Biomedical : Innovation + Job News

A person's body sends countless silent messages that health care professionals need to know for optimal diagnosis and treatment. A Cleveland company creates high-tech ways to capture those messages.

Cleveland Medical Devices, or CleveMed, specializes in miniaturized wireless telemetry, physiological monitoring and rehabilitation devices. Its products are designed to help people with sleep disorders and movement disorders; they also are used in research and academic settings.

Hallmarks of CleveMed products are accuracy, portability and ease of use, which the company says makes them particularly useful in homes, hospital rooms, private practices and the like all over the world. The company holds 15 patents.

The company says it is close to launching "clinically deployable" monitors that record movement, restore control and enhance function for disorders such as Parkinson's disease, stroke and cerebral palsy.

Earlier this year CleveMed finalized a license agreement with a spinoff company, NeuroWave Systems Inc., transferring anesthesia monitoring and seizure detection technologies. NeuroWave is the only company selected by both the National Institutes of Health and the Department of Defense to develop seizure detection devices to monitor patients exposed to chemical warfare agents.

"The spin-off and license is a testament to the maturity of our products and success of our businesses," Robert N. Schmidt, chairman of both CleveMed and NeuroWave, says.

CleveMed was founded in 1990 and has one other spinoff to its name: Flocel Inc., a maker of in-vitro blood brain barrier testing equipment.

The company, which has 40 employees, is expanding its sales force around the U.S. to increase sales of its new home sleep apnea testing device, the SleepView. This new device and web portal will allow primary care physicians to conduct sleep tests where the patient can sleep in their own bed.

Source: Carole Nittskoff, CleveMed
Writer: Gabriella Jacobs

The University of Cincinnati and Blue Ash-based Ethicon Endo-Surgery have pushed forward their research collaboration to better understand the mechanical, physical, and biochemical changes that happen when people undergo bariatric surgery.

The research goal is to better understand exactly how the procedure causes dramatic weight loss and develop less invasive surgical devices that make the process ultimately more effective and less painful.

Ethicon recently awarded UC's Metabolic Diseases Institute a $13.5 million, three-year research grant extension to study the physiological issues associated with the surgery that is increasingly common in treating obesity. The grant is part of Ethicon's Metabolic Applied Research Strategy (MARS), which also includes research from GI Metabolism Laboratory and Weight Center at the Massachusetts General Hospital (MGH).

Ethicon Endo-Surgery, Inc. develops advanced medical devices for minimally invasive and open surgeries. Its parent company is Johnson & Johnson. Including this new grant, the EES MARS initiative has invested more than $33 million with UC and the GI Metabolism Laboratory and Weight Center at the MGH.

"Ethicon Endo-Surgery is committed to collaborating with clinicians to develop new, comprehensive bariatric solutions while also ensuring that people with obesity have access to current treatment options that can help them achieve sustained weight loss and reduce co-morbidities," says Karen Licitra, Ethicon group Chairperson.

At UC, researchers are studying of why other metabolic procedures, such as vertical sleeve gastrectomy (VSG) and laparoscopic greater curvature plication (LGCP), work. These and other studies have been presented at prestigious national conferences, including most recently the American Diabetes Association Annual Meeting in Florida this past June.

Source: Ethicon Endo-Surgery
Writer: Feoshia Henderson

Imagine you have a chronic illness like diabetes (maybe you don't have to imagine). Now, imagine your next doctor's appointment. And imagine that instead of seeing the doctor first, you see an on-site pharmacist who evaluates the tests you've been given, asks you  questions and then walks with you to visit the doctor -- together.

Tim Schramko, president and CEO of Toledo-based Ceuticare, says that vision is exactly the kind of medical collaboration toward which his four-year-old company is working.

The Ceuticare scenario becomes possible under a set of proprietary algorithms developed by founders Allen Nichol and Kenneth Bachmann, Schramko says. Combined with a pharmacist's intimate knowledge of medications and access to a patient's complete medical profile, the data allow him or her to tell whether a chronically ill patient is following doctor's orders or fibbing. Few physicians are equipped with such tools and must base prescribing decisions on what the patient says -- which may or may not be accurate, Schramko says.

Ceuticare provides data for diabetes, blood lipids, hypertension, asthma, chronic kidney disease and cardiovascular disease. While Schramko says "I haven't talked to one doctor yet who did not like it," he says a reluctance to change long-time business and office models has kept participation low.

