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BioEnterprise

We help bioscience innovators grow companies

These are their stories

Ping Jia and Charu Ramanathan

CardioInsight

Ping and Charu map their way to the heart

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CardioInsight

Charu Ramanathan, Ph.D., and Ping Jia, Ph.D., commercialized a unique, non-invasive advanced cardiac mapping technology to map electrical disorders of the heart. Their product received FDA approval in 2014 and their company, CardioInsight, was acquired by Medtronic for $93 million in 2015.

BioEnterprise: How and when did you launch CardioInsight?

Charu: We founded the company in 2006. Ping and I were graduate researchers in biomedical engineering at Dr. Yoram Rudy’s lab at Case Western Reserve University. The technology we were researching could be applied to patients, and the excitement and promise it held for physicians was pretty stimulating. This encouraged us to start CardioInsight to develop this promising technology into a clinical product.

Ping: From our computer simulations, animal study validation, and human clinical cases, we saw that the technology had numerous potential applications.

Charu: Essentially, it started as a technology that was a bunch of lines of code, a mathematical algorithm that we had to take from that state, make more suitable for hospital workflow and then produce output and imagery that would be suitable for interpretation by a physician.

BioEnterprise: What was your first key milestone?

Charu: When our start-up plans were endorsed and validated by Gil Van Bokkelen, CEO and Founder of Athersys, who was a really good friend and influencer.

Ping: Gil was really encouraging. In order to have our technology go over the globe, we realized that the only avenue was commercialization, although at the time we were not aware of the power and breadth of commercialization.

BioEnterprise: What is unique about the technology?

Charu: CardioInsight’s ECVUE™ system is the first of its kind — a non-invasive way to see how the heart is doing electrically. Our system can pinpoint the source of rhythm issues with the heart, so the physician can analyze the information to plan a treatment strategy. As a noninvasive technology it certainly has the potential to provide mapping information earlier in the care continuum.

Ping: Although its original application was in Atrial Fibrillation, our technology may be of value any time electrical wiring of the heart is affected.

Charu: With the help of Medtronic, we want to take the non-invasive feature of it and really broaden it and address problems with value-based solutions across the patient-care continuum. We don’t need to be in a costly sterile lab; we can provide this information anywhere you want. Ultimately that is our vision.

BioEnterprise: You initially licensed the technology from academia. What have you learned about this kind of tech transfer?

Charu: You see a lot of presentations from top-notch academic researchers that talk about a wonderful technology that can really do great things, but implicitly it’s not clear to a clinician ‘how I can get my hands on that technology and actually deliver it to my patients,’ and we do think that’s a huge gap.

Ping: And for entrepreneurs like us that’s exactly the gap we fill – we really took a technology that had a lot of clinical potential and built it in such a way that we could hand it to a clinician.

Charu: Early on we attracted a partnership with one of the world’s top physicians and thought leaders in our field, Dr. Michel Haissaguerre, at Hôpital Cardiologique du Haut–Lévèque in Bordeaux, France. He was able to clinically validate the product and also play a pivotal role in its scientific and clinical development.

Ping: He was able to persuade his colleagues throughout the world that this type of non-invasive diagnostic technology is really the future of the field.

Charu: It was the most organic ‘marketing’ from someone who was actually using the technology. And that collaboration led to other collaborations and validation to attract other investment dollars and top team talent – and get us to where we are today.

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Tim Miller

Abeona Therapeutics

Tim Miller gives families hope through gene therapy

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Abeona Therapeutics

Tim Miller, Ph.D. is co-Founder, President and CEO of Abeona Therapeutics LLC, a gene therapy company developing and delivering products for severe life-threatening rare diseases.

PlasmaTech Biopharmaceuticals of Dallas acquired Abeona in 2015 and recruited Tim Miller as President & CEO of the publically traded company, now known as Abeona Therapeutics, Inc.

BioEnterprise: What does Abeona Therapeutics do?

Tim: Our lead programs are for Sanfilippo Syndromes type A and B, deadly genetic diseases that attack children between the ages of 3 and 6 years of age. We develop genetically-modified viruses to deliver the functioning version of the defective gene that caused the child’s metabolism to go awry.

