Medimaging Integrated Solution (MIS), an innovative smart healthcare company, has licensed its single-use cystoscope to Boston Scientific (NYSE: BSX) for sales. However, the product’s contribution to revenue has fallen short of expectations, resulting in a 12% year-on-year decrease in revenue for the first 11 months of this year. Chairman Cheng, Chu-Ming stated that this was MIS’s first venture into the urology field, and the company had not anticipated the time required for hospitals to conduct product trials and clinical evaluations. While this delayed revenue contributions, larger-scale shipments are expected to begin in Q2 next year. Meanwhile, MIS is working to expedite shipments of a large September order for digital endoscopes, previously delayed due to supply chain issues. Efforts to resolve these challenges may lead to record-high monthly revenue in December, with hopes to catch up to last year’s revenue performance.
MIS’s single-use cystoscope received FDA 510(k) clearance last year and was subsequently licensed to Boston Scientific, a globally renowned medical device company. This year, the product has undergone certification processes in multiple countries, achieving 15 certifications by mid-year and adding certifications from Colombia, Brazil, and South Korea in the second half, bringing the total to 24 countries.
According to Cheng, this is MIS’s first experience with products used in the urology field. The major client required nearly a year to conduct hospital trials and additional clinical evaluations, including two- and three-phase clinical studies, which extended the product's official market launch timeline. This experience has provided valuable insights for the company. The good news is that formal shipments of the cystoscope will begin in Q1 next year, with significant contributions expected from Q2 onwards.
Regarding digital endoscopes, market demand has gradually recovered in the second half of this year. MIS secured a substantial order in September but faced challenges meeting the demand due to supply shortages. Despite these hurdles, the team has worked hard to expedite shipments, and December is expected to see a significant increase in shipment volume, potentially driving monthly revenue to a new high. The company remains committed to catching up to last year’s revenue performance.
Operationally, MIS experienced a decline in gross margin during the first three quarters of this year, with a loss per share of NT$0.88. This was mainly because a larger portion of last year’s revenue came from non-recurring engineering (NRE) services for CDMO (contract design and manufacturing organization) clients, resulting in higher gross margins. This year, NRE contributions have been minimal. Additionally, losses from its investment in Liang Tzan have persisted, further impacting profitability.
Resource: 晉弘12月營收有望拚新高，拋棄式膀胱鏡明年Q2放量出貨
