VentureBeat

(UPDATED at 11am PT on Sunday, 8/26/07: See below.)

Featured companies: Clinical Data, Epidauros Biotechnologie, Precision Therapeutics, UMD, Zars Pharma

UMD to close $8M for menstrual pain and osteoporosis — Cincinnati’s UMD, a developer of vaginal drug-delivery technologies, expects to close up to $8 million in a fifth funding round, VentureWire reports (subscription required). The company has backing from an undisclosed new investor, and expects former investors Charter Life Sciences and Asset Management to join the round.

UMD is developing a new version of an off-patent anti-inflammatory drug called ketorolac that can be administered on the end of a tampon for menstrual pain, and hopes to begin mid-stage human tests this year. It plans a similar delivery formulation for the active ingredient in Merck’s osteoporosis drug Fosamax, which loses patent protection this year. The company doesn’t have a Web site.

Precision Therapeutics aims to raise $81M in IPO for personalized cancer tests — Pittsburgh’s Precision Therapeutics, a developer of diagnostic tests that aim to predict patient response to chemotherapy, filed to raise $80.5 million in an initial offering. The company’s tests use biopsied tumor cells to assess the likelihood that a given drug or drug combination will be effective.

This is a fairly low-tech sort of diagnostic — as its filing makes clear, Precision basically just removes tumor cells and then starts hitting them with various drugs in the laboratory to see whether they live or die. The company has only been marketing its current test, which it calls ChemoFx, for the last year or so; although it has had ChemoFx on the market since 1997, it ceased sales activity in 2003 and didn’t resume it until last year. Revenues have been predictably anemic, as until recently Precision didn’t have an active sales force, and last year the company managed the feat of posting a gross loss, in which its cost of sales in terms of lab expenses exceeded incoming revenue.

There’s other bad news, too. Precision notes that two respected organizations — the technology-evaluation center of the Blue Cross and Blue Shield Association and a working group of the American Society of Clinical Oncology — concluded in 2004 that “chemosensitivity/chemoresistance assays” such as ChemoFx lacked supporting data that would justify their routine use.

The company also parses several complex reimbursement decisions in a fairly convincing illustration of the risk that relatively few insurers may actually want to pay for its test. It further notes that clinical data supporting use of its test is “limited,” and although it cites the results of three studies carried out between 2002 and 2006, none of them look particularly convincing. In one of the few bright spots in its filing, Precision says it is currently conducting five additional studies, some of which appear to be fairly rigorous “prospective” studies of the diagnostic.

Zars Pharma sets IPO price target — Zars Pharma, a Salt Lake City specialty pharmaceutical company that reformulates pain drugs for delivery via skin patches, set a price range for its IPO and now seeks to raise as much as $92 million in the offering. (See our previous coverage here; the company has apparently changed its name to “Zars Pharma” from “Zars.”) The company plans to offer up to 5.75 million shares at a price of $14 to $16 apiece.

Clinical Data acquires Epidauros Biotechnologie for $11.8M — Clinical Data, a publicly traded diagnostics and personalized-medicine company in Newton, Mass., agreed to pay $11.84 million (€8.75 million) to acquire Epidauros Biotechnologie of Germany. Founded in 1997, Epidauros studies genetic factors that may determine how individuals respond to drugs.

UPDATE (11am PT on Sunday, 8/26/07): Added Clinical Data/Epidauros item.

(UPDATED at 7:40pm PT: See below.)

Featured companies: Adnexus Therapeutics, BioForm Medical, Confirma, Cardiovascular Systems, Mirabilis Medica, Neuromed Pharmaceuticals, PlaCor, Seno Medical Instruments, Vibrynt

BioForm Medical files $115M IPO for “medical aesthetics” — BioForm Medical, a San Mateo, Calif., developer of wrinkle fillers and other products for cosmetic procedures, filed to raise $115 million in an initial offering. BioForm’s major customers are plastic surgeons and dermatologists.

BioForm, however, takes pains to describe itself differently on its Web site. There, BioForm says it is “a privately-held medical device company developing and commercializing injectable implant products for soft and hard tissue augmentation.” It goes on to note that its main product, Radiesse, is marketed for “radiographic tissue marking, vocal cord insufficiency, craniofacial augmentation, and outside of the U.S for facial soft tissue augmentation.”

That all sounds pretty serious — nothing like expensive wrinkle treatments, right? But in its IPO filing, where stretching the truth could get it in trouble with the SEC, BioForm describes itself straightforwardly as “a medical aesthetics company focused on developing and commercializing products that are used by physicians to enhance a patient’s appearance.” As for Radiesse, it notes that “[w]e obtained FDA pre-market approval, or PMA, for our key commercial application of Radiesse, the correction of moderate to severe facial wrinkles and folds in December 2006.”

