Biomedical : Innovation + Job News

Stem cell research is a hot topic, both scientifically and politically, and nowhere is it hotter than at the Center for Stem Cell & Regenerative Medicine in Cleveland.

Founded in 2003 with a $19.4-millon Ohio Third Frontier grant as a Wright Center of Innovation, CSCRM now conducts research that may someday lead to new treatments for cancer and all sorts of blood, neurodegenerative, musculoskeletal, orthopedic and cardiovascular disorders.

"The center has a huge amount of intelligence behind it," says Director Stan Gerson. "We have about 90 investigators with funding. It's fair to argue that we have as many different types of stem cells in clinical trials as anywhere in the world."

The center is not one entity, but a collaboration of six: Case Western Reserve University, The Cleveland Clinic, University Hospitals Case Medical Center, The Ohio State University and Athersys, Inc., a leading company in development of therapeutic stem cell treatments.

CSCRM has continually received support for its work from the State of Ohio, including an additional $8-million award in 2006 from Ohio's Biomedical Research and Commercialization Program and a $5-million award last June from the Ohio Third Frontier Commission.

Despite progress being made, Gerson cautions that cures arising from stem cell research may not come as quickly as some would like.

"If you've heard of early phase technology, this is it," he says. Creating new drugs from stem cells "is a 25-year process."

In early December, the National Institutes of Health announced approval of 13 new cell lines for study using tax dollars.

"It's going to be very helpful to us to have access to additional cell lines," Gerson says.

Source: Stan Gerson, Center for Stem Cell & Regenerative Medicine
Writer: Gene Monteith

Besse Medical Supply in West Chester has accomplished what many small, family-run startups dream of: becoming part of a Fortune 26 company while holding onto family tradition.

Besse Medical Supply started out as a Cincinnati corner pharmacy in 1948, eventually growing into a business supplying medical products to local physicians. Today, as a division of the  AmerisourceBergen Specialty Group, part of the Fortune 26  AmerisourceBergen Corp., Besse Medical Supply continues that business model on a larger scale.

Besse is one of the nation's leading distributors of vaccines and biologicals, brand name and generic injectables and pharmaceuticals, diagnostic test kits, surgical supplies and more. Customers include physician's offices, specialty groups, clinics, occupational health facilities and health departments.

Besse employs 100 in West Chester, most in customer service, and has a shared distribution center in Louisville, Ky.

Mick Besse, company president and general manager, credits Besse's investment in technology � assuring that products get where they need to go, quickly and safely � and commitment to customers among its reasons for success. Much of the business has gone online, Besse said.

"Our investment in technology has gone to improving service to our customers, to support our vision of being partner to our healthcare providers and manufacturing partners," Besse said.

Source: Mick Besse, Besse Medical Supply
Writer: Feoshia Henderson

On Front Street in East Toledo, sandwiched between two abandoned buildings, LexaMed � a medical and pharmaceutical company �opened for business with eight employees in 2006. And hasn't looked back.

Today, LexaMed stands out as a neighborhood bright spot, even though it's surrounded by years of economic neglect.

LexaMed tests medical devices and pharmaceuticals, does auditing and conducts laboratory work. The company's own product line, BEC Growth-Chek � a liquid suspension containing micro-organisms for testing � is helping to take LexaMed to the next level.

The company now boasts 30 employees, not counting an additional 45 contracted employees. President Robert Reich proudly points to the company's hundreds of years of combined in-the-lab experience.

"I think we have a success story to tell, especially in Toledo," says Reich. "The environment in Northwest Ohio is certainly changing. We can't live on automotive batteries and auto parts anymore."

When LexaMed took over the previous company, the building had fallen into receivership. "The whole area has seen better days," he says.

Now, LexaMed is in the process of purchasing the 25,000-square-foot building. And plans are also in the works to spend some cash to fix up the aging facility and its 10 labs.

"It shows our commitment to staying in Ohio," Reich says. "And staying in Toledo."

He says he "wouldn't be surprised" if the company hired an additional half-dozen employees this year. LexaMed is also considering branching out its operations.

"We're constantly looking to improve," says Reich. "We're expanding our product offering, and expanding on our technologies. We want to stay current."

Source: Robert Reich, Lexamed
Writer: Colin McEwen

The U.S. Food and Drug Administration says Meridian Bioscience can market two new tests for upper respiratory diseases. That means more health care providers can detect more problems faster.

