Renovos Biologics receives FDA Breakthrough Device Designation for its synthetic nanoclay bone fusion gel, RENOVITE

Diagram of RENOVITE® BMP-2 an alternative to bone graft materials for interbody spinal fusion

Renovos Biologics receives FDA Breakthrough Device Designation for its synthetic nanoclay bone fusion gel, RENOVITE®

  • RENOVITE® BMP-2 is being developed as an alternative to bone graft materials for interbody spinal fusion
  • It is the first product based on RENOVITE®, Renovos’ novel nanoclay therapeutic delivery platform for precision regenerative medicine

Southampton, UK, 4 January 2024Renovos Biologics (Renovos) is pleased to announce that it has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) for its lead product, RENOVITE® BMP-2 (Bone Morphogenic Protein 2).


RENOVITE® BMP-2, based on a proprietary synthetic nanoclay gel, is in development as a safer and more effective alternative to currently available bone graft materials. The easy-to-use, injectable gel allows precise, localised bone formation at the target site. It contains BMP-2, a growth factor which promotes in-growth of bone forming cells. The nanoclay gel enables safe, highly-targeted bone fusion, as it does not leach BMP-2, with the gel biodegrading as new bone forms.


Dr Agnieszka Janeczek, Chief Executive Officer of Renovos Biologics, said:
“We are very pleased with the Breakthrough Device Designation from the FDA, being among just one hundred or so companies granted this designation in orthopaedics since the programme’s launch in 2015. This designation is a major milestone in our development journey. The accelerated regulatory feedback and prioritised review will shorten the time to market and allow faster access to expanded treatment options for patients suffering from degenerative disc disease.”


Michael Harris, Chief Executive Officer of Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for regenerating bone and managing infection in bone and soft tissue, and Renovos’ investor, said: “The granting of FDA Breakthrough Device Designation is a transformational step for Renovos, supporting its goal to rapidly develop and bring to market RENOVITE® – a next-generation drug carrier. At Biocomposites, our expertise in this field ideally positions us to support and enhance RENOVITE®’s progress towards pre-market approval.


The FDA’s Breakthrough Device Designation program is intended to help provide patients more timely access to medical devices which have the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions, by speeding up the development, assessment and review process. Breakthrough designation is only granted after preliminary evidence has been provided demonstrating a reasonable expectation that the device will provide significant advantages over standard of care. The designation will allow Renovos to have more frequent interaction with the FDA’s regulatory experts when preparing its submissions, followed by prioritised reviews.


Professor Richard Oreffo, Chief Scientific Officer of Renovos Biologics added:
“We are delighted our pioneering nanoclay product, RENOVITE® BMP-2, which provides unprecedented retention of therapeutics at the site of repair, has been granted Breakthrough Device Designation by the FDA. RENOVITE® BMP-2, the first product from our RENOVITE® platform technology, offers unprecedented opportunity for  localised directed tissue regeneration with ease of use, safety and retention providing a transformative solution to address debilitating orthopaedic spinal conditions for an increasing aging population.”


Find out more about RENOVITE® >>

Biocomposites invests in Renovos Biologics

Biocomposites logo

Biocomposites invests in Renovos Biologics –
developers of the RENOVITE® nanoclay therapeutic delivery platform

RENOVITE ® nanoclay is a novel therapeutic delivery platform for precision regenerative medicine

Investment will help fund pre-market approval for use in spine, trauma and orthopaedics

Biocomposites, CEO, Michael Harris will join Renovos Biologics Board of Directors

Keele, UK, 5 July 2023 – Biocomposites, an international medical devices company that
engineers, manufactures and markets world leading products for regenerating bone and
managing infection in bone and soft tissue, today announces it has taken a minority-share
interest in Renovos Biologics (Renovos), an innovative biologics company born out of
research into the properties of nanoclay at the University of Southampton, UK. Michael
Harris, CEO, Biocomposites will join Renovos Biologics Board of Directors.

Renovos’ lead product RENOVITE® is a synthetic, biodegradable nanoclay carrier that can be
used to place a wide range of pharmaceutical drugs and biologics at the site of treatment. It
can be injected through a 23-gauge cannula in support of minimally-invasive procedures and
sets into a stiff gel upon contact with physiological fluids, such as blood serum. As a cell-
responsive carrier it requires a lower dose of therapeutic drug to accelerate healing.

The investment from Biocomposites will allow Renovos to access Biocomposites’ expertise
and know-how in the development of drug carriers to progress RENOVITE® to pre-market
approval as a carrier for use in spine, trauma and orthopaedics. And in due course, provide
Renovos access to Biocomposites’ established, global distribution network.