He expects acceptance to rise with more education and as doctors become more attuned to the collaborative "medical home" concept promoted under the National Healthcare Reform Act. Schramko says one Ohio insurer has already perked up its ears based on the results of a small study that showed Ceuticare patients went to the hospital and the emergency room far less frequency than a control group -- whose costs rose 200 percent.

The five-employee company also has the attention of Rocket Ventures, which invested $175,000 in Ceuticare.

Source: Tim Schramko, Ceuticare
Writer: Gene Monteith

Innovative Medical Device Solutions in Vandalia takes high-tech medical devices from the drawing board to the market place, creating jobs in the process.

IMDS has evolved over the decades, beginning life as AF Leis, a company that designed dedicated machines for the automotive industry in 1950. The company dove into the medical devices industry in the 1980s, says company board chairman and Chief Business Development Officer Harold Linville.

The contract manufacturer and supplier now specializes in product sourcing, co-innovation, and discovery research. IMDS acquired additional companies between 2006 and 2009, and expanded its mission beyond engineering into full-service medical device development, testing and manufacturing.

The company works with international companies like Johnson and Johnson and X-Spine in Miamisburg to develop intricate medical implants like spinal implants and joint replacement materials. The company also works with individuals surgeons who have ideas they want to bring into the medical marketplace.

Though IMDS's main offices and manufacturing facility is on Vandalia, the company also has facilities Oregon and Utah.

IMDS employs 475 and has hired 32 employees and four interns in the past year. The company has 15 open positions currently.

The Ohio Department of Development has also awarded IMDS a $1 million direct loan which it plans expand its Vandalia manufacturing facility.

Source: Harold Linville, IMDS
Writer: Feoshia Henderson

While the global economy has presented a rough road for many companies, Kendle International has managed not only to miss the potholes, but to pave its own way to growth. 

A leading global clinical research company, Kendle recently opened a new operations center in the Special Economic Zone (SEZ) of the Ahmedabad-Gandhinagar Knowledge Corridor in India.

"Growth in India is a key component of our strategy and will be very important to the future of Kendle" says Stephen Cutler, senior vice president and chief operating officer. "Our expanded presence in Asia, and in India in particular, creates efficiencies in the clinical development process for our customers worldwide."

Founded in Cincinnati in 1981 by Candace Kendle and Chris Bergen, Kendle was also ranked a top clinical research organization (CRO) to work with in the 2010 CenterWatch European Investigative Site Survey. Kendle is the only CRO to be ranked consistently among the top three providers for each of the past four years in the annual U.S. and European site surveys conducted by CenterWatch, a leading publishing and information services company focusing on the clinical trials industry.

"Kendle's ability to forge strong and collaborative relationships with investigative sites across the globe is key to our ability to deliver studies more efficiently and cost effectively for our customers, which is increasingly important in today's environment," says Cutler.

The company reported net income of $1.2 million for the first quarter 2010 compared with net income of $886,000 for the first quarter 2009.

Source: Stephen Cutler, Kendle International
Writer: Val Prevish

LifeServe Innovations -- a student-run, ground-stage medical device company -- is bridging the gap between academia and medicine. And its founders hope to save some lives along the way.

Richard Arlow and Zachary Bloom formed LifeServe Innovations after completing undergraduate research at Lehigh University. While the company is incorporated in Pennsylvania, the two are in the process of moving LifeServe permanently to Ohio, where they are getting plenty of attention.

Arlow, a second-year medical student at Case Western Reserve University, says it was his work as an EMT where he began to realize needs in the medical field. "We started talking to emergency physicians and EMTs about what problems they had and we decided to hone in on the airway field," he says.

LifeServe's two products, Cobra Tracheostomy and Viper Cricothyrotomy, are both geared (using a snake's fang design) to open airways in the neck during last-resort emergencies for the delivery of oxygen.

"It was really shocking to see the tools that people are currently using," Arlow says. "A lot of these devices are horrible and can be extremely complicated � it can be even worse in battlefield situations."

So far LifeServe has raised $100,000 in funding, including $25,000 for taking first place at the Akron-based LaunchTown Entrepreneurship Awards last month. The company also won Goldstein Caldwell and Associates Pitch Day Competition in Cleveland in April. Arlow says the company is applying for additional grants from the government and the military.

