Biomedicine

Development of Emerging Interventional Therapeutics: Combinational Device and Implementation of Medical Technology

Principal Investigator: Xi-Zhang Lin, M.D. 
Abstract

Using combinational medical device to implement interventional medicine is the core idea for our team. Drug delivery technology can improve the pharmacokinetics making the drugs safer and more effective. Interventional technology can bring the drugs to the diseased sites to achieve a better pharmacodynamics. Interventional therapeutics is emerging now and the trend of medical practice in the future society. Our goal is to establish a start-up to provide the combinational medical device for interventional therapeutics.

We will provide these three products and associated service. The first is microsphere for embolization therapy—T-ACE Beads; i.e. Taiwan ACE Beads. First-in-Human trial has been conducted under the monitoring of Taiwan FDA. Further pivotal trial is under planning. The microspheres can also treat benign prostate hyperplasia by prostatic artery embolization. Furthermore, it can be loaded with Rhenium 188 for internal radiation therapy. The second is a hydrogel for therapeutic endoscopy—EndoGel. Its application will be submucosal dissection and polypectomies. It can improve the safety of therapeutic endoscopy by providing a submucosal cushion for the gastrointestinal tract. The third is an iodized oil—T-ACE Oil. It can act as an injectable oil and radiological contrast. All the three products can provide interventional radiologists and therapeutic endoscopists for more effective interventional procedure. The market size is about trillion in the world.

Our home base is in Taiwan, including R&D and manufacturer; and by selling products, we can generate our cash flow in a B2B model. We will team up with the opinion leaders in the field by forming an open-innovation consortium for our potential customers and taking their feedbacks. With such partnership, we will go to the relating medical conferences of our customers’ professionals to promote our products in the global markets.

Our team members determine to create a start-up under the sponsorship from this Value Creation Project. The financial resource will come from funding organizations and our team members. We will establish the global market starting from Taiwan and will go for public fund-raising gradually to expand our business. Our vision is to become an international anchor company in the domain of interventional medicine. 

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Team Introduction

Our team leader is Professor Xi-Zhang Lin.  He is a gastroenterologist and a professor in National Cheng Kung University; in addition, he has spent 17 years as a medical consultant in Institute of Biomedical Research and Medical Device of Industrial Technology Research Institute (ITRI) at Hsin-Chu Taiwan. He is active in academic associations also. He served as member of executive boards in Gastroenterology and Gastrointestinal Endoscopy Society of Taiwan for years. He is also one of founder members of Taiwan Society of Hepatocellular Carcinoma.  He has been a prominent member of Taiwan in therapeutic endoscopy, hepatoma treatment and medical device.

We have two acting leaders (Co-PI) in our team. The one is Doctor and Professor Chih-Hsien Chi of Department of Emergency Medicine. He is among pioneers of emergency medicine in Taiwan besides a specialist in Gastroenterology. He has also extensive connections in academic societies of Taiwan and the related foreign countries. He advises our team about the connections and promotion activities of our products.

The other co-PI is Doctor and vice-Professor Chen-Hsi Chou. Dr. Chou is a Pharmacist in Department of Pharmacy in National Cheng Kung University and Hospital. He is a renowned specialist in pharmacokinetics. He advices our team about the pharmaceutical excipients, pharmaceutical system, risk controls and related regulatory process.

Our administrative manager is Miss Hsiu-Hui Wu. She is from National Applied Research Laboratoryies Instrument Technology Research Center. She is familiar the processing of governmental fiscal system and working on the job for years. She is also our connective window with the other independent Research or Governmental Bodies. She works with several colleagues including some part-time students.

Our clinical research nurses are lead by RN. Hui-Yu Hung. They are capable in the preparation of clinical trial processing, including patient recruiting and data collections. They are our internal CRO, although we also consult and contract out with the relating companies.

Our Interventional Radiology partners lead by Dr. Yi-Sheng Liu and his colleagues. We have done first-in-human trial of microspheres for hepatoma. In addition, the clinical trial of microspheres for benign prostatic hyperplasia is also undergoing. Partners are from Urology department, lead by Dr. Yu-Hsian Tsai.

Our clinical trial of EndoGel has been registered on Clinicaltrials.gov. The trial will start in the coming days. The trial is lead by Dr. Jui-Wen Kang and Director of Chiung-Yu Chen from Division of Gastroenterology.

