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    DRUG-ELUTING BIOPSY NEEDLE
    How to make transrectal prostate biopsy safer?

ABOUT

Prostate cancer is the most common malignancy diagnosed in the World. The average chance to develop this cancer during lifetime is approximately 15% and its incidence rate is estimated to be about 150 per 100 000 male. It is associated with high costs of diagnosis and treatment, which are estimated at 8.43 billion euro per year in Europe.

5 M procedures per year and growing

Transrectal ultrasound guided prostate biopsy is a basic tool and gold standard for prostate cancer diagnosis and one of the most practiced urological procedures worldwide.

up to

7%

In the recent years, an increased resistance of rectal flora to standard antimicrobial prophylaxis is associated with a rise of severe infectious complications and hospital readmission rate.

Quantity of prostate biopsy procedures
Quantity of prostate biopsy procedures

Source: Alfabeat report 2017

PROBLEM

The most common complications following transrectal prostate biopsy performed by known prostate biopsy needles are hematuria and hematospermia. However, the most serious clinical problems are infectious complications occur after the prostate biopsy. During the procedure, after introduction of the needle through the rectum, the intestinal bacteria are transferred into the blood and the prostate. Patients undergoing prostate biopsy are exposed to urinary tract infections, prostatitis, and even severe septic complications.

Serious risk and problem for patients

Personal / financial responsibility for urologists

Very high treatment costs for national healthcare systems and hospitals

High liability / payouts for insurance companies

There is an essential need for periprocedural antimicrobial prophylaxis which is indicated in all patients undergoing TRUS-Bx with the best evidence among the urological procedures. European Association of Urology and American Urology Association guidelines on TRUS-Bx antimicrobial prophylaxis stated that oral fluoroquinolones are the first line prophylactic agents. However, in the past few years an increased resistance of rectal flora to fluoroquinolones associated with a rise in severe infectious complications has been reported. The main pathogen responsible for this phenomenon is fluoroquinolone-resistant Escherichia coli (E. coli) which causes most postprocedural sepsis episodes. Rapidly growing literature on this issue showed a large percentage (>20%) of those strains present in rectal flora of patients undergoing TRUS-Bx. This means that significant proportion of patients do not receive effective antimicrobial prophylaxis prior prostate biopsy.

SOLUTION

unique prostate biopsy needle that delivers effective antibiotic combination directly to the prostate

Innovation of biopsy neelde

DEBN is a patent pending (PCT/PL2016/000006) medical device which is a novel approach to the problem of TRUS-Bx related infectious complications. It consists of polymer coated biopsy needle and anesthesia needle that release the drugs directly to the prostate during the procedure. This solution may allow the co-administration of various antibiotics, thereby broaden their spectrum of activity and potentially reduce the number of infectious complications. Presented model of DEBN contains poly(vinyl alcohol), ciprofloxacin and amikacin.

Transrectal intraprostatic antibiotics injections have been studied until now only as method of treatment for prostatitis and chronic pelvic pain syndrome. In 2013 Issa et al. published the first focuses on the biopsy needle as a vector of TRUS-Bx related infections. Authors described a simple and effective method to reduce the risk of infection after prostate biopsy with formalin disinfection of the biopsy needle after each prostate biopsy core. They found an association between the use of this technique and lower incidence rate of urinary infection and sepsis. However, repeat formalin exposure during prostate biopsy may increase the risk of toxicity and adverse effects. DEBN is the first medical device which enable simultaneous organ-targeted delivery of antibiotics during prostate biopsy procedure. Novelty, inventive step and industrial applicability of DEBNs have been confirmed by a decision of European Patent Office.

Intraprostatic injection was first described in 1983 by Baert et al. Since than, a number of investigators have advocated direct injection of antibiotics (including amikacin and ciprofloxacin) into the prostate gland due to prostatitis . Those authors demonstrated safety and feasibility of this procedure. However this method has never been used as an antibiotic prophylaxis prior prostate biopsy.

The high-performance liquid chromatography analysis and the bacterial growth inhibition test showed that DEBNs released high concentrations of amikacin and ciprofloxacin and have strong bactericidal activity against E. coli. The addition of intravenous amikacin to oral ciprofloxacin prophylaxis significantly reduces the incidence of septicemia after prostate biopsy. However, administering intravenous amikacin is not easy nor cost-effective and often requires hospitalization . Drug-Eluting Biopsy Needle could deliver combined antibiotic prophylaxis to the prostate without hospitalization need. Furthermore, Bahk et al. concluded that the direct intraprostatic injection of fluoroquinolone provides antibiotic activity in the entire prostate.

PROJECT TIMELINE

You can check out some of our key milestones on the timeline below. There is still lots to do and we have not lost sight of that.

Milestones of DEBN project

DOCUMENTS

TEAM

We are developing our R&D project with many external experts that supporting us in each field of the project. Our core team members are:

Artur Gibas

ARTUR GIBAS

Doctor of Medicine and Philosophy and Certified Urologist

Marcin Sieczkowski

MARCIN SIECZKOWSKI

Medical Doctor and Certified Urologist

LinkedIn

Michał Krużycki

Michal Kruzycki

General Manager

LinkedIn

FUNDING


Kvarko

The company in cooperation with Kvarko ASI sp. O.o. implements the project entitled "An innovative medical device DEBN that reduces the risk of complications after a prostate biopsy", co-financed with European Union funds under the Intelligent Development Operational Program 2014-2020, Measure 1.3: R & D works financed with participation of capital funds, Sub-measure 1.3.1: Support for research and development projects in the preseed phase by proof of concept funds - BRIdge Alfa. Contract number for Support: nr 5/ Kvarko Projekt B+R from 30 November 2017 The amount of co-financing of the project from the EU: 1000000 PLN The total amount of the project: 1500000 PLN


Alfabeat

The company in cooperation with Alfabeat implements the project entitled "An innovative medical device DEBN that reduces the risk of complications after a prostate biopsy", co-financed with European Union funds under the Intelligent Development Operational Program 2014-2020, Measure 1.3: R & D works financed with participation of capital funds, Sub-measure 1.3.1: Support for research and development projects in the preseed phase by proof of concept funds - BRIdge Alfa. Contract from 13 July 2017 The amount of co-financing of the project from the EU: 500 000 PLN The total amount of the project: 1500000 PLN