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Companies / Restari
Medical device company profile

Restari

Indiana-based developer of renal medical devices and therapeutics, including an investigational acute kidney injury system, MorCor biopsy technology and polycystic kidney disease programs.

Medical Devices & BiopharmaceuticalsUrology & Renal CareRenal CareDevelopment-stage renal devices and therapeutics
Headquarters🇺🇸Indianapolis, Indiana, United States
Founded2022
Commercial statusIn developmentTherapeutic programs investigational; MorCor and generic TIPS/biopsy listings marked coming soon. Commercial sales not independently established.
Employees2–10 [11]LinkedIn company-size range · Checked 2026-10-17
Estimated revenueNot confirmed
Official websitewww.restari.com ↗

Company overview

Restari is a privately held company founded in 2022 by CEO Matt Hedrick and Chief Medical Officer Robert Bacallao. Its company LinkedIn lists headquarters in Indianapolis, Indiana, United States; its research laboratories are at the Indiana Biosciences Research Institute in Indianapolis. The company combines renal device development, biopsy technology and pharmaceutical research.

Its investigational acute kidney injury system is designed to deliver controlled fluid pulses through a specialized venous catheter. Restari describes the program as in late-stage clinical development and states that it is not approved by any regulatory agency. Public evidence reviewed includes preclinical rat research; a corresponding human trial identifier and results were not independently verified. MorCor, a full-core biopsy technology, is listed as coming soon.

In February 2026, Restari announced an exclusive license and commercialization agreement with AriBio for a small-molecule program targeting certain polycystic kidney and cystic liver diseases. The agreement provides rights in agreed territories outside AriBio’s retained regions and includes contingent milestone and royalty economics. It is not a financing round. Restari also describes discovery-stage kidney gene-therapy work; revenue, funding totals and named commercial deployments were not verified.

[8][11][12][13][14][16][17]

Leadership

5 people
Matt HedrickCEO and Co-founder [15]
Robert BacallaoChief Medical Officer and Co-founder [15]
John TimkoChief Commercialization Officer [15]
Eric FlachbartPump Executive Advisor and QMS Advisor [15]
Dirk HoynsDesign and Process Engineering [15]

Products & regulatory status How does MedTechIndex get this information?

Summary

Restari’s acute-kidney-injury device remains unapproved according to the company. No product-matched FDA marketing decision was established for that system or the MorCor biopsy technology. Its renal small-molecule and gene-therapy programs require separate drug/biologic review; another company’s Alzheimer’s trial is not evidence of Restari’s renal development stage. [18][12][1]

No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [5][3]

Regulatory snapshot How to read this snapshot

U.S. FDA
0
510(k) clearances
0
De Novo grants
0
PMA approvals
0
Recall events

Latest recorded source review: 2026-10-20.

Scope: selected product families.

Commercial portfolio snapshot

No commercially marketed product portfolio has been established in the reviewed material.

Commercial development

Investigational renal venous catheter and fluid-delivery system

Acute Kidney Injury device system ↗

Company-described system delivers controlled fluid pulses through a specialized venous catheter, intended to improve renal microvascular perfusion. [16][8]

Investigational / in development

Investigational. Company states late-stage clinical development; exact trial phase and human results not independently verified.

Biopsy tissue-acquisition device

MorCor full-core biopsy technology ↗

Full-core sampling technology in Restari’s announced biopsy portfolio, intended to collect larger, less fragmented specimens. Comparative claims rely on company data on file. [17][7][20]

Investigational / in development

Coming soon on current Restari biopsy page; completed launch and commercial availability not verified.

Investigational small-molecule therapeutic program

PKD / cystic liver disease small-molecule program ↗

Licensed AriBio program for certain polycystic kidney and cystic liver disease indications. Restari separately describes a once-daily oral development approach. [12][19]

Investigational / in development

In development under announced licensing agreement; no marketed renal or hepatic indication established.

Discovery-stage kidney gene-delivery program

PKD gene-therapy research ↗

Explores direct renal gene delivery using the AKI device platform. Website presents animal gene-delivery research as a technical foundation. [19]

Investigational / in development

Discovery-stage research, not commercially available.

Activity & Milestones

2 events
2026-02-04 · Licensing partnership

Exclusive AriBio license announced

Restari announced exclusive development and commercialization rights for a small-molecule PKD and cystic liver disease program in agreed territories outside AriBio’s retained regions. Terms include contingent milestones and royalties; no capital raise inferred. [12]

2022 · Company

Restari founded

Company founding year is 2022, corroborated by company-issued license announcement and LinkedIn. [11]

20 Cited Sources

Accessed 10/20/2026

[1] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record
[2] FDA De Novo database — research search ↗FDA / openFDA · regulatory record
[4] FDA PMA database — research search ↗FDA / openFDA · regulatory record
[6] FDA UDI database — research search ↗FDA / openFDA · regulatory record
[8] Hydrodynamic isotonic fluid delivery in rat kidney injury — author institution publication record ↗Khalifa University / Journal of the American Society of Nephrology · clinical publication
[9] Robert Bacallao faculty and research record ↗Indiana University School of Medicine · academic website
[10] Earlier reporting of AriBio license economics ↗The Asia Business Daily · news · Published 2026-01-23
[11] Company size, founding year and headquarters ↗Restari on LinkedIn · company website
[12] AriBio and Restari announce exclusive license agreement ↗Restari / PRWeb · press release · Published 2026-02-04
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