Patient being scanned in tunnel

Polarean Imaging Enrolled 1st Patient in Clinical Trials

Polarean Imaging, a medical imaging technology company enrolled their first patient in its Phase III FDA clinical trial.  Polarean designs and manufactures equipment for production of hyperpolarized xenon or helium gas. They have developed a system that can better spot the early signs of chronic obstructive pulmonary disease (COPD).

Polarean logo

The goal of the clinical trial is to perform a non-inferiority study of its drug-device combination using hyperpolarised 129-Xenon (129Xe) gas MRI, against 133-Xenon (133Xe) scintigraphy. The theory is that this method is more accurate and less harmful than current methods. They will be evaluating a total of 80 patients with lung lobe resection and lung transplant procedures. The Phase III trial will be conducted at Duke University and the University of Virginia.

When used in conjunction with MRI, these gases offer a fundamentally new and non-invasive functional imaging platform. Additionally, xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs.

Polarean, spun out of Dr. Bastiann Driehuys and Gary Cofer’s technology from the School of Medicine, launched their start-up in 2014.

John Oxaal

Pratt’s 1st Entrepreneur in Residence

Google ‘Entrepreneur in Residence (EIR)’ and you will get a varied set of skill requirements with phases like venture capital, startups, seed funding, spin-offs, and so on.

As a venture capitalist, the objective is to look at deals that come their way and make a determination as to the strength of the technology and management team.  If they like the idea and managers, it’s a good indicator towards investment.

However, for an EIR this notion is flip-flopped—they already like the tech and the team; it’s more about choosing the right investment vehicle.

For Pratt’s Biomedical Engineering (BME) Chair Ashutosh Chilkoti asking a former BME graduate, John Oxaal, to become Pratt’s first EIR was an easy choice. With an undergraduate degree in BME from Duke, an MBA from the University of Chicago, and experience as both an entrepreneur and a venture capitalist, he had the perfect skillset to help catalyze new startups around BME technologies.

John Oxaal

In the early 90s, Oxaal worked with Professor Olaf von Ram to help form Volumetrics Medical Imaging, which developed the first real-time 3-D ultrasound machine. Oxaal stayed with Volumetrics until ’99 before moving to the west coast to work at Sevin Rosen Funds as a venture capitalist.

“I knew John would be an excellent candidate to help expand BME’s knowledge and technology,” Chilkoti said. “As a Duke BME alum, and with previous Duke start-up experience, I knew he could guide us through the process of transferring BME’s innovative research to the market.”

Soon after taking on his position as an EIR, Oxaal landed on the gene editing research of Professor Charles Gersbach and his colleagues Greg Crawford, Tim Reddy, and Kris Wood.

In 2015, through his role as the Duke BME EIR, Oxaal helped Gersbach, et al. found Element Genomics, a Duke startup developing a suite of technologies for understanding gene regulatory elements, such as CRISPR gene editing technologies, to identify new drug targets for common diseases. Oxaal would later become the CEO of Element.

Charles Gersbach
Professor Charles Gersbach, Pratt BME

“As academics interested in translating our work to the biotech industry, it was critical to have a veteran entrepreneur like John to guide us through the unfamiliar territory of founding a company, licensing technology, and setting up operations outside of a university,” Professor Gersbach said of Pratt’s EIR. “Another critical factor to making this all possible was the incredible responsiveness we received from Duke’s OLV. They were diligent in every step of the process from protecting and managing the IP to participating in final license and contract discussions.”

The Element founders also received funding from the Coulter Foundation Translational Partnership Program at Duke that provides $1 million in early-stage funding and management to faculty health care innovations annually with a goal of licensing and creating new life science start-up companies.

The Coulter Foundation is directed by veteran entrepreneur Professor Barry Myers. Myers saw much potential in the Element team and pushed hard to get them to move forward with their idea.

Now the company has moved on to further success with the acquisition announcement this month by UCB, a global biopharmaceutical company based in Belgium with a clinical development office in Raleigh.

“We at Element are thrilled that UCB shared our vision for treating disease through knowledge gained through functional genomics and the vast and largely unexplored biology of the epigenome.  We believe that together with UCB we can much more quickly harness the power of this approach”, Oxaal said. “Duke’s emphasis on entrepreneurship and engagement with industry has paved the way towards research that can powerfully inform today’s drug development process.”

The Element team will continue to work in Durham closely with UCB’s genomics research arm employing eight Duke graduated students and continuing its collaboration with the Gersbach, Reddy, Crawford, and Wood labs at Duke.

ucb logo
UCB is a global biopharmaceutical company focused on creating value for people living with severe diseases.

“Duke has made a significant commitment to improving its tech transfer function and assistance to our startup companies; therefore, we are especially pleased to see these types of successes,” said Robin Rasor, Executive Director of Duke’s Office of Licensing & Ventures (OLV).

On the back of this success, BME and OLV have combined their efforts to make use of OLV’s Mentor-in-Residence (MIR) program, which work under the recently formed Duke New Ventures.

