2021 was mostly focused on the COVID-19 pandemic, however the medical devices industry hasn’t held back on its drive for progress and innovation and continued to demonstrate strength and ambitions to solve many health problems.
While almost every business was affected by the various pandemic measures, as any other year the Medtech industry was at the forefront of ground breaking innovation and below you can find Guided Solutions’s selection of notable developments across innovation, clinical trials, regulatory, M&A and funding achievements in the Medtech world for 2021.
Early in January after scoring two European approvals for its artificial-intelligence-powered cancer pathology platforms, Paige has secured $100 million in new funding to boost its development of biomarkers. The New York-based company’s series C round was led by Casdin Capital and Johnson & Johnson Innovation, the drugmaker’s strategic venture capital arm as clinical applications.
2021 was also gracious for the cardiology innovator – CorWave. Bpifrance, Novo Holdings, Seventure, Sofinnova Partners and Ysios Capital, existing shareholders of CorWave who are leading investors in life sciences, significantly increased their stake in the company. CorWave is the first investment of the $4.4 billion EIC Fund, financed by the European Commission and one of the largest VC funds in Europe.
Caresyntax, the leading enterprise-level digital surgery platform delivering actionable insights to make surgery smarter and safer, announced that it has closed a $100 million Series C funding round during the spring. The investment follows a year in which the company saw 250% growth in new contract value, supported more than 30,000 surgeons, and improved care for more than two million patients.
Regulatory Approvals:
Caristo Diagnostics announces EU approval for AI technology that can predict heart attacks years in advance back in March. The first-of-its-kind technology, CaRi-Heart®, was developed by spinout company Caristo Diagnostics and has the power to detect ‘invisible’ risk in people with possible heart disease by using routine heart scans already performed in clinical practice.
Back in May iRhythm Technologies has announced two US Food and Drug Administration (FDA) 510K clearances—one for a new and improved design of its flagship monitor and a second for updated artificial intelligence (AI) capabilities. “iRhythm’s new Zio monitor and enhanced AI further illustrates our commitment to raising the standard of cardiac care for the providers and patients we serve,” said Mike Coyle, CEO of iRhythm.
The first robotic gamma probe gained its CE Mark at the beginning of 2021. Light Point Medical’s SENSEI® promises accurate real-time cancer detection for robot-assisted cancer surgery. Currently, surgeons have no way to precisely detect cancer intra-operatively.
Olympus has agreed to acquire US-based medical device company Veran Medical Technologies (VMT) in a deal valued up around $340m. “The most significant part of this deal is that we will secure immediate access to VMT’s unique Electromagnetic Navigation system with proprietary devices to build a stronger future respiratory product portfolio.”
March was a business successful month for Boston Scientific who has entered into a definitive agreement with an affiliate of Baring Private Equity Asia (BPEA) to acquire the global surgical business of Lumenis, which develops and commercialises energy-based medical solutions.
To build out women’s health business Ro a direct-to-consumer health startup acquired Modern Fertility, a startup with a similar business model in May. As part of the deal, Modern Fertility co-founders Afton Vechery and Carly Leahy will lead Ro’s women’s health business.
In April 2021 Nevro touted results from a trial of its Senza system for treating PDN – related chronic pain. The randomized SENZA-PDN trial met its prespecified primary endpoint by demonstrating that PDN patients with symptoms refractory to best available treatments can be safely and effectively treated with high-frequency (10 kHz) SCS, Nevro said.
Apollo Endosurgery, a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced in October that study investigators of the Multi-Center ESG Randomized Interventional Trial (MERIT) presented positive outcomes.
BrainQ announced encouraging study results for a new therapy to reduce disability after stroke in March, 2021. In a single site, the double-blind RCT included 25 subjects. After 8 weeks of treatment, 77% of the subjects receiving the BrainQ therapy had scores of 1 or 0 on the modified Rankin Scale (mRS), the gold standard for measuring disability following stroke. This translates to subjects having either no symptoms or minor symptoms, and with no significant disability. Only 25% of the subjects in the sham (control) group scored 1 or less. Additionally, 92% of subjects in the treatment group improved by 2 or more mRS points.
Fusion Robotics LLC, a spinal robotics and navigation company successfully completed the first spine procedure using the company’s technology platform back in March. The procedure, completed by Dr. Kevin Foley at Baptist Memorial Hospital in Memphis TN, was a single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF), including the placement of pedicle screw fixation guided by the Fusion Robotics system.
In June Medtronic announced the first patient procedure executed with their Hugo™ Robotic-Assisted Surgery System. The first patient procedure marks the beginning of the Hugo RAS system patient registry, which will collect clinical data to support regulatory submissions around the world.
In November 2021 with a continued focus on advanced diagnostic imaging, Carestream added the Ziehm Vision RFD C-arm System to its product portfolio. A mobile, fluoroscopic surgical imaging system with a flat-panel detector, the Ziehm Vision RFD C-arm allows for broad procedural work including vascular, cardiac, spine ortho-trauma and pain management, in addition to many general surgical applications.
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