NovaSterilis

NovaSterilis NovaSterilis uses supercritical CO2 solutions to promote safe, innovative products and improve lives.

NovaSterilis is the global leader in the development and manufacturing of supercritical carbon dioxide (scCO2) processes for biomaterials and medical devices, including the decellularization and sterilization of allograft and xenograft tissues. At its core, NovaSterilis is a team of scientists, engineers, and business people committed to meeting our customers' needs through problem-solving. Our multi-disciplinary team of engineers, biochemists, and molecular and cellular biologists bring their broad and deep knowledge to every development challenge. We have the team, equipment, and processes readily available to provide scCO2 solutions that enable the implementation of manufacturing solutions that meet product safety requirements and performance and enable our partners to deliver safe, innovative products that advance patient healing and outcomes. With NovaSterilis you can count on a sterility assurance level 10-6, an environmentally friendly solution, shorter turnaround times, and more. Protect and differentiate your products with supercritical CO2.

EtO emissions constraints are reshaping   strategies and validation planning.Tony Eisenhut, CEO of NovaSterilis, evaluat...
02/23/2026

EtO emissions constraints are reshaping strategies and validation planning.

Tony Eisenhut, CEO of NovaSterilis, evaluates performance and scalability as an alternative.

Explore adoption barriers and infrastructure requirements for scCO2: https://bit.ly/3p7NnIS

Sterilization validation involves multiple pathways, data requirements, and regulatory decision points.Gaps in planning ...
02/19/2026

Sterilization validation involves multiple pathways, data requirements, and regulatory decision points.

Gaps in planning often surface late, increasing risk to timelines and submissions.

This checklist consolidates key elements needed for a defensible validation strategy. Download your copy: https://bit.ly/45f6wrW

High-intensity sterilization can damage devices produced under controlled, low-bioburden conditions.Overkill, bioburden,...
02/18/2026

High-intensity sterilization can damage devices produced under controlled, low-bioburden conditions.

Overkill, bioburden, or the combined sterilization validation method can be leveraged to preserve device performance while still meeting SAL requirements.

Strong Bioburden control processes give device manufacturers more flexibility when choosing sterilization validation strategies. Read more.

Conventional decellularization relies on harsh chemicals that compromise tissue structure and mechanics.Alternative appr...
02/16/2026

Conventional decellularization relies on harsh chemicals that compromise tissue structure and mechanics.

Alternative approaches must remove immunogenic material without degrading scaffold performance.

This study explores a combined protocol that achieves substantial DNA reduction while preserving integrity. Read more: https://bit.ly/4qllAOP

02/13/2026

Our ability to record a video inside the chamber during the sterilization process allows us to gather information about material interaction in real time.

These observations can link sterilization performance directly to material integrity and design decisions. https://bit.ly/3KkJnz8

How could visualization help you innovate safety, structure, and scalability?

NovaSterilis’ supercritical CO2 services include compatibility, optimization, and validation studies tailored to your sp...
02/11/2026

NovaSterilis’ supercritical CO2 services include compatibility, optimization, and validation studies tailored to your specific product.

scCO2 is a low-temperature and deep-penetrating process that supports sterilization, cleaning, decellularization, and functionalization. https://bit.ly/3D6AqCr

Sterilization remains a bottleneck for biologics with complex structures.Conventional heat, radiation, and chemical meth...
02/10/2026

Sterilization remains a bottleneck for biologics with complex structures.

Conventional heat, radiation, and chemical methods can disrupt protein stability and function.

Explore how scCO2 preserves functional integrity during sterilization: https://bit.ly/4cypoa1

The   enables bench-scale scCO2 processing for R&D and method development.The platform supports sterilization, cleaning,...
02/05/2026

The enables bench-scale scCO2 processing for R&D and method development.

The platform supports sterilization, cleaning, decellularization, and material compatibility studies.

Download our product guide to learn more: https://bit.ly/3LCCauw

  ensures microbial safety without compromising device or therapeutic performance.This article explains how validation s...
02/04/2026

ensures microbial safety without compromising device or therapeutic performance.

This article explains how validation strategies must adapt to meet the needs of sensitive, complex materials.

Learn about overkill, bioburden, and combined approaches within current regulatory frameworks: https://bit.ly/3TQ8QD0

With advanced modalities like  , manufacturers can bring sterilization in-house to reduce turnaround times from 2 weeks ...
02/02/2026

With advanced modalities like , manufacturers can bring sterilization in-house to reduce turnaround times from 2 weeks down to a few hours.

This means no longer slows down your workflow or supply chain.

NovaSterilis supports this shift by helping manufacturers integrate scCO2 efficiently.

Radiation and antibiotic washes force trade-offs between   and graft performance.However, clinicians desire terminal   w...
01/28/2026

Radiation and antibiotic washes force trade-offs between and graft performance.

However, clinicians desire terminal without compromising tissue structure or bioactivity.

Dive into how sterilization meets this demand:

Learn how supercritical CO₂ sterilization delivers terminal sterility while preserving tissue graft integrity to meet clinician demands.

Irradiation   can compromise structural and biochemical properties of amniotic membrane allografts.  sterilization is sh...
01/26/2026

Irradiation can compromise structural and biochemical properties of amniotic membrane allografts.

sterilization is shown to preserve growth factors at levels exceeding gamma and e-beam processed tissues. Read more: https://bit.ly/41nAd9L

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3109 North Triphammer Terrace
Lansing, NY
14882

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