Duke New Ventures Logo“It is only fitting,” said Rasor, “that OLV and BME have partnered together in the EIR and MIR programs, given that BME is one of the preeminent entrepreneurial department at Duke.”

“With Robin Rasor at the helm,” said Chilkoti, “Duke has new, progressive leadership at OLV, so it was the perfect time for BME to expand our partnership with them. These and other initiatives on campus promise exciting times for faculty entrepreneurs at Duke.”

What’s your next great idea?

Tell OLV or an EIR about it; we can help move it forward.

Couple hikers success concept in mountains

Prepped Health

MANAGEMENT: Jon Nicolla
DUKE INVENTOR: Arif Kamal, Jon Nicolla
preppedhealthllc.com

Prepped Health provides an approach to developing mobile health platforms that help patients prepare for their journey with serious illness, leading to better health outcomes and a high quality of life for the patient and their loved ones.

prepped health logo

Managing serious illness is unique for each patient. Prepped Health offers multiple tools that empower patients to take control of their healthcare journey.

They have created platforms that center around the three pillars of patient engagement:

  • Communication
  • Education
  • Navigation

Prepped Health has established use cases for their system in:

  • Palliative care
  • Hospice care
  • COPD care
  • Cancer Care

Prepped Health ensures that patients will be ready for their journey with serious illness, leading to better health outcomes and a higher quality of life for patients and their loved ones.

Mobile Application

Prepped is a mobile application that generates helpful, timely suggested questions for patients and caregivers to ask their clinical providers. The app uses a strength in numbers in approach – Prepped crowdsources questions submitted by national experts, patients, caregivers and other users to recommend the best questions for the patient based on the patient’s profile and where they are in the disease process. Current versions of Prepped are focused on patients with cancer and/or COPD

Business concepts,Two men are consulting a business with tablet and laptop.

Infinia ML

DUKE INVENTOR: Lawrence Carin
infiniaml.com

Founded by Lawrence Carin, vice provost for research and professor of electrical and computer engineering, Infinia ML, Inc. is an artificial intelligence company that has built machine learning algorithms to help businesses and organizations make sense of big data.

infinia logo

Infinia ML uses advanced machine learning techniques to solve business challenges for Fortune 500 companies. Our algorithms unlock the hidden potential of our clients’ data, helping them automate complex processes, enhance employee efficiency, and pioneer transformational breakthroughs. Led by serial AI entrepreneur Robbie Allen and computer science luminary Lawrence Carin, our team’s combined accomplishments include over 500 published papers, 30 granted patents, 11 authored or co-authored books, and five PhDs.

“The company is, in many ways, the translation of the work we’ve been doing at Duke for many years on machine learning,” Carin said in an interview with the Triangle Business Journal.

The doctor hands with pill in hospital

Custom Clinical Decision Support (CCDS)

MANAGEMENT: Martha Adams, President & CEO
DUKE INVENTOR: Martha Adams
customdecision.com

Custom Clinical Decision Support, Inc. is a group of medical professionals and technology experts delivering information to clinicians where it matters — at the point of care. The company’s first product is “CustomID®”, a cloud and web-based decision support tool for management of infectious diseases.

CustomID logo

The inventors’ story began at the time of the handheld computer and a growing popularity amongst clinicians for pocket-sized calculators and for ready information resources such as drugs and vaccine schedules. They saw a gap in the delivery of timely updates for management of infections in their large academic hospital in North Carolina. The solution was CustomID® which they first launched for PDA and later as a web app for display either via desktop or mobile internet browser. Subsequently, in 2005, the Dutch Working Party on Antibiotic Policy (SWAB) licensed the CustomID® framework and installed their guide in 30 hospitals in the Netherlands. CCDS is now taking CustomID® for offering beyond the Duke enterprise.

CustomID®

CustomID® is different from other antimicrobial guides by providing site-specific content, easily customizable, which is key for timely updates about drug shortages, outbreaks, and site-specific policies and protocols.

The company vision is to forward cutting-edge technology and knowledge transfer that is suitable for all medical disciplines, a vision to keep at the forefront, the goal of saving lives.

Isolere Bio

MANAGEMENT: Joseph McMahon
DUKE INVENTOR: Ashutosh Chilkoti
isolerebio.com

Chromatography-free solutions for the purification of biological therapeutics.  Isolere Bio was co-founded with the vision of simplifying and streamlining the purification of biotherapeutics to improve global access to these important drugs.

isolerebio logo

Monoclonal antibodies make up an effective and rapidly growing class of drugs. They are also critical research tools and essential for the development of many new diagnostics.

IsoTag Technology

The IsoTag technology works on the basis of affinity and phase separation. An engineered domain from Protein A captures the Fc portion of a monoclonal antibody (mAb). This affinity domain is fused to a stimulus responsive biopolymer. When in complex, the stimulus responsiveness is conferred to the mAb. This allows it to undergo phase separation from all other cellular contaminants. This process is fast, simple, and highly concentrating.