BioForm is not profitable, and its losses have widened over the past three years, although sales have increased over that period. The company accumulated a net loss of $35.2 million from 2005 to 2007 (its fiscal year ends June 30).

Stealthy Vibrynt raises $16M for medical devices — Vibrynt, a Mountain View, Calif., medical-device maker that has just spun out of the ExploraMed device incubator, raised $16 million in a first funding round, VentureWire reports (subscription required), citing regulatory filings. Investors included New Enterprise Associates and Delphi Ventures; NEA backs ExploraMed.

The financing closed in April. Vibrynt doesn’t have a Web site and hasn’t yet disclosed details about its technology.

Cardiovascular Systems raises $12.5M against peripheral artery disease — Cardiovascular Systems, a St. Paul, Minn., device maker focused on the removal of arterial plaque, raised $12.5 million in a still-open extension of its first funding round, VentureWire reports. The funding reportedly came from “some” of the company’s original investors, a group that includes Easton Capital Group, Maverick Capital, Mitsui & Co. Venture Partners and ITX Institutional Holdings.

Cardiovascular Systems has developed a device that essentially “sands” artery-blocking deposits known as plaque from the inside surfaces of blood vessels. The catheter-based device uses a rotating, diamond-coated head to scrub plaque from arteries. The company told VentureWire it is anticipating FDA clearance of the device within the next few weeks.

Mirabilis Medica gets $10.5M for fibroid treatment — Seattle’s Mirabilis Medica, a medical-device company focused on women’s health, raised $10.5 million in an extension to its first funding round. Investors included Arboretum Ventures, Split Rock Partners, Dow Venture Capital, and an individual investor.

Mirabilis Medica uses high-intensity, focused ultrasound to destroy tumors such as uterine fibroids by denaturing cellular proteins and causing cells to collapse into piles of goo. The company says the device may ultimately useful in other applications as well, but hasn’t yet specified them.

Confirma gets $2 million for medical-image analysis — Bellevue, Wash.-based Confirma, a maker of computer systems that automate the interpretation of medical images, raised $2 million in bridge financing on its way to a potential $15 million third round, VentureWire reports. Fluke Venture Partners provided the funding. Confirma’s first product analyzes MRI breast scans, and the company plans to launch a similar system for prostate MRIs later this year.

PlaCor receives $3.5M for blood diagnostics — Plymouth, Minn.-based PlaCor, which just named a new CEO yesterday (see the last item in our briefing here), has also raised $3.5 million in a second funding round, VentureWire reports. Funding was provided by “accredited angel investors,” the company told VentureWire. PlaCor develops diagnostic tests of platelet reactivity, which can help physicians monitor patient response to blood-thinning drugs that help prevent or break up clots.

Neuromed raises $53M, some from mystery investors – Vancouver’s Neuromed Pharmaceuticals, battered earlier this month after it discontinued work on a new pain drug in collaboration with Merck (see our coverage in the third item of this daily briefing), raised $53.3 million in a fifth funding round. The company didn’t disclose the lead investors or new investors in the round, acknowledging only “significant participation” from existing investors including MPM Capital, James Richardson & Sons, Neuro Discovery LP, GrowthWorks Capital (Working Opportunity Fund), BDC Venture Capital, CMDF, and the Royal Bank of Canada.

Neuromed, whose partnership with Merck continues, also recently licensed another experimental pain drug from a J&J subsidiary. BioWorld has more here.

Adnexus files for $86M IPO to develop new targeted biologics — Adnexus Therapeutics, a Waltham, Mass., biotech working on a new class of drugs it calls “Adnectins,” filed to raise as much as $86.25 million in an IPO. The company’s Adnectin drug candidates are engineered proteins derived from human fibronectin, a natural protein that plays a role in wound healing and binding cell receptor proteins.

Adnexus has seven drug candidates in development, only one of which has proceeded to human testing. The company intends to target cancer and other conditions such as autoimmune and neurodegenerative disease. (See our earlier coverage of the company in the fourth item of this daily briefing.)

Seno receives $2M for early cancer detection — Seno Medical Instruments, a San Antonio, Tex., device maker focused on early cancer detection, received $2 million from the Texas Emerging Technology Fund. Seno is developing “opto-acoustic” technology designed to indicate the presence of new blood vessels that feed tumors.

UPDATE (10:15am PT): Added items on Mirabilis Medica, Confirm and PlaCor.

UPDATE REDUX (7:40pm PT): Added items on Neuromed, Adnexus and Seno.