Regeneration and repair can be conceptualized as a continuum often with a blurred transition between them. A simplistic distinction is that regenerated tissues have a structure and function identical to the original tissues they replaced whereas repaired tissues do not. Using skin as our example, a full-thickness injury such as a surgical incision, results in a scar whose visual, structural, and secondary functions are impaired.

By Nikolai Sopko, MD, PhD, Chief Scientific Officer & Chief Operating Officer, PolarityBio

‍ ‍In recent posts, we’ve examined two questions that continue to shape modern wound care: whether living cells matter in advanced wound care, and whether the source of those cells—autologous or allogeneic— meaningfully changes the biology of healing.

‍ ‍If you accept that cells matter, and that autologous biology offers unique advantages, the next logical question is a practical one: what autologous wound care solutions are actually available today?

By Nikolai Sopko, MD, PhD Chief Scientific Officer & Chief Operating Officer, PolarityBio

‍ In regenerative medicine, products derived from human cells and tissues are regulated under different FDA regulatory pathways depending on their characteristics, intended use, and method of manufacture. Two labels frequently used to describe these pathways are “361” and “351.” These pathways represent distinct regulatory approaches with meaningful implications for product oversight and, now, Medicare payment policy.

By Ned Swanson, MD, President & Chief Medical Officer, PolarityBio.

As regenerative therapies advance in wound care, most conversations center on what a therapy contains - cells, matrix, or signaling components. But there’s another important component - where those elements come from.

The source of tissue matters because it influences how a therapy interacts with the body, how well it’s tolerated, and how closely it mimics natural healing processes. In regenerative medicine, the distinction between autologous and allogeneic approaches is essential.

By Ned Swanson, MD, President & Chief Medical Officer, PolarityBio.

As regenerative treatments become more common in wound care, one distinction is critical: cellular versus acellular therapies. These terms often get used interchangeably, but biologically they represent very different approaches. Understanding that difference is key to knowing whether a therapy can truly support tissue regeneration.