Life Sciences : Innovation + Job News

A St. Paul med-tech startup has secured a $1 million bridge loan to keep it going until it can finish its next round of fundraising.

NxThera is developing a minimally invasive ablation procedure for treating enlarged prostate and prostate cancer. Unlike existing ablation treatments, NxThera's device uses vapor rather than radio-frequency or microwave energy.

"The best way to describe it is that we're using vapor to kill tissue," says Bob Paulson, a former Medtronic executive who now NxThera's chief executive.

Paulson says the procedure takes less than two minutes, compared to the 30 minutes or more needed for ablation treatments using radio frequency or microwaves instead of vapor.

"As it phase-shifts from vapor to liquid, it releases stored thermal energy and kills the tissue, but kind of does it gently," says Paulson. It's faster and less painful, and leads to fewer complications, he says.

The company is still proving out those results. It started its first human patient study earlier this year in Chile, and the results have been "extremely favorable" so far, according to Paulson.

NxThera was founded in March 2008 by Michael Hoey, a former physiology professor at the University of Minnesota, along with patent attorney John Shadduck.

The company is currently finalizing its product design and working on completing its next round of fundraising, which will pay for a full-scale U.S. clinical study.

"As you may have heard, it's kind of a tough market to raise money these days," says Paulson. "We haven't slowed down any of our development. It's taking longer to get the dollars to finalize the financing, but we'll get there."

Source: Bob Paulson, NxThera
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OrthoCor Medical kicked off sales last month for its first device: a knee wrap that uses heat and electromagnetic pulses to alleviate pain and swelling.

The product, called the OrthoCor Active Knee System, sells for about $200 and runs on a rechargeable battery and disposable, single-use heat "pods."

The Twin Cities company has been gearing up for sales since December, when the U.S. Food and Drug Administration approved the device for sale. In February, OrthoCor disclosed plans to raise $1 million from investors to grow its sales and marketing force. CEO John Dinusson said in an interview last week that fundraising has since exceeded $1.5 million.

(OrthoCor was the first business certified under Minnesota's new angel investor tax credit program.)

While investors appear to be enthusiastic, insurers remain skeptical. Clinical data about the product's effectiveness is limited, which will hinder any efforts to win reimbursement from insurers. Instead, the company is counting on chiropractors to be the primary distribution channel for the device.

"We know that we have a huge patient population," says Dinusson. An estimated 26 million people in the United States suffer from knee pain, and many become less active instead of seeking treatments, says Dinusson. He hopes their product can change that trend.

OrthoCor has five employees, including inventor Kin-Joe Sham. The devices are manufactured at Sham's father's company in China, and Dinusson has been contracting independent sales reps. Several other products are in the pipeline, including devices for relieving wrist, ankle, elbow, and lower back pain.

Source: John Dinusson, OrthoCor Medical
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A gene database developed at the University of Minnesota could help reduce the time and cost involved with vetting new cancer drugs.

The school is in the process of copyrighting the database, known as OncomiR, and has plans to license it to pharmaceutical companies and other researchers.

"Our final goal is to make this database the one-stop shop for any information related to this gene," says Rasik Phalak, 24, who created the database while earning a computer science masters degree.

OncomiR and Phalak are also semifinalists in the student division of this year's Minnesota Cup entrepreneurship contest.

As a graduate student, Phalak helped Dr. Subbaya Subramanian, a med school researcher, organize his data related to microRNA. MicroRNA is a gene type scientists think may contain clues about the causes of cancer growth.

OncomiR organizes all of Subramanian's data into a single database. Phalak also developed a web application that allows drug researchers to search via a web browser.

"With this, they'll get a good starting point, which will help to eventually reduce the time and the cost involved in the entire process," says Phalak, who plans to continue to populate and update the database.

Source: Rasik Phalak, OncomiR
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Exos Medical Corp. introduced a high-tech alternative to plaster casts last year that can be re-conformed as injuries swell and subside.

