A Medical Device Daily

Predictive Biosciences (Lexington, Massachusetts), an emerging molecular diagnostics company developing non-invasive diagnostic products for informed cancer management, reported the closing of a $21.75 million Series B financing.

New investor New Enterprise Associates (NEA), a global healthcare and technology venture capital firm, led the financing with additional new participation from Kaiser Permanente Ventures, an investment arm of Kaiser Permanente.

The existing investors from the company's $10 million Series A financing — Flybridge Capital Partners and Highland Capital Partners — also participated in the "B" round.

In conjunction with this financing, Predictive Biosciences has appointed to its board of directors M. James Barrett, PhD, general partner with NEA, along with Jordan Kramer, senior venture manager at Kaiser Permanente Ventures, as a board observer.

"The completion of this financing ensures on-track development of our innovative urine-based diagnostic assays designed to enable physicians to conveniently and reliably determine the presence or absence of cancer," said President/CEO Peter Klemm, PhD. "Over the coming months, we will continue to execute our clinical development and commercialization plans, and complete preparations to launch a multi-center clinical trial in bladder cancer recurrence patients."

Predictive said it intends to use the proceeds from the Series B financing to complete current clinical validation studies and initiate multi-center clinical trials. Its biomarkers are applicable across multiple cancer types and it is initially focused on diagnostic applications in bladder cancer.

The company also is exploring the application of its assays in breast, prostate, ovarian and colorectal cancers. In addition, the funds will support the company's efforts to open an independent Clinical Laboratory Improvement Amendments (CLIA)-compliant lab for diagnostic testing.

Mara Aspinall, chairman of the Predictive board of directors and former president of Genzyme Genetics, said, "I look forward to working with Dr. Barrett and Mr. Kramer on the board of directors. I believe their ... experience and perspective will prove very valuable as the company continues to advance."

"We are very impressed with Predictive Biosciences' strategic approach to diagnostics, the track record of the management team and the speed with which the company has demonstrated its ability to apply its novel technology platform across multiple types of cancer," commented Barrett.

Kramer noted, "Kaiser Permanente Ventures looks to emerging companies and entrepreneurial management teams that we believe best represent advancements in quality clinical practice, service, and affordability. We support companies like Predictive that have a goal of continued progress toward delivering highly accurate and convenient diagnostic tests, which will allow physicians to create personalized follow-up and treatment plans."

Predictive Biosciences says it is "pioneering intervention diagnostic assays for informed cancer management." The company says its tests "will enable physicians to reliably determine the presence or absence of cancer. This information, incorporated into current standard clinical practice, should lead to more effective utilization of existing diagnostic tools and ultimately better outcomes for patients."

Its first assays are designed to detect urinary biomarkers associated with the physiological changes resulting from cancer development and progression. The initial focus for these tests will be the growing cancer survivor population and the large number of individuals undergoing clinical workups for cancer.

In other financings news:

• Micronics (Redmond, Washington), a developer of molecular and immuno-hematology diagnostic products, said it has completed a Series C financing led by the Southwest Michigan First Life Science Fund. Patrick Morand, managing director of the fund, has joined Micronics' board of directors as a result of its participation.

The Series C financing complements the company's Series B financing that was completed earlier this year. Private investors led the Series B financing. Together, these two financings are expected to result in $9 million in new capital being infused into Micronics.

"Micronics is poised to advance a new class of clinical diagnostic tests, and the Series C provides additional leverage to advance product development, including clinical testing required for initial product launch," said President/CEO Karen Hedine.

She added, "Earlier investments in the company made it possible for Micronics to build a formidable technology platform, particularly with respect to rapid DNA and RNA testing in a disposable device. We are now able to apply that established technology platform to a number of products in development that will be responsive to global healthcare needs for improved infectious disease detection and diagnosis."

Micronics is advancing a portfolio of point-of-care products for disease detection, diagnosis and treatment monitoring. It holds patents in microfluidics and related technologies that it said "make it possible to process biological and environmental samples directly in disposable devices and to perform accurate and affordable tests in a fraction of the time required by most molecular diagnostic tests in use today."

The company also provides custom product development on behalf of partners and clients worldwide.

• BioImagene (Cupertino, California), a provider of scalable digital pathology solutions, said Siemens Venture Capital (SVC) has joined as a new investor in the company, following on the recent closing of a $26 million Series D financing round led by Burrill & Co. and the appointment of Dr. Ajit Singh of Siemens Healthcare's Image and Knowledge Group as CEO of BioImagene.

BioImagene said it would use the investment from SVC to scale operations to extend its position in digital pathology. The company plans to accelerate the adoption of digital pathology with continued product development and rapid expansion in the European and Asian markets.

Steven Burrill, chairman of BioImagene, said, "We are ... pleased that Siemens Venture Capital has chosen to invest in BioImagene. Their extensive experience in oncology and radiology will help shape and expand the digital pathology industry."

BioImagene provides digital pathology solutions for acquiring, viewing, managing, analyzing, reporting and sharing images in the pathology laboratory. The company said its tools have "improved productivity, quality of results and simultaneously lowered the cost of entry into digital pathology."

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