Sanfilippo kids can’t break down certain kinds of sugar. Over time, these sugars build up in their cells resulting in a cruel neurological and cognitive decline, where 70% don’t reach age 18 – and there’s currently no approved therapy.

BioEnterprise: What is unique about Abeona?

Tim: Abeona is a rare disease company developing gene therapies that are delivered as a one-time injection rather than surgical interventions.

Abeona was formed in 2013 through a venture philanthropy model: the company was founded and funded by a dozen international foundations that, collectively, represent the global Sanfilippo community. Their support came with a directive to find and accelerate the development and global access of the most promising therapies for Sanfilippo Syndrome (Types A and B).

If we are able to demonstrate that our therapies are safe and efficacious, we expect to go commercial earlier than usual so that children around the world may have rapid access to our therapies. This would achieve the overarching mandate and goal held by our team and the foundations that helped us launch.

BioEnterprise: What is your timeline for commercialization?

Tim: By end of 2016 we anticipate having three gene therapies in clinical trials in multiple countries: in the U.S., Western Europe and Australia. If clinical results are positive, our products could be available over the next two to three years.

Essentially, we are explorers developing something no one else has tried to do, and our role is to help bridge the gap between the scientific and the clinical to develop products that can be manufactured large-scale and quickly.

BioEnterprise: What does “Abeona” mean?

Tim: Abeona is named after the Roman goddess who protected children as they took their first steps away from home.

BioEnterprise: Why are you doing this work?

Tim: Time is the enemy for kids with Sanfilippo Syndrome. The disease usually presents between ages three and six, and the children spend the rest of their lives regressing. Even something as small as a fever can cause the loss of the power of speech – forever.

We believe in hope. When we meet the families and see how desperate they are, and what they are willing to do for their children, we gain an understanding of real courage. It is the reason for us to get up in the morning – to help accelerate development of these promising treatments.

We may be working on the only therapy they will ever get.

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Geoff Thrope

NDI

Taking the lead in neurodevice innovation

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NDI

Geoffrey B. Thrope is Founder, Managing Director and Chairman of NDI. The enterprise pursues, funds and develops neurodevice opportunities addressing unmet clinical needs, with the potential to provide significant returns to its investors.

In 2008, NDI sold its first portfolio company to Medtronic Inc. for $42 million. Its current portfolio companies include Checkpoint Surgical, Deep Brain Innovations, and SPR Therapeutics.

NDI was initially founded in 2002 by Geoff Thrope and Dr. Warren Grill to commercialize Grill’s research on treating urinary incontinence using electrical stimulation. Six years later, the $42 million sale of their first portfolio company to Medtronic motivated the founders and their team to replicate that success.

“The sale was unusually transformative to our group of individuals who had come together courageously and naively and created a great product and also generated success,” said Thrope. “And we were not done, so we said let’s do this again!”

Due to the financial crisis and recession of 2008-2009, traditional financing sources such as venture capital had dried up, so Thrope and his partners decided to form the NDI Healthcare Venture Fund.

“We had a great team, core intellectual property, and seed financing from a group of us,” said Thrope, “so we morphed NDI into an enterprise concept, fully invested our fund into core technologies, and then these translated themselves into portfolio companies.” Thrope also successfully secured non-dilutive funding from federal and state grants to support the company.

By 2010 they spun out two companies: Checkpoint Surgical, to market the CHECKPOINT® Nerve Stimulator/Locator, its first FDA-cleared product in a line of unique surgical devices to locate, identify, and test excitability of nerves and muscles in surgical procedures; and SPR Therapeutics to develop a novel peripheral nerve stimulation (PNS) therapy platform for minimally invasive, long lasting, and cost effective pain treatments across an array of painful neuropathic and orthopedic conditions.

In 2012, NDI launched Deep Brain Innovations to commercialize a proprietary method for optimizing deep brain stimulation (DBS) therapy through novel patterns of stimulation.

All three ventures are quite diversified, with cultures, missions and exit opportunities that are entirely independent from each other. Yet, according to Thrope each portfolio company has been built to satisfy unmet clinical needs with unique disruptive technology that could potentially change the manner in which medicine is practiced. The ultimate goal is to have these companies acquired by corporate strategics and bring a high return on investment to its shareholders.

