More than 64,000 men are diagnosed with prostate cancer in the UK annually, but the current mainstay method of detecting prostate cancer carries significant discomfort, risk of infection, and cost. The majority of diagnoses are achieved via a needle biopsy of the prostate, guided by a transrectal ultrasound probe inserted into the rectum, which carries a significant risk of side effects including urinary infections and severe sepsis, as the needle traverses the rectal wall multiple times on the way to the prostate. The annual costs associated with UK hospitalisation for biopsy-related sepsis are estimated to be £7-11 million.
Professor Vincent Gnanapragasam, and his colleagues at The University of Cambridge and Cambridge University Hospitals NHS Trust, developed the Cambridge Prostate Biopsy Device (CamPROBE®), an innovative device to safely access the prostate using fewer incisions through the perineum instead of via the transrectal route. As such, the device reduces the risk of infection.
In addition to negotiating the exclusive licence agreement for the device, Health Tech Enterprise (HTE) assisted with the procurement of grant funding and Intellectual Property (IP) protection for the device.
Technology
The CamPROBE device is a simple and cost effective solution that is intended to facilitate transperineal prostate biopsies under local anaesthetic. It is a surgically invasive, single use, sterile device consisting of a stainless steel cannula, an integrated coaxial needle and an adhesive attachment base.
The needle is inserted at two entry points on either side of the perineum and CamPROBE is then advanced to the prostate area under simultaneous local anaesthetic infiltration. Once in position, the integrated delivery needle is removed and the cannula can be used as an access sheath for prostate biopsies.
CamPROBE can be angled or repositioned to reach different areas of the prostate without the need for superficial and deep structure repuncture. Two body puncture points are required to introduce CamPROBE, resulting in low pain scores, patient comfort and patient acceptability. Procedural access through the perineum reduces complications due to infections and sepsis compared to transrectal procedures.
IP protection
Following an assessment of the IP and literature landscapes, HTE established an initial assessment of patentability and devised an IP strategy to protect the innovation. Patent protection for the device has now been secured, in addition to registering the trademark for CamPROBE®.
Funding and outcomes
Professor Gnanapragasam decided to pursue funding from the National Institute for Health and Care Research (NIHR) to refine, clinically review, and pursue regulatory approval for the device.
During the grant funding application, the HTE team reviewed the initial application and identified areas to strengthen the value proposition for the grant application and assisted with preparations for the application interview process. With the benefit of HTE’s expertise, Professor Gnanapragasam successfully secured nearly £800,000 of funding for a three-year development project, which included a clinical investigation into the use and transferability of the device and a Health Economics study.
The data gathered during the investigation was used to secure the CE marking ensuring that the device can be sold in the UK and European markets.
Commercialisation
HTE’s support culminated in the successful negotiation of an exclusive licensing agreement between Cambridge Enterprise and JEB Technologies Ltd. This provided JEB Technologies Ltd with the exclusive rights to research, develop and sell CamPROBE® to healthcare providers worldwide. JEB subsequently became part of the same group structure as Medovate Ltd, an award-winning medical device development company based in Cambridge.
The CamPROBE device is recommended by NICE for use within the NHS and was launched at MEDICA in 2022. For further information on the product and details of distributors in the US and other countries please visit the Medovate website.
