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Biomotiv announces $46m raised in effort to speed medicines to market

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

Cleveland's NDI Medical continues to grow rapidly in neuro-stim field

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

Brain surgeons get a practice run with simulator from Elyria-based Surgery Theater

For a number of years, pilots have used virtual reality simulators to practice critical missions before taking to the skies. Thanks to a revolutionary new virtual reality training tool developed by Elyria’s Surgical Theater, LLC, surgeons now have a way to practice brain surgery before setting foot in the operating room.
The Surgery Rehearsal Platform (SRP) simulator consists of a desk top computer, a portable laptop system, software, controllers and 3D glasses.
“Using standard CT and MRI images from any patient, the SRP generates accurate models in 3D that show the interaction between life-like tissue and surgical instruments,” explains Moty Avisar, Surgical Theater president and CEO. “The tissue responds realistically to actions taken by the surgeon, enabling pre-surgery planning and rehearsal with complete accuracy.”

Beyond practicing on standard CT and MRI images, surgeons can also use unique images taken of the patient who will be undergoing surgery.
“Using the SRP prior to a procedure enables a surgeon to evaluate, experiment and do a ‘dry run’ on his or her approach beforehand, resulting in a better-prepared surgeon,” Avisar states. “Studies will be done to confirm this, but our belief is that SRP training will lead to improved patient outcomes and reduced risk.”
The Surgery Rehearsal Platform received full FDA approval in February. The SRP’s unique patient-specific capability is one of the key innovations that led to FDA approval, he notes. According to Avisar, it’s the only patented and FDA-cleared training platform for cerebral and spine pre-surgery rehearsal in the marketplace.
The SRP, which took approximately three years to develop, supports several cerebral procedures, including aneurysm repair and tumor resection. The team is working to add capabilities to support other brain-related procedures and spine surgeries.
According to Avisar, the first SRP was recently sold to University Hospital Case Medical Center, where it is being used on a regular basis.

The company, which started with one person in 2010, received funding from the Ohio Third Frontier, private investors and angel groups. It plans to expand to 15 employees by the end of the year.
Source:  Moty Avisar, Surgical Theater, LLC
Writer:  Lynne Meyer

Dayton's NovoSource promises to decrease cost of knee replacement device

According to research released in the Journal of the American Medical Association last year, hospitals in 2010 performed 243,802 knee replacement surgeries, up from 93,230 in 1991. According to the study, annual demand for knee replacement surgeries could reach 3.5 million by 2030. The researchers attribute the potential increase to various factors, including aging baby boomers.

The popularity of the procedure and the price of knee replacement devices are contributing to rising health care costs, says Harold Linville, co-founder and chairman of Dayton’s NovoSource.
“The market for knee replacement devices is dominated by three or four companies,” he explains. “They provide great products that produce excellent results, but their overhead is huge, with large facilities, big staffs, expensive advertising and a costly distribution system.”
NovoSource is introducing its own knee replacement device. “It’s being manufactured by one of the companies the big players use to make their products,” he says. “Our device is made of the exact same materials and has the exact same functionality. The quality is the same. The difference is that ours will be much less expensive.”
The reason, according to Linville, is NovoSource’s streamlined business model. 

“We have a significantly lower overhead, with fewer employees and one sales person,” he says. “We also have better supply chain management because we’re working with our suppliers to establish long-term manufacturing agreements. Our approach also means we can maintain a lower inventory without tying up money.”
The company won’t be doing any advertising and will sell directly to hospitals and surgeons. “In terms of overcoming skepticism about considering our device, we’re able to provide data to prove that the quality of our product is just as good as anything else available on the market,” he states.
NovoSource’s knee replacement device is under final review by the FDA, and results are expected soon. The company plans to start distribution in Florida with the surgeons it worked with to develop the product.

NovoSource received $1.2 million in funding from the Dayton Development Coalition, with the rest coming from angel investors.

