What Biorep Technologies does

Biorep Technologies, Inc. is a privately held, Miami Lakes-based medical device Contract Development and Manufacturing Organization (CDMO) that delivers end-to-end design, prototyping, manufacturing, and assembly services for regulated Class I/II medical devices under ISO 13485 certification and FDA registration. The company serves two primary segments: global med-tech OEMs and medical device startups seeking a single-source partner from concept through commercial launch across therapeutic areas including cardiovascular, ENT, dental, oncology, and diabetes. Engagement is project-based with custom proposals phased across prototyping, pilot, and production; pricing is quote-only with no public tiers or self-serve channels, and go-to-market is exclusively direct enterprise field sales via technical discovery workshops.

Biorep's underlying technical platform combines an ISO 7 Class 10,000 cleanroom, in-house 3D printing and CNC machining for compressed prototyping cycles, a proprietary 5-phase design and development process aligned to FDA 21 CFR 820.30 design controls, and pre-validated cleaning, sterilization, and packaging solution families (Bclean, Bsterile, Bsecure) that materially reduce client validation burden. The company also produces proprietary diabetes research instruments—the Ricordi Chamber (40-year legacy, deployed in 23+ countries across ~630 studies), the PRISM System for cell isolation workflows, a Perifusion System, and an Automatic Islet Cell Counter—and a portfolio of cardiovascular surgical instruments (Knot Pusher, Atrial Lift System, DeTACH, Aortic Cuff, Mitral Collar, TIE) developed in collaboration with Dr. Joseph Lamelas that have collectively been used in tens of thousands of clinical procedures. Additional contract-manufactured products include Circulogix's faCTChecker and CyteCatch liquid biopsy components supporting NIH-funded oncology research at multiple academic centers.

The business operates from a 10,000+ sq ft facility with fewer than 30 employees, generates revenue through CDMO project contracts, proprietary instrument sales, and validation/regulatory services, and remains founder-led without disclosed institutional investment. Recent strategic emphasis has been on international expansion of the PRISM System (first independent European deployment announced December 2025), continued CDMO growth following 2021 FDA Manufacturer status, and entry into adjacent wound-care applications via a patent-pending External Irrigation Apparatus for Hidradenitis Suppurativa tunneling wounds. Notable customers include Medtronic, Corcym (cardiovascular surgical instruments), Circulogix (liquid biopsy), and multiple research institutions such as the University of Miami, Washington University in St. Louis, and Leiden University Medical Center.

Name

Biorep Technologies

Legal name

Biorep Technologies, Inc.

Website

https://biorep.com

Company type

Private

Founded year

1986

Operating status

Operating

Headcount range

11–50 employees

Short description

Biorep Technologies is a Miami Lakes, Florida-based medical device CDMO offering end-to-end contract design, prototyping, and manufacturing under ISO 13485 and FDA registration to med-tech companies, startups, and research institutions, with proprietary diabetes and cardiac surgery instrument product lines.

Ownership category

akta.pro rank

Headquarters

HQ city

Miami Lakes

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Supply Chain, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. Medical Device Contract Manufacturing: Full-scale production manufacturing of medical devices under an ISO 13485-certified, FDA-registered quality system. Services include process validation, traceability & serialization, supply chain sourcing, equipment qualification, change control, and CAPA management. Revenue is generated through project-based contracts with global med-tech companies.
2. Medical Device Prototyping & Design Services: Rapid prototyping (3D printing, CNC machining), design verification and validation testing, risk management, and regulatory planning. Engaged as a CDMO partner from concept through scale-up and launch, with flexible engagement models.
3. Medical Device Assembly Services: Complex subassembly, final device integration, and test staging services including multi-component mechanical/electromechanical assembly, automated or manual assembly, in-process inspection, functional and environmental testing, packaging interface, and labeling readiness.
4. Pre-Validated Solutions (Bclean, Bsterile, Bsecure): Pre-validated cleaning protocols (Bclean), sterilization validations (Bsterile), and packaging solutions (Bsecure) sold as standardized product families that reduce customers' validation burden and time-to-market.
5. Regulatory & Quality Consulting Services: Regulatory correspondence management, 510(k) clearance and CE Mark submission strategy, QMS creation and implementation, internal audits, and regulatory consulting for FDA and ISO compliance.
6. Life Sciences Research Instruments (Biorep Diabetes): Sale of proprietary diabetes research instruments including the Ricordi Chamber, PRISM system, Perifusion System, and Automatic Islet Cell Counter, serving research institutions and life sciences laboratories globally.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Biorep Technologies is a medical device Contract Development and Manufacturing Organization (CDMO) that provides end-to-end regulated device development — including concept design, rapid prototyping, design verification and validation, full-scale contract manufacturing, cleanroom assembly, and packaging — under an ISO 13485-certified and FDA-registered quality system. The company also designs, manufactures, and sells proprietary diabetes research instruments (Ricordi Chamber, PRISM System, Perifusion System, Automatic Islet Cell Counter) and a portfolio of cardiac surgical instruments.