Michael Harris, Chief Executive Officer of Biocomposites, commented: “The potential for
RENOVITE® as a next generation drug carrier that can enhance the activity of therapeutic
drugs at lower doses, whilst giving the surgeon much greater freedom to use in minimally
invasive procedures, is very exciting. Following on from our recent acquisition of Artoss in
June this year, and Subiton and Synimed last year, Biocomposites has established itself as
the go-to provider for surgeons requiring bone regeneration and/or managing infection in
bone and soft tissue.”

Dr Agnieszka Janeczek, Chief Executive Officer of Renovos Biologics added: “We have long
believed in the potential of RENOVITE® to overcome the challenges in tissue regeneration by
providing unprecedented retention of therapeutics at the site of repair. With the
opportunity to partner with Biocomposites, Renovos now have access to their deep
knowledge and expertise in drug developments, as well as their global distribution network
as products come to market.”

Contact for media enquiries:
Optimum Strategic Communications
Hollie Vile, Charlotte Hepburne-Scott, Zoe Bolt, Katie Flint
Tel: +44 (0)20 3882 9621

About Biocomposites

Biocomposites is an international medical device company that engineers, manufactures
and markets world leading products for use in infection management in bone and soft
tissue. Based in Keele, UK, it has global operations across Europe, USA, Canada, China and
India. Biocomposites is a world leader in the development of innovative calcium compounds
and polymers for surgical use. Its products regenerate bone and target infection risks across
a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine,
foot and ankle, podiatry and sports injuries. Biocomposites products are now used in over
120,000 procedures per annum and sold in more than 40 countries around the world.

Following the acquisition of Artoss GmbH, Biocomposites has acquired proprietary
NanoBone technology to its product portfolio, a combination of nanocrystalline
hydroxyapatite and silica gel – to provide optimal bone formation with easy handling.

Please visit to learn more.

About Renovos Biologics

Renovos is a regenerative medicine company and a specialist developer of RENOVITE®
synthetic nanoclay for medical use. Stemming from research at the University of
Southampton, UK, Renovos’ proprietary RENOVITE® technology greatly improves the
performance of a range of regenerative medicine products, with first targets in
orthobiologics. RENOVITE® presents a novel mechanism of action, offering unprecedented
retention of therapeutic agents at the target site of repair, mitigating their effects to a
precisely controlled area, creating a step-change improvement in their efficacy, safety and
ease of use, in biodegradable and injectable formulations, suitable for minimally-invasive

Please visit to learn more.

Professor Richard Oreffo contributes to Bone series as guest editor

R C Oreffo and diagram of article for Bone Series

A new series of articles covering scaffolds and applications for bone regeneration and tissue engineering has been published in a Special Issue “VSI: Bone Regeneration” in the journal Bone with Guest Editors, our co-founder Richard OC Oreffo and Jill Cornish.

As the editors state, the current unmet need for simple cost-effective approaches translatable to the clinic to replace bone lost as a consequence of age or disease emphasise the importance of skeletal tissue engineering. Nevertheless, despite extensive in vitro and in vivo work, few strategies have routinely translated into clinical practice. While skeletal tissue regeneration promises to deliver specifiable replacement skeletal tissues with significant health care benefits therein and socio-economic benefits, a number of challenges remain.

The series of articles collated cover recent developments in skeletal biology, skeletal cell populations, biomaterial design, 3D printing, and niche environments for bone reparation. The series also includes work detailing preclinical evaluation, translation, and emerging clinical strategies in tissue regeneration.

The issue is available on ScienceDirect via the following link:

Renovos wins Innovate UK’s Biomedical Catalyst funding!

Injectable Renovite gel for localised tissue regeneration

Renovos has been awarded a £692,472 Biomedical Catalyst grant from Innovate UK, the UK’s innovation agency*. Innovate UK funds businesses to accelerate promising innovations towards commercially successful products, in specific areas of interest that promote economic growth.

Musculoskeletal conditions are the leading contributor to disability worldwide, with the most common and disabling conditions such as arthritis, back and neck pain, fractures and injuries. Current bone healing agents are poorly localised and rely on very high doses which have been associated with some dangerous side effects such as excess bone growth outside of the skeleton, inflammation leading to tissue swelling and sometimes nerve damage when used in the spine.

Renovos provides a novel solution that can address the current limitations of localising bone agents/biologic factors at the site of repair, improving their safety and efficacy. RENOVITE® is injectable and enables the use of bone-healing agents in a more precise, localised manner, and – thanks to strong retention – at a significantly reduced dose. Renovos’ compelling pre-clinical data shows that these agents are only released upon contact with regenerating cells, so they can enhance healing in a more targeted manner to improve outcomes with greater safety, efficacy and at a lower cost. The project “RENOVITE® – regenerative nanoclay for orthobiologic applications” will deliver further pre-clinical development in models aligned with clinical applications and accelerate the regulatory path.

