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TODAY’S HEADLINES:

Boston Scientific spinout TriVascular2 takes in $65M – In 2005, Boston Scientific acquired a Santa Rosa, Calif., medical-device startup called TriVascular. Today, it spun it out once again.

The newly private startup raised $65 million in a “first” funding round from the likes of MPM Capital, New Enterprise Associates, Delphi Ventures and Kearny Venture Partners. Thirty million dollars of that sum went straight to Boston Scientific, which also retains the right to take a minority stake in the company.

TriVascular’s original CEO, Michael Chobotov, will resume that position at the new company, joined by two other TriVascular founders. It’s not, however, entirely clear what TriVascular will be doing. The company was originally focused on repair of abdominal aortic aneurysms, which are unusual swellings of blood vessels that can rupture unexpectedly, often fatally. Boston Scientific, however, shut down its aneurysm-repair business in 2006, so it’s not immediately obvious that the reborn TriVascular will jump right back in.

transave-logo-150px.gifInhaled-drug startup Transave raises $35M – Transave, a Monmouth, N.J., biotech working on inhaled drugs for lung disease, raised $35 million in a fourth funding round. Investors included Quaker BioVentures, Bessemer Venture Partners, TVM Capital, Prospect Venture Partners, Fidelity Biosciences, Forbion Capital Partners and Easton Capital.

The startup is working on inhalable drugs for cystic fibrosis — in particular, a long-lasting form of the antibiotic amikacin, which is currently in mid-stage, phase II human testing. Transave had previously raised $58 million in venture capital, including a “recently completed” $40 million round.

triage-wireless-logo-150px.gifTriage Wireless gets $20M for vital-signs monitors – Triage Wireless, a San Diego medical-device maker, raised $20.3 million in a second funding round. Investors included Qualcomm Ventures, Sanderling Ventures, 3i Group and Intel Capital.

Triage is developing wireless vital-signs monitors for long-term or continuous use. Its first product is a blood-pressure sensor that doesn’t require the old familiar inflated cuff.

TODAY’S HEADLINES:

breathe-tech-logo-150px.gifBreathe Tech raises $15M for respiratory disease – Breathe Technologies, a Fremont, Calif., medical device maker, raised $15 million in a second round of funding. Investors included Kleiner Perkins Caufield & Byers, Synergy Partners International, Delphi Ventures and Life Science Angels.

Breathe is developing “compact” and “lightweight” respiratory systems for the hospital and home markets, and estimates that annual sales of the devices its equipment could enhance or replace amount to $2 billion. The Breathe ventilators could be used by patients with chronic obstructive pulmonary disease, cystic fibrosis, and other lung disorders.

pieris-logo-150px.gifProtein-drug maker Pieris takes in €25M – Pieris, a German biotech pursuing a new form of protein-based drug, raised €25 million ($38 million) in a second funding round. Investors included OrbiMed Advisors, Novo Nordisk, Global Life Science Ventures, Gilde Healthcare Partners and Forbion Capital Partners.

Pieris is the latest biotech to think it can improve on monoclonal antibodies as drug candidates by developing its own engineered protein structures. The startup calls its protein structures Anticalins — they’re derived from a class of human proteins called lipocalins — and says they’re smaller and simpler than monoclonals with similar power to selectively bind to particular molecular targets.

Pieris joins a number of other companies pursuing similar strategies, including Adnexus Therapeutics, which sold itself to Bristol-Myers Squibb for $430 million, and Molecular Partners, a Swiss biotech working on modular proteins it calls DARPins. Although these are all interesting ideas, none have yet proven themselves, and all have to address a potentially significant hurdle — the fact that none of these engineered proteins are likely to engage the immune system’s disease-fighting elements the way monoclonal antibodies often do.

apthera-logo-150px.gifApthera takes in $2.1M toward cancer vaccine – Apthera, a Scottsdale, Ariz., biotech working on therapeutic cancer vaccines, raised $2.1 million of an expected $3.9 million second funding round, VentureWire reports. Investors included the University of Texas M.D. Anderson Cancer Center, Blackmont Capital, Land Ventures and individuals.

