A Patent Win and Axolotl DNA: The Future of Wound Care Is Here

ALACHUA, FL – December 11, 2025 – In the high-stakes arena of medical technology, a strong patent portfolio is both a shield and a sword. For Florida-based startup NeXtGen Biologics, this axiom was recently put to the test. The company emerged victorious after the U.S. Patent and Trademark Office (USPTO) declined to review two of its core patents, a decision that not only solidifies its intellectual property but also validates the groundbreaking science behind its flagship product: a wound-healing matrix derived from the near-mythical regenerative powers of the axolotl.

This outcome is more than a simple legal footnote; it’s a critical milestone that clears the path for a technology poised to disrupt the multi-billion-dollar chronic wound care market. By successfully defending its intellectual property against a challenge from a former licensee, NeXtGen has reinforced its position as a key innovator, allowing it to focus on scaling a solution that promises to heal wounds previously deemed untreatable.

The Battle for Intellectual Property

At the heart of the matter were two Inter Partes Review (IPR) petitions filed in February 2025 by RegenX Science, a company that was, ironically, a former licensee of the very patents it sought to invalidate. The petitions requested the cancellation of claims in NeXtGen’s U.S. Patent Nos. 10,617,790 and 11,660,376, which protect the core technology behind the NeoMatriX® Wound Matrix.

However, on July 31, 2025, the USPTO’s Patent Trial and Appeal Board (PTAB) issued a discretionary denial. The board’s reasoning was telling: it deemed a review an "inefficient use of Board resources," given that RegenX Science had a prior relationship with NeXtGen and had rights to monitor the prosecution of the patents in question. This decision leaves NeXtGen's patents fully intact and enforceable, a significant win for any startup, but particularly for one in the fiercely competitive biotech sector.

For companies like NeXtGen, which has raised over $16 million to date, intellectual property is the bedrock of its valuation and future growth. A strong patent defense assures investors that their capital is backing a defensible, proprietary technology, de-risking further investment needed for manufacturing expansion, new regulatory filings, and sales growth.

“True innovation to transform patient lives is at the heart of NeXtGen’s mission,” said Jonelle Toothman, NeXtGen Biologics co-founder and CEO, in a statement following the decision. “This outcome solidifies the strength of the Company's patents as the foundation of NeXtGen’s platform technology.”

The Science of Scarless Regeneration

While the legal victory is significant, the true story lies in the remarkable biology that powers NeoMatriX®. The technology is built upon an extracellular matrix (ECM) platform derived from the axolotl (Ambystoma mexicanum), an aquatic salamander with regenerative capabilities that border on science fiction. Unlike mammals, axolotls can regenerate entire limbs, spinal cords, and even portions of their brains without any scar tissue formation.

This scarless healing is the holy grail of regenerative medicine. The key is believed to lie within the axolotl's unique ECM—the complex scaffold of proteins and molecules that surrounds cells, providing structural support and crucial biochemical cues. The axolotl’s ECM appears to orchestrate a perfect "fetal mode" of healing throughout its life, guiding cells to regenerate tissue perfectly rather than patching it with fibrous scar tissue.

This stands in stark contrast to most advanced wound care products on the market, which typically use ECM derived from mammalian sources like pigs, cows, or human cadavers. While effective to a degree, these materials do not possess the unique pro-regenerative signaling properties inherent in the axolotl's biology.

NeXtGen’s FDA-cleared NeoMatriX® harnesses this biological blueprint. The device is a decellularized collagen wound matrix that, when applied to a wound, provides a scaffold that supports the body's natural healing processes. It has already shown remarkable success in clinical settings, facilitating closure in chronic wounds such as diabetic foot ulcers—a condition that often leads to amputation—as well as challenging post-surgical wounds and trauma injuries where standard-of-care procedures have failed.

A Startup's Resilience in a Growing Market

NeXtGen's journey highlights the resilience required to bring a truly novel medical technology to market. The global chronic wound care market is a massive opportunity, estimated to be worth over $18 billion in 2025 and projected to exceed $26 billion by 2032, driven by an aging population and the rising prevalence of diseases like diabetes.

Navigating this space requires more than just innovative science; it demands strategic execution and the fortitude to overcome challenges, including legal ones. The IPR challenge came from RegenX Science, a company founded by Jamie Grooms, who also co-founded NeXtGen. Such disputes, particularly after a licensing agreement sours, can drain a startup's resources and distract from its core mission. By securing a swift and decisive victory, NeXtGen has demonstrated its operational and legal maturity.

With reported revenues of around $100,000 per month and an active $5 million fundraising effort, the company is at a pivotal growth stage. The patent validation will undoubtedly bolster its appeal to investors, providing the capital needed to expand manufacturing, grow its raw material supply of axolotls, and drive adoption among key opinion leaders in the medical community.

Beyond the Wound: A Platform for the Future

NeXtGen views its axolotl-derived ECM not merely as a single product, but as a platform technology with vast potential. The company is already exploring future indications that could extend its reach far beyond the wound care clinic. The unique properties of the ECM could be applied to a host of other medical challenges where scar tissue formation is a significant problem.

Potential future applications include plastic and reconstructive surgery, where minimizing scarring is paramount, as well as orthopedic uses for tendon and bone repair. The technology could also find a role in cardiovascular and neurosurgical applications, where the prevention of adhesions and the promotion of true tissue regeneration could revolutionize patient outcomes.

This patent victory is not an endpoint but a critical enabler. It secures the company's foundational innovation, allowing it to confidently build a pipeline of next-generation regenerative products. For the 6.5 million people in the U.S. suffering from chronic wounds, and millions more worldwide, the promise of the humble axolotl, now protected by the force of U.S. patent law, represents a powerful new source of hope.