Theradaptive Secures Third FDA Breakthrough Designation for Spinal Fusion
FREDERICK, Md. and BOSTON, June 22, 2022 /PRNewswire/ -- Theradaptive, a privately held biopharmaceutical company pioneering a new class of regenerative implants announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Medical Device designation for the use of OsteoAdapt SP in Anterior Lumbar Interbody Fusion. This is the third Breakthrough Designation for Theradaptive in spinal fusion, along with transforaminal interbody and posterolateral fusion, allowing it to address over 90% of lumbar spinal fusion procedures.
The Breakthrough Devices Program is a program for select medical devices that provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Theradaptive with priority review and interactive communication regarding device development and clinical trial protocols during the premarket review process. Expedited review of the PMA is included as a benefit.
"Evidenced by this being the third Breakthrough Designation awarded by FDA to Theradaptive for this technology, there is a significant need for it in the bone grafting space. I see immense opportunity and advantages to the utility of OsteoAdapt SP in ALIF indications. It is exciting to explore the potential advantages of this new product compared to current commercial offerings." said Dr. Jay Jolley, the founder of Southeastern Spine, Brain and Joint and the Riverfront Surgery Center in Chattanooga, TN.
Theradaptive's regenerative implants are best-in-class and are designed to permit precise and directed tissue regeneration for a variety of tissue types and clinical indications. This new technology can enable superior outcomes and safety as well as greatly improved ease of use.
"This is Theradaptive's third Breakthrough designation from the FDA and broadens our portfolio of spinal fusion approaches. This significantly increases the number of patients who can potentially benefit from this game-changing technology. Theradaptive has now been granted Breakthrough Status on three indications for use. No other orthopedic manufacturer has achieved this" said John Greenbaum, Senior Vice President of Clinical & Regulatory Affairs at Theradaptive.
Theradaptive is a venture-backed biopharmaceutical company developing a therapeutic delivery platform technology for targeted tissue regeneration with a total addressable market of over $10B in several clinical indications. Theradaptive was spun out of the Massachusetts Institute of Technology and has received significant research and development support from the US Department of Defense. Theradaptive has operations in Frederick, MD, Orlando, FL, Tennessee, and Boston, MA.
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U.S. DEPARTMENT OF COMMERCE ANNOUNCES 51 “BUILD TO SCALE” GRANTS TOTALING $47 MILLIONTO FUEL INNOVATION AND TECH-BASED ECONOMIC DEVELOPMENT
Contact: EDA Public Affairs Department, (202) 482-4085
October 5, 2022
WASHINGTON – Today, U.S. Secretary of Commerce Gina Raimondo announced that the Department’s Economic Development Administration (EDA) is awarding 51 “Build to Scale” grants – totaling $47 million – to organizations that support technology entrepreneurs, catalyze innovation and fuel economic growth.
EDA’s “Build to Scale” program provides annual grants that aim to accelerate technology entrepreneurship by increasing inclusive access to entrepreneurial support and startup capital. The 2022 awardees will leverage an additional $48 million in matching funds from a variety of private and public sector sources. These EDA investments support advanced manufacturing, bioscience, clean energy and blue economy clusters in regions throughout the United States.
"Strengthening technology ecosystems are a critical key to the Biden Administration's efforts to build a stronger America,” said Secretary of Commerce Gina Raimondo. “Innovation and entrepreneurship have long been keys to American success and will continue to strengthen our collective economic and national security, as well as individual prosperity and well-being.”
"EDA is proud to partner with this year's 'Build to Scale' grantees as they invest in entrepreneurs and create equitable access to capital in their communities," said Assistant Secretary of Commerce for Economic Development Alejandra Y. Castillo. "These projects will give the next generation of industry-leading companies a seminal boost that will result in job creation and private investment – potentially transforming a regional economy and creating economic opportunity beyond what we can foresee.”
The 2022 Build to Scale program was comprised of two competitions––the Venture Challenge and the Capital Challenge. The Venture Challenge supports programs that enable high-growth technology entrepreneurship and foster inclusive access to proven entrepreneurship support models. The Capital Challenge increases access to capital in communities where risk capital is in short supply by providing operational support for early-stage investment funds, networks, and training programs that focus on both traditional and hybrid equity-based financing.
About the U.S. Economic Development Administration (www.eda.gov)
The mission of the U.S. Economic Development Administration (EDA) is to lead the federal economic development agenda by promoting competitiveness and preparing the nation's regions for growth and success in the worldwide economy. An agency within the U.S. Department of Commerce, EDA invests in communities and supports regional collaboration in order to create jobs for U.S. workers, promote American innovation, and accelerate long-term sustainable economic growth.