Our Mission
ASC Bio’s mission is to prevent the progression of osteoarthritis in chronic and acute musculoskeletal injuries.
At ASC Bio we are frustrated with the current state of cartilage repair options available to patients, especially for younger, highly active patients and/or professional athletes. There is a better solution but it requires fundamental shifts in product design and manufacturing.
Rather than designing products that only treat the symptoms of the disease, why not design a product that can prevent the progression of the disease as soon as it is diagnosed and allow the body to repair itself.
Unmet Clinical Need
Osteoarthritis (OA) is a degenerative disease where the articular cartilage surface deteriorates over time. The deterioration can begin spontaneously without a single notable event or may be directly linked to a single traumatic event or a series of many repetitive small micro-injuries over many years or decades.
- 33 million Americans every year suffer from some form of osteoarthritis
- 2.3 mm procedures are performed in the US every year to alleviate pain and inflammation
- $1.5 bn is spent every year on these treatments that address symptoms not disease
15-20 Year Gap In Care
Early-stage treatments favor non-surgical options, which include Over-the-Counter, prescription medicines and injections focused on relief from pain and inflammation. The relief from these palliative treatments lasts between 1 and 3 years and quickly diminishes as OA damage increases.
The patient moves to the next level of treatment, which is usually some form of surgical intervention. Initial surgical treatments include debridement, microfracture and/or application of various biomaterials with or without cells. Unfortunately, these treatments do not stop the progression of the disease and only provide another 5 – 7 years of relief before the inevitable and invasive partial or total knee replacement (P/TKA).
The lifespan of P/TKA has improved, however, they are generally a last resort option for patients with severe OA and certainly not an ideal option for patients under 65 years old with mild or moderate OA.
This creates a gap in the continuum of care where there is no long-term regenerative solution that can eliminate years of “band-aid” treatments that only manage the symptoms and not the underlying clinical disease. As a result, patients are forced to live with a poor quality of life, managing pain with addictive opioids and often seek questionable investigational treatments outside of the U.S. until they are old enough to get a P/TKA.
The ASC Bio Solution
ASC Bio is developing the catalyst for the body to begin regeneration with a tissue engineered cartilage implant that will bridge this 15 – 20 year gap in clinical care and regenerate the patients' own cartilage back to its native, healthy state.
ASC Bio’s proprietary technology allows us to preserve the cells in a pure, undifferentiated state so we can leverage a high throughput bioprocessing model to produce trillions of cells in a Master Cell Bank (MCB) and hundreds of million cells for our Working Cell Bank (WCB). The WCB is used to seed our biodegradable polymer matrix to ensure reliable and reproducible cell concentrations and consistent early passage levels for each implant every time
Our supercharged biomaterial can be inserted into the osteoarticular or osteochondral defect arthroscopically and secured into place using biodegradable sutures or via dry scope and fibrin glue. No microfracture is required.
Product – ASC-OC1
• Human neonatal foreskin
• cGMP biomanufacturing of MCB and WCB
• Cells seeded into Polymer felt
• Storage ambient in cell preservation medium – READY TO USE not frozen
• Implanted without microfracture
• Fixation by stitches or dry scope and fibrin glue
Platform Technology
Once our high-throughput manufacturing model is established, we can enter adjacent or new markets quickly with only incremental costs in manufacturing and additional regulatory/clinical amendments for new indications.
THIS PRODUCT IS CURRENTLY IN DEVELOPMENT AND NOT INTENDED FOR SALE OR DISTRIBUTION
THE FDA HAS NOT REVIEWED OR APPROVED ANY BIOLOGIC PRODUCTS MADE BY ASC BIOSCIENCES, INC.
Contact ASC Biosciences
Have a question or comment? Contact ASC Biosciences to get in touch with our team.
ASC Biosciences is a development stage Tissue Engineering and Regenerative Medicine Company that has developed a proprietary allogeneic adult Stem Cell Platform capable of regenerating nearly every tissue in the human body. The Platform is comprised of Multipotent Adult Stem Cells (“MASCs”) patented by New York Medical College and licensed by ASC Biosciences. MASCs will differentiate into cartilage, bone, tendon, muscle, ligament, fat, blood vessels, nerves, and skin with an unlimited ability to divide in the undifferentiated state thereby providing whatever numbers of cells are needed to repair the damage.