Medical Research : Innovation + Job News

Cleveland Clinic Innovations has launched a spinoff company, Shield Biotech, out of the Lerner Research Institute. Led by Vincent Tuohy, the company is developing a vaccine for breast cancer.

The vaccine uses the body’s own immune system to fight off and kill cancerous tumors. Tuohy, who serves as Shield’s chief science officer, has been working on this theory for the past 11 years. 
 
The next step is to secure FDA approval for human clinical trials, probably within the next two years. Researchers found that a single vaccination could prevent breast tumors from occurring in mice genetically bred to develop breast cancer, while also inhibiting the growth of already existing breast tumors. The research was originally published in Nature Medicine in 2010.
 
“It works in animals,” says Tuohy. “It’s safe and very effective. We’d like to see women live longer without tumors, not women live longer with tumors.”
 
Tuohy sees the vaccine as particularly effective in breast cancers that are aggressive and tend to recur. “Triple-negative breast cancer has a higher recurrence rate than other forms of breast cancer and is insensitive to current forms of adjuvant therapy,” he says. “It’s the predominant form of breast cancer that occurs, for example, in women with BRCA1 mutations. “
 
Tuohy sees potential in eventually immunizing against prostrate and ovarian cancers as well. 


Source: Vincent Tuohy
Writer: Karin Connelly

For the last several years, Great Lakes NeuroTechnologies (GLNT) has been using telemedicine technology to study Parkinson's disease. The Cleveland-based provider of patient-centered diagnostic and therapy systems is planning to expand its approach by adding real-time video conferencing to its existing Kinesia HomeView™ innovation.
 
The technology is currently under development at GLNT with clinical validation studies planned for this fall. Adding video conferencing to currently available remote monitoring of Parkinson's patients will keep patients engaged in treatment, says Dr. Dustin Heldman, biomed research manager at GLNT.
 
"Patients will be more likely to take medications when they're supposed to, and (through the system) will be assessed more regularly," says Heldman.  Through the video feed, patients living far from treatment centers won't have to make potentially pricey trips for medication adjustments and other routine maintenance, notes the technology group research manager.
 
The current Kinesia system includes motion sensors patients wear and a broadband integrated tablet which users employ to follow video instructions and complete motor assessments. Telemedicine is a growing healthcare market trend designed to improve patient care and accessibility. Applications include live video conferencing, remote monitoring and store and forward technologies.   
 
This type of technology is especially useful for monitoring Parkinson's disease, a neurodegenerative movement disorder that can afflict its sufferers with a variety tremors, slowed movements and gait abnormities. These symptoms can change daily in type and severity, making a patient's condition difficult to determine during a short office visit. Creating a visualization tool for such a complex disease will only help in its treatment, Heldman says.
 

Source: Dr. Dustin Heldman
Writer: Douglas J. Guth

BioMotiv, a pharmaceutical accelerator formed last year to speed early-stage medical developments to market, announced last week that the company has now raised $46 million in total capital, adding Nationwide Mutual Insurance and several individual investors to original investors University Hospitals and the Harrington Family Foundation.

Additionally, BioMotiv announced Monday that the company has formed a multi-million dollar, seven-year partnership with San Diego-based Torrey Pines Investment, a specialty life sciences investor. “We have now raised $46 million in total funding,” says BioMotiv CEO Baiju Shah. “This further investment partnership will expand capital available for projects by up to $20 million through co-investment by Torrey Pines.”
 
Shah says BioMotiv has just started to identify and develop projects of interest. The partnership with Torrey Pines expands the scope of BioMotiv’s work. “We’re pleased with the prospective partnership,” says Shah. “It’s been in the works for about nine months now. In the partnership we will jointly invest in projects -- one in the cancer area and two projects in neuroscience.”
 
