Behavioral health personalized medicine company AssureRx Health has secured an $8 million line of credit as it looks to boost adoption of its genetic screening test for psychiatric drugs.

Along with an $11 million series B round of funding that the company obtained last year, the line of credit will help fund the development of several new products to be launched in 2012, according to a statement from Cincinnati-area AssureRx.

An AssureRx spokesman declined to provide further detail on the company’s new products.

However, in the past, AssureRx has said that future products could include tests that help doctors choose medications for patients who have neurodegenerative diseases like Alzheimer’s or Parkinson’s, as well as disorders such as attention-deficit/hyperactivity disorder and post-traumatic stress.

The company’s GeneSightRx test, which helps doctors pick the right psychiatric drugs, was launched in 2009. The test uses a cheek swab, mathematical algorithms and bioinformatics to narrow drug choices to those that work with a patient’s genes.

AssureRx’s series B round was led by California-based Claremont Creek Ventures and Sequoia Capital. Other investors include North Coast Angel Fund, Cincinnati Children’s Hospital Medical Center, Mayo Clinic, CincyTech and Allos Ventures.

The company obtained the $8 million line of credit from Silicon Valley Bank.

Next on tap for Meridian Bioscience‘s (NASDAQ:VIVO) illumigene molecular diagnostic testing platform is a test for Mycoplasma pneumonia, an infection of the lungs.

The illumigene Mycoplasma test is currently in clinical trials, according to a statement from Meridian announcing the Cincinnati-area company’s first-quarter earnings. Meridian plans to launch three to four new illumigene tests per year, CEO Jack Kraeutler said.

After Mycoplasma, the next illumigene test Meridian is expected to release is for group A streptococcus, a type of bacteria often found on the throat or in the skin.

Cincinnati-area Meridian is betting big on the illumigene platform, which it says provides its hospital and laboratory customers with a simpler, cheaper option to test samples for certain types of bacteria without the use of expensive instrumentation.

Tests for C. difficile and group B streptococcus that utilize the platform have already been cleared by the U.S. Food and Drug Administration.

Meridian has completed 750 total “placements” worldwide of the illumigene technology, an increase of about 100 customers in the last 10 weeks, Kraeutler said.

In the first quarter, Meridian’s net income grew 9 percent to $6.6 million, or 16 cents per diluted share. Net sales grew 8 percent to $40 million.

“While these results are positive, especially in a weak economy, we believe our potential for growth continues to increase,” Kraeutler said.

Meridian reaffirmed its previously issued full-year guidance of earnings per share between 85 cents and 89 cents, and net sales between $183 million and $192 million.

The Cincinnati-area company’s GeneSightRx test, which helps doctors pick the right psychiatric drugs for patients based on their genes, was launched in 2009. The test uses a cheek swab, mathematical algorithms and bioinformatics to narrow drug choices to those that work with a patient’s genes.

The latest version of the test, GeneSightRx 1.8, adds six new psychotropic medications to the panel of 26 medications covered by the test, according to a statement from AssureRx.

The company has also updated its physician portal, MyAssureRx.com, which clinicians can use to order tests, view patient reports and order sample collection supplies. The portal is now accessible on an iPad or similar tablet device, according to the statement.

Last year, AssureRx closed an $11 million series B round of funding, led by California-based Claremont Creek Ventures and Sequoia Capital. Other investors include North Coast Angel Fund, Cincinnati Children’s Hospital Medical Center, Mayo Clinic, CincyTech and Allos Ventures.

[Photo from flickr user Harveyben]

The hospital’s $1.7 billion budget will remain flat this year and Cincinnati Children’s plan to keep its employee count steady at around 12,650 workers, the Cincinnati Enquirer reported. Cincinnati Children’s budget will stay flat despite an expected 5 percent increase in demand for medical services.

The hospital is expecting to face $55 million in losses from Ohio Medicaid cuts this year and next. Medicaid patients account for about 45 percent of the hospital’s revenue.

To cope with the funding challenges, Cincinnati Children’s is exploring a couple different avenues. One option is making greater use of the hospital on weekends, and steering some patients toward weekend appointments. “There’s a lot of capacity still left in our system during those times,” Frederick Ryckman, the hospital’s senior vice president of medical operations, told the Enquirer.

