NIA Small Business Showcase: Obatala Sciences
Pressure ulcers commonly complicate the care of bed-ridden patients, including younger individuals with paraplegia or quadriplegia and older adults living in nursing homes. Data in the literature suggests that ischemia reperfusion episodes account for the causative mechanism of pressure ulcer injuries, leading to lesions that range from damage limited to the epidermis (Stage 1) to lesions involving the epidermis, dermis, adipose tissue, skeletal muscle, and bone (Stage 4). Cell therapy is proposed as an alternative therapy for pressure ulcers and related skin injuries, such as burns. There remains a need for additional, controlled clinical trials to document the safety and efficacy of adipose-derived stromal vascular fraction (SVF) cells in the treatment of pressure ulcers, as well as an opportunity to provide products that can significantly reduce the economic and health impact caused by this condition.
Obatala focuses on the production of premium-quality stem cells for scientific investigators in the academic and biotechnology research communities. Obatala’s long-term goal is to facilitate the clinical translation and regulatory approval of stem cells as regenerative therapies. Obatala will first explore the delivery of autologous SVF cells to treat pressure ulcers and will secondarily evaluate the use of culture-expanded, allogeneic adipose-derived stromal/stem cells (ASCs) as an off-the-shelf cell therapeutic modality.
Pressure ulcers afflict up to 11% of nursing home residents annually, and their care was estimated to account for 2% to 4% of health expenditures in 2017 and costs in excess of $26 billion in the United States alone. The treatment market in this space is anticipated to reach $7 billion by 2026.
Clinicians have focused primarily on preventive measures, such as frequent turning of patients and the use of foam or liquid supports under body surfaces at risk for damage (e.g., heels, elbows, sacrum) to reduce pressure ulcers in at-risk populations. However, once a pressure ulcer develops, treatment options rely on surgical interventions such as debridement or negative pressure wound therapy. Obatala’s therapy uses a closed system device to isolate SVF cells from autologous lipoaspirate of patients. The cells are then administered at the base of the wound to help reduce the impact of ischemia, improve blood flow, and speed the reparative stage of healing.
- 2015: Data collection and publication of small animal pressure ulcer model proof of principle
- 2016: Food and Drug Administration permission to proceed with investigational device exemption
- 2016: Completion of Larta program with NIH
- 2020: Completion of the Creative Destruction Lab program at the University of Toronto
- 2020: Final stages of discussion of term sheet with major investment group
- 2020: Strategic alliances with partners for development of biological hydrogels as clinical products
As a result of merging assets with LaCell, Obatala Sciences has received total grant funding of $1.78 million from NIA, the National Center for Advancing Translational Sciences, and the National Science Foundation. Obatala has received $2 million in revenue from sales and contracts and has bootstrapped with $1.5 million in sweat equity from its co-founders.
Obatala is in direct negotiations with investors to raise $4 million to fund the hiring of additional business and marketing experts, research and discovery scientists, and manufacturing personnel, as well as the capital to aggressively pursue intellectual property protection. Additional capital needs include $5 million to conduct the FDA-approved Phase I human clinical trial.
Obatala has a substantial body of intellectual property in the form of trade secrets relating to the production and use of adipose-derived cells and tissues. It is actively pursuing patents. In addition, Jeffrey Gimble, M.D., Ph.D., is the inventor on patent applications that are being filed by academic partners and which are being considered for license agreements.
Product Development and Regulatory Strategy
The major milestone is to carry out a Phase I randomized controlled clinical trial enrolling 21 subjects (7 controls treated with standard of care and 14 subjects receiving SVF cells, 7 of them isolated from 30 ml of autologous lipoaspirate tissue and the other 7 isolated from 60 ml), with 12 months of follow-up. Two academic, university-based plastic surgeons have agreed to enroll subjects for the study, pending funding. Outcomes from the clinical trial will document the safety of the SVF cells and have the potential to demonstrate dose-dependent efficacy. Massive scale can be achieved with cryopreserved, off-the-shelf expanded ASCs.
Obatala is seeking a partnership to provide funding for the initial Phase I clinical trial with an entity that is able to help support subsequent follow-on Phase II clinical studies.
2000 Lakeshore Drive, #4020
New Orleans, LA 70148
- President and Chief Executive Officer: Trivia Frazier, Ph.D., M.B.A.
- Board Member and Co-Founder: Jeffrey Gimble, M.D., Ph.D.
- Board Member and Co-Founder: Xiying Wu, M.D.
- Director of Commercialization: David Bode, M.B.A.
Point of Contact:
Trivia Frazier, Ph.D., M.B.A.
Email Trivia Frazier