ASBTDC client NuShores Biosciences has received a $100,000 Small Business Innovation Research Matching Grant from the Arkansas Economic Development Commission to support Phase II of its National Institutes of Health SBIR Fast Track grant.
Through the SBIR grant, NuShores is developing advanced materials technologies for bone fillers to improve bone healing in dental implant surgery.
“The AEDC match will support pursuit of our required pivotal studies towards regulatory approvals,” said Dr. Alex Biris, chief technology officer of NuShores.
NuShores’ Dr. Alex Biris and Sharon Ballard
Status of NuCress™ Bone Filler Device
“The technology is fairly mature now. In Phase II of this SBIR project, we are focused on manufacturing/device documentation and quality management system policies that the regulatory agency will inspect after their approve for use of our NuCress bone filler device,” said Sharon Ballard, CEO of NuShores.
The company’s collaborators at Stony Brook University College of Dental Medicine are focusing their Phase II SBIR efforts on preclinical studies that the dentists and dental surgeons will expect to refer to in future journals. “Some of the results that they will bring to NuShores as part of this effort include final product dimensions and best clinical practices,” said Biris.
Next Research and Development Milestones
NuShores’ next major milestone will be the pivotal studies that the Food and Drug Administration will require for clearance for use in humans. “Funding for this final set of studies is our focus for 2020. The first set of experiments in Phase II SBIR have gone well and we are encouraged to start the first tiny steps towards pivotal studies,” said Ballard.
This year, NuShores will also be seeking funding for manufacturing process automation.
“This automation will drive up gross margins to be competitive in a price sensitive marketplace. We also need funds to manufacture NuCress devices here in Arkansas,” said Ballard.
Building Relationships with Customers
“We have participated in four major industry events over the last two years. Last year, we presented our first set of data on the efficacy of the NuCress scaffold from the Phase I SBIR results in dental implant indication and as well for spinal fusion indication,” said Biris.
NuShores was also sponsored by the NIH to attend and exhibit their results at the BIO 2019 international convention in Philadelphia.
ASBTDC Assistance
“We leaned hard on the experts at ASBTDC for the detailed market insights required for the original Fast Track proposal. The market data was instrumental in NuShores engaging with the marketplace leaders and obtain their expressions of interest once testing is completed,” said Ballard.
“Rebecca Todd worked closely with our team in the preparation of the entire commercialization section of the proposal and performed a thorough review of the entire proposal prior to submission,” said Biris.
Advice for Prospective SBIR Matching Funds Applicants
The NuShores team recommends that all recent Arkansas SBIR awardees explore the SBIR Matching Grant program through AEDC.
“Seek AEDC expression of interest and support early for proposals, as well as their insights and advice. The agencies and their reviewers value state interest and support in their ventures. It might surprise entrepreneurs that it really matters to the federal agencies that there is such local support for their ventures,” said Ballard.