NeXtGen Biologics, Inc.

More than $25 billion a year is spent on treating wound-related complications by the U.S. healthcare system. Chronic wounds, described as taking from four weeks to more than three months to heal, have a significant impact on the health and quality of life of patients and their families, causing pain, depression, and financial burden. Chronic wounds affect more than 6 million U.S. patients each year, a figure that will continue to grow given the country’s aging population.* The industry also includes surgical wounds and burns.

While many technological advancements have taken place over the last decade in wound care, chronic and surgical wound healing continues to be problematic. No product has conquered the challenge of expedited, infection-adverse, scar-free healing. And, surgically treated conditions can result in non-closure, dehiscence (re-opening) and recurrence leading to extended suffering for patients and high costs for payors. Chronic, non-healing wounds are a serious issue worldwide, and have even been called a “silent epidemic.” If these types of wounds aren’t properly treated, they can lead to severe infections, recurrent hospitalizations—and, in the worst cases, amputation and death.

NeXtGen Biologics is an innovative medical device company focusing on advanced wound care. Currently, NeXtGen is developing a novel extracellular matrix (ECM) product and a pipeline of varying formulations. Leveraging a world-class team with expertise in medical devices and breakthrough tissue technologies, the company’s platform technology is being designed to offer surgeons unique options that are designed to be transformative for patients. Product development is focused on solutions for a myriad of complex conditions seen in general surgery, trauma, cardiovascular diseases, neurosurgery, orthopedics and ophthalmology.

Derived from the dermis of an axolotl amphibian species, the NeoMatriX patch is applied to human wounds similar to ECM technology developed previously from pig, cow or human tissue. NeoMatriX® Wound Matrix was recently cleared by the FDA as a 510(k) medical device. Two human studies were conducted and demonstrated no immunological response to axolotl tissue. Challenging animal performance studies demonstrate no delay in wound healing. Other properties relating to inflammation, vascularization and fibrosis may be valuable to explore further.

When NextGen’s CEO, Jonelle Toothman, reached out to her previous colleague, Dr. Elad Levy, Chairman of the Department of Neurological Surgery at UB’s Jacobs School of Medicine and Biomedical Sciences, she was linked with a network of knowhow. The Proteomics and Bioanalysis Core at the New York State Center of Excellence, Bioinformatics & Life Sciences, assisted NeXtGen with cost effective, safe, timely product testing. And, they lent some much-needed guidance regarding applying for FDA clearance. Their support helped get the NeoMatriX Wound MatriX product one step closer to market. Moving forward, NeXtGen plans to work with UB to help identify the best uses for this product.

The Center of Excellence in Bioinformatics and Life Sciences (CBLS) is a hub for life sciences innovation and technology-based economic development driving scientific discovery, facilitating collaboration among academia, industry and the public sector to create jobs that directly impact the region’s and state’s economies. CBLS helped NeXtGen with one product so far. They’ll be working with them more as new products are developed. These could include bone regeneration and anti-aging applications.

The FDA clearance of NeoMatriX allows NeXtGen to advance its product line for marketing in the United States. This is a pivotal milestone, allowing NeXtGen to move forward in providing physicians with a novel platform solution to treat patients who suffer from a wide variety of wounds. NeoMatriX offers helpful features including: it is a room temperature product which can be accessed right-off-the-shelf, and on-demand manufacturing using scalable, cost-competitive technology. NeXtGen is now gearing for its phase as a
start-up and will begin building its infrastructure, raising additional capital and working to create product awareness among physicians.

*According to the National Institutes of Health.