High Intensity Focused Ultrasound (HIFU): A Therapeutic Tool in the Treatment of Solid Tumors
High Intensity Focused Ultrasound (HIFU) has emerged as a promising non-invasive therapeutic ultrasound technology for treatment of a range of disorders like Prostate Cancer, Uterine Fibroids, neurological disorders, solid tumors and other cancers. In this treatment focused high energy ultrasound waves in the range of 100-10,000 W/cm with 30MPa of compressing pressure and 10MPa of peak rarefaction pressure is used. Through a probe, therapeutic ultrasound energy is sent and these waves focus on a small spot. High intensity focused ultrasound heats up the targeted area to 700 and 800 Celsius, this increase in temperature results in thermal tissue coagulation, necrosis, cavitations and heat shock. According to IQ4I estimation HIFU market is expected to grow at a CAGR of 22.4% from 2016 and to reach $264 million by 2023.
Some of the factors driving the HIFU market are, a high prevalence of cardiovascular diseases and cancer, increasing aging population, growing number of clinical studies regarding the applications of HIFU, emerging applications like gynecology & obstetrics, neurosurgery, urinary disorders imaging would further boosting the growth of the HIFU market in coming years. However, stringent regulations by regulatory bodies like FDA, the high cost of the device, poor reimbursement scenario are the factors controlling the growth of the HIFU market
HIFU applications include hemostasis, thrombolysis, targeted drug/gene delivery, transcranial brain therapy and guiding/monitoring of therapy. In hemostasis, solid organ repair and vascular injuries are being treated where high energy ultrasound waves cause coagulation of the adventitia of vessels and fibrin-plug formation. In transcranial brain therapy, use of HIFU allows selective opening of the blood brain barrier without destroying normal neuronal tissue. As of 2016, about 120 therapeutic application programs are in different stages of testing (which includes pre-clinical, clinical and approval stages) by major players like Theraclion (France), InSightec (Israel), FUS instruments (Canada), Alpinion medical systems (Korea). Among these programs, majority of companies focused on Oncology application followed by Neurology, Women’s Health, Cardiology, Urology and Others. Oncology applications which holds an estimated share of 52.5% has 63 programs (13 companies) followed by Neurology (9 companies).
HIFU offers advantages like being non-invasive it reduces the duration of hospital stay and faster recovery period and repeatability of treatment, there exists disadvantages and complications such as long procedural duration, difficulty in targeting and monitoring of moving organs, high cost, skin burning due to high energy ultrasound waves, collateral damage to the soft tissues and skin during the liver treatment, thermal injury to bowel wall after the HIFU therapy for uterine leiomyoma. It is difficult to predict the side effects of this treatment and HIFU is available only in specialist centers..
Since HIFU devices are subjected to stringent regulations from FDA and European Union and the requirement of high capital investments for the HIFU device development and for the expansion of device distribution network, the threat of the new entrants in this market is low. Surgeries are often considered to be an alternative where, instead of using high-cost HIFU devices, cost effective open surgeries can be one of the therapeutic substitutes for the ablation of tumors. As a technological advancement, HIFU along with the combination of MRI guidance can effectively treat a range of central nervous system disorders as it offers the capability to target and treat many central nervous system conditions which were initially complicated to perform. Some of the companies like SuperSonic Imagine (France),Changjiangyuan Technology (China), Chongqing Haifu (China), FUS instruments (Canada) uses MR guided ultrasound technology to treat tumors. However, the use of high-intensity sound waves as a therapeutic tool is not new and though results to date are assuring, more research is needed in establishing the best method for using HIFU to treat the pancreatic and other tumors.
Europe accounts for largest share in number of units sold and clinical research sites of the global HIFU devices market in 2016 followed by North America. InSightec, an Israel-based company dominates in this technology field & has pioneered use of focused ultrasound treatment and MRgFUS (Magnetic Resonance guided Focused Ultrasound, where solid tumor is treated by combining two technologies HIFU and MRI) for the treatment of prostate cancer. InSightec is the first and only company with FDA approval to use MRgFUS for any medical indications. According to IQ4I estimation, InSightec accounts for the largest share in the global HIFU market. Insightec is privately held by GE Healthcare, Elbit Imaging, York Capital Management, GEOC Hentong Investment Limited Partnership, and MediTech Advisors, who have invested $300 million in the company’s ultrasound technology. There are an estimated 100 installed ExAblate devices across the world and the device has received FDA approval in July 2016 for treating essential tremor. InSightec is followed by Sonacare a U.S. based company, its HIFU device Sonablate 450 is used for the ablation of prostate tissue and was approved by USFDA in October 2015. More than 15,000 patients around the world have been treated till date with this device and the company has sold close to 100 Sonablate systems in 50 countries. Similarly, EDAP TMS (France) with its HIFU devices Ablatherm and Focal One have performed approximately 45,000 treatments worldwide for the prostate cancer. Currently, it is working on several projects and has clinical trials for liver metastases, pancreatic cancer, gynecologic applications, and others. Major players in the HIFU market are SonaCare Medical (U.S), EDAP TMS (France), Theraclion (France), Insightec (Israel), FUS Instruments (Canada), Alpinion Medical Systems (South Korea), Sonic Concepts Inc (U.S.), Misonix Inc (U.S.), Aishen Medical Technologies (China), Chongqin Haifu Technology Co. Ltd (China).