Source:  Harold Linville, NovoSource
Writer:  Lynne Meyer

CWRU researchers turn to squid beaks for medical inspiration

Researchers at CWRU have developed a material that can morph from stiff to soft, making its gradient properties potentially useful in medical implants. The research was conducted by professors Stuart Rowan, Justin Fox and Jeffrey Capadona of the macromolecular science and engineeringchemistry and biomedical engineering departments, and Paul Marasco of the Louis Stokes Cleveland Department of Veterans Affairs Medical Center.
The inspiration for the new material came from studying the properties of squid beaks. “Squid beaks are a stiff material, but they have to attach to very soft tissue,” explains Rowan. “They don’t have any bones per se. Imagine a piece of steel attached to a piece of plastic and you started bending or putting stressors on it. Things would start to tear, and that’s obviously not very good for the squid.”
Capadona, Marasco and Rowan came up with the idea after reading a research paper published in 2008 at the University of California, Santa Barbara. Rowan and his team looked at how the squid’s beak transitions from hard to soft material. “How the squid solves the problem is with a gradient design that goes from hard to soft when wet,” explains Rowan. “We created a material with a similar kind of structure. We tried to mimic the architecture and properties.”
The nanocomposite material the researchers developed changes properties when wet -- going from a rigid material to a soft material. It potentially will prove useful in medical devices such as diabetic glucose sensors, prosthetic limbs and central vein ports. The researchers are now working with the Cleveland Department of Veterans Affairs to develop uses for the material.
The research was recently published in the Journal of the American Chemistry Society.
Rowan and Capadona previously had studied the properties of the sea cucumber, developing a self-healing polymer that is useful in coating. Rowan enjoys taking his cues from natural phenomena.
“As a materials person, I can learn a lot from seeing how nature has evolved to tackle the challenges that we see in our world, too,” Rowan says. “Nature makes a wonderful variety of very cool materials. The key is in understanding how nature does that.”

Source: Stuart Rowan
Writer: Karin Connelly

Nanofiber Solutions and Celartia team up on innovative cell culturing system

Personalized stem cell therapy is in the forefront of medical advances. Using cultured clones of a patient’s own cells, medical scientists can develop personalized stem cell treatments, produce antibodies for vaccines and grow skin replacement patches and other types of human tissue for medical implants.
Two leading Central Ohio bioscience companies – Nanofiber Solutions and Celartia – have teamed up to develop a new cell culturing system – PetakaG3 NanoMatrix.  The system accelerates personalized stem cell therapies by enhancing stem cell expansion rates.
A petaka is a cell culture device with all the air space inside the chamber eliminated, which enables cells to grow on all internal surfaces. Nanofiber Solutions and Celartia added nanofibers to this closed, sterile environment to create PetakaG3 NanoMatrix.
“With regenerative medicine, the big issues are cell expansion rates and cell extraction rates – how quickly you can grow them and how many you can harvest,” explains Ross Kayuha, ceo of Nanofiber Solutions. “The PetakaG3 NanoMatrix is a significant first step in making personalized stem cell treatments possible in days versus weeks, as is the case now.”
He notes that there’s a growing trend in medicine and life science research to use three-dimensional cell culturing products to grow and study cells. “The body provides a 3-D environment for cells, but so much basic research in labs is performed on flat 2-D surfaces, which is a very unrealistic environment,” Kayuha says. “The PetakaG3 NanoMatrix is a tool at the intersection of personalized medicine and regenerative medicine that clinicians can use to perform cell-based analyses and develop stem-cell treatments.”
According to Emilio Barbera-Guillem, M.D., Ph.D., ceo of Celartia, “This PetakaG3-plus- nanofibers technology is important for direct applications for regenerative medicine and also new pharmaceutical discoveries and production.” Research centers, regenerative medicine centers and pharmaceutical companies will be primary purchasers of the new product, he notes.
PetakaG3 NanoMatrix was publicly introduced in December 2012 at the American Society for Cell Biology and will soon be available for worldwide distribution.
Sources:  Ross Kayuha, Nanofiber Solutions
               Dr. Emilio Barbera-Guillem, Celartia
Writer:     Lynne Meyer

Great Lakes Neurotechnologies receives $280k to study deep brain stimulation

Great Lakes NeuroTechnologies (GLNT), which creates biomedical technologies for the treatment of movement disorders, announced last week that they will be leading a study to improve algorithms for deep brain stimulation in treating Parkinson’s disease.

