biomedical : Innovation + Job News

John Steidley says the smart phone has come of age as a prime tool for just-in-time training. His company, Intelligent Mobile Support, is now trying to prove that vision.

Formed in June of 2009, the Solon-based, company launched its services this past August as a more efficient, less costly and more rapid way to channel information to sales personnel and other mobile workers.

"If you think about how training happened 25 years ago, we'd fly people in, give them a three-ring binder try to teach them everything we knew in three days," says Steidley, the company's CEO and founder. "Three days afterward, 90 percent of the information was gone, it had evaporated from their minds." 

After receiving an iTouch for Christmas a couple of years ago, "it occurred to me that the mobile smart phone was the perfect training device," Steidley says. "It was portable, it was just in time, you could go anywhere , you could catch a couple of minutes of training while you were waiting to go somewhere. And that was the turning point in my mind."

Intelligent Mobile Support, which hosts any type of web-based training material, alerts those in the field to product or software updates, market conditions or competitor data, he says. For example, someone on a sales trip can access new PowerPoint slides while waiting in the airport. The service is synced up in such a way that users can move from phone, to laptop, to PC all while keeping their place using tags, or bookmarks.

Besides mobile personnel such as sales people, Steidley says "we've got a particular focus on the healthcare sector," specifically an application directed at the physical therapy segment that shows patients how to do their exercises, all while tracking the workout for the care giver � and comparing the plan with the actual execution.

The company has three full-time employees, but partners with Youngstown-based Empyra, which has an equity stake in the company and provides software development and hosting services.

Source: John Steidley
Writer: Gene Monteith

Our bones, it seems, need some reconstruction occasionally too. A Medina company has been successful in developing the right "hardware" for the job and may now double in size thanks to a new product offering.

OrthoHelix Surgical Designs was founded by David Kay, an orthopedic surgeon, in 2004. The company develops orthopedic implants for hand and foot surgery - small bone areas.

With a successful line of screw and plate instruments used across the U.S., OrthoHelix is a competitive leader in its marketplace and is expected to see sales of $20 million this year.

An Ohio Third Frontier grant for $1 million awarded to the company in June will make it possible for OrthoHelix to add an additional 42 employees to its current 50, says Dennis Stripe, CEO, as the company will commercialize a new locking mechanism product, OrthoLock, that complements its existing offerings.

"We expect to double sales in the next three years," says Stripe. "This locking mechanism is unique to us. We already have FDA approval and early trials are underway. We expect to roll out the product early in the first quarter of next year."

The growth will enable OrthoHelix to add a wide range of new jobs, says Stripe. Additional workers in engineering, technical inspection, product management, customer service, finance and marketing will be needed.

The grant will also help OrthoHelix expand distribution of its full product line throughout more areas of the country, says Stripe.

Looking even further ahead, Stripe says his company sees a bright future because of current R&D.

"We've got a very strong pipeline of product ideas coming down the line," he says.

Source: Dennis Stripe, OrthoHelix
Writer: Val Prevish

A few years ago, Yosry Attia, who had long been looking for new uses for an old technology, mentioned his latest work to his neighbor, Thomas Hubbell, and the hope that it could hold the key to better cancer treatments. Attia was investigating the use of aerogel -- a low-density porous solid material that some call "frozen smoke" -- and its ability to improve the targeting of cancer cells. Hubbell encouraged his friend to continue his pursuit, then joined him.

Two years later, their company, Delaware-based BioAerogel, is poised to change cancer treatment forever.

"The problem is, in order to get chemotherapy drugs to cancer cells, you have to immerse the body in the drugs," explains Hubbell. "That means you have to use much bigger doses than will ever reach actual cancer cells, and more healthy cells will be damaged."

Through the use of aerogel, a gel in which the liquid component has been replaced by gas, the pair have found a way to bind cancer cell-targeting proteins with chemotherapy drugs. When injected into a patient intravenously, the proteins within their gel attach themselves to the cancer cells at the molecular level, then deliver cancer-killing drugs. Better targeting means smaller doses of chemotherapy drugs, less damage to healthy cells and fewer side-effects.

Because each cancer has a special structure, aerogels with different properties must be designed for each kind of cancer. Attia and Hubbell started by tackling lung cancer cells, with lab results already showing great promise. Earlier this year, the duo got a TechColumbus start-up grant to continue their work while looking for new investors.

"Right now, we're working on perfecting the science and process, and then we have to go through the FDA approval process," says Hubbell. 

In the meantime, they'll start designing treatments for other cancers and investigating whether their aerogel delivery platform could be used to treat other diseases.