Apthera is developing a vaccine intended to stimulate an immune response against breast-cancer cells. The startup plans to start a late-stage, phase III trial of the vaccine in the fourth quarter of this year, and hopes to raise another $10 million later this year to finance the test.

(UPDATED: See below.)

arbor-surgical-logo-250px.gifIrvine, Calif.-based Arbor Surgical Technologies, a developer of minimally invasive heart-valve replacement devices, raised another $5.5 million in its third funding round, VentureBeat Life Sciences has learned. The cash came courtesy of the Laguna Fund, a new investor, and Delphi Ventures and Alloy Ventures, which have participated in previous funding rounds.

Arbor said it raised $20 million in the round in late January, so the extension brings that round to a total of $25.5 million. The company’s CEO, Steve Bacich, didn’t return a phone call or an email seeking comment.

Arbor, founded in 2002, is currently conducting European clinical tests of its replacement device for the heart’s aortic valve, which controls the flow of oxygen-rich blood from the left ventricle into the aorta. The valves are made of bovine pericardium, the tough tissue sac that surrounds a cow’s heart.

Many existing aortic-valve replacements require open-heart surgery; Arbor says its device can be implanted in a minimally invasive procedure, although it doesn’t describe the procedure in any of its available public information. The company plans U.S. trials of the device later this year. In January, Arbor licensed manufacturing, marketing and distribution rights to the device to Medtronic in exchange for an equity investment and, most likely, other undisclosed payments.

Of course, no Valentine’s Day would be complete without some messy pictures of heart surgery. I’ve put an Arbor photo comparing the implantation of its device to that of traditional aortic-valve replacements after the jump.

UPDATE: Bacich got back to me about ten minutes after this post went up — which was close to three hours after I called and emailed him — and said he doesn’t know anything about this funding. He’s running down the facts, and I’ll update again when I know more. He also said that Laguna is an existing investor — according to Bacich, it’s a “branch” of funds owned by Arbor co-founder Thomas Fogarty. Laguna isn’t listed as an investor on the Arbor Web site, although Fogarty is.

Read the rest of this entry »

alder-bio-logo.jpgAlder Biopharmaceuticals, a Bothell, Wash., developer of antibody drugs, raised $40 million in a third funding round. Investors included Delphi Ventures, TPG Biotech, Sevin Rosen Funds, Ventures West, H.I.G. Ventures, and WRF Capital.

Alder develops antibody-based drugs for inflammation and autoimmune disease. The company’s lead candidate, ALD518, is currently in clinical trials as a treatment for rheumatoid arthritis and cancer, although neither Alder’s Web site nor its statement disclose when the drug began human tests.

Alder’s work is also noticeable because it produces its antibodies in genetically modified yeast cells, a new manufacturing technique that the company claims is faster and cheaper than traditional genetic-engineering methods involving mammalian cells. Not only does production in yeast allow companies to sidestep the need for expensive patent licenses that cover traditional methods, Alder claims it can speed the development process to months from years, making it possible to evaluate a much wider range of antibody candidates.

Alder also claims that ALD518 is the first full-length functioning antibody to be made on an industrial scale in yeast. For an additional information on the merits of yeast-based antibody manufacture, see our previous coverage of Adimab, a startup developing its own yeast-production system for similar reasons. If you’re a technical-detail junkie, don’t miss the discussion in comments.

TODAY’S HEADLINES:

tacere-logo-150px.gifTacere Therapeutics strikes RNAi deal with Pfizer for up to $145M — San Jose, Calif.-based Tacere Pharmaceuticals, a biotech developing new drugs based on the gene-silencing technique known as RNA interference, struck a partnership deal with Pfizer that could be worth up to $145 million. The company’s release is here.

The deal involves Tacere’s leading drug candidate for hepatitis C. Known as TT-033, the drug consists of short stretches of RNA designed to trigger cellular mechanisms that shut down the activity of specific genes — an exciting but so far still unproven approach. In this case, TT-033 aims to shut down three separate parts of the hepatitis C genome, theoretically not only inactivating the virus, but also preventing the development of resistant viral strains.