Agnieszka Janeczek, CEO of Renovos Biologics said: “We are thrilled that our RENOVITE® nanoclay gel technology has once again been recognised by the Innovate UK experts. As pioneers of nanoclay gels for tissue regeneration, we are excited about this funding and the progress in development it will allow us to achieve to get closer to the clinic.”

Renovos ultimately anticipates its products based on the RENOVITE® platform will provide novel solutions for bone fusion procedures and difficult to treat fractures, benefiting the increasingly active younger demographics, requiring tissue regeneration, as well as the progressively ageing population.

If you are interested in supporting Renovos’ vision, please get in touch. 


* Innovate UK drives productivity and economic growth by supporting businesses to develop and realise the potential of new ideas. We connect businesses to the partners, customers and investors that can help them turn ideas into commercially successful products and services and business growth. We fund business and research collaborations to accelerate innovation and drive business investment into R&D. Our support is available to businesses across all economic sectors, value chains and UK regions. Innovate UK is part of UK Research and Innovation. For more information visit

How Renovite nanoclays open up new opportunities in regenerative medicine

nanoclay injected into spine

For anyone pioneering a new technology in regenerative medicine, it’s not long before you are asked what it is that sets your tech apart from the rapidly growing number of other competing technologies out there. It’s an important question because, like many areas of exciting opportunity, the research field of regenerative medicine has experienced explosive growth over the last couple of decades.

I think it is important to understand, however, what has driven this growth. Technological growth sometimes happens because new enabling innovations have come about which mean solutions that were, before, technically very challenging or even impossible, have suddenly become much more possible. Think of the tantalising medical possibilities of AI or CRISPR-Cas9 gene editing, for example. In this case an explosion of innovation occurs because something that was previously very hard has become (or, at least, appears to have become) considerably easier and more accessible.

Other times, almost the mirror image applies. Innovation happens because a compelling opportunity we originally thought to be within reach, turns out to be rather more elusive than we first imagined. In this situation, while the power of the idea continues to attract innovators and entrepreneurs, new technologies arise because earlier efforts at realising the potential opportunity fall short.

The innovative drive around regenerative medicine and biologics would seem to fall into this second category. The simple concept at the heart of regenerative medicine – that by activating the potential of stem cells we can regenerate diseased and damaged tissues – may have proven to be harder than we first thought, but the idea lives on and continues to inspire new concepts and technologies.

Renovite nanoclay provides, we believe, an elegantly simple and low-cost enabling technology with real potential to unlock the long-awaited promise of regenerative medicine.

The fundamental challenge facing regenerative medicine has always been the need to bridge the gap between the biological context of the stem cell and the clinical context of adult health care. As increasingly elaborate technologies have been developed to address the demands of biological complexity, the associated increase in cost, regulatory hurdles and technicality has meant that the gap between the stem cell and the clinic has seemed to grow rather than shrink as science has progressed.

Renovite nanoclay has unique potential to bridge this impasse in ways that other technologies have not been able to. The following features stand out:

  • Renovite is synthetic – The mineral formulation of Renovite allows for low-cost manufacture and sterile processing.
  • Renovite is biocompatible – Renovite gels can be degraded by cells and processed by the body.
  • Renovite is versatile – Renovite can be delivered as a gel, applied as a coating, complexed with polymers as a nanocomposite or combined with graft material as a carrier.
  • Renovite is injectable – Renovite spontaneously sets into a stiff gel by complexing with proteins in the blood allowing for minimally invasive outpatient interventions,
  • Renovite is bioactiveRenovite’ s unique gelation properties also serve the complex demands of biology by stabilising a protein-rich environment proven to foster cell invasion and remodelling.
  • Renovite enhances biologicsRenovite’s ability to bind biological molecules allows for dramatic enhancements in efficacy and safety profiles and opens up new applications for delivery of growth factors, drugs and antimicrobials.


nanoclay injection

Renovite nanoclay has the potential to make the complex simple and drive new innovations in regenerative medicine. Since pioneering nanoclay gels over a decade ago with our first publication on “Clay gels for the delivery of regenerative microenvironments”, there has been significant growth in the use of nanoclays in biomaterial design. In a 2013 progress report on the opportunities nanoclays present we uncovered only a small handful of studies exploring the use of clay in this context. This review has now itself been cited over 200 times as more research groups have begun working on nanoclay all over the world.