Source: Thomas Hubble, BioAerogel
Writer: Dave Malaska

A conversation two years ago between Cincinnati physician Sambhu Choudhury and his cousin, an Iraqi veteran, sparked an idea for a medical device that could help save soldiers' limbs after traumatic bomb blasts.

"My cousin was an Army Ranger who did four tours in Iraq. After his last one, we were talking about him and his buddies and some of the things they went through. A lot of them are surviving blasts that would have killed them in the past, because of body armor. The armor covers their torso and organs, but not their limbs," Choudhury says.

From that conversation, the idea sprang for a sterile, stabilizing wound sleeve that would protect limbs during emergency transport. The idea got a boost in September as a winner of Xavier University's XLAB (Xavier Launch-a-Business) first-ever business competition.

Choudhury was one of eight Greater Cincinnati innovators awarded an academic year's worth of business mentoring services designed to take ideas from concept to marketplace.

Choudhury is an orthopedist who developed the idea along with fellow Cincinnatians Sean Lynch, a certified physican's assistant and Arturo Sanchez, an engineer. Xavier is giving the developers something they lack: business acumen. They will get a business adviser, consulting services, access to Xavier workshops, mentors and networking events. They will also get help in developing a business plan and a meeting with potential investors for their new company Concepto.

"As a company we don't have a business background," Choudhury said. "Developing the technology is easy for us, and we have a good handle on it. But we need to work with people who can help us get into the market without breaking the bank."

Source: Sambhu Choudhury, Concepto founder
Writer: Feoshia Henderson

As if awaiting results from a breast biopsy isn't frightening enough, a woman also may have to endure pain and scarring from the procedure itself.

While the waiting part remains, the physical discomfort is being lessened by use of a minimally invasive device known as a mammotome. The device is so innovative and increasingly well known its name now is also the name of the company that makes it.

Mammotome began as the breast care segment of Johnson & Johnson's Ethicon Endo-Surgery, based in the Cincinnati area. Devicor Medical Products Inc. of Pleasant Prairie, Wisconsin, acquired the segment and has established Mammotome's headquarters in the Cincinnati suburb of Sharonville. The transaction closed in July.

The Ohio Department of Development granted the company a 60- job creation tax credit for seven years, valued at $1.5 million.
Mammotome, the device, is sold in more than 50 countries. Mammotome, the company, employs 300 around the world; 100 of which are in Ohio; total employment is expected to reach about 600 eventually.

Besides the namesake device, the company also makes breast tissue markers called MammoMARK, MicroMARK, and CorMARK.
The company has said it plans to build a new manufacturing plant in the next year or so. A spokesman declined to discuss possible locations.

However, "The senior management team shares my commitment to investment and innovation as we continue to build on Mammotome's position as a leading global breast care company," CEO Tom Daulton said in a news release.

Source: Devicor Medical Products/Mammotome
Writer: Gabriella Jacobs

A pacemaker for the heart is commonplace. So why not a pacemaker for the diaphragm?

Thanks to Synapse Biomedical in Oberlin, that vision is now a reality.

Formed 2002 as one of Cleveland-based JumpStart's original portfolio companies, Synapse has commercialized technology developed at Case Western Reserve University and University Hospitals in Cleveland.

The company's NeuRx Diaphragm Pacing System works by electrically stimulating the nerves that control the diaphragm -- the organ that works like an internal billows to relax and contract the lungs. People with spinal cord injuries, Lou Gehrig's Disease and other neurological ailments previously spent their lives attached to mechanical ventilators.

One early user -- in fact the third ever -- was actor Christopher Reeve, who needed assistance breathing after he was paralyzed in a fall from a horse.

"We now have about 350 people implanted with the device from Iceland to Australia," says Tony Ignagni, Synapse's president and CEO.

Approved in Europe for a wide range of disorders, the pacing system currently is approved in the U.S. only for spinal cord injuries, Ignani says.

"Right now our main focus is on getting the ALS (Lou Gehrig's Disease) approval in the U.S. We've collected all the data and we're working through an FDA process."

The company has about a dozen employees, but with approval for additional uses in the United States, that number could rise, Ignani says.

"The ALS market is actually about 10 times the size of the spinal cord market."

Source: Tony Ignagni, Synapse Biomedical
Writer: Gene Monteith

The algae may not be greener on the other side. Executives at Algisys LLC are looking at sites in Ohio for the Cleveland biotech startup's first manufacturing plant.

No timeline or other details about the site selection process have been disclosed.