Tacere is already co-developing TT-033 with Oncolys BioPharma of Japan, and in fact has deep Japanese roots, as the company also received its founding capital from Hokkaido Venture Capital of Sapporo, Japan. (Our coverage of the Oncolys deal is here.) The Pfizer deal appears to be complementary to Tacere’s previous agreement, as the Big Pharma will receive worldwide rights to TT-033 excluding Asian nations. Pfizer will fund all future development of the drug, and will make milestone payments to Tacere as development proceeds. TT-033 has not yet entered human testing.

aragon-sugical-logo-150px.gifSurgical-device maker Aragon Surgical receives $25M — Aragon Surgical, a Palo Alto, Calif., developer of surgical instruments, raised $25 million in a second funding round. Investors included Bay City Capital, Integral Capital Partners, Delphi Ventures and Onset Ventures.

Founded in 2005, Aragon develops tools and instruments intended to speed surgical procedures and to improve their safety. The company is working on two major classes of devices — “electrosurgical” instruments, which use electric current to stop bleeding, remove growths and cut tissue, and tools that improve the speed and safety of minimally invasive surgeries known as laparoscopies. Last September, Aragon launched its first product, the LapCap, which guides a needle used to inflate a patient’s abdomen with gas in order to reduce the risk of inaccurate placement and injury.

benvenue-logo-150px.jpgBenvenue Medical raises $15M for spine-repair devices — Mountain View, Calif.-based Benvenue Medical, a developer of minimally invasive devices for spine surgery, raised $15 million in a second funding round. Investors included Three Arch Partners, Versant Ventures and De Novo Ventures.

Benvenue is developing spinal implants designed for the treatment of spinal compression fractures and degenerative disk disease via spinal fusion. The company’s Web site is a stub, and it doesn’t seem to have described its technology in much detail yet.

Stem-cell biotech BioE seeks $3.5M — St. Paul, Minn.-based BioE, a provider of stem-cell products for the drug and biotech industries, hopes to raise $3.5 million in a first funding round, VentureWire reports (subscription required). The company has so far raised $30 million from angel investors, and disclosed its plans in a regulatory filing. The funds will allow the company to commercialize lines of “multi-lineage” progenitor stem cells and a system for processing and freezing of umbilical-cord blood stem cells.

Inovise raises $3.4M for heart diagnostics — Inovise Medical, a Portland, Ore., developer of cardiac diagnostics, raised $3.4 million in convertible notes, VentureWire reports, citing a regulatory filing. The company is in the midst of fundraising for a sixth financing round. Inovise makes a non-invasive cardiac monitoring system called Audicor that records and analyzes sounds emitted by a beating heart.

Fairway Medical pockets $1M for medical devices, aims for $10M — Fairway Medical Technologies, a Houston incubator that develops a variety of medical devices, raised $1 million from angel investors and is looking to draw another $5 million to $10 million in a first institutional round later this year, VentureWire reports. Founded in 1992, Fairway Medical in-licenses medical devices and ushers them through the development process.

Cancer-drug biotech Genspera pulls in $650K, looks for $5M more — Santa Monica, Calif.-based Genspera, a biotech focused on cancer drugs, raised $650,000 in a seed round and aims to close another $5 million in funding later this quarter, VentureWire reports. The company plans to list its shares on the Nasdaq over-the-counter bulletin board following the financing. Genspera is working on cancer drugs using technology licensed from Johns Hopkins University.

E-trolZ looks for $400K for electrophysiology devices — North Andover, Mass.-based E-trolZ, a developer of electrophysiology measurement devices, raised $400,000 in a follow-on to its first $1.2 million funding round, VentureWire reports. The company is developing components that measure various physiological signals and which can be integrated into other medical devices.

evalve-logo.jpgEvalve, a Menlo Park, Calif., developer of minimally invasive heart-valve repair implants, raised $60 million in a fourth funding round.

mr-pre-mitraclip.jpgEvalve’s device is designed to replace risky open-heart surgery for patients whose mitral valve, which regulates blood flow between the left two chambers of the heart, fails to close properly. The device allows interventional cardiologists to thread an implant clip through the femoral artery of the leg to the heart, where it can pin together two “leaflets” on the mitral valve.

