What ReGelTec does

ReGelTec, Inc. is a clinical-stage medical device company incorporated in 2018 and headquartered in Baltimore, Maryland. The company is developing a single core platform — the HYDRAFIL® System — built around a proprietary, second-generation thermally responsive hydrogel. When heated, the hydrogel becomes a viscous liquid that can be delivered percutaneously via needle into the nucleus pulposus of an intervertebral disc; on cooling in situ, it forms a single cohesive solid implant that mimics the biomechanical properties of the native disc, seals the annulus access site to limit expulsion risk, and preserves spinal motion. The intended use is outpatient disc augmentation for adult patients with chronic low back pain attributed to degenerative disc disease (DDD) who have failed conservative care and seek an alternative to invasive spinal fusion or other open surgery. The company targets interventional pain physicians and spine specialists performing procedures in hospitals, ambulatory surgery centers (ASCs), and specialty clinics, and reports meaningful pain and disability reductions within one month maintained through twelve months in a peer-reviewed 60-patient study (Pain Physician, 2026), with two-year follow-up completed.

ReGelTec is currently pre-commercial. The HYDRAFIL System holds CE Mark under the European Union Medical Device Regulation (MDR) as a Class III device (received May 2025) and FDA Breakthrough Device Designation (2020), and is an investigational device in the United States limited by U.S. law to investigational use. The company is sponsoring the HYDRAFIL-D U.S. FDA IDE clinical trial, with the first patient enrolled in June 2025 at Boomerang Healthcare, Inc. in Walnut Creek, California, by interventional pain physician Dr. Kas Amirdelfan. Ex-U.S. clinical activity has enrolled 75 patients across sites in Colombia (Barranquilla, Cali) and Canada (Calgary). Future revenue is expected to come from per-procedure hardware sales of the HYDRAFIL implant and delivery system to interventional pain physicians and hospitals/ASCs, with EU commercialization enabled by the 2025 CE Mark and U.S. commercialization contingent on successful completion of the IDE trial. The company maintains ISO 13485 and MDSAP certifications, composition-of-matter patent protection in the U.S., Europe (to 2040), and Japan (to 2040), and is led by CEO Bill Niland, Co-Founder/CTO Anthony Lowman, EVP Business Development & General Counsel Peter Boyd, and VP R&D Peter Wilson. Total disclosed venture funding to date is approximately $6 million, with a 2018 seed round (Abell Foundation, TEDCO) and a 2020 Series A (Abell Foundation).

Name

ReGelTec

Legal name

ReGelTec, Inc.

Website

https://regeltec.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

ReGelTec is a clinical-stage medical device company developing HYDRAFIL, a proprietary thermally responsive injectable hydrogel for percutaneous, outpatient disc augmentation to treat chronic low back pain caused by degenerative disc disease. It targets interventional pain physicians in the U.S. (investigational) and EU (CE Marked).

Ownership category

akta.pro rank

Headquarters

HQ city

Baltimore

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Investigational / pre-commercial: ReGelTec is a clinical-stage medical device company; the HYDRAFIL System is an investigational device limited by U.S. law to investigational use and is not yet generating commercial revenue. Future commercial revenue is expected from one-time sales of the HYDRAFIL hydrogel implant and delivery system per procedure performed in outpatient interventional pain settings.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

ReGelTec develops the HYDRAFIL System, a Class III medical device consisting of a proprietary, thermally responsive hydrogel plus percutaneous delivery instrumentation for minimally invasive disc augmentation. The hydrogel becomes a flowable liquid when heated, is injected via needle into the nucleus pulposus of an intervertebral disc, and cools in situ to form a single cohesive solid implant that mimics native disc biomechanics and preserves spinal motion as an outpatient treatment for chronic low back pain caused by degenerative disc disease.

Product overview

ReGelTec, Inc. is a clinical-stage medical device company commercializing a single core platform — the HYDRAFIL® System — built around its proprietary injectable hydrogel. The portfolio centers on HYDRAFIL®, the underlying hydrogel material (a viscous fluid that sets in situ into a solid cohesive implant for nucleus pulposus augmentation), and the HYDRAFIL® System, the Class III disc augmentation device that delivers it percutaneously (CE Marked under EU MDR, investigational in the U.S.). Supporting this core platform, ReGelTec is sponsoring the HYDRAFIL-D Study, the U.S. FDA IDE clinical trial intended to support eventual U.S. market access. Together these constitute one unified, device-plus-clinical-program offering rather than a multi-module software platform.