The company hopes its new Arden Hills facility will allow it similar flexibility. And right now, sales are swelling.

CEO Fariborz Boor Boor described sales as "nothing short of phenomenal" for a new medical technology, which often have slow adoption curves. (A recent filing with the U.S. Securities and Exchange Commission listed revenue at less than $1 million.)

Meanwhile, Exos' products have been worn by some high-profile athletes, from NFL quarterbacks to Olympic skier Lindsay Vonn, and also noted on national tech blogs by Fast Company and BoingBoing.

"Actually, part of our growth challenge right now is meeting the demand, so we're taking steps to make sure we have product to sell," Boor Boor said.

Exos moved on April 1 from a 4,000-square-foot space in White Bear Lake to a 12,000-square-foot facility in Arden Hills, tripling its floor space. Meanwhile, it's grown from just five employees at the start of the year to more than 20 today. It expects to be at around 30 employees by the end of the year.

The company's technology is a lightweight foam and polymer product that can be molded and hardened into casts, braces, and splints. Unlike plaster casts, they're breathable, waterproof, and adjustable during the course of healing.

"Beyond that, the comfort level of our products is unprecedented," Boor Boor said. "That really was our focus, making sure we could make a product that was comfortable for the patient and easy for the practitioner to apply."

The cost is "a bit higher" than traditional casts, he said, but the price becomes competitive when you factor in that traditional casts often have to be replaced.

The company was created in Aug. 2007 as a spin-off from Boor Boor's previous endeavor, a med-tech incubator called Enova Medical Technologies.

Source: Fariborz Boor Boor, Exos Corporation
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Bringing a new medical device to market is a complicated, highly regulated process, one that requires documentation at every turn.

Kristin Mortenson doesn't believe there's been a simple solution for most medical device companies to keep track of it all, until now.

Mortenson is co-founder of Acera Innovation, maker of a software-as-a-service application built specifically to help medical device companies manage workflow and collaboration around product development, regulatory compliance, and quality management.

"Our goal to lower their time, risk, and cost to bring their product to market," says Mortenson.

Most medical device companies are like the ones Mortenson has worked with the past 20 years: fewer than 100 employees and too small to be able to afford large enterprise software customized to their needs.

As a consultant, she looked for software that would help clients stay organized but couldn't find any good solutions. As a result, regulatory compliance became a time-consuming headache for many firms.

About a year and a half ago she met with a couple of software entrepreneurs, Myke Miller and Steve Swartz, and they formed Acera Innovation. The company signed up its first paying user about a year ago. It's in a "limited-release" mode right now with about a dozen customers, mostly in the Twin Cities.

Because it's a cloud-based service, companies don't need any specialized staff or hardware to run the program, just a computer with Internet access. This frees up companies to concentrate on the task at hand:

"Placing the energy and the time and the creativity on the device."

Acera Innovation is currently raising money and also preparing to release an updated version of the software in the fall.

Source: Kristin Mortenson, Acera Innovation
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A Burnsville startup is making progress vetting its promising but still unproven diabetes treatment.

Exsulin CEO Lisa Jansa says the company's Phase II clinical trial at the Mayo Clinic and Canada's McGill University is now more than 50 percent enrolled and on track to be completed by the end of the year.

"The good news is we're very close to having data," says Jansa, one of more than two dozen scheduled speakers at a diabetes innovation summit Wednesday at Park Nicollet's International Diabetes Center.

The company's product, a drug called ExsulinTM, aims to help the body regenerate insulin-producing cells within the pancreas. If it proves successful, it could reverse the effects of diabetes in Type 1 and Type 2 patients and reduce the use of injected insulin.

Jansa says there's reason for optimism based on previous animal and clinical studies. If the current 27-patient trial suggests the drug is safe and effective, then larger studies will follow. If those are also successful and the drug is approved by regulators, it could be for sale within five years.