Meridian makes, markets and distributes a broad range of diagnostic test kits, purified reagents and related products and technologies. Its customers are hospitals, reference laboratories, research centers, veterinary testing centers, physician offices and diagnostics manufacturers in more than 60 countries.

Fiscal 2009 net sales were $148.3 million, up six percent from the previous year. Operating income was of $48.8 million, up 10 percent.

The first half of '09 was "challenging," CEO Jack Kraeutler says. However, during the second half, "Our respiratory sales were robust as shipments of our rapid influenza tests, driven by the H1N1 pandemic, drove a major portion of the growth of our diagnostics business units." Flu test sales outside of the U.S., especially in Europe, were key.

"Rapid tests for foodborne diseases, such as toxigenic E. coli, also grew double digits in (the fourth quarter) and are expected to be a major contributor to fiscal 2010 sales increases," Kraeutler says.

For fiscal 2010, the company expects its revenue to come mostly from tests for C. difficile, H. pylori (stomach bacterias), upper respiratory infections and foodborne disease.

Founded in 1977, the company employs about 400 people worldwide. R&D, manufacturing and warehousing are at corporate headquarters in Hamilton County.

Meridian has been named to Fortune magazine's list of Fastest Growing Small Companies four times.

Source: Jack Kraeutler, Meridian Bioscience
Writer: Gabriella Jacobs

 

As a urological surgeon for OhioHealth, Wayne Poll knew there must be a way to keep his laparoscopic lenses clear without constantly having to stop and clean them. While it took him 10 years to bring that vision to fruition, Poll's FloShield is now in the marketplace.

"I tried going to companies with my ideas, and I did that for ten years," says Poll, whose Columbus-based Minimally Invasive Devices gained FDA clearance for the product last year. "But I was constantly frustrated. I got to know some people and entered the Ohio State University (Fisher College of Business) 2006 business plan competition, and we won it. That got us some momentum and we started to raise money."

With the help of TechColumbus, a technology business incubator serving a 15-county area in Central Ohio, MID raised an initial $200,000 in start-up capital and a total of $2.4 million in angel funds, a portion of which came from funds supported by the Ohio Third Frontier. In October, following FDA approval of FloShield, the company raised $2 million in Series B funding.

FloShield works by keeping air flowing around the end of the scope, blowing away debris that can obscure a clear image at the surgical site. Poll says the company, so far, has sold about 600 of the devices and has introduced a new product, FloShield Plus, that uses a saline solution to clear the lens.

MID was founded in 2006 and grew from one employee to five this year. Poll serves as MID's founder and chief executive officer and as director of innovation for the OhioHealth system.

Source: Wayne Poll, Minimally Invasive Devices
Writer: Gene Monteith

CardioInsight Technologies takes its work to heart. Literally.

The Cleveland-based company is working to develop the first non-invasive, real-time, beat-to-beat simultaneous mapping solution for the treatment of cardiac arrhythmias and heart failure.

And with heart disease as the leading cause of death worldwide, there is certainly a market for CardioInsight's work.

Headquartered at University Hospitals of Cleveland, CardioInsight has taken tremendous strides lately, including its involvement in a number of trials and its movement toward a commercial trial for its technology called Electrocardiographic Mapping.

The technology -- which takes non-invasive images of the heart's surface -- was developed at Case Western Reserve University.

The mapping and localization technology could be critical to ongoing efforts to improve the diagnosis and treatment of heart conditions, company officials say. The ECM will provide detailed cardiac electrical activity information for the entire epicardial surface of the heart for each heartbeat by combining body surface electrical data simultaneously with 3-D anatomical data obtained from CT scans.

Officials say ECM fills the gaps where current cardiac mapping falls short -- including simultaneous, beat-by-beat mapping and making the entire process quicker.

CardioInsight was quietly founded in May 2006 as a collaborative enterprise by Dr. Charu Ramanathan and Dr. Ping Jia, Case Western Reserve University, Jumpstart Inc. and Draper Triangle Ventures.

There are now 14 people employed with the company including contractors and researchers, says CardioInsight spokesperson Norma Simione. The technology has been evaluated extensively in animal studies and more than 75 human studies. Stay tuned.