The images at left show the mitral valve prior to the procedure and following installation of the company’s MitraClip. (Obviously, these represent a somewhat idealized view of how this is all supposed to work.) Evalve also has a video illustrating the technique at its Web site here.

mr-post-mitraclip.jpgThe company said the funding will lay the groundwork for commercial launch of its MitraClip device in Europe and to complete late-stage human tests of the device in the U.S. Evalve is still enrolling patients in that study, which will compare MitraClip to standard open-heart surgery. and expects to complete enrollment next year. Patients will be followed for 24 months following the procedure.

Investors included BBT Fund, Delphi Ventures, New Enterprise Associates, Split Rock Partners and Abbott Laboratories. Evalve isn’t alone in this market, although it appears to be ahead of one rival we’ve previously covered, Cardiosolutions (see here).

Cardiosolutions aims to restore mitral-valve function with a paddle-type implant that pushes the valve’s leaflets closed during ventricular contraction. For additional — albeit somewhat dense — explanation, plus its own video of the process, see the company’s site here.

(UPDATED: See below.)

relypsa-logo-1.jpgA common dilemma in biotech acquisitions is how to keep a startup’s entrepreneurial management happy and productive when they’ve just been assimilated by the Borg. The answer, often enough, is not to bother, and to let them spin out a new company with scientific “leftovers” that weren’t the point of the acquisition in the first place.

That’s more or less what Amgen has just done in launching Relypsa, a new Santa Clara, Calif., biotech just spun out of the big biotech’s Ilypsa unit. Relypsa is basically a full restart of Ilypsa — thus the name, I suppose — which Amgen acquired earlier this year for roughly $420 million (see our coverage here).

Of course, the new startup now lacks the kidney-disease drug (specifically, a treatment for hyperphosphatemia) that Amgen had shown particular interest in. But Relypsa is free to rev up its existing drug-discovery platform — one focused on making drugs out of long-lasting polymers that grab and eliminate excess molecules such as potassium or sodium — and also managed to keep a pipeline of promising candidates that might one day be useful in treating kidney and heart disease.

Such restarts of acquired biotechs aren’t unknown in the industry, although they’ve been growing in popularity. For instance, the former management of Eyetech Pharmaceuticals recently banded together to form Ophthotech with technology left over from Eyetech after it was swallowed by OSI Pharmaceuticals (our coverage here). This sort of strategy is likely to hold increasing relevance for Big Pharma as its companies fire up their biotech-acquisition machines.

The Relypsa deal, however, may set records for speed and continuity. The former CEO of Ilypsa, Jay Shepard, reprises that role at Relypsa; Ilypsa co-founder Garrett Klaerner returns as COO; and Ilypsa’s former chief medical officer Detlef Albrecht now resumes that position at Relypsa. (Honestly, props to whoever came up with the name “Relypsa,” because it’s really apropos here.) And so on down the line.

Relypsa raised $33 million in a first spinout round, with investors that included 5AM Ventures, New Leaf Venture Partners, the Sprout Group, Delphi Ventures, CMEA Ventures and Mediphase Venture Partners. Amgen, of course, retains a minority stake in Relypsa, and probably insisted on some form of right-of-first-refusal should Relypsa get interested in striking a partnership with — or selling itself to — another company. (I’ve asked Relypsa’s representatives about that, and will report back if I learn more.)

UPDATE: Relypsa’s external PR person got back to me on the right-of-first-refusal question, but kudos to you if you can make any sense of it. Here’s the response in its entirety: “Amgen retained certain rights related to transferred programs customary for spin outs at this stage. Relypsa will initiate partnering campaigns for certain indications and territories as appropriate.” Well, that was helpful. Sometimes I wonder why I bother asking.