However, the bulk of the reduced spending is expected to come from a “capacity management” program that aims to more closely align the supply of Cincinnati Children’s workers with the demand from patients for their services. That involves the hospital getting better at predicting when patients will be discharged and transferred and when they will have elective surgeries, for example.

Additionally, the hospital has implemented a software program that, for example, can look at the last four Mondays during a particular time of year to schedule staff for future Mondays, according to the Enquirer.

Cincinnati Children’s ranked No. 3 nationally in U.S. News & World Report’s most recent list of the top children’s hospitals in the nation.

Ohio Gov. John Kasich’s most recent two-year budget called for $478 million in reduced Medicaid payments to hospitals.

[Photo by flickr user James Bowe]

Barrington Research listed Cincinnati-area AtriCure as among its top 15 stock picks for the year and called the company a strong candidate for a buyout, the Cincinnati Business Courier reported.

“ATRC has the only approved (left atrial appendage) product that is effective on the U.S. market and the only product we expect for at least three years,” Barrington said.

That’s a reference to the company’s AtriClip system, a device used to block a thumb-sized pouch on top of the left side of the heart to reduce blood clots.

The company scored a huge win last month when an AtriCure ablation system received U.S. regulatory clearance for atrial fibrillation, which made it the first-ever surgical device to be cleared by the U.S. Food and Drug Administration for treatment of the condition.

This certainly isn’t the first time (and won’t be the last) that AtriCure receives buzz as a buyout candidate. A Canaccord Genuity analyst last year said essentially the same thing, and MedCity News wondered last year about when a strategic acquirer would step up to grab AtriCure. “If” no longer appears to be the question, but “when” certainly is.

[Photo from flickr user bsabarnowl]

Akebia Therapeutics has spun off a new company, the similarly named Aerpio Therapeutics, to develop drugs for diabetic macular edema and inflammatory bowel disease.

Akebia will continue developing its oral anemia drug candidate, according to a statement from the Cincinnati-area company.

The new company is looking to raise a series A round of financing this year.

“The formation of Aerpio allows us to focus and attract resources to the substantial opportunity we believe our lead programs represent,” said Joseph Gardner, CEO of both companies.

Aerpio plans to begin a phase 2a trial of its lead candidate, the diabetic macular edema drug, in the second quarter. The disease involves the swelling of the retina due to fluid leakage from blood vessels within the central portion of the retina.

Akebia last year raised a $22 million series B round to support clinical trials of its anemia drug. The round was led by Novartis Venture Fund and Venture Investors, and featured participation from a number of other investors.

Akebia was started several years ago after acquiring the rights to two drugs from Procter & Gamble, which dismantled its pharmaceuticals division.

Here’s how Kraeutler’s 2011 compensation breaks down, according to a recent regulatory filing: $546,000 in base salary; $228,000 in stock awards and $69,000 in “other” compensation, which includes retirement contributions, auto allowance and financial planning.

Unlike most CEOs, Kraeutler was not his organization’s highest-paid employee. That distinction went to William Motto, the company’s executive chairman, who was paid $885,000 in 2011. Motto is Meridian’s founder and has been chairman of the company’s board since 1977, according to the regulatory document.

For its fiscal year ended in September 2011, Meridian reported a 12 percent increase in sales to $160 million, and a 1 percent increase in profits to $27 million.

Earlier this week, Meridian announced that it had received U.S. regulatory approval to begin selling a new Clostridium difficile test.

The ImmunoCard C. difficile GDH test has already been launched in global markets for screening of the bacteria, a common hospital-acquired infection. Toxigenic strains of C. difficile cause diarrhea and can lead to life-threatening complications or death.

In 2010, researchers reported that the C. difficile superbug surpassed Staphylococcus aureus as the most common hospital-acquired infection in the U.S., infecting about half a million people each year.

This approval makes Meridian the only manufacturer that can provide a complete portfolio of C. difficile testing solutions, the company said in a press release. Meridian already has a few tests for C. difficile on the market, but sales stagnated last year because of increasing competition. In March, the company received FDA clearance on what it called the only C. difficile test on the market aimed at patients younger than 2 years old.

Just two weeks ago Meridian received FDA approval for a molecular diagnostics test for group B streptococcus, part of its illumigene line of molecular diagnostics.

