Novian Health

OVERVIEW

Novian Health is a privately held medical device company based in Chicago with a subsidiary in Evry, France.  It has developed the Novilase® Laser System, image-guided treatment that enables physicians to ablate tumors.  Novilase Breast Therapy uses parametrically controlled heating to ablate breast tumors with improved outcomes and lower costs versus surgery.

Novian was founded by Dr. Kambiz Dowlat, a former professor of surgery at Rush University Medical Center in Chicago and a pioneer in breast cancer diagnosis and treatment.  Early on he recognized that imaging would be able to detect earlier stage tumors and that a minimally invasive alternative to surgery would be beneficial for patients.  To his credit, Dr. Dowlat introduced stereotactic core needle biopsy into the U.S. (the most common type of breast biopsy) and developed the initial version of Novilase Breast Therapy.  Sadly, Dr. Dowlat passed away on March 17, 2022.  He is greatly missed and his Vision continues to drive us forward.

Data from a multicenter trial in the UK and U.S. that evaluated Novilase for ablation of small breast cancers was published in Annals of Surgical Oncology (see article here).  A parallel clinical trial is ongoing in France.

In Europe, Novian Health has received a CE Mark for treatment of malignant and benign breast tumors.  Novilase is the first thermal ablation device to be approved for focal destruction of breast cancer.

In the U.S., Novian Health has received FDA 510(k) clearance for the treatment of benign breast tumors (i.e., fibroadenomas) and ablation of soft tissue.  In addition, IDE approval has been received to launch the BR-003 confirmatory study, which the Company anticipates will support marketing clearance for focal destruction of malignant breast tumors.

Other tumor sites and indications are also being explored.

Novilase is a percutaneous, ultrasound-guided laser procedure that can be performed in a breast center with only local anesthesia, offering potentially significant advantages over surgery including minimal scarring, quicker recovery, and less pain or fatigue.  It may be performed by physicians (e.g., surgeons or radiologists) with experience in image-guided breast procedures (e.g., biopsies).

MANAGEMENT

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Henry “Chip” APPELBAUM 

President, Chief Executive Officer & Director

Mr. Appelbaum has more than 25 years of life sciences & biotech experience, including business development, marketing, sales, and management. He was appointed President & CEO of Novian Health in 2005 and has led the development of an image-guided, laser ablation therapy for treating tumors. He has successfully raised over $20 million and led the development of Novian’s manufacturing operations.

Previously, Chip spent five years as Vice President of Corporate Development at Source Precision Medicine, a molecular diagnostics startup he helped found and nine years at Amgen where he managed the business development department and then led the Infergen® launch team. Prior to Amgen, he served in a technology transfer role at Argonne National Laboratory and conducted contract research at Battelle. He holds an MBA from the University of Chicago and an S.M. in Chemical Engineering from MIT.

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Eugene BAJORINAS

Vice President of Operations

Mr. Bajorinas joined Novian Health in 2007 with more than 20 years of health care experience, including multi-site operations, marketing, strategic planning, and international business development. He also serves as managing director of European operations. In addition to assisting the CEO with fund-raising and strategic planning, he leads clinical trial operations.

Prior to joining Novian Health, he was Vice President of Marketing for Norton Healthcare, a $1.1 billion health system in Louisville, where he strengthened the brand and transformed the marketing function into one of the nation’s best. In San Francisco, as Regional Vice President Operations for TLC Laser Centers, he led the post-merger integration of two companies and was responsible for 12 surgery centers. As the Company’s first U.S. employee, Mr. Bajorinas previously helped launch Lasik Vision’s U.S. expansion and in less than a year grew his region to 12 de novo centers generating more than $50 million in revenue. Previously, he was Chief Operating Officer for California Laser Centers. Earlier, he led marketing, planning and international business development for Mercy Health System in Miami. He also has served on private boards. Mr. Bajorinas earned an MBA from the University of Miami and a B.Sc. from the University of Toronto.

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William GRAVEMAN

VP of Engineering & Development

Mr. Graveman is owner and CEO of Biomedical Devices of Kansas (BMDK), a design-build company which specializes in medical devices. Biomedical Devices of Kansas, is the engineering and development arm of Novian Health Inc., and developed and refined the Novilase system's design and technology. BMDK supports Novian Health's ongoing operations as well as the design and development of future products.