UPDATE REDUX: In a later interview, Relypsa COO Gerrit Klaerner told me that “of course” Relypsa has an “entanglement” with Amgen, although he wouldn’t go much further than the official statement in describing Amgen’s particular rights. “There is enough skin in the game for Amgen to keep an interest in Relypsa,” he said. “If you see us doing a partnership, you will get an answer to your question.”

Klaerner added that the idea of recreating Ilypsa came up shortly after the acquisition. “We wanted to save a bunch of jobs and create a new home for the technology,” said Klaerner, who worked as an advisor to 5AM for the deal. “We had 38 people who, after the success of Ilypsa, had multiple job offers and asked them to stick with us, even though the company wasn’t really created.” What’s more, he said, Amgen’s backing of the deal didn’t waver despite the company’s recent woes (see, for instance, here). “Given what they were going through, to give this level of high-level support was really, really remarkable,” Klaerner said.

Oh, and the name Relypsa was apparently an internal placeholder that turned into the real thing when no one could think of anything better, Klaerner said.

FINAL UPDATE: I started thinking about other recent deals that resemble Ilypsa-Relypsa after an email correspondent planted the bug in my ear. The one that comes most immediately to mind would be the launch of Sequel Pharmaceuticals — another clever name — out of NovaCardia’s acquisition by Merck (our coverage here). Another example would be Cerexa Pharmaceuticals, which spun out of Peninsula Pharmaceuticals in 2005 after Peninsula was purchased by J&J. Cerexa was acquired by Forest Labs this past January, and doesn’t appear to have launched another spinout.

Have any other good examples? Sound off in comments.

Featured companies: Mawell, OpGen, Vital Therapeutics

opgen-logo.jpgOptical genome-mapper OpGen raises $23.6M in a restart — OpGen, a Madison, Wisc., biotech developing a genomic test for identifying disease-causing microbes, raised $23.6 million in what the company is billing as a first funding round. In fact, however, the funding is more of a restart for the company, which was founded in 2001 and previously provided genomic services to researchers.

OpGen is now focused on developing speedy genome-based tests that can help identify and track infectious disease microbes. The company has set its sights on clinical microbiology laboratories as potential customers; such laboratories now try to identify the source of a patient’s infection by growing up the responsible bacterial in culture, a process that can take days. OpGen’s technology, which identifies patterns in single molecules of DNA to identify particular microbial strains, can deliver answers within two to three hours, the company says.

Investors included CHL Medical Partners, Highland Capital Partners, Versant Ventures and Mason Wells.

Vital Therapies gets $28.1M for artificial liver — San Diego’s Vital Therapies, a device maker developing an “artificial liver,” raised $28.1 million in a third funding round. Investors included Versant Ventures, Delphi Ventures, HBM BioMed China, DFJ DragonFund China, MedVenture Associates, Valley Ventures, Toucan Capital and Heights Capital.

Vital’s main focus is on a cartridge-style device that mimics the toxin-breakdown and waste-filtering function of the liver. The device, which contains artificially grown human liver cells, is intended for use while patients await a liver transplant. The device has completed four early-to-mid-stage trials, two of them in China, where prevalent hepatitis frequently contributed to liver failure.

Finland’s Mawell draws €8M for healthcare IT — Helsinki’s Mawell, a bioinformatics company providing software and services to drug companies and hospitals, raised €8 million ($11.1 million) from the private-equity firm CapMan, VentureWire reports (subscription required). CapMan will become Mawell’s largest owner.

(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-logo.jpgBioForm 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).

vibrynt-logo.jpgStealthy 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-logo.jpgCardiovascular 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-logo.gifMirabilis 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-logo.JPGConfirma 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-logo.jpgPlaCor 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-logo.jpgNeuromed 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-logo.jpgAdnexus 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-logo.jpgSeno 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.

(UPDATED at 7:10pm PT: See below.)