Product overview

Biorep Technologies is a medical device Contract Development and Manufacturing Organization (CDMO) offering a portfolio of specialized products primarily focused on diabetes research and cardiac surgery instrumentation. The core products include the Ricordi Chamber (pancreatic islet isolation device) and PRISM System for islet isolation, alongside perifusion and automatic islet cell counting equipment for diabetes research. The cardiac surgery portfolio includes surgical instruments such as the Knot Pusher, Atrial Lift System, Suture Belt, Aortic Cuff, Mitral Collar, TIE, and DeTACH. Additionally, Biorep manufactures components for Circulogix products (faCTChecker, CyteCatch) and provides external irrigation apparatus for wound care. As a CDMO, the company also offers validation services (Bclean, Bsterile, Bsecure) and contract manufacturing including prototyping, assembly, and kitting.

Differentiator

Problem solved

Functional benefit

Brands

• Biorep Diabetes: A dedicated division focused on diabetes research solutions including the Ricordi Chamber, perifusion systems, automatic islet cell counters, and islet isolation equipment.

Products and services

• Ricordi Chamber Proprietary specialized device for pancreatic islet isolation, developed in collaboration with Dr. Camillo Ricordi and the Diabetes Research Institute. It advanced pancreatic islet isolation and diabetes research, enabling the Edmonton Protocol. Sold to research institutions and life sciences laboratories globally.
• PRISM System Cell isolation workflow system developed by Biorep Technologies for human pancreatic islet isolation. Sold to research institutions and life sciences laboratories conducting diabetes and cell therapy research.
• Perifusion System Diabetes research instrument for islet cell function testing via dynamic stimulation and monitoring of pancreatic cells. Complements the Ricordi Chamber for comprehensive islet isolation and analysis workflows. Sold to diabetes research laboratories.
• Automatic Islet Cell Counter Automated counting device for islet cells used in diabetes research and isolation procedures. Complements the Ricordi Chamber and Perifusion System. Sold to diabetes research laboratories.
• Knot Pusher Extracorporeal knot placement device for surgical procedures requiring precise knot delivery. Used in 15,000+ minimally invasive cardiac surgery procedures. Designed and manufactured by Biorep for surgical customers.
• Atrial Lift System Atrial wall retraction instrument designed to provide exposure during cardiac surgical procedures. Used in 10,000+ minimally invasive cardiac surgery procedures. Designed and manufactured by Biorep.
• DeTACH Detachable head aortic cross clamp for cardiac surgery applications. Used in 6,000+ cardiac surgery procedures. Designed and manufactured by Biorep.
• Aortic Cuff Aortic root exposure device designed to facilitate access during aortic valve and root surgeries. Used in 5,000+ procedures. Designed and manufactured by Biorep.
• Mitral Collar Papillary muscle exposure device for mitral valve surgical procedures. Used in 3,000+ procedures. Designed and manufactured by Biorep.
• Suture Belt Circumferential surgical suture organizer for managing and organizing sutures during surgical procedures. Designed and manufactured by Biorep.
• TIE Intracorporeal knot placement assist device for laparoscopic and minimally invasive surgical procedures. Designed and manufactured by Biorep.
• faCTChecker Automated CTC (circulating tumor cell) capture instrument manufactured by Biorep for Circulogix. Enables blood-based cancer cell isolation for clinical research, biomarker discovery, and longitudinal clinical trials. Used in NIH-funded clinical trials and peer-reviewed cancer research.
• CyteCatch Microfilter Slide Parylene membrane microfilter slide manufactured by Biorep for Circulogix. Used in the faCTChecker instrument for blood-based cancer cell isolation in clinical research and clinical trials.
• External Irrigation Apparatus Multi-head catheter irrigation syringe attachment enabling self-irrigation of multiple wounds simultaneously, designed for treatment of Hidradenitis Suppurativa and tunneling wounds. Features a rotatable Luer slip connection, three-outlet manifold, and low-profile patient-worn design compatible for 7+ days of use. Patent pending.
• Medical Device Contract Manufacturing Services Full-scale production manufacturing of medical devices under an ISO 13485-certified, FDA-registered quality system. Includes process validation, traceability and serialization, supply chain sourcing, equipment qualification, change control, and CAPA management. Engaged by global med-tech companies and OEMs via project-based contracts.
• Medical Device Prototyping & Design Services Rapid prototyping (3D printing, CNC machining), design verification and validation testing, risk management, and regulatory planning. Includes design for manufacturability (DFM) review, tolerancing, and early risk reduction across the 5-phase design and development process.
• Medical Device Assembly Services Complex subassembly, final device integration, and test staging services performed in Biorep's ISO 7 Class 10,000 cleanroom. Includes multi-component mechanical and electromechanical assembly, automated or manual assembly, in-process inspection, functional and environmental testing, packaging interface, and labeling readiness.
• Pre-Validated Solutions (Bclean, Bsterile, Bsecure) Pre-validated solution families sold as standardized products to medical device manufacturers. Bclean provides pre-validated cleaning protocols for removing manufacturing residues from CNC machined and injection molded components. Bsterile covers gamma and Ethylene Oxide (EtO) sterilization validations for different bioburden counts and dosages. Bsecure provides pre-validated pouch packaging with completed seal validation, 3-year accelerated aging testing with Gamma sterilization, and complete validation reports.
• Regulatory & Quality Consulting Services Regulatory correspondence management, 510(k) clearance and CE Mark submission strategy, QMS creation and implementation, internal audits, and regulatory consulting for FDA and ISO compliance.