The company generated net earnings of $26.8 million in fiscal year 2011, flat from 2010. Shares were trading up half a percent at close on Tuesday.

The group B strep test is the second in the Cincinnati-area company’s illumigene line of molecular diagnostic tests to be cleared by the U.S. Food and Drug Administration. The illumigene product line is key to Meridian’s future as more customers look to molecular diagnostics, a means of analyzing the makeup of an organism at the genetic level.

Meridian says the illumigene platform provides its hospital and laboratory customers with a simpler, cheaper option to test samples for certain types of bacteria without the use of expensive instrumentation. Meridian’s first illumigene test, for the bacterium C. difficile, received FDA approval in July 2010.

The new group B strep (GBS) test yields results in an hour and works via a “simple” procedure that includes heat treatment, amplification and detection, according to a statement from Meridian.

GBS is a bacterial infection that can be passed to a woman’s baby during delivery. The bacteria is normally found in the vagina and/or rectum of about 25 percent of all healthy adult women, the American Pregnancy Association said.

The U.S. Centers for Disease Control and Prevention has recommended routine screening for GBS for all pregnant women to be performed between the 35th and 37th weeks of pregnancy.

Meridian is planning to release several other new tests on the illumigene platform over the next year or so.

The $943,000 in financing for Cincinnati-area IschemiaCare comes through the Innovation Ohio Loan Fund program, which is aimed at helping companies in the state develop “next-generation” products.

IschemiaCare‘s project funded through the loan is expected to create 22 jobs, according to the Ohio Department of Development. The state recently has stopped providing anything beyond the most of basic of details about the projects it finances.

IschemiaCare CEO Jeff June declined comment when reached by email.

In September, June said the company had closed on $800,000 of a $1.1 million series B round of investment he hoped to complete by the end of the year. IschemiaCare plans to use the investment to establish a certified CLIA lab and test up to 500 samples with the goal of showing the stroke test’s accuracy.

IschemiaCare’s blood test, called ISCDX, uses gene expression profiles to differentiate strokes that originate in the heart from those that originate in large blood vessels leading to the brain. June has said he envisions the company’s test as a companion diagnostic to imaging and plans to sell the test mostly to stroke centers and hospitals. The company is developing a second test that can also be used to diagnose the cause of transient ischemic attacks, also known as mini-strokes.

IschemiaCare hopes to begin generating revenue from its test by the third quarter of next year.

Photo from flickr user ConstructionDealMkting

AtriCure's AtriClip device

Medical device maker AtriCure (NASDAQ:ATRC) is looking to obtain regulatory clearance to use its AtriClip heart device on stroke patients.

The Cincinnati-area company is planning next year to begin a clinical trial that will investigate the AtriClip for use in stand-alone procedures that involve exclusion of the left atrial appendage, a thumb-sized pouch on top of the left side of the heart from which blood clots that cause strokes often originate.

Using the clip device to exclude the pouch could reduce the risk of stroke-causing blood clots in patients who can’t tolerate anti-coagulation drugs, said AtriCure CFO Julie Piton.

But don’t expect the company to obtain clearance for the stroke indication any time soon: Piton said the clinical process to get the label will likely take several years.

Currently, the AtriClip device is cleared in the U.S. only for use in conjunction with other open-cardiac surgical procedures in which the physician has direct visualization. If the company obtains the new clearance it seeks, the device could be marketed for stand-alone thoracoscopic procedures, which involve inserting a a narrow tube with a camera through a small incision in the chest wall.

Obtaining the new clearance would widen the potential market for the AtriClip and facilitate long-term commercialization of the device, CEO David Drachman said during the company’s most recent quarterly earnings conference call with analysts.

Along with the push for a new marketing clearance of the AtriClip, the company is developing a new version of the device’s deployment system, though that doesn’t involve any changes to the clip device itself, Piton said. The changes would make the device easier for surgeons to use in thoracoscopic procedures, she said.

The AtriClip obtained initial U.S. Food and Drug Administration clearance to begin marketing the AtriClip in June 2010.

The document didn’t specify a dollar amount or number of shares the company could sell, or a date by which the company would make the sale.