Algisys specializes in cost-effective growth and harvesting of algae for the production of nutritional oils and high protein biomass. These " algal omega-3 oils" and high protein additives are used for the multi-billion-dollar supplement, food and beverage, pharmaceutical, pet food, and animal feed markets.

Current industry practice is to obtain the nutritional oils from fish, which eat algae.

Algisys has an exclusive global license on the intellectual property and technology created at Virginia Tech by Dr. Zhiyou Wen, its chief science officer, over a 12-year period.

Things are moving fast for the company incorporated in July, 2009.

"We have letters of intent from prospective customers, we are looking at manufacturing facilities in Ohio, we have secured new funding, and we will be one of the presenters at the Ohio Early Stage Summit VI put on by the Ohio Capital Fund," said Matthew M. Minark, vice president of business development.

Algisys has received funding from BioEnterprise in Cleveland, the Center for Innovative Food Technology in Toledo, and Tower Wealth Management in Shaker Heights.

Plus, this summer, Algisys got funding from the Cuyahoga County New Product Development and Entrepreneurship Loan Fund; this spring it was awarded a National Science Foundation Small Business Innovation Research Phase I grant.

Sources: Matthew M. Minarik and Charles L. Roe, Algisys LLC
Writer: Gabriella Jacobs

A $5-million federal grant is aimed at revving up the skills of Ohio's displaced auto and other workers, training them for jobs in the growing bioscience world.

The grant was awarded to BioOhio, a nonprofit, Columbus-based bioscience accelerator, for its Ohio Bioscience Industry Workforce Preparedness Project. BioOhio doled grants to Cincinnati State Technical and Community College,  Columbus State Community College,  Cuyahoga Community College, Lakeland Community College,  Owens Community College and Sinclair Community College.

The initiative will take place over three years, and more than $2.8 million of grant has been set aside for tuition reimbursement and trainee scholarships

The dollars will be used to create new programs or build on new ones at the colleges, which are partnering with employers and labor, workforce development and non-profit organizations to develop programs to retrain and identify workers in Ohio's auto and other declining industries.

The program is focused not just on education and training but moving people into jobs through the public and private partnerships says Dr. Bill Tacon, Senior Director, Workforce & Education at BioOhio.

"We will help them find a job. We're not simply training and just letting them go. Each has an industry advisory board, and when we got the grant the industry advisory board signed a letter of commitment saying they are looking at new potential hires," Tacon says.

The program has a goal of retraining 660 displaced or underemployed workers in declining industries

Northeast Ohio is leading the charge, because the region's colleges have several programs in place that likely will spread to other campuses, Tacon says. For example, Cuyahoga Community College and partners have a medical device and pharmaceutical manufacturing program that could be implemented across the state.

Source: Bill Tacon, BioOhio
Writer: Feoshia Henderson

ZIN Technologies traces its roots back to 1957, the days of the Cold War and the great "Space Race" between the U.S. and the former USSR. Back then, the company provided aerospace design and fabrication services to NACA (National Advisory Committee for Aeronautics), the forerunner of NASA. Then, in 1961, ZIN received its first NASA contracts -- and has never looked back.

Today, the Cleveland company specializes in man-rated, space-flight hardware design, development, fabrication and operations. The company has developed more than 133 payloads, which have logged thousands of hours in-orbit. Zin also transfers its advanced engineering service and products, developed for space flight, to other specialized markets such as aeronautics and medicine.

"We are one of a few small businesses with the expertise and core competencies to provide space flight hardware from development through operations," says Carlos Grodsinsky, vice president of technology.

While ZIN made its name in outer space, the company recently has gone where it had not gone before: the biomedical industry. ZIN partnered with the Cleveland Clinic to form ZIN Medical, a remote patient management company. Ohio Third Frontier funding helped the company commercialize its services and ZIN is currently seeking venture capital financing.

"We are commercializing remote physiologic health-monitoring technology that we jointly developed for the tracking and management of astronaut crews in-orbit," says Grodsinsky.

Over the past few years the company has boasted double-digit growth and increased its headcount to about 200. ZIN expects continued growth in 2011.

Source: Carlos Grodsinsky, ZIN Technologies.
Writer: Patrick Mahoney

The Dayton region may be known as Ohio's sensors corridor, but northeast Ohio's capabilities in sensor technology just got a boost -- and a big one at that.

Last week the Wright Center for Sensor Systems Engineering at Cleveland State University, allocating funds from the Ohio Third Frontier initiative, awarded six grants totaling more than $17 million to universities and other organizations for development and commercialization of sensors and sensor technologies.

