Augment Health is transforming the $12.3B urodynamics market by replacing complex in-clinic testing with the first at-home monitoring system, immediately unlocking significant revenue opportunities for clinics while solving a critical access gap for 200K patients actively seeking care.
Augment Health is addressing chronic bladder dysfunction facing 7M US patients following neurologic injury or disease — a $12.3B annual market opportunity. Urodynamic studies are the primary diagnostic for this patient population, but major barriers exist: 60% of US counties lack a urologist, scheduling can be delayed up to 5 months, and 44% of tests are non-diagnostic. Nearly 200K patients are actively seeking urodynamics but unable to access it, representing a $114M initially obtainable market. Augment Health's solution includes a portable bladder pressure monitor, patient app to gather and transmit data, and a physician dashboard for reviewing the data collected. Three key innovations drive value in the platform: (1) miniaturized electronics, (2) single-catheter measurement, and (3) artifact filtering and classification. The design allows physicians to bypass urodynamic suite constraints and monitor in the home setting, on-demand during natural bladder filling. Our patent-pending monitor transforms urodynamic testing from a complex in-clinic procedure to a simple at-home solution. By integrating with existing catheter systems, we eliminate the need for new clinical training while delivering superior diagnostic data. This drives immediate ROI for clinics through both increased patient throughput and new reimbursement opportunities of up to $282K annually per clinic.
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.
Neurogenic lower urinary tract dysfunction (NLUTD) is a chronic condition impacting 7M US patients with impaired bladder function following neurologic injury or disease. The current $1.1B urodynamics market, plus $114M in unmet demand from nearly 200K US patients who are recommended but unable to access screening, represents our serviceable addressable market. 10K US urologists and advanced practice providers treat some number of NLUTD patients and about 1,000 of these clinicians are neuro-urologists, having a predominant focus on this patient demographic. 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 NLUTD populations. Success during Phase 1 provides clinical validation and key opinion leader buy-in that will facilitate further expansion and adoption over time. Our market entry is supported by partnerships with manufacturers and distributors, and our current Scientific Advisory Board reinforces clinician buy-in for our approach. 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 represents a potential $126K in annual contract value for Augment Health with the clinic itself becoming eligible for $282K in new reimbursement through CPT codes.
Augment Health is seeking $490K in funding from investors to complete a total $1.1M seed financing with previous investments into the round from Vanderbilt University, Georgia Tech, and angel investors. This capital will be used to achieve core value inflection milestones: a 10-patient study to demonstrate the device's accuracy which translates into further commercial support, manufactured devices which are tested fully according to FDA requirements, and move toward 510(k) clearance of the device. We are especially seeking investors with the right background to support the team beyond capital, having the ability to make introductions to subject matter experts, potential customers, and future investors as the company continues to mature.
The company is currently at the seed stage, with animal study data collected and an upcoming clinical study. Notable completed milestones include: - Developed final prototypes as the transfer to manufacturing process is nearly finished. - Established advisory board including key opinion leaders and subject matter experts. - Collected animal data to demonstrate our sensor's functionality with an accuracy level over 99%, which we then presented at the 2024 Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) meeting. - Confirmed existing insurance coverage under the CPT codeset. - Met with FDA across two pre-submissions to validate our product submission pathway and testing plan. From an intellectual property standpoint, utility patents have been filed with priority to a provisional filed in 2020 and a PCT filed in 2021.
Pre-Seed: $650K from investors including ZeroTo510, Regional One Health Innovations, and various angels. Seed: $610K / $1.1M from investors including Vanderbilt University, Georgia Tech, and angel investors. NIH submission currently in-progress.