Shah says BioMotiv is also working on developments on several other fronts, including anti-inflammatory and blindness. “Our mission is to accelerate breakthrough discoveries in medications that actually benefit patients,” says Shah. “These are medications that are in the early stages of clinical validation -- phase one or two patient studies. Once we prove it works in patients, then we’re in a place to partner with agencies to get it to market.”
 
Cleveland is the hot spot for companies like BioMotiv, Shah says, making it attractive to companies like Torrey Pines. “Cleveland is an incredible medical innovation environment,” he says. “We are on the global radar for medical innovations, so it’s easy for us to find partners. In many ways, healthcare is our defining industry as a community.”
 
BioMotiv currently has eight employees, but Shah says they will be adding staff as the company continues to grow.

 
Source: Baiju Shah
Writer: Karin Connelly

Arteriorcyte, a developer of stem cell products and medical devices in Cleveland, has launched Compass Biomedical to speed up the delivery to patients three Arteriocyte stem cells products. Created in December 2012, Compass officially got underway in June.
 
“The purpose of Compass is to help solve the issues in getting stem cells to patients,” says Kolby Day, Compass Biomedical vice president and general manager of research and development. “The challenges are having enough stem cells and improving the tools used.”
 
Compass supplies three product lines used to grow stem cells for research and in clinical settings. The products mimic bone marrow and promote the growth of stem cell cultures. “Arteriocyte is more the research and development company, while Compass is more of the team that sells, markets and gets those products into the hands of people who can use them,” says Day.

Compass has hired four people since December. As Arteriocyte develops new products, Day expects Compass will in turn expand its team. “We want to continue to build the sales team and continue finding products to sell,” he says. “We anticipate bringing in at least two to three products in the next six months, and we will be hiring based on demand.”

 
Source: Kolby Day
Writer: Karin Connelly

Cleveland Clinic Innovations (CCI) announced last month that Wisconsin’s Marshfield Clinic Applied Sciences is the seventh clinic to join the Clinic’s Healthcare Innovation Alliance. The collaboration will help Marshfield develop and commercialize its innovations and improve healthcare.
 
The alliance, formed two years ago based on CCI’s 13 years of experience, is a way for the Clinic to share its knowledge while also improving upon its reputation within the healthcare industry. In Marshfield’s case, the Clinic is hiring a senior commercialization officer who will be embedded in Wisconsin.
 
The officer will help to advance diagnostic tools and treatments created by Marshfield Clinic physicians, researchers and staff. The Innovation Alliance also will foster the transfer of Marshfield Clinic technology into commercialization.
 
“It’s about getting the technology quickly to the patient,” says Brian Kolonick, associate general manager of the Innovation Alliance. “It’s all collaboration, these are not bilateral relationships. We look for ways to collaborate, to share knowledge.”
 
There are 65 Clinic employees working within the alliance. “If someone in the alliance has an idea, we get a person on the ground there,” says Kolonick. “We find the right person with the right expertise. It’s getting the right people to the table.”
 
Conversely, the Clinic also learns about what other researchers are doing around the country. “We’re about going in there and getting fresh ideas, flushing them out and commercializing them,” says Kolonick. “It’s about getting in there and shaking trees.”
 
The Innovation Alliance gets a percentage of the revenues from any idea that goes to market.
 

Source: Brian Kolonick
Writer: Karin Connelly

Researchers at CWRU School of Medicine and the Cleveland Clinic Lerner Research Institute have discovered a way to restore bladder function in rats with severe spinal cord injuries. Jerry Silver, professor of neurosciences at CWRU School of Medicine, and Yu-Shang Lee, assistant staff scientist in the Cleveland Clinic’s Lerner Research Institute, paired a traditional nerve bridge graft with scar degrading and growth factor treatments to grow new nerve cells. 

The neural bridge spans the gap between the severed sections of the spinal cord -- from the thoracic region to the lower spinal cord. The new nerve cells regrew in the bridge, which allowed the rats to regain bladder control. 
 