LifeServe is still in the pre-clinical testing phase, but Arlow says the company will soon begin testing cadavers and a product on the market within one year � adding as many as five positions.

Source: Richard Arlow, LifeServe
Writer: Colin McEwen

Despite the fact that only about three quarters of patients who undergo spinal-fusion procedures receive appreciable benefits, nearly 400,000 of the operations are performed annually. The odds are even grimmer for those hoping for complete recovery, with only half of the patients reporting total pain relief.

Companies like Cleveland-based AxioMed Spine Corporation will soon offer a new solution with more promising outcomes: total disk replacement.

Unlike the first generation of artificial disks that utilized ball-and-socket articulating bearings, the latest "next-gen" devices better replicate the natural function of the native disk. AxioMed's patented polymeric core, along with the device's unique design, provides three-dimensional motion that reduces pain and increases mobility.

Following a successful European clinical study, the company's Freedom Lumbar Disc received CE Mark approval, signifying that the product meets European Union consumer safety standards.

"The Freedom Lumbar Disc is the only elastomeric lumbar total disk replacement device to receive CE Mark approval based on a rigorous multi-center clinical study conducted in the European Union," explains Patrick McBrayer, AxioMed's president and CEO. "We are particularly pleased to be able to provide surgeons in Europe with the Freedom technology that has been shown to provide patients pain relief, reduced disability and improved lifestyle."

The company recently completed the first part of its third financing round. An unnamed venture capital firm that participates in the Ohio Capital Fund has invested $6.4 million toward a Series C goal of $18.5 million. The lumbar disk is still a few years away from approval for a U.S. launch, McBrayer says.

Source: Patrick McBrayer, AxioMed
Writer: Douglas Trattner

By working with customers ranging in size from large pharmaceutical companies to small biotech startups, WIL Research has managed to weather many of the economic problems faced by its competitors.

Able to serve the contract research needs of a wider market, WIL has grown to nearly 700 employees since its 1976 launch.

Headquartered on a 78-acre campus in Ashland, Ohio, the company provides product safety assessment research and services to a wide range of industries, including pharmaceutical, biotechnology, agriculture, food additive and veterinary medicine.

The interdisciplinary staff includes experts in toxicology, pharmacology, neuroscience, pathology and animal medicine.

A recent expansion added 52,000 square feet of lab space to the already massive facility.

In addition to working with clients in all parts of the United States, WIL is poised to increase its European presence following the acquisition of Notox, a contract research firm in the Netherlands.

Source: WIL Research
Writer: Douglas Trattner

Rocker Bret Michaels has one. Patriots linebacker Tedy Bruschi has one. Beau Biden, son of Vice President Joe Biden, has one too.

What they have is a hole in the heart known as a patent foramen ovale, or PFO. It's a problem shared with millions of other Americans -- one that, left undetected, can lead to strokes and death.

Until now, detecting a PFO has required the skills of two physicians, use of a heart catheterization lab, mild sedation and a plastic tube shoved uncomfortably down the throat, says CardioX CEO Larry Heaton. That procedure is so uncomfortable that many patients refuse follow-up tests to determine if treatments have been effective.

But if all goes as planned, the Dublin-based CardioX will complete clinical trials this summer -- and next year begin marketing -- a siimpler process that requires only a small injection of dye into the blood, sensors attached to a person's ears and a tube into which a patient blows to open the flap covering the PFO. (Because blood passing through a PFO doesn't go to the lungs as it should, the dye will reach the ears ahead of schedule -- proving the existence of the hole).

CardioX, founded in 2008, has raised about $4 million in outside investments, including two rounds led by Reservoir Venture Partners and Early Stage Partners, respectively. The company has also benefited from angel funding led by Ohio TechAngels and $500,000 through the TechColumbus Regional Commercialization Fund.

"The combination of (state) initiatives, along with the source of capital, have combined to make a very nice climate for CardioX to stay here in this area," Heaton says.

The company has five full-time employees and a network of about half-a dozen outsourced or part-time people, Heaton says. More will come on board as the system goes to market.

Source: Larry Heaton, CardioX
Writer: Gene Monteith

"The traditional paradigm in regenerative medicine consists of injecting stem cells into injured organs so that the damaged tissue can begin to repair itself," explains Juventas Therapeutics president Rahul Aras. "Ours is a more simplified approach that moves away from extracting and reinjecting stem cells."

