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Problem
Surgical wounds are still an unsolved problem, despite advances in technology
To our knowledge, no product has conquered the challenge of scar-free healing. Furthermore, surgically treated conditions can result in non-closure, dehiscence, and recurrence—leading to suffering for patients and high costs for payors.
Additional problems include:
- 100M people in the US suffering from diabetes or prediabetes conditions4
- Diabetic ulcers are responsible for most foot and leg amputations in the United States3
- Surgical site infections contribute to mortality in 75% of cases and is the 2nd leading cause of hospital-acquired infections5
Solution
NEXTGEN ™ is on a mission to capture the regenerative power of the axolotl
to produce a new ECM to address this challenge.
The Extracellular Matrix (ECM) is a large, three-dimensional network of proteins and other molecules important to cell functions and plays a major role in health and disease6 through repairing damaged tissue.7 Available for decades, ECM products have been used to address many complex conditions seen in wounds (chronic and acute such as burns), general surgery, trauma, plastic surgery, cardiovascular and gastrointestinal diseases, neurosurgery, orthopedics, and ophthalmology.
However, we believe no ECM product has conquered the challenge of scar-free healing.
The axolotl
One of the few known vertebrates that
can regenerate organs, entire limbs, skin, and compound tissues including its nervous system. The axolotl is a neotenic organism – meaning they retain juvenile characteristics throughout adult life.
Tissue repair in humans and axolotls involve the same basic mechanisms.
With this knowledge, NeXtGen is committed to study how ECM derived from the axolotl can be used in a variety of regenerative medicine applications including usage in gastrointestinal diseases and surgery (plastic, cardiovascular, and neurological), reduction of inflammation and scar tissue, and the repair of bone and cartilage.
Product
New skin in the game
NEOMATRIX ® is poised to be the first ECM product derived from the axolotl and available to physicians and patients in 2022. NeXtGen’s recently FDA cleared product, NEOMATRIX is indicated for numerous applications.
Advantages of NEOMATRIX
- The first ECM derived from a regenerative species
- Versatile, suturable and naturally conforming
- Easy placement for use on partial and full-thickness acute and chronic defects
- Delivered sterile in sheets ready to be placed on the wound bed
- On-demand manufacturing
- Scalable technology that’s cost competitive
- Stored at room temperature, ready to use
Traction
NEOMATRIX launch in progress
Having already completed several pre-clinical and many benchtop studies characterizing the material used to make NEOMATRIX, we have demonstrated biocompatibility, safety and efficacy, and see the promise this new technology holds.
Revenue projections*
* Click here for important information regarding Financial Projections which are not guaranteed.
Customers
Medical professionals treating surgical & chronic wounds
The NeoMatriX launch strategy will target surgeon users who treat patients with complex wounds and will provide case feedback in multiple different indications:
Market
An immediate
market of $19.8B
Total Addressable Market of $152B
The global regenerative medicine market will grow to over $66bn by the end of 2022, with a compounded annual growth rate (CAGR) of 23.3% due to the increases in chronic diseases, genetic disorders, cancer, and other pressing medical issues within recent history. This hot and growing market, in addition to potential partnerships with auxiliary markets, gives NeXtGen access to a total addressable market of $152 billion.
The regenerative technologies market is broken down into six main segments, which include:
NeXtGen's current focus is on the product segment of scarless healing, which accounts for the largest share of increasing adoption in the past three years. This allows us to have substantial application within the wound care and neuromusculoskeletal aspects of the regenerative medicine market, since there has been a growing necessity to treat geriatric populations and prevent future orthopedic diseases. We plan on also potentially expanding into key regions across the world, focusing first in North America. With this, NeXtGen is poised best to offer a new platform solution to an existing $19 billion market.
Competition
Robust IP protection issued
Claims filed and issued for exclusive ownership:
“A tissue graft comprising extracellular matrix components. derived from a Urodele, said tissue graft derived by:
a) obtaining a tissue sample from a urodele, which tissue sample comprises extracellular matrix; and
b) decellularizing said tissue sample to produce decellularized extracellular matrix by removing sufficient cellular components of the sample to reduce or eliminate antigenicity of the biomaterial making suitable for use as a xenograft.”
Vision and strategy
We are building a company for the future to address a growing unmet medical need:
Scar-free healing.
We begin with our first product, NeoMatriX® Wound MatriX—cleared for use in a variety of acute and chronic wounds.
Your investment will help drive value by:*
- Broadening our portfolio and pipeline to address unmet need in regenerative medicine
- Strengthening expected growth due to enlarging market and market share gains
- Improving margin as portfolio expands
- Financing to carry the company through initial product launch to cash flow-positive
- Investing in scaling sales management, market development, clinical data and new product innovation
* Click here for important information regarding Financial Projections which are not guaranteed.
Funding
Raised $13,998,288 to date
CF target $5M
Financing to bridge the gap to positive cash flow AND make significant headway in producing data to support new product claims (antimicrobial, anti-inflammatory, growth factor profile) and product line extensions (gel, spray, liquid, sponge) to address larger size wounds including burns.