Featured companies: NeurAxon, VytronUS, Avila Therapeutics, CardioNet, Ventana Medical Systems, CytoLogix, PlaCor

neuraxon-logo.jpgNeurAxon raises $32M for pain drugs — You have to hand it to Waltham, Mass.-based NeurAxon — the company certainly knows how to keep itself in the news. Today, it announced it has raised $32 million in a second funding round, a week after it reported a positive early-stage trial result for its experimental migraine treatment.

Investors included Delphi Ventures, OrbiMed Advisors, BDC Venture Capital, Genesys Capital Partners, H.I.G. Ventures, NeuroVentures Fund, Ventures West Capital and Lawrence Bloch, NeurAxon’s CEO.

Stealthy VytronUS gets $6.6M — Los Altos, Calif.-based VytronUS, a secretive medical-device company, raised $6.6 million in a first funding round, PE Hub reports, citing a regulatory filing. Delphi Ventures and New Enterprise Associates provided the funds.

Avila Therapeutics receives undisclosed first funding — Avila Therapeutics, a Waltham, Mass., biotech focused on cancer and viral disease, raised an undisclosed first funding round in February, VentureWire reports (subscription required). Investors included Abingworth Management, Advent Venture Partners, Atlas Venture and Polaris Venture Partners. The company doesn’t have a Web site.

cardionet-logo.jpgWireless heart monitor CardioNet files to raise $150M in an IPO — CardioNet, a San Diego medical-device firm focused on wireless heartbeat monitors, filed to raise up to $150 million in an IPO. The company still isn’t profitable, although its sales appear to be set to double this year.

The In Vivo blog has some additional insight into CardioNet’s rather convoluted funding history.

ventana-logo.jpgDefunct device maker wins patent case against Ventana — CytoLogix, a failed medical-device startup formerly based in Cambridge, Mass., won a patent-infringement suit against publicly traded Ventana Medical Systems of Tuscon, Ariz. A jury awarded CytoLogix $10.8 million in damages, but said Ventana wasn’t liable for related antitrust claims. CytoLogix attorneys have said they will seek to have the damages paid to the company’s shareholders, VentureWire reports.

From VentureWire:

CytoLogix alleged in the patent litigation that Ventana learned about CytoLogix’s proprietary intellectual property by gaining access to a confidential business plan that CytoLogix had distributed in the mid-1990s as part of its search for venture capital. This allegation stemmed from an admission made by Ventana’s then-Chairman Jack Schuler, as part of an address he made in October 1999, at a U.S. Trust investment conference in Tarrytown, N.Y.

In the speech, Schuler described in detail how years before, Ventana had made use of information in the business plan. A 2002 Barron’s article about the litigation quotes him in the speech as having acknowledged the competition in a major way.

CytoLogix sold its business operations to Dako in 2002, and currently exists only to pursue the litigation. Ventana, meanwhile, is trying to fend off an unsolicited takeover offer from Roche.

The original Barron’s article on the lawsuit is here, and there’s a little more detail on the decision in this AP story.

placor-logo.jpgPlaCor names new CEO — PlaCor, a Plymouth, Minn., developer of blood-cell diagnostics, named John Reinke as CEO, effective Sept. 4. PlaCor is developing diagnostic tests of platelet reactivity intended to determine patient response to anticoagulant treatment following serious blood-clot incidents, which can lead to heart attacks or strokes. Current CEO Bill Haworth will become the company’s chief scientific officer.

UPDATE (7:10pm PT): Added items on Ventana/CytoLogix lawsuit and PlaCor.

Aragon Surgical, a Palo Alto, Calif., medical-devices maker, said the FDA cleared its LapCap product for use in general surgery. Aragon, which doesn’t seem to have a Web site, gained ownership of the LapCap when it acquired VeriSure, another device maker, in March.

The LapCap is designed to ease the initial steps of minimally invasive, or laparoscopic, surgery, in which surgeons must pass a needle into the abdomen in order to blow in gas that will expand the abdominal cavity. The LapCap guides this needle into the proper location, helping to avoid inadvertent needle-related injuries. The device was previously only cleared for use in gynecologic laparoscopies.

