aibioBioRestorative suspends orders and shipments of two biocosmeceutical lines
Tickers BRTX
The company paused its ExoCR and BioX products on August 7, 2026 while it reviews documentation, sourcing and regulatory status. It has not decided to discontinue them.
Key facts
- Company
- BioRestorative Therapies, Inc. (NASDAQ: BRTX)
- News type
- Company Updates
- Primary source
- BioRestorative Therapies, Inc. 8-K (2026-08-14)
BioRestorative Therapies, Inc. (Nasdaq: BRTX) suspended all orders and shipments of its biocosmeceutical product lines on August 7, 2026, according to an 8-K dated August 14, 2026. The suspension covers two lines, its ExoCR products and its BioX products. The company said it is reviewing the documentation, sourcing and regulatory status of the products, and that it has not decided to discontinue them.
What the company said
The suspension took effect immediately, pending a business review and a regulatory assessment. The company has not made a decision to discontinue these product lines. The review covers the documentation, sourcing and regulatory status associated with the products.
The filing also says that the outcome of the review, the company's ability to resume sales of the affected lines, the costs of the suspension and its need for additional capital are uncertain. It refers readers to the risk factors in its annual report on Form 10-K for the year ended December 31, 2025. The 8-K was signed by Katharyn Field, who is listed as Director, Chief Executive Officer, President and Interim Chief Financial Officer.
The business behind the products
The company's 10-K, filed on March 26, 2026, describes a commercial biocosmeceuticals business. Its current commercial product is a cell-based secretome containing exosomes, proteins and growth factors. The company says the serum is formulated and manufactured in its cGMP ISO-7 certified clean room, and that it was engineered to reduce the appearance of fine lines and wrinkles. The company also said it intends to explore expanding that offering to a broader family of cell-based biologic aesthetic products and therapeutics through IND-enabling studies.
The company's lead research program is the Disc/Spine Program, built around BRTX-100. The company is running a Phase 2 trial of BRTX-100 in chronic lower back pain arising from degenerative disc disease. In June 2025, it presented preliminary blinded data from 36 patients in that trial. Over 74% of the subjects showed greater than 50% improvement in function by 52 weeks, and over 72% reported greater than 50% reduction in pain by 52 weeks. These are preliminary blinded figures from a small group, which cannot separate drug from placebo, and the sources give no p-values. No serious adverse events or dose limiting toxicities were reported between 26 and 104 weeks at the target dose.
In November 2025, the company was granted a Type B meeting with the FDA to discuss a potential accelerated biologics license application pathway for the program. The meeting took place in December 2025. Based on the official summary of that meeting, the company has started Phase 3 enabling activities with the goal of submitting a Phase 3 IND during 2026. Its ThermoStem Program is pre-clinical.
Financial position
For the year ended December 31, 2025, research and development expense was $10.1 million, compared with $6.7 million for 2024. The net loss was $14.2 million for 2025 and $9.0 million for 2024. Cash used in operations was $10.8 million in 2025 and $8.2 million in 2024. At March 31, 2026, cash and cash equivalents were $3.1 million and short-term investments were $479,351.
In October 2025, the company issued 678,125 shares in a registered direct public offering, with gross proceeds of $1,085,000. In February 2026, it received gross proceeds of $5,000,000 from a public offering.
What comes next
The filing does not say what problem prompted the review, beyond naming documentation, sourcing and regulatory status. Cash and cash equivalents were $3.1 million at March 31, 2026, against $10.8 million of cash used in operations in 2025, and the company itself lists its need for additional capital as uncertain. The filing does not set a date for completing the business review or the regulatory assessment. It also does not say when, or whether, the affected products will resume sales. The company has not decided whether to discontinue them. Its lead program has a stated goal of a Phase 3 IND submission during 2026.