Differentiator

Problem solved

Functional benefit

Brands

• HYDRAFIL®: Proprietary hydrogel technology / percutaneous disc augmentation system for chronic low back pain due to degenerative disc disease.

Products and services

• HYDRAFIL® System Class III disc augmentation system consisting of the proprietary HYDRAFIL® hydrogel plus percutaneous delivery instrumentation, designed for outpatient, minimally invasive implantation into the nucleus pulposus. The hydrogel becomes a flowable liquid when heated for needle-based delivery, then cools in situ to form a cohesive solid implant that mimics native disc biomechanics, preserves spinal motion, and seals the annulus access site to minimize expulsion risk. Intended for interventional pain physicians and spine specialists treating adult patients with chronic low back pain due to degenerative disc disease who have failed conservative care. Holds CE Mark under EU MDR for Class III; investigational in the United States.

Quantifiable outcome

• Significant reduction in chronic low back pain and disability within 1 month, with results maintained through 12 months in a 60-patient study (1-year results published in Pain Physician).
• +2 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Two partnerships are on record, tiered core.

• Boomerang Healthcare, Inc.coreImplementation/ SI/ Consulting Partner · 18 June 2025Boomerang Healthcare, Inc. (Walnut Creek, CA) was the first U.S. clinical site to enroll and treat a patient in ReGelTec's HYDRAFIL-D FDA IDE clinical trial. The patient was enrolled by Kas Amirdelfan, M.D., an interventional pain physician and founding member of Boomerang Healthcare. ReGelTec announced the first-patient milestone via Business Wire on June 18, 2025.
• MedTech Innovator (MTI)coreGTM or Marketing Partner · 1 January 2025ReGelTec was selected as one of 64 companies (top 4% of nearly 1,500 global applicants) for the MedTech Innovator 2025 Accelerator Cohort and was named a MedTech Innovator Breakthrough Medtech Startup. MTI is the world's largest medical technology accelerator and runs a four-month program designed to de-risk innovation and accelerate U.S. market success.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• DiscGenics: Clinical-stage regenerative medicine company developing injectable cell therapy (IDCT) for degenerative disc disease — the most directly comparable emerging peer, pursuing a percutaneous, minimally invasive DDD therapy via a different mechanism (discogenic cells vs. hydrogel augmentation).
• Intrinsic Therapeutics: Developer of the Barricaid annular closure device for disc repair — a percutaneous spine technology targeting the same degenerative disc disease patient population as HYDRAFIL, addressing structural failure of the disc via a different implant modality.
• Mesoblast: Late-stage cell therapy company whose lead programs include rexlemestrocel-L for degenerative disc disease — competes in the same percutaneous, regenerative DDD therapy space as ReGelTec and represents a much larger, public-market-capitalized alternative.
• Centinel Spine: Spine device company focused on motion-preserving total disc replacement technologies (prodisc) — a relevant peer because both companies target the same patient population with motion-preserving alternatives to spinal fusion, although Centinel's products are surgical implants rather than percutaneous hydrogels.

Broad incumbents

• Orthofix Medical: Diversified spine and orthopedics medical device company with motion-preservation and biologics offerings — a broad incumbent that competes for the same interventional pain and spine specialist customer base, providing scale, distribution, and clinical evidence ReGelTec will need to match at U.S. launch.
• Stryker (Spine division): Global medical device incumbent with a significant spine portfolio including cervical and lumbar disc replacement and interbody fusion products — directly competes for interventional pain physician and spine surgeon adoption, with the resources to either out-execute or potentially acquire emerging DDD technologies.
• NuVasive / Globus Medical: Major spine device companies with broad portfolios spanning motion-preservation, interbody fusion, and minimally invasive spine surgery — directly comparable on customer base (interventional pain and spine specialists) and represents the most likely strategic acquirer profile for an emerging DDD technology like HYDRAFIL.
• Spinal Kinetics (now Orthofix): Developer of the M6 artificial cervical and lumbar disc (now part of Orthofix) — a motion-preserving disc technology targeting the same DDD patient population, providing a useful comparator for the clinical and commercial pathway of motion-preserving disc technologies.

Emerging players

• Vivex Biomedical: Emerging orthobiologics and spine company developing cellular and tissue-based therapies for degenerative spine conditions — a partial-overlap emerging competitor in the regenerative DDD space, with adjacent but distinct technology.
• Xtant Medical: Spine-focused medical device and biologics company developing fixation and orthobiologic products for spine surgery — adjacent emerging peer in the degenerative spine treatment market, with similar commercialization challenges in reaching interventional pain specialists.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds2 records

Investors2 records

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 ReGelTec