VentureBeat

TODAY’S HEADLINES:

• MRI image-analysis firm Confirma receives $18M (release)
• Specialty pharma Zogenix raises $18M (release)
• Arcion pulls in $8.8M for topical pain gel (release)
• Bayhill Therapeutics files for $87M IPO (Edgar)
• Peakdale Molecular, chemistry-services provider, raises £1M (release)
• Radiopharmaceutical maker Cellectar draws in $13M (release)
• Critical-care drug maker Ikaria names Daniel Tasse as CEO (release)
• Noxxon Pharma appoints Frank Morich as CEO (release)

MRI image-analysis firm Confirma receives $18M –Confirma, a Bellevue, Wash., developer of automated systems for medical-image analysis, received $17.5 million in a third funding round. Investors included Telegraph Hill Partners, Fluke Venture Partners, Northwest Venture Associates, Prism Ventureworks and Versant Ventures.

The company already sells image-analysis software and associated equipment for breast-cancer detection, and is developing a similar system for prostate cancer. We previously covered the company here.

Specialty pharma Zogenix raises $18M – Zogenix, a San Diego specialty pharma, raised $18 million in a new financing round. Investors included Abingworth Management, Clarus Ventures, Domain Associates and Scale Venture Partners.

Zogenix previously raised $60 million in a first funding round back in Aug. 2006, and apparently has been quiet since then. Our coverage of them is here. Zogenix is developing a needle-free injection system for pain and CNS drugs, which it licensed from Aradigm in 2006.

Bayhill Therapeutics files for $87M IPO – Bayhill Therapeutics, a Palo Alto, Calif., biotech focused on autoimmune disease, filed to raise $86.3 million in an IPO. The company aims to restore the immune system to a state of “tolerance,” theoretically defusing particular autoimmune diseases while leaving the body’s defenses intact.

Bayhill’s approach to inducing tolerance is by using small loops of DNA, known as plasmids, that code for a specific protein antigen that appears to set off the body’s attack against itself. By introducing those plasmids in such a way that they’ll be taken up and “turned on” by the immune-system’s antigen presenting cells, the company hopes to re-educate the immune system to ignore those particular proteins.

Like most novel biotechs at this stage, Bayhill’s technology is intriguing but unproven. Its lead candidate, a drug for multiple sclerosis, has completed a mid-stage, phase II trial, but the result are complex to interpret. The company’s drug is a plasmid that codes for “myelin basic protein,” or MBP, one of the immune-system’s targets in MS. In that phase II trial, however, Bayhill only tested some patients to see if they had high levels of antibody to MBP — and the company only saw a significant reduction in MS-related brain lesions among those few patients with high MBP-antibody levels.

(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.

Featured companies: Reliant Technologies, Leptos Biomedical, Calidora Skin Clinic

Reliant Tech seeks $95M IPO for dermatology lasers — Mountain View, Calif.-based Reliant Technologies, a developer of medical lasers for “skin rejuvenation” treatment, filed to raise as much as $95 million in an initial offering. The company currently markets two laser systems for skin treatment under the Fraxel brand name, and intends to launch a third one next year.

Oddly enough, Reliant Tech’s IPO filing comes just days after Reliant Pharmaceuticals filed for a $400 million initial offering (see our coverage in this daily briefing). That should certainly keep investors on their toes. Journalists, too — I almost didn’t cover this IPO because I thought I’d already written about it.

Although it has products on the market, Reliant Tech is not only still losing money, its losses are apparently continuing to mount. Total revenues have grown substantially, to $57.4 million in 2006 from $4.5 million in 2004, but its net losses have also kept pace, largely as a result of mounting sales and marketing expenses. Net losses in 2006 were $20.9 million, up from $13.3 million in 2004; for the first half of 2007, the company posted a loss of $10.9 million on $35.3 million in revenue.

Reliant Tech raised $37 million in its two most recent fundings, most recently drawing in $15 million in a fifth round, according to VentureWire (subscription required).

Neuromodulator Leptos raises $20M for obesity implant — Leptos Biomedical, a Brooklyn Center, Minn., developer of obesity-control implants, raised $20 million in a third funding round, VentureWire reports. Investors included Latterell Venture Partners, Spray Venture Partners, Thomas McNerney & Partners and Technology Partners.

Leptos is developing what it calls an “implantable pulse generator” designed to send electric signals into the sympathetic nervous system in order to suppress appetite and induce the burning of fat. The company has apparently already conducted a pilot trial of the device, which it says the new funding will allow it to extend. Leptos hasn’t disclosed additional details about its technology; on its Web site, the page devoted to approach is a two-paragraph stub filled with boilerplate.

I’ve written earlier about EnteroMedics, another company hoping to treat obesity using an implant that interferes with signals transmitted along the vagus nerve — you can read our previous coverage here. In general, the whole field of “neuromodulation” is heating up quite a bit these days, with companies hoping to use timed electrical pulses to the nervous system for treating everything from epilepsy to sleep apnea to hypertension — although it’s worth bearing in mind that almost all of these approaches are so far unproven. See our previous coverage of other companies in this space here, here, here, here, and here.

Founded in 2003, Leptos is the brainchild of serial physician-entrepreneur John Dobak, who previously founded hypothermia-inducer InnerCool Therapies and CryoGen, which developed a cryothermic technique for stanching uterine bleeding. Both companies have since been acquired — InnerCool for $6 million (after raising $49 million) and CryoGen for something between $40 million and $150 million (after raising roughly $60 million).

Skin-clinic chain Calidora raises $4M for SoCal expansion — Calidora Skin Clinic, a chain of four “medical-aesthetic” skin-care clinics in the Seattle area, raised $4 million in a first funding round to expand its operations into southern California. Roughly half the funding was provided by the company’s existing angel investors and insiders, with Fluke Venture Partners providing the rest.

From the release:

Courtion said the funding enables the completion of expansion plans underway in Manhattan Beach, Marina Del Ray, and Glendale, Calif., and other real estate and partnership opportunities on the near horizon. The company is working with Southern California based Caruso Affiliated, a leading retail developer, on two of the three properties, including the Americana at Brand, which is slated to open in downtown Glendale in Spring of 2008.