Burst Biologics Prepares for Comprehensive Clinical Trial for Spinal Fusions
- Written by Newsfile
Boise, Idaho--(Newsfile Corp. - August 1, 2022) - Burst Biologics has begun preparation to file an investigational new drug application on its patented technology platform to support spinal fusions. The company is in the process of taking its advanced tissue technology through the designated regulatory framework in support of the Federal Food & Drug Administration's (FDA) mission to transition certain human cell and tissue-based technologies, known as HCT/P's, to the drug approval pathway.
Since 2017 Burst Biologics has collected comprehensive clinical data through an IRB-approved multicenter prospective clinical registry for spinal fusions and intends to use this data in support of its regulatory filings.
The current fusion market represents $2.75 billion in annual spend and is anticipated to have a compound annual growth rate of 4% to 6% for a total market opportunity of over $3.5 billion upon product approval. The company intends to file for additional indications following its initial submission for spinal fusion.
As Christopher Jones, CEO of Burst Biologics, explains, "Significant market opportunity and unmet need represent substantial value for investors and patients alike. It is our mission to advance healthcare in a meaningful and impactful way that supports patients returning to daily activities following these procedures."
For more information on this prospective multicenter clinical study, please visit:
About Burst Biologics
Burst Biologics is a clinical trial stage pharmaceutical company developing advanced biologics to support the musculoskeletal system and unmet needs with orthopedic pain management. The company's headquarters, state-of-the-art research facility, and manufacturing facility are located in Boise, Idaho.
For more information about Burst Biologics and its drug development pipeline please visit its website at:
https://www.fortunebusinessinsights.com/industry-reports/spinal-fusion-devices-market-101689[3]
Media Contact
Christopher JonesBurst BiologicsInvestor Relations1-888-322-1191info@smart-surgical.com[4]
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/132458[5]
References
- ^ www.clinicaltrials.gov (www.newsfilecorp.com)
- ^ www.BurstBiologics.com (www.newsfilecorp.com)
- ^ https://www.fortunebusinessinsights.com/industry-reports/spinal-fusion-devices-market-101689 (www.newsfilecorp.com)
- ^ info@smart-surgical.com (www.newsfilecorp.com)
- ^ https://www.newsfilecorp.com/release/132458 (www.newsfilecorp.com)