Prior to forming NDI, Thrope conducted research at Case Western Reserve University and led commercial product development, sales and marketing in the neurodevice industry.

Eventually Thrope became dissatisfied with his role of just positioning companies and products like “a tugboat helping a ship get out to sea,” so he jumped off and became the captain of his own ship by starting NDI. “I put my life savings into this, putting my family potentially at risk,” said Thrope. “But with much hard work, great talent, and luck, it fortunately worked out for the benefit of all.”

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Arthur" Buzz" Brown

ChanTest

Putting drug development to the test

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ChanTest

Arthur M. “Buzz” Brown, M.D., Ph.D. established ChanTest Corp. in Ohio in 1998. The company was a contract research organization that tested compounds for more than 500 global pharmaceutical and biotechnology companies and partnered with them to speed the drug development process for the release of better and safer drugs.

In 2014, ChanTest was acquired by Charles River Laboratories International for $59 million. Dr. Brown continues to serve as Scientific Advisor to ChanTest and recently founded a new drug discovery company, MemChan Pharma.

The company first started in 1989 as ChanGene, when Dr. Brown was Chairman of Physiology and Biophysics at Baylor College of Medicine in Texas. A trained cardiologist and well-published researcher, Brown had developed a method for assessing cardiac risk in drugs with in-vitro assays.

He moved to Cleveland in 1994 to become Vice President of Research at MetroHealth System and a faculty member at Case Western Reserve University. In 1998, after consulting on cardiac risk for major drug companies, Brown incorporated ChanGene as ChanTest in Ohio. Brown and his wife, neuroscientist Diana Kunze Ph.D., started the company in a small room with one other employee who still works with them.

“At that time we had the great good luck of leveraging research funds from the State of Ohio, which had turned a substantial amount of its tobacco awards to funding research, and we were expert enough and lucky enough to get a couple of those grants,” said Dr. Brown.

They also greatly benefited from the unique ability of their preclinical assay to assess clinical cardiac risk in drugs which enabled pharmaceutical companies to fail candidates much earlier in the drug discovery process, potentially saving millions of dollars.

“So if you look at the preclinical process, from identifying your target, getting your lead compounds and carrying them through the absorption, distribution, metabolism, and toxicity tests – carrying them through animal studies and putting the drug into people – that actually can run between $100 and $500 million over a 5-8 year span,” said Brown. “If you can fail early and fail for the right reasons, it maybe costs you between $20,000 and $100,000. So you can do the arithmetic and it’s pretty clear what the cost benefits are.”

At the time, cardiac risk – especially for non-cardiac drugs – became an alarming issue at the FDA. The agency was frightened that there was an epidemic of antihistamines, antibiotics and antipsychotic medications posing grave risk to patients. Reported cases of sudden cardiac death from billion dollar drugs like Seldane, the first non-sedating antihistamine, were associated with arrhythmias, and ChanTest’s assays could be used to detect the molecular target of these changes.

Marion Merrell Dow, the pharmaceutical company developing Seldane, employed a post-doctoral researcher who had worked with Brown at Baylor who knew there was a problem with one of the molecules in the heart causing the issue. ChanTest was able to identify the molecule and target the specific genes responsible.

“We had this happy coincidence of powerful biophysical techniques that enabled us to look at the function of the target molecule, we had genomics that let us identify the target molecule and we had stem cells that let us make human cells so you can pry the different components apart,” said Brown.

“So there were many things coming together that allowed us to make the tests more and more precise, specific, and sensitive.”

In 2002, Brown left his position at MetroHealth to work full-time on the company. At the time and to the present, ChanTest’s cardiac risk assays comprised 95% of the assays used by pharmaceutical companies in FDA submissions. “I didn’t have much of a clue about business, but people were paying good money for the assays, we did them well, and were profitable from the beginning” said Brown.

In 2007, private equity firm Ampersand Capital Partners bought a minority stake in ChanTest, and seven years later, Charles River Laboratories International acquired the company for $52 million.

ChanTest and its 60+ employees remain in Cleveland as Charles River Labs– as does Brown, who still consults for the company and has founded a new venture, MemChan Pharma, developing novel drugs and treatments for conditions such as contact dermatitis.

