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Bionik Laboratories Provides Corporate Update and Business Outlook
TORONTO and BOSTON, Oct. 27, 2016 (GLOBE NEWSWIRE) -- Bionik Laboratories Corp. (OTCQX:BNKL) (“Bionik” or the "Company"), a global pioneering robotics company focused on providing rehabilitation and mobility solutions to individuals with neurological disorders, today provided a corporate overview and business outlook including the Company’s development and commercial strategy. The Company also summarized anticipated events and key near-term corporate, development, clinical and regulatory milestones. Peter Bloch, Chief Executive Officer and Chairman of the Board, stated, “2016 has been a transformative year for Bionik with the significant expansion of our product portfolio with the acquisition of Interactive Motion Technologies (IMT) in April. Our product portfolio now includes both lower and upper body robotic rehabilitation products, including three FDA-cleared commercial products and four development-stage products. Following the completion of this transaction, the Bionik team conducted an in-depth strategic review including a comprehensive market analysis, product pipeline development prioritization, business development and growth focus and marketing and commercial planning. It is clear that opportunities to unlock tremendous value for Bionik lie ahead with our focus on addressing the stroke market, a large, well-established and growing opportunity, and this clear and deliberate strategic pivot underscores our vision of becoming a leading robotic medical technology Company offering complete rehabilitation and mobility solutions for the neurologically impaired from hospital to home.” In the United States, stroke is the third leading cause of death and the leading cause of serious, long-term disability. Stroke costs are estimated at $34 billion each year, including services, medications and missed workdays. Approximately 795,000 people suffer a stroke each year of which 650,000 people survive. The Company believes that over 400,000 of those survivors are sufficiently impaired to benefit from interactive robotic therapy. There are over 6.5 million stroke survivors in the U.S. alone, and in Europe, the numbers are roughly 20-25% larger than in the U.S. and in China approximately 3 times larger, across similar measures and with the same trending. “The number of people worldwide affected by stroke has been growing rapidly, especially in younger age groups and in low-to-middle-income countries. It is estimated that the number of stroke patients are expected to double by 2030 and double again by 2050. These numbers are absolutely staggering, but importantly, obviate the need for innovative solutions for rehabilitation and recovery for stroke patients worldwide to address the shortcomings of traditional treatment in addition to the socioeconomic impact that exists globally. We plan to offer complete product solutions that treat the patients through the continuum of care to ensure that every patient achieves their mobility goals,” added Mr. Bloch. Bionik provided an overview of its three U.S. Food and Drug Administration (FDA) cleared commercial products and its four development stage programs expected to be advanced towards commercialization. Upper Extremity Commercial-Stage Rehabilitation Robots InMotion ARM™ Interactive Therapy System InMotion WRIST™ Interactive Therapy System InMotion HAND™ Interactive Therapy System Upper Extremity Development-Stage Rehabilitation Robots InMotion ARM/WRIST/HAND Version 2 (AWH V2) InMotion LIGHT “Stroke is a lifelong condition and nearly 70% of stroke patients requiring therapy are still impaired enough to justify ongoing treatment beyond the initial phase of recovery and we believe, would benefit significantly from home robotic therapy. This underserved patient population, combined with the millions of people living with chronic neurological impairment, is our justification for developing the InMotion LIGHT product and why we believe the market opportunity is so large,” commented Hermano I. Krebs, Ph.D., M.S., the Company’s Chief Science Officer. Lower Body Development-Stage Product Pipeline ARKE Lower Body Exoskeleton Validation testing is expected to continue through 2016. The Company then anticipates the completion of clinical testing of ARKE 2.1 in the first quarter of 2017 and the completion of clinical testing of ARKE 2.5 in the first quarter of 2018. InMotion AnkleBot™ In addition, Bionik has a new product candidate for gait assistance for rehabilitation based on a design being developed by Dr. Krebs. The Company expects to further advance the development of this product in 2017. InMotion Products are Evidenced Based and Clinically Proven There has been an extensive pool of research conducted that demonstrates the clinical efficacy of the InMotion