83% of Urologists say "No" to MRI use for guided biopsys

In an article first published in Urology Times, March 2014, the poll of practising Urologists clearly shows that MRI is not going to be a viable commercial nor technical solution in the near- nor mid-term. 

The review article goes on to describe the numerous issues in terms of: costs, availability, acquisition time, and specificity for MRI, and MRI-Utrasound fusion as a viable co-registered imaging and diagnosis platform for Prostate Cancer patients.

Source: http://urologytimes.modernmedicine.com/urology-times/content/tags/art-rastinehad/mri-guiding-future-prostate-cancer-diagnosis?page=full

Hybridyne Health Collaborates with Aytu BioScience for Minimally Invasive Prostate Cancer Detection

Englewood, CO – March 2, 2016 – Aytu BioScience, Inc. (OTCQX: AYTU), a commercial-stage specialty healthcare company focused on commercializing treatments for urological conditions, today announced that it has entered into a study agreement with Hybridyne Imaging Technologies to investigate the efficacy of Hybridyne’s ProxiScan™ compact gamma cameras to detect local prostate cancer using Aytu’s imaging agent ProstaScint®. The study is being conducted at The Princess Margaret Cancer Centre in Toronto, Canada, and supported by Hybridyne. As part of the agreement Hybridyne will purchase ProstaScint for the study, establishing Aytu’s first ProstaScint sales outside the U.S.

ProstaScint is FDA-approved and the only imaging agent that specifically targets prostate cancer cells and demonstrates high sensitivity, specificity, and accuracy. Hybridyne’s high-resolution ProxiScan gamma camera utilizes cutting-edge cadmium zinc telluride (CZT) detector technology and is small enough for trans-rectal prostate cancer diagnosis, after the patient is injected with a radiopharmaceutical such as ProstaScint. Combined, these technologies stand to offer additional diagnostic and prognostic assurances to urologists, ultimately increasing the quality of care for prostate cancer patients in Canada.

Josh Disbrow, Chief Executive Officer of Aytu, stated, “Prostate cancer is the second leading cause of cancer death among men, marking a great need for better detection in both newly diagnosed, high-risk patients and patients with biochemical recurrence. We are excited to initiate this study with Hybridyne and Princess Margaret Cancer Centre as it is Aytu’s first clinical collaboration with ProstaScint outside the U.S. This collaboration demonstrates our strong interest in gaining clinical acceptance of ProstaScint around the world while developing additional clinical data supporting ProstaScint’s use. ProstaScint is the only FDA-approved agent that can specifically target prostate cancer, while ProxiScan has demonstrated highly detailed trans-rectal image quality in prostate cancer. Both products have strong potential roles to play in the identification and treatment of both new and recurrent prostate cancer patients, and we look forward to seeing the results of this clinical study following study completion.”

The planned study Detection and localization of carcinoma using high resolution transrectal gamma imaging (TRGI) is being led by Principal Investigator Dr. Antonio Finelli. The study is being conducted at Princess Margaret Cancer Centre, Canada’s largest cancer treatment center.

Approximately 60 men will take part in this three-arm, open label study, including the following patient groups:

  • Group 1: Patients who have rising levels of PSA (>0.05ng/ml) after radical prostatectomy treatment
  • Group 2: Patients who have rising PSA (>10ng/ml) and/or abnormal digital rectal exam and have previously undergone at least one prostate biopsy that was determined to be negative for prostate cancer
  • Group 3: Patients diagnosed with prostate cancer (with at least one positive prostate biopsy) and have a scheduled biopsy as part of their routine follow-up

About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty healthcare company focused on global commercialization of novel products in the field of urology. Aytu’s current portfolio of commercial and late-stage urology products addresses prostate cancer, urinary tract infections, male infertility and male sexual dysfunction, and the company plans to expand into other urological indications for which there are significant medical needs. The company currently markets ProstaScint® (capromab pendetide), the only radio-labeled monoclonal antibody that targets prostate specific membrane antigen (PSMA), a protein highly expressed by prostate cancer cells. ProstaScint is FDA-approved as an imaging agent for use in both newly diagnosed, high-risk prostate cancer patients and patients with recurrent prostate cancer. Aytu also markets Primsol® (trimethoprim hydrochloride) – the only FDA-approved trimethoprim-only oral solution for urinary tract infections. 

Hybridyne Imaging Technologies Inc. rebrands to Hybridyne Health.

Terry Lall announced that as of today Hybridyne Imaging Technologies Inc. will be known as Hybridyne Health.

"The name change reflects a genuine and natural re-orientation in our core business over time, from initially being an Imaging R&D company; to our emergence in 2016 as a company with a strategic focus on applied health outcomes," said Mr Lall.

"Our concern for the sub-optimal imaging and treatment outcomes in prostate cancer, where we are accelerating the development of 2 new products, is just the start. We are also in the planning stages of a suite of new products to address other major Oncology imaging and treatment challenges."

Hybridyne Imaging Technologies Inc. Expands Advisory Board with Appointment of Paul Chipperton.

Having recently expanded Hybridyne’s clinical advisory team with the appointment of notable Canadian Urologist Dr Neil Fleshner MD, we can also now announce an expansion of the commercial advisory team, in the shape of industry veteran Paul Chipperton.

Paul will spend the next few months scoping our strategy to develop both optimal product configurations, and identification and validation of vanguard launch markets for the Prostate Cancer business. “I’m intrigued by the potential of the technology to impact at least two major points of the clinical diagnosis and intervention value chain, and aim to help Terry define the company’s commercial strategy to achieve that outcome.”

Paul comes with a proven track-record of success in both Medical Devices and Prostate Cancer, most notably as 2008 co-founder and CEO of Profound Medical Inc., an MR-guided prostate ablation technology company that went public on the TSX Venture exchange in 2015. He also annually lectures MBA courses at Queens School of Business on Strategic Innovation, Venture Finance, and Marketing.