Medical devices & diagnostics · Breast cancer imaging
NearWave
A handheld near infrared scanner built to tell an oncologist within a week whether chemotherapy is working on a breast tumor. The physics has thirty years of literature behind it. The device is investigational, and its first registered study is a 15 patient pilot.
The assignment nobody expected anyone to build
Two electrical engineering doctoral students at the University of Notre Dame had to write a mock grant proposal for a biophotonics course. They proposed a handheld version of an instrument that then filled a cart.
“It hadn’t been done before then so we wrote a grant for it,” Roy Stillwell told TechPoint in 2021. “Then we thought, ‘could we make this real?’ and it turns out you can.”
What they built measures how deep tissue absorbs and scatters near infrared light, and computes hemoglobin, water and lipid concentrations one to three centimeters below the skin. No radiation, no contrast, no compression. The readout lands on an iOS app.
The months you cannot get back
Neoadjuvant chemotherapy is given before surgery to shrink a tumor. It works well for some patients and barely at all for others, and the standard way to learn which is to finish the course and read the surgical pathology.
“About 30% of women don’t respond to the primary therapy during that pre-surgery therapy period,” Stillwell told Inside INdiana Business in 2022. “For three to six months, they’re taking really nasty chemotherapy that’s making them sick, and there may be no effect [on the tumor].”
The optical idea is that metabolism moves before size does. A dying tumor changes its blood and water content within days, long before a ruler or a scan registers anything. That claim is not NearWave’s invention. It was tested in ACRIN 6691, a six site trial run by the American College of Radiology Imaging Network with instruments built at UC Irvine.
The ACRIN result is the benchmark, and it is mixed. Sixty subjects enrolled, 34 had complete evaluable data, and the mid therapy change in the tissue optical index predicted pathologic complete response with an area under the curve of 0.60, confidence interval 0.39 to 0.81. In the 17 patients whose baseline tumor oxygen saturation sat above the 77 percent median, it rose to 0.83. The authors wrote that the approach “shows promise for clinical outcome prediction”, and every word there was chosen carefully.
A student and his adviser
Stillwell has a PhD in electrical engineering from Notre Dame and, the company says, twelve years of embedded design work behind it. He is co-founder, CEO and chief scientist. Thomas O’Sullivan, his doctoral adviser, is the second founder.
O’Sullivan is no bystander here. Before Notre Dame he directed the Diffuse Optical Spectroscopy and Imaging Laboratory at the Beckman Laser Institute at UC Irvine, and he is a co-author on the ACRIN 6691 paper. He was elected an SPIE Fellow in August 2026.
“This advanced near-infrared technology has been around for 30 years now, but mainly in the hands of physicists and engineers in their labs,” he told Notre Dame News in 2022.
Prizes, then accelerators, then a hospital
The early record is a run of competition wins: the McCloskey New Venture Competition at Notre Dame in 2020, the top regional pre-seed prize in the Elevate Ventures Nexus competition that year, a $40,000 Elevate Nexus pre-seed investment in September 2021, the TechPoint Mira Award for Innovation of the Year, and a $100,000 non-dilutive prize from Arizona State University in early 2022. Y Combinator took the company into its Winter 2022 batch.
First prototypes went into a clinical setting in March 2022 at the Paqui and Brian Kelly Comprehensive Breast Center at Saint Joseph Health System in South Bend. In November 2023 the Notre Dame IDEA Center reported $1.5 million in outside investment, an open seed round, and a device sold to researchers in oncology, women’s health and optics.
