A New Class of Clinical AI

• RecovryAI's Virtual Care Assistants (VCAs) represent a new class of regulated clinical AI, engaging patients directly, delivering clinically validated recovery guidance and escalating deviations in recovery to licensed providers. VCAs are designed, evaluated, and governed as regulated medical devices.

• Provider-facing clinical AI supports clinicians at the point of care. Responsibility and liability remain with the provider.
• Consumer health apps deliver education and wellness guidance directly to consumers, without regulation as medical devices.

Virtual Care Assistants for Post-Operative Recovery

Virtual Care Assistants for Post-Operative Recovery

A New Class of Clinical AI

• Provider-facing clinical AI supports licensed clinicians at the point of care, such as clinical decision support systems and ambient documentation tools, with responsibility and liability remaining with the provider.
• Consumer health and wellness applications deliver education, coaching, and general health guidance directly to consumers, without clinician prescription or regulation as medical devices.
• Regulated, patient-facing clinical AI. Representing a new class of clinical AI, RecovryAI's Virtual Care Assistants engage patients directly, delivering clinically validated recovery guidance and escalating deviations in recovery to licensed providers. VCAs are designed, evaluated, and governed as regulated medical devices.

• Provides clear, consistent guidance based on procedure-specific recovery protocols.
• Surfaces symptoms that may need a clinician's attention, with full visibility for the care team.
• Built on structured medical reasoning rather than open-ended chat.

• Designed to align with existing RTM reimbursement pathways for post-operative monitoring.
• Well-positioned for the upcoming CMS TEAM model, where continuous recovery oversight becomes financially important for providers.

Pivotal Study Underway to Support FDA De Novo Submission

• RecovryAI is nearing completion of a multi-site pivotal clinical study supporting VCAs for post-operative recovery following total joint arthroplasty (TJA).
• VCA medical reasoning is evaluated by measuring concordance between AI-generated recommendations and physician judgment across scores of thousands of real-world patient conversations.

• RecovryAI is nearing completion of a multi-site pivotal clinical study supporting VCAs for post-procedure recovery following total joint arthroplasty (TJA).
• VCA medical reasoning is evaluated by measuring concordance between AI-generated recommendations and physician judgment across scores of thousands of real-world patient conversations.

• RecovryAI is nearing completion of a multi-site pivotal clinical study supporting Virtual Care Assistants for post-operative recovery following total joint arthroplasty (TJA).
• RecovryAI VCA medical reasoning is evaluated by measuring concordance between AI-generated recommendations and physician judgment across tens of thousands of real-world patient conversations.

Breakthrough Designation – What It Means for FDA Review

• Breakthrough Device Designation is reserved for medical devices that address serious conditions and represent the potential for meaningful improvement over existing standards of care for defined patient populations.
• For RecovryAI, the designation applies to its Virtual Care Assistants supporting post-operative recovery following total joint arthroplasty.
• For RecovryAI, the designation applies to its Virtual Care Assistants supporting post-procedure recovery following total joint arthroplasty.
• The designation enables earlier and more frequent engagement with the FDA during development and review, while not altering the standards required for authorization or the need for full regulatory review.