Medtronic disclosed Thursday it acquired Ai Biomed Corp, which won De Novo authorization from FDA in 2018 for a device to help physicians identify and preserve parathyroid tissue, an important regulator of calcium in the body, during thyroid surgery. Financial terms were not shared.
The medtech will combine Ai Biomed's PTeye system, its Santa Barbara, California facility and an undisclosed number of employees with its ENT business, which saw revenue decline in the mid-twenties each of the last two quarters as COVID-19 impacted procedure volumes.
- Medtronic said the deal is its seventh tuck-in acquisition so far this year. The others were dialysis access medtech Avenu Medical, connected insulin pen maker Companion Medical, spinal surgery specialist Medicrea, distal blood flow monitoring device maker Laser Associated Sciences, OR tech company Digital Surgery and spinal cord stimulation waveform developer Stimgenics.
Having bolstered various diabetes, neuromodulation, surgery and peripheral vascular business lines with deals in 2020, Medtronic has now applied the acquisition strategy to its ENT business. Those actions track with commentary throughout the year from CEO Geoff Martha that the company planned to be strategic, and potentially opportunistic, about M&A during the pandemic.
While thyroid procedures often involve at least partial removal of the thyroid glands, surgeons try to avoid inadvertently harming parathyroid tissue, which if removed can result in hypocalcemia symptoms like numbness in extremities, muscle cramps in legs and feet, and seizures, Medtronic described. This accidental damage or removal occurs in up to 20% of the 150,000 thyroid surgeries performed annually in the U.S., according to Vanderbilt University Medical Center, which announced this year it's further testing the technology.
Although surgeons can sometimes spot parathyroid tissue on their own, the use of technology can enhance accuracy and provide confirmation. Ai Biomed's handheld probe-based PTeye system provides visual and audio signals in real time when it identifies a parathyroid gland during a procedure. The study that supported FDA's marketing OK found the device had overall accuracy of 96% in identifying parathyroid glands, with a false positive rate of 2.7% and a false negative rate of 7.7%.
Medtronic expects the impact of the acquisition to be immaterial to revenue and earnings in its ENT business for the coming year before turning accretive.
In the same announcement Thursday, Medtronic said it received 510(k) clearance for its NIM Vital product meant to reduce risk of nerve damage in head and neck surgery.