Sword Health Technologies Inc. slipped another $189 million into its coffers with an oversubscribed $163 million series D fundraising round that spilled into an additional $26 million secondary transaction. The enthusiasm for the round points to the keen interest in digital delivery of musculoskeletal (MSK) physical therapy, which has driven Sword and competitor Hinge Health Inc. both into rarified unicorn territory with valuations of $2 billion and $6.2 billion, respectively.

Medical science has not yet convincingly duplicated the remarkable properties of cartilage, an omission that sustains an epidemic of life-altering knee replacement surgeries. Anthony Ratcliffe, CEO of Synthasome Inc., of Del Mar, Calif., said on a recent FDA webinar that companies might want to consider the lowly goat as the animal model of choice in preclinical studies of cartilage products because “the cost, ease of management, and the social aspects were all manageable” with goats.

Stryker Corp.’s analyst day provided comfort to those concerned about the company’s ability to return to its strong pre-pandemic revenue and earnings growth after its lower than expected third-quarter earnings results. Management offered positive reports of fourth-quarter trends and a long-term strategy unfolding according to plan.

Trendlines Group Ltd. reported the acquisition of its portfolio company Orthospin Ltd. by Synthes GmbH, a division of Depuy Synthes, the orthopedics company of Johnson & Johnson (J&J), for $79.5 million in cash. Johnson & Johnson’s involvement in the company goes back to July 2018, when J&J Innovation (JJDC) led the company’s series A round.

Digital musculoskeletal health company Hinge Health Inc. kicked its fundraising into high gear this year, reporting $400 million in a series E round and $200 million in a secondary investment today. It closed a $300 million series D just last January. The San Francisco-based company has now raised more than $1 billion and achieved a valuation in excess of $6.2 billion. Returning investors Tiger Global and Coatue Management led the series E, while new investors Alkeon and Whale Rock took a stake in the company with their $200 million. Investors in the series D and previous rounds included Atomico, Insight Partners, Quadrille, 11.2 Capital, Lead Edge Capital, Bessemer Venture Partners and Heuristic Capital.

PERTH, Australia – Singular Health Group Ltd. was awarded AU$50,000 (US$37,000) in funding from Australia’s Commonwealth Scientific and Industrial Research Organization’s (CSIRO) Kick-Start program to undertake a research project to develop artificial intelligence (AI)-based tools to automatically design patient-specific cranial implants. The AI will be integrated into Singular Health’s surgical planning software for editing before the cranial implants are 3D printed.

The term of follow-up in clinical studies is the subject of massive speculation at FDA advisory hearings, but a recent FDA workshop suggests the agency may adjust its expectations, depending on the device. Darrell Brodke, of the University of Utah, said on a recent spinal device workshop that the two-year endpoint in some spinal device studies struck him as somewhat arbitrary, adding that a longer duration of follow-up is necessary to capture some device failures, but that two years is perhaps overly long where some other outcomes measures are concerned.

Orthopedics device startup Amber Implants BV has received an FDA breakthrough designation for its cementless spinal implant Vcfix. The system is designed to treat vertebral compression fractures (VCFs), which can cause patients severe back pain and limited mobility. Currently, VCFs are treated with injection of bone cement into the vertebra.

TORONTO – Numalogics Inc. has entered a partnership deal with Sawbones Inc. to develop computational modeling and simulation software for small and medium sized orthopedic manufacturers. Adding Montreal-based Numalogics’ computational simulation software to Seattle-based Sawbones’ biomechanical test line is intended to help customers optimize their orthopedic device designs more quickly and efficiently. The software is expected to be market ready in 2022.

Australia’s TGA provided updates regarding up-classification of several device types, including a number of spinal implants, which will henceforth be regulated as high-risk, class III devices, rather than medium-to-high risk devices (class IIb).