Since then the visible cadence has been accelerators: Creative Destruction Lab, Tampa Bay Wave HealthTech|X in 2024, the Texas Medical Center HealthTech cohort in 2025, and the thirteenth Health Wildcatters cohort in September 2025, which lists the company in Austin, Texas. The first registered study opened on March 7, 2025 at the Indiana University Simon Comprehensive Cancer Center, with Tarah J. Ballinger, MD as principal investigator.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA status | No 510(k), PMA, registration or listing found for NearWave as of Sep 22, 2026. The company labels the product an investigational device, “currently used for research only.” | Public record |
| Company FDA claim | The Y Combinator launch post says the company received “a letter that the FDA agrees with our regulatory pathway.” Pre-submission correspondence is not published, so this cannot be checked against the record. | Company-stated |
| Registered study | NCT06744465. Prospective pilot, single group, 15 patients estimated, recruiting since Mar 7, 2025. Primary completion estimated Jan 2027. Sponsor: Indiana University. Collaborators: University of Notre Dame, Elevate Ventures, NearWave Corp. | Public record |
| What that study measures | Primary outcomes are data quality, not accuracy: signal to noise above 10 dB for at least 80 percent of points. The protocol states that “there does not exist any preliminary data with this device.” | Public record |
| Evidence for the modality | ACRIN 6691, Cancer Research, Oct 2016: 60 subjects at 6 sites, 34 evaluable, 10 reached pathologic complete response. Area under the curve 0.60 (95% CI 0.39 to 0.81), 0.83 in 17 stratified patients. Instruments came from UC Irvine, not NearWave. | Public record |
| Publications on this device | Engineering validation in Biomedical Optics Express (Nov 2021) and SPIE conference papers in 2019 and 2020. No peer reviewed clinical outcome study of the Scanner itself found. | Not found |
| The 90 percent figure | Notre Dame’s IDEA Center writes that the technology separates benign from malignant tumors “with 90 percent specificity and sensitivity”, and the company site cites “one study showing >90% specificity and sensitivity.” Neither points to a study of this device; that work used earlier instruments. | Claim outruns the record |
| Patents | US 12,004,843 B2 (Jun 11, 2024) and EP 3,773,204 B1 (Jul 26, 2023), both assigned to the University of Notre Dame, priority Apr 5, 2018. Inventors: Stillwell, Kitsmiller and O’Sullivan. WO 2023/230071 A1 published Nov 30, 2023, applicant Nearwave Corp. | Public record |
| Federal grants | No NIH, NSF or SBIR award to NearWave found. NIBIB grant R01EB029595 to O’Sullivan at Notre Dame totals $1,877,447 across FY2021 to FY2024. That money is the university’s. | Public record |
| Revenue | “We already have 4 systems sold to customers ($123k)” per the Y Combinator launch post. Buyers are research groups. No later figure found. | Company-stated |
Read plainly: the science under NearWave is real, published and independently tested, and that literature says optical monitoring predicts response well in some patients and poorly in others. NearWave’s contribution is engineering, shrinking a cart into an instrument a nurse can hold. That is a serious achievement and it is not clinical proof. The first study to put this device in front of patients asks only whether its data is clean enough to justify a real trial.
What to watch
- Results from NCT06744465, estimated January 2027. The endpoint is data quality, so a clean result is a permission slip, not a verdict.
- A larger study powered on pathologic complete response. None is registered.
- An FDA submission appearing in the 510(k) or De Novo databases. In 2021 the company expected to finish that process in about eighteen months.
- Where the company operates. Accelerator listings put it in Austin in 2025; databases carry the South Bend address.
- A priced round. The last dated financing event in commercial databases is an accelerator, September 2025.
In their words
“It hadn’t been done before then so we wrote a grant for it.”
Roy Stillwell, co-founder and CEO, TechPoint, December 2021 · Independent
“For three to six months, they’re taking really nasty chemotherapy that’s making them sick, and there may be no effect [on the tumor].”
Roy Stillwell, Inside INdiana Business, April 2022 · Independent
“This advanced near-infrared technology has been around for 30 years now, but mainly in the hands of physicists and engineers in their labs”
Thomas O’Sullivan, co-founder, Notre Dame News, March 2022 · University news
“You can know within a week or even days if the tumor is shrinking.”
Thomas O’Sullivan, Notre Dame News, March 2022 · University news
“Both my mother and grandmother are breast cancer survivors, as is my co-founder’s wife.”
Roy Stillwell, Y Combinator launch post · Company
“It’s potentially a billion-dollar idea if we can make sure we avoid all the landmines on the way there.”
Roy Stillwell, Inside INdiana Business, April 2022 · Independent
“Due to the investigational nature of the NearWave device, imaging data collected will not be used to inform patient treatment.”
Study protocol summary, NCT06744465, Indiana University · Public record
“We conclude that the combination of baseline functional properties and dynamic optical response shows promise for clinical outcome prediction.”
Tromberg and colleagues, ACRIN 6691, Cancer Research, October 2016 · Peer reviewed
Related companies
Sources
- Public recordClinicalTrials.gov NCT06744465
- Public recordFDA 510(k), PMA and registration databases
- Public recordSEC EDGAR company and full text search
- Public recordNIH RePORTER grant R01EB029595
- Peer reviewedACRIN 6691 Trial of Diffuse Optical Spectroscopic Imaging
- Peer reviewedPerformance assessment of DOSI instruments in a multicenter trial
- Peer reviewedA scalable frequency-domain near-infrared spectroscopy platform
- IndependentSouth Bend hospitals test a Notre Dame breast imaging device
- IndependentNearWave Imager wins Innovation of the Year Mira Award
- IndependentNearWave Revisited
- IndependentElevate Ventures invests $320,000 after a statewide pitch competition
- Independent11 Startups Join Health Wildcatters in Dallas
- IndependentTMCi 2025 HealthTech Accelerator Cohort
- University newsDoctoral students design new breast imaging device
- University newsO’Sullivan takes first in the 2023 Commercialization Awards
- CompanyNearWave launch post and founder profile
- CompanyNearWave website: about, publications, studies, news
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