Based on the research of Cleveland Clinic cardiologist and Juventas co-founder Marc Penn, the biomed company developed an innovative technology that offers a fresh way of looking at regenerative therapy. Penn discovered that it wasn't a lack of stem cells that made an organ's natural repair process ineffective, but rather because the molecular signals that recruit those stem cells are too short-lived.

The key molecule that serves as the beacon for stem cells is Stromal�cell Derived Factor 1 (SDF�1). Injecting SDF-1 into damaged tissue, they found, restarts a patient's natural repair process.

Presently, Juventas is in Phase 1 clinical trials to evaluate the safety and efficacy of using SDF-1 to improve cardiac function following a heart attack. But in the future, adds Aras, the same repair biology likely can be used to treat other diseases as well.

Thanks to help from the State of Ohio's Third Frontier initiative, Global Cardiovascular Innovation Center and JumpStart, Juventas spun out from the Cleveland Clinic in 2007. The Cleveland-based company currently employs four full-time and two part-time members. But as the technology moves into other disease applications, Aras anticipates exponential growth.

Source: Rahul Aras, Juventas Therapeutics
Writer: Douglas Trattner

People who suffer from chronic pain could someday toss their painkillers into the garbage. For good.

Neuros Medical is developing a device that uses an electrode to deliver high-frequency stimulation to sensory nerves in the peripheral nervous system. Basically, pain signals in the spine just won't make it to the brain.

The Willoughby-based company was founded in 2008 using technology invented by two Case Western Reserve University doctors.

Jon Snyder, founder and CEO of Neuros Medical, says Northeast Ohio has become an international hub for researching � and producing � neurostimulation devices.

"There's a great amount of this type of technology being discovered and refined here, especially with institutions in the area like the Cleveland Clinic, University Hospitals, Case Western and the Functional Electrical Stimulation Center," Snyder says. "This region is very well-known for uncovering new uses for neurostimulation."

Neuros Medical is currently in the product-development stage, but the company's pace is moving quickly. Human studies are expected this year.

Investors have taken notice � to the tune of $1.8 million so far. That includes support from JumpStart ($275,000), North Coast Angel Fund ($200,000) and Ohio TechAngels ($200,000).

"In Ohio, we've got some great support organizations, to help companies get through their early stages of development," he says.

Neuros Medical employs three people, not including consultants that are hired regionally. Within the next few years, Snyder expects to have a product on the market � which will add even more jobs. However, the company could add as many as six positions within one year. "Maybe even more," he adds.

Source: Jon Snyder, Neuros Medical
Writer: Colin McEwen

Both patients and docs benefit when new medical advances reduce the cost, complexity and risks of surgery. Miamisburg-based X-spine has built a growing business on that idea.

Founded in 2004 by spine surgeon and medical device inventor David Kirschman, the company is growing on the strength of nine FDA- approved products.

The company bills itself as "leader in design and development of novel technologies for the spine." That includes the highly successful X90 screw system, a one-piece product that Kirschman, X-spine's CEO, says simplifies the old two-piece system used before.

The company's new Fixcet Spinal Facet Screw System, which received FDA clearance just last week, sports a novel dual thread design, which Kirschman -- X-spine's CEO -- says provides a more stable way to connect bones. Not just that, but it can be put in through the skin of the patient with only a very small incision.

Kirschman says X-spine is growing 20 percent to 30 percent in both revenues and employment, with nearly 30 employees to date. Along the way, it has benefited from Ohio Third Frontier programs like the Entrepreneurial Signature Program, which provided a $300,000 commercialization investment two and a half years ago, and a current University of Cincinnati-led project funded by a $3-million Third Frontier grant for development of a laser metal processing technology for use in transplants.

"Most of our products are manufactured right here in Dayton," says Kirschman. "There are a lot of skilled engineers here and lot of people with good manufacturing skills."

Source: David Kirschman, X-spine
Writer: Gene Monteith

Northeast Ohio has expanded its business attraction efforts outside of Ohio, hiring a full-time director to lead an international marketing program designed to attract two to four new companies to the region in the next two years.