Source: Norma Simione
Writer: Colin McEwen

A clinical-stage biopharmaceutical company with a growing pipeline of "potential best-in-class therapeutics" with high-hopes of tackling issues such as heart attacks, obesity and cognitive disorders�

Sound too good to be true?

The drugs � although still in the clinical stages � are very real to Athersys.

Currently, the Cleveland-based company is continuing its enrollments in safety and efficacy trials of its adult stem-cell therapy MultiStem, for heart attack patients and for those who run the risk of rejecting bone marrow transplants. MulitStem is a biologic product manufactured from human stem cells obtained from adult bone marrow.

However, Athersys is also exploring other avenues of development including medicines for the treatment of metabolic and central nervous system disorders � utilizing proprietary technologies, including Random Activation of Gene Expression (RAGE).

While the company is still in the clinical phase of developing its pharmaceutical remedies, Ahtersys leaders remain optimistic.

"Based on our research to date, we believe that MultiStem may provide key benefits over current standards of care in the bone marrow transplantation area, as well as other areas such as heart attack, stroke and other ischemic neurological disorders," Athersys CEO Gil Van Bokkelen says in a recent statement to his shareholders.

Van Bokkelen co-founded Athersys in October 1995 and has served as its CEO and a director from the beginning. Just recently, he rang the NASDAQ closing bell in Times Square.

"In addition to advancing our clinical and preclinical programs, we remain actively engaged in partnering discussions involving multiple programs," Bokkelen says.

Source: Gil Van Bokkelen
Writer: Colin McEwen

Akebia Therapeutics has stepped up to the plate, is waiting for the pitch, and is confident in its abilities to hit the ball out of the park.

"Both are potential home runs," says Ian Howes of Akebia's two revolutionary drugs for treatment of anemia, blood vessel leakage and cancer.

The Cincinnati-based biomedical company spun off of Procter & Gamble Pharmaceuticals in 2007. Since then, Akebia has focused on two drugs with technical-sounding names: AKB-6548 and AKB-9778.

The first has moved into the early stages of human trials and is designed as a safer alternative to traditional anemia treatments. According to Howes, chief financial officer and vice president of corporate development, one of the problems in combating anemia is the traditional treatment. Current drugs boost EPO -- the hormone that triggers production of red cells -- but at a dangerous 500 to 1,000 times the needed amount.

Akebia's AKB-6548 has shown in animal and early human trials to boost EPO production only two to three times the normal amount, Howes says.

The second drug is still six months from clinical trials, but is even more promising, Howes says. AKB-9778, designed to stop blood vessel leaks, could revolutionize treatments for diseases like sepsis and acute influenza as well as the effects of Interleukin 2, a cancer drug that can cause blood vessel leaks. Akebia's new drug stopped 100 percent of the leaks that IL2 caused in animal tests. But the most surprising -- and potentially most beneficial finding? Howes says early results indicated the new drug also stopped cancer tumors from spreading to other parts of the body.

Akebia currently has 11 employees, but Howes says once the second drug enters clinical trials, the company could grow to 15 to 20.

Source: Ian Howes, Akebia
Writer: Gene Monteith

If you've got a suspicious bump, you'll want a doctor to look at it. The question is, if it comes time for a biopsy, would you rather make two stops -- first, to your family doc, then to the dermatologist -- or one? And would you rather go home with stitches or a quick closure that creates less blood?

The folks at CleveX believe that patients will prefer the latter. And doctors seem to agree.

The Columbus-based company recently signed an exclusive national distribution agreement and its first stocking order for $180,000 worth of its ExiClip, making it one of a small, but growing, group of Ohio biomedical startups that are off the drawing board and into the marketplace.

Sam Finkelstein, CleveX's chief executive officer, says the device reduces the time a physician needs to do a biopsy from the traditional 20 to 30 minutes to less than five. It does so with a small, hand-held tool that removes the skin and closes it up in one single motion.

"You can clip, cut and close in ten seconds," Finkelstein says, adding that docs still must take time to anesthetize the area.

According to Finkelstein, the company first tested ExiClip with dermatologists, who said they would prefer to do fewer biopsies so they could concentrate on other parts of their practice. They steered CleveX toward primary care docs and OBGYNs, who often send patients to specialists because of the time it traditionally takes to remove a skin lesion and stitch it up.

Last year, CleveX raised more than $1.9 million from angel and venture investors. The company employees 10, but Finkelstein says "we expect to increase personnel, and, depending on sales, it would not be unrealistic to expect us to double."