The study will use GLNT’s Kinesia technology and is funded by a $283,828 phase I Small Business Innovative Research grant from the National Institutes of Health's National Institute of Neurological Disorders and Stroke. It will take place at the University of Alabama at Birmingham this spring.
Deep brain stimulation involves implanting an electrode in a certain area of the brain to treat the side effects of Parkinson’s disease and other movement disorders. But the technology has varied results. GLNT hopes to improve the outcomes.
“Implanting the electrode is more art than science right now,” says Dustin Heldman, biomedical researcher and principal investigator for GLNT, explaining that outcomes depend on amplitude and frequency -- leaving a lot of variables on the individual programmer.
“With the existing Kinesia system we’re trying to level the playing field for everyone by making an objective standard way of programming,” explains Heldman. “We’re taking the guesswork out of it.”
While phase I will just collect preliminary data, deep brain stimulation could be another application for GLNT’s Kinesia. “It’s great for us,” Heldman says. “We have this sensor technology now, it’s released and it’s FDA cleared. This is just another application. Assuming we get good results, we'll apply for a much larger study.”
GLNT grew from 15 to 23 employees last year, and is hiring three additional people now.

Source: Dustin Heldman
Writer: Karin Connelly

Guided interventions uses revolutionary technique to asses coronary blockages

JumpStart recently invested $250,000 in Guided Interventions, a startup company that has developed technology to assess coronary artery blockages. The company was formed two years ago and has been mainly focused on developing its intellectual property and proof of concepts, says Guided Interventions CEO Matthew Pollman.

“The concept is revolutionary,” Pollman says. “It uses a pressurized guideline to measure fractional flow reserve (FFR). It facilitates assessing blockages in the coronary artery and determines whether to perform an intervention.”
Pollman cites a clinical study, published in the New England Journal of Medicine, that showed using technologies like Guided Interventions’ FFR product instead of traditional angiogram indicate that 37 percent of the time the blockage should be left alone. “Sometimes leaving it alone is actually the best thing for patients,” he says.
Pollman plans to use the JumpStart investment to build out operations at GLIDE and the SMART Commercialization Center for Microsystems at Lorain County Community College.
The money will also allow the company to hire as many as six employees in the next two years, in particular engineers, and then triple or even quadruple the number of employees in the next three to five years. Currently, Pollman and his partner, Reinhard Warnking, are the only two employees.
Pollman, who is in the process of moving to Northeast Ohio from California, says he is looking forward to moving to a region that is so supportive of startup biotechnology companies and research.

Source: Matthew Pollman
Writer: Karin Connelly

cleveland's milo biotech reaches milestone with fda drug designation

Milo Biotechnology, a BioEnterprise startup created to find therapies for neuromuscular diseases, received FDA orphan drug designation for its AAV1-FS344, a drug that increases muscle strength.
The drug is a myostatin inhibitor that produces the protein follistatin, which increases muscle strength. Milo is focused on using the drug for treatment of Becker and Duchenne muscular dystrophy. In both types of the disease, patients have progressive muscle weakness and cardiac and respiratory degeneration. The drug also has potential uses in muscle degeneration in AIDS and cancer patients, but Milo's initial focus is on muscular dystrophy.
Orphan drug classification is given to therapies that treat diseases that affect less than 200,000 people nationwide. “Orphan says two things: One, it says this compound looks like it’s effective in some model of whatever disease it’s treating,” explains Al Hawkins, Milo CEO. “Second,  it means that the  target population is under 200,000 patients." The designation gives expedited regulatory review, seven years of post-market exclusivity and it qualifies for an FDA grant program in clinical trials.
Milo was founded about a year ago, after receiving a $250,000 investment  from JumpStart. The company also received funding from the North Coast Opportunities Technology fund.
Milo's drug is being used in clinical trials at Nationwide Children’s Hospital in Columbus with patients who have Becker muscular dystrophy and inclusion body myositis. Hawkins says the designation will expedite development of the therapy.
“There are no approved  drugs for muscular dystrophy, but there are a lot of promising therapies in development,” says Hawkins. “The community has banded together in supporting this, but we are still years away from getting to market.”