Renovite represents the first clinical grade nanoclay manufactured for biomedical application. These are exciting times for Renovos. By bringing nanoclay to the clinic we hope to see renewed growth in the regenerative medicine sector as new, previously unrealised, opportunities for harnessing the potential of stem cells in healthcare begin to open up.

If you are interested in supporting our vision, please get in touch. 


By Jonathan Dawson

Nanoclays and regenerative medicine: a journey towards the clinic

Renovite cells

What role could clay play in the biomedical field and why is Renovos Biologics focussing on this industrial-type material for cutting edge regenerative medicine technologies? It is an interesting question, after all, clays are mainly used for making things like paint or cosmetic formulations. And those applications seem far removed from the highly regulated world of medical products and devices.

Before shedding light on the surprising promise of nanoclay, let me tell you a bit of my background and my involvement in Renovos.

I am a materials scientist. I always envisioned myself diving into those fundamental questions that only research can approach. That vision for exploration and inquiry later evolved into the application of new biomedical materials to improve quality of life. As a basic materials scientist with an interest in biomedicine, I could not help but wonder how to get the best of both worlds.

And that is why I became involved with Renovos, where bringing my experience with cells and novel biomaterials to target tissue regeneration would have a translational value and make a difference to people’s lives.

At Renovos, we are developing a product portfolio based on a synthetic nanoclay gel platform, Renovite®. Renovite® gels can localise and retain biologics at ultra-low doses to promote tissue regeneration. We discovered that the physicochemical properties of nanoclays are extremely well-suited and sought for in biomaterials (you can learn more about it from our previous post by Allison and our technology site). Nanoclay particles spontaneously form a gel in the body that binds biological molecules and provides a scaffolding for cell growth. These exciting properties open up a wide range of regenerative medicine applications encompassing drug-delivery, stem-cell therapy, wound repair and infection control!

Renovite diagram

Let me explain the example of bone growth and repair. Now here come a couple of questions that I had before working with nanoclays:

1) Why is nanoclay a good candidate for tissue regeneration?

2) How does nanoclay offer an advantage when combined with biological molecules?

To answer the first question, the high affinity of nanoclay particles for proteins is key. When injected into the body, nanoclay particles form a gel network that binds proteins from the blood – a bit like in a blood clot. This protein-rich nanoclay network provides a matrix for cells to grow into and remodel into new tissue. Because Renovite® nanoclay is biocompatible, specialised cells can safely degrade the gel over time as new tissue forms.

This links quite well with the second question. Again, the advantage lies in the ability for nanoclays to bind proteins. Besides, the gels retain the biologics until they have degraded. Therefore, Renovite® nanoclay gels are able to safely localise potent biological molecules that stimulate bone formation. This reduces the side-effects of these molecules outside the gel whilst simultaneously enhancing their activity within the gel, allowing for ultra-low doses. It all implies that we can use Renovite® nanoclay gels in combination with these biologics to safely and reliably repair bone.

This is where my job comes in. I verify that our products are safe and effective by validating this technology in various assays and models. Have a look at Renovite® loaded with a biomolecule and ready for addition to cells in culture!

Renovite cells

Ultimately, we want to reach those who may benefit the most. For instance, patients suffering from musculoskeletal conditions or microbial infections in orthopaedics impairing tissue repair.

Although the journey to the clinic is not an easy ride, it is certainly an exciting one! And anything that serves to improve the treatment of health conditions sounds worthwhile to me!

Juan at Renovos

By Juan Aviles Milan

Chemistry? Clays? Isn’t this a biologics company?

lab in sunlight

I’m a chemist working on clay for a biologics company.

That may well sound like a juxtaposition. Add to that the fact that the biological application isn’t to do with creatures in the environment, but rather regenerative medicine, and you may well be raising an eyebrow or two. Let me explain…

Clay from the ground has been used for thousands of years for a variety of applications including pottery and topical skin treatments. Indeed, the Ancient Egyptians used clay as an antiseptic!

‘Clay’ refers to a huge group of largely silica-based materials, which are comprised of long chains sitting together to form layers. This confers highly attractive properties such as being highly ab- and adsorptive, having a low permeability, and being malleable when wet but solid when dry. This means that clays can be used in applications from drying pearls used within packaging, to carbon dioxide capture, but also many others in between.

Furthermore, clays have good cation exchange capability, which just means that parts of the clay can be substituted out and replaced by species such as drug molecules. (See an upcoming blog post by Juan for more information on this!)

However, clays from the ground also contain a mixture of minerals and metals depending on where exactly you have found the clay and this variable is far from ideal, especially when considering medicinal applications. Fortunately, it is possible to synthesise clay in a laboratory to control for such things and create a highly reproducible product with no batch-to-batch variability.