“It’s exciting news for us,” says Lee, who has been working on this research for the past 10 years. He cites a bladder control survey in which spinal cord injury patients ranked bladder control in the top two most important concerns -- higher than motor or sensory function. “It’s new hope for future treatments.”

The team’s work was detailed in the June 26 issue of the Journal of Neuroscience. Lee and Silver plan to test their method on larger animals before moving on to human trials in a few years. Silver and Lee hope their research will ultimately result in restoration of bodily functions in paralyzed humans.

 
Source: Yu-Shang Lee
Writer: Karin Connelly

The two square miles of real estate between downtown Cleveland and University Circle are bursting with development. To ensure that work continues to flourish, a local nonprofit has established an endowment fund.

Last month, economic development corporation MidTown Cleveland, Inc. announced the creation of the MidTown Cleveland, Inc. Endowment Fund at the Cleveland Foundation. The fund, under the foundation's guidance, proposes to build a sustainable revenue source to secure continued activity in the burgeoning district. This will include promotion of the health-tech corridor, a three-mile expanse of hospitals, business incubators, educational institutions and high-tech companies situated within MidTown.

The growing tech corridor isn't the only project the fund will support, notes MidTown chairman John Melchiorre. The group plans to leave other "footprints" on the community as well, be they demolishing old buildings, planting flowers along Euclid Avenue or helping transform distressed properties into job-creating enterprises.

"The Cleveland Foundation has been a leading supporter of the revitalization of Midtown, so this is just the latest way our two organizations have joined forces for the betterment of that neighborhood," said Kaye Ridolfi, senior vice president of advancement at the Cleveland Foundation.

Founded by Cleveland businessman Mort Mandel and others some 30 years ago, MidTown Cleveland has helped develop the area into a business district home to 600 companies and 18,000 employees. Executive director Jim Haviland views MidTown as part of the city's renaissance, and believes the fund will sustain the region for decades to come.

"It helps us to continue the role we play" within the neighborhood, says Haviland.

 
Sources: John Melchiorre, Jim Haviland, Kaye Ridolfi
Writer: Douglas J. Guth

Zuga Medical, a medical device company, recently received a $250,000 investment from JumpStart to launch its dental implant system. In April Zuga received FDA approval for its system, which allows a general dentist to perform implants using a screw, a procedure previously done only by oral surgeons.
 
“Our patent-pending technology makes it simpler, easier and more cost-effective for both the dentist and the patient,” says Zuga CEO Steve Cornelius, who met the company’s founder and CSO, Chan Wang, a year-and-a-half ago through BioEnterprise and joined the board of directors. He then became CEO. With 15 years of experience in the dental industry, Cornelius was intrigued with Wang’s product. “Chan had a vision of making things simple for general dentistry.”
 
Zuga will use the JumpStart investment to conduct a soft launch with eight to nine local dentists. Those dentists will take a training course on placing the implants next month. “We’re using the local soft launch in Cleveland to prove out our business model and raise the next round of investments,” Cornelius says. “Our vision is to create a dental company right here in Cleveland.”
 
As Zuga grows, Cornelius hopes to hire three to four sales reps, a marketing person and a customer service rep by the end of the year.
 
Zuga Medical has also received investments from the Cuyahoga County North Coast Opportunities Fund and the Innovation Fund.

 
Source: Steve Cornelius
Writer: Karin Connelly

When Geoff Thorpe founded NDI Medical in 2002 with his neurostimulation device for bladder control, he saw a market with a lot of potential. The company sold its MEDSTIM device to Medtronic in 2008, kept the NDI name and branched into developing and commercializing new neurostimulation device companies.
 
The move has proved successful. NDI has launched two companies and has grown to 32 employees, 21 of whom work in NDI’s Cleveland headquarters. The company also has offices in North Carolina and Minnesota. Most recently, NDI Medical named Marilyn Eisele as president of the company. She has been with NDI about a year, previously serving as vice president of finance and CFO.
 