Source: Al Hawkins
Writer: Karin Connelly

biomedical job fair helps start-ups fill spots, keep pace with growth

This week BioEnterprise and Global Cleveland are hosting their fourth online biomedical job fair, hoping to attract top talent to the industry. “This is really driven by the growth in the biomedical sector in Northeast Ohio,” explains Aram Nerpouni, BioEnterprise interim CEO. “We’ve gone from 300 to 700 biomedical companies in the area. Cleveland is becoming a national hotbed for biomedical.”

The job fairs are an effective resource for employers. It is free for employers to post their listings and reach a wide population of qualified candidates. Arteriocyte, which does stem cell research for regenerating bones, has participated in three of the four job fairs this year. In each job fair the company has hired an employee.
“For us it’s appealing because it’s pretty easy as an employer,” explains Kolby Day, Arteriocyte‘s vice president and general manager of research and development. “We’ve seen really high caliber talent applying to the postings." Day says they’ve seen applicants from local schools as well as residents who left Cleveland and wish to return.
“We’ve interviewed a lot of people and, interestingly enough, they all want to be in Cleveland,” says Day. “A big part of that is how quickly the biotech industry is growing in Cleveland.”
Nerpouni points out that the online job fairs especially help the smaller employers. “For smaller companies that are growing rapidly and don’t have an HR staff, it helps them keep up with the pace of growth,” he says. “It’s much easier to hunt as a pack, so potential candidates aren’t looking at just one position.”
Close to 50 employers are participating in the job fair this week, posting 200 open positions. BioEnterprise plans to continue the biomedical jobs fairs on a quarterly basis.

Sources: Aram Nerpouni and Kolby Day
Writer: Karin Connelly

case western reserve university receives $4.8 million for regenerative medicine project

Case Western Reserve University is expanding their regenerative medicine research thanks to $2.4 million in funding awarded from the Ohio Third Frontier Commission. Case Western’s National Center for Regenerative Medicine (NCRM) will match funds along with a variety of collaborators, including Ohio State, Nanofiber Solutions and BioOhio to provide $4.8 million for the university’s “OH-Alive Innovator Platform: A Process and Manufacturing Platform for Cell Therapy” project.
The goals, says NCRM Marketing and Operations Manager Michael Gilkey, are twofold: first, to transform medical therapy through the use of cells rather than drugs to heal tissues and organs; second, to create the commercial and academic infrastructure in Ohio to establish a self-sufficient industry of biotechnology and support services that prove attractive to cell-therapy institutions across the U.S.
If successful, taxpayers and private companies in the industry stand to benefit. “[This project] plays a significant role in building the biotechnology infrastructure in Ohio,” explains Gilkey, reiterating that lives will be directly impacted by this research. “New cell therapies will be accelerated into clinical trials and market approval, so patients will get access to effective, cutting-edge therapies sooner.”
This project will save in public health costs. “Many diseases and injuries have no regenerative or curative therapy, so costs to U.S. tax payers is often high,” says Gilkey. “For example, the Centers for Disease Control and Prevention estimated the cost of diabetes to be $174 billion in 2007.” Functional cell therapy could cure the disease early on and eliminate the possibility of developing complications associated with diabetes, saving billions of dollars every year.
The project’s finish date is slated three years from the start of the grant in late October or early November 2012. Gilkey says the platform will result in a new startup company that will commercialize the platform’s base technology. “We hope to have a long legacy of successful spinout companies from OH-Alive whose manufacturing technology is based from work by this innovative platform.”

Source: Michael Gilkey
Writer: Joe Baur

cincinnati pharmaceutical company developing new drug to treat ADHD

A small pharmaceutical development company is in the process of developing a new ADHD drug, which could net over $1 billion per year, if it makes it to market.
P2D Bioscience was started in 2005 by a former University of Cincinnati psychiatry professor, Dr. Frank Zemlan.

P2D partnered with Advinus, a drug discovery company based in Bangalore, India. The two companies are working on developing a drug, which was once used for cocaine addiction, to treat ADHD, but with fewer side affects and no addiction liability. 
ADHD is the most commonly diagnosed psychiatric disorder in children, with symptoms continuing into adulthood in up to 50 percent of cases. Recent estimates show that approximately 4.7 percent of American adults live with ADHD.