products in independent, randomized, controlled studies. Over 200 papers have been published and presented at prestigious scientific congresses and in peer-reviewed journals. There have been more than 1,000 patients studied in clinical trials with outcomes demonstrating clinical and economically significant results compared to conventional therapy. The Company’s clinical studies meet the highest standard of scientific rigor. In addition to improved health outcomes, a randomized clinical trial demonstrated a 25% reduction in total health care expenses over a 36-week period, as compared to a matching intensity therapist delivered intervention. The 2010 and 2016 American Heart Association (AHA) guidelines for stroke care, as well as the 2010 Department of Veterans Affairs post-stroke rehabilitation guidelines recommended robot assisted therapy for upper extremity motor rehabilitation. The Company previously announced its ongoing Robot Assisted Training for the Upper Limb after Stroke (RATULS) study being led by Newcastle University under the auspices of the National Institute for Health Research (NIHR) HTA Programme. This landmark study is the largest ever conducted with robotics rehabilitation. This three-arm randomized clinical trial enrolling 720 subjects across four study centers in the United Kingdom is designed to determine whether robot assisted training improves upper limb function post stroke using InMotion therapy products compared to enhanced upper limb therapy or conventional therapy. The investigating team expects to complete the study in 2018 and publish the results in 2019. The Company believes the outcome of this study is expected to significantly impact reimbursement for Bionik products as well as international market expansion. Timothy A. McCarthy, Chief Commercialization Officer of Bionik commented, “The commercial plan that we have put in place emphasizes Bionik’s competitive advantage, which includes clinical evidence supporting improved outcomes and reduced overall cost with robotic treatment when compared to conventional treatment. The Company’s commercial plan is a potentially game-changing strategy to take control of the channel by delivering clinically and economically proven robotic solutions throughout the continuum of care for the neurologically impaired, which we believe will build enormous value to shareholders.” Growth Strategy Focused on Further Pipeline Expansion Bionik’s growth strategy is designed to leverage its current product portfolio and internal development programs. Its newly formed commercialization team is expected to build out a robust sales and distribution channel. This includes leveraging sales models for the product pipeline with revenue sharing, leasing and rental strategies. Bionik’s management team expects to further leverage its in-depth research and development relationships including those with professors at MIT to identify additional synergistic robotic technologies. Over time, the Company expects to expand its product pipeline through strategic partnering and acquisitions. “Due to the huge market opportunity that exists, we plan to launch financing model options for customers requiring flexibility, while we establish strategic partnerships with companies who can support our efforts to build a comprehensive distribution network to access key markets globally. Given our position in the market as the only evidence-based solution and our robust product portfolio, we believe that with the right partners and people, we have the right plan in place that will propel Bionik forward in a meaningful way, ultimately enabling us to achieve our stated goal of becoming the leading robotic medical technology company by offering complete rehabilitation solutions from hospital to home for the neurologically impaired,” added Mr. McCarthy. “We fully intend to build upon the groundwork and momentum we have created this year and will continue to focus on operational excellence as we drive the development and commercialization of our product portfolio forward. This is just the beginning for Bionik with the many growth and value driving opportunities that exist for the Company in the near and long term. I believe we have firmly positioned Bionik to become a leader in this transformative shift from conventional to robotic treatment for neuro rehabilitation and most importantly, significantly impact the lives of millions of individuals recovering from those impairments, most notably stroke, and ultimately unlocking significant value for our shareholders,” Mr. Bloch concluded. About Bionik Laboratories For more information, please visit www.bioniklabs.com and connect with us on Twitter, LinkedIn and Facebook. Forward-Looking Statements Bionik Laboratories, Inc. Investor and Media Contact: Jenene Thomas Jenene Thomas Communications, LLC (908) 996-0239 [email protected] |