“What attracted me to the company was the innovation coming out of the collective enterprise,” Eisele says. “We took a step back after we sold the company in 2008 and decided to reinvent and continue the business as a development company where we develop new therapies.”
 
Since selling the company and regrouping as a developer of new technologies, NDI Medical has raised $17 million in private equity and another $9 million in grants and loans. In 2010, the company launched Checkpoint Surgical, which makes a device that allows surgeons to locate nerves and muscles before making an incision, and SPR Therapeutics, which develops nerve stimulation devices for pain management. Sales have doubled each year since Checkpoint was launched.
 
“In some ways we are a development company, and in some ways we’re an incubator company,” says Eisele. “We’re able to develop medical devices so each portfolio company doesn’t need its own team of engineers. It’s a very cost-effective way to use research.”
 
NDI Medical is in the process of launching a third company in the next few months.

 
Source: Marilyn Eisele
Writer: Karin Connelly

The Irish Taoiseach (Prime Minister) announced a new partnership between Ireland-based company i360medical and Cleveland Clinic Innovations during a speech at the City Club of Cleveland last week.
 
The partnership will result in i360medical representing the European wing of the Cleveland Clinic’s Innovation Alliance program -- the corporate venturing arm of the Cleveland Clinic. The program itself has 52 spinoff companies that have raised approximately $620 million in equity financing, according to Executive Director Chris Coburn.
 
i360medical bills itself as a medical device innovation company acting as an international and national hub for new healthcare ideas and medical technologies.
 
Frank Ryan, CEO at Enterprise Ireland -- a government funded organization tasked with developing and growing Irish companies in world markets, says there are two reasons why they wanted to work with the Cleveland Clinic.
 
“First of all, innovation. The clinicians here at the Cleveland Clinic are renowned for competence and expertise,” he says. “Secondly, it means exposing Irish companies to those clinicians and the development of new medical device technologies.”
 
Coburn says the Clinic first linked with Enterprise Ireland in the middle of the last decade. “20 percent of cardiologists in Ireland were trained in Cleveland Clinic,” he says, adding Cleveland’s strong Irish heritage was another building block early on in their relationship. It quickly became clear that Enterprise Ireland was “a perfect fit.”
 
“We view Enterprise Ireland as an absolute leader in terms of public-private entities looking to stimulate growth,” says Coburn. “This is a very sophisticated operation, and I think a role model for other entities, whether state or county or local, in terms of doing it right.”
 
 
Source: Chris Coburn, Frank Ryan, Brian O’Neil
Writer: Joe Baur

Akron has become known as a hub for biomedical companies in recent years, and now a new fund is seeking to further cultivate growth in that sector. The $1.5M Akron BioInvestments Fund targets high-growth companies in orthopedics, wound healing, cardiovascular science, biomaterials, medical devices and other areas for investments.

“While a small part of the Fund supports product development, the main focus is on supporting companies that are 2-3 years away from generating revenues," explains Dr. Zev Gurion, Executive Director of the Akron BioMedical Corridor. "We want companies we invest in to repay the loan so that the Fund will not become depleted over time. That’s why the business potential of the company is considered, as well as economic development elements."

Companies that receive investments must maintain an Akron headquarters or plan to establish a local presence, with an emphasis placed on the Biomedical Corridor. The Fund gets most of its backing from private organizations such as Medical Mutual, First Energy, Cascade Capital and NEOMED. The City of Akron created the fund through its Akron Development Corporation.

The Fund is composed of two parts. The Rapid Commercialization Loan Fund provides low-interest loans to companies that are close to commercialization. The Product Development Fund supports biomedical startups by financing proof of concept, prototyping, market assessment and business-plan development.

Committees made up of representatives from the University of Akron, county and regional government, private businesses and regional organizations make recommendations to the Fund’s board. Cascade Capital acts as the Fund Manager.

Zurion says that the Fund has made two investments so far, a $25,000 grant and a loan for $200,000. The Fund received six qualified applications in the first partial round of applications which ended December 31.