Our System Engineer are Mr. Chih-Hong Chen and his partners. They are very skillful about the machine mechanics. They work together with colleagues from the Industrial Technology Research Institute Drug Substance GMP Pilot Plant. We also have a representative in the plant, Dr. Nai-Jen Wong, working under Dr. James Sheu. Part of our technology to produce medical devices are from Professor Muh-Rong Wang (Distinguished retired professor, Department of Aeronautics and Astronautics, NCKU) and from Professor Chau-Nan Hong (Department of Chemical Engineer Science). They are our partners also.

Our Preclinical Animal Study Team leads by Miss Wen-Hsuan Kang. She works under the helps from Surgeon and Veterinarian in our Animal Center.  Recently, we work with our National Animal Center for porcine studies, where we have several formal colleagues working there. Miss Kang also participates the research and develop works for pre-clinical bench studies.

Our Research and Development lead by M.S. Chih-Chiang Lin. M.S. Lin is a specialist in oil chemistry, who learned the technology from Food Industry Research and Development Institute. He develops our T-ACE Oil. He commits to pushing the product to the market for clinical purpose—radiopaque contrast. We gain the support and instruction from CDE. T-ACE Oil is an index case of our collaboration.  M.S. Lin is also responsible for our future development of our new devices.

Our team has consultants from collaborative institutes, such as Dr. Shiaw-min Hwang, Dr. Fong-Jen Chien, CEO Chi-Tzong Huang, CEO Chung-Ho Wu, and Dr. Po-Li Wu and Dr. Chia-Wen Lin. They provide information and suggest the strategy about the regulatory process and the possible financial planning.

Our team keeps growing and we will establish a start-up company under the instruction of specialists from NCKU and the team of Taiwan Startup Institute.

Goals and Plan

Business model:

    The business model will be B2B. The products will be sold to the doctors doing interventional therapeutics, who are usually in medical centers.  Our team will establish Start-up Company that is user enterprise and will evolve into an anchor company of medical device.

Products:

    We will start from three major products, microspheres (T-ACE Beads), hydrogel (EndoGel) and radiopaque contrast (T-ACE oil).

  • T-ACE Beads
  • T-ACE Beads provide vascular embolotherapy. It is a medical device made of injectable pharmaceutical excipients. We used the ingredients to form an emulsion. Then, through spray-and-dry technology, we can make radiopaque, degradable, and drug-eluting microspheres for tumor embolization.  The size ranges from 70 mm to 1000 mm, but we can select the appropriate size for specific clinical purposes, such as 100 to 300 mm for hepatoma treatment, 70 to 150 mm for prostatic artery embolization to treat benign prostatic hyperplasia, and 700 to 1000 mm for uterine myoma and partial splenic embolization.

    T-ACE Beads can be loaded with chemotherapy or other positive charged drugs and behave as controlled drug-eluting. The function can improve pharmacokinetics of the medication and enhance the efficacy of the treatment modalities.

  • EndoGel
  • EndoGel is a hydrogel of ion-responsive polymers from pharmaceutical excipients. The hydrogel is used to assist the procedures of endoscopic submucosal dissection, endoscopic mucosal resection and difficult endoscopic polypectomies. Injecting hydrogel into submucosal space can elevate the mucosa to form a cushion for therapeutic endoscopic procedures. The cushion can prevent the unexpected muscle layer injuries to reduce perforation.

    Our EndoGel is in lyophilized form and can be dissolved by normal saline or pure water immediately before injection.The design is safer and more stable than that in liquid form and can tolerate more storage conditions.

  • T-ACE oil
  • T-ACE oil is a new lipophilic radiopaque contrast made from injectable vegetable oils in USP and Chinese Pharmacopeia. It contains similar amount of Iodine and esterized fatty acids as Lipiodol. However, Lipiodol is made from poppy seeds, which are quite expensive when compared with that from the other vegetable seeds. Since the amount of iodine is similar, the effect of radiopaque is also similar. In addition, the viscosity is slightly lower in T-ACE oil rendering that easier for injection.

    Our T-ACE oil can be used in vascular embolization.  For conventional TAE/TACE, it can be injected into hepatic artery with no more than 10 ML. It can be used with surgical glue, such as NCBA, Histoacryl, with appropriate mixed up portion, usually Histoacryl: T-ACE oil == 1: 1/2 to 1. The mixture can be used in endoscopic injection for treating gastric variceal bleeding.

    T-ACE oil is entering the regulatory process Phase I clinical trial as IND application is under the instruction of CDE.

Video Introduction