With Last Patient Out today, the company concludes a 15-month, three-site study involving 525 hip and knee replacement patients and more than 43,000 AI-patient clinical conversations independently reviewed by surgeons in support of RecovryAI’s planned FDA De Novo submission.
DANVILLE, Calif.--(BUSINESS WIRE)--RecovryAI, a clinical AI company developing patient-facing Virtual Care Assistants (VCAs) for postoperative recovery, today announced that its prospective pivotal study has reached last patient out, marking the completion of patient participation and clinical data collection.
The 15-month study was conducted under institutional review board oversight at three U.S. orthopedic centers: OrthoArizona in Scottsdale, Kansas Joint & Spine in Wichita, and Mercy Medical Center in Baltimore.
A total of 525 patients completed the prospective study, generating more than 43,200 AI-patient clinical conversations for independent physician adjudication. During each interaction, the VCA evaluates whether a patient’s reported recovery is consistent with the expected postoperative course and provides appropriate guidance, or identifies a potential deviation and alerts the monitoring care team with the relevant clinical context and synthesis.
“Last patient out is not the finish line, but it is a significant milestone in a rigorous, multi-site pivotal trial,” said Scott Walchek, co-founder and CEO of RecovryAI. “It reflects an extraordinary effort by our clinical partners, patients and team, and gives us the evidence base to begin the final adjudication and statistical work supporting our planned FDA De Novo submission.”
The study’s primary endpoint measures concordance between the VCA’s clinical classifications and recommendations and the independent assessments of experienced orthopedic surgeons. Each eligible conversation is presented in a blinded format and reviewed independently by three physicians, generating more than 129,000 individual physician assessments.
The resulting dataset will provide a direct measure of concordance between the VCA and independent physician assessment and form the statistical basis for the company’s planned De Novo submission to the U.S. Food and Drug Administration later this year. With last patient out achieved, RecovryAI will proceed with final physician adjudication, database lock and the study’s prespecified statistical analysis.
“We participated in the pivotal trial because postoperative demand is outpacing available clinical capacity,” said Dr. Ken Schmidt, an orthopedic surgeon at OrthoArizona and principal investigator in the RecovryAI pivotal trial. “We’re confident that AI can safely carry a meaningful share of that workload, but without rigorous evaluation and FDA authorization, it cannot earn our trust as part of patient care.”
Additional evaluation of workflow, utilization and clinical complexity
The prospective study is paired with a retrospective analysis involving 579 additional patients, bringing the total patient population evaluated under the protocol to 1,104. The retrospective component supports a secondary endpoint examining the VCA’s potential effect on clinical workflow and downstream healthcare utilization.
The protocol also includes a supplemental stress-testing dataset of approximately 1,500 conversations designed to evaluate the VCA against uncommon and clinically complex patient presentations that are difficult to capture at meaningful scale in a prospective study.
These conversations were created through a proprietary controlled-generation framework developed by RecovryAI to simulate combinations of clinical conditions, comorbidities, communication styles and levels of health literacy. Each generated conversation is anchored to a real, physician-adjudicated clinical interaction and independently validated for clinical plausibility before being used to evaluate the VCA.
This supplemental analysis extends the evaluation into complex, multivariable scenarios that prospective trial data alone may not produce in sufficient numbers.
Advancing toward FDA De Novo submission
RecovryAI received FDA Breakthrough Device Designation for the VCA earlier this year and is pursuing De Novo authorization as a Class II medical device.
The study’s primary endpoint, sample-size methodology and physician-adjudication framework were informed by an earlier pilot study and refined through numerous pre-submission interactions with the FDA beginning in 2024. The pivotal study was conducted as a Non-Significant Risk study, with the investigational device operating under physician oversight throughout.
“There is a meaningful difference between AI that supports a clinician and AI that engages a patient with clinical guidance. The latter must be evaluated as a medical device, with evidence sufficient to establish that it performs safely and reliably,” said Dr. Benjamin Ma, Chair of the Department of Orthopaedic Surgery at the University of California, San Francisco. “RecovryAI’s prospective study, independent physician adjudication and FDA pathway reflect the diligence required for patient-facing clinical AI to earn a place in clinical practice.”
Expanding clinical capacity through patient-facing AI
The VCA is designed to manage a significant share of the clinical conversations that follow surgery while escalating potential deviations from expected recovery to the appropriate care team.
If authorized, the VCA would allow patient-facing clinical AI to absorb postoperative clinical workload before it reaches the care team while preserving physician oversight and supporting, rather than replacing, human clinical judgment. This safety-first division of labor is intended to expand clinical capacity and allow providers to focus their time and expertise on the patients who need them most.
About RecovryAI
RecovryAI develops Virtual Care Assistants, procedure-specific clinical AI prescribed by physicians to manage and support patients through post-procedure recovery. Each VCA engages patients directly, provides clinically validated recovery guidance, and escalates potential deviations from the expected course to the care team. By shifting a significant share of postoperative clinical work to AI, VCAs are designed to identify complications earlier and allow clinicians to focus their attention on the patients who need it most.
RecovryAI’s first VCAs are being developed for patients recovering from total hip and total knee arthroplasty, with plans to expand across major procedural domains subject to regulatory authorization. The company’s lead VCA has received FDA Breakthrough Device Designation and is being developed through the FDA De Novo pathway as patient-facing clinical AI capable of performing postoperative assessment and triage without requiring a licensed provider to participate in every interaction.
RecovryAI is building toward a future in which every patient is prescribed a Virtual Care Assistant upon discharge: infinitely scalable, patient-facing clinical AI for a healthcare system whose demand is outpacing its workforce. The company is headquartered in the San Francisco Bay Area. Visit recovry.ai for more information.
The VCA has not been authorized by the FDA and is not currently commercially available for the proposed indication.
Contacts
Media Contact
Scott Walchek
Chief Executive Officer
press@recovry.ai