However, the document notes that Meridian is authorized to sell up to 71 million shares of common stock and that the company currently has about 41 million shares of common stock outstanding.

Similarly, the company is authorized to sell up to 1 million shares of preferred stock, but has issued none, according to the document.

The document also gives Meridian the right to exercise other financing options, including issuing debt and warrants.

By filing registration statements like this one (known in Securities and Exchange Commission parlance as a form S-3), companies can go through the securities-registration process before they actually issue any new shares, which allows them to more quickly pull the trigger once they decide to do the offering. Filing the statement doesn’t mean the company is obligated to eventually sell the shares, however.

Meridian expects to use the proceeds from any sale for “general corporate purposes,” which may include repaying outstanding debt, according to the document.

CFO Melissa Lueke didn’t immediately return a call.

Earlier this month, Meridian said it plans to launch up to four new tests from its illumigene molecular diagnostic testing platform over the next year.

Cincinnati-area AtriCure’s DEEP AF feasibility study was investigating the hybrid procedure, which received that name because it combines catheter ablation, which occurs inside the heart, with a minimally invasive ablation procedure that creates lesions on the outside of the heart.

The change in plans involves when the two major portions of the hybrid procedure are performed. Rather than perform each part of the procedure in a single session, AtriCure will now focus on a “staged approach” in which each portion is scheduled separately.

AtriCure said a staged approach would lessen the learning curve related to the hybrid procedure for clinicians. Additionally, the staged approach would alleviate some scheduling and logistical challenges, AtriCure CEO David Drachman said.

AtriCure enrolled 24 of an expected 30 patients in the trial before closing it.

For AtriCure, the change in plans creates some uncertainty around the future regulatory path associated with the procedure. (Successful trials could lead to AtriCure receiving approval from the U.S. Food and Drug Administration to label its bipolar ablation system for the treatment of  atrial fibrillation.)

Drachman said it was unclear whether the FDA would require the company to design and conduct a new feasibility study of the procedure before proceeding to a pivotal trial. Also unclear is the length of time the FDA will require patients to wait between undergoing the two parts of the procedure in the new, staged approach.

“We still have to talk to the agency and get their view,” Drachman said on a conference call with analysts.

AtriCure had planned to launch a 35-center pivotal trial next year, which Drachman had said would be an “inflection point” for the company. Now, the arrival of that “inflection point” will be delayed, at the very least.

Still, Drachman put a positive spin on the news, noting that “we accomplished our objective of gaining a better understanding of the procedure prior to proceeding to a pivotal trial.”

AtriCure’s shares were up less than 1 percent in early trading, indicating that the market isn’t particularly concerned about the company’s change in plans.

Cincinnati-based Ausio is developing a drug, now called AUS-131, to treat vasomotor symptoms (night sweats and hot flashes) in postmenopausal women and benign prostatic hyperplasia (enlarged prostate) in men. The drug is currently in phase 2a trials that are expected to be completed this year.

In the licensing deal, Ausio gets patents to develop, manufacture and sell products utilizing the isoflavone metabolite known as equol for nononcology applications, according to a statement from San Diego- based Marshall Edwards. The San Diego company will receive royalty payments from the sales of any products from Ausio that contain equol.

Isoflavones are a class of organic compounds that are similar in structure to estrogen. They can be used to promote or reduce the activity of estrogen.

Ausio says its drug candidate could offer a safer alternative with fewer side effects than estrogen therapy. The company is looking for development and commercialization partners for the drug.

Ausio CEO Richard Jackson declined comment.

Ausio was founded in 2006 and based on technologies licensed from the Australian Health and Nutrition Association and Cincinnati Children’s Hospital Medical Center. Ausio focuses on developing drugs for “the aging population.”

Cincinnati-area Meridian is betting big on the illumigene platform, which it says provides its hospital and laboratory customers with a simpler, cheaper option to test samples for certain types of bacteria without the use of expensive instrumentation.

The first expected new illumigene test will be for Group B streptococcus, a bacterial infection that pregnant women can pass on to newborns. CEO Jack Kraeutler said the company was awaiting U.S. Food and Drug Administration clearance to market the test, according to a statement accompanying the company’s fourth-quarter earnings data.