*Raised $13,998,288 as of 9/1/22
What Investors Are Saying
“At F&M we’re focused on identifying and investing in companies that provide cutting-edge solutions to the most pressing challenges of our time — these themes include food security, decarbonization, and the health of our growing global population. Nextgen is a key part of our healthcare exposure with a management team that has the capability to commercialize a novel healthcare technology with broad-based applications.”
- Stan Bharti, Chair and Founder Forbes & Manhattan, Inc.
"As educators, my husband and I encourage students to embrace innovation and technology and become thinkers and leaders who will eventually make a global impact. When the opportunity to invest in Nextgen Biologics came along, we knew this type of company was exactly what we want our future-ready graduates to aspire to. We feel personally invested in a company with the mission to impact the future of medicine and patients' wellbeing."
- Christina Head
Founders
Leadership strength built on generational knowledge & passion
Jamie Grooms and Jonelle Toothman, though a generation apart, discovered a common
passion for the science behind improving health care. He was looking for a developing leader and she was in search of a new challenge. Their lunch meeting led to a founding partnership of NeXtGen Biologics, Inc. The medical device company that grew out of their discussion is taking a novel approach to regenerative medicine, capitalizing on the healing properties found in a naturally sourced extracellular matrix — or ECM.
Armed with a bachelor’s degree in biology more than 30 years ago, Grooms launched his career in health care, working for tissue donation and grafting companies. The more he learned about the technology of tissue healing and bone reconstruction, the more he wanted to improve on patient care. Soon his scientific path merged into the business of health and medical products.
His career achievements helping to bring pivotal medical device companies to life is well-‐documented by the success of Gainesville startup companies like RTI Surgical, Inc., that grew a global implant market, and AxoGen, Inc., which he founded and served as board chairman.
Grooms honed his business and early CEO leadership skills the hard way transitioning his roles between science and business, always learning on the job. He learned that successful development of a new technology begins with one question. “Does it have a calling?” asked Grooms. “You have to look at what’s currently on the market, and what opportunity this new technology offers,” said Grooms. “It must be substantial and add significant value to the user to have a calling.”
Attending a scientific presentation, he learned about an ECM material that caught his attention and he knew this was a significant new technology. He licensed the patent for future development.
“Then, I met a unique leader — Jonelle Toothman,” said Grooms. “When you have a unique opportunity drop in your lap, and then you find the right leader, you change plans.”
While earning her degree in journalism and mass communications at Marshall University, Toothman lost her sister who had been suddenly diagnosed with a rare brain tumor. This changed her career thoughts, making her the first in her family to think about health care and medicine. Upon graduation, she began working for Pfizer, Inc., where she learned everything from sales and marketing to the pharmacogenetics of disease. She even trained in hospital operating rooms, gaining knowledge about neurosurgery and medical devices.
What started as an introductory lunch with Jamie, turned into a 3-hour meeting—that ended with Grooms asking her to look at his patent and come back with her thoughts on marketability.
Their new partnership began and NeXtGen was Incorporated in April 2014.
An ancient Chinese philosopher Lao Tzu, wrote, “To lead people, walk behind them.” Now, with the right mentor behind her, Toothman was ready to lead in a new role.
Six years later, as CEO, Toothman has accelerated and maneuvered the company from proof of concept toward commercialization with the agility of a young racecar driver. Raising over $13 million in startup capital, she has assembled a world-class team to commercialize an innovative healing technology to improve upon patient care.
“I’m honored to be a part of a company from development to completion, working with a technology so significant that it can be life changing for many patients,” said Toothman. “I dream of the day when a child who suffers a traumatic injury, heals without disfiguring scars.”
1. Block, L. Et al. 2015. Emerging Therapies for Scar Prevention, Advances in Wound Care. 4:10
2. Chronic Wound Care Market Size, Share, Global Industry Trends [2027]
3. Torre, J. et al. 2021. Chronic Wounds. Medscape. https://medicine.medscapte.com/article/1298452-overview
4. Wound care market Size. 2021-2028. https://www.grandviewresearch.com/industry-analysis/wound-care-market#.
5. Sen, C. 2019. Human Wounds and its Burden: An updated Compendium of Estimates. Advances in Wound Care. 8:2
6. Piez, K. 1997. History of extracellular matrix: a personal view. Elsevier Science. Aug;16(3):85-92. https://pubmed.ncbi.nlm.nih.gov/9314158/
7. National Cancer Institute. Definition of extracellular matrix. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/extracellular-matrix
8. Godfrey, M. 2009. Extracellular Matrix. Science Direct. https://www.sciencedirect.com/topics/medicine-and-dentrisry/extracellular-matrix
9. Kular, J. et al. 2014. The extracellular matrix: Structure, composition, age-related differences, tools for analysis and publications for tissue engineering. J of Tissue Eng. 5:1-17
10. Vieira, W. et al. 2020. Advancements to the Axolotl Model for Regeneration and Aging. Gerontology 66:212-222