The largest of the six grants -- 25 percent of which will be matched by recipients -- went to Lorain County Community College, which will receive $5.5 million to work with R.W. Beckett Corp., Acence and Greenfield Solar Corp., to create a center for sensor commercialization.

The Cleveland Clinic Foundation's Learner Research Institute will receive $2.67 million to lead establishment a new center for sensor and microdevices for biomedical applications, and the Austen BioInnovation Institute is getting $2.6 million to lead development of an advanced instrumentation platform for product development in biomedical areas.

Meanwhile, the Ohio State University is slated to receive $3 million to lead commercialization of terahertz sensors for applications such as medical imaging and homeland security, and the University of Akron will receive $1.66 million to lead commercialization of sensor technologies for clean energy products.

Youngstown State University will also receive $1.66 million, for a collaboration with the Youngstown Business Incubator and M-7 Technologies to create systems for next generation manufacturing and inspection systems.

Some recipients are already predicting new jobs due to the awards.

"Our principal commercial partner, M-7 technologies, is looking to hire an additional 70 employees over five years," says Julie Michael Smith, the Youngstown incubator's chief development officer. "That is the direct employment, and then of course there will hopefully be downstream employment by companies employing this technologies."

She says the grants are good for northeast Ohio and for the Youngstown area, where old-line industries like steel have been battered in recent years.

Sources: The Wright Center for Sensor Systems Engineering and Julie Michael Smith, Youngstown Business Incubator
Writer: Gene Monteith

A Youngstown-based startup medical device company is changing the way critically ill patients are cared for � and tossing out the notion of a painfully difficult startup process � one innovative feeding tube at a time.

The entire process of starting up Syncro Medical Innovations was made a whole lot easier because of the simple design of the BlueTube, the company's staple product, says Syncro CEO Gary Wakeford. Instead of relying solely on lots of X-rays to guide a feeding tube into the stomach, two powerful magnets do the job. And they do it a lot faster.

One of the magnets is at the tip of the feeding tube, and the other is placed near the patient's belly button, and voil�. "We solve a real problem," Wakeford says. "It's very difficult to insert a feeding tube. We turn a difficult procedure with a low success rate, into an easy procedure with a very high success rate."

People are taking notice. Prestigious customers, including Johns Hopkins Medical Center in Baltimore and the Brooke Army Hospital in San Antonio, have placed orders. The Ohio Third Frontier recently OK'd $490,000 for Syncro through its Innovation Ohio Loan fund.

The BlueTube is currently manufactured in Germany, but plans are in the works to manufacture the product in Ohio by the end of 2010. "Depending on our success, our long-term goal is to do our manufacturing in-house, which could add 30 jobs within three to five years," Wakeford says, adding that there are currently four full-time, two part-time and one intern employed with the company.

"We've really been welcomed here," he adds, noting the company moved to the Buckeye State from Macon, Ga. "This is our headquarters and we plan on always having our base rooted in the Youngstown area."

Source: Gary Wakeford, Syncro
Writer: Colin McEwen

IR Diagnostyx is working to develop fast, accurate and painless diagnosis techniques for a variety of functional diseases like irritable bowel syndrome, interstitial cystitis (painful bladder syndrome) fibromyalgia and chronic fatigue syndrome.

Formed last year and based at TechColumbus, the company grew out of Ohio State University's Technology Entrepreneurship and Commercialization Institute at the Fisher College of Business.

Company founders -- OSU graduate students in OSU's Fisher College -- won third place in the 2008 Fisher business plan competition, says president and CEO Gary Smith. Since then, IR Diagnostyx has received a $50,000 TechGenesis grant and is currently under consideration for an additional $250,000 in funding through the TechColumbus Pre-Seed Fund.

While the company is looking for new diagnostic techniques for a variety of ailments, "we're really focused on interstitial cystitis," Smith says. "The technology's based on work done in Tony Buffington's laboratory in veterinary medicine, and that of Luis E. Rodriguez-Saona. Ironically, Luis is a food scientist, but his competency, his research area, is in infrared micro-spectroscopy."

How does that relate to the diagnosis of functional ailments?

"We take a blood sample and we're developing an algorithm, and using some complicated software we can take a look at a serum sample and see a characteristic signal generated from patients with these specific diseases," Smith explains. "And we take that diagnostic information and compare it with others and provide the physician with some feedback on the health of the patient."

The company is still in the early stages of its product development, having completed feasibility work and now preparing to launch regulatory research, Smith says.

"We're going to collect data from about 500 patients to submit to the FDA later this year," he says.

Source: Gary Smith, IR Diagnostyx
Writer: Gene Monteith

Who knew that radioactivity could actually save your life?