In 1987, Mr. Graveman founded Magnatech Engineering, Inc., a multi-disciplinary design and engineering firm specializing in industrial processes and industrial processing equipment. William serves as Magnatech's President and CEO and is active in all phases of engineering, production, design and development. He holds a number of patents and has authored numerous articles for various trade publications. Previously, Mr. Graveman worked under contract for the U.S. Department of Energy in the development and production of nuclear weapons and weapons testing equipment. He graduated from the University of Kansas with a degree in Electrical and Electronics Engineering.

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Julian ITZCOVITZ, Ph.D.

President, Novian Health, SAS

President of Novian Health SAS since 2011, Dr. Itzcovitz is a recognized expert in multi-modality imaging and image-guided, minimally invasive, interventional procedures. With more than 20 years of experience in medical devices and biotech, the last 10 were focused in thermal ablation.

He has been Principal Consultant with Venture Technologies for the past 9 years. He has worked with numerous companies to successfully launch medical devices in Europe and spin-off mature and innovative technologies from leading academic research institutions. Previously he served as GE Healthcare’s clinical research manager for Europe and was director of marketing and member of the board at Elscint. He earned a Ph.D. in nuclear physics at the Universite Louis Pasteur in Strasbourg.

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Stephen RHODES

Regulatory Affairs and Quality Assurance

Mr. Rhodes is a principal at Streamline Regulatory.  He has 29 years of experience in the regulation of medical devices and combination products. Prior to starting Streamline Regulatory in 2018, Mr. Rhodes worked as a Senior Consultant at Biologics Consulting Group.  Previously he had more than 20 years of experience with the Food and Drug Administration, Center for Devices and Radiological Health. Most recently, he was the Director of the Investigational Device Exemptions (IDE) and Humanitarian Device Exemptions (HDE) programs in the Office of Device Evaluation.

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John Lewin, M.D.

Chief Medical Advisor

As a consultant to the company, Dr. Lewin provides oversight to the Company’s clinical activities. He is Division Chief, Breast Imaging at Yale School of Medicine and an Associate Professor of Radiology and Biomedical Imaging. He completed his undergraduate and medical school education at Harvard followed by residency and breast imaging fellowship at the University of Colorado. Dr. Lewin has worked in both academic and private practice settings. His research accomplishments include the first clinical trial of digital mammography for screening and the development and first clinical demonstration of dual-energy contrast-enhanced mammography. He has served on many national radiology bodies including ACR’s ACRIN Working Group on Digital Mammography, its Breast MRI Lexicon Working Group and its Contrast Mammography BI-RADS Group. Dr. Lewin is principal investigator of the Novilase BR-003 clinical trial. He is currently the President for the Society of Breast Imaging (SBI).

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Barbara SCHWARTZBERG, M.D.

Medical Consultant

Dr. Schwartzberg is a consultant to the company. She is President and Co-Founder of Western Surgical Care, PC, a general surgical private practice in Denver, Colorado. Her practice specializes in the detection and treatment of breast cancer, treatment of varicose veins, and surgical management of atypical mycobacterium infections. Dr. Schwartzberg was the principal investigator in the Novilase BR-002 clinical trial.

She received her bachelor’s degree in chemistry from Franklin and Marshall College in Lancaster, Pennsylvania, a master’s degree in pharmaceutical chemistry from Purdue University, and her medical degree from George Washington University.

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Gianfranco BELLEZZA

European Scientific & Marketing Manager

Mr. Bellezza brings a wealth of expertise cultivated over 35 years in the medical device industry. With a proven track record as a serial founder of MedTech companies, he has successfully launched multiple ventures and achieved six exits. He earned an MD from Milan University.

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BOARD OF DIRECTORS

IN MEMORIAM

INVESTORS

iNetworks

Founded in 1999, iNetworks companies and entrepreneurs accelerate their solutions by providing capital and intellectual resources to solve critical problems. iNetworks focuses primarily on healthcare and life sciences businesses that develop breakthrough technologies to improve clinical outcomes for patients and save time, money, and resources for healthcare providers. Learn more at www.inetworkspe.com.

Illinois Investment Venture Fund (IIVF)

The Illinois Investment Venture Fund (IIVF) is a venture capital program seeking to support young, innovative companies, and start-ups that show a high potential for future growth resulting in the creation of high-paying professional Illinois jobs.