And he remains fascinated with the promise of integrating functional, genetic and stem cell technologies to generate huge amounts of data from which drugs can be culled. “Putting it all together and picking a winner in a therapeutic area is pretty damn interesting – like betting on a horse at the races!”

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David Kay

Orthohelix

Tooling a cutting-edge company for success

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Orthohelix

David Kay, M.D. founded Orthohelix in 1995 to develop innovative implants and instruments for use in small bone reconstructive foot and ankle surgery.

Orthohelix was acquired by Tornier N.V. in 2012 for $140 million.

In 1995, David Kay was an orthopedic surgeon working at Akron General Hospital frustrated with the instruments and implants then currently available for use in operating rooms. “The tools were from the 1950s, and looked like they came straight from a hardware store,” said Kay. “I was seeking solutions that would lead to better results.”

A self-described “intuitive as opposed to trained engineer,” Kay literally took matters into his own hands by designing his first surgical device – a corkscrew open-wire helix for orthopedic surgery – and bootstrapping his company, Orthohelix, out of the basement of his house.

In 2004, the company received a major investment from Synogen, a Florida-based firm, and Mutual Capital Partners of Cleveland led a multi-million Series A round in 2006. Professional management was then brought in to grow the business, with Kay serving as chief medical officer and board member.

Kay translated surgical needs and biomechanical concepts into commercializable proprietary products, acting as go-between to the designers, management team, sales force and surgeons. “This definitely isn’t an easy process,” said Kay. “I ruminated about serious surgical needs and solutions surrounded by crumpled paper with smoke coming out of my ears.”

Kay and his Orthohelix team soon developed a comprehensive line of innovative implants and tools for foot and ankle surgery helping the orthopedics industry focus for the first time on extremities, now the industry’s only growing market segment.

Orthohelix soon became one of the fastest growing companies in the region and, after several successful financing rounds, was acquired by Tornier N.V. for more than $140 million in 2012. Kay credits his entire team for the company’s successful development and exit.

Kay recently founded and serves as Managing Partner of EDC (Extremity Development Company), an incubator led by an investment group of internationally renowned orthopedic surgeons to spinout individual standalone companies in a range of orthopedic specialties.

The firm has already filed six patents for ankle braces (a $2 billion market) and has spun out a new company, Rubber City Bracing, LLC.

In addition to his role at EDC, Kay is Clinical Professor of Orthopedic Surgery at Northeast Ohio Medical University and maintains a private surgical practice at the Crystal Clinic. But he is not considering retirement anytime soon.

“If I’m not seeing problems every day, I’m not sure what problems need to be solved,” said Kay. “My motivation, my passion is to get better surgical results consistently – how can you make even very good surgeries better and elevate ability? So many things need to be addressed.”

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Mark Woodka

OnShift

Answering industry’s call for staffing solutions

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OnShift

Mark Woodka is CEO of OnShift, delivering cloud-based human capital management software with a suite of products for hiring, scheduling and workforce analysis in the post-acute care and senior living markets.

OnShift recently reached a major milestone – hiring its 100th employee.

In 2015, OnShift was ranked No. 240 on Deloitte’s Technology Fast 500™, a list of the 500 fastest growing technology, media, telecommunications, life sciences and energy tech companies in North America, growing 312 % during that period.

The company was founded in 2007 by two gentlemen from American Greetings who built a mobile communications platform. One of the founders had a friend who ran nursing homes and thought “Wow, if I could use the application to fill shifts that would be fantastic.”

Mark Woodka initially joined OnShift as an angel investor and then helped launch the company as CEO in 2008, bringing with him over twenty-five years of experience in sales and marketing for technology start-ups. Woodka introduced OnShift to the long-term care market, initially to help nursing homes more efficiently fill shifts.

“If a caregiver at a facility calls off at 1 o’clock for a 3 o’clock shift they generally have to replace that person. Without our software, it’s a very laborious process – they’d pick up the phone and spend two or three hours calling people to come to work or asking people to work a double shift,” said Woodka.

OnShift’s software helps solve this problem, enabling nursing homes and assisted living communities to fill shifts by alerting their staff through text messaging, email, automated phone call, or mobile push notification.