Exsulin TM's progress is being tracked closely by the diabetes industry because it's the only treatment of its kind at this stage of development, Jansa said. If it makes it all the way to pharmacy shelves, the product would likely find a massive potential market. Diabetes affects 24 million Americans. In Minnesota alone, 15,000 people are diagnosed each year.

The Twin Cities could play a key role in developing treatments for those patients. The region has strong research expertise at the Mayo Clinic, University of Minnesota, and International Diabetes Center, says Jansa, as well as emerging companies like Exsulin that could help diversify the area's reputation beyond medical devices. She hopes Wednesday's event will give a glimpse of that future.

"I'm hoping it'll be the first of what we'll see as some real momentum in the region."

Source: Lisa Jansa, Exsulin Corporation
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A group of ProUroCare Medical investors have upped their anti, loaning the Eden Prairie medical device startup an additional $885,000.

The company is seeking approval from federal regulators to begin selling an imaging product it believes will help doctors detect and document abnormalities that could be related to prostate cancer.

ProUroCare's device is inserted into a patient's rectum and applied against the prostate gland. It can then map how the tissue responds to pressure. Abnormal tissue tends to be denser and less elastic and shows up differently on the electronic image generated by the device.

The new financing, which comes from "a small group of existing investors closely aligned with the company," will be used to pay off debt, as well as boost manufacturing and marketing activities, expand the company's intellectual property portfolio and create a scientific advisory board, the company said. It brings the total amount the company has raised since 2007 to more than $9.3 million.

"We are very pleased by the support that we continue to receive from investors for the ProUroScan prostate imaging system and the market opportunities that exist for this technology," CEO Rick Carlson said in a statement.

The device is not yet for sale in the United States. The company applied for approval to the U.S. Food and Drug Administration in November. The Star Tribune reported then that the company's next challenge would be convincing Medicare and private insurers that the scans result in improved medical care.

Source: ProUroCare Medical
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A Waconia-based website that aims to be a matchmaker between patients and healthcare providers announced last week that it's received a $1 million angel investment to help expand its services.

WellClicks.com lets consumers search for physicians and other health and wellness providers by criteria such as location, specialty, gender, and years of experience. Providers, meanwhile, pay to be included in the search results.

Mark Prondzinski and Lisa Suchy launched a limited pilot version of the service in July 2009 with backing from Ridgeview Medical Center in Waconia. Up to now the site has only covered providers in the southwest metro.

The site's usage has been "low to moderate," but with a limited marketing budget and small geographic area, they didn't expect an overnight blockbuster. The goal was only to prove the concept for investors.

"Our objective now, with the investment funds, is to expand the concept, both from the product side and from a geographic point of view, and then really try to turn the business model into something that is profitable and see and realize some of our longer-term business objectives," Prondzinski said. "It's not a tremendously huge amount, but it's enough to help us take the next steps down that path."

WellClicks.com is the first product from CreateHealth, a for-profit healthcare innovation center created and spun off by Ridgeview Medical Center in 2007. Prondzinski, who previously interned in the hospital's operations department, was tapped with Suchy to co-found the center.

Source: Mark Prondzinski, WellClicks.com
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Minnesota's medical technology industry employs more people per capita than any other state, according to a new economic study by a national medical technology trade group.

The report (PDF), authored by The Lewin Group and released last week by AdvaMed, says med-tech accounts for 1.06 percent of Minnesota's employment (the next highest per capita figures come from Utah and Delaware). It estimates the total number of med-tech jobs in Minnesota at 26,862, placing it second behind California and ahead of Massachusetts.

"Minnesota has long had a strong network of academic, industry, and government assets working together to support our life-science ecosystem," LifeScience Alley President/CEO Don Gerhardt said in an e-mail statement. LifeScience Alley is the local trade association for life science companies.

Gerhardt said the numbers in AdvaMed's report aren't surprising, and if anything they under-count the number of med-tech jobs in Minnesota. The Minnesota Department of Employment and Economic Development estimates Minnesota has around 35,000 med-tech jobs.