Other new versions of the illumigene test include those for Mycoplasma pneumonia, an infection of the lungs; Group A streptococcus, a type of bacteria often found on the throat or in the skin; and Pertussis, a contagious bacterial disease that causes whooping cough.

“Longer term, our business is dependent upon technological innovation that can improve diagnosis and detection while materially reducing the total costs of healthcare,” Kraeutler said.

Meridian’s first illumigene test, for the bacterium C. difficile, received FDA approval in July 2010. It’s the only test from the illumigene platform that’s received market clearance in the U.S. During the quarter, Meridian added 150 “placements” of the test for a global total of 650, Kraeutler said.

Turning to financials, the company reported a 26 percent increase in fourth-quarter earnings to $6.7 million. Adjusted earning per diluted share came in at 18 cents, a penny below the consensus analysts’ estimate.

Fourth-quarter sales jumped 16 percent to $41 million.

For the full year, Meridian reported adjusted earnings per diluted share of 69 cents, which also fell a penny short of analysts’ expectations.

Meridian reaffirmed its full-year 2012 guidance of diluted earnings per share in the range of 85 cents to 89 cents.

AtriCure's Synergy ablation system

Cardiology devicemaker AtriCure (Nasdaq:ATRC) expects FDA approval of an atrial fibrillation label for a surgical ablation device in the first quarter of 2012.

U.S. Food and Drug Administration approval of the atrial fibrillation (AF) label would make AtriCure the first company to have a device approved for the surgical treatment of AF and represent a significant milestone for Cincinnati-area AtriCure.

Approval of an AF label for the company’s Synergy ablation system “will mark a new era of expansion and growth for AtriCure,” CEO David Drachman said during a conference call with analysts to discuss the company’s third-quarter earnings.

The company’s Synergy ablation system has already received FDA approval, but without an AF label, the company doesn’t have the legal right to market the system for use with AF patients.

“An AF indication will allow us to thoroughly train surgeons, which will optimize patient care and patient outcomes,” Drachman said.

AtriCure received a boost last week when an FDA panel recommended approval of the label. The FDA isn’t obligated to follow the panel’s advice, but it usually does.

Also beneficial to AtriCure was the panel’s rejection of a competing device from Medtronic. The panel found that Medtronic’s device was effective for treating AF, but that the company’s clinical trials hadn’t established the device as being safe.

Turning to the company’s financials, AtriCure reported a net loss per share of 7 cents, the same as last year’s third quarter. That beat analysts’ estimates by a penny. Loss from operations in the quarter was $1.2 million.

Revenues grew 5 percent to $15.2 million, slightly below analysts’ estimates of $15.9 million. International revenues grew 19 percent to $3.5 million, helped by strong demand in Europe and Asia, according to the company.

AtriCure shares climbed the most in 16 months to around $12 in Thursday afternoon trading as enthusiastic investors reacted to positive news about the company’s Synergy ablation system from the U.S. Food and Drug Administration.

An FDA panel recommended that the agency approve the ablation system for the treatment of atrial fibrillation during open-heart surgeries, according to a statement from Cincinnati-area AtriCure. The FDA isn’t obligated to follow the panel’s advice, but it usually does.

If the FDA approves the atrial fibrillation label for the ablation system, it would mark the first-ever surgical device to be approved for atrial fibrillation, a type of irregular heart rhythm. Approval would be a significant milestone for the company and make it a highly desirable acquisition target — if it isn’t already — to big device makers like Medtronic and St. Jude Medical.

The FDA is expected to make the final decision on the atrial fibrillation label by the middle of next year, AtriCure CFO Julie Piton said last month.

The device is already approved by the FDA for the ablation of heart tissue, but not for the treatment of atrial fibrillation.

Earlier this week, a report from FDA staffers noted some “concerns” with clinical trials of the device for the treatment of atrial fibrillation, but those concerns apparently weren’t enough to prevent the panel’s recommendation. News of the report sent AtriCure’s shares reeling, but Thursday’s gains made up for the tumble.

Cincinnati-area Meridian is betting big on the technology, hoping it’ll help rescue the diagnostic testing company from its recent struggles. The company has reported declining year-over-year earnings in several recent quarters and twice in the last few months downwardly revised its full-year earnings outlook for 2011.