At Renovos, we have developed a synthetic clay, Renovite, which has nano-sized particles. This makes Renovite a nanoclay. If you’d like to read more about this, check out and we’ll also come back to this in a future blog post, so stay tuned! At the top of this page there’s a photo of the laboratory set up, making some Renovite in the evening sunshine.

Renovite looks like fine sugar (no photo necessary as I am sure you all know what that looks like!) but when added to an aqueous solution, it forms a gel with some very interesting and useful properties.

The gel is as clear as water but also thixotropic, which basically means it is like ketchup – it can be piped into position and holds the form in which it was placed. This means that the gel can be injected into the desired site and relied upon to remain there, thus allowing localised drug treatment. The gel then gets gradually biodegraded and replaced with regenerated tissue.

Here’s a photo of the gel, I’m holding it upside down to demonstrate that it is acting like a solid:

Gel as a solid

And here’s a video demonstrating the thixotropic nature:

I joined Renovos having worked with clays for a couple of other applications but nothing quite like this.

I am excited by the application and believe Renovite creates an excellent scaffold for medical treatments in regenerative medicine. To me, the research and development motives for localised treatments are clear – improved patient safety and prognosis.

That’s why I joined Renovos. That’s how a chemist can be developing nanoclays for a biotech company and be very excited about it all!

Alison Shaw at Renovos lab

By Allison Shaw

Renovos wins Innovate UK SMART grant


We are excited to announce that we have launched another project funded by Innovate UK!

Renovos won funding via the highly competitive SMART competition run by Innovate UK, the UK’s innovation agency*. SMART grants fund ambitious or disruptive R&D innovations that can make a significant impact on the UK economy.We are delighted that our innovation has been recognised by the Innovate UK experts.

In collaboration with our partners from University of Southampton, the project “Renovite – pioneering use of synthetic nanoclays in regenerative medicine” will deliver further development of the Renovite nanoclay technology platform and accelerate its path to regulatory approval.

We are excited to start another Innovate UK-funded project and look forward to updating you all on our progress in the near future!


* Innovate UK drives productivity and economic growth by supporting businesses to develop and realise the potential of new ideas. We connect businesses to the partners, customers and investors that can help them turn ideas into commercially successful products and services and business growth. We fund business and research collaborations to accelerate innovation and drive business investment into R&D. Our support is available to businesses across all economic sectors, value chains and UK regions. Innovate UK is part of UK Research and Innovation. For more information visit

Renovos Biologics has appointed Patrick O’Donnell as Advisor to the Board

Patrick O'Donnell

Patrick O’Donnell

Previously a General Manager and Executive Vice-President of North America for BoneSupport A.B.,  CEO at Proteothera, Inc, Histogenics Corporation, Prochon-BioTech, and in commercial roles of escalating management responsibility at Confluent Surgical Inc. and J & J DePuy-Spine, Patrick has a wealth of experience in the medical device, biologics, and biomaterials industries with technologies in the orthopedic, spine, neurosurgery, sports medicine, interventional radiology markets.

As an executive officer of biosurgery and medical device companies, he has created the strategy, built and led the commercial organizations, and raised capital (over $80M) to fund and execute the product development and clinical programs towards regulatory milestones.

With a passion for outstanding technologies in the orthobiologics space, Patrick will contribute to Renovos’ strategy for nanoclay commercialisation.

It is exciting for Renovos to welcome someone with such experience and enthusiasm for our Renovite nanoclay technology and we are looking forward to not only working with Patrick but also to the advances we can make with his support.

Three new nanoclay publications out this year!

Nature Communications magazine featuring Renovos

Key read for nanoclays in drug delivery – group’s new publication on nanoclay in Nature Communications! The paper, which can be found here, reports on the use of bisphosphonate interactions with nanoclay edges to make drug-loaded composites without compromising materials properties or drug loading, which has been a common trade-off to date.

The Biofabrication paper, which can be found here, presents the in vitro, ex vivo and in vivo investigation of bioprinted skeletal or mesenchymal cells encapsulated in a nanoclay-based bioink. This produces viable and functional three-dimensional constructs for clinically relevant skeletal tissue regeneration.

Complexities of bringing small scale stem cell and scaffold therapies to a clinically relevant model, with an example of an ovine condyle defect model, are described in the Biomaterials publication, which can be found here. The study reports on the enriched ovine skeletal stem cell population (Stro-4+) and its efficacy for bone formation using a novel biocompatible melt electro-written medical grade polycaprolactone scaffold.