Quantifiable outcome

• Reduces development time by up to 2 years per customer testimonial (Corcym CEO)
• +4 more outcomes

Named customers15 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Ten partnerships are on record, tiered core, major and supporting.

• Scottish National Blood Transfusion Service (SNBTS)coreTechnology or Integration · 1 December 2025SNBTS conducted the first successful independent human pancreatic islet isolation using Biorep's PRISM system, in collaboration with Leiden University Medical Center. This milestone demonstrated the PRISM system's reproducibility across different laboratories and represents a significant step toward establishing it as a global standard for cell isolation workflows. Results to be presented at EPITA 2026.
• Leiden University Medical Center (LUMC)coreTechnology or Integration · 1 December 2025LUMC collaborated with SNBTS on the first successful independent use of Biorep's PRISM system for human pancreatic islet isolation. The collaboration demonstrates the system's reproducibility across European laboratories and supports the goal of establishing the PRISM system as a new standard in cell isolation workflows.
• CirculogixcoreStrategic or Co-development Partner · 1 January 2015Biorep serves as the exclusive manufacturing partner for Circulogix, producing the CyteCatch microfilter slides and fluid handling components for the faCTChecker automated CTC capture instrument. Circulogix was incorporated in 2014 and founded by Dr. Richard J. Cote, Ram Datar, and Anthony Williams. Biorep has manufactured their components since first deployment in 2015, enabling Circulogix to supply systems to NIH-funded clinical trials and peer-reviewed research. This partnership represents a core strategic relationship where Biorep enables Circulogix's entire product platform.
• Diabetes Research Institute, University of MiamicoreStrategic or Co-development PartnerLongstanding collaboration with Dr. Camillo Ricordi and the Diabetes Research Institute leading to the development of the Ricordi Chamber, Perifusion System, and islet isolation equipment used worldwide for diabetes research. Dr. Ricordi is quoted as stating that the Biorep team designed and manufactured instruments to automate the islet isolation process. This collaboration has been the foundation of Biorep's 40-year legacy in diabetes innovation.
• Dr. Joseph LamelascoreStrategic or Co-development PartnerCollaboration with renowned cardiac surgeon Dr. Joseph Lamelas on surgical instrument design and manufacturing. This partnership led to the development of Biorep's portfolio of cardiovascular surgical instruments including the Knot Pusher, Atrial Lift System, Suture Belt, Aortic Cuff, Mitral Collar, DeTACH, and TIE devices — many of which are used in thousands of clinical procedures.
• Changhuei Yang / CaltechcoreStrategic or Co-development PartnerCo-development collaboration with Changhuei Yang at Caltech's electrical engineering and bioengineering departments. Caltech developed a custom in-focus imaging system and deep learning algorithms specifically for the CyteCatch microfilter surface geometry, resulting in 99.3% in-focus image acquisition and 94% precision / 96% recall for CTC detection. Work funded by NCI U01 grant and published in Scientific Reports 2023 (Top 100 Cancer papers).
• Alan Pollack / University of Miami Sylvester Comprehensive Cancer CentermajorStrategic or Co-development PartnerDr. Alan Pollack's radiation oncology team at University of Miami conducted two registered Phase II randomized clinical trials (BLaStM NCT02307058; CoMBINe NCT02997709) using Circulogix's Biorep-manufactured faCTChecker and CyteCatch platform. 215+ patients enrolled, 500+ blood samples processed. CTC enumeration used alongside single-cell genomic profiling with 10X Genomics Chromium. Abstract presented at AACR Annual Meeting 2020.
• Richard J. Cote / Washington University in St. LouiscoreStrategic or Co-development PartnerCo-inventor of the parylene membrane microfilter technology and co-founder of Circulogix. Dr. Cote serves as co-investigator on the NCI U01 Liquid Biopsy Consortium grant. The collaboration enabled the AI-based imaging paper (Scientific Reports 2023) and multi-site liquid biopsy research across 320+ patients and 600+ samples.
• Dorraya El-Ashry / University of MinnesotamajorStrategic or Co-development PartnerBreast cancer research collaboration using the Circulogix/Biorep microfilter platform funded by Breast Cancer Research Foundation (BCRF-16098, BCRF-19-099). Research led to discovery that cancer-associated fibroblasts (CAFs) co-circulate with CTCs in heterotypic clusters with substantially higher metastatic potential — a novel finding published in Breast Cancer Research and Treatment 2021.
• BSI GroupsupportingOthersBiorep is audited annually by BSI as their ISO 13485 registrar. Additionally, Biorep hires an independent auditor approximately midway between BSI's surveillance or recertification audits to verify continued compliance.

