The race continues to heat up in the bioprinting space over which players will first reach the finish line in gaining approval for tissue and organ replacements. Research organizations and companies worldwide are in various states of development for these milestones in regenerative medicine, ranging from bioprinting skin to a mini human heart. But regulatory hurdles and quality testing could be formidable.

Momentum is rising for patients with chronic kidney disease to be treated with hemodialysis in the comfort of their own home as opposed to traveling several days a week to a freestanding clinic. Manufacturers, government and payers are paving the way for a higher home-therapy adoption rate. That said, many patients remain unsuitable for home care and the large volume of water needed to operate hemodialysis can be logistically daunting.

Transcatheter aortic valve replacement (TAVR) is performed routinely using devices providing protection from stroke as standard of care. However, cerebral embolic protection devices currently available do not capture and remove emboli from all three vessels leading to the brain. The Emblok Embolic Protection System from Innovative Cardiovascular Solutions (ICS) has developed an embolic filter designed to protect all three cerebral vessels during TAVR and remove debris from the entire circulatory system.

Liquid biopsy is a rapidly developing noninvasive technology for the early detection of cancer. Multiple companies have entered clinical testing, using mostly blood to detect circulating tumor cells and/or circulating tumor DNA. But urine and even cerebral spinal fluid are promising liquids too. Regardless of the fluid, testing costs a fraction of a traditional, invasive tissue biopsy and offers much quicker results.

A new hearing aid lets users enjoy the full range of normal hearing frequencies, activated by a contact lens on the eardrum. The hearing aid from Earlens Corp. also provides audio gain without feedback. In October, the company completed an $87m round of financing, which will help launch its next-generation hearing aid, which employs magnetic induction for further hearing refinement.

Although certainly not a given, many researchers and companies are pursing the eventual goal of bioprinting human organs, starting with the three-dimensional printing of a structure that has cellular function. If organ function via bioprinting becomes a reality for the skin, bone, lung, liver, eye and/or kidney, among other potential organs, the market opportunity could be in the billions. But challenges, including cost and ethics, stand in the way of this milestone in regenerative medicine.