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Archives for August 2007

Vermillion Closes $20.6 Million Equity Financing

Vermillion (formerly Ciphergen Biosystems), a Fremont, CA-based molecular diagnostics firm, has closed a $20.6 million equity financing with new and existing investors. The financing, which comes two weeks after the company received a non-compliance letter from Nasdaq, will be used to further Vermillion’s three leading development candidates.

The company’s most established development program is an ovarian tumor triage test, designed to distinguish between benign and malignant pelvic masses. Based on an analysis of over 2,500 clinical samples, the Ov CA Assay utilizes a panel of novel biomarkers to help identify women who have ovarian cancer so that they can be referred directly to a gynecologic oncologist for their initial surgery. Results from a prospective clinical trial suggest that the use of this test could more than double the ovarian cancer cases referred to the appropriate specialist for treatment.

The company is partnered with

30 August 2007 | Blog, news1 | No Comments

Indiana Seed Fund Invests in FlowCo

Indiana’s only life sciences seed-stage fund has invested $250,000 in FlowCo, a local company that’s developing a device that helps size and deliver stents more accurately. The company will use the money to create a human-use prototype for clinical trials scheduled to take place by next summer.

The device, developed by a biomedical engineer from Indianapolis, IN, is called LumenRECON. It’s a catheter-based device that uses electricity to size the cross-section of a blood vessel. Four very small electrical wires are mounted on the exterior of any standard catheter and inserted into the blood vessel. Electrical currents are sent to the electrodes which give the cardiologist a digital output of the measurement for the blood vessel’s cross-sectional area digitally in real-time.

More than 1.5 million Americans undergo coronary stent procedures each year. But currently, the routine catheter used to deploy the stent

29 August 2007 | Blog, news1 | No Comments

CryoCor Completes Enrollment of A-Fib Trial

San Diego-based CryoCor has completed enrollment of the pivotal clinical study for using its Cryoabalation System to treat atrial fibrillation, bringing the company one step closer to its goal of U.S. approval for both a-fib and atrial flutter.

The Cryoabalation System, which uses extreme cold to destroy damaged cardiac tissue, was approved earlier this month for the treatment of right atrial flutter. That approval was a longtime coming: In June, the company learned that an FDA advisory panel was not convinced of the Cryoablation System’s longterm efficacy or safety profile, only to find out two days later that the panel had approved the device. The initial negative review in June was the second time FDA had found fault with CryoCor’s device. The agency rejected the company’s PMA application last year, prompting CryoCor to amend and resubmit in November 2006.

CryoCor intends to begin selling the

28 August 2007 | Blog, news2 | No Comments

Presenters Selected for AdvaMed 2007

AdvaMed, the industry trade association, has selected 22 emerging med tech companies to present at an inaugural conference, developed in part to create networking and partnering opportunities for its smaller member companies.

The event, AdvaMed 2007, will be held October 1-3 in Washington, D.C., and will cover such issues as Medicare, compliance, intellectual property, global market opportunities, corporate finance and public policy. Of interest to small companies is the event’s Business Development Forum, which will feature a partnering program, company presentations, and an exhibition showcasing new technologies and products.

The partnering program facilitates one-on-one meetings between conference attendees. It’s a Web-based system that enables participants to select meetings by viewing profiles of every registered company; search features facilitate the process of identifying potential partners or clients. Through an internal messaging system, participants can submit up to 50 requests to meet with representatives

24 August 2007 | Blog, Member Spotlight, news2 | No Comments

Pittsburgh Partnership Backs Three Up and Comers

The Pittsburgh Life Sciences Greenhouse (PLSG), a public/private partnership founded in 2001 to grow Southwestern Pennsylvania’s life sciences industry, has added two local companies — Separation Design Group and ThermalTherapeutics Systems — to its expanding investment portfolio and contributed additional funding to a firm already under its wing, Applied Computational Technologies.

The bulk of the $450,000 total investment went to ThermalTherapeutics Systems. The company will use $200,000 from PLSG to develop a prototype pump for delivering chemotherapy more effectively. ThermalTherapeutics’ device will deliver both intraperitoneal chemotherapy and intraperitoneal hyperthermic chemotherapy (IPHC) to treat metastastic abdominal cancers, especially ovarian and colon cancer, regardless of primary site. Currently, there is no device on the market designed specifically for treating advanced abdominal cancers.