Scale indicators6 records

Recent moves9 records

Expansion highlights5 records

Direct peers

• Confluent Medical Technologies: Confluent Medical is a medical device CDMO specializing in nitinol components, textiles, and finished device manufacturing for cardiovascular, neurovascular, and structural heart applications. It directly overlaps with Biorep's cardiovascular surgical instrument portfolio and offers larger-scale manufacturing capacity.
• Donatelle: Donatelle is a medical device CDMO offering design, development, and contract manufacturing for Class I-III devices, particularly in interventional and surgical applications. It is comparable to Biorep in serving OEMs needing precision components, assembly, and regulatory support.
• Resonetics: Resonetics is a specialized medical device contract manufacturer focused on nitinol components, laser micromachining, and catheter/interventional device assembly. It competes with Biorep in the cardiovascular minimally invasive device space, particularly for complex subassemblies and components requiring tight tolerances.
• SMC Ltd. SMC Ltd. is a medical device contract manufacturer specializing in disposable and reusable medical devices, including molding, assembly, and packaging. It is a direct peer to Biorep in providing end-to-end regulated device manufacturing for OEM customers.
• Cretex Medical: Cretex Medical is a medical device contract manufacturer offering precision machining, medical tubing, and device assembly for interventional and surgical applications. It directly overlaps with Biorep's capabilities in cardiovascular and minimally invasive surgical instruments.
• Tegra Medical: Tegra Medical is a medical device contract manufacturer offering precision machining, injection molding, assembly, and sterilization management. It competes with Biorep for surgical instrument and implantable device OEM customers and is similarly focused on regulated ISO 13485 production.

Broad incumbents

• Jabil Healthcare: Jabil's healthcare division is one of the largest medical device and diagnostics CDMOs globally, offering design, prototyping, manufacturing, and packaging across multiple therapeutic areas. It competes with Biorep for enterprise OEM outsourcing work but at vastly larger scale and with multi-site global capacity that Biorep cannot match.
• Sanmina: Sanmina's Medical business offers end-to-end design, manufacturing, and regulatory services for medical devices, including complex electromechanical assembly. It is a direct CDMO competitor for the same OEM customer segment Biorep targets, but at significantly larger scale.
• Flex (Flextronics): Flex's Health Solutions business provides medical device design, manufacturing, assembly, and supply chain services worldwide. Like Biorep, it serves global med-tech OEMs, but with substantially broader capabilities, larger engineering teams, and a multi-continent footprint.

Others

• Circulogix: Circulogix is Biorep's exclusive manufacturing customer for the faCTChecker CTC capture instrument and CyteCatch microfilter slides, used in NIH-funded liquid biopsy clinical trials. While not a CDMO competitor, it is a key strategic partner whose commercial trajectory directly drives Biorep's oncology platform revenue.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@bioreptechnologies
• LinkedInlinkedin.com/company/biorep-technologies-inc-

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Biorep Technologies