Source: Dr. Zev Gurion
Writer: Patrick G. Mahoney

The effort to build a world-class biomedical industry in Northeast Ohio took another step forward last week, when JumpStart Inc. invested $250,000 in Milo Biotechnology, a new company formed to pursue promising treatments for muscle degeneration.

Columbia Station native Al Hawkins will serve as Milo's CEO. The former director of new ventures at Boston University, Hawkins returned to Northeast Ohio last year to serve as CEO in Residence at BioEnterprise, the Cleveland-based biotech incubation initiative, and to find emerging technologies worthy of investment. The adeno-associated virus (AAV) delivered follistatin protein developed and patented by researchers at Nationwide Children's Hospital in Columbus fit the bill. Follistatin can stimulate muscle growth, and early trials with mice and macaques suggest it could help patients suffering from muscular dystrophy and other conditions that weaken muscles, Hawkins says. According to JumpStart, a Phase I/II trial, funded by Parent Project Muscular Dystrophy, is enrolling patients.
 
Hawkins will retain his position with BioEnterprise until Milo has raised at least $1.5 million. Longterm, his job will be to keep raising funds for the six to seven years it could take to get follistatin all the way through the FDA-approval process, or to hire a new CEO and find another new technology on which to build a company in Cleveland.
 
Moving back to Northeast Ohio, he says, “is something I considered for a couple years. There are great opportunities here.”
 
 
Source: Al Hawkins
Writer: Frank Lewis

Three northeast Ohio businesses, with the aid of a $2.5 million grant from Ohio's Third Frontier, are researching first-of-their-kind imaging technology that will help detect medical conditions, such as cancer, sooner and save hospitals money by reducing the number of biopsies taken.
 
Case Western Reserve University, University Hospitals and Philips Healthcare, partnered in the summer of 2010 to form the Philips Healthcare Global Advanced Imaging Innovation Center, where they have multiple projects aimed at combining the best attributes of CT, PET and MRI imaging systems to give doctors better tools in identifying breast cancer and take earlier action in heart attack patients.
 
The projects, which combine medical imaging technologies already in use, could eventually save hospitals millions in costs, give Ohio a leg-up on their commercialization and--most importantly--save lives.
 
In one project, the partners hope to combine PET (Positron Emission Tomography) with Magnetic Resonance Imaging (MRI) systems, both of which are currently used to detect early signs of breast cancer, to provide doctors with higher resolution imaging that will ultimately give doctors a clearer picture of what’s happening inside the body.
 
"The focus is on improving the spatial resolution, allowing us to find tumors much smaller than we can find now," says Dr. Raymond Muzic, the project's leader and an associate professor at Case Western. "MRI's, when used clinically, often show spots that look suspicious but turn out to not be a problem. Getting images with higher resolution will help us determine which spots are a problem and which are not."
 
The better imaging would reduce the number of biopsies doctors order to determine malignancy, saving hospitals thousands of dollars. It would also help doctors catch tumors much earlier, which could mean the difference between life and death.
 
According to the American Cancer Society, patients who are diagnosed with Stage I breast cancer, with tumors two centimeters or smaller, have up to a 20 percent greater chance of surviving cancer than patients who advance to Stage II, in which tumors are larger and start spreading to the lymph nodes.
 
The second project looks to do something similar--only with heart patients. Researchers are pairing cardiac perfusion technology with CT scanners, creating a novel imaging system that would allow emergency room doctors to assess the extent and location of damaged heart muscle when time is of the essence.
 
The partners are each contributing $1 million toward the projects, along with equipment and the time of researchers and engineers. Once the engineering is completed, University Hospitals and Case Western will oversee the clinical trials. Results are expected "within a few years," according to Muzic.
 
"The projects are a win-win for everybody involved," he said. "The goal is to develop a product here in Ohio that can be manufactured in Ohio by an Ohio company and marketed throughout the world. It's a win for each of the partners and it's a win for the state."