Meridian’s illumigene platform provides its hospital and laboratory customers with a simpler, cheaper option to test samples for certain types of bacteria without the use of expensive instrumentation. It represents Meridian’s first foray into molecular diagnostics, a means of analyzing the makeup of an organism at the genetic level.

Molecular diagnostic tests tend to offer better sensitivity and specificity than their antibody-based counterparts, said Zarak Khurshid, a senior research analyst with Wedbush Securities. “The world appears to be moving in the direction of molecular tests,” he said.

So for Meridian to stay at the cutting edge of its industry and build the best products it can, the company’s push into molecular diagnostics must succeed.

“Illumigene is critically important to Meridian’s future — the reason being that the diagnostic space is fiercely competitive,” Khurshid said.

Thus far, Meridian has just one illumigene test on the market, for C. difficile, a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. CEO Jack Kraeutler said in July that Meridian expects to begin selling a second illumigene test, for Group B Streptococcus, to international markets before the end of the year.

Kraeutler said at the time that the company had achieved 500 “placements” of the test, with 90 percent of those in the U.S. Those sales contributed $6 million in revenue in 2011. (Kraeutler didn’t return calls for this article.)

That performance is a little better than Khurshid had expected, though he warned the true test of the illumigene platform will be whether it can help Meridian regain market share it’s lost to competitors like Cepheid, Becton Dickinson and Thermo Fisher Scientific.

Cepheid, in particular, has bruised Meridian with a molecular C. difficile test that came on the market in 2009. Khurshid estimates that the Cepheid test has taken a 10 percent bite out of Meridian’s market share in each of the last two years.

If Meridian is going to succeed, it needs to turn that around quickly — and that’s among the company’s biggest looming challenges.

“The jury is still out as to whether illumigene will allow Meridian to take back some of its lost market share and whether they can develop additional tests on that platform to build a meaningful, high-growth franchise in molecular diagnostics,” Khurshid said.

AtriCure's AtriClip device

Atrial fibrillation device company AtriCure (Nasdaq:ATRC) is among five medical companies most likely to be targeted for an acquisition in the next year, according to a new analyst report.

In addition to Cincinnati-area AtriCure, the other device companies identified by Canaccord Genuity analyst Jason Mills as likely near-term acquisition targets were: HeartWare, Spectranetics, Thoratec and Volcano, Forbes reported.

Here’s what Mills said about AtriCure:

We like the company’s leadership position in the surgical atrial fibrillation market currently, and we also favor the company’s new product and clinical trial pipeline. Both make us optimistic the company can produce double-digit growth for awhile. We also see ATRC as a potential take-out candidate over the next 12-18 months.

That fits exactly with what MedCity News reported last month: That medical device giants looking to boost their atrial fibrillation (AF) product portfolios would do well to take a long, hard look at AtriCure.

AtriCure appears likely to be the first company to obtain a label for the surgical treatment of AF from the U.S. Food and Drug Administration, and that could spark lots of interest from huge device firms like Medtronic (NYSE:MDT), St. Jude Medical (NYSE:STJ) and Johnson & Johnson (NYSE:JNJ).

“A-fib is a big market opportunity and a huge unmet need,” Matt Dolan, an analyst with Roth Capital Partners, said last month. “It’s an area of cardiovascular care that a lot of the big players are interested in.”

AtriCure is in the midst of clinical trials for a “hybrid” AF procedure that combines catheter ablation with a technique that involves ablation via three small incisions between the ribs on each side of the heart. By investigating different techniques using its surgical devices, AtriCure may be positioning itself to control a larger share of the market once it obtains the necessary regulatory clearances.

If the Cincinnati company continues to make clinical progress, market chatter about an acquisition by a big device maker will only heat up.

The five-year study will involve 675 children ages 8 to 17 years old and compare two drugs often prescribed to treat childhood migraines — amitriptyline and topiramate. The grant comes from the National Institutes of Health.

There is no FDA-approved medication to prevent childhood migraines and there are no evidence-based studies, according to a statement from Cincinnati Children’s.

Amitriptyline was originally used to treat depression but has long been used to prevent headaches. Topiramate is used to treat epilepsy and approved to treat migraines in adults. Neither have been extensively studied in treating children’s migraines, and both have side effects.