Team NEO, a business attraction organization that represents the region's largest chambers of commerce in a 16-county area, last month hired Bernardine R. van Kessel as Director, International Business Attraction. Team NEO also has contracted with PM&P Consultants of Germany to act on its behalf in Europe.

The initiative is financed by a $1-million, two-year grant from the Cleveland Foundation and is intended to reach out not only to European companies but to business interests in Canada and China for renewable energy, biomedical and advanced manufacturing opportunities.

Carin Rockind, Team NEO's vice president of marketing and communications, noted that a new Team NEO report issued last month demonstrated that northeast Ohio is well-positioned for "clean tech" growth. Those industries now represent $12.5 billion, or 7.5 percent of northeast Ohio's economy, but are expected to grow more than 20 percent in the next five years.

"Northeast Ohio in particular has the benefit of tremendous access to transportation systems in terms of rail, highway and port access," she says. "Then, our workforce is accustomed to these particular (high tech) industries."

Rockind says Team NEO has set a first-year goal of 10 "hard leads" (a company that could bring at last 20 new jobs to the region and commit to at least $1 million in capital investment) -- and a goal of 12 such leads in the second. The organization also is developing a process to work with foreign businesses that aren't ready to open new offices here but are interested in U.S. partners.

Sources: Carin Rockind, Team NEO and http://www.clevelandplusbusiness.com/
Writer: Gene Monteith

In no other field is it as important to be perfect than the operating room, where increasingly complex procedures bring dwindling margins for error. One innovative Cleveland-based firm has stepped in to ensure doctors get all the practice they need.
 
Simbionix USA Corp. has become an international leader in simulation-based medical training and education simulators, allowing young doctors to gain experience in surgical procedures, veteran surgeons to hone their skills and all doctors to better visualize intricate procedures beforehand.

"It's made a huge difference in patient care, especially for procedures where it's critical, where there's little room for error," says Simbionix's U.S. Director of Marketing, Bill Lewandowski. "We have about 900 of our simulators in hospitals worldwide, mostly in hospitals that are associated with teaching institutions like the Cleveland Clinic and the Mayo Clinic."

"We're on every continent but Antarctica. We just can't get any of the sales guys to go there," he jokingly adds. 

Simbionix's exponential growth � founded in Israel in 1997, it later moved to Cleveland to follow investment money � has mirrored hospitals' use of highly technical, minimally invasive surgery robotic systems. The most prominent, Intuitive Surgical's highly precise da Vinci surgical system, is a multi-armed operating room robot that allows for less invasive procedures, fewer post-surgical complications for patients and quicker recovery times. It also demands extensive training, which is one area where Simbionix's simulators have proven invaluable.

Using actual patient data, Simbionix simulators allow doctors to practice the surgery electronically beforehand, identifying possible problems before the first incision is made. 

The company has more that 70 employees, but because of a recent Ohio Third Frontier grant expects to surpass 80 and expand its Medical Education Divison in Cleveland.

Source: Bill Lewandowski, Simbionix
Writer: Dave Malaska

NDI Medical is taking a big step into the future of implantable surgical devices.

With its new FDA approval in-hand, the Beachwood-based firm is taking its newest product to market.

NDI Medicals' neurostimulation device will be implanted next month into the shoulder of a patient to alleviate chronic shoulder pain. Robert Strother, NDI Medical's vice president of engineering and chief technology officer, called implantable medical devices "an area of explosive growth."

As a member of the pacemaker family, the neurostimulation device � about the size of a silver dollar � works where conventional pharmacology stops short.

"Often, the solution is you take pill, it goes in the blood and goes everywhere. But sometimes there are side effects," he says. "With the device, if it has any problems it's going to be limited to where the device is."

The future, Strother says, is in the "deep brain" market. Products he says that could treat a number of maladies, ranging from Parkinson's disease to depression. "Our goal is to continue to use the technology and come up with other applications to provide alternatives to what else is out there."

Since its founding in 2002, the incubation firm has attracted over $17 million in grants (including two from the Third Frontier and exited its first venture capital round � returning over 150 times the original investment back to shareholders. In 2008, the company sold its first product � a bladder pacing device called MedStim � to medical device giant Medtronic in Minneapolis for $42 million.

There are 25 employees at NDI including entrepreneurs, scientists and physician advisors. Strother says the company has plans to grow.

Source: Robert Strother, NDI
Writer: Colin McEwen