Augment Health is developing a noninvasive bladder monitor and AI algorithm for 7M patients with bladder dysfunction following neurologic disease or injury, a $10.2B market.
Augment Health is developing a noninvasive bladder monitor and AI algorithm for 7M patients with bladder dysfunction following neurologic disease or injury, a $10.2B market. The technology shifts in-clinic diagnostics, which today face a 44% inconclusive test rate, to the home while also eliminating reversed bladder filling and rectal catheterization through proprietary data analysis.
Jared Meyers (CEO/Co-Founder) brings expertise from sales and product roles across multiple startups. Personally, he's seen the issues with bladder care his grandmother faced for decades after sustaining a spinal cord injury. Stephen Kalinsky's (CTO/Co-Founder) background spans healthcare technology development at startups and research institutions. The founders met at Georgia Tech, both studying biomedical engineering. They are supported by a deeply experienced advisory team, including the following Scientific Advisors: - Dr. Melissa Kaufman, VUMC Urology Division Chief and American Urologic Association guidelines panel member. - Dr. Emily Blum, urologist at Georgia Urology and professor at Emory University. - Linda Schultz, PhD, certified rehabilitation nurse and independent contractor to the Reeve Foundation. And corporate advisors: - Shawn Glinter, deep life sciences background and multiple successful exits. - Tyler Godoff, experience driving investment initiatives at family offices. The founders' backgrounds, thorough customer discovery, and expert advisory board are positioned perfectly to address this critical need.
Augment Health's go-to-market strategy has two core phases post-clearance: (1) target high-volume neuro-urology practices through direct sales which then transitions into (2) expanding to general urology practices with significant chronic bladder dysfunction populations. Success during Phase 1 provides clinical validation and key opinion leader buy-in that will facilitate further expansion and adoption over time. Clinician buy-in for our approach is reinforced by our established Scientific Advisory Board. The product is in the final stages of transfer to manufacturing, with a pre-clinical study and FDA pre-submissions complete. From there, next steps include regulatory testing and subsequently a 510(k) submission for the Class II product, alongside a commercially-focused clinical study.
The revenue model is based on a per-study charge of approximately $210 which includes the hardware as well as software cost, while urology clinics benefit from a total of $470 per study in reimbursement codes that they are newly eligible to bill. One neuro-urology clinic would gain $282K in annual reimbursement through those CPT codes and represent $126K in annual contract value for Augment Health.
Augment Health is raising a $5.9M Series A. This capital will be used to achieve core value inflection milestones: a 10-patient clinical study, 510(k) clearance, and limited market release.
The technology has been preclinically validated and will be further validated in the upcoming clinical study. Notable completed milestones include: (1) final designs for production at scale, (2) preclinical data demonstrating sensor functionality with an accuracy level over 99% in porcine bladders, (3) preclinical study presented at the 2024 Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) meeting, (4) confirmed insurance coverage via existing CPT codes with superior margin, (5) 510(k) pathway confirmed by FDA pre-submission meetings, (6) utility patents have been filed with priority to a provisional filed in 2020 and a PCT filed in 2021.
Augment Health is at the preclinical stage with key near-term milestones including a clinical study, regulatory testing, and 510(k) submission. $1.2M of investment capital has been previously raised, with notable investments from Vanderbilt University, Georgia Tech, and Regional One Health, and an NIH grant has been submitted and is currently pending. The company is supported by leading medtech accelerators ZeroTo510 and MedTech Innovator.