Amitriptyline’s side effects include nausea, vomiting and drowsiness. Topiramate’s side effects include numbness in the hands and feet, slowed reactions and difficulty concentrating.

The study is intended to determine which drug is superior in reducing migraines, as well as the drugs’ safety profiles and how well each is tolerated in children.

“The results of this trial will change current clinical practice by ensuring that decisions on early, effective treatment for millions of children and adolescents with migraine can now be based upon sound evidence,” said Scott Powers, co-director of the headache center at Cincinnati Children’s.

Cincinnati-area HealthWarehouse.com bills itself as the only online, mail-order retail pharmacy that sells directly to the U.S. consumer in all 50 states. The primary difference between HealthWarehouse and most of its online competitors is the customers they’re targeting: The company sells mainly to the uninsured and underinsured, while other online prescription drug sellers such as pharmacy benefit managers sell only to members.

Dhadphale likens his company to an Amazon.com for prescription drugs.  ”We are open to anyone, not just members, and allow you to purchase medications online just as you would books or music,” he said. “The current pharmacy landscape does not have this type of business model selling nationwide. Insurance equals membership, so if you are not a member, you cannot purchase.”

Adding to Dhadphale’s confidence in HealthWarehouse’s business model is the “generics wave.” As much as 75 percent of 2008 global pharmaceutical sales will go off-patent within five years, estimates Roland Berger Strategy Consultants, and that means billions of dollars worth of prescription drugs will become much more affordable to most Americans. When those patents expire, HealthWarehouse aims to be there to capitalize.

“We’re riding this tidal wave of brands to generics and it may be the biggest transformation yet in the pharmacy industry,” Dhadphale said. “If you’re competing in the pharmacy space, the guy who can sell it for $4 will be the only guy left.”

With the low overhead that comes from avoiding bricks-and-mortar locations, Dhadphale plans on being that guy, though HealthWarehouse sells more than just generics. The company received a boost earlier this year recently when Consumer Reports found that it boasted the lowest prices amongst online retailers for four well-known generics — Lipitor, Nexium, Plavix and Singulair.

So HealthWarehouse has low prices, but the company isn’t without challenges. One is the federal health overhaul and its plan to provide health insurance to 32 million additional Americans. Wouldn’t that take a bite out of the company’s customer base, which is mainly the uninsured?

Dhadphale says it’s too early to tell, but HealthWarehouse has signed prescription drug coverage deals with some small insurers, potentially insulating itself from a loss of uninsured customers.

More challenging for the company is overcoming negative perceptions of online pharmacies, fueled in part by scores of illegal pharmacies on the web. Google has been fighting rogue online pharmacies since 2003, The New York Times reported, but apparently hasn’t been doing a good enough job. In August, the search giant paid the federal government $500 million to settle charges that it knowingly showed illegal ads from fraudulent pharmacies.

“The space has been tainted with lots of illegal pharmacies,” Dhadphale acknowledged.

To help distinguish itself from the pack, HealthWarehouse went public in a reverse merger and is traded on the over-the-counter bulletin board. Dhadphale said the move adds to the company’s transparency.

Additionally, HealthWarehouse is one of 29 online pharmacies to receive an accreditation from the National Association of Boards of Pharmacy (NABP) called VIPPS (Verified Internet Pharmacy Practice Sites), which involve a review of the company’s policies and procedures and an on-site inspection.

Dhadphale hopes those moves will help separate HealthWarehouse from the 96 percent of online pharmacies that aren’t in compliance with pharmacy laws and standards, according to the NABP. And that’ll help the company as it looks to aggressively add business and expand market share.

“It’s almost like a land grab at this point,” Dhadphale said. “We’d like to get out in front of everybody and have that first-mover advantage.”

Patients at Mayfield Clinic sometimes had to wait two months for appointments, and often when they came in to consult with a surgeon, the surgeon found their conditions would be better solved through some other type of therapy by other medical providers.

For patients, that meant they’d waited two months for no good reason before getting the proper treatment. For Mayfield, it meant physicians were often spending time with patients who didn’t need their services, costing the clinic time and reducing revenue. Plus, the clinic was in danger of losing referrals from other physicians who had to deal with angry patients complaining about lengthy waits for appointments, Gilligan said.

