CHICAGO--(BUSINESS WIRE)--Surgical Innovation Associates (SIA), a medical device spin-out from Northwestern University, announced today it secured a $2M grant from the National Cancer Institute (NCI), the largest institute within National Institutes of Health (NIH), via the Small Business Innovation Research (SBIR) program. The Chicago-based company is focused on developing and commercializing implantable, absorbable devices in the rapidly growing, multi-billion-dollar market for reconstructive and aesthetic surgery. Its lead product, DuraSorb® Monofilament Mesh, received initial 510(k) clearance for soft tissue support from the US Food and Drug Administration (FDA) in late 2018.
The NCI/NIH SBIR grant project, entitled First and Only Soft Tissue Support Device to Improve Patient Experience and System Cost in Breast Reconstruction, comes on the heels of a successfully over-subscribed Series A Financing. The grant partially offsets the costs of a clinical trial that the company has been planning, the goal of which is to expand DuraSorb’s FDA indications to include prosthetic breast reconstruction. SIA plans to pursue FDA approval of an IDE application for the study in 2020.
Approximately 100,000 women in the US every year undergo prosthetic breast reconstruction in the course of their cancer care.1 These procedures benefit psychosocial recovery after a mastectomy.2 Although cadaver-skin-based mesh products have been studied and used in clinical practice, none have received FDA clearance for this specific application.3-5 SIA hopes to address the unmet need for additional, FDA-approved mesh materials for use in reconstructive procedures by studying DuraSorb® in prosthetic breast reconstruction, under an Investigational Device Exemption (IDE).
One of the co-principal investigators (co-PI’s) of the NCI grant is Albert Losken, MD, FACS, Professor of Plastic Surgery at Emory University School of Medicine who has over 20 years of clinical plastic surgery experience and over 150 peer-reviewed publications. “SIA’s technology has the potential to address significant challenges associated with current breast reconstructive surgery. DuraSorb® represents an absorbable and biocompatible support system to help achieve both a speedy recovery and optimal long-term results, potentially also making the procedures more cost-effective,” commented Dr. Losken.
Alexei Mlodinow is the CEO and co-founder of the company and co-PI of the grant with Dr. Losken. “The SBIR program is highly competitive, and this National Cancer Institute grant validates our market opportunity, innovative technology, and the fact that we are planning a rigorous scientific development program, with FDA input,” Mr. Mlodinow commented. “With this transformational multi-million dollar grant, we hope to work with FDA to provide a safe, effective, alternative to current practice for mastectomy patients.”
About the SBIR Program
The United States Congress created the SBIR program in 1982 to stimulate technological innovation and to increase private sector commercialization of innovative technology. Federal agencies with extramural research budgets over $100 million are required to set-aside a certain percentage of their budget to the SBIR program. Eleven federal agencies have SBIR programs including the NCI. Last year, a total of 257 SBIR Phase II grant applications received awards totaling over $213 million, with only 5 of 27 applications receiving awards in Illinois, where SIA is headquartered.
About Surgical Innovation Associates (SIA)
SIA is committed to bringing better outcomes to patients and lowering systemic costs through “for surgeon, by surgeon” innovation in reconstructive and cosmetic surgery. Founded in Chicago in 2016, SIA has since advanced its initial DuraSorb® product line from ideation through FDA 510k clearance and into the operating room. Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue in order to provide strong support during the critical initial phases of healing, and then slowly dissolve within one year, leaving the patient free from foreign material. The company plans to pursue investigation and development of additional products and indications for breast reconstruction and facial aesthetic applications, among others. Implantation of any medical device carries risk of complications, and a full list of Warnings and Precautions is available in the Instructions for Use document for DuraSorb®. In the United States, the device has been cleared only for soft tissue support and remains investigational for the other specific applications discussed above.
Learn more at SIA.health.
References
1 - American Society of Plastic Surgeons. “2018 Plastic Surgery Statistics Report.” Available at: https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-full-report-2018.pdf. Accessed October 29, 2019
2 - Atisha D, Alderman AK, Lowery JC, Kuhn LE, Davis J, Wilkins EG. Prospective analysis of long-term psychosocial outcomes in breast reconstruction: two-year postoperative results from the Michigan Breast Reconstruction Outcomes Study. Ann Surg. 2008 Jun;247(6):1019-28.
3 - Kim JY, Davila AA, Persing S, Connor CM, Jovanovic B, Khan SA, Fine N, Rawlani V. A meta-analysis of human acellular dermis and submuscular tissue expander breast reconstruction. Plast Reconstr Surg. 2012 Jan;129(1):28-41.
4 - Smith JM, Broyles JM, Guo Y, Tuffaha SH, Mathes D, Sacks JM. Human acellular dermis increases surgical site infection and overall complication profile when compared with submuscular breast reconstruction: An updated meta-analysis incorporating new products(✰). J Plast Reconstr Aesthet Surg. 2018 Nov;71(11):1547-1556.
5 - Macadam SA, Lennox PA. Acellular dermal matrices: economic considerations in reconstructive and aesthetic breast surgery. Clin Plast Surg. 2012 Apr;39(2):187-216.