In the U.S. alone, the rate has grown from 12 per 1,000 children in the 1970s to 34 per 1,000 in the 1990s.
"This drug has a big advantage over similar drugs," says Zemlan, CEO of P2D. "Without the risk of addiction liability, there is potential for a huge market."
The drug was designed not to be addictive because it had been used for cocaine addicts. The drug has passed the first round of pre-clinical testing, and Zemlan says it will be able to begin testing on humans in eight to 12 months, if all goes as planned. Currently, the drug is undergoing safety tests.
"It's a big boom for Cincinnati to have drug development company based here," Zemlan says. "It gives a lot of opportunity for hiring high-tech and highly skilled employees." 
In its short existence, P2D has had great success and already has patents around the globe. Much of the work is through a partnership with the National Institute of Health, which is where P2D obtains many of its grants for research. 
"This year alone we have received $4.5 million in grants from the NIH," Zemlan says. "We hope to keep growing."
By Evan Wallis

life core receives $250k jumpstart investment for its cerebral cooling system

Life Core Technologies received a $250,000 investment from JumpStart for its Excel disposable cerebral cooling system, a device that reduces chances of death in a medical emergency.

“Excel has a cooling element that cools the brain 1.5 to 2 degrees Celsius very quickly after cardiac arrest, stroke, or traumatic brain injury,” explains Life Core CEO Mike Burke. “The cooling allows the brain to use less oxygen and prevent oxygen depletion and swelling.”
The technology was developed by cardiothoracic surgeon Aqeel Sandhu in the late 1990s. “He discovered though his work with animals that cooling the brain can reduce the metabolic rate and several hours later they came back,” explains Burke. “In 2010, the American Heart Association came up with guidelines stating the cooling as soon as possible after cardiac arrest increases the chances of survivability and retained mental capacity."
The JumpStart investment will allow Life Core to conduct additional scientific studies. “We are working with a number of organizations to do additional studies,” says Burke. “We are proving the effectiveness.”
Burke is proud that the product is manufactured by a local company and assembled by Patriot Packaging, which employs veterans.
Life Core currently has five employees. “We will be expecting to grow as we attain commercialization,” says Burke. “We expect to grow internally with two people and also grow externally through distributors in Northeast Ohio.”

Source: Mike Burke
Writer: Karin Connelly

cincinnati life sciences corridor spurred by $100K grant from duke energy

The next phase of Covington’s growing life sciences corridor got a boost from Duke Energy, which has awarded the city a $100,000 urban renewal grant for its bioLOGIC accelerator.

The grant will go toward an expansion at bioLOGIC’s 7,000-square-foot second floor at its Russell Street headquarters. The addition will include office and lab space, along with classroom facilities at the life science accelerator. The building’s 5,000-square-foot first floor is at capacity.

bioLOGIC houses seven life sciences companies. Its growth is being fueled in two areas: through expanding existing companies and attracting new companies to locate or relocate to Covington.

The accelerator has a pipeline of nearly a dozen companies looking to locate in its space, either temporarily or permanently, says bioLOGIC Managing Director Keith Schneider. The organization hopes to secure more funding through grants or private investments to complete the build out, which could be finished late this year.

The Duke Energy Foundation’s Urban Revitalization Pilot Program grant is designed to help spur job growth and retention in urban core communities served by Duke Energy. Ohio and Kentucky serves as the young programs pilot area. Duke operates in five states in the southeast and the Midwest.

Duke has been investing in the region’s economic development for years, says Rhonda Whitaker, company director of government and community relations. Traditionally, Duke focused more on large manufacturing and industrial projects, but realized in urban areas such projects are rare.

“We have a Site Readiness program that helps prepare large tracts of land for manufacturing projects, but local leaders said they didn’t meet an urban community’s needs," Whitaker says. "And the urban core is significant and important in our area. Successful regions rely on a strong urban core. And this is really an effort to concentrate on those community’s job growth and sustainability."

The Duke Foundation chose Covington’s bioLOGIC because it was an emerging, successful innovator in the growing life sciences arena. From its inception, it’s been a private, public partnership that relied on private and government investment and support.

“It’s an effort to harness the power of entrepreneurship in the region with space for training and creates a targeted, skilled workforce,” Whitaker says.

By Feoshia Henderson
Follow Feoshia on Twitter

akron bioinvestments fund seeks to attract biomedical companies

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
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