Surgical Innovation Associates Secures $2M NCI Grant to Expand DuraSorb® Indications for Breast Reconstruction

VCBeat (WeChat ID: vcbeat) learned from foreign media that on November 5, 2019, local time, Surgical Innovation Associates (hereinafter referred to as SIA), a biotechnology company headquartered in Chicago, announced that it had received a $2 million grant from the U.S. National Cancer Institute (NCI) through the Small Business Innovation Research (SBIR) program.

SIA, a medical technology company spun out of Northwestern University in 2016, focuses on the research, development, and commercialization of implantable and bioresorbable medical devices for plastic and reconstructive surgery. The company’s flagship product, DuraSorb®, received FDA 510(k) clearance in 2018 for soft tissue support in the human body.

It is reported that the grant obtained this time offset part of the costs for the clinical trials planned by SIA, which aims to expand the indications of DuraSorb® on the FDA list to include prosthetic breast reconstruction. In addition, SIA also plans to seek FDA approval for its Investigational Device Exemption (IDE) application in 2020.

In the United States, approximately 100,000 women undergo prosthetic breast reconstruction as part of their cancer care each year. Although meshes derived from medical-grade cadaveric skin have been developed and implemented in clinical practice, no such products have received FDA approval. SIA aims to address this challenge by submitting an Investigational Device Exemption (IDE) application to study the use of DuraSorb® in prosthetic reconstruction.

Dr. Albert Losken, Professor of Plastic Surgery at Emory University School of Medicine and one of the co-principal investigators for the NIC SBIR project, stated that SIA’s technology holds significant potential to address major challenges associated with breast reconstruction surgery. “DuraSorb® represents an absorbable and biocompatible support system that facilitates rapid short-term recovery and optimal long-term outcomes, while also potentially enhancing the cost-effectiveness of the procedure.”

Alexei Mlodinow, CEO and Co-founder of Surgical Innovation Associates (SIA), commented, “The SBIR program is highly competitive. The funding from the National Cancer Institute validates our market opportunity and innovative technology, as well as the fact that our rigorously planned scientific development program has received FDA support. With this multi-million-dollar grant, we hope to collaborate with the FDA to provide a safe and effective alternative treatment option for mastectomy patients.”

Previously, SIA secured seed and Series A financing in 2018 and 2019, respectively. On March 13, 2018, the company completed a $325,000 seed funding round. On October 2, 2019, it closed an oversubscribed $4 million Series A round, led by Harvard Business School Angels Chicago and Gopher Angels. The funds raised by SIA were all allocated to advancing the research, development, and commercialization of DuraSorb®.

The U.S. Congress established the SBIR program in 1982 to stimulate technological innovation and increase the commercialization of innovative technologies by the private sector. Eleven federal agencies, including the NCI, operate SBIR programs, and federal agencies with external research budgets exceeding $100 million are required to allocate a certain percentage of their budgets to the SBIR program. Last year, a total of 257 SBIR Phase II grant applications received awards totaling more than $213 million; among the 27 applications from Illinois, where Surgical Innovation Associates is headquartered, only five were funded.

Surgical Innovation Associates (SIA) is committed to innovating in reconstructive and cosmetic surgery through its “by surgeons, for surgeons” philosophy, providing patients with better treatment options while reducing system costs. Since its establishment in Chicago in 2016, SIA took just two years to bring its initial DuraSorb® product line from concept to FDA 510(k) clearance and into the operating room. Similar to absorbable sutures, DuraSorb® monofilament mesh is designed to integrate into patient tissue, providing robust support during the critical early stages of healing, and then gradually dissolving within one year, thereby sparing patients from long-term presence of foreign materials. The company plans to conduct research and development on other products for applications such as breast reconstruction and facial aesthetics. Implantation of any medical device carries a risk of complications; a complete list of warnings and precautions is provided in the DuraSorb® Instructions for Use. In the United States, this device is indicated only for soft tissue support, and the aforementioned other specific applications remain under investigation.

(Compiled by Hu Lushuang)