A Diagnostics & Imaging Week

Scivanta Medical (Spring Lake, New Jersey) reported that it has entered into development agreements with Ethox International (Buffalo, New York) regarding the Hickey Cardiac Monitoring System (HCMS).

Ethox will provide Scivanta engineering and development support for the catheter component of the HCMS in exchange for the rights to manufacture the component upon regulatory approval and commercialization of the HCMS. Manufacturing terms will be subject to a supply agreement, which will be entered into by Scivanta and Ethox upon regulatory approval of the HCMS, the companies said.

Scivanta also amended its technology license agreement dated Nov. 10, 2006 with The Research Foundation of the State University of New York, for and on behalf of the University of Buffalo, and Donald Hickey, MD and Clas Lundgren, MD, PhD. According to the amended agreement, the Foundation, Hickey and Lundgren were permitted to enter into a nonexclusive manufacturing license agreement with Ethox, whereby Ethox was granted the right to manufacture the catheter component of the HCMS for Scivanta.

As a result of these agreements, the development of the HCMS will now be partially funded through a technology incentive program contract awarded by the New York State Office of Science Technology and Academic Research to the Foundation and the Foundation’s company partner, Ethox. Up to $750,000 is available under this incentive program for the development of the HCMS, the company said.

Ethox is required to match the $750,000 of proceeds available under the incentive program by providing $187,500 of cash and $562,500 of in-kind contributions. Scivanta will provide Ethox with the $187,500 of cash required under the technology incentive program while Ethox will provide the $562,500 of in-kind contributions. The technology incentive program funding will primarily support the catheter and software development of the HCMS by Ethox and Applied Sciences Group (ASG; Buffalo, New York).

Scivanta also entered into a development agreement with ASG. ASG will provide software engineering services to Scivanta for the continuing development of the HCMS. The fees being charged by ASG related to this agreement could range between $335,000 and $400,000.

Scivanta says it is focused on acquiring and developing medical technologies and products which offer advantages over available medical procedures and treatments. The company has acquired the exclusive worldwide rights to develop the Hickey Cardiac Monitoring System, a minimally-invasive two-balloon esophageal catheter system used to monitor cardiac performance. The HCMS is expected to provide the primary measurements of cardiac performance in a minimally invasive and cost-effective manner and is designed to be used outside of an intensive care setting, the company said.

Ethox is a manufacturer and provider of medical products and laboratory services.

ASG provides software engineering solutions for applications involving research, industrial and manufacturing environments, design-oriented engineering services, technical project management and training.

In other agreements:

Axela Biosensors (Toronto) reported that it will be a commercial partner in the University of Toronto’s “BioOptics: Transformative Technologies for Life Sciences Project,” recently awarded a $7.8 million grant through the Research Excellence program of the Ontario Research Fund (ORF).

BioOptics Project researchers are developing devices that are expected to enable medical testing and treatment at a patient’s bedside.

University of Toronto Department of Physics and Chemistry professors R.J. Dwayne Miller and Cynthia Goh and their teams will base these devices on a newly developed laser technology to diagnose and treat disease.

Those instrument platforms will detect trace amounts of specific proteins and other biological molecules in cells, observe how they interact with each other, and determine what factors lead to expression of certain proteins and disease states.

“Axela has taken technology developed at the University of Toronto and incorporated it into the dotLab System which is commercially available,” said Rocky Ganske, president/CEO of Axela. “Diffractive Optics Technology (dot) is being used to accelerate biomarker assay development in clinical research. The domain expertise relative to interactions between light-based technologies and biological molecules as well as other nanotechnologies within the University is a strong asset to Axela as we move forward with our development of novel diagnostic devices.”

Axela Biosensors provides products that accelerate the validation of protein biomarkers from discovery into routine clinical use.

As part of The Cancer Genome Atlas (TCGA) pilot project, the National Institutes of Health (NIH) has awarded eight two-year grants totaling $3.4 million to support the development of innovative technologies for exploring the genomic underpinnings of cancer.

Cook Medical (Spencer, Indiana) and Gynecor (Richmond, Virginia), an anatomic pathology laboratory focused on gynecology, reported a partnership to provide the Tao Brush to Ob/Gyn offices across the country, thus offering a method of endometrial biopsy with minimal patient discomfort, the companies said. The Tao Brush is made by Cook, and the partnership makes Gynecor the exclusive distributor of the device in the U.S. and the UK.

The Tao Brush is a part of Gynecor’s TruTest endometrial biopsy kit, which incorporates a gentle brushing technique to collect a uterine biopsy from a patient, the company said. The brush is enclosed in a sheath that protects the bristles from contamination during insertion and protects all collected biopsy tissue during removal. The brush and the tissue specimen are then sent to the Gynecor laboratory for processing and interpretation.

Christina Ann , the Women’s Health strategic business unit leader, said that the partnership “helps meet two of our important objectives. First, TruTest with the Tao Brush improves the quality of life of the female patient by providing a more gentle procedure that minimizes the pain from conventional uterine biopsies while providing specimens that can be better tested. The test’s fast turnaround time may also help stem the patient’s anxiety. Secondly, together, our partnership provides physicians with a state-of-the-art diagnostic test that can effectively detect early signs of endometrial cancer.”

Alison Lippincott, director of marketing for Gynecor, said, “No woman should have to go through a painful procedure, wait over a week for results, and risk not getting a clear diagnosis. Our goal is to address these issues by offering a comprehensive picture of the patients’ uterine health with less discomfort and a more definitive result in the shortest amount of time possible.”