One-hundred-and-fifty-thousand dollars went to Applied Computational Technologies, to help propel the company’s ProACTive product into the marketplace. ProACTive is Applied Computational Technologies’ radiation dose-calculation

23 August 2007 | Blog, news2 | 1 Comment

A+ for Mirabilis Medica

Mirabilis Medica, a three-year old startup based in Bothell, WA, has closed a $10.5 million extension to the Series A financing it completed a year ago. The funding — led by Arboretum Ventures of Ann Arbor, MI, and participated in by Split Rock Partners, Dow Venture Capital, and an individual investor — will be used to continue development of Mirabilis’ non-invasive treatment for uterine fibroids.

The company’s image-guided High Intensity Focused Ultrasound (HIFU) system is designed to destroy pathological tissue deep inside the body without damage to intervening tissue, and to monitor effects with real-time ultrasound imaging. The HIFU system is not first-in-class, but Mirabilis is well poised given the groundwork already laid in this area by competitors like InSightec and Biosphere.

Mirabilis believes its technology could address a variety of gynecological conditions but for now is targeting uterine fibroids, which cause cramps

22 August 2007 | Blog, news2 | No Comments

Signalife Completes $102 Million Financing

Signalife, a Greenville, SC, firm specializing in biomedical signal monitoring, has completed $102 million in financing — a much anticipated boost following the company’s June receipt of an AMEX deficiency letter stating that stockholder equity had fallen below the requirement for companies with market caps less than $50 million.

The company has received $2 million in immediately funding through the sale of common stock to YA Global Investments, a Yorkville Advisors fund. It also has entered into a Standby Equity Distribution Agreement that permits the sale of $100 million in additional stock over the next three years. The money will be used to advance Signalife’s main product, the Fidelity 100 heart monitor.

Originally developed to monitor brain waves of U.S. Air Force Pilots, Fidelity 100 compresses and reduces noise prior to amplifying an ECG signal, improving signal quality. The improved clarity may

21 August 2007 | Blog, news2 | 1 Comment

Minrad Appoints Two Senior Execs

Minrad, of Orchard Park, NY, today announced two senior-level appointments. Dennis Goupil was named senior vice president technical and Terence Vollrath was appointed vice president of operations.

Goupil joins Minrad from Biocure,  an early stage medical device company based in Norcross, GA, where he was chief technology officer and VP of R&D. He’s also held posts at Boston Scientific, Datascope and Pharmacia focusing on R&D processes, and business development.

Vollrath most recently was working as a consultant to clients in the pharmaceutical, chemical, biotech and manufacturing industries. Before that, he was director of operations at Aerojet Fine Chemicals. He has held various management positions at Abbott Laboratories focusing on chemical manufacturing operations.

20 August 2007 | Member Spotlight | No Comments

DiagnoCure Acquires Cancer Tests for $3 Million

DiagnoCure, a Quebec City company that sells cancer diagnostics, has acquired Worcester, MA-based Catalyst Oncology and its lead prognostic tests for breast, colon and potentially other cancers. DiagnoCure, which will pay $3 million upfront followed by future milestone payments, will take over development of the tests, including additional clinical studies.

The acquired tests already have been validated in multiple clinical studies involving patients with five tumor types, including breast and colon. Results have shown the tests to be strong indicators for a patient’s risk of disease recurrence, as well as predictors of response to certain cancer therapies, such as tamoxifen or traditional chemotherapy.

The tests measure the level of activated tyrosine phosphorylated Shc protein and p66 Shc protein in tissue specimens. The Shc proteins are involved in a number of well documented cellular pathways that are correlated with tumor aggressiveness across many

17 August 2007 | Blog, news2 | No Comments

West Michigan Life Sciences Sector on the Rise

According to The Grand Rapids Press, “West Michigan is on its way to attaining prominence in the life sciences industry.”

The paper, reporting this week on a just released study on attracting investment to the region, says, “Grand Rapids’ growing medical research capabilities, combined with Kalamazoo’s heritage of producing drugs and medical devices, create a critical mass that can compete with such life sciences hotbeds as Boston, Seattle and Singapore.”

The study, which says $750 million to $1 billion will need to be spent upfront in order to attract $5 billion in new investment to West Michigan over the next 10 years, calls for attracting venture capital for later-stage research, drawing larger pools of engineering and life sciences talent, and expanding the region’s global connections.

Efforts are already underway to help nurture West Michigan’s life sciences sector, of which roughly 200 companies are part.

In

16 August 2007 | Blog | No Comments

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