NIA Small Business Showcase: Modulim
Silent changes in the microvasculature are a hallmark of chronic disease progression and precursor to irreversible complications. For example, approximately 40 million individuals with either diabetes or peripheral arterial disease (PAD) in the United States are at risk for lower limb complications (e.g., ulcers, amputations). Roughly 25% of diabetes patients will get a foot ulcer in their lifetime, and PAD is thought to be undetected in half of patients. Studies have shown that microvascular disease and PAD increase the risk of amputation 23-fold. The microvascular system is a barometer of overall tissue and vascular health. A quantitative method is needed to replace the visual and subjective standards of today.
Modulim’s Clarifi® Imaging System is the first noncontact, noninvasive microvascular assessment tool that uses a proprietary optical imaging technique — spatial frequency domain imaging (SFDI) — to provide insight into the delivery and extraction of oxygen in the microvasculature. This information can help clinicians identify patients who are at risk for vascular/tissue complications by assessing quantitative physiological information up to 4 mm beneath the skin’s surface. Studies have shown that integrated care combining front-line providers, podiatrists, and vascular specialists can reduce amputations by up to 84%. Clarifi establishes a common language between specialties through objective assessment of the microvasculature.
Based on an established reimbursement code with evidence of payment, Clarifi can be used on more than 100 million patients in the United States alone, resulting in a total addressable market size of $3.4 billion. This means Clarifi can significantly reduce catastrophic complications that currently cost the U.S. health care system more than $80 billion a year.
Patented and licensed exclusively to Modulim, SFDI technology measures five critical tissue and vascular health biomarkers that enable clinicians to institute preventive interventions earlier and treat patients proactively. Modulim has demonstrated reimbursement with payment using a proprietary code that is specific to SFDI technology.
- 2019: Review article published on SFDI theory and applications
- 2019: Publication in Journal of Vascular Surgery highlighting diabetes and PAD-related circulatory signatures
- 2020: Publication in Journal of Diabetes and its Complications, in partnership with Kaiser Permanente, highlighting ability to see pre-ulcerative circulation signatures
- 2010–2019: Awarded multiple federal research and development grants
- 2016: Seed raise
- 2017: Series A raise
- 2018: Food and Drug Administration (FDA) clearance received for Clarifi Imaging System
- 2018: Received ISO 13485 certification
- 2018: Name changed to Modulim to signal commercialization
- 2019: Series B raise
- 2020: First sale of medical device in United States
- 2020: Received CE mark
- 2020: First payment of Proprietary Lab Code
- 2020: Series C raise and business growth
Modulim has raised approximately $10 million from private investors and $10 million in grants from NIH and the Department of Defense. Series C funding ($20 million) is targeted for Q1 2021 to accelerate commercialization and sales.
Modulim has an exclusive world-wide license for SFDI that was the premise for starting the company and the foundational technology behind commercial instruments. Since then, Modulim has developed company-specific intellectual property, with a focus on efficient, rapid, quantitative measurements that facilitate important clinical scenarios. In addition, Modulim possesses algorithmic trade secrets that create a unique advantage.
Product Development and Regulatory Strategy
Modulim has used SBIR funding to successfully commercialize two devices. The first is Reflect RS, a research-grade SFDI system that has been sold to researchers in academia and industry. This device has been used to conduct pilot clinical work and preliminary research, to develop the company’s go-to-market medical device, and to build the product pipeline. Modulim has since commercialized Clarifi, an FDA-cleared device to measure oxygenation in superficial tissue for patients with potential circulatory compromise. The Clarifi Imaging System was first available on the market in 2020. The company also demonstrated reimbursement and payment for Clarifi in 2020 in order to reduce barriers to adoption. Finally, Modulim continues to develop clinical evidence to inform decision support scenarios for clinicians to review patient microvascular status and to recommend follow-on care. This will enable broader adoption of the technology.
Modulim’s commercialization strategy is to focus on reducing lower limb complications and amputations due to diabetes and PAD. The company’s proprietary lab analysis reimbursement code can be used at a variety of patient care locations: hospital wound care centers, nursing homes, physician offices, office-based labs, and dialysis centers. The clinicians in this segment are diverse and include podiatrists, interventional radiologists, nephrologists, vascular surgeons, internists, and endocrinologists. Modulim’s strategy is to target the major stakeholders in each of these areas — clinical thought leaders and key clinical providers — as they establish clinical guidelines and to promote adoption of this new technology for wide-scale use across larger health care systems.
- Co-Founder, President, and Co-Principal Investigator: David Cuccia, Ph.D.
- Chief Product Officer and Co-Principal Investigator: Amaan Mazhar, Ph.D.
- Vice President, Sales and Marketing: Gary Marston
Point of Contact:
Email David Cuccia
Showcase selected for: RESI San Francisco