Regenesis Biomedical, Inc.
Regenesis is a device company dedicated to improving human welfare through the research, design, manufacture, and sale of energy-based medical products and services that alleviate pain to improve quality of life. The company values dedication, innovation, integrity, respect, excellence, compassion, and teamwork. It specializes in non-drug pain relief devices, such as the Reprieve by Regenesis, which is FDA approved and clinically proven to provide deep tissue heating and pain relief through electromagnetic therapy. Regenesis offers products for home use, including the Reprieve Duo and Reprieve CW, and provides comprehensive support and education to its patients and healthcare providers.
Industries
Nr. of Employees
medium (51-250)
Regenesis Biomedical, Inc.
Scottsdale, Arizona, United States, North America
Products
Reprieve 60 Duo
Home-use pulsed short-wave diathermy device configured with two treatment pads intended for longer-term patient use.
Single-pad short-wave diathermy device (single-pad and CW mode options)
Home-use device with a single treatment pad available in pulsed and continuous wave modes for targeted therapy and long-term use.
Instruction manuals and treatment pad positioning guides
Official Instructions for Use, treatment pad positioning guides and a video library supporting device setup and treatment protocols.
Reprieve 60 Duo
Home-use pulsed short-wave diathermy device configured with two treatment pads intended for longer-term patient use.
Single-pad short-wave diathermy device (single-pad and CW mode options)
Home-use device with a single treatment pad available in pulsed and continuous wave modes for targeted therapy and long-term use.
Instruction manuals and treatment pad positioning guides
Official Instructions for Use, treatment pad positioning guides and a video library supporting device setup and treatment protocols.
Services
60-day Compliance & Compatibility Assessment (CCA)
Short-term device deployment to evaluate individual patient response before purchase; assesses suitability for long-term home use.
Patient support and education services
Patient Care Coordinator program providing onboarding, troubleshooting, follow-up (calls, texts, email), educational materials, and access to instructional videos.
Clinical evidence generation and study support
Design, execution and analysis of clinical studies and case series to produce evidence for therapeutic effectiveness across multiple indications.
Regulatory and quality compliance services (internal capability)
Implementation and maintenance of QMS aligned to FDA and ISO standards, preparation of regulatory submissions including multiple 510(k)s and CE marking efforts.
60-day Compliance & Compatibility Assessment (CCA)
Short-term device deployment to evaluate individual patient response before purchase; assesses suitability for long-term home use.
Patient support and education services
Patient Care Coordinator program providing onboarding, troubleshooting, follow-up (calls, texts, email), educational materials, and access to instructional videos.
Clinical evidence generation and study support
Design, execution and analysis of clinical studies and case series to produce evidence for therapeutic effectiveness across multiple indications.
Regulatory and quality compliance services (internal capability)
Implementation and maintenance of QMS aligned to FDA and ISO standards, preparation of regulatory submissions including multiple 510(k)s and CE marking efforts.
Expertise Areas
- Clinical trial management and outcomes analysis
- Energy-based pain therapy (pulsed electromagnetic/short-wave diathermy)
- Medical device development and manufacturing
- Regulatory compliance and submissions (510(k), CE marking, QMS)
Key Technologies
- Pulsed short-wave diathermy / pulsed electromagnetic field therapy
- Treatment-pad transcutaneous applicators
- Embedded biometric authentication
- Home-use medical device design