Source: Sam Finkelstein, CleveX
Writer: Gene Monteith

Hearts beat, lungs expand and patients squirm, all factors that can cause a magnetic resonance imaging machine to produce blurry images. And when it comes to detecting potentially cancerous tissues, a blurry MRI scan is not a good thing.

Quality Electrodynamics, located in Mayfield Village, is helping companies like Siemens and Toshiba produce machines that scan in a much shorter period of time, resulting in crisper, clearer images. Founded by Hiroyuki Fujita, QED manufactures the radio frequency coils that have made these machines the platinum standard of the industry.

"These machines are setting the standard for spatial resolution," explains Fujita, the company's president. "By producing better images of a patient's anatomy, we can find cancerous tissues that may be impossible to detect otherwise." QED crafts a variety of coils that are optimized for different parts of the body.

What began in a 300-square-foot incubator space at the Case Western Reserve University physics department is now a 27,000-square-foot manufacturing facility. In four short years, the company expanded from just two employees to more than 50. Things are going so well for QED, says Fujita, that he expects the company to double it staff in the next two years.

While Fujita deserves credit for the success of his company, he says that he couldn't have done it without help from the State of Ohio. "Without the Third Frontier grant for our business," he explains, "we never could have remained financially independent. Thanks to the state, we didn't have to raise any funds from venture capital companies."

Source: Hiroyuki Fujita, QED
Writer: Douglas Trattner

David Scholl says it took his company more than 10 years before it sold its first product. But what he describes as "care and nurture" within the Ohio University community appears to have paid off.

Founded at OU in 1983 with about a dozen employees, Scholl's Athens-based Diagnostic HYBRIDS has grown to 225. Scholl, president and chief executive officer, cites a 75 percent increase in jobs over the past four years.

Among the products powering growth are those related to thyroid conditions. For example, in 2000, the company partnered with OU on a $1 million grant from the Ohio Third Frontier's Action Fund, luring scientist Leonard Kohn to Ohio to support development of early detector of Graves' disease.

"About 32 million people have the disease, and there are 300,000 to 400,000 new cases diagnosed per year in the United States," Scholl says. "We began commercialization of that product in 2001, and it's been selling to the point where we decided to make a refined version, which the FDA approved in May."

The new test cuts the typical results time from three days to one. Diagnostic HYBRIDS is counting on a new web-based education and marketing effort -- and direct mail to doctors -- to raise awareness and drive earlier treatment.

The firm won a $5-million Third Frontier Award last year to further develop viral diagnostic and treatment capabilities. More recently, Diagnostic HYBRIDS licensed a test to detect recurring thyroid cancer. And it just won FDA approval for FastPoint, a test that detects two common influenza strains in less than 30 minutes.

Source: David Scholl, Diagnostic HYBRIDS
Writer: Gene Monteith

A plasma volume expander may sound like something plucked from the pages of a science fiction novel, but to a trio of University of Toledo researchers working on the innovative lifesaving drug, it's very real.

After working with a patient in 1999 whose blood pressure was critically unstable as plasma seeped out of her blood vessels, frustrated UT doctors Joseph Shapiro and Ragheb Assaly sought out a treatment.

They teamed up with UT biochemist J. David Dignam and found a solution in their plasma volume expander, Pegylated albumin -- or PEG-Alb as it is known as in the biotech biz.

Toledo-based ADS Biotechnology was born.

The researchers created a molecule similar to the native albumin already present in the blood, but with a larger diameter to prevent leakage into vital organs that can cause serious injury or death.

PEG-Alb is the only known treatment for CLS -- a biomedical stat that is bound to drum up some serious attention� and cash.

The UT college of medicine -- where Shapiro is the department chair and Assaly is a pulmonary-critical care specialist -- has contributed $1 million. The northwest Ohio-based Rocket Ventures Ignite! Grant was for $50,000, then Rocket Ventures gave a $250,000 investment courtesy of the Third Frontier Program. The U.S. Department of Defense committed $200,000.

Mary Shapiro, chief financial officer of ADS Biotechnology, says PEG-Alb could be a crucial advancement for military medicine as a resuscitation fluid on the front lines.

The firm is now working to set up clinical trials in hopes of marketing PEG-Alb in the next three to five years.

