Focal Healthcare
Project Overview:
Focal Healthcare is developing technology that fuses previously captured MRI and real-time ultrasound images. The system, comprised of a novel mechanical arm and 3D visualization software, tracks and guides the transrectal ultrasound transducer to the suspicious cancer regions as identified in the prostate gland by MR imaging.
Need or Opportunity:
Prostate cancer care has not changed significantly in the last 25 years. To diagnose prostate cancer, urologists perform a needle-based biopsy procedure. Due to the inherent limitations of standard 2D ultrasound imaging where visualization of tumours is not possible, urologists use a random-based approach to determine where tissue biopsy samples are taken. As such, prostate biopsy procedures often result in poor discernment of the location and extent of disease, leading to over-treatment of indolent cancer or under-treatment of aggressive cancers. In fact, approximately 33% of men receive false negative diagnoses, meaning the biopsy did not find cancer, but the individual has a cancerous lesion.
The current uncertainty in detection and diagnosis also means that patients diagnosed with cancer have limited options. Most patients opt, often unnecessarily, to treat the cancer using a whole gland approach in which the entire prostate is irradiated or surgically removed. The side effects of whole gland removal or irradiation are incontinence and impotence, both of which significantly affect quality of life.
Solution:
Focal Healthcare is developing MRI-Ultrasound Fusion Biopsy (Fusion BxTM) and Therapy (FusionTxTM) systems that have the potential to become the new “gold standard” in prostate care by capitalizing on CIMTEC’s unique intellectual property.
Focal Healthcare’s biopsy system enables urologists to co-register MRI prostate images with live ultrasound to accurately target suspicious cancer regions during transrectal ultrasound (TRUS) biopsy procedures. Once a cancerous lesion has been identified, Focal’s therapy system will guide delivery of targeted treatment modalities. By facilitating targeted procedures, Focal Healthcare is enabling a more streamlined and expedited workflow with improved clinical outcomes and patient experience.
CIMTEC provided a $200,000 loan which helped to pay for the initial software development and hardware design.
Progress:
Partnering with CIMTEC helped Focal Healthcare to accelerate development of its two products: the Fusion BxTM and Fusion TxTM systems. By having products for both biopsy and needle-based therapy procedures, Focal Healthcare is perfectly poised to improve the state of prostate cancer care.
Focal Healthcare opened an office in Toronto, Ontario employing a team of engineers, researchers, regulatory affairs, clinical development and business development specialists to grow the company and position it for market sales.
Focal Healthcare has received FDA clearance for their targeted prostate biopsy device, Fusion Bx TM. With the availability of Fusion Bx, clinicians are no longer limited to the traditional systematic biopsy approach for diagnosis, but can instead accurately take targeted biopsies directly from suspicious cancer regions within the prostate using MRI-ultrasound “fusion” technology.
Following its U.S. market penetration, Focal Healthcare’s goal is to secure additional funding to move the Fusion BxTM and TxTM systems into international markets. Fusion biopsy has been shown to detect high-grade cancer in 30% more men compared to traditional systematic biopsy.