What turned out to be the solution to Mayfield’s problems has turned into a health IT firm, Priority Consult, that has licensed its software to 62 spine and breast care clinics across the U.S.

The key to Priority’s software is a comprehensive and expedited patient-information-gathering process. Before an appointment can be scheduled, the software guides one of the clinic’s staff members to obtain all relevant medical history information from a patient. Scans of medical images can also be added to the patient record.

Next, a physician reviews the patient information and makes a recommendation — typically that involves scheduling an appointment or referring the patient to another specialist. It sounds very simple, but for Mayfield, the result has been that 40 percent to 50 percent of the patients who call the clinic are referred for treatment elsewhere. And that’s meant far more efficiency for the clinic and its doctors, who have appointments only with the patients who really need their services.

“In my 24 years with the clinic, this has been the single-most impactful change we’ve made in how we take care of patients,” Gilligan said.

For Mayfield the results have been tangible. The clinic has doubled the rate of surgeries it performs on patients who are seen for appointments, but has actually decreased the rate of surgery among all the patients who call, Gilligan said.

“The benefit for us is that patients who don’t need to see a surgeon get help faster with the right resource,” he said. “Those who do see us are a more surgery-rich population.”

Since the software was developed at a spine center, it’s not surprising that the majority of Priority’s clients (39 of 62) are spine centers, as well. The other 23 are breast centers.

In the future, Priority aims to expand its client base, with oncology or cardiology groups potential targets.

“There’s no area of medicine that wouldn’t benefit from the kind of work we do,” Gilligan said.

On Oct. 26, the FDA’s Circulatory System Devices Panel will review the Cincinnati-area device maker’s Premarket Approval Application (PMA) for its Synergy ablation system, according to a statement from West Chester, Ohio-based AtriCure.

The review marks yet another step in a process that could end up with AtriCure becoming the first company to obtain a label for the surgical treatment of atrial fibrillation (AF), which would be a huge milestone and value driver for the company and its shareholders.

The panel is expected to make a nonbinding recommendation on the same day of the review. The panel’s recommendation then goes to the FDA itself, which is expected to make the final decision on the AF label by the middle of next year, AtriCure CFO Julie Piton said.

It’s important to note that AtriCure’s Synergy ablation system is already on the market; the company is now simply seeking the AF label for the device, which would give the company the right to market it for the treatment of AF.

AtriCure studied the ablation device in treating AF patients in a clinical trial called ABLATE that it initiated in 2007. The trials investigated the use of AtriCure’s ablation device on AF patients who were already undergoing other surgical heart procedures, typically valve replacements or bypasses, Piton said.

“An AF label would allow us to educate and train the medical community about this procedure and increase its adoption for the AF patient pool already undergoing surgical procedures,” Piton said.

The Cincinnati-based retail mail-order pharmacy sourced the funding from two investors, according to the document.

CEO and co-founder Lalit Dhadphale didn’t return a call.

Founded in 2007, HealthWarehouse.com is a licensed pharmacy in 49 states. The company says it’s able to sell over-the-counter and prescription drugs more cheaply than brick-and-mortar retail chains due to its low overhead.

The company offers free shipping in the U.S. and 90-day returns with no restocking fees. It operates a warehouse in Florence, Kentucky and says the centralized location allows orders to reach customers in about 80 percent of the U.S. within two to three days.

Last month, HealthWarehouse.com reported limited financial data for the second quarter. The company’s net loss increased about 70 percent to $1.1 million, compared with the prior year.

However, the company reported solid growth elsewhere. Revenue jumped 43 percent to $2.5 million and prescriptions filled increased 147 percent to about 37,500, according to HealthWarehouse.com.

The new offices bring Cincinnati-based Medpace’s number of European locations to 10, according to a statement from the company.

“Medpace continues to grow to support clinical studies conducted in Europe, and investment for these initiatives is an ongoing process,” said Dr. Dieter Seitz-Tutter, a vice president with Medpace in Europe.

Much of the European growth is focused around oncology, cardiovascular and metabolic studies, according to the statement.

In addition to Cincinnati, Medpace has U.S. operations in Minneapolis. The company has more than 1,000 employees across the world.

New York private equity firm CCMP Capital  paid a reported $600 million in May to acquire a majority stake in Medpace.