-invasive leading to faster recovery times.

TULSA-PRO is customizable and can be used for treating a variety of cases such as Benign prostatic hyperplasia (BPH), Post-radiotherapy salvage as well as salvage. It can be used to treat prostates up to 250cc. Furthermore it provides active protection against urethra and rectum damage during treatment and ensures predictable prostate volume reduction.

The Company has entered into its first U.S agreement with Vituro Health to make TULSA-PRO available to Vituro physicians. Vituro health is a Company providing integrated, concierge-care model in the field of prostate cancer care.

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Risk Assessment

  • The Canadian regulatory approval will act as a shot in the arm for the Company and will set precedent for more international approvals. Some markets give regulatory approvals based upon the home country approval, such as China, a market that Profound is already targeting. The approval process will become simpler and the Company will be able to gain more international orders and expand its footprint.
  • The Company has tied up with Knight Therapeutics to distribute its product in the Canadian market. The deal involves estimated royalties of an estimated 20 to 40 percent, with Profound being responsible for the sales and training of the team. Knight has a reputation for being proficient at securing reimbursement which will be prove advantageous for the Company.
  • Profound is making forays into other international markets such as in Japan, having sold its first TULSA-PRO to Hokuyu Hospital in Sapporo, and has received a 501(k) clearance from the US FDA to market the TULSA-PRO. The Company has approached more than 75 US institutions and has received encouraging response as per Arun Menawat, Profound’s CEO. The Company is gearing for the launch of its first commercial TULSA-PRO site operational by end of 2019.
  • Installation delays will prove challenging for the Company, as in the case with its two Sonalleve® purchase orders, that were delayed. These will delay the realization of revenues and affect its revenue estimates. The Company reported revenue of $682,224, with $528,578 from the sale of products and $153,646 from installation and training services. This represented recurring revenue growth of 125% year-over-year and 17% sequentially over the previous quarter, as there were no sales during the previous quarters as per a Company Statement.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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