Aragon is backed by Delphi Ventures and Onset Ventures.

heartnet-device.gif(UPDATED: See below.) Paracor Medical, a Sunnyvale, Calif., startup developing a mesh restraint designed to support failing hearts, raised $44.35 million in a fourth round of funding. The company is vying with another device startup, Acorn Cardiovascular, to prove that this sort of device works and to bring it to market.

The idea behind Paracor’s device, which it calls HeartNet, is simple. In heart failure, a general term for a variety of similar conditions with different causes, the heart muscle grows progressively weaker and loses the ability to pump enough blood through the body. In many cases, the heart reacts to its reduced pumping strength by enlarging, which temporarily makes it possible to contract more strongly. Over time, however, the enlarged heart tires again, triggering a new cycle of enlargement and weakness.

Paracor’s HeartNet is an elastic metal-alloy mesh designed to wrap around the heart and support it, theoretically improving its efficiency and slowing or stopping failure-related expansion of the muscle. (See the photo above.) Doctors stretch this mesh over a still-beating heart via a less-invasive form of the surgery known as a thoracotomy, which Paracor calls a “mini-thoracotomy.” (For some mildly gory photos, see this research abstract, which is a PDF file.)

In early clinical trials, heart-failure patients who received the mesh were able to walk farther, reported fewer symptoms and witnessed improvement in a variety of heart-related measurements such as oxygen transport and utilization. Paracor is currently enrolling volunteers in a large, randomized study of the device in 272 patients, which company officials hope will allow them to apply for FDA approval by 2010, according to VentureWire (subscription required).

Acorn’s experience, however, provides a cautionary tale. The St. Paul, Minn., company is developing a similar polyethylene mesh wrap called CorCap, which it already markets in Europe (see its PDF brochure here). CorCap requires a full open-chest surgery (see slide #8 in this PowerPoint deck) and can complicate subsequent heart surgeries.

In a 300 patient trial, CorCap appeared to improve a variety of outcomes for patients who received it. Last December, however, an FDA dispute-resolution panel said the company would need to conduct an additional clinical trial before the agency would consider U.S. approval, after an FDA advisory panel recommended against approval in 2005. Some panel members called the study a “quagmire” because of its poor design and statistical anomalies. Acorn hovered on the brink of dissolution until this May, when it reached an agreement with the FDA to conduct a 50 patient confirmatory trial for which it is currently raising $15 million, the company told VentureWire.

Paracor’s funding round was led by Aberdare Partners, joined by Montagu Newhall Associates and existing investors Delphi Ventures, Pequot Ventures, InterWest Partners, Alta Partners, De Novo Ventures, Saratoga Ventures, and Palo Alto Investors. The company said the new funds will support its pivotal trial of HeartNet.

UPDATED: Expanded and rewritten throughout.

(CORRECTED: See below.)

brain.jpgSeattle-based NeuroVista, a developer of devices for the treatment of epilepsy, raised $33.8 million in a second-round funding and left behind its former name, BioNeuronics.

The company, founded in 2002 by whiz kid Daniel DiLorenzo, has been quiet about its technology and commercial direction. In April, however, DiLorenzo received a patent for a “neurological control system” using “closed-loop intracranial stimulation” for the “optimal control of neurological disease.” In other words, given NeuroVista’s public interest in epilepsy, it sounds very much like it’s working on implantable neuromodulation devices that could monitor and perhaps counteract the early signs of an oncoming seizure. (Hat tips: VentureWire and Neurotech Business Report).

VentureWire also reports that one other venture-backed company, NeuroPace, and two established device makers, Medtronic and Houston-based Cyberonics, may also be researching epilepsy devices.

Here’s NeuroVista’s vaguely worded announcement. The round was led by Advanced Technology Partners and Delphi Ventures, who were joined by Three Arch Partners, Sprout Group and Foundation Medical Partners.

CORRECTION: An earlier version of this item stated that Dan DiLorenzo “co-founded” NeuroVista. He’s informed us that he was the sole founder, and I’ve corrected the item to reflect that.

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