Source: Mary Shapiro
Writer: Colin McEwen

There's a glimmer of hope for "no-option" cardiovascular patients, thanks to the work being done by a Cleveland-based medical device company.

Cardiovascular disease continues to be the leading cause of death in America. For many sufferers, traditional treatments prove ineffective, leaving the patient with no practical options.

Now, advances in stem cell research and innovations developed by Arteriocyte Medical Systems, Inc., promise to give these so-called "no-option" patients a new lease on life. Arteriocyte is currently testing proprietary adult-derived stem cell therapies for use in surgery. The technology will allow a surgeon to harvest stem cells and platelets from a patient's own body for immediate use.

"Our bodies naturally build all the cells and tissues necessary to repair injury," explains CEO Don Brown. "By harvesting and redelivering therapeutically derived cells, we can affect repair of tissues damaged by poor blood flow."

In April, the company announced the receipt of a $4.99-million award courtesy of Ohio's Third Frontier Research Commercialization Program. Brown says that the state funding will allow the company to conduct efficacy studies of its bedside blood fractionation device for treatment of cardiac disease and also amputation prevention. Research partners within the state include The Cleveland Clinic, The Ohio State University and The University of Toledo.

Brown anticipates that the grant will lead to the generation of 30 new jobs during the next three years, and 50 during the next six. Success of the technologies could lead to $150 million in revenue within six years, he adds.

Source: Don Brown
Writer: Douglas Trattner

Just a few years into its founding, AssureRx, a Mason-based personalized medicine company, has brought on a new president and CEO with more than 30 years of strategic executive experience to grow the company.

James Burns was most recently president and CEO of Maryland-based EntreMed Inc., a public, clinical-stage pharmaceuticals company that develops cancer and inflammatory disease drug treatments.

Burns now is bringing that expertise to AssureRx, founded in 2006, through a joint investment of Queen City Angels, CincyTech, Blue Chip Venture Co., Cincinnati Children's Hospital Medical Center Tomorrow Fund, Ohio Tech Angels, DHC Tech and private investors. The company was formed to license and commercialize personalized medicine technology research from Cincinnati Children's Hospital Medical Center and Mayo Clinic.

AssureRx is developing the next generation of medicines, recently bringing to market its first product GeneSightRx, a lab-developed test that will measure and analyze genetic variants in psychiatric medicine -- in other words, how individuals respond to the drugs they get. The test will help doctors determine the appropriate drug and dosage for each patient's individual needs, which could lessen side effects in patients taking them.

"I believe that this technology has the potential to place AssureRx on the forefront of the emerging personalized medicine market. I look forward to leading the company during this exciting period of its development," Burns says.

The test is based on pharmacogenetics, or the study of how a person's genetic makeup influences his or her body's reaction to drug treatments.

Source: Carolyn Pione of CincyTech USA, and AssureRx
Writer: Feoshia Henderson

What are the next steps for Ohio biosciences companies?

Find out Sept. 30 and Oct. 1 when a diverse audience descends on Columbus to discuss the topic "Where in the world are bioscience opportunities?"

Sponsored by  BioOhio, the organization's annual conference is expected to draw a diverse statewide audience of researchers, entrepreneurs, suppliers, service providers, bioscience executives -- you name it, they're likely to be there, says Matt Schutte, BioOhio's director of corporate communications.

"It's a unique conference in a way," says Schutte. "There are a lot of biomedical, biosciences events around Ohio, but very few have a statewide mission."

With more than 1,100 bioscience-related organizations in Ohio, more than $2.5 billion were invested here to accelerate Ohio's bioscience growth in 2007 alone. BioOhio's annual conference -- its 20^th since the organization began -- aims at bringing the best minds together to keep that ball rolling, Schutte says.

"The best thing people will get out of it is the networking," Schutte says, which can lead to new partnerships, collaborations and job growth.

The conference itself will feature numerous topics related to globalization of bioscience business and research, including the benefits and challenges of conducting clinical trials abroad, Schutte says. Panelists were drawn from a who's who within the industry; Battelle President and CEO Jeffrey Wadsworth will give the keynote address.

Want to attend? Information is available at http://www.bioohio.com/news/Annual-Conference.aspx.

BioOhio, founded in 1987, is a non-profit organization designed to build and accelerate bioscience industry, research, and education in Ohio.

Source: Matt Schutte, BioOhio
Writer: Gene Monteith