Thanks to some very smart people at Neoprobe, a Dublin-based company specializing in the development of diagnostic systems for cancer patients, gamma detection treatments in tracking the spread of cancer are becoming more effective.

Neoprobe is about to begin a third multi-center Phase 3 clinical study of Lymphoseek®, which has received investigational review board approval and begun enrollment of subjects diagnosed with breast cancer or melanoma, says Brent Larson, senior vice president and CFO.

Lymphoseek® is an injectable radiopharmaceutical used by surgeons as a sentinel node targeting agent in intra-operative lymphatic mapping (ILM) procedures for the diagnosis and treatment of cancer and related diseases.

ILM procedures provide useful information to avoid the unnecessary removal of non-cancerous lymph nodes and surrounding tissue. The Lymphoseek® technology enhances the determination of cancer stage and may help improve the complete diagnosis of disease, says Larson.

In an ILM procedure, a radioactive tracing agent is injected at the site of the primary tumor. Following injection, the tracing agent follows the drainage path of the tumor to the nearest lymph node or nodes. A gamma detection device is used to detect the path of the tracing agent. Since the lymph nodes are connected, oncologists believe that if the sentinel nodes show no sign of malignancy, then the downstream nodes in the pathway are likely to be clear of disease.

If approved, Lymphoseek® will be the first tracing agent specifically labeled for lymph node detection.

Neoprobe was founded in 1983 and is considered a leader in gamma detection systems. Earlier this month, Neoprobe initiated the application process for listing on the New York Stock Exchange. The company currently has 35 employees and expects to add as many as 10 new jobs in the next year, says Larson.

Source: Brent Larson, Neoprobe
Writer: Val Prevish

The Cleveland HeartLab is taking its life-saving technology to heart. A real heart, that is.

The company � affiliated with the Cleveland Clinic � has developed a profile of tests focused on managing and reducing inflammation, a root cause of heart disease.

Using an enzyme immunoassay (a biochemical technique used to detect the presence of an antibody in a sample), CHL uses its CardioMPO technology to test for myeloperoxidase in human plasma.

The product received its FDA approval in May of 2005 for use on the market. Cleveland HeartLab purchased that technology in Nov. 2009 from Cleveland-based PrognostiX.

Cleveland HeartLab, located on the campus of the Cleveland Clinic, bills itself as a specialty clinical laboratory and disease management company focused on novel molecular biomarker technologies and the creation of proprietary diagnostic tests.
But the company doesn't stop there. CHL also runs a research and development laboratory where next-generation cardiovascular disease biomarkers are being developed for use in the clinical community.

CHL has a significant pipeline of tests protected by exclusive intellectual property and target large, under-addressed markets. In addition, an agreement with the Cleveland Clinic provides the company access to intellectual property developed at the Clinic in the areas of cardiovascular and inflammatory biomarkers.

The company is keeping itself busy. In August 2010, the HeartLab hosted the summer symposium "Where Inflammation Meets Lipids," with doctors attending from all over the world.

"Things are going great," says CHL spokeswoman Rachele Rhea. "We are super swamped right now."
 
Source: Rachele Rhea, Cleveland HeartLab 
Writer: Colin McEwen

New Product Innovations (NPI) has been doing business in China for years. Now, it wants to help American medical device manufacturers do more business there, too.

On July 19, the Chinese Medical Device Trade Association (MDTA) announced it had chosen NPI as its official U.S. branch. The association between NPI and MDTA is seen as a way to provide easier access to Chinese markets, particularly Shanghai, where MDTA is based.

NPI designs, develops, engineers and manufacturers new products for client companies. It also helps customers bring those products to market. While the Columbus-based firm serves consumer, industrial and medical clients, it has begun to put more focus on the medical device marketplace, says Mike Billman, managing director for the new MDTA branch and NPI's development manager for new product innovation. As an MDTA branch, NPI will concentrate on medical devices used in non-invasive procedures, he says.

"We've been doing business in terms of manufacturing in China for a long period of time," explains Billman, "A couple of years ago, we realized that since we already have assets in China with three offices," as well as an intimate knowledge of the banking and legal infrastructure, "that we can help U.S.-based medical device companies tap into the growing market in China."

The July 19 announcement piggybacks onto a four-phase process that NPI has been using to assist companies interested in doing business in China, Billman says. The process includes early market analysis, formal due diligence, distribution channel development and, finally, assistance bringing the product to the marketplace..

NPI was established in 1989 as a joint venture of GE Plastics and Fitch, a global design firm. The company has 40 employees in the U.S.

Source: Mike Billman, NPI
Writer: Gene Monteith