In 2009, OnShift added full staff scheduling capabilities to its solution, as many communities were relying on pen and paper to manage employee schedules. “We combined communications and scheduling and built an automated solution that is very easy to use,” said Woodka. “We try to do a lot for our customers and have them do less. We pride ourselves on how little time our customers spend in our software. That means we’re being efficient, and they can spend more time taking care of their residents.”

Last year OnShift introduced two new products: OnShift Insight, a labor-analytics platform that helps identify staff capacity utilization and recommends positions to hire; and OnShift Hire, an applicant tracking and sourcing solution.

Additional products will be introduced later this year and beyond as the company continues building a robust and innovative human capital management platform for long-term post-acute care and senior living.

Helming such a fast-growing company doesn’t leave Mark Woodka time for his favorite hobbies of golf and photography. When asked to name his main activity outside of work, he quickly replied: “Sleeping!”

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Al Hawkins

Milo Biotechnology

From bootstrapping a company to muscular growth

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Milo Biotechnology

Al Hawkins is Founder and CEO of Milo Biotechnology, a clinical-stage start-up developing therapies to strengthen muscle and improve the lives of patients with neuromuscular diseases.

Milo has successfully treated nearly twenty patients, one of the largest totals for any gene therapy, anywhere – by leveraging resources from Cleveland and Columbus seed funds, economic development organizations, disease foundations and Nationwide Children’s Hospital

Al Hawkins founded Milo Biotechnology in 2011 when he served as a CEO-In-Residence at BioEnterprise. Given the lack of venture capital funding in recessionary times, he was interested in exploring a rare disease space where there were no viable therapies and developing a company that would be primarily foundation-funded and bootstrapped.

“The idea was to take a muscular dystrophy therapy and bring it from animal proof of concept to human proof of concept in a few years with not a lot of funding, without having to bring in institutional money,” said Hawkins.

He attended muscular dystrophy conferences all over the globe in order to learn about the sector and eventually found promising research nearly in his own backyard – at Nationwide Children’s Hospital in Columbus.

Hawkins was impressed with the follistatin program at Nationwide’s Center for Gene Therapy, conducted by Brian Kaspar, Ph.D. and the Center Director Jerry Mendell, M.D. “They had studied muscular dystrophy therapy in mice, had amazing results in non-human primates, and they were ready to start clinical studies,” said Hawkins.

Follistatin is a naturally expressed protein that increases muscle function and prevents fibrosis primarily by blocking other proteins that activate signaling pathways leading to reduced muscle mass and strength. Researchers discovered if you give follistatin to mice you get a stronger mouse, literally “a mighty mouse.”

Al Hawkins and Brian Kaspar founded Milo Biotechnology in late 2011, naming the company after Milo of Croton, a 6th Century BC Greek wrestler famed for his strength and athletic prowess. In January 2012, they signed an exclusive license for the technology and clinical trials began at this same time.

Milo Biotechnology’s therapy for multiple muscular dystrophies is based on adeno-associated virus (AAV) delivery of follistatin. AAVs are small, non-pathogenic carriers that can be tailored to deliver long-lasting administration of follistatin via a single dose.

Initial clinical results of the therapy in Becker muscular dystrophy were reported in January 2015 and indicate that the therapy is safe and effective. Results were presented in May 2016 demonstrating initial proof of concept in sporadic inclusion body myositis patients, and a third Phase I/II clinical study in Duchenne muscular dystrophy is underway.

Milo received funding from Cuyahoga County’s North Coast Opportunity Fund, JumpStart, Rev1 Ventures, SBIR and multiple disease foundations. The company was also supported by BioEnterprise and leverages critical clinical, drug manufacturing and regulatory resources from Nationwide Children’s Hospital.

Hawkins is now looking to raise additional funds for two-year pivotal studies in Becker muscular dystrophy involving 30+ patients in multiple centers – which may take the form of partnerships with strategics or other financing options.

Hawkins was formerly VP of Business Development of BioMotiv, a therapeutics accelerator, and a Founder and Chairman of Abeona Therapeutics (NASDAQ:ABEO), developing AAV-based therapies for rare neurodegenerative diseases.

Prior to these positions, he was CEO-in-Residence at BioEnterprise and Director of New Ventures at Boston University. In Madison, WI, Hawkins was Founder and Partner of Agave Group. He received an SM in Biomedical Enterprise from MIT and a Master’s in Business from UW-Madison.

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