One explanation for the accounting gap: The data used in the AdvaMed report misses jobs at med-tech suppliers, such as Phillips Plastics, that don't operate exclusively in med-tech.

Sources: AdvaMed, LifeScience Alley
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Minnetonka-based medical device maker Anulex disclosed last week that it's raised about $18.3 million in new venture capital.

The company makes a product that lets doctors repair spinal tissue that's punctured during herniated-disc surgeries. Xclose has been on the market since 2007, but there's still little clinical data about its effectiveness, which makes collecting reimbursements from insurers more difficult.

David Noel, vice president of finance and chief financial officer for Anulex, said the funding will allow the company to continue a two-year clinical study it started in 2009, as well as further commercialization and product development efforts.

About 10 percent of herniated disks require a surgery called a diskectomy that involves removing the part of the disc that's coming in contact with nerves. The soft, outer layer of the disc typically isn't sewn up after the procedure because it's difficult to reach.

"It's been very, very difficult to get down there and suture that defect. Our product allows the surgeon to go in there and in approximate and bring that tissue together," Noel said. "We believe that if you're able to do that you're going to have a better result, and that's what our clinical study is intended to prove."

The 750 patients enrolled in the study will have a one-year follow-up in August and a more intensive two-year check-in next year. The company hopes the results will assist in with both marketing and establishing an insurance reimbursement code.

Source: David Noel, Anulex
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Doris Taylor earned international acclaim in 2008 when she and her team at the University of Minnesota grew a living, beating rat's heart from stem cells in a jar.

Now, the state is betting that a Minneapolis biotech startup can grow that technology into a successful company.

The state Agricultural and Economic Development Board announced an agreement last week to loan $250,000 in seed capital to Miromatrix Medical, a six-month old U of M spinoff. Under the terms, the state's loan is to be matched by private investors.

Miromatrix has an exclusive licensing agreement with the university to commercialize the technology, which might one day be used to grow human replacement organs.

Miromatrix CEO Robert Cohen said in an e-mail that he is pleased with the state's support, but that as a "matter of corporate policy" stopped commenting publicly several months ago.

"Our preference is to let the ultimate success of our products speak for itself," Cohen said.

Cohen and Taylor did speak with MedCity News in January, when they commented on the incredibly high expectations many have for the company and its significance to the state's biotech industry.

The Ag Board has traditionally funded the expansion of manufacturing firms but its scope is broadening to include emerging high-tech businesses, according to the Department of Employment and Economic Development.

Source: Department of Employment and Economic Development
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Minnesota researchers may have a brighter future thanks to a new cross-border compact.

The BioBusiness Alliance of Minnesota signed an agreement last month giving members improved access to the Canadian Light Source synchrotron facility at the University of Saskatchewan in Saskatoon, Canada.

The synchrotron is a giant X-ray microscope that lets scientists see what's going on inside cells at the atomic-particle level. The device works by accelerating electrons around a football-field-sized racetrack, then focusing them into a light beam brighter than the sun and sending it through the material being studied.

Only a handful of synchrotrons exist around the world because they are so expensive to build. Canada completed its $174-million national synchrotron facility in 2004.

Canadian researchers have always had preferential pricing and access to the synchrotron, but under the new agreement with the BioBusiness Alliance, "they're in effect treating us as through we're Canadians," said Dale Wahlstrom, CEO of the BioBusiness Alliance.

Wahlstrom said many university and larger companies already use synchrotrons for research, but many other companies aren't aware of the potential applications. The BioBusiness Alliance's next step is educating Minnesotans about the technology.

"It's very broadly applicable," Wahlstrom said, citing the life sciences, computer industry and materials sciences as a few areas where the light source could be used.

The hope is that giving Minnesota researchers better access to the facility will speed up the time it takes to develop products and get them to market, said Wahlstrom.

Source: Dale Wahlstrom, CEO, BioBusiness Alliance of Minnesota
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